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11857384 | DETAILED DESCRIPTION OF THE INVENTION Turning descriptively to the drawings, in which similar reference characters denote similar elements throughout the several views, the figures illustrate dental device having motor that drives a tool, wherein the tool is activated or otherwise controlled in response to a load placed upon the motor through the tool, such as by touching the tool to a surface. A motor-driven dental handpiece such as a rotary prophy handpiece delivers power as speed×torque. Ordinarily in the conventional art, the motor speed is regulated, even if only approximately—the speed is either maintained under load or it drops. The practitioner then can demand more or less power by applying more or less force between the rotary instrument and the tooth (or dental appliance, etc.) This force, by the nature of the rotary instrument, in turn applies more or less load (torque) to the motor. According to the present invention, instead of regulating the speed to a constant value under varying load, the speed is increased in response to increasing load. The increase can be in as few as two steps, on/off, or many steps, or in some constant or variable proportion to the load, or any combination of these, as appropriate to the application. For example, a prophy handpiece could idle at a very low speed, 300 rpm exemplified in the chart ofFIG.1, well below what would cause spatter. It could remain at this speed until the applied load increases, above what is seen when loading prophy paste, to the still higher values encountered in DPA prophy procedures. At that point, the speed could jump from idle speed to cleaning speed, even a speed that increases with increasing load. The instant the load is removed, the speed could drop back to the low idle speed. In another embodiment of the invention, an ultrasonically driven tool such as used with a Cavitron brand ultrasonic scaler (available from DENTSPLY International of York, PA) that controls for stroke could idle at a very small stroke, barely perceptible to the user but enough to return sufficient feedback to the controller to determine if a load were applied, if the tip touched a tooth or other work surface. At that moment, the commanded stroke would be increased to the working value and remain until the load were removed and scaling were at an end. A benefit of this approach according to the present invention is that as the motor output (speed, stroke, angle, frequency, etc.) will increase as needed, the idle speed can be very low. It will be appreciated that the present invention provides a motor-control profile that increases the controlled output (speed, stroke, angle, etc.) with load (torque, etc.). It will be appreciated therefore, that the present invention may be embodied, then, in an electrically-operated handpiece, even an ultrasonic scaler, even when the only control available is on-off. It can also be embodied in an air motor, such as a high-speed dental handpiece, when motor speed can be monitored and the air driving the motor controlled. A powered instrument, such as a dental handpiece, that incorporates this innovation can be made simpler and less expensive, more responsive, safer, more reliable, and to last longer on a battery-charge. No extra devices, such as a foot pedal, push button, or pressure or force sensor, is needed to adjust the output (speed, angle, stroke, etc.) to suit the clinical need of the moment. This simplifies equipment requirements and reduces cost. By eliminating the delay in the practitioner continually adjusting energy delivered, the instrument is made more responsive to the practitioner, with clinical effect that more accurately reflects the clinical requirement, and in less time. Particularly for a rotary prophy handpiece, the spatter of prophy paste is a nuisance but also a serious source of cross-contamination. But, the more quickly the motor is stopped after it is done working, the less spatter of prophy paste occurs. In making this automatic in the present invention, such a handpiece minimizes spatter. Idling only at a low output and increasing output only to what is required in response to demand, such an instrument can be made more reliable, subjected as it is to less wear-and-tear; safer, by generating less heat; and, longer lasting, by minimizing battery-drain, etc. It will be appreciated that the present invention can be applied to any medical or dental instrument, whether electrically or pneumatically powered, or rotary (low-speed or high-speed), reciprocating (rotary or longitudinal) or oscillating (sonic or ultrasonic), or the like. It can also be applied to powered tools of many kinds, such as a cordless drill, screwdriver, or saw. Turning to the figures,FIG.1, is a chart showing speed-vs-load (torque) for a load applied to the motor; a corresponding speed can be found, a speed at which the motor will run steady-state. The present invention as represented on the chart, is an example of a speed response to load for an embodiment in an electric prophy handpiece. At loads below 0.5 ozf·in, the motor response is a speed of about 300 rpm. As load increases, speed also increases. FIG.2is a flow-chart exemplifying an embodiment of the operation of the present invention. FIG.3shows the general structure of a prophy handpiece according to the invention comprising an Inner Module10, Outer Sheath8, disposable prophy angle6, cordless Foot Pedal12with LEDs13, Charging Base11, grip7, and a power supply (not shown). The inner module is partially covered by the outer sheath8. The inner module detachably engages with the disposable prophy angle6and the grip7allows the user to hold onto the handpiece. A foot pedal12is not needed but may be used preferably when the inventive motor control feature is disabled. A pushbutton9allows for activating the inner module. FIG.4is a side view illustrating the inner module10which comprises a front end23, and a back end24. FIGS.5-10show different views of the housing of the front end23of the inner module10. The nose1receives a disposable prophy angle6. A snap ring2allows the outer sheath to snap tightly onto the inner module. The proximal end3houses an overmolded seal4which prevents ingress of fluid into the inner module. A latch5allows for connection to the back end24of the inner module. The outer sheath8and inner module10have a plurality of seals to prevent the ingress of fluids. The outer sheath seals are illustrated inFIG.11which shows an outer sheath8with a proximal end and a distal end wherein the distal end has a drive which includes a standard o-ring seal14to allow for simultaneous sealing and rotation between the drive and the housing of the sheath. A low drag seal15allows for the internal components of the drive to spin without any fluid ingress.FIG.13illustrates the seals of the inner module10. A tight seal17is formed between an end cap and the plastic body of the front end23of the inner module. Another tight seal18is formed between the end cap and motor of the inner module. Seal19(showing cross sectional views of seal4) is formed between the front end23and back end24of the inner module. In addition, an overmolded button seals, preferably in a cohesive manner, a hole in the back end20of the inner module while a window21seals a hole in the back end of the inner module. In an alternate embodiment of the inner sheath housing,FIG.15, a hole25running through the housing allows for drainage of fluids that enter from the nose1of the inner module when detached from the outer sheath, for example, during spraying of the inner module.FIG.14shows a side view of the inner module illustrating a charging contact22sealing a hole in the back end24of the inner module. Elastomers (not shown) may also be used in the inner module to create compression seals that keep fluids outside the module. Those skilled in the art will recognize that many variations of seals to prevent the ingress of fluids are possible within the spirit and scope of the invention.FIG.16A-FIG.16Billustrate perspective views of a detailed design of the components of the outer sheath assembly26whileFIG.16. C illustrates a cross-section A-A of the detailed design of the components of the outer sheath assembly26. Another handpiece embodying the invention may preferably comprise a cordless inner module, outer sheath, DPA, cordless foot pedal, charging base, handpiece cradle, and a power supply as shown in theFIG.19. The inner module may further comprise a motor, gear box assembly, a printed circuit board (PCB) with a wireless communication protocol and a rechargeable battery. The foot pedal may also be composed of a PCB with a wireless communication protocol and a rechargeable battery. A DPA for the cordless prophy handpiece may be designed as part of the closed system to spin smoothly. The speed of the DPA cup is controlled by the motor control as disclosed in the invention, where a preset polishing speed is reached when the DPA touches the tooth, thus reducing or eliminating the need for constant use of the foot pedal. It should be noted that the polishing speed may increase in steps, up to a preset maximum speed, as the torsional load increases. Accordingly, the polishing speed may decrease in steps, down to an idle speed, as the torsional load decreases.FIG.20shows an example speed-torque relationship of an embodiment of the invention. At the completion of a procedure, the DPA is disposed of. The inner module is preferably rechargeable and houses the motor control circuitry. In a preferred embodiment, the prophy handpiece may have a button and an indicator to trigger and indicate the current state of the motor control. Where a foot pedal accompanies the motor control feature in a handpiece, standard synchronizing means may be used to synchronize the use of the motor control and the pedal wherein the pedal may, for example, override the motor control when pressed and the motor control may override the pedal when activated by the button. The motor control feature may work in conjunction with a cordless foot pedal through a secured RF protocol. In another preferred embodiment, the motor control feature allows the operator to control the motor speed to allow the application of a paste to the DPA with a preset slow rotational speed, a torque dependent motor speed, or no rotation. In a further preferred embodiment the torque-response mode operation allows the motor to accelerate or decelerate in a controlled rate to reach one of a plurality of preset polishing speeds when the DPA touches or is removed from the tooth, with the preset speed depending on the torsional load exerted on the motor, a time delay and a hysteresis current threshold. In another preferred embodiment, the inner module may enter a low current mode after, for example, 60 seconds of non-operation and automatically shut down to conserve energy. The handpiece may also “wake up” from a low current mode when the handpiece is picked up through the use of conventional accelerometer means which sense accelerative forces and translate the forces to changes in velocity and/or orientation. Other modes such as a “sleep” mode may be incorporated after long periods of non-operation, for example, 1 hour. Furthermore, the inner module may have a shutdown switch that may preferably override the different modes in the handpiece. In a further preferred embodiment, a start time delay is observed after which the systems activates the motor and sets a no load idle current. This calibration may be needed to give a frame of reference with which to compare increasing and decreasing currents. FIG.17illustrates an overall implementation incorporating the concepts described herein. When the motor control (referred to as “torque-response mode”) button is pressed102, the motor is turned on with an initial speed equal to an idle speed104. The idle speed is preferably a preset value and the no load motor current corresponding to the idle speed is obtained as part of a startup calibration of the handpiece. This allows zeroing out the motor current generated by the drive system friction (i.e. friction generated by the motor itself, gearbox, outer sheath and DPA). A preset time delay106is observed before the motor current, I motor, is measured. A predetermined hysteresis constant is used in the determination and update of an upper hysteresis limit current (I_Hyst_Upper) and a lower hysteresis limit current (I_Hyst_lower). For example, if the hysteresis constant is 10 mA and motor current, I motor, is 50 mA, I Hyst Upper is 60 mA, and I_Hyst_lower is 40 mA. If I motor changes to 70 mA, then I_Hyst_Upper is 80 mA and I_Hyst_lower is 60 mA. As shown in108-120, if the measured motor current is greater than I_Hyst_Upper, as witnessed, for example, when the DPA cup makes contact with a tooth, the speed of the motor is increased as desired. The speed correlates with the amount of torque exerted on the motor by the application of the DPA to a surface (i.e. tooth) as shown inFIG.25. The application force of the DPA generates a thrust friction between the DPA cup or brush and the surface intended to be polished. This thrush friction is translated into a torsional load on a short gear of the DPA, which then transfers this torsional load into a long gear, then onto a drive dog in the outer sheath, which is mechanically coupled to the gearbox that then transfers the torsional load directly to the motors drive shaft. This torsional load opposes the motors ability to rotate freely dampening its speed. The new speed is maintained by the PID control loop. Alternatively, if the measured motor current is less than I_Hyst_lower, as witnessed for example when the DPA cup is removed from contact with a tooth, the speed of the motor is decreased as desired. The new speed is thus maintained by the PID. FIG.18illustrates an embodiment of the present invention wherein the motor control apparatus operates in turn with a foot pedal and wherein the foot pedal operates only in Bluetooth mode. After turning on the handpiece200, the system is put in Bluetooth mode202. The system checks if the handpiece is charging206and deactivates the motor accordingly208. When the handpiece is not being charged, a short button press216causes system to verify if Bluetooth mode is still on224. If not, torque-response mode button has been pressed and this torque-response mode228is made available to the user. Torque-response mode refers herein to a mode employing the motor control feature of the invention. Preferably, the foot pedal operates only when blue tooth mode is active. Furthermore, a long button press may signify a power system shut down request220. FIG.19is a perspective view of a prophy handpiece employing the motor control technology of the present invention. An outer sheath306detachably engages with a cordless inner module302of the handpiece. The inner module houses the circuitry of the rotary handpiece. A mode indicator312may show the current mode of operation of the handpiece. An on/off/mode button308may be used to power on the handpiece or toggle between modes. A charging base310and charge indicator314may show the amount of charge accumulated. A cradle316for the handpiece as well as a wireless foot pedal318may be used with the handpiece. When the dental practitioner powers on the handpiece, it is first calibrated to attain a baseline motor current and a corresponding motor idle speed. Any pressure applied to the prophy cup is transmitted through a drive dog to the handpiece motor to increase the speed above the idle speed. The rotational speed of the DPA cup is manageably controlled by the dental practitioner by exerting increasing pressure over a time period, for example 1 second, between the DPA cup and tooth to increase the speed of rotation of the cup and releasing pressure, over a time period, for example 1 second, between the DPA cup and tooth to decrease said speed. A foot pedal may override the motor control mode through a mode switch button or by simply pressing on the foot pedal. After a predetermined time of no use, the handpiece can automatically shut down or go into rest mode. In an embodiment, a maximum motor speed above which speed cannot increase may be observed. In this case, further torsional load on the motor may preferably cause the motor speed to gradually decrease to zero or to the idle speed. FIG.20shows a chart illustrating a speed-torque performance for the embodiments of the invention. The system maintains selected cup speeds within, for example, the range of 300 RPM to 3200 RPM as torques vary between 0.5 to 1.3 ozf-in. Performance may not be required at speeds below, for example 300 RPM. It should be clearly understood that figures shown are set forth by way of illustration only and are not meant as limitations. Accordingly, different performance characteristics may be incorporated in an actual device. FIG.21is a high level block diagram showing an example configuration of a motor control apparatus. According to this embodiment, the apparatus, a wireless prophy handpiece, is powered from a battery418which is charged via an external 5V DC power supply and an internal charging circuit. The battery is protected from discharge during via a button controller426and P-FET420which are used to disconnect the battery from the circuitry of the main controller board. The Lithium Ion battery cell provides a wide range of DC voltages depending on its state of charge. To provide regulated DC power a voltage regulator is used. To drive the motor at the desired RPM a DC-to-DC booster428is used. This boosted DC voltage drives the motor434through an H-Bridge432and current sense chip430. The H-bridge432uses PWM signals from the microprocessor416to regulate speed based on foot pedal position or torque-response mode state. The current sense chip430provides a signal back to the microprocessor416that provides a measurement of the current being delivered to the motor. The microprocessor may be equipped with a wireless radio; an example wireless communication protocol can be blue tooth low-energy (BLE). The BLE radio provides wireless communication between the handpiece and the foot pedal. In a preferred embodiment, the main controller board may be equipped with sensors such as a temperature sensor410and accelerometer412, the output of which may provide signals to control the motor434. The temperature sensor may monitor, for example, the internal ambient temperature of the inner module. The accelerometer may be used by the microprocessor416to determine the state of the handpiece. For example, the device may enter a sleep mode if it is inactive for 60 seconds, wherein the motor speed is reduced to zero. The accelerometer may also be used to wake the device up from sleep mode. The microprocessor416may communicate with the Fuel gauge422, temp sensor410, and accelerometer412, charger404and H Bridge432. An A to D converter to take measurements of the motor current from the current sense430and the motor's back-emf. The motor speed is controlled via a PID loop. Motor voltage may be, for example, be determined by brief periods that permit the motor to idle so that a Back-EMF voltage generated by the motor's speed can be monitored. The Back-EMF voltage provides motor speed information to the microprocessor. Motor current is interpreted by the microprocessor as torque loading of the drive mechanism. Motor current is used during torque-response mode to determine when to alter the motor speed. The sensed motor current may also be used to shut down the unit if the user applies a high torque for too long a period of time. It will be appreciated therefore, from one of ordinary skill in the art, that the present invention may be embodied, then, in an electrically-operated handpiece, even an ultrasonic scaler, even when the only control available is on-off. It can also be embodied in an air motor, such as a high-speed dental handpiece, when motor speed can be monitored and the air driving the motor controlled. In further embodiments, there may be a plurality hysteresis threshold and time delay values which may be predetermined or not predetermined and varied as desired to achieve appropriate motor speed control. What has been described and illustrated herein is a preferred embodiment of the invention along with some of its variations. The terms, descriptions and figures used herein are set forth by way of illustration only and are not meant as limitations. Those skilled in the art will recognize that many variations are possible within the spirit and scope of the invention in which all terms are meant in their broadest, reasonable sense unless otherwise indicated. Any headings utilized within the description are for convenience only and have no legal or limiting effect. | 20,862 |
11857385 | EXAMPLE Although the present invention will be specifically described below on the basis of Examples and Comparative Examples, the present invention is not limited to the following Examples. The materials used are shown below. <Compound> Photocurable monomer; Methylmethacrylate, Urethane dimethacrylate, 2,2-bis(4-methacryloyloxypolyethoxyphenyl)propane (hereinafter, abbreviated as D-2.6E), Trimethylolpropane trimethacrylate. Photopolymerization initiator (absorption wavelength effective for initiation of polmerization); Bis(2,4,6-trimethylbenzoyl)phenylphosphineoxide (ultraviolet to 420 nm) Camphorquinone (450 to 490 nm) Reducing compound; 4-(N,N-dimethylamino)ethyl benzoate Filler; PMMA (molecular weight of 100,000 to 400,000): manufactured by Negami Chemical Industrial Co. Ltd., D250ML, average particle diameter of 36 μm <Artificial Tooth> Acrylic resin artificial tooth; Commercially available artificial tooth: New Ace Anterior and Million Posterior (manufactured by YAMAHACHI DENTAL MFG., CO.) Custom artificial tooth: custom artificial tooth with a projecting shape (edge structure for snap fit) having a height of 1 mm connected around the side surface of the artificial tooth on the basis of the shapes of New Ace Anterior and Million Posterior Three-dimensional data of the custom artificial tooth was created by using a model scanner (manufactured by Dental Wings Inc., 3 series) to acquire three dimensional data of New Ace Anterior and Million Posterior and giving a projecting shape having a height of 1 mm so as to be connected at a position of 1 mm from the basal place of the artificial tooth of the obtained three-dimensional data. A resin disk formed of PMMA (manufactured by YAMAHACHI DENTAL MFG., CO., Product name: Resin Disk) was set in a milling machine DWX-50 (manufactured by Roland DG Corporation.), the resin disk was cut on the basis of the three-dimensional data of the custom artificial tooth, and a custom artificial tooth having an edge was prepared. <Design of Plate Denture and Method of Creating Three-Dimensional Data of Denture Base> The design of a maxillary plate denture for preparing a maxillary plate denture and three-dimensional data of a maxillary denture base were created as follows. A mandibular model (including 14 teeth) that matches with a maxillary edentulous model was prepared, and a model scanner (manufactured by Dental Wings Inc., 3 series) was used to acquire three-dimensional data of the maxillary edentulous model and the mandibular model. Further, a model scanner was used to acquire three-dimensional data of the artificial teeth (anterior teeth and posterior teeth, 14 teeth in total) to be used. After arranging the three-dimensional data of 14 artificial teeth at the ideal position with respect to the obtained three-dimensional data of the maxillary edentulous model, the position of the artificial teeth data arranged on the maxillary edentulous model is adjusted such that the three-dimensional data of the mandibular model and all the artificial teeth are engaged with each other, a denture base shape was given in accordance with the edentulous mucosal surface, and three-dimensional data of a plate denture (full denture) was created. Finally, the shape data of the artificial teeth was deleted from the three-dimensional data of the plate denture (full denture) to create three-dimensional data of a maxillary denture base including an artificial-tooth-arrangement recessed portion. The evaluation method is shown below. <Evaluation of Plate Denture Preparation Time> The total time of the denture base preparation time, the cleaning process time, and the artificial tooth adhesion or preparation time was used as the plate denture preparation time, and the lengths of the times were compared with each other. (Plate Denture Preparation Time) The time during which a 3D printer or a cutting machine had been actually driven when modeling a denture base by stereolithography or cutting was used as the denture base preparation time. (Cleaning Process Time) The time required for the cleaning work was used as the cleaning process time. In the case where there was no cleaning process, it is described as none. (Artificial Tooth Adhesion or Preparation Time) The time required for applying an adhesive (only when necessary), arranging artificial teeth, and performing polymerization work for adhering the artificial teeth to/on the modeled denture base or for performing stereolithography of artificial teeth on the denture base was used as the artificial tooth adhesion or preparation time. <Evaluation of Occlusion of Plate Denture> The occlusion of a plate denture was evaluated by visually observing the occlusion between the plate denture (maxillary full denture) and the mandibular model in accordance with the following criteria. A: Very good. All the artificial teeth of the maxillary full denture are in occlusal contact. B: Good. Eight or more artificial teeth of the maxillary full denture are in occlusal contact and rattling does not occur. C: There is partial rattling. Four to seven teeth of the maxillary full denture are in occlusal contact and slight rattling occurs. D: There is a lot of rattling. Three or less teeth of the maxillary full denture are in occlusal contact and rattling occurs with two occlusal contacts as fulcrums. <Evaluation of Adhesion Between Artificial Tooth and Denture Base> A test piece for adhesion evaluation was prepared by the method described in Examples, and the adhesiveness thereof was evaluated. The evaluation of adhesiveness was performed by the following method. A hole was formed in the center of the right central incisor of the plate denture (maxillary full denture) in advance, an S-shaped hook was attached to the tooth of the test piece obtained above, a weight of 10 Kg was put thereon, and the degree of adhesion when the denture base was pulled up by hand was evaluated in accordance with the following criteria. A: It cannot come off even if it is pulled for 30 seconds or more. B: It comes off if it is pulled for 30 seconds. C: The artificial tooth came off immediately. Example 1 A maxillary plate denture was prepared as a plate denture. First, the photocurable composition for stereolithography described in Table 1 was used to perform stereolithography of the maxillary denture base data obtained by designing in accordance with commercially available artificial teeth by the method of designing a plate denture and creating three-dimensional data of a denture base described above using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm) to prepare a maxillary denture base having a recessed shape for arranging artificial teeth. After that, the obtained denture base is not cleaned, and commercially available artificial teeth were arranged on the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C. to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, evaluation of the plate denture preparation time and evaluation of occlusion of the plate denture were performed. Further, similarly, a denture base having a recessed shape in which a maxillary right central incisor of commercially available artificial teeth can be arranged with a length of 30 mm×a width of 30 mm×a height of 10 mm was modeled using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm). After that, the obtained denture base was not cleaned, and the commercially available artificial teeth were arranged on the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C. to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, the adhesiveness was evaluated. The evaluation results are shown in Table 2. Example 2 The photocurable composition for stereolithography described in Table 1 was used to perform stereolithography of the maxillary denture base data obtained by designing in accordance with custom artificial teeth having an edge structure for snap fit by the method of designing a plate denture and creating three-dimensional data of a denture base described above using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm) to prepare a maxillary denture base having a catch structure corresponding to the edge structure given to the artificial teeth in a recessed shape for arranging artificial teeth. After that, the obtained denture base was not cleaned, and the custom artificial teeth were arranged so as to be fitted into the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C. to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, evaluation of the plate denture preparation time and evaluation of occlusion of the plate denture were performed. Further, a denture base having a recessed shape in which a maxillary right central incisor can be arranged with a length of 30 mm×a width of 30 mm×a height of 10 mm was modeled using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm). At this time, three-dimensional data was created such that the recessed shape gives a catch structure corresponding to the edge structure for snap fit of the custom artificial teeth to be used, and modeling was performed. After that, the obtained denture base was not cleaned, and the custom artificial tooth were arranged on the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C. to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, the adhesiveness was evaluated. The evaluation results are shown in Table 2. Example 3 The photocurable composition for stereolithography described in table 1 was used to perform stereolithography of the maxillary denture base data obtained by designing in accordance with commercially available artificial teeth by the method of designing a plate denture and creating three-dimensional data of a denture base described above using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm) to prepare a maxillary denture base having a recessed shape for arranging artificial teeth. After that, the obtained denture base was not cleaned, and the commercially available artificial tooth were arranged on the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C. to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, evaluation of the plate denture preparation time and evaluation of occlusion of the plate denture were performed. Further, similarly, a denture base having a recessed shape in which a maxillary right central incisor of commercially available artificial teeth can be arranged with a length of 30 mm×a width of 30 mm×a height of 10 mm was modeled using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm). After that the obtained denture base was not cleaned, and the commercially available artificial teeth were arranged on the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C. to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, the adhesiveness was evaluated. After that, the adhesiveness was evaluated. The evaluation results are shown in Table 2. Comparative Example 1 IvoBase (manufactured by Ivoclar) that is a resin disk for cutting a denture base formed of an acrylic resin was attached to a cutting machine (DWX-50 manufactured by Roland DG Corporation.), and the maxillary denture base data obtained by designing in accordance with commercially available artificial teeth by the method of designing a plate denture and creating three-dimensional data of a denture base described above was used to prepare a maxillary denture base having a recessed shape for arranging artificial teeth by cutting. After that, a small amount (0.1 to 0.3 g) of Beautiful II manufactured by SHOFU INC., which is a dental composite resin, was built-up as a temporary adhesive on the respective recessed portions, and then, commercially available artificial teeth were arranged on the recessed portion on which the temporary adhesive was built-up. After that, light was applied thereto for 30 seconds by a visible light irradiator (light source wavelength of 470 nm) to cure the temporary adhesive, and thus, the commercially available artificial teeth were temporarily adhered to the maxillary denture base. Next, as an acrylic resin, PalaXpress ultra manufactured by Heraeus Kulzer GmbH (chemically polymerized resin for denture base) was poured into the gap between the denture base and the artificial teeth and polymerized to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, evaluation of the plate denture preparation time and evaluation of occlusion of the plate denture were performed. Further, similarly, a denture base having a recessed shape in which a maxillary right central incisor of commercially available artificial teeth can be arranged with a length of 30 mm×a width of 30 mm×a height of 10 mm was prepared using a cutting machine (DWX-50 manufactured by Roland DG Corporation.). After that, as a temporary adhesive, a small amount (0.1 to 0.3 g) of Beautiful II manufactured by SHOFU INC., which is a dental composite resin, was built-up on the recessed portion, and then, commercially available artificial teeth were arranged on the recessed portion on which the temporary adhesive was built-up. After that, light was applied thereto for 30 seconds by a visible light irradiator (light source wavelength of 470 nm) to cure the temporary adhesive, and thus, the commercially available artificial teeth were temporarily adhered to the denture base. Next, as an acrylic resin, PalaXpress ultra manufactured by Heraeus Kulzer GmbH (chemically polymerized resin for denture base) was poured into the gap between the denture base and the artificial teeth and polymerized to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, the adhesiveness was evaluated. The evaluation results are shown in Table 2. Comparative Example 2 The photocurable composition for stereolithography described in Table 1 was used to perform stereolithography of the maxillary denture base data obtained by designing in accordance with commercially available artificial teeth by the method of designing a plate denture and creating three-dimensional data of a denture base described above using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm) to prepare a maxillary denture base having a recessed shape for arranging artificial teeth. After that, the obtained denture base was placed in a cleaning bath of isopropyl alcohol, cleaned twice, and dried. After that, as a temporary adhesive, a small amount (0.1 to 0.3 g) of Beautiful II manufactured by SHOFU INC., which is a dental composite resin, was built-up on the respective recessed portions, and then, commercially available artificial teeth were arranged on the recessed portion on which the temporary adhesive was built-up. After that, light was applied thereto for 30 seconds by a visible light irradiator (light source wavelength of 470 nm) to cure the temporary adhesive, and thus, the commercially available artificial teeth were temporarily adhered to the denture base. Next, as an acrylic resin, PalaXpress ultra manufactured by Heraeus Kulzer GmbH (chemically polymerized resin for denture base) was poured into the gap between the denture base and the artificial teeth and polymerized to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, evaluation of the plate denture preparation time and evaluation of occlusion of the plate denture were performed. Further, similarly, a denture base having a recessed shape in which a maxillary right central incisor of commercially available artificial teeth can be arranged with a length of 30 mm×a width of 30 mm×a height of 10 mm was modeled using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm). After that, the denture base was placed in a cleaning bath of isopropyl alcohol, cleaned twice, and dried. After that, as a temporary adhesive, a small amount (0.1 to 0.3 g) of Beautiful II manufactured by SHOFU INC., which is a dental composite resin, was built-up on the respective recessed portions, and then, commercially available artificial teeth were arranged on the recessed portion on which the temporary adhesive was built-up. After that, light was applied thereto for 30 seconds by a visible light irradiator (light source wavelength of 470 nm) to cure the temporary adhesive, and thus, the commercially available artificial teeth were temporarily adhered to the denture base. Next, as an acrylic resin, PalaXpress ultra manufactured by Heraeus Kulzer GmbH (chemically polymerized resin for denture base) was poured into the gap between the denture base and the artificial teeth and polymerized to adhere the artificial teeth and the denture base to each other, thereby preparing a plate denture. After that, the adhesiveness was evaluated. The evaluation results are shown in Table 2. Comparative Example 3 The photocurable composition for stereolithography described in Table 1 was used to perform stereolithography of the maxillary denture base data obtained by designing in accordance with commercially available artificial teeth by the method of designing a plate denture and creating three-dimensional data of a denture base described above using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm) to prepare a maxillary denture base having a recessed shape for arranging artificial teeth. The obtained maxillary denture base was placed in a cleaning bath of isopropyl alcohol, cleaned twice, and dried. After that, commercially available artificial teeth were arranged on the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C., thereby preparing a plate denture. After that, evaluation of the plate denture preparation time and evaluation of occlusion of the plate denture were performed. Further, similarly, a denture base having a recessed shape in which a maxillary right central incisor of commercially available artificial teeth can be arranged with a length of 30 mm×a width of 30 mm×a height of 10 mm was modeled using a stereolithography 3D printer (Formlabs, Form2, irradiation wavelength of 405 nm). After that, the obtained denture base was placed in a cleaning bath of isopropyl alcohol, cleaned twice, and dried. After that, commercially available artificial teeth were arranged on the recessed portion and irradiated with light for 3 minutes by a polymerization apparatus for dental technicians (α-light V manufactured by MORITA TOKYO MFG. CORP., wavelength of 400 to 408 nm, 465 to 475 nm) while being immersed in hot water of 40° C. to prepare a test piece. After that, the adhesiveness was evaluated. The evaluation results are shown in Table 2. TABLE 1Components (mass parts) of curableExam-Exam-Comparativecomposition for stereolithographyple1.2ple3Example2,3PhotocurableMethyl methacrylate202020D−2.6E383838monomerUrethane dimethacrylate303030Trimethylolpropane101010trimethacrylateFirstBis(2,4,6-21.22polymer-trimethylbenzoyl)izationphenylphosphineoxideinitiatorFillerPMMA101010SecondCamphorquinone—0.6—polymer-4-(N,N-dimethylamino)—0.2—izationethylbenzoateinitiator TABLE 2Denture preparation timeCleaningArtificial toothDenture base preparationprocessadhesion or preparationTotalEngage-AdhesionMethodTimeTimeMethodTimeTimementstrengthExample1Stereolithography1 hourNoneOnly light irradiation5 minutes1 hourBB30 minutes35 minutesExample2Stereolithography1 hourNoneArtificial tooth fitting5 minutes1 hourAA30 minutesshape + light irradiation35 minutesExample3Stereolithography1 hourNoneStereolithography ×5 minutes1 hourAA30 minutesPhotopolymerization35 minutes(different wavelength)ComparativeCutting5 hoursNoneDental resin adhesion30 minutes5 hoursDBExample 130 minutesComparativeStereolithography1 hour10Dental resin adhesion30 minutes2 hoursDBExample 230 minutesminutes10 minutesComparativeStereolithography1 hour10Cleaning and light5 minutes1 hourD *CExample 330 minutesminutesirradiation45 minutes* Artificial tooth and denture base are not bonded to each other | 21,934 |
11857386 | DESCRIPTION Referring to the accompanying drawings, a method40for use in the manufacture of a milling tool10is illustrated. The method40is undertaken in two main stages. In a first stage or operation, a rod12is provided that constitutes a plain blank, the rod12being of a suitable material, for example tungsten carbide or another suitable hard, wear resistant material. The rod12is machined to form it into a pre-fluted blank14. In the second stage or operation, the pre-fluted blank14is machined to form it into the shape of the final milling tool10. Referring toFIG.6, the first stage may comprise steps42to48that will be described below. The second stage may comprise steps50to58described below. The present invention relates primarily to the second of these stages or operations, as illustrated by the right hand part ofFIG.1and by steps50to58ofFIG.6, making use of a pre-fluted blank14manufactured in the first stage as illustrated by the left hand side ofFIG.1and by steps42to48ofFIG.6. As shown inFIG.1, in the first stage, the rod12is placed into a support16forming part of a first machine18. A cutter in the form of a grinding wheel20or the like of the first machine18is then moved to a position in which it is able to bear against the surface of the rod12, cutting or grinding material therefrom to form the rod12into the shape of the pre-fluted blank14. Specifically, the cutter20forms the rod12to a shape including a relatively large diameter shank22, and a smaller diameter stem24projecting co-axially from the shank22, the manner in which the stem24is formed also resulting in the formation of at least one generally helical groove or flute26formed integrally with the stem24, the flute26extending along a significant part of the length of the stem24. The flute26may be formed, if desired, using a suitable cutting or grinding procedure, and the formation of the flute26results in the stem24being shaped to include one or more integral upstands or ribs26a, formed integrally with the stem24. In the arrangement illustrated, three flutes26, and three upstands or ribs26a, are provided. However, it will be appreciated that the invention is not restricted in this regard, and arrangements including fewer flutes, for example one or two flutes, or a greater number of flutes such a four or more flutes, are also possible without departing from the scope of the invention. While the flutes26extend to an end24aof the stem24, the end24ais otherwise left untreated. As such, the end24aof the stem24is not shaped to a particular cutting shape, and therefore is characterised by the absence of a cutting end such as a ball-nosed end, flat ended, bull-nosed end, or otherwise. The end24ais not provided with a surface finish and can be considered un-finished. A pre-fluted blank14may be characterised by the presence of an unfinished end24a. In addition, whilst the rod12is fitted to the support16, the first machine18is preferably operable to form an orientation indicator28onto the shank22(although in some arrangements, the formation of such an orientation indicator28may be omitted). The orientation indicator28conveniently takes the form of a flat or a groove or recess cut into the shank22, for example on a part thereof spaced significantly from the stem24. However, the axial position of the orientation indicator28is not of importance to the invention and it may be located elsewhere, for example on a part of the shank22adjacent the stem24(as illustrated), or on the stem24itself. Furthermore, rather than take the form of a flat, groove, or recess, the orientation indicator28could take the form of a projection upstanding from the surface of the stem24or shank22. Likewise, the orientation indicator28may be provided in the form of a surface marking such as a dye or etching such as a laser-etching. The purpose of the orientation indicator28is to provide a datum indicative of the angular orientation and/or position of the flute or flutes26for use during subsequent stages in the manufacturing process. It will be appreciated that the orientation indicator28, having been created after formation of the flutes26, is detectable by an orientation probe. Whilst the description hereinbefore is of an arrangement in which the first operation is undertaken using a single first machine, as described hereinbefore it may be undertaken using several machines in sequence. For example, one machine may be used to form the stem, and another may be used to form the flute upon the stem. The term “first machine” as used herein is intended to cover both situations, and so may refer to more than one machine where the first operation is undertaken using a plurality of machines. Where two or more machines are used in performing the first operation, the orientation indicator (see below) is preferably formed using the same machine as that used to form the flute, so as to ensure that the orientation indicator is properly aligned or orientated relative to the flute. After manufacture of the pre-fluted blank14, the blank14is removed from the first machine18and positioned within a second machine30, supported by a support32thereof. In accordance with the invention, the second machine includes a sensor or probe that is operable to detect the orientation of the pre-fluted blank14, and hence the positions of the flutes thereof. This may be achieved by identifying, using the probe, the orientation and/or location of the orientation indicator28, where provided, or may be achieved by directly sensing the position and/or orientation of at least one of the flutes of the pre-fluted blank14. The method may include detecting the location of an end, such as the shank end or the stem end24a, of the pre-fluted blank14to derive therefrom the orientation and/or position of the flute relative to the end of the blank. The probe conveniently comprises a physical probe that contacts the pre-fluted blank14and outputs information that can be used to identify the orientation of the pre-fluted blank. Alternatively, it could comprise an optical probe, for example, that does not physically contact the pre-fluted blank14. The position or orientation information derived through the use of the probe is supplied to control unit of the second machine30for use in controlling the operation thereof. FIGS.4A,4B,5A and5Bschematically illustrate one example of a probing method, using a mechanical probe tip38to detect the orientation of a pre-fluted blank14.FIGS.4A and4Billustrate a section of the shank22, taken perpendicularly to the shank axis, the shank22having been provided with an orientation indicator28in the form of a flat portion cut into the shank22. The probe tip38is brought into sensing range with the pre-fluted blank14, for instance into physical contact, by moving it along a movement axis M (e.g., towards and away from the pre-fluted blank). As the pre-fluted blank14is axially rotated, for instance in the direction of the arrow R, the probe tip38follows the circumferential contour of the shank22, and therefore the contour of the pre-fluted blank14. It will be understood that the probe tip38may be moveable, or may be held in a fixed position allowing it to deflect when encountering a structure and/or to relax into a rest position in the absence of a structure, to thereby detect a change of a degree of deflection of it. Other probing principles may be used. As illustrated inFIG.4A, while the probe tip38follows a circular contour, no movement is expected of the probe tip38neither towards nor away from the pre-fluted blank14. Turning toFIG.4B, as the probe tip38engages the flat portion of the orientation indicator28, it is able to move further towards the axis of the shank22. Thereby the orientation of the pre-fluted blank14can be identified by way of a different (i.e., more or less) displacement, relative to a reference position, of the probe tip38. As will be appreciated, other orientation indicator geometries may be used to result in correspondingly different probe behaviour to be observed. The size and form of the orientation indicator may depend on the probe design. Some high precision/high accuracy probes may have a tip diameter in the region of a few millimetres, in a similar region or even larger than the shank diameter or the size of the orientation indicator. FIGS.5A and5Billustrate another example of a probing method, and show a section of a stem14, the section taken perpendicularly to the stem axis, the stem14being provided with a flute26. Only one flute26is illustrated inFIGS.5A and5B, although the stem14may have been provided with two, three, or more flutes. Similarly to the sequence ofFIGS.4A and4B, inFIG.5Athe pre-fluted blank is rotated while the probe tip38A is brought into sensing range, e.g. into contact, with the surface of the stem24. Axial rotation of the pre-fluted blank14allows the probe tip38to follow the circumferential contour of the pre-fluted blank14, in this instance the contour of the stem24. As shown inFIG.5B, at a location of a flute26the probe tip38may experience a displacement towards the stem axis. The probing principle may be similar or identical to that described in relation toFIGS.4A and4B. A displacement of the probe tip38can then be correlated with the orientation of the flute26. While the examples ofFIGS.4A,4B,5A and5Bshow a mechanical probe tip38, other probe systems may be used, such as other mechanical probing principles or optical systems such as laser-based distance measurements may be used instead or in addition. The second machine30includes a cutter in the form of a grinding wheel34operable to cut or grind the end part of the stem24remote from the shank22to form a cutting end region36thereon, for example of ball-nosed, bull-nosed or flat ended form. The operation of the grinding wheel34involves removing parts of the ends of the upstands or ribs26ato form the cutting end region36. As a result of the formation of the cutting end region36, the unfinished end24amay be shaped or removed. It will be appreciated that, as shown, the flutes26extend into the cutting end region36. The grinding wheel34is further used to generate a required land width and relief along the upstands or ribs26a. In order to achieve all of this, it is important for the control unit of the second machine to have knowledge of the position and/or the orientation of at least one flute26, hence the need use a sensor or probe to detect the position of the orientation indicator28as described hereinbefore, or to directly identify the orientation of the at least one flute26, and control the operation of the machine30accordingly. The position of the flute26may be determined by detecting the end location of the pre-fluted blank14, and determining the position of the flute14with reference to the end location. The method may include a peeling step in which a peeling region of the shank22, constituted by a region of the shank22adjacent the stem24, is machined to remove portions thereof, to reduce the diameter of the peeling region to the diameter of the stem24. The peeling step provides, effectively, a longer stem. The peeling step may result in a removal of an orientation indicator28located in the peeling region, as illustrated inFIG.3by the absence of an orientation indicator28. In embodiments of the invention, the method may comprise providing the orientation indicator28in a peeling region of the pre-fluted blank14. In that manner, the tool10in its final form has no orientation indicator. After machining of the tool10using the second machine30, the tool10is removed from the second machine30, and a hard material coating or the like may be applied thereto to enhance the wear resistance and extend the useful working life of the tool10. Accordingly, the method40comprises a step50of providing a pre-fluted blank. The pre-fluted blank may be provided, for instance, by sourcing it from a supplier. The pre-fluted blank may be manufactured from a plain blank. To this end, in a variation of the method40, an optional step42comprises providing a plain blank. In an optional step44, a shank and coaxial stem may be formed in the plain blank. Step44may be omitted in embodiments using a blank with uniform diameter having a shank region and a stem region. In a step46, at least one helical flute is formed on the stem, or in the stem region, to thereby form the pre-fluted blank. Steps44and46may be carried out contemporaneously or as different forming operations, but this is not necessarily the case in all embodiments. In accordance with the invention, as part of step48or of step50, an orientation indicator may be formed on the pre-fluted blank. A pre-fluted blank may be recognised by its unfinished end, or tip, to (such as the end24ainFIG.2) and one or more flutes26extending to the unfinished end. Once transferred and located in a cutting machine for end cutting, a probe is used to identify the position and/or the orientation of a reference point of the pre-fluted blank. In step52, the position and/or the orientation of an orientation indicator28is determined using a probe. As an alternative or concurrently to step52, step54may be carried out in which the position and/or orientation of at least one flute of the pre-fluted blank is determined using a probe. It will be appreciated that the method40may, in one variant, start with step50in which a pre-fluted blank is provided and positioned in a forming machine, followed by step54, for instance if the pre-fluted blank is not provided with an additional orientation indicator28. In a step56, the cutting end region of the pre-fluted blank is formed. In step56, the unfinished region of the end24ais formed into a cutting end such as a ball-nosed, flat ended, or bull-nosed end. In a step58, other features such as lands and reliefs are formed at locations along the flutes26on the pre-fluted blank. Steps56and58are conveniently carried out in the same machine, although the invention is not necessarily so limited. It will be appreciated that the sequence of steps is exemplary and some of the steps may be carried out in a different order and/or contemporaneously. The use of the invention is advantageous in that manufacturing efficiencies may be made, using machines or equipment specifically adapted for use in the steps of the process. The stages of the manufacturing process need not be conducted in the same location as one another, for example the first machine may be located at a first site, from where the pre-fluted blanks14are dispatched to a second site at which the second machine30is located. A time consuming part of the manufacturing process is the completion of the first stage mentioned hereinbefore. It is envisaged that by having this stage completed elsewhere, a manufacturer specialising in the formation of the cutting end region and other finishing processes may make significant time savings and efficiency enhancements through using pre-fluted blanks, using the method of the invention to ensure that machining thereof is undertaken correctly. While it will be appreciated that the method requires additional time, compared to a conventional manufacturing methods, to position a pre-fluted blank in a machine and to identify the position and/or location of a flute or a separate orientation indicator, as applicable, the overall manufacturing time may be reduced. By way of example, time savings in the region of 20% or more may be made, thus the invention can lead to significant manufacturing efficiencies. To illustrate the benefits of the invention with an illustrative example, the manufacture of a conventional tool requires a number of grinding operations to be carried out at the stem to create features such as flutes, lands, end formations such as a ball end, bull end, or flat end, etc., to turn the stem into a body of a milling tool. Of these grinding operations, the fluting operation is typically the most complex operation. The time required for forming flutes varies depending on tool head diameter, shank diameter, length of flute, etc. and may amount to 20% or more of the total manufacturing time excluding setup time for a tool. It will be understood that the time savings may depend on the size of the tool and, consequentially, the time required to position a pre-fluted blank, and to identify the position and/or orientation of the flutes on it. The exemplary pre-fluted blank described herein comprises a shank with larger diameter than the stem, in which a shank region and a stem region can be visually distinguished. However, the invention is not so limited. Some blanks may comprise a stem and shank of the same diameter, the stem region of the pre-fluted blank being identifiable by the location and extension of the flutes. Whilst a specific embodiment of the invention is described hereinbefore with reference to the accompanying drawings, it will be appreciated that a wide range of modifications and alterations may be made thereto without departing from the scope of the invention as defined by the appended claims. | 17,074 |
11857387 | BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring toFIG.1which shows a dental dam10in accordance with the invention. The dam includes a substantially planer membrane12having a plurality of locating portions, collectively numbered14, a guide formation16and a frame18. A clamp arrangement20, having a handle22and pocket region24, is shown engaged with the guide formation. The membrane12and the clamp arrangement20are both formed of a shape memory polymer. The polymer, specifically a shape memory rubber, is a material which can be manipulated to a new shape, and retain that shape until heated. Once heated the polymer will revert to its initial shape. The material stretches at a higher temperature, but at lower temperatures will stiffen and harden, thus retaining the new form. Once the new form is no longer necessary the material may be heated to the higher temperature with the result that the material will revert to its initial shape. Forming the membrane12and the clamp20of the memory polymer provides advantages over what is the current practice in the art. The membrane may provide for better isolation of an oral structure, particularly in setting the membrane about the structure and for removing the membrane once it is no longer needed. Traditionally clamps used in support of dental dams are a metallic material. These clamps compress intensely on the oral structure. The compression caused by the clamp is painful and uncomfortable to a patient. The clamp20, formed of the polymer, provides a conservative approach to securing the membrane and oral structure, such that the gingival tissues may remain largely unaffected and the need for local anaesthesia is generally not required. These and other advantages of the use of the shape memory polymer will be discussed and explained in the description that follows. Turning back toFIG.1where, membrane12includes a major surface26, delimited by edges28A,28B,28C and28D. Frame18encircles the membrane toward the respective edges. The frame is used to hold the membrane substantially flat and moderately taught. The effect is such that the membrane provides a protective cover over the mouth and throat of a patient during a dental or restorative process. The frame includes an arm30to help in mounting the frame and for general use. Locating portions14are positioned along the surface26. Each portion may be in the form of a pre-punched hole through the membrane; alternatively, a perforated hole which may be pressed about an oral structure; alternatively, the portion may be a marking along the major surface of the membrane. The marking may be any visual indicator to set out the position of the portion, which would be visible to a user. The portions14are set out along the surface26in an elliptical fashion. The portions are representative of the position of oral structures of a patient, where each portion matches, as closely as possible, the location of an oral structure. The portions will aid the user in correctly aligning the membrane over the mouth of a patient. Additionally, the elliptical shape of the portions14is centrally located on the membrane12. A user will thus be assured that the membrane is positioned correctly over the patients mouth, to cover the entire mouth region when a portion14is over the respective oral structure it represents. In use, the area of the membrane12around a particular portion14will be pressed downwardly over the structure to be worked on. The structure thus protrudes through the portion14. The area about the structure serves as the isolating layer between the oral structure. Saliva, and other unwanted fluids are kept away from the structure by the membrane. The guide formation16is positioned along surface26. The formation may be in the form of a protrusion formed on the surface, as a projection of the material of the membrane12. Alternatively, the formation may be a tendon which is secured to the surface. The tendon would preferably be formed of a metallic wire or other similarly rigid material. The formation16provides a track which runs along the surface26. The clamp arrangement20is designed such that it will slide along the formation. This is discussed in more detail below. The elliptical shape of the portions14will be matched, to a degree, by the formation16.) The formation may run alongside the portions on either an inner or outer circumference of the portion's ellipses. In the current embodiment, there exist a pair of formations16, which flank the portions, so as to place the elliptic shape of the portions in a channel32. Referring toFIG.2andFIG.3, which show clamp arrangement20in accordance with the invention. The clamp, as formed of the shape memory polymer, is created by manipulating a single piece of the polymer into an oral engaging structure. The clamp20includes an undercut section34, used for slidably engaging the clamp with the formation16, and for the purpose of creating the oral engaging structure, includes a handle22and a pocket region24. The handle22is shown in the drawings as a bow, but this is not deemed to be limiting. As an example, the purpose of the handle could be served by having a projecting member of polymer which extends away from the pocket region. Any design which allows for a gripping and maneuvering the clamp would suffice. The pocket region24includes at least a first pair of opposing surfaces40A and40B. The surfaces are biased toward each other. The surfaces result in a clamping force being exerted against a structure placed therebetween. The force is exerted on what would be the front and the back of an oral structure, more correctly, the force is exerted against the lingual surface and the buccal surface of an oral structure. To round out the pocket region24there is at least a second pair of opposing surfaces42A and42B. The pocket region24is designed such that a downward pressure applied to the handle22, once the pocket region has been aligned over the oral structure of interest, will deform to a degree so as to receive the oral structure within the region. As may be seen in the drawings the region is formed as an opening, surrounded by the opposing surfaces,40A and40B, as well as42A and42B. The oral structure will thus protrude through the opening in a manner that clear access is made to the structure for further working. Opposing surfaces40A and40B, under the influence of their nature bias, will clamp to the oral structure on the lingual and buccal surfaces. Opposing surfaces42A and42B pass between adjacent structures and provide added support and rigidity to the clamp18. The undercut section34is formed toward a lower end44of the clamp20. The section is engageable with the formation16. When there exist a pair of formations, as shown inFIG.1, the clamp will include a pair of undercut sections34A and34B to engage with each formation. The clamp20and the formation16are engageable in a sliding fashion through engagement of the formation with the undercut section34. The section allows for controlled sliding movement of the clamp relative to, and along, the surface26of the membrane12. This sliding action will aid the alignment of the clamp. Turning toFIG.4, which shows a method of use of the dental dam10, in accordance with the invention. First the membrane12is placed to a frame18, in such fashion to create a substantially flat surface of the membrane, thus creating the dental dam10. Additionally, the surface is taught, such that any deformation along the surface26is resisted by the nature of the material and the tensile arrangement attempting to retain the flat shape. Next, using the arm30of the frame18to manoeuvre the dam10, finding the guide formation16which runs along the major surface26of the membrane12. Once the formation is located placing the dam over the mouth of the patient such that the formation is facing away from the patient. Then, positioning the dam10so as to align a respective locating portion14over an oral structure to be worked on. Once the alignment has taken place, fixing the dam10in place by mounting or securing the dam through the arm30. Next, depressing the area of the membrane12around the respective locating portion14about the oral structure of interest. The depressing force being such that the membrane slides down around the oral structure until the structure, or a sufficient portion thereof, projects through the membrane and the portion. Once this occurs allowing the area of the membrane around the portion to retract about the base of the structure, thus isolating the structure. Then, finding the guide formation16along the surface26. Next, engaging the clamp20with the guide formation16. The clamp is preferably engaged by mating the undercut section34with the formation. This engagement provides for slidable movement of the clamp along the formation and over the surface. Then, slidably moving the clamp20along the formation16until the pocket region24is aligned over the oral structure of interest. Next, applying a force to the handle22in the direction of the oral structure, so as to receive said structure within the pocket region24. The structure thus protruding through the opening created by the pocket region, to be accessible for further work. Then, allowing opposing surfaces40A and40B to exert a compressive force to the lingual and buccal surfaces of the oral structure, while additionally, allowing the opposing surfaces42A and42B to pass between adjacent structures and provide added support and rigidity to the clamp20. Once the work is complete, and the removal is required, the user may pull the clamp20off the oral structure and withdraw the dam10from the patients mouth. If removal of either the clamp of the membrane12becomes problematic, the user may gently warm each until the material becomes elastic. The dam and clamp will then deform and allow for less restrictive and less painful removal. The embodiment above provides a scenario in which the locating portions14are either holes, or perforated holes. If however, the portions14are merely marking on the surface26which serve as visual indicators, the user may include a step which involves punching through the membrane12at the position, using means well known in the art. The method for use would then continue in the fashion discussed above. The description above additionally provides for embodiments in which the membrane12is black in colour, as opposed to a common green colour which is currently being used in the art. A person skilled in the art will appreciate that a number of variations may be made to the above described invention or features thereof, without departing from the scope of the present invention. | 10,715 |
11857388 | While the system and method of use of the present application is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular embodiment disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present application as defined by the appended claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Illustrative embodiments of the system and method of use of the present application are provided below. It will of course be appreciated that in the development of any actual embodiment, numerous implementation-specific decisions will be made to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The system and method of use in accordance with the present application overcomes one or more of the above-discussed problems commonly associated with conventional aligner devices. Specifically, the invention of the present application allows for inserting or removing an aligner or other dental device without introducing germs or damaging the person. In addition, the invention configuration allows for precise placement or alteration to the position of the aligner without damage thereto. These and other unique features of the system and method of use are discussed below and illustrated in the accompanying drawings. The system and method of use will be understood, both as to its structure and operation, from the accompanying drawings, taken in conjunction with the accompanying description. Several embodiments of the system are presented herein. It should be understood that various components, parts, and features of the different embodiments may be combined together and/or interchanged with one another, all of which are within the scope of the present application, even though not all variations and particular embodiments are shown in the drawings. It should also be understood that the mixing and matching of features, elements, and/or functions between various embodiments is expressly contemplated herein so that one of ordinary skill in the art would appreciate from this disclosure that the features, elements, and/or functions of one embodiment may be incorporated into another embodiment as appropriate, unless described otherwise. The preferred embodiment herein described is not intended to be exhaustive or to limit the invention to the precise form disclosed. It is chosen and described to explain the principles of the invention and its application and practical use to enable others skilled in the art to follow its teachings. Referring now to the drawings wherein like reference characters identify corresponding or similar elements throughout the several views,FIG.2depicts a front view of an aligner placement system in accordance with a preferred embodiment of the present application. It will be appreciated that system201overcomes one or more of the above-listed problems commonly associated with conventional aligner devices. In the contemplated embodiment, system201includes a body203having a handle end205and a placement end207. It is contemplated that the handle end205includes a hole209through which the finger or a portion thereof passes. The placement end207includes a hook211that extends out and away from the body203so as no not increase the total thickness301thereof as depicted byFIG.3. It is contemplated that the hook211is attached to the body203via a rounded support213. In use, as depicted byFIG.4, the system201is held by a user via the handle end205and the placement end is used to apply force to an aligner to seat against the user's teeth. It should be appreciated that one of the unique features believed characteristic of the present application is that the handle end205with its hole209allows for the system201to be rotated, angled and supported in such a way to allow for precise force to be applied to the aligner. It will be further appreciated that the handle end205prevents the system201from uncontrolled movement that causes injury to the person or damage to the aligner. Referring now toFIG.4the preferred method of use the system201is depicted. Method501includes loosely placing an aligner over teeth503, gripping the handle end of the body505, applying force to the aligner via the placement end507, adjusting the grip on the system509, applying force to the aligner via the placement end to finish the insertion of the aligner511, allowing the person to wear the aligner513, gripping the handle end of the body515and applying force to remove the aligner517. The particular embodiments disclosed above are illustrative only, as the embodiments may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. It is therefore evident that the particular embodiments disclosed above may be altered or modified, and all such variations are considered within the scope and spirit of the application. Accordingly, the protection sought herein is as set forth in the description. Although the present embodiments are shown above, they are not limited to just these embodiments, but are amenable to various changes and modifications without departing from the spirit thereof. | 5,812 |
11857390 | DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS FIGS.1a,1b, and2ashow a first preferred exemplary embodiment of a dental implant1with an implant extension2, which is formed along a longitudinal axis.FIGS.3a-8show a correspondent designed receptacle for holding and transporting the dental implant. In general, the dental implant1with the implant extension2is designed along a longitudinal axis and as follows, wherein:a) the dental implant1comprises an apical end1a, a coronal end1band a section1cfor receiving and securing an abutment; a connection of the dental implant with the abutment can be made both externally and internally; the section1calso forms an adapter connection to a suitable tool,b) the implant extension2is formed in one piece with the implant1and extends away from one end face of the apical end1aalong the longitudinal axis,c) the implant extension2has a first section3along the longitudinal axis with an annular constriction6, which is directly connected to the end face of the apical end1aof the implant1and is designed as a predetermined breaking point with such a small material diameter that, in the event of bending or torsion of the implant1against the implant extension2, the implant1breaks off from the implant extension2at the constriction6,d) wherein according to the invention the implant extension2has along the longitudinal axis following the first section3, a second section4and a splined shaft section5, wherein the second section4and the splined shaft section5being further away from the implant1than the first section3and wherein the second section4having therein perpendicular to the longitudinal axis an outer annular groove7which is designed to hold the implant extension2by clamping the groove7in the direction of the longitudinal axis. The splined shaft section5is designed to hold the implant extension2in a secured manner against rotation around the longitudinal axis. The implant extension2is designed in such a way that it can be inserted in a cover10of a receptacle which is a transport receptacle, in order to allow to hold and transport the dental implant1firmly in it by holding the implant extension2. The receptacle or transport receptacle preferably comprises the cover10and a bottom receptacle part14, as shown inFIGS.3a-3c, for example, which can be tightly closed together and opened for removal of the dental implant1. In the cover10preferably a channel is formed into which the implant extension2can be inserted and locked. Preferably, the groove7is designed with at least one edge in such a way that for example spring arms31or holding elements of the cover10, which must be elastic in the cover, can engage in the groove, wherein the spring arms31or holding elements form a barb function with the edge or groove. The edge is thus preferably formed at the apical end of the groove, against which the spring arms31or holding elements abut when the implant extension2is pulled back away from the cover10, retaining the implant extension2in it. The edge is preferably also the outer edge of an annular surface extending perpendicular to the longitudinal axis in order to form the barb function with the spring arms31or holding elements engaging therein. In this way the dental implant1can be securely inserted and held in the cover10and broken off when removing it from the cover10with the implant extension2. Preferably, in a coronal section of the splined shaft section5, as shown inFIGS.1a,1b, and2a, circular segment-like first wedges8are formed around the longitudinal axis, which are formed by first hubs8alying in between. Preferably also on an apical outer section of the splined shaft section5, as shown, second circular segment-like wedges9are formed around the longitudinal axis, which are formed by second hubs9alaying in between. Preferably a second groove is formed along the longitudinal axis between the first wedges8and the second wedges9, which can also serve to allow other spring arms or similar holding elements of a cover or part thereof to snap into it. The first wedges8and the second wedges9are designed to withstand a greater torsional torque than, that that is necessary to separate, break off or twist off the dental implant1from the implant extension via the predetermined breaking point6. FIGS.2band2cshow a second preferred embodiment of the dental implant1with a different implant extension2, wherein the splined shaft section being formed therein by being designed in the shape of a square bar and thus forming an anti-rotation feature in conjunction with the holder20as a corresponding counterpart. For the sake of clarity, the term anti-rotation section could also be used as a generic term instead of the term splined shaft section, wherein the anti-rotation section having the feature of being merely not circular or rotationally symmetrical. The splined shaft section5or anti-rotation section is preferably provided with notches or protuberances or with plane sections. In other words, the splined shaft section5has, along the longitudinal axis and around the longitudinal axis, at least one lateral plane section or at least one splined shaft section as a groove or as a protuberance in order to generate the anti-rotation feature with a corresponding counterpart. For the sake of clarity, the counterpart is the holder20of the cover10. Possible cross-sectional shapes of the splined shaft section5or anti-rotation section could be a square or rectangular, a star-shaped or a torx-like shape. Preferably the second section4is located along the longitudinal axis between the first section3and the splined shaft section5. Alternatively, the splined shaft section5is located along the longitudinal axis between the first section3and the second section4. Preferably the material diameter of the constriction6is in a range, especially in the embodiment ofFIG.2a, between 0.4 mm and 0.8 mm or, especially in the embodiment ofFIG.2bor2c, between 0.8 mm and 1.2 mm or, more preferably, it is less than 1.0 mm (especially in the embodiment ofFIG.2bor2c) or less than 0.7 mm or less than 0.6 mm (especially in the embodiment ofFIG.2a). Preferably, the material diameter of the constriction6is designed in such a way that the constriction6breaks at a torsion of less than 25 Ncm or less than 20 Ncm, or more preferably less than 10 Ncm or even more preferably less than 5 Ncm. The dental implant1is preferably made of a biocompatible material such as titanium, a titanium alloy or ceramic such as zirconium oxide ceramic. Preferably, the constriction6is designed so that the material diameter of the first section3increases continuously along the longitudinal axis beginning at the end face of the apical end1aof implant1. Preferably, the material diameter of a first partial section of the first section3of the implant extension2, which is directly adjacent to the end face of the apical end1a, has an inclination relative to the longitudinal axis of less than 35° and preferably 31° to 25°. Preferably, the dental implant1has threads between the apical end1aand the coronal end1bfor screwing the dental implant1into a bone. FIGS.3a-8show an exemplary embodiment of the receptacle and preferred parts thereof, which are suitable for holding and transporting the dental implant1. If possible, the receptacle should be designed in such a way that the dental implant1with its implant extension2can be inserted, held and transported safely and easily without falling down or kinking. The dental implant1is inserted into the cover10and locked in it. It should also be possible to open the receptacle easily and remove the dental implant1out of it. The receptacle may be designed to comprise the following:a) the cover10which is formed along the longitudinal axis with a first end section11which is open towards the outside in the direction of the longitudinal axis and with a second end section12which is closed towards the outside. The cover10surrounds an interior space15which is open to the first end section11and in which a holder20is arranged along the longitudinal axis, said holder having the channel which is open to the outside along the longitudinal axis, the channel being formed to at least partially receive the implant extension2and thus to hold the dental implant1during transport;b) the bottom receptacle14formed tubularly along the longitudinal axis with an outer third end section14aand an opposing fourth end section14b, the third end section14abeing tightly sealed to the outside;c) wherein the fourth end section14bof the bottom receptacle14and the first end section11of the cover10being designed to be interconnectable and manually detachable to form a substantially gas tight and liquid tight space therebetween in which the dental implant1is located;d) wherein in the cover10towards the longitudinal axis the at least three spring arms31are formed and arranged in such a way that they are each connected to the cover10at an outer first end31aalong an annular region around the longitudinal axis and are equally spaced and resilient radially towards the longitudinal axis with a respective opposing second end31b;e) wherein the second ends31btowards the longitudinal axis each having a nub32formed to engage a groove7formed annularly on the implant extension2when the implant extension2is in its final position; andf) wherein the spring arms31are designed geometrically and so flexible that the nubs32are pushed away from the longitudinal axis during insertion of the implant extension2and, in the final position, push into the groove7with a clamping force perpendicular to the longitudinal axis. Preferably, the holder20is connected to cover10in a rotationally fixed manner around the longitudinal axis, and the channel has a splined hub section or a second anti-rotation section along the longitudinal axis at least in sections. The splined hub section or the second anti-rotation section, as it could also be called, is designed in such a way that it forms the rotationally fixed anti-rotation connection with the splined shaft section or the anti-rotation section of the implant extension2in the final position. For the sake of clarity, the terms “splined shaft section” and “second anti-rotation section” are synonyms for each other in this document. Preferably, the splined hub section has greater torsional stability to hold the splined shaft section of the implant extension2than is necessary to break off the implant1from the implant extension2by rotational movement around the longitudinal axis. The torsional stability between the splined hub section of the holder and the splined shaft section of the implant extension2is selected to ensure that the implant is held securely during transport and storage. In a well-known manner, the lower torque force required to separate the implant from the implant extension is selected in such a way that the security of the connection between the implant and the implant extension during transport and storage is ensured and, at the same time, no damage to the implant or its adapter occurs when the implant is separated. As exemplary shown inFIGS.6aand6b, the holder20preferably has a splined hub section which is complementary to the splined shaft section5of the implant extension2, wherein third hubs22of the holder20at least match the first wedges8of the implant extension2and third wedges21of the holder20at least match the first hubs8aof the implant extension2, wherein, however, preferably third hubs22of the holder20match the first wedges8and the second wedges9of the implant extension2and third wedges21of the holder20match the first hubs8aand the second hubs9aof the implant extension2in order to establish a rotationally fixed connection. As mentioned above, the splined hub section or the second anti-rotation section is complementary to the splined shaft section5or anti-rotation section of the implant extension2. Preferably, the torsional stability between the splined shaft section of the holder20and the splined shaft section of the implant extension2is greater than 25 Ncm or greater than 20 Ncm, preferably greater than 10 Ncm and particularly preferably greater than 5 Ncm, to ensure that the dental implant1can be safely broken off the implant extension2and the cover10. Preferably, the holder20is connected with the cover10in one piece. Alternatively, the holder20is connected to the cover10in two pieces or via at least one intermediate connecting element13. Preferably, the holder20is designed as a bushing separate from the cover10, which has a plug connection towards the cover10, which can be pushed into one another along the longitudinal axis with the cover10and thereby forms a rotationally fixed connection. Preferably, the plug connection has a torsional stability that is higher than the torsional stability of the connection between the splined hub section of the holder20and the splined shaft section of the implant extension2. The plug connection between the holder20and the cover10preferably comprises the separate intermediate connecting element13, which is formed along the longitudinal axis in such a way that when the two elements are plugged into each other along the longitudinal axis, a rotationally fixed connection to the holder20is formed at one end section and a rotationally fixed connection to the cover10is formed at an opposing end section. The intermediate connecting element13can have an adapter function, in order to be able to connect different holders20, which match a respective dental implant1, to the cover10, for example.FIG.4shows such an intermediate connecting element13, which is arranged between the cover10and the holder20and connects them. The connection via the intermediate connecting element13is preferably a rotationally fixed connection and/or preferably a tension-resistant connection. Preferably, the intermediate connecting element13can also be formed elastically in order to absorb shocks in the longitudinal direction along the longitudinal axis. Preferably, the at least three spring arms31are designed in one piece as a clip element30, which is formed around the longitudinal axis, as shown inFIGS.7aand7b, for example. Particularly preferably, four spring arms31are formed in one piece as one clip element30, which is formed around the longitudinal axis, as shown inFIGS.7aand7b, for example. The clip element30can be connected to the cover in the direction of the longitudinal axis in order to be connected to the cover10in a tension-resistant manner in a fitted, pushed on, latched and/or screwed state. In other words, the clip element30is preferably designed to form a direct connection to the cover10, wherein the clip element30thereby fixes the holder20in the cover along the longitudinal axis. Preferably, the cover10, the holder20and the clip element30are formed in such a way that in the interior space15of the cover10, first the holder20is inserted into the cover10and then the clip element30is placed on the holder20and connected to each other. Preferably, the clip element30and the cover10are formed to hold the holder20between them on the cover10in the longitudinal direction. Preferably, the cover10, the intermediate connecting element13, the holder20and the clip element30are formed in such a way that in the interior space15of the cover10, first the intermediate connecting element13is inserted into the cover10, then the holder20onto the intermediate connecting element13and then the clip element30onto the holder20and connected to each other. Preferably, the clip element30is made of a more flexible material than the holder20and/or is designed with a flexible geometry, for example by means of slots or spring-armed webs, as shown exemplary inFIGS.7aand7b. Preferably, the second end section12has a non-circular grip surface on the outside in order to be able to manually hold and turn the cover10on it so that it is non-slip and can be safely released from the bottom receptacle14. Preferably, the channel in the holder20for holding the implant extension2is designed to be at least so stable that it can withstand at least one bending moment by the implant extension2in the final position, which occurs when implant1is separated from implant extension2by a bending break-off. According to the invention, the term “separable” or “separating” includes any type of separating, such as by breaking off or twisting off. For the sake of clarity, the features “above” and “below” are understood to mean relative locations in a vertical direction, as shown in the figures. Apical refers to a position that is located on the bone and further away from the abutment or tooth attachment than a coronal end. Sometimes apical is also understood to be distal and coronal is understood to be proximal to the dentist, in the case of an inserted dental implant1. Other possible embodiments are described in the following claims. In particular, the various features of the embodiments described above can also be combined with one another, provided they are not technically mutually exclusive. The reference signs mentioned in the text above and in the claims serve only for better comprehensibility and do not limit the claims in any way to the shapes represented in the figures. LIST OF REFERENCE SIGNS 1dental implant1aapical end1bcoronal end1cadapter connection2implant extension (appendix)3first region4second region5splined shaft section6constriction7groove8first wedges (preferably circular segments)8afirst hubs9second wedges9asecond hubs10cover11first end section12second end section13intermediate connecting element14bottom receptacle14athird end section14bfourth end section15interior space20holder for the implant21third wedges22third hubs30clip element31spring arm31aouter first end31bouter second end32nub (or nose-like bulge) | 17,811 |
11857391 | DETAILED DESCRIPTION Embodiments of systems, components and methods of assembly and manufacture will now be described with reference to the accompanying figures, wherein like numerals refer to like or similar elements throughout. Although several embodiments, examples and illustrations are disclosed below, it will be understood by those of ordinary skill in the art that the inventions described herein extends beyond the specifically disclosed embodiments, examples and illustrations, and can include other uses of the inventions and obvious modifications and equivalents thereof. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner simply because it is being used in conjunction with a detailed description of certain specific embodiments of the inventions. In addition, embodiments of the inventions can comprise several novel features and no single feature is solely responsible for its desirable attributes or is essential to practicing the inventions herein described. Certain terminology may be used in the following description for the purpose of reference only, and thus are not intended to be limiting. For example, terms such as “above” and “below” refer to directions in the drawings to which reference is made. Terms such as “front,” “back,” “left,” “right,” “rear,” and “side” describe the orientation and/or location of portions of the components or elements within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the components or elements under discussion. Moreover, terms such as “first,” “second,” “third,” and so on may be used to describe separate components. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. FIG.1depicts an example traditional dental drill bit10drilling a hole20into a jaw bone30in order to prepare the jaw bone30for receiving a dental implant. Long-term success of a dental implant can depend on proper preparation of the implant site. For example, the torque required to advance the implant into the jaw bone30(also referred to as “insertion torque”) can serve as an indication of initial stability of the implant. Implant stability can be an important factor for implant osseointegration and immediate loading. Given that the jaw bone30can consist of different bone types and/or each patient may have a jawbone of different quality, orientation and/or density, the method of preparing the jaw bone30to receive an implant may need to be tailored according to the density, orientation and/or quality of the bone at the site of implantation. For example, failure to remove a sufficient amount of bone from an implant site having high-density bone can result in a high insertion torque, which can harm the surrounding bone. Removing too much bone from an implant site having low-density bone can result in a low insertion torque, which can be indicative that implant micro-motion will frustrate osseointegration. FIG.2illustrates a traditional method of preparing the jaw bone30to receive a dental implant that employs relatively complex drill protocols with multiple steps and decisions, especially for dense bone situations. For example, a dense bone drilling protocol may include up to seven drills and taps, including: a precision drill11, a 2-mm-diameter tapered drill13, a first direction indicator15, a 3.5-mm-diameter tapered drill17, a 4.3-mm-diameter tapered drill19, a 5.0-mm-diameter tapered drill21, a second direction indicator23, a 5.0-mm-diameter dense bone drill25, and a 5.0-mm-diameter screw tap tapered drill27. Dental implant manufacturers provide guidelines on which combination of tools to use, in which bone quality situations, to achieve the desired insertion torques. In some situation, a clinician must first estimate local bone quality before choosing which drill protocol to follow. If the estimation of bone quality is incorrect, the chosen drill protocol may also be incorrect, which can lead to an insertion torque that is too high or too low. One aspect of the present disclosure is the recognition that in regions having low-density bone, insertion torques can be improved by leaving the low-density bone in place. Moreover, in regions of high-density bone, it can be desired to remove the high-density bone from the site of implantation in order to make room for the incoming implant. Accordingly, it would be advantageous to have an instrument and/or method that can selectively cut away high-density bone from the implant site while leaving low-density bone in place. Such an instrument and/or method may also advantageously simplify drill protocol procedures. FIG.3Ashows a non-limiting, illustrative embodiment of a drill bit100having certain features and advantages of the present disclosure. The drill bit100can have a longitudinal axis102, an apical end104, and a coronal end106. In the illustrated embodiment, the drill bit100is tapered so that the outer dimension of the drill bit100decreases as the drill bit100extends toward the apical end104, as shown inFIG.3A. In some variants and embodiments, the drill bit100is not tapered. For example, in some embodiments, the outer dimension of the drill bit100can remain substantially constant as the drill bit100extends toward the apical end104. The drill bit100can also include an attachment110by which the drill bit100can connected to a drilling machine (not shown) and/or handle (not shown). The attachment110can be at the coronal end106of the drill bit100and can be in certain embodiments coupled to the drill bit100and/or formed integrally with the drill bit100. The drill bit100can be rotated about the longitudinal axis102as described below to form a hole in a patient's jawbone. With continued reference toFIG.3A, the drill bit100can have a guide thread113that extends radially outward from a drill bit core120of the drill bit100. In the illustrated embodiment, drill bit core120is tapered so that the outer dimension of the drill bit core120decreases as the drill bit100extends toward the apical end104. As with the drill bit100, in other embodiments, the drill bit core can have substantially cylindrical or taper in a different manner. In the illustrated embodiment, the guide thread113is not a working tap but is instead configured to guide the drill bit100in and out of the bone in a controlled manner while allowing measurement of the insertion torque to determine the bone quality. In this way, the guide thread113can aid in providing an objective measurement of bone quality and thereby reduce error that may arise from a subjective determination of the clinician regarding bone quality. The guide thread113controls the insertion speed relative to the number of revolutions of the drill bit100. The full insertion of the drill bit100in the bone is reached after a constant number of revolutions and therefore, after full insertion, the maximum torque measured by the drill unit or a torque wrench is directly related to the average bone quality over the length. The decision to use one drilling protocol over another can be based on the insertion torque of the drill bit100. For example, if the insertion torque is below a certain level, the clinician may elect to use a drilling protocol that is designed for low-density bone. If the insertion torque is above a certain level, the clinician may elect to use a drilling protocol that is designed for high-density bone. In another embodiment, if the insertion torque of the drill bit100is below a certain level, the full insertion depth may not be needed (for example in case of soft bone), thus creating a shorter and smaller osteotomy. This would be the case in low quality or softer bone. For a human being, the bone density may vary from 16 g/cm3 (soft bone) to 80 g/cm3 (hard bone). In hard bone, the tool would be used to the full depth, thus creating a longer and larger osteotomy. The guide thread113can be adapted to allow the drill bit100to be advanced into the bone in a controlled fashion, at a low speed (e.g., about 10-100 rpm), without irrigation, or a combination thereof. Low-speed drilling can generate less heat than high-speed drilling, making low-speed drilling potentially less harmful to the bone tissue than high-speed drilling. Drilling methods that avoid irrigation can have biological benefits for bone healing by not removing (e.g., washing) bone chips and blood out of the osteotomy. FIG.3Bshows a transverse cross-sectional view of the drill bit core120of the drill bit100taken a point along the longitudinal axis102of the drill bit100. For the sake of clarity, the guide thread113is not shown on the outer surface of the drill bit core120in the cross-sectional view. The drill bit core120can have a non-round or non-circular cross-sectional shape along a length l (in the longitudinal direction) of the drill bit100with the cross-sectional shape being taken along a plane that is generally perpendicular to the longitudinal axis102of the drill bit100as shown inFIG.3A. In one embodiment, the drill bit core120has a non-round cross-sectional shape over the entire length of the drill bit core120(or of the portion of the drill bit100intended to be in contact with the bone) and in certain embodiments, the non-round cross-sectional shape can extend over 50 to 90% of the length of the drill bit core120. In the illustrated embodiment, the shape of non-round cross-sectional shape of the drill bit core120can remain generally constant over the length of the drill bit core120. For example, in an embodiment in which the drill bit core120tapers such that the outer dimension of the drill bit core120decreases as the drill bit100extends toward the apical end104, the non-round cross-sectional shape of the drill bit core120can remain generally constant while changing in dimensions. In other embodiments, the drill bit core120can have more than one non-round cross-sectional shape over the length of the drill bit core120. The drill bit core120can have a minimum radius202and a maximum radius204. The drill bit100can be rotated about the longitudinal axis102, as indicated inFIG.3Bby the semi-circular arrow201. As the drill bit100is rotated about the longitudinal axis102, the minimum radius202will sweep out an inner circle212, and the maximum radius204will sweep out an outer circle214. Accordingly, a reference point on the surrounding bone will be pushed radially outward as the maximum radius204approaches the reference point. The reference point can reach a maximum displacement301when the maximum radius204arrives at the reference point. After the maximum radius204passes the reference point, the reference point can move radially inward to occupy the space vacated by the rotating drill bit100. The reference point can reach a minimum displacement301′ when the minimum radius202arrives at the reference point. In this way, the surrounding bone can move back and forth across a working margin302, as indicated by the double-headed arrow inFIG.3B. The drill bit100can form a compression zone220corresponding to the region of the drill bit100that compresses the surrounding bone. For example, in the illustrative embodiment shown inFIG.3B(in which the drill bit100is rotating in the clockwise direction), the compression zone220extends from the maximum radius at the twelve o'clock position of the drill bit core120to the minimum radius at the two o'clock position of the drill bit core120. The drill bit100can have a decompression zone222corresponding to the region of the drill bit100that allows decompression of the surrounding bone. For example, in the illustrative embodiment shown inFIG.3B, the decompression zone222can extend from the minimum radius at the two o'clock position of the drill bit core120to the maximum radius at the four o'clock position of the drill bit core120. In some variants, the drill bit100can include more than one compression zones220and decompression zones222. For example, the tri-oval embodiment ofFIG.3Bhas three compression zones220and three decompression zones222. Modified embodiments can include more or less compression zones and/or three compression zones with different shapes. Moreover, as noted above, the drill bit core120can have regions in which the non-round cross-sectional shape of the drill bit core120can be different or change. In addition, in the illustrated embodiment tri-oval embodiment includes three compression and decompression zones that have similar dimensions that fluctuate from the same maximum radius to minimum radius. However, in modified embodiments, the compression and decompression zones can fluctuate from maximum radii to minimum radii of different dimensions such that a different amount of compression and/or decompression occurs in each zone. An aspect of certain embodiments of the disclosure is the recognition that the surrounding bone can have a recovery time defined as the time required for the surrounding bone to move from the maximum displacement301to the minimum displacement301′. The recovery time of the surrounding bone can depend on the quality of the bone. For example, hard bone can have a shorter recovery time compared to soft bone. Thus, hard bone will tend to move more quickly from the maximum displacement301to the minimum displacement301′ than will soft bone. As discussed below, the drill bit100can be adapted to exploit the difference in recovery times between the hard and soft bone so that the drill bit100can selectively cuts hard bone while leaving soft bone intact or disproportionately cut hard bone as compared to softer bone. The drill bit core120can include a cutting flute230. The cutting flute230can have a cutting edge232and a trailing edge234. The cutting edge232can be a cutting distance233from the longitudinal axis102, which will be equal to the radius or rotation of the cutting edge232. The trailing edge234can be a trailing distance235from the longitudinal axis102, which will be the radius of rotation of the trailing edge234. The cutting flute230can be positioned in the compression zone220, as illustrated inFIG.3B. Referring toFIG.3B, by positioning the cutting flute230in the compression zone220, the cutting distance233can be larger than the trailing distance235. The cutting edge232can be positioned within the working margin302, as illustrated inFIG.3B. In other words, the cutting distance233can be intermediate to the maximum displacement301and minimum displacement301′ of the surrounding bone. The cutting edge232can sweep out a cutting circle213that can be interposed between the inner and outer circles212,214that are swept out by the minimum and maximum radii of the drill bit core120. The region between the outer circle214and the intermediate circle213represents a “no-cutting” zone because bone in this region will not encounter the cutting edge232as the cutting edge232passes by the bone. In some embodiments, the width of the “no-cutting” zone can be about 50 μm. The region between the intermediate circle213and the inner circle212represents a “cutting” zone because bone in this region will be cut by the cutting edge232as the cutting edge232passes by the bone. The circumferential placement of the cutting edge232and the rotational speed of the drill bit100can be adjusted so that as the cutting edge232passes by the bone, the hard bone has had sufficient time to enter the “cutting” zone while the slower recovering soft bone remains in the “no-cutting” zone. A rotation time (RT) can be defined as the time needed for the cutting edge232to travel the distance between the cutting edge232and the preceding maximum of the drill bit core120. Referring toFIG.3B, RT would be equal to the time needed for point A to travel to line B. A soft bone recovery time (SBRT) can be defined as the time needed for the soft bone to return from the outer circle214to the intermediate circle213. A hard bone recovery time (HBRT) can be defined as the time needed for hard bone to return from the outer circle214to the intermediate circle213. The drill bit100and drill speed (e.g., rpm) can be tuned so that two criteria are met: (1) SBRT>RT, thereby avoiding cutting soft bone; and (2) HBRT<RT, thereby cutting hard bone. Parameters that can be considered when designing the drill bit100include: the difference in recovery times between hard and soft bone, the difference between the maximum radius of the drill bit core120and the radius of the cutting edge232, the circumferential placement of the cutting flute230, the rotational speed of the drill bit100, the rate of radial change of the outer surface of the drill bit core120, and the insertion speed of the drill bit100. Referring toFIGS.4A-4B, the drill bit100of the present disclosure can include different configurations of the drill bit core120. For example, the drill bit100can include a plurality of tri-oval drill bit cores120that are interlinked in a helical configuration to form a screw-like structure that extends to the apical end104of the drill bit100. The drill bit cores120of the illustrated drill bit100can taper in the apical direction. However, in some variants, the outer dimension of the drill bit cores120can remain substantially constant along the length of the drill bit100. As shown inFIG.4A, in an embodiment, the cutting edges232of the drill bit core120can be aligned with one another along a line107that extends from the apical end104toward the coronal end106of the drill bit100, thereby forming a straight or substantially straight cutting flute230in which the line107extends generally parallel to the longitudinal axis102of the drill bit100. As shown inFIG.4B, in some variants, the cutting edges232of the drill bit core120can be aligned with one another along a curve109that extends from the apical end104toward the coronal end106of the drill bit100, thereby forming a curved cutting flute232. The drill bit core120can taper or can have a substantially constant outer dimension along the length of the drill bit100. In the illustrated embodiment, the curve109bends generally in the same direction of a helical thread on the drill bit core120(e.g., counter-clockwise toward the coronal end106). In some variants, the curve109can bend generally in the direction opposite of the helical thread of the drill bit cores120. Referring toFIG.4C, the drill bit100can include a plurality of planar tri-oval drill bit cores120that are aligned substantially perpendicular to the longitudinal axis102of the drill bit. The planar tri-oval drill bit cores120can be spaced apart from one another, thereby forming a gap111between adjacent planar tri-oval drill bit cores120. In the illustrated embodiment, the drill bit cores120near the apical end104of the drill bit100have a smaller outer dimension than the drill bit cores120toward the coronal end106of the drill bit. In other words, the drill bit100tapers toward the apical end104. However, in some variants, the outer dimension of the drill bit cores120can remain substantially constant along the length of the drill bit100. In the illustrated embodiment, the cutting surfaces232of adjacent drill bit cores120are circumferentially shifted relative to one another so that the cutting surfaces232lie along a curve109, thereby forming a disjointed cutting flute230that spirals around the outer surface of the drill bit100. In some variants, the cutting surfaces232of the plurality of planar tri-oval drill bit cores120align with one another along a line, as described above with regard toFIG.4A. Referring toFIG.4D, the maximum outer dimension of the drill bit core120can taper and shift circumferentially in the apical direction in an uninterrupted manner, thereby producing a spiraling and continuous cutting flute230. A spiraling cutting flute can facilitate removal of cut material (e.g., bone chips) from the osteotomy, as discussed below. In the illustrated embodiment, the position of the cutting edge232relative to the maximum outer dimension of the drill bit core120remains substantially fixed along the length of the drill bit100. As shown inFIG.4D, the trailing edge234can align along a curve105that spirals around the longitudinal axis102. The cutting edge232can also align along a curve that is substantially parallel to the curve105. The drill bit100of the present disclosure can include various configurations of the cutting edge232and of the maximum and minimum dimensions of the drill bit core120. For example, the position of the maximum and minimum outer dimensions of the drill bit cores120can be aligned along the length of the drill bit, as shown inFIG.4A. In certain variants, the position of the maximum and minimum outer dimensions of the drill bit cores120can shift circumferentially along the length of the drill bit, as shown inFIG.4C. The position of the cutting edge232relative to the maximum outer dimension of the drill bit cores120can remain constant along the length of the drill bit100, as shown inFIG.4A. The position of the cutting edge232can shift toward or away from the maximum outer dimension of the drill bit core120. In some variants, both the position of the maximum outer dimension of the drill bit cores120and the position of the cutting edge232relative to the maximum outer dimension of the drill bit core120can shift circumferentially along the length of the drill bit100. Moreover, the aforementioned variations of the drill bit core120can be achieved on a drill bit core120that is continuous along the length of the drill bit100(as inFIG.4D) or on a drill bit core120that is discontinuous (as inFIG.4C). FIG.5Ais a non-limiting, illustrative embodiment of the drill bit100having an oval-shaped drill bit core120.FIG.5Bshows a cross-section of the drill bit core120along a plane that is perpendicular to the longitudinal axis102of the drill bit100. The maxima of the oval-shaped drill bit core120can be twisted in sync with the cutting flute230. The guide thread113can have a height that is defined as the distance the guide thread113extends radially away from the drill bit core120. The guide thread113can have a substantially round profile, e.g., a substantially circular profile, while the core120can have an oval-shaped profile. Thus, the height of the guide thread113can vary along the circumference of the drill bit core120, with the height of the guide thread113being greatest at the minima of the oval-shaped drill bit core120and the height of the guide thread113being least at the maxima of the oval-shaped drill bit core120. FIG.5Cis an end view of the drill bit100from the apical end104. As shown inFIG.5C, as the drill bit100tapers in the apical direction, the ovality of the drill bit core120can increase in the apical direction. The apical tip of the drill bit100can have the highest eccentricity. The eccentricity (ratio between the maximum and minimum radii of the drill bit core120) is a consequence of the ovality, which is the absolute difference between the maximum and minimum radii of the drill bit core120. In other words, the transverse cross-section of the drill bit core120can be more round toward the coronal end106of the drill bit100compared to the transverse cross-section of the drill bit core120toward the apical end104of the drill bit100. This is because in some variants the working margin302(shown inFIG.3B) can be substantially constant along the length of a drill bit100that tapers toward the apical end104. For example, in the illustrated embodiment, the working margin302can remain about 150 μm along the length of the drill bit100, while the outer diameter of the drill bit core120can taper from about 4 mm at the coronal end106of the drill bit to about 2 mm at the apical end104of the drill bit. At the apical tip, the cutting edge232can be at about 40° from the maximum radius of the oval-shaped drill bit core120. In one embodiment, the eccentricity can vary over the full length of the drill bit core120such that it is higher at the apical tip. In another embodiment, the apical tip has a round shape at least on a portion of the length of the drill core120to allow insertion of the drill bit and because very little cutting occurs at the tip. The eccentricity can increase after the round apical section and then decrease toward the coronal end. This round section can extend, for example up to 2 mm along the longitudinal axis of the implant from the apical end104of the drill bit. Referring toFIG.6, the attack angle of the cutting edge232can be modified to make the drill bit100more or less aggressive at cutting the surrounding bone. In the illustrated embodiment, the cutting edge232forms and angle238of about 50° with the maximum radius204of the drill bit core120. In some embodiments, the angle238can be at least about: 10°, 20°, 30°, 40°, 50°, or otherwise. In certain variants, the cutting flute230can be made larger by moving the cutting edge232and trailing edge234apart from one another. In some embodiments, the cutting flute230can be made large in order to accommodate bone chips that are cut by the cutting edge232. In some variants, the drill bit100can include a cavity240for collecting bone chips that are cut from the surrounding bone by the cutting edge232. In other embodiments, the cutting edge can be placed on the maximum radii. In the illustrated embodiment ofFIG.6, the cutting edge232has been positioned near to the maxima of the drill bit core120. As discussed above, by positioning the cutting edge232closer to the maxima of the drill bit core120, RT can be increased because it can take longer for the cutting edge232to arrive at the site of the bone that was compressed by the preceding maxima. Also, by positioning the cutting edge232closer to the maxima, the cutting distance233(shown inFIG.3B) can be enlarged. Enlarging the cutting distance233can reduce SBRT and HBRT because the distance from the maximum displacement301to the cutting zone is reduced. Thus, the combined effect of a longer RT and a shorter SBRT can result in more soft bone being cut by the drill bit100. Similarly, the combined effect of a longer RT and a shorter HBRT can result in more hard bone being cut by the drill bit100. The illustrated drill bit100is an aggressive tri-oval drill bit100that may cut soft bone as well as hard bone, although the extent of hard bone cutting can be greater than the extent of soft bone cutting because hard bone will recover faster and therefore extend further into the cutting zone than will the soft bone. Referring toFIGS.7A-7D, the drill bit core120of the drill bit100can have different cross-sectional shapes. The cross-sectional shape of the drill bit core120can be configured to minimize cutting soft bone, minimize friction, minimize heat, and/or maximize directional control (e.g., avoid wobbling) or maximize cutting of hard bone. In the illustrated embodiments, the direction of rotation of the drill bit core120is indicated by the arrow210.FIG.7Ashows a drill bit core120having a substantially rounded profile. The radial distance of the cutting edge232is substantially equal to the radial distance of the trailing edge234. In the shown embodiment, the drill bit core120has two cutting flutes230that are circumferentially spaced 180° apart from one another.FIG.7Bshows an oval-shaped drill bit core120having two cutting flutes230that are circumferentially spaced 180° apart from one another, with the radial distance of the cutting edge232being substantially equal to the radial distance of the trailing edge234. In some variants, the ovality of the drill bit120can be small as indicated by the dashed core121.FIG.7Cshows a tri-oval drill bit core120having three cutting flutes230circumferentially spaced about 120° apart from an adjacent cutting flute232. In the illustrated embodiment, the radial distance of the cutting edge232is substantially equal to the radial distance of the trailing edge234.FIG.7Ddepicts a cruciform drill bit core120having four cutting flutes230circumferentially spaced about 90° apart from an adjacent cutting flute232. In the illustrated embodiment, the radial distance of the cutting edge232is substantially equal to the radial distance of the trailing edge234. As shown inFIG.7D, the drill bit core120can include one or more protrusions245. In some variants, the protrusion245can extend radially beyond the radial distance of the cutting edge232by about 50 μm. Referring toFIGS.8A-8C, the drill bit100can have a variety of macro-shapes. The macro-shape of the drill bit100can be defined by the outer dimension of the drill bit core120along the longitudinal axis102of the drill bit100. The shape of the osteotomy will match the macro-shape of the drill bit100that was used to produce the osteotomy. Referring toFIG.8A, the macro-shape of the drill bit100can be tapered in the apical direction. The taper can be pointed or blunted. The taper can be constant along the length of the drill bit100. The taper can vary along the length of the drill bit100. For example, the taper in some regions of the drill bit100may be steeper than in other regions of the drill bit100. In some embodiments, the macro-shape of the drill bit100is selected to match the macro-shape of the implant. As shown inFIG.8B, the drill bit100can have an apical base404and a coronal base406. The apical base404is the apical-most surface of an apical portion414, and the coronal base406is the coronal-most surface of a coronal portion416, as shown inFIG.8B. In some variants, the coronal base406can have an outer dimension405that is greater than the outer dimension403of the apical base404. For example, in the illustrated embodiment, the drill bit100can have a coronal base406that has an outer dimension405of about 3.2 mm wide and an apical base404that has an outer dimension403of about 2 mm wide. The coronal portion416can taper in the apical direction while the apical portion has a substantially constant width. The coronal portion416can have a longitudinal length409and the apical portion414can have a longitudinal length407. In some embodiments, the coronal portion416has a longitudinal length409of about 13 mm and the apical portion414has a longitudinal length407of about 2 mm. Referring toFIG.8C, the drill bit100can have an intermediate portion418interposed between the coronal portion416and the apical portion414. In some embodiments, the drill bit100can have more than one intermediate portion418, as shown in the embodiment on the far right ofFIG.8A. The intermediate portion418can have a coronal surface420that is the coronal-most portion of the intermediate portion418. In the embodiment depicted inFIG.8C, the drill bit100can have a coronal base406that has a width of about 3.8 mm, a coronal surface420that is about 3.2 mm, and an apical base404that is about 2 mm. The longitudinal length of the coronal portion416can be about 12 mm, the longitudinal length of the intermediate portion418can be about 1 mm, and the longitudinal length of the apical portion414can be about 2 mm. FIG.9depicts a non-limiting, illustrative embodiment of the drill bit100having a twisted and tapered oval drill bit core120, as described above. In some variants, the cutting flute230can be adapted to transport cut bone out of the osteotomy. For example, in the illustrated embodiment, the cutting flute230has a spiral configuration at a pitch of about 45°. The pitch of the cutting flute230can be selected so that bone chips do not get stuck in the cutting flute230and are transported out of the osteotomy. In the illustrated embodiment, the cutting flute230wraps in the direction of rotation of the drill bit100, which is clockwise toward the apical end104. This configuration can transport bone chips toward the coronal end106of the drill bit100and out of the osteotomy when the drill bit100is rotated in the direction for cutting bone. The depicted embodiment has guide threads113with a round profile. The guide threads113can be substantially perpendicular to the longitudinal axis102, as shown inFIG.9. In some variants, the guide threads113can be angled toward the apical end104of the drill bit100. As the function of the guide threads113is only to control the insertion of the tool and not cut a thread for the implant to be subsequently placed, the pitch of the guide thread does not match the one of the implant. This has the advantage that the user does not have to be concerned about following the same thread path. FIG.10depicts a schematic of an embodiment of a method of use of the drill bit100of an embodiment of the present disclosure to prepare an osteotomy for receiving an implant. As discussed, the drill bit100can be adapted to reduce the number of tools and/or steps needed to prepare the osteotomy. The procedure of preparing an osteotomy for receiving an implant may be referred to herein as “normalizing” the bone. The drill bit100can be adapted to normalize the bone with the use of only one drill bit100. In some variants, two or more drill bits100can be used to normalize the bone. As shown inFIG.10, the method may include a step600in which a hole is drilled into the bone using a pilot drill bit that has a diameter smaller than the drill bit100. In some embodiments, the pilot step600uses a pilot drill bit having a diameter of 2 mm. The pilot step600can be performed using irrigation. The drill speed in step600can be about 800 rpm. Still referring toFIG.10, the method of preparing the osteotomy for receiving an implant can include a normalizing step602. A first drill bit100according to an embodiment described herein can be used in the normalizing step602. The first drill bit100can be selected based on the implant that will be implanted into the osteotomy. In some variants, the first drill bit100can be used to enlarge the hole created by a drilling step600. In certain variants, the normalizing step602can be performed without performing a preceding drilling step600. The normalizing step602can be performed with or without irrigation. The normalizing step602can be performed using a drill speed of about 50 to 100 rpm. In some variants, the normalizing step602can include a measuring step604that determines the insertion torque. The measuring step604can determine the insertion torque by sensing the torque applied to the drill bit100. The measuring step604can include an evaluating step606that evaluates whether the normalization of the bone is successful. In some variants, the evaluating step606can compare an actual insertion torque as measured in the measuring step604with a desired insertion torque. The desired insertion torque can be determined by a look-up table that correlates implant success to insertion torque. In some variants, the normalization can be adequate when the insertion torque is less than or equal to about 40 Ncm. In some embodiments, the desired insertion torque may be modified based on the type of implant that is intended to be installed in the osteotomy. The method of preparing the osteotomy for receiving an implant can include a further normalizing step608. The further normalizing step608can be performed using a second drill bit100′ according to an embodiment described herein. The second drill bit100′ can have a different macro-shape compared to the first drill bit100. The second drill bit100′ can have a different configuration of the drill bit core120compared to the first drill bit100. The method of preparing the osteotomy for receiving an implant can be iterative. For example, the method can proceed from the further normalization step608to the measuring step604and the evaluating step606multiple times until the normalization is adequate to receive an implant. In another embodiment during the normalization step602the torque is measured, by a drilling unit or controller connected to the drill bit100, at or until a predefined length of the drill bit100has been inserted into the hole created by a drilling step600. Said predefined length can be controlled mechanically, for example, the drill bit can have a removable stop whose position is calibrated for soft bone indicating the maximum drilling length for the torque measurement. Alternatively, the predefined length can be controlled by a software of the drill unit measuring the torque. If the torque measured until or at said predefined length is above a certain value indicating the presence of hard bone, then the drill unit can indicate to the user to continue drilling beyond the predefined length. The removable stop can be removed and drilling resumes until a second fixed stop, whose position is calibrated for hard bone. If the torque measured until or at said predefined length is below a certain value indicating the presence of soft bone the drill unit can indicate to the user to stop drilling and to start implanting an implant620. Furthermore the drill unit can be provided with a screen or any kind of user interface indicating to the user the quality of the bone to help the decision. The type of bone can also be indicated by the drilling unit to the user using and audible signal such as an alarm. Alternatively the drilling unit can directly control the insertion depth based on the torque measured and stop the drilling with first drill bit100after a specified number of turns. The drill bit100of the present disclosure can be used in a method of implanting an implant into a jaw bone30(shown inFIG.1). The method of implanting an implant into a jaw bone30can include the method of preparing the osteotomy for receiving an implant described above. The method of implanting an implant into a jaw bone30can include an installing step610. The installing step610can include implanting an implant620into an osteotomy prepared with the drill bit100. The installing step can be performed with or without irrigation. The installing step610can be performed at a rotational speed of the implant620of about 50 rpm. In some variants, the installing step610can be performed at a rotational speed of the implant620of about 25 rpm. FIG.11is a schematic representation of another embodiment of a method of use of the drill bit100of an embodiment of the present disclosure to prepare an osteotomy for receiving an implant. As is shown inFIG.11, the method may include a pilot step700in which a hole is drilled into the jaw bone730using a pilot drill bit that has a diameter smaller than the drill bit100. The hole created in the pilot step700serves as a guiding hole for the following steps. The hole created in the pilot step700may be an underprepared site. The pilot step700can be performed using irrigation. The drill speed in the pilot step700can be about 800 rpm. For example, the pilot drill bit used in the pilot step700may have a diameter in the range of 1.8 to 2.4 mm. In some embodiments, the pilot step700uses a pilot drill bit having a diameter of 2 mm. Still referring toFIG.11, the method of preparing the osteotomy for receiving an implant can include a first normalizing step702. A first drill bit100according to an embodiment described herein can be used in the first normalizing step702. The first drill bit100can be selected based on the implant that will be implanted into the osteotomy. In some variants, the first drill bit100can be used to enlarge the hole created by the pilot step700. In certain variants, the first normalizing step702can be carried out without performing a preceding drilling step700. The first normalizing step702can be performed with or without irrigation. The first normalizing step702can be performed using a drill speed of about 50 to 100 rpm, in particular, using a drill speed of about 50 rpm. In particular, the first drill bit100may be configured such that the first cutting edge is a first radial distance from the longitudinal axis and a maximum outer dimension of the drill bit core is a second radial distance from the longitudinal axis, wherein the second radial distance is larger than the first radial distance. The drill bit core of the first drill bit100may have a no-cutting zone defined as the difference between the second radial distance and the first radial distance. The method illustrated inFIG.11may comprise a first evaluating step704in which it is evaluated whether the first drill bit100can be fully inserted into the osteotomy in the first normalizing step702. In this first evaluating step704, it is determined whether the first drill bit100is properly inserted into the osteotomy, i.e., inserted along a sufficient length of the first drill bit100, and the torque applied to the first drill bit100is measured. Based on the results of this evaluation, i.e., on the results of determining the insertion length or depth and of measuring the applied torque, the next steps are selected, as will be further detailed in the following. For example, in order to determine whether the first drill bit100is properly inserted, the first drill bit100may be provided with a marking, such as a shoulder, which indicates an insertion length of the first drill bit100that is equal or at least similar to the length of the implant720to be implanted into the osteotomy. If it is found that, in the first normalizing step702, the first drill bit100has been inserted into the osteotomy along such a length that the marking is arranged at the coronal end of the osteotomy, it is determined that the first drill bit100is inserted along a sufficient length. The torque applied to the first drill bit100can be measured, for example, by a drilling unit or a controller connected to the first drill bit100, e.g., when or until a predefined length of the first drill bit100has been inserted into the hole created in the pilot step700. In some variants, the first evaluating step704can compare an actual insertion torque as measured in this step with a desired insertion torque. The desired insertion torque can be determined by a look-up table that correlates implant success to insertion torque. In some variants, the normalization can be adequate when the insertion torque is less than or equal to about 40 Ncm. In some embodiments, the desired insertion torque may be modified based on the type of implant that is intended to be installed in the osteotomy. If the first evaluating step704provides a positive result, i.e., a result indicating that the first drill bit100has been inserted along a sufficient length and the measured torque has a desired value, an installing step706is performed. In the installing step706, the implant720is inserted into the osteotomy prepared with the drill bit100. The installing step706can be performed with or without irrigation. The installing step706can be performed at a rotational speed of the implant720of about 50 rpm. In some variants, the installing step706can be performed at a rotational speed of the implant720of about 25 rpm. In the installing step706, the implant720may be inserted into the jaw bone730under the application of an insertion torque in the range of about 25 to 70 Ncm (seeFIG.11). If the first evaluating step704provides a negative result, a second normalizing step708is performed. The second normalizing step708can be performed using a second drill bit100′ according to an embodiment described herein. The second drill bit100′ can have a different macro-shape compared to the first drill bit100. The second drill bit100′ can have a different configuration of the drill bit core120compared to the first drill bit100. In particular, the second drill bit100′ may be configured such that the first cutting edge is arranged at a maximum of the non-round or non-circular portion of the drill bit core or arranged so as to be circumferentially spaced from a maximum of the non-round or non-circular portion of the drill bit core in a direction which is opposite to the rotation direction in which the second drill bit100′ is rotated when inserting it into the osteotomy. The second drill bit100′ may be configured such that the first cutting edge is disposed outside the first compression zone of the drill bit core. The method of preparing the osteotomy for receiving an implant can be iterative. For example, the method can proceed from a further normalization step, e.g., the second normalizing step708, to an evaluating step, which may be performed in substantially the same or a similar manner as the first evaluating step704, multiple times until the normalization is adequate to receive the implant720. In particular, in the method illustrated inFIG.11, the second normalizing step708may be followed by a second evaluating step710in which it is evaluated whether the second drill bit100′ can be fully inserted into the osteotomy in the second normalizing step708. The second evaluating step710can be performed in substantially the same manner as detailed above for the first evaluating step704. If the second evaluating step708provides a positive result, an installing step712is performed. In the installing step712, the implant720is inserted into the osteotomy prepared with the drill bit100′, e.g., in the same manner as detailed above for the installing step706. In the installing step712, the implant720may be inserted into the jaw bone730under the application of an insertion torque in the range of about 35 to 70 Ncm (seeFIG.11). If the second evaluating step708provides a negative result, a drilling step714is performed. The drilling step714can be performed using a drill bit that has a diameter larger than that of the pilot drill bit used in the pilot step700. For example, the drill bit used in the drilling step714may have a diameter in the range of 3.4 to 3.9 mm. The drill bit used in the drilling step714may be a dense bone drill bit. The drilling step714can be performed using irrigation. The drill speed in the drilling step714can be about 800 rpm. The drilling step714may be followed by another evaluating step (not shown inFIG.11). This further evaluating step may be performed in substantially the same manner as detailed above for the first evaluating step704. After the drilling step714, if the further evaluating step has provided a positive result, an installing step716may be performed. In the installing step716, the implant720is inserted into the osteotomy prepared in the drilling step714, e.g., in the same manner as detailed above for the installing step706. In the installing step716, the implant720may be inserted into the jaw bone730under the application of an insertion torque in the range of about 35 to 70 Ncm (seeFIG.11). In the first and second normalizing steps702,708detailed above, the threshold of the torque applied to the first drill bit100and the second drill bit100′, respectively, is chosen such that it is smaller than the torque threshold of the implant720. The implant620used in the above mentioned methods can be an implant as described in the International Patent Application PCT/EP2017/051953 entitled “Dental Implant, Insertion Tool for Dental Implant and Combination of Dental Implant and Insertion Tool”, under Attorney Docket No. P1542PC00, and filed on the same day as the present application by the Applicant, Nobel Biocare Services AG, the entirety of this application is hereby expressly incorporated by reference herein in particular the embodiments of FIGS.1,2,10-12,13-15,20and21,34and35and related paragraphs of said application are expressly incorporated by reference herein. Said implant can be a dental implant, comprising: a core body having an apical end, a coronal end, and an outer surface extending along a longitudinal direction between said apical end and said coronal end; andat least one thread extending outwardly from said core body, wherein said core body comprisesa first core shaped zone, in which first core shaped zone the cross-section of said core body has a number of main directions in which the radius measuring the distance between the center of the cross section and its outer contour takes a relative maximum value and thus a higher value than in neighboring orientations,a core circular zone, in which core circular zone the cross-section of said core body is basically circularly shaped, anda core transition zone positioned between said core shaped zone and said core circular zone, in which core transition zone the geometry of the cross-section of said core body, as a function of a parameter characteristic for a coordinate in said longitudinal direction, changes continuously from a basically circular shape next to said core circular zone to a shape in which the cross-section of said core body corresponds to the shape of the cross section in said core shaped zone. Said implant can also have a second core shaped zone, in which second core shaped zone the cross-section of said core body has a number of main directions in which the radius measuring the distance between the center of the cross section and its outer contour takes a relative maximum value and thus a higher value than in neighbouring orientations, and wherein in said first core shaped zone a core eccentricity parameter defined as the ratio of the maximum radius of the cross section of said core body to its minimum radius is larger than in said second core shaped zone. Such an implant can also comprise at least one thread extending outwardly from said core body, said thread defining a thread outer volume, wherein said thread comprisesa first thread shaped zone, in which thread shaped zone the outer cross-section of said thread outer volume has a number of main directions in which the radius measuring the distance between the center of the cross section and its outer contour takes a relative maximum value and thus a higher value than in neighbouring orientations,a thread circular zone, preferably next to said apical end, in which thread circular zone the outer cross-section of said thread outer volume is basically circularly shaped, anda thread transition zone positioned between said thread shaped zone and said thread circular zone, in which thread transition zone the geometry of the outer cross-section of said thread outer volume, as a function of a parameter characteristic for a coordinate in said longitudinal direction, changes continuously from a basically circular shape next to said thread circular zone to a shape in which the outer cross-section of said thread outer volume corresponds to the shape of the outer cross section in said thread shaped zone. The implant can also comprise a second thread shaped zone in which second thread shaped zone the outer cross-section of said thread outer volume has a number of main directions in which the radius measuring the distance between the center of the cross section and its outer contour takes a relative maximum value and thus a higher value than in neighboring orientations,wherein in said first thread shaped zone a core eccentricity parameter defined as the ratio of the maximum radius of the outer cross section of said thread outer volume to its minimum radius is larger than in said second core shaped zone. Such an implant can also have a number of cutting flutes provided at least in said transition zone. The dental implant, in particular for insertion into bone tissue of a patient, can also comprise:a core body having an apical end, a coronal end, and an outer surface extending along a longitudinal direction between said apical end and said coronal end;at least one thread extending outwardly from said core body, anda characteristic implant volume defined by said core body or by the thread outer volume as defined by said thread, in which for each value of a parameter characteristic for a coordinate in the implant's longitudinal direction the cross section of said characteristic implant volume is characterized by an eccentricity parameter defined as the ratio of the maximum distance of the contour of this cross section from its center to the minimum distance of the contour of this cross section from its center; wherein said characteristic volume comprisesat least one coronal zone in which said eccentricity parameter has a maximum, preferably a constant, value, said coronal zone extending along the implant's longitudinal axis over a coronal zone length of at least 10% of the total length of the implant;at least one apical zone in which said eccentricity parameter has a minimum, preferably a constant, value, said apical zone extending along the implant's longitudinal axis over an apical zone length of at least 30% of the total length of the implant, and at least one transition zone positioned between said coronal zone and said apical zone in which said eccentricity parameter, as a function of a parameter characteristic for a coordinate in said longitudinal direction, changes continuously, preferably in a linear manner, from a minimum value next to said apical zone to a maximum value next to said coronal zone, said transition zone extending along the implant's longitudinal axis over a transition zone length of at least 10% of the total length of the implant. Such a “non round implant” continues, during it insertion in the jawbone, the bone normalization initiated by a drill bit as above described. According to another aspect the invention also concerns a kit of parts comprising and a drill bit as above defined and an implant, and in particular an implant as above defined. It should be appreciated that certain embodiments and methods described above are in the context of dental surgery and forming a hole in a patient's jawbone to receive a dental implant; however, it should be appreciated that certain features and aspects of the embodiments described herein can also find utility in other surgical applications. For example, certain features and aspects of the embodiments described herein may be used in a drill configured to form a hole in another portion of the body (e.g., bones of the leg, spine, and/or arm) and/or a hole configured to receive a different type of device (e.g., a rod, a spacer, etc.) It should be emphasized that many variations and modifications may be made to the herein-described embodiments, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims. Moreover, any of the steps described herein can be performed simultaneously or in an order different from the steps as ordered herein. Moreover, as should be apparent, the features and attributes of the specific embodiments disclosed herein may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment. Moreover, the following terminology may have been used herein. The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to an item includes reference to one or more items. The term “ones” refers to one, two, or more, and generally applies to the selection of some or all of a quantity. The term “plurality” refers to two or more of an item. The term “about” or “approximately” means that quantities, dimensions, sizes, formulations, parameters, shapes and other characteristics need not be exact, but may be approximated and/or larger or smaller, as desired, reflecting acceptable tolerances, conversion factors, rounding off, measurement error and the like and other factors known to those of skill in the art. The term “substantially” means that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide. Numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also interpreted to include all of the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 1 to 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but should also be interpreted to also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 2, 3 and 4 and sub-ranges such as “about 1 to about 3,” “about 2 to about 4” and “about 3 to about 5,” “1 to 3,” “2 to 4,” “3 to 5,” etc. This same principle applies to ranges reciting only one numerical value (e.g., “greater than about 1”) and should apply regardless of the breadth of the range or the characteristics being described. A plurality of items may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary. Furthermore, where the terms “and” and “or” are used in conjunction with a list of items, they are to be interpreted broadly, in that any one or more of the listed items may be used alone or in combination with other listed items. The term “alternatively” refers to selection of one of two or more alternatives, and is not intended to limit the selection to only those listed alternatives or to only one of the listed alternatives at a time, unless the context clearly indicates otherwise. | 58,648 |
11857392 | DETAILED DESCRIPTION For purposes of better understanding some embodiments of the present invention, as illustrated inFIGS.1A to6of the drawings, reference is first made to the construction and operation of a multifocal intraocular lens (IOL). Multifocal Intraocular lenses (IOL) are designed such that to produce one, two, three or more diffractive orders or foci on the optical axis such that each image focal point is formed on the retina when an object associated with the image is located at a corresponding distance from the eye. Most of the intraocular lenses are designed to have a refractive (lens) focal point and energy flux (power) that corresponds to far vision i.e. the spherical/aspherical surfaces of the lens are designed to focus an image of an object on the retina when the object is located at the far-sighted distance from the eye (>5-6 meters). The diffractive surfaces in most bifocal and trifocal lenses create additional foci at the near (30-40 cm) and intermediate distances (60-80 cm). Most refractive-diffractive IOLs have the same general structure—a lens comprising multiple rings, each ring having a diffractive profile that is scaled to the ring width. The diffractive profiles are repeated along the radius for each Fresnel zone. In some cases, the rings are also scaled vertically (apodization). According to an aspect of the invention there is provided an IOL comprising diffractive steps which are partially inside and partially outside the base curvature of the IOL. In some embodiments, the thickness of the IOL is variable and the curvature is constant. In some embodiments, change in curvature is produced by optimization of the sphericity between steps. According to an aspect of some embodiments of the present invention there is provided an IOL that has a spherical surface and an aspherical surface. In some embodiments, the IOL comprises an asymmetrical number of active diffractive orders along the optical axis of the eye. In some embodiments, the IOL comprises more than three diffractive orders on the optical axis of the eye. In some embodiments, the IOL comprises five diffractive orders on the optical axis. In some embodiments, the IOL comprises a diffractive pattern on one or more surfaces of the lens. In some embodiments, the diffractive pattern comprises a repetitive pattern of diffractive profiles. In some embodiments, the profiles are asymmetrical. Reference is now made toFIGS.1A and1B(not drawn to scale), in whichFIG.1Ais a plan view simplified illustration of a multifocal IOL andFIG.1Bis a cross-section view simplified illustration of a diffractive surface of a multifocal IOL according to some embodiments of the present invention. As shown in the exemplary embodiment depicted inFIG.1A, An IOL100comprises a diffractive surface having a plurality of discrete, adjacent, diffractive, concentric sections or rings102. In some embodiments, the IOL diffractive surface comprises diffractive steps which are partially inside and partially outside the base curvature of the IOL. This induces changes in diffractive status between two steps. In some embodiments, the thickness of the IOL is variable but the curvature is maintained. In some embodiments, change in curvature is produced by optimization of the sphericity between steps. Potential advantages in the described design are in that:1. The designing of the diffractive steps does not change the diffractive profile in between the steps. This allows to have multifocal IOL of any added power and more efficiency for near focal lengths without losing contrast for distance.2. Design of diffractive steps allows rays of light to be parallel to the step which is the ideal condition for diffraction. In some embodiments, the rings are distributed along Fresnel zones (102-1/1022). In some embodiments, and a shown inFIG.1B, an IOL surface150topography features repetitive triangular forms, squared forms or parabolic forms depending on the type of lens. Reference is now made toFIG.2Awhich is a radial, cross-section, simplified illustration of a diffractive surface topography of a portion of the IOL andFIG.2B, which is a graph of distribution of energy flux (power) levels over specific diffractive orders associated with the diffractive surface topography shown inFIG.2A. FIG.2Adepicts a radial cross-section or radial phase profile200of a diffractive surface topography through a concentric ring. The specific cross-section of the radial phase profile is generated by using a Gerchberg-Saxton (GS) iterative algorithm.FIG.2Adepicts an exemplary embodiment of a radial phase profile cross-section showing an asymmetrical double-peaked cross-section having a near-symmetric local diffractive surface topography. Radial phase profile200is converted to a height profile which is radially and parabolically integrated to each of the Fresnel zones (rings) of the diffractive lens with a specific focal length. The authors of this disclosure have come to learn that symmetric local diffractive surface topography function combined with an odd number of diffraction diffractive orders e.g., 1, 3, 5, 7 or 9 diffraction diffractive orders, and specifically a number of diffraction diffractive orders greater than three increase the overall light transmission efficiency of the IOL above 90% and in some cases up to at least 93%. In some embodiments, IOL100comprises five diffractive orders on the optical axis. In some embodiments, one of the diffractive orders e.g., the far vision focal length has a high energy flux level. In some embodiments, one of the diffractive orders is entirely suppressed. In some embodiments, the five diffractive orders or foci correspond to the following five diffractive orders: −2, −1, +1 and +2 which are diffracted diffractive orders produced by the diffractive pattern and a single order 0 which is the refractive power produced by the spherical/aspherical surfaces of the IOL. In some embodiments, the spherical/aspherical surfaces of the lens are designed such as to focus an image on the retina when the imaged object is located at an intermediate distance from the eye, between near vision (−30-40 cm) and far vision (several meters). In some embodiments, and as depicted inFIG.2B, of the five diffractive orders, the diffractive order −2, corresponds to far vision has the highest energy flux level. In some embodiments, of the remaining diffractive orders, the diffractive order +2, which corresponds to near vision has the highest energy flux level. In this embodiment, the diffractive order −1 is suppressed. Reference is now made toFIG.3Awhich is a radial, cross-section, simplified illustration of a diffractive surface topography of a portion of the IOL andFIG.3B, which is a graph of energy flux levels distribution over specific diffractive orders associated with the diffractive surface topography shown inFIG.3A. FIGS.3A and3Bshow a design different than that illustrated inFIGS.2A and2Bhowever both have been designed using the same method of profile generation by using a Gerchberg-Saxton (GS) iterative algorithm and conversion of the phase profile to a height profile which is radially and parabolically integrated to each of the Fresnel zones (rings) of the diffractive lens with a specific focal length. FIG.3Adepicts an additional example of a radial cross-section or radial phase profile300of a diffractive surface topography through a concentric ring.FIG.3Adepicts an exemplary embodiment of a radial phase profile showing an asymmetrical double-peaked cross-section having a near-symmetric local diffractive surface topography. Radial phase profile300is converted to a height profile which is radially and parabolically integrated to each of the Fresnel zones (rings) of the diffractive lens with a specific focal length. In some embodiments, and as depicted inFIG.3B, of the five diffractive orders, the diffractive order −2, corresponds to far vision has the highest energy flux level. In some embodiments, of the remaining diffractive orders, the diffractive order +2, which corresponds to near vision has the highest energy flux level and the energy flux level at order 0 is higher than the energy flux level at diffractive order +1. In this embodiment, the diffractive order −1 is suppressed. As shown inFIG.4, which is a graph superimposing radial phase profile300over radial phase profile200demonstrates phase differences between the designs in accordance with some examples of the invention. When using this technique with more than 5 foci (for example 7), the diffractive focal length determines the location of the far focus (diffractive order −3) and near focus (diffractive order +3) and the refractive focal length (spherical surfaces) determines the location of one of the intermediate foci (order 0). In the exemplary embodiment depicted inFIG.4, radial phase profile200comprises phases: 1, 0, 0.333, 0.38 and 0.637, wherein radial phase profile300comprises phases: 1, 0, 0.6, 0.45 and 0.65. In some embodiments, the IOL comprises two zones—a central zone102-1(FIG.1AandFIG.1B) and a peripheral zone102-2. In some embodiments, the diffractive pattern of central zone102-1is not apodized. In some environments, the diffractive pattern of the peripheral zone102-2is not apodized. The height of the diffractive surface topography of zone102-2is maintained constant and does not have a gradual step height reduction when advancing radially outwards in respect to the center height of the IOL. This arrangement and design are planned in diffractive order to vary the intensity distribution when increasing the aperture and allow increased light flux, even if not optimally focused, with pupil dilation (low intensity environmental) light. A potential advantage in this design is in that the apodization design allows for diffraction efficiency near 100% thus minimizing loss of light. For modifying the intensity distribution according to the aperture size, the technique used here is to change the diffractive pattern at any radius of the intraocular lens or at one of the Fresnel Zone (or near one of them) for better performance. For this invention, the design transition occurred at radius—1.228 mm. As shown inFIGS.5A and5B, in whichFIG.5Adepicts an example of a radial cross-section or radial phase profile500of a diffractive surface topography through a concentric ring of the peripheral zone of the IOL in accordance with some embodiments of the invention.FIG.5Adepicts an exemplary embodiment of a radial phase profile cross-section at the IOL peripheral zone102-2showing an asymmetrical single-peaked cross-section having a near-symmetric local diffractive surface topography. In some embodiments, a radial phase profile cross-section at the IOL peripheral zone102-2comprises an asymmetrical double-peaked cross-section having a near-symmetric local diffractive surface topography. Radial phase profile500is converted to a height profile which is radially and parabolically integrated to each of the Fresnel zones (rings) of the diffractive lens with a specific focal length. In some embodiments, and as depicted inFIG.5B, the flux energy level declines from the far diffractive order to the near diffractive order with two suppressed orders at −1 and +1. The phase obtained at the source plane and used in the design (at radius >1.228 mm) depicted inFIGS.5A and5Bis obtained using normalized target intensity [1, 0, 0.5, 0, 0.34] in the Gerchberg-Saxton (GS) algorithm. However, in some embodiments, the other diffractive profile (after transition) can be a different diffractive design based on three or more foci and can be also a monofocal design with full energy at far vision or bifocal with energy at far vision and other foci at intermediate or near vision Also, for fine tuning of the intraocular lens, the entire diffractive height profile (before and after transition from IOL zone102-1to IOL zone102-2) can be tunable. In the exemplary embodiment depicted inFIGS.5A and5B, the first diffractive profile before the transition has been increased by 5% and the second diffractive profile after the transition has been increased by 12%. Our multifocal IOL, based on zero order for intermediate vision, has a high efficiency—over 90%—in the used diffractive orders (−2, −1, 0, 1, 2). Reference is now made toFIG.6, which is a graph of a simulation of a through-focus Modulation Transfer Function (MTF) of the IOL in accordance with some embodiments of the invention. As shown in the exemplary embodiment depicted inFIG.5, three graphs are drawn for three levels of eye pupil diameter: graph602for a 2 mm pupil diameter (i.e., intense light condition), graph604for a 4.5 mm pupil diameter (i.e., low light condition) and graph606for a 3 mm pupil diameter (i.e., normal light condition). The graphs depicted inFIG.6exhibit the biphasic nature of the IOL at all three shown levels of environmental light however, as the level of environmental light decreases changing the pupil diameter from 2 mm to 4.5 mm, the MTF value correspondingly increases on the far-sighted range of the IOL, even though it is limited from a diopter range between approximately 22 and 24.5 to a narrower diopter range between approximately 23 to 23.75 and allows for an improved low-light intensity vision. FIG.7which is a simplified graph illustration depicting a profile of a diffractive portion of an exemplary lens in accordance with some embodiments of the current invention. As shown inFIG.7, the depicted cross-section profile comprises an asymmetrical single-peaked topography comprising a plurality of peaks having a height of between 1.5 and 2.5 uM dispersed along a portion of the lens radius between 0 and 3000 uM. Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween. In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. In addition, where there are inconsistencies between this application and any document incorporated by reference, it is hereby intended that the present application controls. The descriptions of the various embodiments of the present invention have been presented for purposes of illustration but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein. | 16,042 |
11857393 | DETAILED DESCRIPTION OF THE INVENTION The present invention will now be described more fully in detail with reference to the accompanying drawings, in which the preferred embodiments of the invention are shown. This invention should not, however, be construed as limited to the embodiments set forth herein; rather, they are provided so that this disclosure will be complete and will fully convey the scope of the invention to those skilled in the art. FIGS.1-29illustrate an internal bone fixation device100according to the invention. The device may be suitable for use with any number of implant situations, such as long bone reconstruction, knee replacements, both anterior lumbar inter-body fusion and posterior lumbar inter-body fusion, as well as with the foot and ankle. The following disclosure largely discusses the internal bone fixation device100, which may also simply be referred to as an “implant,” in terms of its use with lumbar inter-body fusion, however, it is understood that this is only one example of use and is not limiting in any way. The embodiment shown inFIGS.1-15is particularly advantageous for use as a lumbar interbody fusion device, while the embodiment shown inFIGS.26-29is particularly advantageous as a mid-shaft implant for a long bone. The internal bone fixation device100according to the invention includes a support frame10that bounds and surrounds a porous architecture50. Generally, the frame is shaped to match the shape of the bone regions in which the device100is used for fusion, with approximate geometric shapes ranging from rounded and oval, rectangular or trapezoidal, or rounded rectangles and trapezoids having rounded edges. Generally, any corners are rounded so as to reduce the risk of harming other parts of the body during insertion. FIGS.1-16illustrate the first embodiment of the device100, in which the frame10, best illustrated byFIGS.8-12, includes three layers12. Each layer12includes an inner rim14and an outer rim16. The layers12are connected to one another by a first set of struts18, and the inner rims14and outer rims16are connected to one another by a second set of struts22. Additional layers12may be added in a similar manner to create a larger version of the device.FIG.7illustrates one use of the first embodiment of the device100, with the device100inserted into the disc space between two vertebra V. The outer rim16and inner rim14in this first embodiment generally have a shape that is approximately in the form of an oval or a rectangle or trapezoid with slightly rounded edges, which is generally intended to be the shape of device needed for lumbar interbody fusion. One side of each rim14,16, is slightly narrower than the other. The layers are separated by approximately the same distance from one another, with the layers12on side of the device100tapered inward slightly. The angle and curvature of the device100is intended to match the Lordotic Angle of the area of the spine where the implant is intended to be inserted. The inner rim14bounds and defines an open channel through the center of the device. Again, as previously noted, the overall size and/or shape of the device100may vary to correspond to the size and/or shape of the cross section of the bones at the fusion or osteotomy site, thereby providing an optimal environment for bone ingrowth to occur. The outer surfaces of the device100, and in particular the outer surface of the outer rim16, may be substantially smooth and/or be polished so as to limit the risk of damaging internal body structures as the device is being inserted. Alternatively, or in addition, some portion of the outer surface may also be roughened to facilitate bone fusion and/or interactions with other materials. The device may be made of any suitable medical grade material such as, for example, titanium or a biocompatible polymer. The first set of struts18are connected to the layers12in an offsetting manner, which to say that the first and second layers are connected to one another by struts18that are attached to the outer rims16while the second and third layers are connected to one another by struts18that are attached to the inner rims14. If viewed from the cross-sectional side view, as shown inFIGS.10and12, this offsetting arraignment forms an approximate S-shape. When adding additional layers, it is preferred if the total number of layers is an odd number so that the same three-layer strut arrangement may be maintained throughout the additional layers. The distance between the individual struts in the first set of struts18may vary. For example, an implant that is designed to be used with a human spine may measure approximately 50 millimeters (“mm”) wide, 25 mm deep and 12 mm in height. In this example, the individual struts in the first set of struts18may be spaced approximately 15 mm apart. Changing the spacing, or incorporating more or fewer struts, alters the strength and flexibility of the device at various points. As previously noted, the size and/or shape of the device may vary to correspond to the size and/or shape of the cross section of the bones at the fusion or osteotomy site. FIGS.13-22illustrate the porous architecture50. The porous architecture50may be any architecture that includes a plurality of openings on an outer surface of the architecture such that these openings may contact a bone surface. It is advantageous if there are openings or spaces throughout the porous architecture so that bone is able to grow into and throughout the porous architecture. The porous architecture may be a lattice or matrix structure that is configured to allow, promote or encourage bone to grow into it and around it. The porous architecture may be mostly comprised of a uniform or mostly uniform non-variable arrangement. Conversely, the porous architecture may be comprised of any number of suitable patterns, such as a plurality of diamond or square shapes trusses or in the form of a honeycomb. It may also be a randomly generated or distributed architecture or lattice, or it may include a different architecture in differing portions. The only requirement of the porous architecture is that it has openings or spaces that contact a bone segment. The device may be affixed to the bone using conventional attachment means such as a plate or fastening devices such as screws.FIGS.23-25illustrate an embodiment of the device having apertures24for the insertion of screws S. FIGS.26-29illustrate a second embodiment of the device100. This embodiment may be used with a number of different bone structures such as, for example, a mid-shaft for a long bone such as the femur or in the foot and/or ankle.FIGS.26and27illustrate the same 3-level design shown inFIGS.1-15, albeit in a relatively cylindrical arrangement rather than the approximately rectangular cuboid with rounded corners shown in the first embodiment. The key structure of the second embodiment is the same as in the first embodiment. More specifically, the second embodiment includes a support frame10that bounds and surrounds a porous architecture50. The frame10includes a number of layers12. Each layer12includes an inner rim14and an outer rim16. The layers are connected to one another by a first set of struts18, and the inner rims14and outer rims16are connected to one another by a second set of struts22. The first set of struts18are connected to the layers12in an offsetting manner, which to say that the first and second layers are connected to one another by struts18that are attached to the outer rims16while the second and third layers are connected to one another by struts18that are attached to the inner rims14. If viewed from the cross-sectional side view, as best shown inFIG.27, this offsetting arraignment forms an approximate S-shape. The porous architecture50is the same as with the first embodiment. FIGS.28and29illustrate the use of this second embodiment as a mid-shaft insert for a long bone, such as the femur F. A longer insert is needed in this instance, and so a total of 13 layers12are provided. The off-setting strut arraignment is maintained throughout all 13 layers12. It is understood that the embodiments described herein are merely illustrative of the present invention. Variations in the construction of the Internal bone fixation device may be contemplated by one skilled in the art without limiting the intended scope of the invention herein disclosed and as defined by the following claims. | 8,466 |
11857394 | A thigh prosthetic component1ashown in a perspective view inFIG.1has a knee joint2a, a foot part unit6awith an ankle3aas well as a lower leg unit7as essential assemblies. The knee joint2apossesses a proximal knee joint upper part4athat is articulated to a distal knee joint lower part5a. The proximal knee joint upper part4ahas a shaft seat8aby means of which the thigh prosthetic component1ais connected to the patient by, for example, a thigh shaft which is not shown in this case. The shaft seat8ais designed as a single part and is connected by a ventral upper knee joint axis34to two ventral articulated arms19arranged on opposite sides of the shaft seat8a. The articulated arms19are secured to the shaft seat8aby countersunk screws21. Moreover, the shaft seat8adesigned as a single part is articulated by a dorsal upper knee joint axis36to a dorsal articulated arm20awith a U-shaped cross-section, wherein the position of the shaft seat8aon the dorsal articulated arm20ais secured by flathead screws14. At their ends opposite the shaft seat8a, the articulated arms19are also articulated by a ventral lower joint axis35formed by a shaft24to a knee lower part11of the distal knee joint lower part5a, wherein the ends of the articulated arms19opposite the shaft seat8aare also secured in their position by countersunk screws21. The knee lower part11is moreover also connected by a dorsal lower knee joint axis37to the dorsal articulated arm20a. The knee joint2adesigned in this manner is accordingly a polycentric joint whose pivot point results from the intersection of the straight lines running a direction of longitudinal axis through the ventral articulated arms19and the dorsal articulated arm20a. The knee joint2adesigned in the above-mentioned manner is connected at its distal end by a ventral connecting element15as well as a dorsal connecting element16to a foot part10a. The dorsal connecting element16has a dorsal lower leg rod42that is connected at one end to a coupling element17which is connected at its end opposite the dorsal lower leg rod42by the dorsal upper knee joint axis36to the shaft seat8a. The dorsal lower leg rod42can be screwed into the coupling element17for adjustment in the direction of longitudinal axis, wherein the set position is secured relative to the coupling element17by a hexagon nut22. At its end opposite the coupling element17, the dorsal lower leg rod42is screwed into a dorsal foot element13, wherein the effective longitudinal extension of the dorsal lower leg rod42can be set by the screw-in length. The position of the dorsal lower leg rod42is secured on the dorsal foot element13by a hexagon nut22. For its part, the dorsal foot element13is articulated by a dorsal ankle axis39to the foot part10aand is secured with flathead screws14. The knee lower part11is furthermore connected to a ventral foot element12by two ventral lower leg rods41of the ventral connecting element15that extend parallel to each other, wherein the effective longitudinal extension of the ventral lower leg rods41can be fixed between the knee lower part11and the ventral foot element12because the ventral lower leg rods41can be screwed into the knee lower part11and the ventral foot element12. The set position of the ventral lower leg rods41on the knee lower part11and the ventral foot element12is secured by hexagon nuts22. Like the dorsal foot element13, the ventral foot element12is also articulated by a ventral ankle axis38to the foot part10a, wherein the position of the ventral foot element12on the foot part10ais secured by flathead screws14. A foot plate9is rigidly fastened to the foot part10aby which ground contact is established. To establish the pivot point of the knee joint2athat results from the intersection of the straight lines which extend through the ventral upper knee joint axis34and the ventral lower knee joint axis35on the one hand and the dorsal upper knee joint axis36and the dorsal lower knee joint axis37on the other hand, an adjusting element designed as a set screw23is arranged on the dorsal articulated arm20a. In this case, the set screw23is arranged within a threaded through-hole in the articulated arm20aand, depending on the screw-in depth, extends by its ventral end toward a contact surface33of the coupling element17. Depending on the screw-in depth, the longitudinal orientation of the articulated arm20ais aligned and, moreover the longitudinal orientation of the articulated arms19is adjusted via the connection of the articulated arm20ato the knee lower part11, which altogether can shift the intersection of these straight lines defining the pivot point of the knee joint2a. The thigh prosthetic component1acan be adjusted between the stance position of the knee joint2ashown inFIG.1to3and the swing position of the knee joint2ashown inFIG.4. When the thigh prosthetic component1ais being used, i.e., in its position on a thigh stump of a patient, the knee joint2apivots out of the stance position into the swing position, i.e., a flexion of the knee joint2awhen the vector from of the body's center of gravity to the contact point on the ground by the thigh prosthetic component1ais located behind the pivot point of the knee joint2a. In this flexed position of the knee joint2a, a flexion stop18arranged on the outside on the dorsal articulated arm20ais in exterior contact with the shaft seat8aand thereby restricts the maximum possible flexion angle of the knee joint2a. In the flexed position of the knee joint2ashown inFIG.4in which it is located in the swing position, there is a dorsal extension of the foot part10avia the connection with the foot part10a, which lifts the foot tip and thereby makes it possible for the thigh prosthetic component1ato swing through easily. Another exemplary embodiment of a thigh prosthetic component1bis shown inFIG.5to9which largely corresponds to the thigh prosthetic component1ashown inFIG.1to4in terms of basic construction and functioning. The ankle3bof the foot part unit6bdiffers from the ankle3aof the thigh prosthetic component1aonly by an alternative embodiment of the foot part10bof the foot part unit6b. In the region of the knee joint2b, the distal knee joint lower part5bhas a slight difference in comparison to the distal knee joint lower part5aof the thigh prosthetic component1adue to a shorter construction of the articulated arm20b. Moreover, a spring seat26is arranged on the knee lower part11. A significant difference is however the construction of the proximal knee joint upper part4b. In contrast to the proximal knee joint upper part4aof the thigh prosthesis1a, the shaft seat8bis not designed as a single part but is instead articulated by the ventral upper knee joint axis34to a support25which, on its end opposite the shaft seat8b, is also articulated by the dorsal upper knee joint axis3bto the dorsal articulated arm20band the dorsal connecting element16composed of the coupling element17and dorsal lower leg rod42. The articulated connection of the shaft seat8band dorsal support25makes it possible to pivot the shaft seat8brelative to the support25between the walking position shown inFIG.5to8and the seated position shown inFIG.9. The shaft seat8bcan be locked by a locking body30in the walking position, wherein the locking body30is arranged in a latching recess31loaded by a spring element28. To pivot the shaft seat8babout the ventral upper knee joint axis34, a shifting of the locking body30in a slot29out of the latching recess31counter to the spring force provided by the spring element28is necessary, wherein this displaces the locking body30in the slot29. In the unlocked position, it is possible to pivot the shaft seat8bout of the walking position shown inFIG.5to8into the seated position shown inFIG.9in which the shaft seat8bis pivoted about the ventral upper knee joint axis34. A spring element40furthermore extends between the spring seat26on the knee lower part11and a spring seat27on the support25. The functioning of the thigh prosthetic component1bis shown inFIG.10to16in different positions of the gait phase of a patient. In the neutral position shown inFIG.10, the vector from the body's center of gravity to the contact point on the ground runs in front of the pivot point of the knee joint2bthat results from the intersection of the lines (shown dashed in the figures) that extend on the one hand through the ventral upper and the ventral lower knee joint axis34,35and on the other hand through the dorsal upper and dorsal lower knee joint axis36,37. FIG.11shows the position of a patient upon heel impact. The vector from the body's center of gravity to the contact point on the ground is clearly located in front of the pivot point and thereby ensures stable support by the thigh prosthetic component1b. Also in the middle of the stance phase shown inFIG.12, the resulting vector of the ground reaction forces clearly runs in front of the pivot point of the knee joint2band further ensures stable support by the thigh prosthetic component1b. FIG.13shows the point in time shortly before toe-off. The momentary pivot point is still within a safe range in this position as well. However, the pivot point quickly approaches the resulting vector of the ground reaction forces under a forefoot load associated with slight hip flexing torque and then exceeds it, which results in a flexion of the knee joint2bshown inFIG.14in which the thigh prosthetic component1bis arranged in the swing phase, wherein a dorsal extension of the foot part10bpermits safe swing-through given the increased ground clearance. At the end of the swing phase, heel contact again occurs as shown inFIG.11, wherein the knee joint2bis then again arranged in the stance position and ensures safe support for the user. In the position shown inFIG.15, the shaft seat8bis located in a pivoted seat position relative to the support25. To reach this position, unlocking occurs in which the locking body30is manually moved out of the latching recess31. After the seated position has ended, the shaft seat8benters its home position in which it independently enters the latching recess31due to the spring pretension of the locking body30. FIG.16shows the situation of the thigh prosthetic component1bwhile the patient is stumbling. Due to the flexion stop18, knee flexion is restricted so that stable support in this position is ensured even while stumbling due to the limited flexion of the knee joint2bfrom the flexion stop18. LIST OF REFERENCE SIGNS 1a,1bThigh prosthetic component2a,2bKnee joint3a,3bAnkle4a,4bProximal knee joint upper part5a,5bDistal knee joint lower part6a,6bFoot part unit7Lower leg unit8a,8bShaft seat9Foot plate10a,10bFoot part11Knee lower part12Ventral foot element13Dorsal foot element14Flathead screws15Ventral connecting element16Dorsal connecting element17Coupling element18Flexion stop19Ventral articulated arm20a,20bDorsal articulated arm21Countersunk screw22Hexagon nut23Adjusting element/set screw24Shaft25Support26Spring seat27Spring seat28Spring element29Slot30Locking body31Latch recess33Stop surface34Ventral upper knee joint axis35Ventral lower knee joint axis36Dorsal upper knee joint axis37Dorsal lower knee joint axis38Ventral ankle axis40Spring element41Ventral lower leg rod42Dorsal lower leg rod | 11,295 |
11857395 | DETAILED DESCRIPTION The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. Referring now toFIG.1, the triple flexion device10of the present invention is an alternative to traditional orthotics for correcting foot drop, but in addition, it corrects hip and knee drop. In an embodiment of the present invention, the triple flexion device10is a light-weight and flexible device worn on the leg to provide hip, knee and ankle flexion in the swing phase of walking in people who have paralysis or are too weak to pick up their leg. Referring now toFIGS.4and5, the device10is made of conforming material that fastens to the limb through hook and loop fastener. Accordingly, the device10is adjustable in size to fit a variety of people having the foot drop condition. The device10includes four high tension, flat elastic bands24,26,28and30. Bands24and26are between the thigh and knee and act to flex the hip and knee. Bands28and30are between the knee and foot and act to dorsiflex the foot. Additionally, a waist belt32shaped in a V is provided. The V shape of the waist belt32allows the waist belt to lay flat against the body as downward tension is created on waist belt32at the V from the two thigh elastic straps or bands24and26connected thereto. Soft padding on the underside of the waist belt32cushions the waist belt32against the skin. The waist belt32is retained on the pelvis though a hook and loop fastener or other fastener means and does not apply force to the lower back. Bands24and26are adjustable by threading the bands through a pair of loops25and27that are attached to the belt32. The bands24,26are threaded through the loops and then folded back on themselves and secured through hook and loop fastening means. Similarly, bands28and30are adjustable by threading the bands through a pair of loops29and31that are attached to the knee cuff34. The bands28,30are threaded through the loops and then fold back on themselves and are secured through hook and loop fastening means. Further, a proximal lower leg wrap-around knee cuff34with a cutout36for the patella grips the proximal lower leg to prevent rotation and distal or proximal migration of the knee cuff34. The cutout36has a padded and rolled edge to increase comfort of the user and prevent skin abrasions proximate the knee. Lower leg wrap-around knee cuff34is connected at one end to straps24and26and at another end to straps28and30. The proximal lower leg knee cuff34has stiffening elements38,40and42that prevent stretch in the cuff34are made of Dacron or similar non-stretch, stiffening material. The anterior-proximal and the posterior-distal stiffening elements38,40together prevent proximal and distal migration of the cuff32. Preventing stretch of the cuff34material is critical since the cuff34must not migrate from its position to maintain tension in the thigh straps or bands24and26and the lower leg elastic straps or bands28and30. Lower leg wrap-around knee cuff34is secured to the knee by a hook and loop fastener or other fastener means. Moreover, an ankle wrap50is provided that has two loops52and54that allow the passage of the lower leg tension straps or bands28and30, but holds the straps to the ankle wrap50and prevents the straps from bowstringing. Ankle wrap50is secured to the ankle by a hook and loop fastener or other fastener means. Moreover, the device10further includes a foot wrap60that is connected to the straps or bands28and30and is configured to wrap around and be secured to the foot. Foot wrap60is secured to the foot by a hook and loop fastener or other fastener means. Once attached to a user, as shown inFIGS.6and7, device10operates to provide the following functions:1) Flexes the hip in the swing phase of gait;2) Flexes the knee in the swing phase of gait;3) Dorsiflexes the ankle/foot in the swing phase of gait;4) Reduces genu recurvatum (hyperextension of the knee);5) Slows down and dampens the plantarflexion moment of the ankle at heel strike;6) By flexing the hip, knee and ankle in the swing phase of gait, the device lowers the energy expenditure of the user who otherwise compensates for the lack of joint movements;7) Lowers the energy and force required by the hip, knee and ankle flexors in a user who has partial paralysis and muscle weakness; and8) When the user sits, the tension from the thigh and lower leg tension straps is eliminated so that the user sits in comfort with no forces applied to the leg. With reference toFIGS.8,9and10, the operation of device10is illustrated. The lower leg elastic tension straps or bands28and30allow the foot to plantarflex. When the calf muscle relaxes, the elastic tension straps or bands28,30flex the foot and ankle to 90 degrees or to a more acute angle, as shown inFIG.9. Device10flexes the hip, knee and ankle which lifts the foot from the ground for much needed ground clearance during walking, as shown inFIG.10. With reference toFIGS.11and12, a user having muscle paralysis is shown without and with the device10. Some users with paralysis of the lower leg muscles may experience not only foot drop, but a drop of the lateral aspect of the foot, also called inversion and supination, as illustrated inFIG.11. The two elastic tension straps or bands28,30attached to the foot wrap60are independently adjustable. The independent adjustability of the bands28,30allows the user to increase the tension in the straps or bands28,30which corrects inversion of the foot, as illustrated inFIG.12. For example, the lateral elastic strap or band28is adjusted to increase the force on the lateral aspect of the foot. With reference toFIGS.13and14, how device10is attached to a user and allows the user's foot to plantarflex is illustrated. The lower leg elastic tension straps or bands28,30allow the foot to plantarflex when the heel strikes the ground. Advantageously, device10allows the foot to reach the ground until it is flat on the ground. The dampening effect of the elastic straps or bands28,30prevents the foot from plantarflexing too rapidly. When the foot drops to the ground unassisted by muscles or mechanical restriction, the condition is known as foot slap. Device10prevents foot slap by dampening the rotation of the foot. With reference toFIGS.15and16, device10attached to a user who is seated and standing is illustrated. When the user sits, the elastic tension straps or bands28,30of device10loosen so that the user sits comfortably. When the user stands, the tension straps become taut. With reference toFIGS.17and18, device10attached to users of different size having different hip centers is illustrated. In another embodiment of the present invention, adjustable belt panels70and72are slidably attached to the belt32. Adjustable belt panels70and72can adjusted by sliding the panels along the belt32and fixing the panels by hook and loop fastening or by other fastening means to accommodate the differences in distance between hip centers. For example, the belt panels70and72can be adjusted to accommodate a user have a hip center distance of X and belt panels70and72may be adjusted again to accommodate a user having a hip center distance of Y, where Y>X. With reference toFIGS.19and20, two different positions or placements of the foot wrap or shoe strap60of device10are illustrated. The foot wrap or shoe strap60can be positioned in the arch area of the shoe or underneath the metatarsal heads of the foot. The advantage of placing the foot wrap or shoe strap60under the metatarsal heads is to increase the lifting force of the foot. FIG.21illustrates a soling material of foot wrap or shoe strap60of device10wrapping around the plantar surface of the shoe. Foot wrap or shoe strap60of device10includes soling material78that wraps around the sole of the shoe on the inside and outside of the shoe. The foot wrap60closes with a hook and loop fastener or similar fastening system. The soling material78is thin, yet durable enough to withstand the wear and tear of normal walking. With reference toFIGS.22and23, the adjustability of the panels70and72on the belt32is illustrated. Advantageously, the modularity of the device10and the waist belt32with panels70and72is shown. The panels are connected to the belt32with hook and loop fastener system80or similar fastening means and, thus, the panels70and72may be positioned anywhere along the belt32. The hook part of the hook and loop fastener system80is attached to the panels70and72while the loop part of the hook and loop fastener system80is attached to the underside of the belt32. Of course, the present invention contemplates that alternatively the loop part of the hook and loop fastener system80is attached to the panels70and72while the hook part of the hook and loop fastener system80is attached to the underside of the belt32. With reference toFIG.24, a cross-section through a user's torso at the hips is illustrated showing the hip centers82,84and the adjustability of the panels70and72on the belt32relative to the hip centers. As shown, panels70and72may be adjusted or shifted along the belt32of device10to different positions in relation to the left and right hip centers82,84to address different user issues. Depending on where the panels70and72are placed with respect to a hip center82,84, device10will impart various movements to the lower extremity. For example as shown inFIGS.25and26, when the adjustable panel is placed lateral to the hip center82with the active straps or bands24,26located laterally, device10will abduct the hip. It should be noted, that the locations of the active straps or bands24,26are equally spaced anterior and posterior to the hip center line. Thus, equal force on the hip is created that abducts the hip without deviation anteriorly or posteriorly. Combined movements can be created by choosing active strap or bands24,26locations that produce the desired movement. Moreover,FIGS.27and28illustrate the position of the adjustable panels70or72required to adduct the right hip. As shown, the panel72is positioned proximate the left hip center84. Accordingly,FIGS.29and30illustrate the position of the adjustable panel70required to rotate the right hip. As shown, the panel70is positioned proximate the right hip center82and towards the side of the user. Further,FIGS.31and32illustrate the position of the adjustable panel70required to move the right leg forward. As shown, the panel70is positioned proximate the right hip center82and towards the front of the user. Referring now toFIGS.33,34and35, a perspective view of a user wearing the device10in conjunction with other devices to treat muscular deficiencies and other problems are illustrated. For example, device10may be configured to be worn with an Ankle Foot Orthosis (AFO)90, as shown inFIG.33. Alternatively, device10may be configured to be worn with a Functional Electrical Stimulation (FES) device92, as shown inFIG.34. In yet another embodiment of the present invention, device10may be configured to be worn with a Knee Orthosis94, as shown inFIG.35. The present invention has many advantages and benefits over the prior are the following are just a few: 1) Adjustable tension elastic straps or bands24,26,28and30that flex the hip and knee. 2) Adjustable tension elastic straps or bands24,26,28and30that dorsiflex the foot. 3) Waist belt32shaped in a V allows the waist belt to lay flat against the body as downward tension is created on waist belt32at the V from the two thigh elastic straps or bands24,26and soft padding on the underside of the belt cushions the waist belt32against the skin. The waist belt32is retained on the pelvis and does not apply force to the lower back. 4) Proximal lower leg wrap-around cuff34with cut out for the patella grips the proximal lower leg to prevent rotation and distal or proximal migration of the cuff34. 5) The proximal lower leg cuff34has38,40and42stiffening elements that prevent stretch in the cuff34. The anterior-proximal and the posterior-distal stiffening elements together prevent proximal and distal migration of the cuff34. Preventing stretch of the cuff34material is critical since the cuff34must not migrate from its position to maintain tension in the thigh and the lower leg elastic straps or bands24,26. 6) The position of the thigh and lower leg elastic straps or bands24,26provide balancing forces to each other. The force generated in the thigh elastic straps or bands24,26tend to draw the lower leg cuff34proximally while the lower leg elastic straps or bands28,30tend to draw the lower leg cuff34distally. These opposing forces tend to help keep the cuff34from shifting proximally or distally. The lessening of forces on the cuff34makes the cuff34more comfortable on the user (seeFIGS.4,5and6). 7) The U-shaped cut-out36on the lower leg cuff34contours around the distal aspect of the patella and is padded and more comfortable on the user. 8) The two lower leg elastic straps or bands28,30provide foot dorsiflexion (seeFIGS.4,5and6). When the lateral elastic strap or band28is adjusted with greater tension than the medial strap or band30, the foot will invert. This is critically important in users who have foot drop resulting in an inverted foot. An inverted foot will strike the ground on the lateral border of the foot which can be painful and can cause pressure breakdown. The user can adjust the lateral strap or band28to apply increased tension in the strap28until the foot no longer inverts. To achieve neutral position of the foot in the coronal plane, the lateral tension strap or band28should be greater than the medial tension strap or band30. 9) The ankle strap50has two loops that allow the passage of the lower leg tension straps or bands28,30, but holds bands28,30to the ankle and prevents bands28,30from bowstringing. 10) The foot wrap60secures the lower leg tension straps or bands28,30to the foot. 11) When the user sits, the elastic straps or bands24,26,28,30loosen so there is no tension in the straps. This makes sitting comfortable (seeFIG.15). 12) The tension straps or bands24,26,28,30keep the foot dorsiflexed so that the heel strikes the ground first as necessary for normal walking (seeFIG.31). The lower leg elastic straps or bands28,30lengthen as the heel strikes the ground. This added tension in the straps dampens the angular forces at the ankle. This softens the forces of the foot as it strikes the ground. The lengthening of the lower leg elastic straps or bands28,30allow the foot to plantarflex as the foot should in normal walking. The description of the invention is merely exemplary in nature and variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention. | 14,843 |
11857396 | DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS The following description of exemplary embodiment(s) is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses. Processes, methods, materials and devices known by one of ordinary skill in the relevant arts may not be discussed in detail but are intended to be part of the enabling discussion where appropriate. For example material used for flexible members of various durometer, elastic membrane material, balloon material, may not be specified but are known by one of ordinary skill by earpiece, hearing aid, earplug, and medical angioplasty manufacturers. Additionally, the size of structures used in exemplary embodiments are not limited by any discussion herein (e.g., the sizes of structures can be macro (millimeter, centimeter, meter, size), micro (micro meter), nanometer size and smaller), and can be used in various orifices besides ear canals although ear canals will be discussed. The materials used for earplug construction will not be discussed in detail, however any materials, as known by one of ordinary skill in the art of earplug manufacturing and medical balloon manufacturing, can be used to fabricate earplugs in accordance with exemplary embodiments of the present invention. For example Lucite, ultraviolet resin, polyethylene, soft acrylic, soft ultra-violet silicone, polyvinyl chloride, medical polymers, foam, can all be used for various portions of the earplug construction. At least one exemplary embodiment is directed to an earplug comprising: at least a partially flexible distal end; an inflatable element; and a flexible anti-distal end, where the anti-distal end has at least one portion that is deformable, where the inflatable element is operatively attached to the distal end by an inflation channel, where when the at least one portion is deformed the inflatable element expands to an adjustable pressure, where at least one portion of the anti-distal end provides a pressurizing force to maintain the expansion of the inflatable element. The distal end can include a flexible and inflexible portion. The flexible portion can be an elastic membrane for example an elastic membrane that can be stretched to several initial lengths then returned to its original size. Many materials can be used (e.g., silicon) that provide a restoring force when deformed (e.g., stretched). Typically such materials have a lower Durometer (e.g., less than 50 Shore). The inflexible portion can be made of less stretchable material, for example when stretched to less than 100% the material returns to its shape, for example typically such materials have a higher Durometer (e.g., greater than 50 Shore). The flexible portion can also be a compressible or expandable bladder operatively attached to the inflexible portion. The deformable portion of the anti-distal end can be any deformable portion of the anti-distal end for example it can be a bladder, or a deformable dome of the anti-distal end, where deformation moves fluid from one section into the inflatable element. The inflatable element can be any element that can be inflated for example a self contained bladder or balloon, or a sheath around a stent that can expand away from the stent. The inflatable element can be operatively attached to the distal end by an inflation channel. The inflation channel can be a tube carrying fluid from the anti-distal end to the inflation element, or can be a channel for example within a stent. The inflatable element can be pressurized via fluid transfer into the inflatable element. For example deformation of a portion of the anti-distal end moves fluid from a chamber (e.g. a bladder) through an inflation channel into the inflation element. A pressure can be chosen (e.g., by deforming a portion of the anti-distal end by a given amount) for the gauge pressure inside the inflation element. Note that the fluid can be water, air, or any type of fluid and gas that provides the requisite time of pressurization. For example if the inflation element is to be pressurized from 0.30 bar gauge pressure to 0.25 bar gauge pressure for 12 hours, then the material requirement for the inflation element and other pneumatic systems can be determined (e.g., the inflation channel can also be designed to reduce permeability within the given limits). Thus in the non-limiting example above a material can be chosen to provide the necessary permeability for the given fluid used (e.g., Teflon for air for 12 hours or more for an inflation element that maintains gauge pressure from 0.30 bar gauge pressure to 0.25 bar gauge pressure). In accordance with at least one exemplary embodiment a pressurizing force can be applied to the pneumatic system (e.g., bladder in the anti-distal end, the inflation channel and the inflation element). For example a screwed in plate can press against an anti-distal end bladder deforming it increasing the pressure in the pneumatic system, where the thread force maintains the pressurizing force. Additionally other systems can provide the pressurizing force, for example an elastic membrane can provide a restoring force. For example one can pre-pressurize a closed pneumatic system to the desired gauge pressure, then one end pulled (e.g., a plate attached to an elastic membrane pulled), pulling the fluid out of the inflation element, where when the pulling action is released the elastic membrane provides a restoring force that forces the fluid back into the inflation element. A further exemplary embodiment can use a resilient member to provide a restoring force when deformed. For example a plastic clip can be pulled then released to return to its original shape. In at least one exemplary embodiment a resilient member in the form of an opened plastic clip presses against a bladder, so that when the plastic clip is pinched it closes around a stent and the bladder is free to fill, which if coupled to an inflation element will inflate the inflation element. The volume of the deformation can be calculated to provide the requisite inflation element pressure. The inflatable element can be a sheath around a stent, where a hole in the stent allows fluid to flow into the sheath stretching the sheath until the orifice in which the sheath is placed is obstructed or occluded. The inflation element can also be a balloon attached to a stent that is inflated or deflated. The inflation element can be made of various elastic materials. Additionally the inflatable element can be a non-elastic material that is preformed to a size and shape when inflated. For example a variable volume balloon can be tight against the stent when deflated. When inflated it can expand until a predesigned shape is obtained, for example by varying the thickness of the balloon along the stent direction. For example a constant volume balloon can be preformed into a shape (e.g., a cone). The inflatable element can be pressurized to a range of gauge pressures (pressure difference between inside the inflation element and outside the inflation element). For example the inflatable element can be pressurized to a gauge pressure range between 0.05 bar and 3.0 bar. The pressurized inflation element can provide sound isolation when the inflation element occludes an orifice (e.g., ear canal). FIG.1illustrates a generic illustration of an inflatable element100including balloon110. The permeability ε can be expressed in terms of radius140R, the internal pressure150P1, the outside pressure130P0, the temperature T, the volume V, the change of volume160ΔV, the change of mass Δm, the surface area A, the permeability ε, a thickness of a membrane120δ and time t, as: ε=[ΔVδ]/[At(P1−P0)] (1) For example if air is used, which has a molecular weight of 4.817E-26 Kg/molecule, a density ρ of 1.29 kg/mA3, a temperature of 20 C or 293K, a radius of 7 mm, an internal pressure P1=1.2 atm, and outside pressure of P0=1.0 atm, a surface area of 6.15 cm{circumflex over ( )}2, a thickness of a balloon δ=0.002 inch or 0.005 cm, where the pressure drops from 1.2 atm to 1.0 atm in t=8 hours, a permeability value ε of ε=1.24E−10 cm{circumflex over ( )}3/(scm{circumflex over ( )}2 cmHg) (2) is obtained. Thus materials that have an equivalent permeability or less will satisfy the design criteria. For example butyl rubber, polystyrene, polyethylene high density, nylon 6, and Teflon and other like materials. FIGS.2A and2Billustrate a generic variable volume inflatable element attached to a reservoir and a stent.FIG.2Aillustrates a non-inflated variable volume balloon having an uninflated volume220V1, having an uninflated internal pressure of150P1and an outside pressure of130P0. The variable volume balloon can be attached to a reservoir having a pump volume230V2. The reservoir can be reduced starting at time t=t0to a final volume240V3(FIG.2B) at time t=t1. The decrease of the reservoir volume moves fluid into the variable volume balloon210, increasing the volume270V4, where the radius has increased to250R4and the internal pressure increases to260P3. If one assumes an initial volume V1about 0, V3about 0, and P1=P0, then one can solve for the volume V4and the pressure P3as: V2=(P3*V4)/P1 (3a) P3=P1+[(2σ)/R4] (3b) Where a is the surface tension of the expanded inflation element. For example if one wishes to have V4=1000 mm{circumflex over ( )}3, P3=1.2 atm and P0=1.0 atm, then V2=1.2 cm {circumflex over ( )}3. FIGS.3A and3Billustrate a generic constant volume inflatable element attached to a reservoir and a stent. InFIG.3A, the constant volume inflatable element has an initial volume305V1, an internal pressure365P1and an outside pressure130P0. At time t=t0, the reservoir has a pump volume330V2. The reservoir can be reduced to a final volume340V3at time t=t1(FIG.3B). The decrease of the reservoir volume moves fluid into the variable volume balloon310, increasing the volume370V4, where the radius has increased to350R4and the internal pressure increases to360P3. Assuming that the initial volume305V1is not 0, that370V4is not 0, that305V1is not equal to370V4, the reservoir volume330V2can be calculated as: V2=[(P3*V4)/P1]−V1 (4) If one assumes that the balloon310(inflatable element) is a constant volume, thus V1is about=V4, then the reservoir volume needed can be expressed as: V2=[(P3*V4)/P1]−V4 (5) For example if one designs V4=1000 mm{circumflex over ( )}2, an internal pressure 1.2 atm, an outside pressure of 1.0 atm, one can obtain V2=0.2 cm{circumflex over ( )}3. FIGS.4aand4billustrate an earplug400including an inflatable element460attached to a reservoir (e.g., a chamber enclosed by an elastic membrane430and a stop flange body440) and a stent450, where an elastic membrane430provides a pressurizing force in accordance with at least one exemplary embodiment.FIG.4aillustrates the earplug400with an inflated B1inflation element460.FIG.4billustrates a deflated B2inflation element460. For example when a moveable plate420in a first position A1is pulled to position A2, fluid from the inflated inflation element460flows into the reservoir via an inflation channel445, where the elastic membrane430provides a restoring and in this example a pressurizing force. In the operation of the exemplary embodiment a thumb can be placed on knob410while a finger pulls moveable plate420. FIGS.5aand5billustrate an earplug500including an inflatable element560attached to a reservoir530and a stent550, using a pinchable resilient member520to provide a pressurizing force in accordance with at least one exemplary embodiment. The resilient member520can have a portion that provides a restoring force equivalent to a spring constant542. When the resilient member520is pinched reservoir530expands moving fluid from the inflation element560to the reservoir530. When the resilient member is unpinched the resilient member520presses the reservoir530against the stop flange540where the fluid moves through the inflation channel545into the inflation element560. A stent550with an anti-distal end510forms a core that the other elements can be anchored to. FIGS.6A and6Billustrate an earplug600including an inflatable element660attached to a reservoir630and a stent650, using a screwable605plate620to provide an adjustable pressurizing force in accordance with at least one exemplary embodiment. When the knob610is moved from position D to position E, plate620presses the reservoir630against the stop flange640to move fluid through the inflation channel645into the inflation element660. A user can use knob610to screw clockwise and anti-clockwise to adjust the deformation of reservoir630to move fluid in and out of inflation channel645to inflate the inflation element660. While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and function. | 13,094 |
11857397 | DETAILED DESCRIPTION OF THE INVENTION As used herein “disposable absorbent article” or “absorbent article” shall be used in reference to articles such as diapers, training pants, diaper pants, refastenable pants, adult incontinence pads, adult incontinence pants, feminine hygiene pads, tampons, pessary devices, cleaning pads, and the like, each of which are intended to be discarded after use. As used herein “hydrophilic” and “hydrophobic” have meanings as well established in the art with respect to the contact angle of water on the surface of a material. Thus, a material having a water contact angle of greater than about 90 degrees is considered hydrophobic, and a material having a water contact angle of less than about 90 degrees is considered hydrophilic. Compositions which are hydrophobic, will increase the contact angle of water on the surface of a material while compositions which are hydrophilic will decrease the contact angle of water on the surface of a material. Notwithstanding the foregoing, reference to relative hydrophobicity or hydrophilicity between a material and a composition, between two materials, and/or between two compositions, does not imply that the materials or compositions are hydrophobic or hydrophilic. For example, a composition may be more hydrophobic than a material. In such a case neither the composition nor the material may be hydrophobic; however, the contact angle exhibited by the composition is greater than that of the material. As another example, a composition may be more hydrophilic than a material. In such a case, neither the composition nor the material may be hydrophilic; however, the contact angle exhibited by the composition may be less than that exhibited by the material. The term “filament” refers to any type of artificial continuous strand produced through a spinning process, a meltblowing process, a melt fibrillation or film fibrillation process, or an electrospinning production process, or any other suitable process to make filaments. The term “continuous” within the context of filaments are distinguishable from staple length fibers in that staple length fibers are cut to a specific target length. In contrast, “continuous filaments” are not cut to a predetermined length, instead, they can break at random lengths but are usually much longer than staple length fibers. As used herein, “machine direction” refers to the direction in which a web flows through an absorbent article converting process. For the sake of brevity, may be referred to as “MD”. As used herein “cross machine direction” refers to the direction which is perpendicular to the MD. For the sake of brevity, may be referred to as “CD”. Absorbent articles of the present disclosure may provide improved fluid handling, conformity and recovery. By utilizing repeating patterns of bending modes on a meso-scale versus historical micro and/or macro scale that are bendable and shapeable based on each user's unique anatomical shape and how the user deforms the absorbent system while wearing, it has been found that an absorbent structure can be created that is able to have improved contact between the absorbent product and the user. The inventors have surprisingly found that with the creation of intimate contact between layers of the absorbent article, improved fluid kinetics may be achieved along with improved mechanical fit. The inventors have also found that if not implemented correctly, such intimate contact between layers can create leakage issues with their respective absorbent articles. Additionally, depending on the scale of the integration, the inventors have surprisingly found that some integration processes can provide the additional benefit of conformity to the complex contours of a user's body in addition to fluid kinetics benefits. Cross sections of conventionally processed topsheet and secondary topsheet combinations which lack intimate contact are shown inFIGS.1A and1B. InFIG.1A, a topsheet is shown fusion bonded to a secondary topsheet in cross-section. While the layers are joined together, they lack the intimate contact. For example, an opening7is shown between the topsheet and secondary topsheet. Additionally, fusion bond areas9, while arguably integrating the constituent material of the topsheet and the secondary topsheet, destroy the form of the constituent material and instead form film-like areas through which liquid does not pass. So, the fusion bonded topsheet and secondary topsheet lack the intimate contact described herein. InFIG.1B, the cross-sectional view of a topsheet and a secondary topsheet joined via gluing is shown. Similar to the topsheet and secondary topsheet configuration ofFIG.1A, the configuration shown inFIG.1Balso comprises an opening7between the topsheet and the secondary topsheet. So, like the fusion bonded configuration, the glued configuration does not provide the intimate contact between the topsheet and secondary topsheet that is desired and described herein. Another conventional method to encourage contact between layers involves the utilization of vacuum. During formation, a substrate, e.g. nonwoven, may be exposed to a vacuum conveyor. Additional material, e.g. fibers, can be deposited on the substrate. At the interface between the substrate and the fibers, the vacuum can induce some material integration; however, this is considered more of a surface phenomenon rather than the intimate contact created via integration disclosed herein. Further, while embossing arguably creates intimate contact between adjacent layers, embossing tends to create areas of densification through compression. And, as noted previously, the densification of areas can create localized stiffness which can create conformity issues and can negatively impact consumer comfort during use. So, the desired intimate contact between adjacent layers of the present description does not include embossing. In contrast to the conventional configurations shown inFIGS.1A and1B, a cross section of a topsheet and secondary topsheet of the present disclosure is shown inFIG.2A.FIG.2Ashows a cross section of a topsheet hydroentangled with a secondary topsheet. As shown, constituent material of the topsheet and constituent material of the secondary topsheet are integrated in a Z-direction. This Z-direction integration can create intimate contact between the topsheet and the secondary topsheet throughout the cross section of the topsheet and the secondary topsheet such that there are no openings or a reduced number of openings between the topsheet and the secondary topsheet. As used herein, “intimate contact” refers to the integration of layers of an absorbent article. The integration causes constituent material of the layers to be in contact such that constituent material of a lower layer is more readily accessible through an upper layer. For example, via the merging of constituent material between layers, the constituent material of the lower layer is more readily accessible through the upper layer. And, as noted previously, intimate contact between/among layers allows for a more efficient fluid transfer from an upper layer to a lower layer rather than inhibiting such fluid transfer as noted with embossing and bonding. For example, it is believed that filaments and/or fibers from one layer penetrate into the adjacent layer. It is believed that this filament and/or fiber penetration provides a bridge crossing the interface between one layer to another. It is further believed that this bridge facilitates fluid transfer from one layer to another. And unlike the conventional processes described previously, the intimate contact created by the processes described herein can create integration of material layers not only at the surface but millimeters deep into an adjacent layer. Additionally, by creating intimate contact between adjacent layers as described herein, the resultant absorbent article may then be less reliant on glues to hold layers together. Glues tend to increase stiffness which can negatively impact conformability and may, in some instances, inhibit fluid transfer. Lastly, the intimate contact described herein is unlike the surface interaction (two-dimensional) created by vacuum formation in that intimate contact via the processes described in the present disclosure can create provide three-dimensional access to the material of an underlying layer, e.g. an absorbent core. Data showing the fluid acquisition speed of the hydroentangled topsheet/secondary topsheet combination is shown inFIG.2B. As shown inFIG.2B, a hydroentangled topsheet and secondary topsheet coupled with an absorbent core are represented by curve201and a conventionally processed topsheet, secondary topsheet, and absorbent core are shown by curve200. As shown, the sample having the hydroentangled topsheet and secondary topsheet exhibits quicker fluid acquisition as depicted by the slope of the curve201versus curve200. Additionally, over time, the sample with the hydroengangled topsheet and secondary topsheet moves fluid more quickly from the surface of the topsheet than does the conventionally processed topsheet, secondary topsheet, and absorbent core combination. The data shown inFIG.2Bwas acquired via NMR-Mouse, e.g. Profile NMR-MOUSE model PM25 with High-Precision Lift available from Magritek Inc., San Diego, CA The NMR-Mouse measured the level of liquid in the top 200 microns of the topsheet, secondary topsheet, and absorbent core samples shown inFIG.2B. FIG.2Cis a cross sectional view of a topsheet in intimate contact with an absorbent core in a Z-direction. Much like the topsheet and the secondary topsheet, there are no apparent openings between the topsheet and the absorbent core. The topsheet and the absorbent core were subjected to meso-scale processing as described herein. As shown, there are a plurality of peaks and depressions. Due to the intimate contact between the topsheet and the absorbent core, it is believed that such construction of the topsheet/absorbent core laminate, would improve fluid acquisition and rewet. The disposable absorbent articles of the present disclosure comprise at least one intimate contact region where a topsheet, a secondary topsheet, an absorbent core, additional layers between the topsheet and a backsheet, or any combinations thereof, comprises intimate contact. Forming intimate contact between layers requires operations which mechanically manipulate the constituent material of adjacent layers. For example, the constituent material of adjacent layers may be manipulated via hyrdroentangling as discussed above regardingFIGS.2A and2Bor meso-scale processing as mentioned regardingFIG.2C. These processes can create intimate contact between or among adjacent layers of an absorbent article. Additional processes for creating intimate contact between layers in an absorbent article are disclosed herein. And, combinations of processes may be utilized. For example, some layers may be hydroentangled/needlepunched while other layers may be integrated via another process that is not hydroentangling/needlepunched. Or, the hydroentangled/needlepunched layers subsequently may be combined with another layer via a different process than hydroentangling/needlepunching. Or, some layers may be integrated via meso-scale processes without being hydroentangled/needlepunched. It is worth noting that in addition to hydroentangling, it is believed that some processes which are taught to be utilized for lofting materials, e.g. nonwovens, may also provide some amount of intimate contact between layers. These processes generally utilize hot air jets to move fibers of material. The process is described in detail in U.S. Pat. No. 8,720,021 which is incorporated herein by reference. So where the provision of hydroentangling or needlepunching is mentioned, the provision of hot air jetting may also be utilized. Additionally, while nonwoven (fibrous) materials are depicted inFIGS.2A and2C, intimate contact may be established with a large variety of materials as described herein. For example, films may be utilized in conjunction with a nonwoven (fibrous material) as described herein. It has also been surprisingly found that using formation means to integrate the topsheet, secondary topsheet, and the absorbent core, providing a fibrous network results in improved flexibility of the pad (as measured by bunched compression). This is unlike traditional systems that become stiffer due to welding, glues, embossing, or when they improve capillarity through densification. For the sake of brief introduction and clarity for the following disclosure, topsheets are generally soft feeling to the wearer of the absorbent article. Additionally, the topsheet should be configured to readily receive liquid insults to keep the wearer feeling dry. Topsheets are described in additional detail hereafter. Fluid management layers, for the sake of brevity “FM” layers, are generally positioned directly below the topsheet and should be configured to quickly acquire liquid insults to the topsheet and distribute the liquid insult to an absorbent core. While FM layers may have some ability to absorb and retain liquid insults, they may be designed primarily to de-water the topsheet quickly and transfer liquid to the absorbent core. FM layers are discussed further herein as well. Absorbent cores are the primary storage elements of the disposable absorbent articles. Absorbent cores receive and store liquid insults to the topsheet. Absorbent cores are generally positioned subjacent to the FM layer or may be positioned subjacent the topsheet. Additionally, absorbent cores tend to have more mass associated with them than other components of the absorbent article and therefore tend to also dominate the mechanical properties of the absorbent article. For example, mechanical properties such as flexibility, conformability and shapability, i.e. the shape the product assumes while worn, may be primarily influenced by the properties of the absorbent core. Absorbent cores are discussed in additional detail hereafter. Process The processes of the present disclosure can provide an absorbent article having regions of intimate contact between/among components of the absorbent article which can improve acquisition speed along with a reduction in the likelihood of leakage. And, as discussed herein, the processes of the present disclosure can provide an absorbent article with improved acquisition speed along with the ability to conform to much more complex surfaces than their conventional counterparts. Intimate contact between the topsheet and the FM layer; FM layer and absorbent core; topsheet and absorbent core; or topsheet, FM layer, and absorbent core, can be achieved via mechanical manipulation of at least two of the topsheet, the FM layer, and the absorbent core. However, as noted previously, FM layers and absorbent cores are generally configured to receive liquid insults from the topsheet rapidly and/or store liquid insults. As such, both the FM layer and absorbent core are typically absorbent to a further extent than the topsheet. Without pre-processing of the FM layer and/or absorbent core, there is a risk that the FM layer and/or absorbent core is coextensive with the topsheet which could result in liquid insults leaking out of the FM layer and/or absorbent core of a finished product. And, trimming of the FM layer and/or absorbent core post joining with the topsheet while plausible, would prove to be difficult at best for high speed manufacturing. The inventors have discovered processes which greatly reduce the likelihood of leakage via the mechanism of the FM layer and/or absorbent core being coextensive with the topsheet. By pre-processing the FM layer and/or absorbent core, the FM layer and/or absorbent core can be reduced in size, e.g. width, such that a periphery of the FM layer and/or absorbent core is disposed inboard of the periphery of the topsheet. The processes are discussed in additional detail hereafter. As shown inFIGS.3A and4, a topsheet web10(shown as a roll) can be provided as a carrier to a cut and place operation30. An FM web20(shown as a roll) can be provided to the cut and place operation30as well. The cut and place operation30can cut the FM web20into a plurality of discrete portions20A. The topsheet web10may be created as part of an absorbent article converting process or may be obtained from a manufacturer of suitable topsheet materials. Similarly, the FM layer may be made as part of an absorbent article converting process or may be obtained from a manufacturer of fluid management materials. The absorbent core web may similarly be created as part of the absorbent article converting line or may be obtained from a manufacturer of suitable absorbent core materials. Still referring toFIGS.3A and4, the discrete portions20A have opposing longitudinal sides24and lateral ends26connecting the opposing longitudinal sides24. The topsheet web10comprises longitudinal sides14which are outboard of the longitudinal sides24of the discrete portions20A. Lateral sides for the topsheet web10can be determined during subsequent processing. Where it is desired that the discrete portions20A are not longitudinally coextensive with the topsheet web10, the lateral sides for the topsheet web10—after cutting—should be outboard of the lateral ends26of the discrete portions20A. Additionally, it is important to ensure that the longitudinal sides24are inboard of the longitudinal sides14of the topsheet web10. In some forms, the longitudinal sides24can be disposed more than 2 mm inboard, greater than 3 mm inboard, greater than 4 mm, inboard, greater than 5 mm inboard, or about 6 mm inboard, specifically reciting all values within these ranges and any ranges created thereby. The distance between the longitudinal sides14and the longitudinal sides24can be beneficial when the final product seal is created. The larger distance can ensure a robust seal between the topsheet and backsheet and/or another layer in the final absorbent product. It should be noted that philic layers in general may be beneficially trimmed to ensure that the philic layers are not part of the edge seal of the article as this could lead to leakage. For example, the topsheet may comprise multiple layers of nonwoven material. A wearer-facing layer may be hydrophobic and a subjacent layer may be hydrophilic. With such a construction, the subjacent layer may be cut such that longitudinal edges of the subjacent layer are inboard of the edge of the hydrophobic layer. Additionally, the longitudinal edges of the subjacent layer may be spaced inboard of wings which extend laterally outward. In such construction, the hydrophobic layer may extend into the wings while the hydrophilic layer terminates inboard of the wings and/or inboard of the edge seal of the absorbent article. The discrete portions of FM web20A are placed on the topsheet web10thereby forming a topsheet and FM layer laminate web35, hereafter, “TFM laminate web”. As shown, the TFM laminate web35may be subjected to a first unit operation40. The first unit operation40may mechanically manipulate the TFM laminate web35to create intimate contact between the topsheet web10and the discrete portions of FM web20A thereby forming a final web58. Various mechanical manipulations are described hereafter which can create intimate contact between the topsheet and the FM layer. Suitable mechanical manipulations are discussed in additional detail hereafter. Still referring toFIGS.3A and4, the cut and place operation30may cut the FM web20in any suitable shape. For example, the discrete portions of FM web20A may be dog-bone shaped (two bulbous ends with a narrow mid-section connecting the bulbous ends). As another example, the discrete portions20A may be tapered at a first end and/or a second end to facilitate folding of the article. In yet another example, the discrete portions20A may comprise a shape which communicates a specific orientation of the article in which the discrete portion is placed. For example, a front end of the discrete portion20A may be narrower than an opposing back end of the discrete portion20A. As another example, the front end may comprise a plurality of scallops with small radii where the back end has a large radius. Each of these forms may signal to a wearer the appropriate orientation of the article in which the discrete portions20A are disposed. If an FM layer is not provided, the FM web20ofFIGS.3A and4may be replaced by an absorbent core web. Or, an FM layer and absorbent core web may be provided to the cut and place operation30and subsequently processed as described herein. The form of the final web58can vary greatly depending on the unit operations involved and the way that the corresponding webs are processed.FIGS.3B-3Fdisclose additional processing options which yield differing final webs58. Referring now toFIGS.3B and4, the TFM laminate web35may be subjected to more than one unit operation. For example, after passing through the first unit operation40, the TFM laminate web35may become an intermediate web48. The intermediate web48may then be subjected to a second unit operation50. Similar to the first unit operation40, the second unit operation50may provide additional intimate contact between the topsheet web10and the discrete portions of FM web20A. After passing through the second unit operation50, the intermediate web48becomes the final web58. The TFM laminate web35may be subjected to one or more unit operations plus a needlepunching or spunlacing (hydroentangling) operation. Additional details are provided below regarding some exemplary unit operations. The order of operation of these processes may be interchanged unless specifically stated otherwise. For example, the TFM laminate web35may be subjected to needlepunching and/or hydroentangling prior to being subjected to a separate unit operation as described herein or vice versa. Where an FM layer is not provided, the FM web20ofFIGS.3B and4may be replaced by an absorbent core web. Or, an FM layer and absorbent core web may be provided to the cut and place operation30and subsequently processed as described herein. Referring now toFIGS.3C and4, the topsheet web10(shown as a roll) may pass through the first unit operation40prior to being supplied to the cut and place operation30. The first unit operation40may mechanically manipulate the topsheet web10as described herein. Post mechanical manipulation by the first unit operation40, the topsheet web10becomes the intermediate topsheet web11. Downstream of the first unit operation40, the intermediate topsheet web11and the FM web20may be provided to the cut and place operation30. As noted previously, the cut and place operation30may cut the FM web20into discrete portions20A. These discrete portions may then be placed on the intermediate topsheet11thereby forming the intermediate topsheet and FM layer laminate or “iTFM laminate”148. The iTFM laminate148may then be provided to the second unit operation50which provides intimate contact between the intermediate topsheet11and the discrete portions20A of FM web20. Post processing by the second unit operation50, the iTFM laminate148becomes the final web58. The second unit operation50may comprise a hydroentangling or needlepunching operation for integrating the layers of the iTFM laminate148thereby forming the final web58. Additional unit operations may be provided in the process above to provide additional mechanical manipulation of the iTFM laminate148. It is worth noting that the topsheet web10and the FM web20may switch places in the process. For example, the FM web20may be provided to the first unit operation40and subsequently provided to the cut and place operation30. The topsheet—unmanipulated—may be provided to the cut and place operation30along with the modified FM web20. The remainder of the process may be as described herein. Additionally, the topsheet web10may pass through the first unit operation40, and the FM web20may pass through a separate unit operation. The intermediate topsheet11and the modified FM web20may then be provided to the cut and place operation30. The remainder of the process may be as described herein. Where an FM layer is not provided, the FM web20ofFIGS.3C and4may be replaced by an absorbent core web. Or, an FM layer and absorbent core web may be substituted for the FM layer20and subsequently processed as described herein. RegardingFIGS.3D and4, the topsheet web10and the FM web20may be provided to the cut and place operation30as described previously regardingFIG.3A. The resultant TFM laminate35may then be exposed to the first unit operation40. The first unit operation40may integrate the topsheet and the FM discrete portions20A thereby creating the intermediate web48. Downstream of the first unit operation40, the intermediate web48can be provided to a second cut and place operation31. Along with the intermediate web48, an absorbent core web18may be provided to the second cut and place operation31. The second cut and place operation31may create a plurality of discrete absorbent cores from the absorbent core web18. Much like the discrete FM portions, the discrete absorbent cores may not be coextensive with the topsheet. For example, longitudinally extending side edges of the discrete absorbent cores should be disposed laterally inboard of the longitudinally extending edges14of the topsheet web10. The discrete absorbent cores may be larger than the discrete FM portions20A, may be smaller than the discrete FM portions20A, or may be the same size as the discrete FM portions20A. The plurality of discrete absorbent cores and the intermediate web48may be combined in the second cut and place operation31thereby creating an intermediate laminate and absorbent core web laminate37, hereafter, “TFMAC laminate.” The TFMAC laminate37can then be further processed by the second unit operation50thereby producing the final web58. After the addition of the discrete absorbent cores, no further manipulation of the TFMAC laminate37may occur. If that is the case, then the TFMAC laminate37may be the final web58. The first unit operation may comprise a hydroentangling/needlepunching process which integrates the layers of the topsheet and FM layer for the TFM laminate35. The second unit operation50may comprise a mechanical manipulation process as described herein which integrates the layers of the TFMAC laminate37. Additionally, the topsheet web10and/or the FM web20may be subjected to separate unit operations prior to being provided to the cut and place operation30. In conjunction or independent thereof, the absorbent core web18may be provided to a unit operation prior to being provided to the second cut and place operation31. Referring toFIGS.3E and4, the topsheet web10may be provided to the first unit operation40which mechanically manipulates the topsheet web10thereby forming the intermediate topsheet web11. The absorbent core web18and the FM web20may be provided to a second unit operation50which mechanically manipulates and creates intimate contact between the absorbent core web18and FM web20thereby forming an absorbent core and FM web laminate, hereafter, “FMAC” laminate web49. The intermediate topsheet web11and the FMAC laminate web49may then be provided to the cut and place operation30. The cut and place operation30can cut discrete portions from the FMAC laminate web49. The cut and place operation30can combine the intermediate topsheet11web and the discrete portions of the FMAC laminate web49to create an iTFMAC laminate137. The iTFMAC laminate web137may then be provided to a third unit operation which integrates the layers of the iTFMAC laminate web137. Referring toFIGS.3F and4, as shown, the topsheet web10may be provided to the cut and place operation30in an unmanipulated state, i.e. sans a first unit operation40. After the cut and slip operation30, discrete portions of the FMAC laminate web49are combined with the topsheet to create the TFMAC laminate37. In some forms, the TFMAC laminate web37may not be manipulated further other than processing required to create an absorbent article from the TFMAC laminate web37. If that is the case, then the TFMAC laminate web37may also be the final web58. Additionally, the FM web20and the absorbent core web18may be subjected to separate unit operations prior to being provided to the cut and place operation30. Referring now toFIGS.3E and3F, the absorbent core web18may be subjected to a cut and place operation and joined to the FM layer web20in a plurality of discrete absorbent cores. The benefit of providing the absorbent core web18to a cut and place operation prior to joining with the FM layer web20is that the cut and place operation can shape the discrete absorbent cores as desired. In contrast, where the FM layer web20and the absorbent core web18are provided to the cut and place operation in conjunction, the shape of the discrete FM portions and the discrete absorbent cores is likely going to be the same. So, for maximum flexibility in the design of the absorbent article, it may be beneficial to provide the absorbent core web18to a cut and place operation and then joining the discrete absorbent cores to the FM layer web20. The unit operations of the present disclosure may impart a variety of different features/structures to the webs which are subjected to the unit operations. Hereafter, there is a discussion of some suitable structures/features for creating intimate contact between adjacent absorbent article layers which can be created via unit operations. And as discussed hereafter, intimate contact features include conforming features, but conforming features is a smaller subset of intimate contact features as not all intimate contact features comprise conforming features. For the discussion regarding suitable features/structures, the generic term “modified web” shall be utilized in place of the intermediate topsheet11, intermediate web48, iTFM laminate web148, TFMAC laminate web37, iTFMAC laminate web137, FMAC laminate web49, and final web58, or any web that has been mechanically manipulated by a unit operation, unless otherwise noted. So, the features/structures discussed hereafter may be applied to the webs described herein. The term “precursor web” shall be utilized to refer to those webs which are unmodified (not mechanically manipulated) by a unit operation, e.g. topsheet web10, FM web20, absorbent core web18, combinations thereof, and TFM laminate35, or those webs which are upstream of one or more unit operations which will create intimate contact between two adjacent webs or portions thereof, unless otherwise noted. Unit Operations There are several unit operations which can be utilized to create intimate contact between adjacent layers of an absorbent article. Some examples are discussed in additional detail below. Spunlacing One example of a process for creating intimate contact between/among layers is hydroentangling or spunlacing. For the spunlacing unit operation, a precursor web or modified web is subjected to high-speed jets of water which causes interlocking of filaments and/or fibers of nonwoven webs. In addition to providing structural integrity to the resultant laminate, the spunlacing process can create intimate contact between nonwoven webs by creating Z-direction integration of the filaments and/or fibers of the nonwoven webs. The spunlacing process is generally known in the art. Any unit operation or a plurality thereof described herein may comprise a spunlacing process. Needlepunching Another example is needlepunching. Similar to spunlacing, the needlepunching process can create intimate contact between layers by creating Z-direction integration of filaments and/or fibers of nonwoven webs. Needlepunching involves the mechanical interlocking of filaments and/or fibers of a spunbonded, carded, or textile fabric web. In the needlepunching process, a plurality of barbed needles repeatedly pass in and out of a precursor web or a modified web, and push filaments and/or fibers of the webs in a positive and/or negative Z-direction. The needlepunching process is generally well known in the art. Any unit operation or a plurality thereof described herein may comprise a needlepunching process. Protrusions/Depressions Some examples of suitable unit operations for creation of intimate contact between layers of an absorbent article includes those unit operations which can create protrusions in precursor webs. RegardingFIG.5, some unit operations described herein can produce modified webs335comprising protrusions460in a positive and/or negative Z-direction. Protrusions in the negative Z-direction may also be referred to as depressions. In general, the protrusions460comprise a distal end462and sidewalls466connecting the distal end to a base portion450. And the base portion450connects the sidewalls466to a first surface60or an opposing second surface62of the modified web335. The protrusions of the present disclosure may comprise outer tufts, tunnel tufts, filled tufts, nested tufts, ridges and grooves, and corrugations. It is worth noting that passing the precursor web between two rolls (of opposing protrusions and groves) with a relatively small space there between will likely apply some shear and compressive forces to the material. The present processes however differ from embossing processes in which the teeth or male members compress the precursor web against an opposing roll or the bottom of the female elements, thereby increasing the density of the region in which the material is compressed. Instead, the processes described herein provide displacement of material and to the extent that there are density changes, such changes are negligible when compared to the density changes created via embossing. Referring toFIG.6A, the unit operations40,50, and60, (shown inFIGS.3A-3F) may comprise an apparatus500for forming tufts in the modified web335. The apparatus500comprises a pair of intermeshing rolls502and504, each rotating about an axis A—the axes A being parallel and in the same plane. Roll502comprises a plurality of ridges506and corresponding grooves508which extend unbroken about the entire circumference of roll502. The depth of engagement (DOE) is a measure of the level of intermeshing of the rolls502and504. The DOE should be selected to provide the desired structure. For the purposes of fluid management, the DOE should be selected to ensure that constituent materials of the layers being manipulated, are provided with sufficient intimate contact. Additionally, clearance between ridges and grooves is going to depend greatly on the caliper of the material being manipulated. For example, where a topsheet, FM layer, and absorbent core layer are being manipulated, the clearance between the ridges and grooves may need to be higher than what it would be for a topsheet and FM layer only. Too small of a clearance could shred the webs. Roll504, similar to roll502, but rather than having ridges that extend unbroken about the entire circumference, roll504comprises a plurality of rows of circumferentially-extending ridges that have been modified to be rows of circumferentially-spaced teeth510that extend in spaced relationship about at least a portion of roll504. The individual rows of teeth510of roll504are separated by corresponding grooves512. In operation, rolls502and504intermesh such that the ridges506of roll502extend into the grooves512of roll504, and the teeth510of roll504extend into the grooves508of roll502. A nip516is formed between the counter-rotating intermeshing rolls502and504. Both or either of rolls502and504can be heated by means known in the art such as by using hot oil filled rollers or electrically-heated rollers. The apparatus500is shown in a configuration having one patterned roll, e.g. roll504, and one non-patterned grooved roll502. However, it may be preferable to use two patterned rolls similar to roll504having either the same or differing patterns, in the same or different corresponding regions of the respective rolls. Such an apparatus can produce modified webs335with tufts protruding from both sides of modified webs335, i.e. tufts extending in a positive Z-direction and tufts extending in a negative Z-direction. Also different rolls with different patterned regions may be utilized to create zones of different manipulation having different fluid handling and/or different mechanical properties and performance. Such configurations are discussed hereafter. The modified webs335of the present disclosure can be made by mechanically deforming a precursor web100that can be described as generally planar and two dimensional prior to processing by the apparatus shown inFIG.6A. By “planar” and “two dimensional” is meant simply that the precursor web100may start the process in a generally flat condition relative to the modified web335that has distinct, out-of-plane, Z-direction three-dimensionality due to the formation of tufts570. “Planar” and “two-dimensional” are not meant to imply any particular flatness, smoothness or dimensionality. The intermeshing rolls502and504can urge the material of the precursor web100in the positive Z-direction or negative Z-direction depending on whether roll504engages the second surface62or the first surface60(shown inFIG.5). Referring now toFIGS.3A-6A, the process described regardingFIG.6Acan provide for a variety of tufts, e.g. tunnel tufts, filled tufts, outer tufts. For example, tunnel tufts may be created when localized areas of constituent material of the precursor web100are urged in the positive Z-direction such that material of the precursor web100in the localized area may be urged toward the first surface60of the modified web335. The localized area may be disposed superjacent to the first surface60. It is worth noting that the webs depicted inFIGS.3A through5comprises multiple layers, e.g. topsheet web10and discrete portions20A of FM web20. So where constituent material of the precursor web100is urged in a positive Z-direction, the tunnel tuft may comprise, as an example, constituent material of the discrete portion20A of the FM web20, and the topsheet web10, as an example, may form the outer tuft. In contrast, where localized areas of the constituent material of the precursor web100are urged in the negative Z-direction, material of the precursor web100in the localized areas may be urged toward the second surface62. The constituent material may be disposed subjacent to the second surface62of the modified web335. Where constituent material of the precursor web100is urged in the negative Z-direction, the tunnel tuft, as an example, would be formed by the topsheet web10, and the outer tuft, as an example, may be formed by discrete portions20A of the FM web20. A photograph of a suitable roll for use with the apparatus500is shown inFIG.6B. As shown, the roll comprises teeth510and a plurality of open areas511. Each of the open areas511is separated by teeth510disposed therebetween. The patterns of teeth510and open areas511correspond to the depressions and nodes, respectively inFIGS.12A-12C,13A-13C, and15A-15C. In addition to or independent of the tufts discussed heretofore, the modified web335may comprise filled tufts. Filled tufts may occur when the precursor web100comprises crimped filaments. Where the precursor web100of the present invention comprises crimped filaments, the precursor web100has a higher caliper for a given basis weight. This higher caliper can in turn deliver consumer benefits of comfort due to cushiony softness, faster absorbency due to higher permeability, and improved masking. Additional benefits may include less redmarking, higher breathability and resiliency. Crimped filaments may be utilized in a variety of layers of an absorbent article. For example, the topsheet web10may comprise crimped filaments, the FM web20may comprise crimped filaments, and/or the absorbent core may comprise crimped filaments. The difference between filled tufts and tunnel tufts is that filled tufts generally appear filled with filaments. Because of the nature of the crimped filaments, mechanical manipulation tends to simply uncoil the filaments to some extent. In contrast, non-crimped filaments may be stretched and thinned during mechanical manipulation. This stretching and thinning generally means that these resultant tufts have far fewer fibers within its interior space thereby looking much more like a tunnel. Methods of making tunnel tufts, outer tufts, and filled tufts are discussed in additional detain in U.S. Pat. Nos. 7,172,801; 7,838,099; 7,754,050; 7,682,686; 7,410,683; 7,507,459; 7,553,532; 7,718,243; 7,648,752; 7,732,657; 7,789,994; 8,728,049; and 8,153,226. Filled tufts and corresponding outer tufts are discussed in additional detail in U.S. Patent Application Serial No. 2016/0166443. Referring back toFIGS.3A through6A, the apparatus500for forming tufts in the precursor web100may be the first unit operation40, the second unit operation50, and/or the third unit operation60. In some forms, the apparatus500, aside from the cut and place operations30and31, may be the only operation which provides the intimate contact between layers of the precursor web100. Additionally, forms are contemplated where tufts, e.g. tunnel, outer, and/or filled tufts are provided in a positive Z and negative Z direction on the modified web335. Still another form of protrusion which is suitable for the modified webs335of the present disclosure comprise nested tufts.FIGS.7A-7Ddepict an apparatus600which is suitable for use as a unit operation in accordance with the present disclosure. As shown, the precursor web100may be subjected to the apparatus600. The apparatus600may comprise forming members602and604which may be in the form of non-deformable, meshing, counter-rotating rolls that form a nip606therebetween. The precursor web100may be fed into the nip606between the rolls602and604. Although the space between the rolls602and604is described herein as a nip, as discussed in greater detail below, in some cases, it may be desirable to avoid compressing the precursor web100to the extent possible. The first forming member (such as “male roll”)602has a surface comprising a plurality of first forming elements which comprise discrete, spaced apart male forming elements612. The male forming elements are spaced apart in the machine direction and in the cross-machine direction. The term “discrete” does not include continuous or non-discrete forming elements such as the ridges and grooves on corrugated rolls (or “ring rolls”) which have ridges that may be spaced apart in one, but not both, of the machine direction and in the cross-machine direction. As shown inFIG.7B, the male forming elements612have a base616that is joined to (in this case is integral with) the first forming member602, a top618that is spaced away from the base, and sidewalls (or “sides”)620that extend between the base616and the top618of the male forming elements. The forming elements612also have a plan view periphery, and a height H1(the latter being measured from the base616to the top618). Referring again toFIGS.7A through7D, the second forming member (such as “female roll”)604has a surface624having a plurality of cavities or recesses614therein. The recesses614are aligned and configured to receive the male forming elements612therein. Thus, the male forming elements612mate with the recesses614so that a single male forming element612fits within a periphery of a single recess614, and at least partially within the recess614in the Z-direction. The recesses614have a plan view periphery626that is larger than the plan view periphery of the male elements612. As a result, the recesses614on the female roll604may completely encompass the male forming elements612when the rolls602and604are intermeshed. As shown inFIG.7C, the recesses614have a depth D1which in some forms may be greater than the height H1of the male forming elements612. The recesses614have a plan view configuration, sidewalls628, a top edge or rim634around the upper portion of the recess where the sidewalls628meet the surface624of the second forming member604, and a bottom edge630around a bottom632of the recesses where the sidewalls628meet the bottom632of the recesses. As discussed above, the recesses614may be deeper than the height H1of the forming elements612so the precursor web100is not nipped (or compressed) between the male forming elements and the recesses to the extent possible. The depth of engagement (DOE) is a measure of the level of intermeshing of the forming members. As shown inFIG.7C, the DOE is measured from the top618of the male elements612to the (outermost) surface624of the female forming member614(e.g., the roll with recesses). The DOE should be sufficiently high, when combined with extensible nonwoven materials, to create nested tufts. Still referring toFIG.7C, there is a clearance, C, between the sides620of the forming elements612and the sides (or sidewalls)628of the recesses614. The clearances and the DOE's are related such that larger clearances can permit higher DOE's to be used. The clearance, C, between the male and female roll may be the same, or it may vary around the perimeter of the forming element612. For example, the forming members can be designed so that there is less clearance between the sides of the forming elements612and the adjacent sidewalls628of the recesses614than there is between the sidewalls at the end of the male elements612and the adjacent sidewalls of the recesses614. In other cases, the forming members can be designed so that there is more clearance between the sides620of the male elements612and the adjacent sidewalls628of the recesses614than there is between the sidewalls at the end of the male elements612and the adjacent sidewalls of the recesses. In still other cases, there could be more clearance between the side wall on one side of a male element612and the adjacent side wall of the recess614than there is between the side wall on the opposing side of the same male element612and the adjacent side wall of the recess. For example, there can be a different clearance at each end of a forming element612; and/or a different clearance on each side of a male element612. Some of the aforementioned forming element612configurations alone, or in conjunction with the second forming member604and/or recess614configurations may provide additional advantages. This may be due to by greater lock of the modified web335on the male elements612, which may result in more uniform and controlled strain on the modified web335. The apparatus600is further described in U.S. Patent Application Serial No. 2016/0074252. As shown inFIG.7D, the precursor web100may be provided to the nip606between the first roll602and the second roll604. As the precursor web100passes through the nip606, the forming members612engage the second surface62(shown inFIG.5) of the precursor web100and urge constituent material of the precursor web100into the recesses614. The process forms the modified web335having a planar first surface and a plurality of integrally formed nested tufts extending outward from the first surface60(shown inFIG.5) of the modified web335. (Of course, if the second surface62of the modified web335is placed in contact with the second forming member604, the nested tufts will extend outward from the second surface62of the modified web335, and the openings will be formed in the first surface60of the modified web335.) Referring now toFIGS.3A-4and7A, the apparatus600for forming nested tufts in the modified web335may be the first unit operation40, the second unit operation50, or the third unit operation60. The apparatus600, aside from the cut and place operations30and31, may be the only operation which provides the intimate contact between the topsheet web10, the discrete portions20A of the FM layer web20, and/or discrete portions of absorbent core web18. The process and equipment for making nested tufts as described herein is further described in U.S. Patent Application Publication Nos. 2016/0074256 and 2016/0074252A1. Other suitable protrusions which can be comprised by the modified webs335of the present disclosure comprises ridges and grooves or corrugations. Referring toFIGS.8A-8D, an apparatus2200may be utilized to create corrugations in the precursor web. The apparatus2200comprises a single pair of counter-rotating, intermeshing rolls2202,2204that form a single nip N therebetween. As shown inFIGS.8A and8B, the first roll2202comprises a plurality of grooves2210and ridges2220and a plurality of staggered, spaced-apart teeth2230extending outwardly from the top surface2222of the ridges2220. The configuration of the roll2202is such that the top surface2222of the ridges2220is disposed between the tips2234of the teeth2230and the bottom surface2212of the grooves2210, directionally relative to the axis A of the roll. As shown, the second roll2204comprises a plurality of grooves2240and ridges2250. The grooves2240have a bottom surface2242and the ridges2250have a top surface2252. Here, the distance between the top surfaces2252of the ridges2250and the bottom surfaces2242of the grooves2240is substantially the same around the circumference of the roll. The teeth2230and ridges2220of the first roll2202extend toward the axis A of the second roll2204, intermeshing to a depth beyond the top2252of at least some of the ridges2250on the second roll2204. Teeth suitable for this process may be conducive to aperturing webs. The teeth on the rolls may have any suitable configuration. A given tooth can have the same plan view length and width dimensions (such as a tooth with a circular or square shaped plan view). Alternatively, the tooth may have a length that is greater than its width (such as a tooth with a rectangular plan view), in which case, the tooth may have any suitable aspect ratio of its length to its width. Suitable configurations for the teeth include but are not limited to: teeth having a triangular-shaped side view; square or rectangular-shaped side view; columnar shaped; pyramid-shaped; teeth having plan view configurations including circular, oval, hour-glass shaped, star shaped, polygonal, and the like; and combinations thereof. Polygonal shapes include, but are not limited to rectangular, triangular, pentagonal, hexagonal, or trapezoidal. The side-walls of the teeth may taper at a constant angle from the base to the tip, or they may change angles. The teeth may taper towards a single point at the tooth tip, like that shown inFIG.8A. The teeth can have tips that are rounded, flat or form a sharp point. In some forms, the tip of the tooth may form a sharp vertex with at least one of the vertical walls of the tooth (for example, the vertical walls on the leading and trailing ends of the teeth so the teeth aperture or puncture the web. In some forms, each tooth may form2apertures, one at the leading edge and one at the trailing edge of each tooth. The apparatus2200can deform the precursor web creating alternating regions of higher and lower caliper, and alternating regions of higher and lower basis weight, with the higher caliper and higher basis weight regions being located in the tops of the ridges and bottoms of the grooves, and the regions with lower caliper and lower basis weight located in the sidewalls in-between. In the case of a nonwoven, the basis weight is also decreased in the stretched areas, again resulting in a modified web with alternating regions of higher and lower basis weight, with the higher basis weight regions located in the tops of the ridges and bottoms of the grooves, and the lower basis weight regions located in the sidewalls in-between. Referring now toFIGS.3A-4, and8A, the apparatus2200for forming ridges and grooves in the precursor web may be the first unit operation40, the second unit operation50, or the third unit operation60. The apparatus2200, aside from the cut and place operations30and31may be the only operation which provides the intimate contact between the topsheet web10, the discrete portions20A of the FM layer web20, and/or discrete portions of the absorbent core web18. Any suitable process for forming ridges and grooves may be utilized. Some additional processes for producing ridges and grooves in webs are described in additional detail in U.S. Pat. Nos. 6,458,447; 7,270,861; 8,502,013; 7,954,213; 7,625,363; 8,450,557; 7,741,235; U.S. Patent Application Publication Nos. US2003/018741; US2009/0240222; US2012/0045620; US20120141742; US20120196091; US20120321839; US2013/0022784; US2013/0017370; US2013/013732; US2013/0165883; US2013/0158497; US2013/0280481; US2013/0184665; US2013/0178815; US2013/0236700; PCT Patent Application Publication Nos. WO2008/156075; WO2010/055699; WO2011/125893; WO2012/137553; WO2013/018846; WO2013/047890; and WO2013/157365. As noted previously, protrusions may be oriented in the positive Z-direction or the negative Z-direction. In the positive Z-direction, the protrusions may have some shape associated with them assuming that there is no constituent material surrounding the protrusion. However, when oriented in the negative Z-direction, these protrusions/depressions may simply take comprise sidewalls and a bottom without much for to them. Compressive forces of the surround constituent material can force cause these depressions to have very similar shapes when oriented in the negative Z-direction. It is worth noting that the spunlace and needlepunch operations are typically primarily utilized to create integrity within a web. However, as discussed above, both the spunlace and needlepunch processes can also provide some level of intimate contact between adjacent layers. These processes operate in a micro-scale. In other words, they displace small amounts of constituent material in a plurality of locations on a web. Comparatively speaking, without wishing to be bound by theory, it is believed that the operations which create conforming features can provide additional benefits above needlepunch and spunlace. Rather than operating on a micro-scale, processes for conforming features operate on a meso-scale. These meso-scale processes involve the displacement of a larger amount of constituent material. For example, needle punching may involve the displacement of 1 to 10 fibers whereas a meso-scale mechanical process may involve greater than 10 and up to 100 fibers or more. In contrast, the tooling for meso-scale processes described herein can have a length ranging from, as an example, about 3 mm to 11 mm. There are patterns which can utilize longer teeth and patterns which may utilize shorter. However, a length of about 1 mm is probably about as low as one would expect to see regrading meso-processing. Accordingly, while spunlace and/or needle punching processes may be utilized, meso-scale mechanical processes may also be provided to the precursor web such that additional benefits are realized, e.g. conformance and/or resiliency. And, recall that meso-scale processes are different than embossing. While embossing provides a highly densified bottom surface where constituent material has been compressed, any densification in a bottom surface created by meso-scale processing is minor in comparison. Additionally, the conforming features made by meso-scale processes are generally visible to the naked eye from a reasonable distance, e.g. 30 cm, without the use of a microscope—assuming that the viewer has 20/20 or better corrected or uncorrected vision. Depending on the layers which are subjected to meso-scale processing, the topsheet and/or secondary topsheet may need to be removed from the article to see the conforming features. In contrast, micro-scale processes may require the assistance of a microscope to determine their existence. Some suitable examples of conforming features include protrusions, ridges, grooves, depressions, tufts, and the like. Additional Process Apertures A suitable unit operation which provides some level of benefit in fluid management includes apertures. However, for the sake of the present disclosure, apertures are not considered to be conforming features. Referring toFIGS.3A-3F and9A-9B, the first unit operation40or the second unit operation may comprise an aperturing process. For example, the unit operations described herein may comprise a weakening roller arrangement108and an incremental stretching system132. The precursor web100can pass through a nip106of the weakening roller (or overbonding) arrangement108formed by rollers110and112, thereby weakening the precursor web100at a plurality of discrete, densified, weakened, areas thereby forming a weakened precursor web100′. The weakened precursor web100′ has a pattern of overbonds, or densified and weakened areas, after passing through the nip106. At least some of or all these overbonds are used to form apertures in the webs of the present disclosure. Therefore, the overbond pattern can correlate generally to the pattern of apertures created in the webs of the present disclosure. Referring specifically toFIG.9A, the weakening roller arrangement108may comprise a patterned calendar roller110and a smooth anvil roller112. One or both the patterned calendar roller110and the smooth anvil roller112may be heated and the pressure between the two rollers may be adjusted to provide the desired temperature, if any, and pressure to concurrently weaken and melt-stabilize (i.e., overbond) the precursor web100at a plurality of locations202. As will be discussed in further detail below, after the precursor web100passes through the weakening roller arrangement108, the weakened precursor web100′ may be stretched in the CD, or generally in the CD, by a cross directional tensioning force to at least partially, or fully, rupture the plurality of weakened, melt stabilized locations202. The patterned calendar roller110is configured to have a cylindrical surface114, and a plurality of protuberances or pattern elements116which extend outwardly from the cylindrical surface114. The pattern elements116are illustrated as a simplified example of a patterned calendar roller110, but more detailed patterned calendar rollers are contemplated and will be discussed hereafter. The protuberances116may be disposed in a predetermined pattern with each of the protuberances116being configured and disposed to precipitate a weakened, melt-stabilized location in the weakened precursor material102to affect a predetermined pattern of weakened, melt-stabilized locations202. The protuberances116may have a one-to-one correspondence to the pattern of melt stabilized locations in the weakened precursor material102. As shown inFIG.9A, the patterned calendar roller110may have a repeating pattern of the protuberances116which extend about the entire circumference of surface114. Alternatively, the protuberances116may extend around a portion, or portions of the circumference of the surface114. Also, a single patterned calendar roller may have a plurality of patterns in various zones (i.e., first zone, first pattern, second zone, second pattern, etc.). The protuberances116may extend radially outwardly from surface114and have distal end surfaces117. The anvil roller112may be a smooth surfaced, circular cylinder of steel, rubber or other material. The anvil roller112and the patterned calendar roller110may be switched in position (i.e., anvil on top) and achieve the same result. Referring toFIGS.9A and9B, from the weakening roller arrangement108, the weakened weakened precursor web100′ passes through a nip130formed by the incremental stretching system132employing opposed pressure applicators having three-dimensional surfaces which at least to a degree may be complementary to one another. After the weakened precursor web100′ passes through the nip130, the weakened precursor web100′ becomes the modified web335. The incremental stretching system132comprises two incremental stretching rollers134and136. The incremental stretching roller134may comprise a plurality of teeth160and corresponding grooves161which may about the entire circumference of roller134. The incremental stretching roller136may comprise a plurality of teeth162and a plurality of corresponding grooves163. The teeth160on the roller134may intermesh with or engage the grooves163on the roller136while the teeth162on the roller136may intermesh with or engage the grooves161on the roller134. As the weakened precursor web100′ having weakened, melt-stabilized locations202passes through the incremental stretching system132the weakened precursor web100′ is subjected to tensioning in the CD causing the weakened precursor web100′ to be extended (or activated) in the CD, or generally in the CD. Additionally, the weakened precursor web100′ may be tensioned in the MD, or generally in the MD. The CD tensioning force placed on the weakened precursor web100′ is adjusted such that it causes the weakened, melt-stabilized locations202to at least partially, or fully, rupture thereby creating a plurality of partially formed, or formed apertures204coincident with the weakened melt-stabilized locations202in the modified web335. The melt-stabilized locations202form melt lips defining the periphery of the apertures204. However, the bonds of the weakened precursor web100′ (in the non-overbonded areas) may be strong enough such that many do not rupture during tensioning, thereby maintaining the weakened precursor web100′ in a coherent condition even as the weakened, melt-stabilized locations rupture. However, it may be desirable to have some of the bonds rupture during tensioning. The apertures204may be any suitable size. For example, apertures204may have an Effective Aperture AREA in the range of about 0.1 mm2to about 15 mm2, about 0.3 mm2to about 14 mm2, about 0.4 mm2to about 12 mm2, and about 1.0 mm2to about 5 mm2, specifically including all 0.05 mm2increments within the specified ranges and all ranges formed therein or thereby. All Effective Aperture Areas are determined using the Aperture Test described herein. Effective Aperture Area is discussed in further detail in U.S. Patent Application Serial Nos. 2016/0167334; 2016/0278986; and 2016/0129661. Smaller apertures may be more aesthetically pleasing to users of absorbent articles; however, the smaller apertures can have a negative impact on fluid acquisition speed. The process described regardingFIGS.9A and9Bexemplify one suitable process for forming apertures. Some additional processes for aperturing webs are described in U.S. Pat. Nos. 8,679,391 and 8,158,043, and U.S. Patent Application Publication Nos. 2001/0024940 and 2012/0282436. Other methods for aperturing webs are provided in U.S. Pat. Nos. 3,566,726; 4,634,440; and 4,780,352. Additionally, the apertures may be provided to the modified webs of the present disclosure in patterns. Processes for forming aperture patterns and some suitable aperture patterns are disclosed in U.S. Patent Application Serial Nos. 2016/0167334; 2016/0278986; and 2016/0129661. Zones The unit operations described herein and features provided thereby, may be provided to an absorbent article in a zoned configuration. Zones are areas exhibiting one of either a visual pattern, a topography, an absorption rate or property, a bending parameter, a compression modulus, a resiliency, a stretch parameter or a combination thereof that is different than another portion of the absorbent article. The visual pattern may comprise any known geometric shape or pattern that is visual and can be conceived by the human mind. The topography may be any known pattern that is measurable and can be conceived by the human mind. Zones may be repeated or discrete. Zones may be orthogonal shapes and continuities that provide a visual appearance. The use of zones allows for tailoring of the fluid handling and mechanical properties of and within the pad. The integrated absorbent structure may have one or more visual patterns including zones along one of either the longitudinal or lateral axis of the integrated layers. The integrated layers may have two or more zones comprising one or more visual patterns. The two or more zones may be separated by a boundary. The boundary may be a topographical boundary, a mechanical boundary, a visual boundary, a fluid handling property boundary, or a combination thereof, provided that the boundary is not a densification of the absorbent core structure. The boundary property may be distinct from the two zones adjacent to the boundary. The absorbent structure may have a perimeter boundary that exhibits a different property than the one or more adjacent zones to the boundary. One specific example of a process that can provide zoning is shown inFIG.10. As shown, an incremental stretching system832may comprise rolls834and836. As shown, the precursor web100may be provided with a plurality of melt stabilized locations722prior to entering nip816. Recall that the melt stabilized locations722may be provided in zones on the weakened precursor web100′ (shown inFIGS.9A and9B). In the case of the incremental stretching system832, the melt stabilized locations722may be provided in a central zone813. Upon stretching in the CD in the portion of the apparatus832corresponding to the region813, the melt stabilized locations722rupture to form apertures. Again, the melt stabilized locations722may be limited to a central region of modified web335. However, where melt stabilized locations722are provided throughout the precursor web100, apertures2214may be created in region813, while a combination of protrusions and apertures may be created in the regions811. As shown, the apparatus832comprises a pair of rolls834and836, each rotating about parallel axes A. Roll834may be configured as described regarding roll502(shown inFIG.6A). Namely, roll834may comprise a plurality of circumferentially-extending ridges760separated by grooves761. A second, intermeshing roll836comprises the central region813having essentially matching roll834and having ridges762separated by grooves763. The intermeshing ridges760,762and grooves761,763of rolls834and836incrementally stretch intermediate web48to form apertures2214. In addition to region813, roll836has two regions811comprising ridges having formed therein teeth810, the toothed ridges separated by grooves812. Ridges760of roll834intermesh with the grooves812of roll836to form the tufts as described herein. By combining both into one apparatus to form both apertures2212and tufts230in the precursor web100. The depth of engagement of the toothed ridges and the grooves can vary over the circumference of the rolls. Where that is the case, protrusions may be created which have varying heights and widths. For example, in a front region of an absorbent article, the depth of engagement may be less than the depth of engagement in the center of the article. The higher depth of engagement in the center may create protrusions which facilitate liquid acquisition of the absorbent article. Modified webs335of the present disclosure may comprise a variety of zones. For example, modified webs335may comprise zones which provide increased conformity and fluid kinetics while other zones may provide a soft feel to the user along with increased structural integrity. And as noted previously, zones of an absorbent article may comprise a variety of layers of the absorbent article as well. So, one zone may comprise intimate contact features while another zone comprises conforming features, a combination of conforming features and intimate contact-features, different arrangements of conforming features, etc. In one specific example, one or more zones may comprise apertures along with protrusions/depressions, e.g. tunnel tufts, filled tufts, nested tufts, or ridges and grooves. In one specific form, a first portion of protrusions (tunnel, filled, or nested) may be oriented in a positive Z-direction while a second portion are oriented in a negative Z-direction. In another specific form, one zone may comprise a combination of tunnel, filled, or nested tufts. In such forms, a first portion may be oriented in the positive Z-direction and a second portion may be oriented in the negative Z-direction. Or, forms are contemplated where at least one zone of a modified web335comprises both apertures and protrusions either in the positive and/or negative Z-direction. Additional zone configurations are contemplated. For example, zones may be discretely positioned along a length of an absorbent article. An exemplary absorbent article1510is shown inFIG.11A. The absorbent article1510is shown in the form of a feminine hygiene pad; however, the zones discussed herein may be applied to absorbent articles as desired. The absorbent article1510may comprise zones which extend laterally across the pad. For example, absorbent articles may comprise a first outer region1520disposed at one end of the absorbent article1510and an opposing second outer region1540disposed at an opposite end of the absorbent article1510. Between the first outer region1520and the second outer region1540is a target region1530. The dashed lines shown inFIG.11Aare imaginary and show exemplary delineations between adjacent regions. The target region1530, along with the first outer region1520and the second outer region1540, may each comprise about one third the length of the absorbent article. Each of the above-mentioned regions may be processed differently to provide a different benefit for the user. For example, the first outer region1520may be associated with the front of the pad and may comprise a first zone1525. The first zone1525may comprise protrusions which are smaller in scale compared to protrusions positioned outside of this area. The smaller scale protrusions may be provided to provide a soft, cushiony feeling to the wearer of the absorbent article1510. As the front of the pad may be associated with the pubic symphysis area of the user, a softer, more-cushiony feel may be beneficial. Additionally, the first zone1525may be provided with a larger number of protrusions than the target zone1535, vice versa, or they may have an equal number. And while the first zone1525is shown in the form of a rectangle, any suitable shape may be utilized. For example, the first zone1525may be in the form of a heart, a moon, a star, a horseshoe, a cloud, a flower, etc. In some forms, a plurality of discrete protrusions may form the aforementioned shapes. It is worth noting that the while the first zone1525is associated with the first outer region1520, the first zone1525may not be necessarily limited to the first outer region1520. Instead, the first zone1525may extend into the target region1530to some extent and/or into the second outer region1540to some extent. A target zone1535and a second zone1545may be similarly configured, e.g. they may extend into adjacent regions to some extent. Or the zones may extend the full length of the absorbent article. As another example, the target region1530may comprise the target zone1535. The target zone1535may correspond to the area of the absorbent article1510that is expected to receive liquid insults from the body. For example, in the context of a feminine hygiene pad, the target zone1535may disposed in the area of the article which corresponds to the vaginal opening in use. In the context of adult incontinence, the target zone1535may be disposed in the area of the article which corresponds to the urethral opening. Because the target zone1535may receive the liquid insults from the body, the target zone1535may be processed such that liquid insults are quickly acquired and distributed to an absorbent core of the article. So, the target zone1535may be provided with apertures as described herein to allow for quick fluid acquisition. In some forms, the target zone1535may be provided with protrusions which are larger than those of the first zone1525, which facilitate liquid acquisition. In some forms, the target zone1535may be provided with larger protrusions than what is provided in the first zone1525along with apertures. In some forms, the target zone1535may be provided with protrusions which are sized similar to the protrusions in the first zone1525along with apertures. Much like the first zone1525, the target zone1535is depicted in the shape of a rectangle; however, any suitable shape may be utilized. For example, the target zone1535may be in the form of a heart, a star, a horseshoe, a cloud, a flower, etc. Forms are contemplated where apertures present in the target zone1535are arranged in patterns. Suitable patterns and methods of making apertures in patterns were mentioned previously. Similarly, forms are contemplated where discrete protrusions in the target zone1535are arranged in patterns as noted via the target zone1535shape. The target region1530and target zone1535of the absorbent article can play important roles in the functionality of the absorbent article. For example, the target region1530and target zone1535should provide a stable yet conformable center of the absorbent article which is close to the source of liquid insult. In some specific forms, the topsheet, the FM layer, and the absorbent core are mechanically manipulated to form intimate contact therebetween. In such forms, protrusions oriented in a negative Z-direction may be beneficial in improving acquisition speed and improving absorbency. And, as another example, the second outer region1540may comprise a second zone1545. The second zone1545may correspond to an area of the article that corresponds to the gluteal groove of the wearer. In such forms, it may be beneficial to specially process the second zone1545to allow the second zone1545to conform to the gluteal groove thereby allowing better fit of the article to the wearer. The second zone1545may be provided with protrusions which increase the flexibility of the second zone1545allowing the article1510to bend more easily than it would without protrusions. The second zone1545may be provided with conforming features as described herein which increases flexibility/conformability within the second zone1545. In one specific example, the second zone1545may comprise protrusions oriented in the positive Z-direction which may provide assistance in wiping fluid from the body. Typically, the most rigid portion of an absorbent article is an absorbent core which is disposed between a topsheet and a backsheet. Some conventional methods utilized to increase the flexibility of the core are to remove (cut-out) core material where additional flexibility is required. However, this can increase cost as absorbent core material is typically thrown away post removal. In contrast, in the case of the present disclosure, the absorbent core in the second zone1545may comprise conforming features which increase the flexibility of the absorbent core in the second zone1545. In some forms, a topsheet and/or the FM layer, in addition to the absorbent core may comprise conforming features to increase flexibility in the second zone1545. And while the second zone1545is shown as a triangle, much like the previous regions discussed, the second zone1545may comprise any suitable shape. Some examples include hearts, rainbows, stars, clouds, animals, etc. In some forms, the conforming features, etc. may be arranged in patterns in the aforementioned shapes. Forms of the present disclosure are contemplated where the first zone1525, the second zone1545, and the target zone1535are processed similarly such that they each comprise conforming features. Such forms may eliminate the need for registration to some extent since all zones comprise the same size features. Forms are contemplated where the first zone1525, the second zone1545, and the target zone1535are processed similarly but include a variety of layers within their respective zones. For example, in some forms, the first zone1525and the second zone1545may comprise mechanical manipulation, e.g. conforming features, of the FM layer and the absorbent core, e.g. a first combination of layers. However, the target zone1535may comprise mechanical manipulation, e.g. conforming features, of the topsheet, the FM layer, and the absorbent core, e.g. a second combination of layers. Such a configuration may allow the absorbent article to be designed such that the first zone1525and the second zone1545may focus on comfort and fit of the absorbent article, while the target zone1535focuses on fluid acquisition and reduction of rewet. Or, zones may comprise intimate contact features and/or conforming features that are different. For example, the first zone and/or second zone may comprise a first plurality of intimate contact features and/or conforming features, and the target zone may comprise a second plurality of intimate contact features and/or conforming features, wherein the first plurality is different than the second plurality in at least one of shape, density (number per square cm), depth, length, shape, and/or spacing (nearest edge of feature to nearest edge of adjacent feature) between adjacent intimate contact and/or conforming features. As noted previously, the shapes of the various zones within the regions may be configured as desired. For example, the zones may extend an entire width of the article in an X-direction. Regardless of the shape of the zones within the regions depicted inFIGS.11A and11B, a first distance1570of unmodified or differently modified material may be disposed between the first zone1525and the target zone1535. The determination of differently modified material and/or unmodified material may be determined via visual inspection of the materials similar to the identification of conforming features mentioned heretofore. Namely, unmodified material will not have been subjected to the meso-processing described herein. For the sake of clarity, unmodified material between adjacent zones, may have been subject to the micro-processing such as hydroentangling and needle punching. Additionally, differently modified material may have been subjected to meso-scale processes as described herein but may have conforming features that are different than the zones in which the differently modified material is adjacent. Similarly, a second distance1575of unmodified material or differently modified material may be disposed between the target zone1535and the second zone1545. In some forms, the first distance1570may be greater than the second distance1575. The areas of unmodified material or differently modified material can help preserve the structure of the absorbent article1510. This can ensure that the article1510maintains some structural integrity which encourages conformance by the article in the desired zones and provides crush resistance. In some forms, the first distance1570may be from about 5 mm to about 10 mm or more. In some forms, the second distance1575may similarly be from about 5 mm to about 10 mm or more. For example, the first and/or second distance may be between about 5 mm to about 30 mm, from about 7 mm to about 20 mm, or from about 9 mm to about 15 mm. The first distance and the second distance represent the shortest straight-line distance between the first zone and the target zone or the target zone and the second zone. The zones discussed herein may be provided to the absorbent article1510in any suitable manner. For example, the article1510may comprise modified webs described herein and may be configured with zones as described above regardingFIGS.11A and11B. For example, the modified webs may comprise the first zone1525, the second zone1545, and the target zone1535. Additional zone configurations are contemplated. In addition to the zone configuration, based on the foregoing process description, there are many possible combinations which may be accomplished regarding zones on an absorbent article. A few of the possible combinations are discussed below along with the associated benefits. For example, forms are contemplated where the zones are provided uniformly through a plurality of layers, through only an individual layer, or through various combinations of layers. Specifically, at least one of the first zone1525or second zone1545may comprise intimate contact features and/or conforming features which are applied to at least two of the topsheet, the FM layer, or the absorbent core. The target zone1535may comprise intimate contact features and/or conforming features which are applied to at least two of the topsheet, the FM layer, or the absorbent core, wherein the layer combination of the target zone1535is different than that of the first zone1525. Or the combination may be the same in these zones. Additional forms are contemplated which include additional material layers disposed between the topsheet and the backsheet. The additional material layers can be processed with one or more zones as described herein. Referring now toFIGS.3A,3B,3D,11A, and11B, in some examples, prior to any unit operation, the topsheet web10and the FM layer web20may be joined in the cut and place operation30thereby forming the TFM laminate35. In such forms, any manipulation provided to the TFM laminate35is provided to both the topsheet and the FM layer. In such forms, the first unit operation40may impart to the TFM laminate features which correspond to the first zone1525, the target zone1535, and/or the second zone1545. And, as noted previously, these features can help create intimate contact between the topsheet and the FM layer. For any of the zones where features are not provided, those zones may remain unmodified. In contrast, inFIG.3Cthe topsheet web10may be mechanically manipulated in the first unit operation40prior to being joined to the FM layer web20in the cut and place operation30. The first unit operation40may provide to the topsheet web10features which correspond to the first zone1525and the target zone1535. In conjunction or independent form the foregoing, the first unit operation may similarly provide conforming features which correspond to the second zone1545. For any of the zones where features are not provided, those zones may remain unmodified. The FM layer web20may be subjected to the first unit operation40prior to being joined to the topsheet web10in the cut and place operation30. In such forms, the first unit operation40may provide to the FM layer web20features which correspond to the first zone1525, the target zone1535, and/or the second zone1545. In such forms, the topsheet web10may be provided to the cut and place operation30unmodified. For any of the zones where features are not provided, those zones may remain unmodified. In some forms, the topsheet web10and the FM layer web20may be subjected to separate unit operations prior to being joined in the cut and slip operation30. The separate unit operations may impart features corresponding to the first zone1525, the target zone1535and/or the second zone1545, or any combination thereof to the topsheet web10and/or the FM layer web20. RegardingFIGS.3D,11A and11B, in some forms, the absorbent core may be provided to the cut and place operation31along with the intermediate laminate48. The resulting TFMAC laminate37may then be provided to the second unit operation50. The second unit operation50may impart features to the TFMAC laminate37which correspond to the first zone1525, the target zone1535, and/or the second zone1545. And, as noted previously, the features provided to the TFMAC laminate37can create intimate contact between the topsheet, FM layer and AC layer. For any of the zones where features are not provided, those zones may remain unmodified. RegardingFIGS.3E,11A and11B, in some forms, the FM layer web20and the absorbent core web18may be provided to a second unit operation50which imparts features to the FMAC laminate web49. In such forms, the features provided to the FMAC laminate web49are provided to both the absorbent core web18and the FM layer web20. In some forms, the second unit operation50may impart features as described herein which correspond to the first zone1525, the target zone1535and/or the second zone1545. As noted previously, as the absorbent core is typically the stiffest portion of an absorbent article, in some specific forms, the second unit operation50may impart conforming features, or the like to the FMAC laminate web49which correspond to the second zone1545. Forms are also contemplated where the absorbent core web18and the FM layer web20are subjected to separate unit operations. In such forms, features may be imparted to the FM layer which correspond to the first zone1525, the target zone1535, and/or the second zone1545. Similarly, features may be provided to the absorbent core web18which correspond to the first zone1525, the target zone1535, and/or the second zone1545. In some specific forms, the absorbent core web may be provided with conforming features in only the second zone1545. Or, the absorbent core web may be provided with conforming features corresponding to zones which are different than that of the FM layer web20. RegardingFIGS.3E,3F,9A, and9B, the topsheet web10may be subjected to the first unit operation40in some forms or may be provided to the cut and place operation30un-modified. For those forms where the topsheet web10may be subjected to the first unit operation40, features imparted to the topsheet web10may correspond to the first zone1525, the target zone1535, and/or the second zone1545. Zones may be further enhanced by creating non-coterminous materials. For example, forms are contemplated where the absorbent core web length is shorter than a length of the FM layer. Such constructions can reduce the amount of absorbent core web utilized per absorbent article. This can in turn save material cost. An example of a non-coterminous arrangement is shown inFIG.11C. As shown, in some forms, the FM layer20and absorbent core layer18may be sandwiched between the topsheet web10and a backsheet web1716. The FM layer20may have a length which is shorter than the topsheet10and the backsheet1716as mentioned previously. However, in some forms, the absorbent core18may have a shorter length than the FM layer20. For example, as shown, the absorbent core18may be disposed in the target region1530and may extend only a slight amount into the first region1520and the second region1540, e.g. less than 50% of the length of the first region and/or second region. In some forms, the absorbent core18may be disposed solely within the target region1530. In such forms, the absence of the absorbent core18adjacent the ends of the absorbent article1510can allow much greater flexibility nearer the ends of the article1510. Such forms may be accomplished via the cut and place operations described herein. Additionally, in such forms, an additional material layer may be added to reduce the likelihood of leakage. For example, as shown inFIG.11D, an auxiliary absorbent layer19can be added between the absorbent core18and the backsheet1716. As shown, the auxiliary absorbent layer19can be primarily disposed in the second zone1540and overlap the absorbent core18in the target region1530. In one specific example, as shown inFIG.11E, the absorbent article1510may comprise protrusions1571and1572, each of which is disposed adjacent a longitudinal side edge of the absorbent article1510. The protrusions1571and1572may be disposed only in the target region1530. Or, in some forms, the protrusions1571and1572may be disposed along the entire length of its respective longitudinal side edge. In some forms, the protrusions1571and1572may comprise tufts as described herein, e.g. tunnel tufts, outer tufts, filled tufts, nested tufts, ridges and grooves, or may comprise corrugations as described herein. For those forms, where the protrusions1571and1572comprise tufts, a plurality of tufts may be arranged longitudinally adjacent the length of the longitudinal side edges of the absorbent article1510. For those forms comprising corrugations, a plurality of ridges and grooves may similarly be arranged longitudinally along the longitudinal side edges of the absorbent article1510. Or in some forms, a single ridge and groove and may be arranged longitudinally along the length of the longitudinal side edges. The forms incorporating the protrusions1571and1572may provide additional leakage protection by acting as barriers. Additional configurations are contemplated. For example, absorbent articles of the present disclosure may comprise a plurality of rows of protrusions which are laterally spaced apart from one another. Such configurations can provide barriers to leakage and can also provide a softness benefit to the user. In some forms, the protrusions1571and1572may be formed in the topsheet of the absorbent article. In other forms, the protrusions1571and1572may be formed in the topsheet and the absorbent core or the topsheet and the FM layer. For these forms, the protrusions1571and1572can be absorbent to some extent. Forms are contemplated where the first region, the target region, and/or the second region comprise more than one zone. For example, regarding the form shown inFIG.11E, the target region may comprise an outer zone in which the protrusions1571and1572are disposed. The outer zone may be disposed outboard of the target zone. And for those forms where the first region and/or the second region comprises protrusions, the protrusions may be disposed in outer zones which are outboard of the first zone and/or the second zone, respectively. In addition to the mechanical manipulation described heretofore and the creation of zones, forms of the present disclosure are contemplated where in addition to the intimate contact via mechanical manipulation described herein, zones may be created or enhanced via chemical heterogeneity. For example, where protrusions are provided in an absorbent article, the distal ends of the protrusions may be provided with a composition. Or land areas between adjacent protrusions may be provided with compositions. In one specific example, where protrusions are oriented in a positive Z-direction, distal ends of the protrusions may be provided with a hydrophobic composition. In another specific example, where the protrusions are oriented in a negative Z-direction, distal ends of the protrusions may be provided with a hydrophilic composition. Suitable compositions and methods for applying compositions to webs are described in additional detail in U.S. Patent Application Publication Nos. 2017/0225449A1; 2017/0120260A1; and 2017/0258650A1. Conforming Modified Webs The inventors have surprisingly found that intimate contact, while beneficial for fluid management, may not be sufficient—on its own—for product conformity. For example, needlepunched and spunlaced modified webs, while providing intimate contact between adjacent layers and therefore good fluid handling properties, cannot provide the level of conformity required on their own. Rather, the meso-scale processes as described herein may be utilized with appropriate spacing, as discussed herein, to form conforming features in the modified webs. The absorbent articles of the present disclosure may provide good conformity to the body of the wearer in addition to the good fluid management. However, while good fluid management may be derived from intimate contact, which can be created via the micro-scale processes and the meso-scale processes, good conformance can only be achieved via meso-scale processes or a combination of micro-scale and meso-scale processes as described herein. Traditional fibrous absorbent core materials such as thick (or densified cellulose fluff) or absorbent airlaid materials are mostly composed of short (˜2.5 mm) cellulose fibers that form inherently weak mechanical structures. These conventional structures struggle to maintain their integrity and shape during dynamic bodily motions in the dry state. And, in the wet state, integrity and product sustaining shape only deteriorates further as cellulose fibers wet plasticize and become soft, pliable and collapse. Historically two approaches have been employed to improve the mechanical performance of cellulosic systems; densification (typical fluff cores range from un-densified 0.04 g/cm3to about 0.2 g/cm3when densified), and in the case of airlaid's, the inclusion of heat bondable bi-component fibers (typically less than 6 mm in length) or latex based binders in addition to densification (airlaid's are typically in the 0.08-0.15 g/cm3). The problem of densification of cellulosic short fiber absorbent core systems is that these tend to significantly stiffen the absorbent core system. Unfortunately, the densification can have a negative impact on both comfort and the ability of the stiffened absorbent system to conform to the intimate body shape. The intimate area is characterized by significant topographic variations on a relatively short (sub centimeter) length scale. This complex geometry can be difficult to conform to due to the densification. Namely, as absorbent systems are densified, their bending modulus (ease of bending) and bending stiffness dramatically increase making intimate conformation to the labial (major and protruding minora) surfaces very difficult. And as noted, these short fiber cellulosic fiber structures significantly collapse in the dry to wet state. The ability of an absorbent article to conform during use is generally governed by the stiffest layer within the absorbent article. To create an absorbent article which can provide good conformance to the body of a wearer, the stiffest layer of the absorbent article should be mechanically manipulated as described herein to create a more conforming structure. In some forms, this may comprise mechanical manipulation of the topsheet, optional FM layer, and absorbent core either across the entirety of the absorbent article or in zones as described herein. As noted previously, such manipulation of these layers may occur throughout the absorbent article or in zones as discussed herein. And, along with the benefit of increased conformity, the benefit of intimate contact and therefore good fluid management can also be realized. ForFIGS.12A-12B and13A-13C, a pattern of struts, nodes and depressions are shown. The nodes are interconnected to one another via struts which are spaced apart from one another via depressions. The nodes are essentially unmodified material of the modified web while the material associated with the struts and depressions is mechanically strained. There may be at least one strut that connects an adjacent node. Or, there may exist a plurality of struts between adjacent nodes. For example, the number of struts may be between about 2 to about 10. Or, more than 10 struts may be utilized. FIGS.12A to12Bshow a plan view of and a cross-sectional view, respectively, of a topsheet integrated with an absorbent core utilizing the tufting process described herein. The tufts were oriented in the negative Z-direction. As shown, a topsheet1217and absorbent core1219composite1200that not only provides good fluid management benefits but also provide good conformance to the body, comprises a plurality of nodes1211and a plurality of struts1213between adjacent nodes. Between adjacent struts1213are depressions1215which extend in a negative Z-direction. The depressions1215can be formed when the tooling described—see for exampleFIG.6Bregarding the protrusions herein—impacts the topsheet and absorbent core web. As shown fibers of the topsheet1217along with fibers of the absorbent core1219are disposed within the depressions1215. The sample ofFIGS.12A-12Bcomprised a 28 gsm calendar bonded, bi-component, spunbond fiber topsheet1217. The absorbent core1219was coformed comprising 30 percent continuous, e.g. longer than staple fiber, about 5 to about 10 microns, or larger, polypropylene fibers. The tooling that created the depressions1215was as described regarding tufts. The DOE of the tooling was 1.9 mm. FIGS.13A-13Cshow a plan view of and cross-sectional views, respectively, of a topsheet1317integrated with an absorbent core1319. The tufts were oriented in the negative Z-direction. As shown, a composite web1300of the topsheet1317and absorbent core1319comprises nodes1311and struts1313. Between adjacent struts1313are depressions1315which extend in the negative Z-direction. The depressions1315can be formed when the tooling described regarding protrusions herein, impacts the topsheet and absorbent core web. As shown fibers of the topsheet1317along with fibers of the absorbent core1319are disposed within the depressions1315. The sample ofFIGS.13A-13Ccomprised a 28 gsm calendar bonded, bi-component spunbond fiber topsheet1317. The absorbent core1219was a hydroentangled nonwoven with 38 mm fiber lengths. The tooling that created the depressions1215was as described with regard to tunnel tufts. The DOE of the tooling was 1.9 mm. For both samples ofFIGS.12A-12B and13A-13C, it is worth noting that the topsheet is displaced down into and between adjacent struts. As noted previously, micro-scale processing of the same, e.g. needlepunch or spunlace would only displace a few fibers of the topsheet within each depression. In contrast, the meso-scale processing described herein displaces a much larger amount of the constituent material of the topsheet into the absorbent core which can allow the resulting features to provide absorbent article conformance benefits. Further, via the meso-scale processing, the topsheet and absorbent core are in intimate contact with each other to provide good fluid management characteristics. FIG.14shows a schematic close up cross section showing a topsheet and an absorbent core composite1400. As shown the depressions1415(exaggerated for ease of visualization) do not extend through the thickness of the composite, but rather rearrange constituent material of the topsheet and/or absorbent core. So in other words, the depressions have a bottom1421. As shown, the depression bottoms1421may be disposed between a first surface and a second surface of the composite1400. Or, the bottom1421of at least one depression may be disposed subjacent to the second layer of the composite1400. When the teeth of the rolls described in, for example,FIG.6A or6Bengage the constituent material of the topsheet and/or absorbent core, some of the constituent material may extend, thin, and some may even break. In the case of nonwoven materials, fibers of the nonwoven may become thinner and some fibers may break. Similarly, in the absorbent core, some of the constituent material may break or become unattached to the constituent material of the absorbent core. So, the depressions1415, in a sense form a weakened area between adjacent struts1413. The weakened area, due to the reduced amount of material, can allow the struts1413to move, bend, and/or rotate somewhat independently from one another. However, the bottom1421ties adjacent struts1413together such that the absorbent core still retains some structural significance. In addition to tying adjacent struts1413together, the bottoms1421also form a bridge between adjacent struts1413. This bridge can serve as a fluid transport pathway which can help utilize more of the material of the absorbent core as opposed to where a bridge is absent. Additionally, it is believed that with the urging of the material of the topsheet and absorbent core in a negative Z-direction, that material of the topsheet and absorbent core mix to some extent along the side walls of the depressions and in the bottoms of the depressions. As such, the depressions can provide a fluid management benefit via faster fluid acquisition. In contrast, while embossing may provide some mixing of material between the topsheet and the absorbent core, the densification of the area formed by embossing does not increase fluid acquisition speed in the densified areas. Each of the depressions1415has a length which extends generally parallel to its long axis. As shown in theFIGS.12A-12C and13A-13C, the lengths of the depressions can vary. As shown, the long axis may be generally oriented in a direction which is parallel to a longitudinal axis of an absorbent article. However, the depressions1415can have a long axis which is generally parallel to a transverse axis of an absorbent article. The depressions1415may have a long axis which is at an angle with respect to the longitudinal axis of the absorbent article. For example, a first portion of depressions1415may have a long axis which is generally parallel to the longitudinal axis, and a second portion of depressions1415may have a long axis which is generally parallel to the transverse axis. A third portion of depressions1415may have a long axis which is generally at an angle with respect to the longitudinal axis. The depressions1415of the third portion may comprise depressions having a long axis which are at a variety of angles with respect to the longitudinal axis. As an example, a portion of the depressions1415may have a long axis which is at a first angle with respect to the MD, and a portion of depressions1415may have a long axis which is at a second angle with respect to the MD. A portion of the depressions' long axis may be at a third angle, and a portion of the depressions' long axis may be at a fourth angle, etc. The spacing between adjacent depressions—generally perpendicular to the long axis of the depression—can be any suitable distance and depend on the spacing of the forming elements on the associated rolls. As there may be mechanical limits regarding the rolls regarding spacing, such limits may then impact the spacing between adjacent depressions. Additionally, the caliper of the layers being integrated may drive spacing between depressions as well. For example, thicker caliper materials may require a higher spacing between adjacent teeth. Closer spacing between teeth, depending on the materials being integrated, can cause shredding/tearing of the layers. In some specific forms, the depressions may be spaced apart by greater than about 1 mm in the CD and greater than about 2 mm in the MD. In some forms, the bottoms1421may be bonded via heated teeth or other suitable mechanism. The bonded bottoms1421can provide additional stability to the web and ensure that the topsheet is firmly anchored to the absorbent core. A suitable process is described in additional detail in U.S. Pat. No. 7,682,686. Even though the composites described regardingFIGS.12A-12B and13A-13Ccomprise topsheets and absorbent cores, topsheet and FM layer composites may be formed. Or, composites may comprise an FM layer and absorbent core. Or, composites may comprise a topsheet, FM layer, and absorbent core. As noted previously, some cellulose based materials, when exposed to the meso-scale processes as described herein, may be torn, ripped, and/or shredded to some extent. An example of what happens to some materials when subjected to the meso-scale processes described herein is shown inFIGS.15A-15C. As shown, from a plan view inFIG.15A, the topsheet and absorbent core composite1500does not appear all that different from the composites1200and1300(shown inFIGS.12A-12B and13A-13C, respectively). The composite1500comprises a node1511and a plurality of struts1513A and1513B. Each strut forms a sidewall portion of the depression1515opposite one another. However, as shown inFIGS.15B and15Cthough, a depression1515extends all the way through the composite1500and acts like a slit between adjacent struts. From a mechanical standpoint, the depression1515can allow the struts1513A and1513B to move relative to one another without any tie connection to the adjacent struts. This can allow for great conformance initially. However as shown, without the connection between adjacent struts as described regardingFIG.14(present inFIGS.12A-12B and13A-13C), the struts1513can have too much flexibility in the degree of movement available. For example, as shown a portion of a first strut1513A is disposed beneath a portion of a second strut1513B. So, any movement of the absorbent core requires sufficient energy to overcome the sliding of the struts1513A and1513B over one another. And rather than being stored as potential energy within the core, the energy of the movement is dissipated in overcoming the relative movement of the struts one over the other—similar to friction loss. Because of the lost energy, once deformed, without the connected areas described inFIG.14, the struts1513A and1513B may not have the requisite energy to recover to their undeformed state. And as such, the composite1500lacks sufficient integrity to withstand the mechanical stresses produced while the article is worn and ends up collapsing into a bunched state. This can create discomfort to the wearer as well. So too much conformance can lead to comfort issues during wear just as not enough conformance can. In contrast, the materials selected in accordance with the present disclosure can reduce the friction loss of a portion of one strut disposed beneath another strut. Referring now toFIG.15C, the adjacent struts overlap to a large extent. When materials are selected in accordance with the present disclosure, an overlap distance1503may be less than about 0.75 mm, less than about 0.5 mm, or less than about 0.2 mm, or about 0 mm. The overlap distance test is described in additional detail herein. The materials utilized for the sample ofFIGS.15A-15Cwere a 28 gsm, bi-component 80 percent polypropylene and 20 percent polyethylene, spunbond, topsheet and an airlaid absorbent core comprising 180 gsm, 4.9 percent, 3 mm length, 1.7 dtex bi-component fiber, 14.7 percent of particle AGM and about 80 percent short cellulose fibers. As noted previously, traditional fibrous absorbent core materials, comprise short cellulose fibers. It is believed that due to the length of the fibers, e.g. short, they are unable to form a substantial fiber network that can withstand the meso-scale processing described herein. It is believed that mechanical manipulation of these short fibers results in these short fiber materials being deformed and stretched (as they flow around the teeth for example) to such an extent that such processing typically leads to material tearing. The material tearing weakens the structure's ability to recover its shape when deformed while being worn as the user goes about their daily routine. For example, as shown regardingFIGS.15A-15C, slits and tearing can occur where the fibers are too short. As mentioned previously, to drive good conformance, the layer of the absorbent article which provides the most stiffness will likely be a good candidate for the formation of conforming features as described herein. So, as an example, an FM layer disposed between the topsheet and absorbent core may not need to be designed to withstand the meso-scale processes described herein. In such forms, if the absorbent core is the stiffest portion of the absorbent article, the breakage of constituent material of the FM layer, may not negatively impact the integrity of the absorbent article. And the converse is also applicable. If an absorbent article includes an FM layer that is stiffer than its absorbent core counterpart, then the FM layer may be designed to withstand the meso-scale processes described herein. The absorbent core in such forms, however, may not need to be designed to withstand such processes. Or, in some instances, it may be beneficial to design the system to withstand the meso-scale processes described herein. So, material selection can impact the level of conformance of the modified webs of the present disclosure. The inventors surprisingly have found that through the support of long fiber networks, e.g. longer than 6 mm, conformance features may be created in absorbent articles which provide fluid kinetic benefits along with desirable mechanical properties. These long fiber networks may be realized in the absorbent core, in the FM layer, and/or the topsheet, or any combination thereof. However, it is worth noting that a sufficient amount of long fibers/filaments should be utilized in order to create the long fiber network. Appropriate materials to accomplish the weakened areas between struts is described in additional detail hereafter. As noted previously, the DOE between tooling impacts the level to which one layer is engaged with another layer. For example, as shown inFIG.16, for lower DOE, a bottom1621B of a depression may be disposed proximate to a wearer-facing surface of the absorbent core. In contrast, for a higher DOE, a bottom1621A of a depression may be disposed more distal than the bottom1621B. Forms are contemplated where variable depths of engagement are utilized. In such cases, depressions where the DOE is higher may be deeper than for depressions where the DOE was not as high. Without wishing to be bound by theory it is believed that a long fiber network can reduce the likelihood of shredding of the absorbent core or shredding of the layer which dominates the flexibility of the absorbent article. It is believed that fibers within the absorbent core, the FM layer, and/or the topsheet should be greater than about 6 mm. It is further believed that longer thermoplastic fibers can span the depressions and support the bottoms of the depressions which connect adjacent struts. It is also believed that shorter fibers, e.g. cellulose, during mechanical manipulation, tend to separate from one another as they do not have sufficient length to tie into the fiber network of the absorbent system. It is worth noting that for a higher depth of engagement of the tooling mentioned herein, longer fibers may be required. Conversely for a lower depth of engagement, shorter fibers may be utilized; however, it is believed that a lower depth of engagement, below 5 mm, for example, may detrimentally impact the conformability of the absorbent article. In some forms, fiber lengths longer than tooling length, e.g. the length of the teeth510(shown inFIG.6A), may be sufficient to create a long fiber network that can withstand the meso-scale processing. So, the depth of the depression may be shorter than the average length of thermoplastic fibers in the absorbent system, e.g. the FM layer and/or absorbent core. The long fiber network is believed to allow the constituent material of the layers to more easily flow around the tooling utilized for the meso-scale processing. This flowing of the constituent material allows the constituent material to stay in-tact post processing without significant breakage of the fibers. It is further believed that extensible materials and/or crimped fibers can help the long fiber network maintain its structural integrity. In addition to the length of fibers, it is believed that the way the fibers are tied together can also influence the fiber network. For example, it is believed that the density of bond sites (bond sites per square cm) via calendar bonding can impact the long fiber network. For example, where there is a high bond density, long fibers can effectively be made short due to the spacing of adjacent bond sites. In contrast, it is believed that air through bonding may beneficially impact the long fiber network as these types of bonds are seen as more easily broken during processing. As another example, ultrasonic bonding and/or thermal bonding of the fibers of these layers can be utilized to build a fiber network which can assist the long fiber network. Additional examples include spunlacing and needlepunching. Bond spacing, spunlacing and/or needlepunching can allow the long fiber network to flex/move and then recover. Appropriate bond spacing would ensure that effective fiber lengths are not less than about 6 mm. Some specific examples of sufficient fiber networks are described regarding Tables 1-4. For the absorbent articles of the present disclosure, the dominant layer, i.e. the layer which most influences the flexibility of the article—generally the thickest material, may benefit from comprising a long fiber network. The “long” filaments or fibers of the long fiber network should make up between 15% and 50% by weight of the filaments and/or fibers in the fibrous structure, between 17% and 40% of the fibers in the fibrous structure, or between 20% and 30% of the fibers in the fibrous structure, specifically reciting all values within these ranges and any ranges created thereby. For example, long filaments, i.e. longer than 6 mm, may be in the absorbent core. In order for the absorbent core to survive the meso-scale processes described herein, it is believed that the basis weight of long fibers should be at least 15 percent of the basis weight of the absorbent core. However, where the absorbent core does not comprise the requisite long fiber percentage, layers of material adjacent to the absorbent core, e.g. fluid management layer and/or topsheet may contribute to the long fiber network. But it is believed that where the absorbent core lacks the requisite percentage of long fibers, a higher percentage than 15 percent may be required from the adjacent layers. For example, assuming that the fluid management layer and the absorbent core are provided with conforming features, if the absorbent core does not comprise at least 25 percent of long fibers, then the long fibers of the fluid management layer should also be assessed. In such instances, the cumulative basis weight of the long fibers should be evaluated against the cumulative basis weight of the fluid management layer and the absorbent core to determine the appropriate percentage of long fibers. The filaments and/or fibers of the long fiber network may be capable of interconnecting or bonding with other filaments and/or fibers, such as, for example thermoplastic fibers. The filaments and/or fibers of the long fiber network should have an average length that is longer than the average strut height in the absorbent mesh and/or longer than the average depression depth. The average length of fibers of the long fiber network may be between about 6 mm to about 100 mm. Or, the long fiber network may comprise continuous filaments, e.g. meltblown, spun melt, spunbond, etc. Still, the long fiber network may comprise continuous filaments as well as fibers. The filaments and/or fibers used to form the long fiber network may be bundles of filaments and/or fibers. For example, between 10 and 100 fibers may be in the form of a bundle such that at least 5% of the filaments and/or fibers will bond together. Bundling the filaments and/or fibers together allows for the filaments and/or fibers to form a fibrous network while maintaining desirable permeability. An exemplary absorbent article1700created in accordance with the present disclosure is shown inFIG.17A. The article shown has been modified to provide good fluid acquisition in the target region1530. As shown the target zone1535having a figure eight shape may comprise intimate contact between an FM layer and the absorbent core in the target zone1535. Additionally, in some forms, the target zone1535may comprise apertures which extend through the topsheet, or through the topsheet and the FM layer. Additionally, because the absorbent article1700may comprise conforming features as well in the target region1530which can allow the absorbent article1700to conform to the external labial structure of the wearer. Similarly, the first region1520and the second region1540may comprise conforming features which allow those portions of the absorbent article1700to conform to the complex surfaces of the user. However, the patterns utilized in the first and second regions1520and1530may provide more structural integrity to the absorbent article while the pattern in the target zone1535may provide more conformance to the body. Similarly, outboard of the target zone1535, the target region1530may comprise the pattern of the first region1520and/or the second region1540or may comprise a pattern which provides additional structural integrity over that of the target zone1535. As shown, the first region1520and the second region1540may comprise conforming features which are generally diamond shape and which have a repeating pattern. Within each of the diamond shapes, there are a plurality of depressions of varying length. As shown, the depressions are generally oriented generally parallel to a long axis of the absorbent article1700. However, the depressions may be oriented at an angle thereto or may be oriented generally parallel with a lateral axis of the absorbent article. Or, some of the diamonds within the pattern may comprise depression oriented in one direction while other diamonds within the pattern comprise depressions oriented in another direction. The same hold true regardless of the shape of units within the pattern, e.g. diamonds, circles, etc. Additional suitable shapes are disclosed below. Also, as shown, the target region1530, in a portion thereof, may comprise conforming features which are generally oriented in columns and staggered rows, where the columns are generally parallel to the long axis of the absorbent article1700. The depressions may be longer than those of the diamond or longer than at least some of the depressions within the diamond pattern. Additional patterns which can be utilized for the webs of the present disclosure are provided regardingFIG.17B. As shown, nodes may be any suitable shape, e.g. ovals, hexagons, diamonds, semicircles, hearts, donuts, rainbows, etc. Additional shaped include moons, clovers, balloons, stars, or combinations thereof. As shown, a plurality of struts extends between each of the nodes. Absorbent Articles After the topsheet, FM layer, absorbent core, or any combination thereof, are provided with intimate contact and/or conforming features, the modified web may be further converted to produce an absorbent article. As shown inFIG.18, a final web1058(which is inclusive of the final webs described herein) may be subsequently processed as described regardingFIG.18to create a plurality of absorbent articles1039. For example, for those forms where an absorbent core was not previously provided, an absorbent core web1718A (shown as a roll) may be provided to a cut and place operation1030which cuts the absorbent core web1718A and creates a plurality of discrete absorbent cores therefrom. The plurality of discrete absorbent cores may be placed on the plurality of discrete FM portions20A (shown inFIG.4) thereby forming the TFMAC laminate web37. Subsequently, a backsheet1716A (shown as a roll) may be placed on the TFMAC laminate web37thereby forming an absorbent article laminate web1073. A joining operation1031may be utilized to join the backsheet with the TFMAC laminate web37. Subsequently, the absorbent article laminate web1073may be subjected to a cutting operation1032which cuts the absorbent article laminate web1037into a plurality of discrete absorbent articles1039. Cutting operations as well as cut and place operations are known in the art of disposable absorbent article production. Topsheets of disposable absorbent articles are the wearer-facing surface of the article. The absorbent articles of the present disclosure may comprise any known or otherwise effective topsheet, such as one which is compliant, soft feeling, and non-irritating to the wearer's skin. Suitable topsheet materials include a liquid pervious material that is oriented towards and contacts the body of the wearer permitting bodily discharges to rapidly penetrate through it without allowing fluid to flow back through the topsheet to the skin of the wearer. A suitable topsheet may be manufactured from a wide range of materials, such as porous foams, reticulated foams, apertured plastic films, woven materials, nonwoven materials, woven or nonwoven materials of natural fibers (e.g., wood or cotton fibers), synthetic fibers or filaments (e.g., polyester or polypropylene or bicomponent PE/PP fibers or mixtures thereof), or a combination of natural and synthetic fibers. Additional fibers or filaments include meltblown, nano, spunbond, carded, or the like. The topsheet may have one or more layers, for example a spunbond-meltblown-spunbond material. Any portion of the topsheet may be coated with a skin care composition, an antibacterial agent, a surfactant, and/or other beneficial agents. The topsheet may be hydrophilic or hydrophobic or may have hydrophilic and/or hydrophobic portions. If the topsheet is hydrophobic, typically apertures will be present so that bodily exudates may pass through the topsheet. Where topsheet is desired to be mechanically manipulated, for example, for the formation of conforming features, the topsheet may comprise extensible material or material which comprises crimped fibers/filaments. If, non-extensible materials are utilized in the formation of conforming features, the topsheet may break or shred. Additional details of nonwoven webs with extensible fibers/filaments is provided in U.S. Patent No. US 2014/0170367. And, details of nonwoven webs with crimped fibers is provided in U.S. Patent Application Publication No. 2016/0166443. Additionally, in some forms the idea of intimate contact can be applied to the topsheet. For example, the topsheet may comprise a film substrate and a nonwoven substrate. In such forms, the nonwoven substrate may be a carrier material upon which the film substrate may be extruded. Because the extruded film is in a semi-molten state, it is believed that the resultant composite provides intimate contact and performance benefits over a film and nonwoven laminate of the same constituent material. The film/nonwoven composite may then be processed as described herein, e.g. the addition of apertures to provide the ability to acquire fluid and the provision of conforming features may be performed on such film/nonwoven composites. Such film/nonwoven composites and processing thereof are described in additional detail in U.S. Patent Application Publication No. 2009/0026651, PCT Application Serial Nos. PCT/CN2017/089550, PCT/CN2017/089553, and PCT/CN2017/089554. In some forms, the topsheet may comprise a composite of nonwoven materials. For example, a first nonwoven substrate may be created via a first spinbeam, and a second nonwoven substrate may be created via a second spinbeam. In some forms, the second spinbeam may form filaments on the filaments of the first spinbeam. It is believed that such creation of a composite nonwoven can create intimate contact between the substrates of the topsheet as opposed to creation via lamination of a first web to a second web. Such nonwoven webs and processes for forming such webs are described in U.S. Patent Application Publication No. 2017/0258651A1. The FM layer and absorbent core may comprise any suitable material in some forms. For example, where the FM layer is not the stiffest layer of the absorbent article, the FM layer may comprise any suitable material which can rapidly absorb liquid insults from the topsheet and subsequently allow the liquid insults to be transferred to the absorbent core. Similarly, where the absorbent core is not the stiffest layer of the absorbent article, the absorbent core may comprise any suitable material which can absorb and retain liquid insults from the FM layer (where present) or the topsheet. There are many commercially available variants for the FM layer and absorbent core where conventional materials may be utilized. However, where the FM layer or the absorbent core are the stiffest layers of the absorbent article, the materials of the FM layer or absorbent core should be carefully selected. Note that in some forms, the FM layer and the absorbent core may be designed to withstand the meso-scale processes described herein, e.g. comprising a long fiber network. The absorbent system, either the FM layer and/or the absorbent core, may be webs such as, for example, nonwoven, a fibrous structure, a long thermoplastic filament and/or fiber reinforced airlaid web, a high loft nonwoven, a needlepunched web, a hydroentangled web, a fiber tow web, a woven web, a knitted web, a flocked web, a spunbond web, a layered spunbond/melt blown web, a carded fiber web, a coform web of cellulose fiber and melt blown or spun-melt fibers, a coform web of staple fibers and melt blown or spun-melt fibers, and layered webs that are layered combinations thereof. The constituent filaments and/or fibers of the absorbent system can be comprised of polymers such as polyethylene, polypropylene, polyester, and blends thereof. The filaments can be spunbond. The filaments can be meltblown. The filaments and/or fibers can comprise cellulose, rayon, cotton, or other natural materials or blends of polymer and natural materials. The filaments and/or fibers can also comprise a super absorbent material such as polyacrylate or any combination of suitable materials. The filaments and/or fibers can be monocomponent, bi-component, and/or bi-constituent, non-round (e.g., capillary channel fibers), and can have major cross-sectional dimensions (e.g., diameter for round fibers) ranging from 0.1-500 microns. The constituent filaments and/or fibers of the absorbent system web may also be a mixture of different fiber types, differing in such features as chemistry (e.g. polyethylene and polypropylene), components (mono- and bi-), dtex (micro dtex and >20 dtex), shape (i.e. capillary and round) and the like. The constituent filaments and/or fibers can range from about 0.1 dtex to about 100 dtex. Suitable thermoplastic filaments and/or fibers can be made from a single polymer (monocomponent fibers) or can be made from more than one polymer (e.g., bi-component fibers). The polymer comprising the sheath often melts at a different, typically lower, temperature than the polymer comprising the core. As a result, these bi-component filaments and/or fibers provide thermal bonding due to melting of the sheath polymer, while retaining the desirable strength characteristics of the core polymer. Suitable bi-component filaments and/or fibers for use in the present invention can include sheath/core fibers having the following polymer combinations: polyethylene/polypropylene, polyethylvinyl acetate/polypropylene, polyethylene/polyester, polypropylene/polyester, copolyester/polyester, and the like. Particularly suitable bi-component thermoplastic filaments and/or fibers for use herein are those having a polypropylene or polyester core, and a lower melting copolyester, polyethylvinyl acetate or polyethylene sheath (e.g., DANAKLON®, CELBOND® or CHISSO® bi-component fibers). These bi-component filaments and/or fibers can be concentric or eccentric. As used herein, the terms “concentric” and “eccentric” refer to whether the sheath has a thickness that is even, or uneven, through the cross-sectional area of the bi-component fiber. Eccentric bi-component filaments and/or fibers can be desirable in providing more compressive strength at lower fiber thicknesses. Suitable bi-component filaments and/or fibers for use herein can be either uncrimped (i.e. unbent) or crimped (i.e. bent). Bi-component fibers can be crimped by typical textile means such as, for example, a stuffer box method or the gear crimp method to achieve a predominantly two-dimensional or “flat” crimp. The length of bi-component fibers can vary depending upon the particular properties desired for the fibers and the web formation process. Ideally, in an air formed web such as a long fiber reinforced airlaid web, these thermoplastic fibers have a length from about 6 mm to about 15 mm long, preferably from greater than about 6 mm long to about 12 mm long. The properties of these thermoplastic fibers can also be adjusted by varying the diameter (caliper) of the fibers. The diameter of these thermoplastic fibers is typically defined in terms of either denier (grams per 9000 meters) or decitex (grams per 10,000 meters). Suitable bi-component thermoplastic fibers as used in an airlaid making machine such as a DanWeb machine can have a decitex in the range from about 1.0 to about 16, preferably from about 1.4 to about 10, and most preferably from about 1.7 to about 7 decitex. Without wishing to be bound by theory, it is believed that FM layers and/or absorbent cores with good long fiber networks can withstand meso-scale processing. And, as noted previously, topsheets may contribute to the long fiber network to some extent as well. It is believed that fibers 6 mm or longer may be utilized to help provide the good long fiber network. For example, coform utilizes continuous filaments which measure well over 6 mm. It is further believed that thermoplastic bondable filaments and/or fibers are better to utilize than latex bonding. For those forms of the absorbent system that comprise an FM layer and absorbent core, the FM layer and/or the absorbent core may be constructed as described herein. In one particular example, the absorbent core may comprise a substrate which comprises superabsorbent polymeric material. For example, a tissue web may comprise absorbent gelling material granules or fibers disposed on the tissue web. The backsheet is generally that portion of the absorbent article positioned proximate to the garment-facing surface of the absorbent core. The backsheet may be joined to portions of the topsheet, the absorbent core, and/or any other layers of the absorbent article by any attachment methods known to those of skill in the art. The backsheet prevents, or at least inhibits, the bodily exudates absorbed and contained in the absorbent core from soiling articles such as bedsheets, undergarments, and/or clothing. The backsheet is typically liquid impermeable, or at least substantially impermeable. The backsheet may, for example, be or comprise a thin plastic film, such as a thermoplastic film having a thickness of about 0.012 mm to about 0.051 mm. Other suitable backsheet materials may include breathable materials which permit vapors to escape from the absorbent article, while still preventing, or at least inhibiting, bodily exudates from passing through the backsheet. Exemplary absorbent articles of the present invention include diapers and/or feminine pads. Referring toFIG.19, an absorbent article1710which may utilize the material webs described herein may be a sanitary napkin/feminine hygiene pad. As shown, the sanitary napkin1710may comprise a liquid permeable topsheet1714, a liquid impermeable, or substantially liquid impermeable, backsheet1716, and an absorbent core1718positioned intermediate the topsheet1714and the backsheet1716. The sanitary napkin1710may comprise wings1720extending outwardly with respect to a longitudinal axis1780of the sanitary napkin1710. The sanitary napkin1710may also comprise a lateral axis1790. The wings1720may be joined to the topsheet1714, the backsheet1716, and/or the absorbent core1718. The sanitary napkin1710may also comprise a front edge1722, a rear edge1724longitudinally opposing the front edge1722, a first side edge1726, and a second side edge1728laterally opposing the first side edge1726. The longitudinal axis1780may extend from a midpoint of the front edge1722to a midpoint of the rear edge1724. The lateral axis1790may extend from a midpoint of the first side edge1726to a midpoint of the second side edge1728. The sanitary napkin1710may also be provided with additional features commonly found in sanitary napkins as is known in the art. In some forms of the present invention, the wings may be provided with zones of extensibility as described in U.S. Pat. No. 5,972,806. The absorbent article1710may further comprise an FM layer disposed between the topsheet1714and the absorbent core1718. The FM layer may be configured as described herein. Similarly, the absorbent core may be configured as described herein. One suitable material for the backsheet can be a liquid impervious thermoplastic film having a thickness of from about 0.012 mm (0.50 mil) to about 0.051 mm (2.0 mils), for example including polyethylene or polypropylene. Typically, the backsheet can have a basis weight of from about 5 g/m2to about 35 g/m2. However, it should be noted that other flexible liquid impervious materials may be used as the backsheet. Herein, “flexible” refers to materials which are compliant and which will readily conform to the general shape and contours of the wearers body. The backsheet can be typically positioned adjacent an outer-facing surface of the absorbent core and can be joined thereto by any suitable attachment device known in the art. For example, the backsheet may be secured to the absorbent core by a uniform continuous layer of adhesive, a patterned layer of adhesive, or an array of separate lines, spirals, or spots of adhesive. Illustrative, but non-limiting adhesives, include adhesives manufactured by H. B. Fuller Company of St. Paul, Minn., U.S.A., and marketed as HL-1358J. An example of a suitable attachment device including an open pattern network of filaments of adhesive is disclosed in U.S. Pat. No. 4,573,986 entitled “Disposable Waste-Containment Garment”, which issued to Minetola et al. on Mar. 4, 1986. Another suitable attachment device including several lines of adhesive filaments swirled into a spiral pattern is illustrated by the apparatus and methods shown in U.S. Pat. No. 3,911,173 issued to Sprague, Jr. on Oct. 7, 1975; U.S. Pat. No. 4,785,996 issued to Ziecker, et al. on Nov. 22, 1978; and U.S. Pat. No. 4,842,666 issued to Werenicz on Jun. 27, 1989. Alternatively, the attachment device may include heat bonds, thermal fusion bonds, pressure bonds, ultrasonic bonds, dynamic mechanical bonds, or any other suitable attachment device or combinations of these attachment devices. The backsheet may be additionally secured to the topsheet by any of the above-cited attachment devices/methods. Still another example of a disposable absorbent article which may utilize the material webs of the present invention are diapers which include non-refastenable pants, re-fastenable pants and/or re-fastenable diapers. Diapers have can have a similar construction to that of sanitary napkins. An exemplary diaper is described below. Referring toFIG.20, a plan view of an example absorbent article that is a diaper1900in its flat-out, uncontracted state (i.e., with elastic induced contraction pulled out) with portions of the structure being cut-away to more clearly show the construction of the diaper1900and with its wearer-facing surface toward the viewer. This diaper is shown for illustration purpose only as the present disclosure may be used for making a wide variety of diapers and other absorbent articles. The absorbent article may comprise a liquid permeable topsheet1924, a liquid impermeable backsheet1925, an absorbent core1928positioned at least partially intermediate the topsheet1924and the backsheet1925, and barrier leg cuffs1934. The absorbent article may also comprise a distribution layer1954and an acquisition layer1952that will both be further discussed below. In various forms, the acquisition layer1952may instead distribute bodily exudates and the distribution layer1954may instead acquire bodily exudates or both layers may distribute and/or acquire bodily exudates. The absorbent article may also comprise elasticized gasketing cuffs1932joined to the chassis of the absorbent article, typically via the topsheet and/or backsheet, and substantially planar with the chassis of the diaper. The Figures also show typical taped diaper components such as a fastening system comprising adhesive tabs1942or other mechanical fasteners attached towards the rear edge of the absorbent article1900and cooperating with a landing zone on the front of the absorbent article1900. The absorbent article may also comprise other typical elements, which are not represented, such as a rear elastic waist feature and a front elastic waist feature, for example. The absorbent article1900may comprise a front waist edge1910, a rear waist edge1912longitudinally opposing the front waist edge1910, a first side edge1903, and a second side edge1904laterally opposing the first side edge1903. The front waist edge1910is the edge of the absorbent article1900which is intended to be placed towards the front of the user when worn, and the rear waist edge1912is the opposite edge. Together the front waist edge1910and the rear waist edge form waist opening when the absorbent article1900is donned on a wearer. The absorbent article1900may have a longitudinal axis1980extending from the lateral midpoint of the front waist edge1910to a lateral midpoint of the rear waist edge1912of the absorbent article1900and dividing the absorbent article1900in two substantially symmetrical halves relative to the longitudinal axis1980, with article placed flat and viewed from the wearer-facing surface as illustratedFIG.20. The absorbent article may also have a lateral axis1990extending from the longitudinal midpoint of the first side edge1903to the longitudinal midpoint of the second side edge1904. The length L of the absorbent article1900may be measured along the longitudinal axis1980from the front waist edge1910to the rear waist edge1912. The crotch width of the absorbent article1900may be measured along the lateral axis1990from the first side edge1903to the second side edge1904. The absorbent article1900may comprise a front waist region1905, a rear waist region1906, and a crotch region1907. The front waist region, the rear waist region, and the crotch region each define ⅓ of the longitudinal length of the absorbent article. Front and back portions may also be defined on opposite sides of the lateral axis1990. The backsheet1925may be joined to the topsheet1924, the absorbent core1928, and/or any other element of the absorbent article1900by any attachment methods known to those of skill in the art. Suitable attachment methods are described above with respect to methods for joining the topsheet1924to other elements of the absorbent article1900. The absorbent article1900may comprise a pair of barrier leg cuffs1934. Each barrier leg cuff may be formed by a piece of material which is bonded to the absorbent article so it can extend upwards from the inner surface of the absorbent article and provide improved containment of liquids and other bodily exudates approximately at the junction of the torso and legs of the wearer. The barrier leg cuffs1934are delimited by a proximal edge1964joined directly or indirectly to the topsheet1924and/or the backsheet1925and a free terminal edge1966, which is intended to contact and form a seal with the wearer's skin. The barrier leg cuffs1934extend at least partially between the front waist edge1910and the rear waist edge1912of the absorbent article on opposite sides of the longitudinal axis1980and are at least present in the crotch region1907. The barrier leg cuffs1934may be joined at the proximal edge1964with the chassis of the absorbent article by a bond1965which may be made by gluing, fusion bonding, or combination of other suitable bonding processes. The bond1965at the proximal edge64may be continuous or intermittent. The bond1965closest to the raised section of the leg cuffs1934delimits the proximal edge1964of the standing up section of the leg cuffs1934. The barrier leg cuffs1934may be integral with the topsheet1924or the backsheet1925or may be a separate material joined to the absorbent article's chassis. The material of the barrier leg cuffs1934may extend through the whole length of the diapers but may be “tack bonded” to the topsheet1924towards the front waist edge1910and rear waist edge1912of the absorbent article so that in these sections the barrier leg cuff material remains flush with the topsheet1924. Each barrier leg cuff1934may comprise one, two or more elastic strands or strips of film1935close to this free terminal edge1966to provide a better seal. In addition to the barrier leg cuffs1934, the absorbent article may comprise gasketing cuffs1932, which are joined to the chassis of the absorbent article, in particular to the topsheet1924and/or the backsheet1925and are placed externally relative to the barrier leg cuffs1934. The gasketing cuffs1932may provide a better seal around the thighs of the wearer. Each gasketing leg cuff may comprise one or more elastic strings1933or elastic elements in the chassis of the absorbent article between the topsheet1924and backsheet1925in the area of the leg openings. All or a portion of the barrier leg and/or gasketing cuffs may be treated with a lotion or skin care composition. The barrier leg cuffs may be constructed in a number of different configurations, including those described in U.S. Pat. App. Publ. No. 2012/0277713. In a form, the absorbent article may comprise front ears1946and rear ears1940. The ears may be an integral part of the chassis, such as formed from the topsheet1924and/or backsheet1925as side panel. Alternatively, as represented onFIG.19, the ears (1946,1940) may be separate elements attached by gluing, heat embossing, and/or pressure bonding. The rear ears1940may be stretchable to facilitate the attachment of the tabs1942to the landing zone1944and maintain the taped diapers in place around the wearer's waist. The rear ears1940may also be elastic or extensible to provide a more comfortable and contouring fit by initially conformably fitting the absorbent article to the wearer and sustaining this fit throughout the time of wear well past when absorbent article has been loaded with exudates since the elasticized ears allow the sides of the absorbent article to expand and contract. Data regarding various samples is provided in the tables below. A description of the samples is provided after the presentation of all the data tables. In Table 1, data is provided regarding the mechanical properties of modified (Samples 6a-8c) and unmodified samples (no conforming features—Samples 1-5). The samples listed in Table 1 are absorbent core samples only. And, the values of the mechanical properties listed in Table 1 are with regard to the three point bend test described herein and the bunch compression test described herein. The three point bend test measures the fundamental bending properties and stiffness that relate to the material or the product's ability to conform to complex anatomical features. A lower number is indicative of a more conforming material. In contrast, the bunch compression test is a measure of a material's ability to recover its original shape or form following compression, particularly as measured, when wet. For this data, a higher value indicates the ability of a material to recover to its initial shape even when wet. A higher number can indicate conformance of a material even after being insulted with liquid. TABLE 1BendingBendingRecoveryRecoveryModulusStiffnessEnergyPercentageSample No.Dry (N/mm2)Dry (N*mm2)Wet (mJ)Wet (%)1 - unmodified0.6830.93.51642 - unmodified0.12613.021.06383 - unmodified0.1218.790.34314 - unmodified2.1211.720.50285 - unmodified0.08511.391.86636a0.0623.420.65436b0.0221.300.59436c0.0242.160.79507a0.063.2550.04267b0.0161.1390.05237c0.0231.950.18258a0.0881.63CollapseCollapse8b0.0140.326CollapseCollapse8c0.0380.81CollapseCollapse Table 2 includes data regarding the three point bend test and the bunch compression test as disclosed herein. The samples of table 2 include an absorbent core and a fluid management layer which comprise conforming features as described herein. The data illustrates that some samples while exhibiting great conformance during initial use, e.g. low bending modulus, low bending stiffness, their in-use states do not show the same promise. For example, these same samples may exhibit an extremely low recovery energy which suggests that in use, these products may collapse and actually lead to leakage problems. However, without additional investigation regarding their potential issues in use, some may be tempted by “fools gold” and simply rely on the great initial conformance of the product. TABLE 2BendingBendingRecoveryRecoveryModulusStiffnessEnergyPercentageSample No.Dry (N/mm2)Dry (N*mm2)Wet (mJ)Wet (%)9a0.0644.720.84589b0.0261.790.81569c0.0272.771.355210a0.0857.490.333710b0.0151.470.313410c0.033.260.763011a0.0937.830.404811b0.0262.770.384011c0.0333.740.6248 The data from Table 2 shows that the addition of a fluid management layer increases the values associated with recovery energy and recovery percentage. It is worth noting that the addition of the fluid management layer also increased the values of the bending modulus and bending stiffness. However, the increases in bending modulus and bending stiffness as compared to the recovery energy and recovery percentage, is not 1 to 1. Table 3 includes data regarding integration of topsheet, fluid management layer, and absorbent core regarding the three point bend test and bunch compression test disclosed herein. In each sample, the topsheet, fluid management layer, and absorbent cores comprised conforming features which integrated all three layers. Additionally, there are some samples of currently marketed products which have been tested as well. TABLE 3BendingBendingModulusStiffnessRecoveryRecoveryDryDryEnergyPercentageCaliperSample No.(N/mm2)(N * mm2)Wet (mJ)Wet (%)(mm)Ratio 1Ratio 212a - emboss0.13612.552.63532.804.774.512b - DIA0.0424.571.97722.962.321.512c - CEN0.0322.771.79492.741.551.012d - ALT0.0534.232.58572.671.641.613a - emboss0.17715.30.88352.7417.395.613b - DIA0.0354.721.04413.174.541.513c - CEN0.0333.740.86392.994.351.313d - ALT0.08410.251.10373.079.323.314a - emboss0.60543.463.16542.5713.7516.914b - DIA0.0617.321.99583.053.682.414c - CEN0.0525.71.68582.963.391.914d - ALT0.10211.321.81572.956.253.8Conventional0.2155.60.58462.3695.823.6Sample 1Conventional0.6869.41.90332.5436.5227.3Sample 2 Ratio 1 is between Bending Stiffness and Recovery Energy. In samples 12a-14d, the Samples illustrate that in most cases, the embossed only samples have a high stiffness to drive acceptable Recovery Energy. Whereas on the Samples comprising conforming features, acceptable recovery energy is achieved at lower stiffness levels. Additionally, the ratio of “stiffness/energy of recovery” is almost 50% reduced or better for the Samples comprising conforming features. So, it is believed that the Samples which comprise these conforming features can recover from bunching, maintain pad shape to be more comfortable and conformable without relying on stiffness to do this. It is believed that a wet recovery energy of below 0.4 mJ, the absorbent article may have conformance and possibly performance issues during use due to its inability to recover its shape when wet. The bending stiffness to wet recovery energy ratio of less than 17 may be achieved as demonstrated by the data regardless of the type of absorbent system. Specifically, where the absorbent core comprised a coformed absorbent core with continuous filaments (Sample 2), a bending stiffness to wet recovery energy ratio of than 4 and even less than 3 was achieved. For those absorbent cores of the airlaid variety, e.g. Samples 3 and 4, a much lower bending stiffness to wet recovery energy was achieved. For example, regarding Sample 3, by utilizing the conforming features as described herein, the bending stiffness to wet energy recovery ratio was lower than 17, lower than 15, and even lower than 10. Regarding Sample 4, by utilizing the conforming features described herein, the bending stiffness to wet recovery ratio was lower than 13, lower than 10, and even lower than 8. Ratio 2 is between bending stiffness and caliper. As the data illustrates, there is a significant reduction in stiffness for the products comprising conforming features compared to those which are embossed. Even where the Samples have a higher caliper, which in theory should increase stiffness, many of the Samples with conforming features exhibit a 50% reduction in stiffness over the Samples which were embossed. The stiffness to caliper ratio of 4 or less may be achieved as demonstrated by the data. Specifically, where the absorbent core comprised a coformed absorbent core with continuous filaments (Sample 2), a stiffness to caliper ratio of 4 or less was achieved and even less than 2. For those absorbent cores of the airlaid variety, e.g. Samples 3 and 4, a much lower stiffness to caliper ratio was achieved. For example, regarding Sample 3, by utilizing the conforming features as described herein, the stiffness to caliper ratio was lower than 5 and even lower than 4. Regarding Sample 4, by utilizing the conforming features described herein, the stiffness to caliper ratio was lower than 15, lower than 10, lower than 5, and lower than 4. Additionally, the data illustrates the fact that bending stiffness and bending modulus can be affected based on the conforming features provided to the article to enable customizable fit to a user's unique anatomical shape. Additionally, the data shows that the arrangement of the zones in the absorbent article can similarly impact the bending stiffness and the bending modulus to provide the most comfortable conforming fit to her body. The same holds true for recovery energy and recovery percentage. Regarding bending stiffness, the absorbent articles comprising conforming features as described herein showed lower bending stiffness than their conventional counterparts. For example, for those products which comprised the Sample 2 absorbent core, bending stiffness was less than 12, less than 8, and even less than 5. For Sample 3, the bending stiffness was less than 15 and even less than 12. For Sample 4, the bending stiffness was less than 40, less than 20, and even less than 15. Data regarding fluid kinetics of the samples listed in Table 3 is provided below in Table 4. The data is derived from the NMR mouse method, the free fluid acquisition test, and the blot test described herein. The NMR test measures the ability of a product to drain fluid from the area closest to the body. A low value on this test suggests that the user may experience a dry feeling. Additionally, a low value on the NMR test suggests that the article is able to regenerate void volume for the next insult. The Free Fluid Acquisition test measures the speed of absorbing fluid insults to the topsheet. A lower number suggests that the article can absorb liquid insults quickly. The Blot test measures the residual fluid that would remain on the body as well as how much of the area of the product would likely be stained. TABLE 4FluidFree FluidRemainingAcquisitionBlot ResidualBlot StainCaliperSample No.0.5 mm (μl)(seconds)(mg)(mm{circumflex over ( )}3)(mm)Ratio 312a - emboss5.01203411922.8012.112b - DIA6.0381314052.964.412c - CEN5.0761614732.745.812d - ALT13.0631613652.676.013a - emboss23.0375414002.7419.713b - DIA15.0392816253.178.813c - CEN7.0612215012.997.413d - ALT15.0172016473.076.514a - emboss262.0645617332.5721.814b - DIA14.0432717333.058.914c - CEN5.0442117322.967.114d - ALT25.0162717342.959.2Conventional5.07350332.3630.9Sample 1Conventional17.06640332.5425.9Sample 2 Ratio 3 is between Blot Residual versus caliper. In the Samples 12a-14d, the Samples comprising conforming features lead to at least a 50% reduction in residual fluid compared to embossing only. So we can achieve not just less fluid on skin analog but we can achieve this in a thin, more conforming and comfortable absorbent article. The blot to caliper ratio of less than 11 may be achieved as demonstrated by the data regardless of the type of absorbent system. Specifically, where the absorbent core comprised a coformed absorbent core with continuous filaments (Sample 2), a blot to caliper ratio of less than 12, less than 11, less than 8, and even less than 7 was achieved. For those absorbent cores of the airlaid variety, e.g. Samples 3 and 4, a much lower blot to caliper ratio was achieved. For example, regarding Sample 3, by utilizing the conforming features as described herein, the blot to caliper ratio was lower than 19, lower than 15, and even lower than 10. Regarding Sample 4, by utilizing the conforming features described herein, the blot to caliper ratio was lower than 20, lower than 15, and even lower than 10. Additionally, the data illustrates the fact that residual fluid (NMR), free fluid acquisition time, blot residual and blot stain size, can be improved over conventional methods of layer attachment or as shown over embossing based on the conforming features provided to the article. For example, NMR data regarding the absorbent cores of Sample 4, were much lower than 200 μl, much lower than 100 μl, much lower than 50 μl, and lower than 30 μl, than those measured for absorbent articles which did not comprise the conforming features of the present disclosure. Similarly, for the absorbent cores of Sample 3, NMR data showed a reduction with the provision of conforming features, i.e. less than 20 μl and even less than 17 μl. Regarding the products which comprised the Sample 2 absorbent cores, they demonstrated NMR data that was less than about 7 μl while also having a free fluid acquisition time of less than 100 seconds. Regarding the blot test, the data also demonstrates that those products comprising conforming features consistently had lower values than their conventional counterparts. For example, for those products utilizing the absorbent core of Sample 2, the blot residual values were less than 30 mg, less than 20 mg, and even less than 18 mg. For each of Samples 3 and 4, the blot residual values were less than 50 mg, less than 40 mg, and even less than 30 mg. Additionally, the data shows that the arrangement of the zones in the absorbent article can similarly impact the bending stiffness and the bending modulus. The same holds true for recovery energy and recovery percentage. The absorbent articles comprising conforming features as described herein, demonstrated at blot residual value of Samples: Sample 1: A coformed absorbent core having a total basis weight of 224 gsm. The coformed absorbent core comprised 121.8 gsm cellulose fibers, 52.2 gsm of 3.0 micron continuous polypropylene fibers, and 50 gsm of superabsorbent polymer (AGM). These materials were homogenously blended.Sample 2: A coformed absorbent core having a total basis weight of 186 gsm. The coformed absorbent core comprised 105 gsm cellulose, 45 gsm, 3.0 micron, continuous polypropylene fibers with 36 gsm of AGM. These materials were homogeneously blended.Sample 3: A 150 gsm airlaid absorbent on a carded nonwoven material. The material comprised 4 mm polyethylene/polyethylene terephthalate fibers, cellulose fibers, and latex binder material. This material did not include superabsorbent polymer.Sample 4: A unitary airlaid absorbent core having a basis weight of 160 gsm. The absorbent core comprises cellulosic fibers and superabsorbent polymer and includes a low percentage of bondable fibers. Available from Gladfelter GmbH, Falkenhagen Germany. Fibrous super absorbent may be utilized in some cases.Sample 5: A carded spunlace (38-40 mm fiber length) material having a basis weight of 140 gsm comprising 21.8 percent viscose rayon, 35.4 percent bicomponent fibers (polyethylene terephthalate and copolyethylene terephthalate), and 42.9 percent polyethylene terephthalate monocomponent fibers. Regarding the Samples 6a-14d many were provided with conforming features oriented in a negative Z-direction in accordance with the following patterns. DIAMOND—shown inFIG.17Ain the first zone1520and the second zone1540. The tooling for the DIAMOND pattern comprises teeth of differing lengths. The depth of engagement for the tooling was 2.54 mm and spacing between the teeth was 2.03 mm CENTER—shown inFIG.17A(within the figure eight looking area) in a portion of the target region1530. The teeth of the CENTER pattern are staggered. The depth of engagement for the tooling was 2.54 mm and spacing between the teeth was 2.03 mm ALT—This pattern is formed by teeth7000shown inFIG.21. As shown, teeth are provided in columns and staggered rows. The depth of engagement was 2.54 mm and the spacing between teeth was 2.54 mm.Samples 6a, 6b, and 6c: The material of Sample 2 was provided with conforming features comprising the DIAMOND pattern for 6a, the CENTER pattern for 6b, and the ALT pattern for 6c.Samples 7a, 7b, and 7c: The material of Sample 3 was provided with conforming features comprising the DIAMOND pattern for 7a, the CENTER pattern for 7b, and the ALT pattern for 7c.Samples 8a, 8b, and 8c: The material of Sample 4 was provided with conforming features comprising the DIAMOND pattern for 8a, the CENTER pattern for 8b, and the ALT pattern for 8c.Samples 9a, 9b, and 9c: A 24 gsm hydrophilic carded nonwoven and the material of Sample 2 were provided with conforming features comprising the DIAMOND pattern for 9a, the CENTER pattern for 9b, and the ALT pattern for 9c. The 24 gsm nonwoven was utilized as a fluid management layer in these Samples and positioned superjacent to the absorbent cores.Samples 10a, 10b, and 10c: The material of Sample 3 and a 35 gsm laminate material comprising AGM and a tissue layer were provided with conforming features comprising the DIAMOND pattern for 10a, the CENTER pattern for 10b, and the ALT pattern for 10c.Samples 11a, 11b, and 11c: A 110 gsm carded spunlace (38-40 mm fiber length) material comprising 35.9 percent viscose, 34.1 percent polyethylene terephthalate, and 30 percent polyethylene terephthalate/copolyethylene terephthalate bicomponent fibers and the material of Sample 4 were provided with conforming features comprising the DIAMOND pattern for 11a, the CENTER pattern for 11b, and the ALT pattern for 11c. Each of Samples 12a-14d comprised a hydrophobic 24 gsm carded air through bonded nonwoven having bi-component fibers with polyethylene and polyethylene terephthalate and a lower layer of 25 gsm spunbond web comprising bi-component fibers having polyethylene and polypropylene components, wherein the lower layer was treated with a surfactant at 0.45 percent by weight. The upper and lower layers were apertured via the overbonding process described inFIGS.9A and9Band comprised the aperture pattern shown inFIG.22. This material will collectively be referred to as the TOPSHEET in the description of the remainder of the Samples. Additionally, some of the Samples, namely 12a, 13a, and 14a, were provided with embossing, which as noted previously, is not considered a conforming feature for the sake of this disclosure. In order to facilitate review of this data, the terms “emboss”; “DIA” (for DIAMOND); “CEN” (for CENTER); or “ALT” are utilized in the Tables regarding Samples 12a-14d.Samples 12a, 12b, 12c, and 12d: The TOPSHEET and the material described in Samples 9a, 9b, and 9c, were provided with embossing for 12a, the DIAMOND pattern for 12b, the CENTER pattern for 12c, and the ALT pattern for 12d.Samples 13a, 13b, 13c, and 13d: The TOPSHEET and the material described in Samples 10a, 10b, and 10c, were provided with embossing for 13a, the DIAMOND pattern for 13b, the CENTER pattern for 13c, and the ALT pattern for 13d.Samples 14a, 14b, 14c, and 14d: The TOPSHEET and the material described in Samples 11a, 11b, an 11c, were provided with embossing for 14a, the DIAMOND pattern for 14b, the CENTER pattern for 14c, and the ALT pattern for 14d.Conventional Sample 1—Always Ultra Thin size 1 available in market in Western Europe.Conventional Sample 2—SCA Bodyform size 1 available in market in Western Europe. Test Methods Layers of Interest For any of the methods below in which all the component layers of an article will not be tested, the layers of interest may be separated using cryo-spray as needed from layers which will not be tested. AMF (Artificial Menstrual Fluid) The Artificial Menstrual Fluid (AMF) is composed of a mixture of defibrinated sheep blood, a phosphate buffered saline solution and a mucous component. The AMF is prepared such that it has a viscosity between 7.15 to 8.65 centistokes at 23° C. Viscosity on the AMF is performed using a low viscosity rotary viscometer (a suitable instrument is the Cannon LV-2020 Rotary Viscometer with UL adapter, Cannon Instrument Co., State College, PA, or equivalent). The appropriate size spindle for the viscosity range is selected, and instrument is operated and calibrated as per the manufacturer. Measurements are taken at 23° C.±1 C.° and at 60 rpm. Results are reported to the nearest 0.01 centistokes. Reagents needed for the AMF preparation include: defibrinated sheep blood with a packed cell volume of 38% or greater (collected under sterile conditions, available from Cleveland Scientific, Inc., Bath, OH, or equivalent), gastric mucin with a viscosity target of 3-4 centistokes when prepared as a 2% aqueous solution (crude form, available from Sterilized American Laboratories, Inc., Omaha, NE, or equivalent), 10% v/v lactic acid aqueous solution, 10% w/v potassium hydroxide aqueous solution, sodium phosphate dibasic anhydrous (reagent grade), sodium chloride (reagent grade), sodium phosphate monobasic monohydrate (reagent grade) and distilled water, each available from VWR International or an equivalent source. The phosphate buffered saline solution consists of two individually prepared solutions (Solution A and Solution B). To prepare 1 L of Solution A, add 1.38±0.005 g of sodium phosphate monobasic monohydrate and 8.50±0.005 g of sodium chloride to a 1000 mL volumetric flask and add distilled water to volume. Mix thoroughly. To prepare 1 L of Solution B, add 1.42±0.005 g of sodium phosphate dibasic anhydrous and 8.50±0.005 g of sodium chloride to a 1000 mL volumetric flask and add distilled water to volume. Mix thoroughly. To prepare the phosphate buffered saline solution, add 450±10 mL of Solution B to a 1000 mL beaker and stir at low speed on a stir plate. Insert a calibrated pH probe (accurate to 0.1) into the beaker of Solution B and add enough Solution A, while stirring, to bring the pH to 7.2±0.1. The mucous component is a mixture of the phosphate buffered saline solution, potassium hydroxide aqueous solution, gastric mucin and lactic acid aqueous solution. The amount of gastric mucin added to the mucous component directly affects the final viscosity of the prepared AMF. To determine the amount of gastric mucin needed to achieve AMF within the target viscosity range (7.15-8.65 centistokes at 23° C.) prepare 3 batches of AMF with varying amounts of gastric mucin in the mucous component, and then interpolate the exact amount needed from a concentration versus viscosity curve with a least squares linear fit through the three points. A successful range of gastric mucin is usually between 38 to 50 grams. To prepare about 500 mL of the mucous component, add 460±10 mL of the previously prepared phosphate buffered saline solution and 7.5±0.5 mL of the 10% w/v potassium hydroxide aqueous solution to a 1000 mL heavy duty glass beaker. Place this beaker onto a stirring hot plate and while stirring, bring the temperature to 45° C.±5 C.°. Weigh the pre-determined amount of gastric mucin (±0.50 g) and slowly sprinkle it, without clumping, into the previously prepared liquid that has been brought to 45° C. Cover the beaker and continue mixing. Over a period of 15 minutes bring the temperature of this mixture to above 50° C. but not to exceed 80° C. Continue heating with gentle stirring for 2.5 hours while maintaining this temperature range. After the 2.5 hours has elapsed, remove the beaker from the hot plate and cool to below 40° C. Next add 1.8±0.2 mL of the 10% v/v lactic acid aqueous solution and mix thoroughly. Autoclave the mucous component mixture at 121° C. for 15 minutes and allow 5 minutes for cool down. Remove the mixture of mucous component from the autoclave and stir until the temperature reaches 23° C.±1 C.°. Allow the temperature of the sheep blood and mucous component to come to 23° C.±1 C.°. Using a 500 mL graduated cylinder, measure the volume of the entire batch of the previously prepared mucous component and add it to a 1200 mL beaker. Add an equal volume of sheep blood to the beaker and mix thoroughly. Using the viscosity method previously described, ensure the viscosity of the AMF is between 7.15-8.65 centistokes. If not the batch is disposed and another batch is made adjusting the mucous component as appropriate. The qualified AMF should be refrigerated at 4° C. unless intended for immediate use. AMF may be stored in an air-tight container at 4° C. for up to 48 hours after preparation. Prior to testing, the AMF must be brought to 23° C.±1 C.°. Any unused portion is discarded after testing is complete. Blot Test The Blot test measures the amount of AMF transferred to an article from a blotter sheet (as the residual AMF left on the blotter sheet), and the size of the stain as measured on the article's surface. This blot is repeated on the same specimen for a total of five times, with the cumulative blot dimension and individual residual mass on the blotter sheet recorded after each blot. A blotter sheet (available as Apollo Plain Paper Copier Transparency Film, ACCO brands, Ronkonkoma, NY, or equivalent) is used as a blotting surface. The surface energy as determined by ASTM D7490-13 of the blotter sheet should be approximately 50 mJ/m2. The blotter sheets are cut to a dimension of 76 mm long by 63 mm wide for testing. A nylon plate 76 mm long by 63 mm wide by 3 mm thick is paired with a weight, which together have a combined mass to provide a confining pressure of 0.69 KPa on the specimen. AMF as described herein is used for the test fluid. Using a cutting die (76 mm long by 63 mm wide) cut a specimen from the longitudinal and lateral midpoint of the article. Remove the release paper and lightly talc the adhesive to reduce stickiness. Measure the mass of a single blotter sheet and record to the nearest 0.0001 g. Place the sheet onto a bench top. Pipet 1.00 mL of AMF onto the center of the blotter sheet. Lineup the specimen with the edges of the sheet and lower the specimen, body facing side down, onto the blotter sheet. Place the nylon plate with weight onto the specimen and wait 15 min. Afterwards remove the plate and weight, then the specimen. Place the specimen body side facing upwards onto the bench. Measure the mass of the blotter sheet and residual AMF and record to the nearest 0.0001 g. Subtract the blotter sheet's original mass from the total mass and report as AMF residual to the nearest 0.0001 g. Using a calibrated ruler, measure a bounding box (rectangle) that encompasses the stain as observed from the top surface of the specimen and record as length in the CD direction and length in the MD direction. Calculate and record the stain area (CD×MD) as observed from the top and record to the nearest 1 mm2. Turn the specimen over and measure a bounding box (rectangle) that encompasses the stain as observed from the bottom of the specimen and record as length in the CD direction and length in the MD direction. Calculate and record the stain area (CD×MD) as observed from the bottom and record to the nearest 1 mm2. In like fashion, using the same blotter sheet and specimen, dose the specimen four (4) additional times using a 1.00 mL aliquot for each cycle. Report the residual AMF from the blotter sheet and the stain area as seen from both top and bottom of the specimen for each cycle. Bunch Compression Bunched Compression of a sample is measured on a constant rate of extension tensile tester (a suitable instrument is the MTS Alliance using Testworks 4.0 software, as available from MTS Systems Corp., Eden Prairie, MN, or equivalent) using a load cell for which the forces measured are within 10% to 90% of the limit of the cell. All testing is performed in a room controlled at 23° C.±3 C.° and 50%±2% relative humidity. The test can be performed wet or dry. Referring toFIGS.25-27B, the bottom stationary fixture3000consists of two matching sample clamps3001each 100 mm wide each mounted on its own movable platform3002a,3002b. The clamp has a “knife edge”3009that is 110 mm long, which clamps against a 1 mm thick hard rubber face3008. When closed, the clamps are flush with the interior side of its respective platform. The clamps are aligned such that they hold an un-bunched specimen horizontal and orthogonal to the pull axis of the tensile tester. The platforms are mounted on a rail3003which allows them to be moved horizontally left to right and locked into position. The rail has an adapter3004compatible with the mount of the tensile tester capable of securing the platform horizontally and orthogonal to the pull axis of the tensile tester. The upper fixture2000is a cylindrical plunger2001having an overall length of 70 mm with a diameter of 25.0 mm. The contact surface2002is flat with no curvature. The plunger2001has an adapter2003compatible with the mount on the load cell capable of securing the plunger orthogonal to the pull axis of the tensile tester. Samples are conditioned at 23° C.±3 C.° and 50%±2% relative humidity for at least 2 hours before testing. When testing a whole article, remove the release paper from any panty fastening adhesive on the garment facing side of the article. Lightly apply talc powder to the adhesive to mitigate any tackiness. If there are cuffs, excise them with scissors, taking care not to disturb the top sheet of the product. Place the article, body facing surface up, on a bench. On the article identify the intersection of the longitudinal midline and the lateral midline. Using a rectangular cutting die, cut a specimen 100 mm in the longitudinal direction by 80 mm in the lateral direction, centered at the intersection of the midlines. When testing just the absorbent body of an article, place the absorbent body on a bench and orient as it will be integrated into an article, i.e., identify the body facing surface and the lateral and longitudinal axis. Using a rectangular cutting die, cut a specimen 100 mm in the longitudinal direction by 80 mm in the lateral direction, centered at the intersection of the midlines. The specimen can be analyzed both wet and dry. The dry specimen requires no further preparation. The wet specimens are dosed with 7.00 mL±0.01 mL 10% w/v saline solution (100.0 g of NaCl diluted to 1 L deionized water). The dose is added using a calibrated Eppendorf-type pipettor, spreading the fluid over the complete body facing surface of the specimen within a period of approximately 3 sec. The wet specimen is tested 15.0 min±0.1 min after the dose is applied. Program the tensile tester to zero the load cell, then lower the upper fixture at 2.00 mm/sec until the contact surface of the plunger touches the specimen and 0.02 N is read at the load cell. Zero the crosshead. Program the system to lower the crosshead 15.00 mm at 2.00 mm/sec then immediately raise the crosshead 15.00 mm at 2.00 mm/sec. This cycle is repeated for a total of five cycles, with no delay between cycles. Data is collected at 100 Hz during all compression/decompression cycles. Position the left platform3002a2.5 mm from the side of the upper plunger (distance3005). Lock the left platform into place. This platform3002awill remain stationary throughout the experiment. Align the right platform3002b50.0 mm from the stationary clamp (distance3006). Raise the upper probe2001such that it will not interfere with loading the specimen. Open both clamps. Place the specimen with its longitudinal edges (i.e., the 100 mm long edges) within the clamps. With the specimen laterally centered, securely fasten both edges. Move the right platform3002btoward the stationary platform3002aa distance 20.0 mm. Allow the specimen to bow upward as the movable platform is positioned. Manually lower the probe2001until the bottom surface is approximately 1 cm above the top of the bowed specimen. Start the test and collect displacement (mm) verses force (N) data for all five cycles. Construct a graph of Force (N) versus displacement (mm) separately for all cycles. A representative curve is shown inFIG.27A. From the curve record the Maximum Compression Force for each Cycle to the nearest 0.01N. Calculate the % Recovery between the First and Second cycle as (TD−E2)/(TD−E1)*100 where TD is the total displacement and E2 is the extension on the second compression curve that exceeds 0.02 N. Record to the nearest 0.01%. In like fashion calculate the % Recovery between the First Cycle and other cycles as (TD−Ei)/(TD−E1)*100 and report to the nearest 0.01%. Referring toFIG.27B, calculate the Energy of Compression for Cycle 1 as the area under the compression curve (i.e., area A+B) and record to the nearest 0.1 mJ. Calculate the Energy Loss from Cycle 1 as the area between the compression and decompression curves (i.e., Area A) and report to the nearest 0.1 mJ. Calculate the Energy of Recovery for Cycle 1 as the area under the decompression curve (i.e. Area B) and report to the nearest 0.1 mJ. In like fashion calculate the Energy of Compression (mJ), Energy Loss (mJ) and Energy of Recovery (mJ) for each of the other cycles and record to the nearest 0.1 mJ For each sample, analyze a total of five (5) replicates and report the arithmetic mean for each parameter. All results are reported specifically as dry or wet including test fluid (0.9% or 10%). Caliper Caliper at 0.69 KPa can be performed on the whole product or specific layers of interest. Layers of interest are separated using cryo-spray as needed. Samples are conditioned at 23° C.±3 C.° and 50%±2% relative humidity for two hours prior to testing. Unless otherwise specified calipers are performed centered at the visibly identifiable zones. The caliper of a specimen is measured using a calibrated digital linear caliper (e.g. Ono Sokki GS-503 or equivalent fitted with a 24.2 mm diameter foot with an anvil that is large enough that the specimen can lie flat. The foot applies a confining pressure of 0.69 KPa to the specimen. Zero the caliper foot against the anvil. Lift the foot and insert the specimen flat against the anvil with the body facing side facing upward and the site of interest centered under the foot. Lower the foot at about 5 mm/sec onto the specimen. Read the caliper (mm) 5.0 sec after resting the foot on the specimen and record to the nearest 0.01 mm. Long Fiber Basis Weight The long fiber basis weight determines the basis weight of fibers longer than 6.0 mm found in the top sheet, secondary top sheet and core of an article. Nonwovens such as spunlace, spunbond, or film laminates used as top sheets or fluid management layers will be treated as long fibers. Cut a specimen 25.4 mm by 25.4 mm at the longitudinal and lateral center of the article through the entire article using a cutting die. The edges of the specimen are cut parallel and perpendicular to the longitudinal and lateral axis of the article. Remove the back sheet from the cut specimen then measure the mass of the remaining specimen to the nearest 0.0001 g and record. Calculate the basis weight of the specimen and record to the nearest 0.01 gsm. Separate the top sheet, secondary top sheet, and core into individual specimens to be tested. Measure the mass of each layer to the nearest 0.0001 g and record as TS1, STS1 and C1 respectively. Inspect each layer to determine if it contains cellulosic fibers. Layers containing cellulosic fibers are analyzed as follows. Prepare a stock Schweizer reagent by dissolving Copper(II) hydroxide in ammonium hydroxide (%50 v/v) at a ratio of 1:4 w/w. Submerge the specimen in a volume of the reagent in excess of 30 g of reagent for each 1 g of cellulose in the specimen. Place the mixture on an orbital rocker to digest for 16 hrs. Afterward collect the polymeric fibers from the mixture and place into 50 mL of water. Repeat wash step until blue reagent is removed from the fibers. Transfer the fibers into a tared petri dish and with the aid of a stereomicroscope determine if the lengths of the fibers are longer than 6.0 mm. Dry the fibers that are longer than 6.0 mm and measure and record their mass to the nearest 0.001 g. Calculate the basis weight of the layers that do not contain cellulose fibers and record to the nearest 0.01 gsm. For layers that do contain cellulose, calculate the basis weight of the fibers that are longer than 6.0 mm and record to the nearest 0.001 gsm. Sum the basis weights for each of the layers to determine the overall basis weight of fibers over 6.0 mm and report to the nearest 0.01 gsm. Three Point Bend The bending properties of a sample are measured on a constant rate of extension tensile tester (a suitable instrument is the MTS Insight HSEL using Testworks 4.0 Software, as available from MTS Systems Corp., Eden Prairie, MN) using a load cell for which the forces measured are within 2% to 90% of the limit of the cell. All testing is performed in a room controlled at 23° C.±3 C.° and 50%±2% relative humidity. The bottom stationary fixture consists of two bars 3.175 mm in diameter by 60 mm in length, made of polished stainless steel each mounted on its own vertical fork. These 2 bars are mounted horizontally, aligned front to back and parallel to each other, with top radii of the bars vertically aligned. Furthermore, the fixture allows for the two bars to be move horizontally away from each other on a track so that a span can be set between them while maintaining their orientation. The top movable fixture consists of a third bar also 3.175 mm in diameter by 60 mm in length, made of polished stainless steel mounted on a vertical fork. When in place the bar of the top fixture is parallel to and aligned front to back with the bars of the bottom fixture. Both fixtures include an integral adapter appropriate to fit the respective position on the tensile tester frame and lock into position such that the bars are orthogonal to the motion of the crossbeam of the tensile tester. Set the span between the bars of the lower fixture to 25 mm±0.05 mm (center of bar to center of bar) with the upper bar centered at the midpoint between the lower bars. Set the gage (bottom of top bar to top of lower bars) to 1.0 cm. Samples are conditioned at 23° C.±3 C.° and 50%±2% relative humidity two hours prior to testing. Remove the overwrap and release papers were removed from pads. Dust the exposed adhesive surfaces on the back sheet and if present wings with talcum powder to eliminate adhesive tack. Remove in excess talc from the surfaces. Lay the pads flat, top sheet facing upward on a lab bench, and mark the longitudinal midline of the product. Next, mark a lateral line across the product using the longitudinal midline of the wings. If no wings are present mark a lateral line at the midpoint of the core. Remove rectangular specimens from the front (Zone A), middle (Zone B) and rear (Zone C). Each specimen is centered along the longitudinal axis of the sample, is 50.8 mm in the longitudinal direction by 30 mm in the lateral direction and is the entire thickness of the product. Zone A specimen is centered 45.4 mm from the front edge of the product. Zone B is centered at the lateral mark on the sample. Zone C is centered at 45.4 mm from the rear of the product. For each specimen measure the caliper at its center as described and record to the nearest 0.01 mm. Program the tensile tester for a compression test, to move the crosshead down at a rate of 1.0 mm/sec for 25 mm collecting force (N) and displacement (m) data at 50 Hz and return the crosshead to its original gage. Load a specimen such that it spans the two lower bars centered under the upper bar. A CD bend refers to bending along the longitudinal axis of the pad (longitudinal direction parallel to bars) and MD bend refers to bending along the lateral axis of the pad (lateral direction parallel to bars). Zero the crosshead and load cell. Start the run and collect data. Construct a graph of force (N) verses displacement (mm). Read the maximum Peak Force from the graph and divide by the specimen width (m). Record as the Peak Force/Width to nearest 0.1 N/m. From the curve, calculate the Slope as the greatest slope of a linear segment fitted to the curve, wherein the length of the segment incorporates 20% of the curve then divide by the width of the specimen and report to the nearest 0.1 N/mm. From the slope calculate: Modulus (N/mm2)=Slope*[253/(4*Sample Width*Caliper3)] Moment of Inertia (mm4)=(Sample Width*Caliper3)/12 Bending Stiffness (N*mm2)=Modulus*Moment of Inertiawhere caliper and sample width are in mm. Measures are repeated in like fashion for 10 MD and 10 CD specimens and report the average separately for each of the ten values for Modulus to the nearest 0.01 N/m2and Bending Stiffness to the nearest 0.01 N*mm2. NMR MOUSE The NMR-MOUSE (Mobile Universal Surface Explorer) is a portable open NMR sensor equipped with a permanent magnet geometry that generates a highly uniform gradient perpendicular to the scanner surface. Referring toFIGS.23and24, a frame1007with horizontal plane1006supports the specimen and remains stationary during the test. A flat sensitive volume of the specimen is excited and detected by a surface rf coil1012placed on top of the magnet1010at a position that defines the maximum penetration depth into the specimen. By repositioning the sensitive slice across the specimen by means of a high precision lift1008, the scanner can produce one-dimensional profiles of the specimen's structure with high spatial resolution. An exemplary instrument is the Profile NMR-MOUSE model PM25 with High-Precision Lift available from Magritek Inc., San Diego, CA Requirements for the NMR-MOUSE are a 100 μm resolution in the z-direction, a measuring frequency of 13.5 MHz, a maximum measuring depth of 25 mm, a static gradient of 8 T/m, and a sensitive volume (x-y dimension) of 40 by 40 mm2. Before the instrument can be used, perform phasing adjustment, check resonance frequency and check external noise level as per the manufacturer's instruction. A syringe pump capable of delivering test fluid in the range of 1 mL/min to 5 mL/min±0.01 mL/min is used to dose the specimen. All measurements are conducted in a room controlled at 23° C.±0.5° C. and 50%±2% relative humidity. The test solution is Paper Industry Fluid (PIF) prepared as 15 g carboxymethylcellulose, 10 g NaCl, 4 g NaHCO3, 80 g glycerol (all available from SigmaAldrich) in 1000 g distilled water. 2 mM/L of Diethylenetriaminepentaacetic acid gadolinium (III) dihydrogen salt (available from SigmaAldrich) is added to each. After addition the solutions are stirred using a shaker at 160 rpm for one hour. Afterwards the solutions are checked to assure no visible undissolved crystals remain. The solution is prepared 10 hours prior to use. Products for testing are conditioned at 23° C.±0.5° C. and 50%±2% relative humidity for two hours prior to testing. Identify the intersection of the lateral and longitudinal center line of the product. Cut a 40.0 mm by 40.0 mm specimen from the product, centered at that intersection, with the cut edges parallel and perpendicular to the longitudinal axis of the product. The garment facing side of the specimen1003is mounted on a 50 mm×50 mm×0.30 mm glass slide1001using a 40.0 mm by 40.0 mm piece of double-sided tape1002(tape must be suitable to provide NMR Amplitude signal). A top cap1004is prepared by adhering two 50 mm×50 mm×0.30 mm glass slides1001together using a 40 mm by 40 mm piece of two-sided tape1002. The cap is then placed on top of the specimen. The two tape layers are used as functional markers to define the dimension of the specimen by the instrument. First a 1-D Dry Distribution Profile of the specimen is collected. Place the prepared specimen onto the instrument aligned over top the coils. Program the NMR-MOUSE for a Carr-Purcell-Meiboom-Gill (CPMG) pulse sequence consisting of a 90°x-pulse follow by a refocusing pulse of 180° y-pulse using the following conditions:Repetition Time=500 msNumber of Scans=8Number of Echoes=8Resolution=100 μmStep Size=−100 μm Collect NMR Amplitude data (in arbitrary units, a.u.) versus depth (μm) as the high precision lift steps through the specimen's depth. The second measure is the Kinetic Experiment of the test fluid moving though the sensitive NMR volume as test fluid is slowly added to the top of the specimen. The “trickle” dose is followed by a “gush” dose added using a calibrated dispenser pipet. Program the NMR-MOUSE for a CPMG pulse sequence using the following conditions:Measurement Depth=5 mmRepetition Time=200 ms90° Amplitude=−7 dB180° Amplitude=0 dBPulse Length=5 μs Echo Time=90 μsNumber of Echoes=128Echo Shift=1 μsExperiments before trigger=50Experiments after trigger=2000Rx Gain=31 dBAcquisition Time=8 μsNumber of Scans=1 Rx Phase is determined during the phase adjustment as described by the vendor. A value of 230° was typical for our experiments. Pulse length depends on measurement depth which here is 5 mm. If necessary the depth can be adjusted using the spacer1011. Using the precision lift adjust the height of the specimen so that the desired target region is aligned with the instruments sensitive volume. Target regions can be chosen based on SEM cross sections. Program the syringe pump to deliver 1.00 mL/min±0.01 mL for 1.00 min for PIF test fluid or 5.00 mL/min±0.01 mL for 1.00 min for 0.9% Saline test fluid. Start the measurement and collect NMR Amplitude (a.u.) for 50 experiments before initiating fluid flow to provide a signal baseline. Position the outlet tube from the syringe pump over the center of the specimen and move during applying liquid over the total sample surface, but do not touch the borders of the sample. Trigger the system to continue collection of NMR amplitude data while simultaneously initiating fluid flow for 1 mL over 60 sec. At 300 sec after the trigger, add 0.50 mL of test fluid at approximately 0.5 mL/sec to the center of the specimen via a calibrated Eppendorf pipet. Utilizing the generated NMR Amplitude versus time graph following the second insult that is the ‘gush dose’ the % change in signal Amplitude versus time can be determined as well as the time required to reduce the Amplitude signal from its peak following the ‘gush dose’ by for example 20%, 30%, 50%, 75% or 100% can be determined. Reduction of signal amplitude occurs as fluid is absorbed and distributed beyond preset NMR viewing range. The third measurement is a 1-D Wet Distribution Profile Immediately after the Kinetic measurement is complete, replace the cap on the specimen. The Wet Distribution is run under the same experimental conditions as the previous Dry Distribution, described above. Calibration of the NMR Amplitude for the Kinetic signal can be performed by filling glass vials (8 mm outer diameter and a defined inner diameter by at least 50 mm tall) with the appropriate fluid. Set the instrument conditions as described for the kinetics experiment. A calibration curve is constructed by placing an increasing number of vials onto the instrument (vials should be distributed equally over the 40 mm×40 mm measurement region) and perform the kinetic measurements. The volumes are calculated as the summed cross sectional area of the vials present multiplied by the z-resolution where Resolution (mm) is calculated as 1/Acquisition Time (s) divided by the instruments Gradient Strength (Hz/mm). The Calibration of the NMR Amplitude for the Distribution Profile is performed as an internal calibration based on the dry and wet profiles. In this procedure, the area beneath wet and dry profile were calculated and after subtracting them the total area (excluding markers) was obtained. This total area is correlated to the amount of applied liquid (here 1.5 mL). The liquid amount (μL) per 100 μm step can then be calculated. From the 1-D Wet Distribution Profile calculate the volume in the top 0.5 mm of the sample and report as microliter to the nearest 0.1 microliter. Free Fluid Acquisition Artificial menstrual fluid (AMF), prepared as described herein, is dosed onto the surface of an article. All measurements are performed at constant temperature (23° C.±2 C.°) and relative humidity (50%±2%). Absorbent article samples are conditioned at 23° C.±2 C.° and 50%±2% relative humidity for 2 hours prior to testing. Place a sample article flat, with the top sheet of the product facing upward. Position the tip of a mechanical pipette about 1 cm above the center (longitudinal and lateral midpoint) of the article's absorbent core, and accurately pipette 1.00 mL±0.05 mL of AMF onto the surface. The fluid is dispensed without splashing, within a period of 2 seconds. As soon as the fluid makes contact with the test sample, start a timer accurate to 0.01 seconds. After the fluid has been acquired (no pool of fluid left on the surface), stop the timer and record the Acquisition Time to the nearest 0.01 second. Wait 2 minutes. In like fashion, a second and third dose of AMF are applied to the test sample and the acquisition times are recorded to the nearest 0.01 second. This entire procedure is repeated on five substantially similar replicate articles. The reported value is the average of the five individual recorded measurements for Free Fluid Acquisition Time (first, second and third) to the nearest 0.01 second. Overlap Distance Test A Scanning Electron Microscope (SEM) is used to obtain an image of the cross-section of an absorbent article where an intentional depression has been made. From this image, the amount of overlap of fiber masses directly adjacent to the depression is measured. All measurements are performed in a laboratory maintained at 23° C.±2 C.° and 50%±2% relative humidity and test specimens are conditioned in this environment for at least 2 hours prior to testing. Obtain a test specimen by excising the layer(s) of interest from an absorbent article, if necessary. When excising an individual layer (or layers), use care to not impart any contamination or distortion to the test region during the process. The test region contains the area where an intentional depression has been made. A razor blade (such as VWR Single Edge Industrial, 0.009″ thick surgical carbon steel available from VWR Scientific, Radnor, PA, USA, or equivalent) is used to section the test specimen. Using the razor blade, a cut is made along the lateral axis of a depression at its longitudinal midpoint so that a cross-section of the depression can be imaged. The test specimen is then adhered to a mount using double-sided Cu tape, with the cross-section face up, and sputter AU coated. Secondary Electron (SE) images of the cross-sectioned test specimen are obtained using an SEM (such as FEI Quanta 450 available from FEI Company, Hillsboro, OR, USA, or equivalent), operated in high-vacuum mode using acceleration voltages between 3 and 5 kV and a working distance of approximately 12-18 mm. This methodology assumes the analyst is skilled in SEM operation so that images are obtained with sufficient contrast for analysis. The instrument is calibrated according to the manufacturer's specifications prior to use to ensure an accurate distance scale. The test specimen is viewed at a magnification that enables clear visualization of the full depth of the depression along with the fiber masses on each side of the depression, and an image is acquired. The image is then analyzed to determine the overlap of the fiber masses. Referring back toFIG.15C, first draw a Center Line1507on the image that runs parallel to the z-direction (thickness) of the test specimen and intersects the center of the depression (e.g. where the fiber masses meet). Draw a Base Line1509on the image that runs parallel to the x-y direction of the test specimen at the base of the depression. Along the contour of the fiber mass along its edge nearest the depression, determine where the fiber mass edge reaches the Base Line and mark as “OD” (line1505). Measure the distance1503between the Center Line and location “OD” to the nearest 0.01 mm and record as Overlap Distance. In like fashion, repeat for a total of 5 replicates. Calculate the arithmetic mean for Overlap Distance and report to the nearest 0.01 mm. Surface Energy/Contact Angle Method Contact angles on substrates are determined using ASTM D7490-13 modified with the specifics as describe herein, using a goniometer and appropriate image analysis software (a suitable instrument is the FTA200, First Ten Angstroms, Portsmouth, VA, or equivalent) fitted with a 1 mL capacity, gas tight syringe with a No. 27 blunt tipped stainless steel needle. Two test fluids are used: Type II reagent water (distilled) in accordance with ASTM Specification D1193-99 and 99+% purity diiodomethane (both available from Sigma Aldrich, St. Louis, MO). Contact angles from these two test fluids can further be used to calculate surface energy based on the Owens-Wendt-Kaelble equation. All testing is to be performed at about 23° C.±2 C.° and a relative humidity of about 50%±2%. Set up the goniometer on a vibration-isolation table and level the stage according to the manufacturer's instructions. The video capture device must have an acquisition speed capable of capturing at least 10-20 images from the time the drop hits the surface of the specimen to the time it cannot be resolved from the specimen's surface. A capture rate of 900 images/sec is typical. Depending on the hydrophobicity/hydrophilicity of the specimen, the drop may or may not rapidly wet the surface of the nonwoven sample. In the case of slow acquisition, the images should be acquired until 2% of the volume of the drop is absorbed into the specimen. If the acquisition is extremely fast, the first resolved image should be used if the second image shows more than 2% volume loss. Place the specimen on the goniometer's stage and adjust the hypodermic needle to the distance from the surface recommended by the instrument's manufacturer (typically 3 mm). If necessary, adjust the position of the specimen to place the target site under the needle tip. Focus the video device such that a sharp image of the drop on the surface of the specimen can be captured. Start the image acquisition. Deposit a 5 μL±0.1 μL drop onto the specimen. If there is visible distortion of the drop shape due to movement, repeat at a different, but equivalent, target location. Make two angle measurements on the drop (one on each drop edge) from the image at which there is a 2% drop volume loss. If the contact angles on two edges are different by more than 4°, the values should be excluded and the test repeated at an equivalent location on the specimen. Identify five additional equivalent sites on the specimen and repeat for a total of 6 measurements (12 angles). Calculate the arithmetic mean for this side of the specimen and report to the nearest 0.01°. In like fashion, measure the contact angle on the opposite side of the specimen for 6 drops (12 angles) and report separately to the nearest 0.01°. To calculate surface energy, the contact angle for both water and diiodomethane must be tested as described above. The value for each test fluid is then substituted into two separate expressions of the Owens-Wendt-Kaelble equation (one for each fluid). This results in two equations and two unknowns, which are then solved for the dispersion and polar components of surface tension. The Owens-Wendt-Kaelble equation: γl(1+cosθ)2=(γld+γsd)0.5+(γlp+γsp)0.5where:θ=the average contact angle for the test liquid on the test specimenγland γs=the surface tension of the test liquid and test specimen, respectively, in dyn/cmγdand γp=the dispersion and polar components of the surface tension, respectively, in dyn/cm Surface Tension (γl) (dyn/cm)SolventDispersionPolarTotalDiiodomethane50.80.050.8Water21.851.072.8 The Owens-Wendt-Kaelble equation is simplified to the following when a dispersive solvent such as diiodomethane is used since the polar component is zero: γl(1+cosθ)2=(γld+γsd)0.5 Using the values from the table and θ (measured) for diiodomethane, the equation can be solved for the dispersive component of surface energy (γds). Now using the values from the table and θ (measured) for water, and the calculated value (γds), the Owens-Wendt-Kaelble equation can be solved for the polar component of surface energy (γps). The sum of γds+γpsis the total solid surface tension and is reported to the nearest 0.1 dyn/cm. The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as “40 mm” is intended to mean “about 40 mm.” Every document cited herein, including any cross referenced or related patent or application and any patent application or patent to which this application claims priority or benefit thereof, is hereby incorporated herein by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with respect to any invention disclosed or claimed herein or that it alone, or in any combination with any other reference or references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern. While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention. | 198,549 |
11857398 | Corresponding reference characters indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION CF THE DRAWINGS Referring now to the drawings and in particular toFIGS.1and2, one suitable embodiment of an absorbent article or substrate is illustrated in the form of a child's diaper and is indicated generally by reference numeral20. While the present disclosure will be made in the context of the diaper20, it should be understood that aspects of the present disclosure are applicable to other absorbent articles, such as, for example, training pants, adult incontinence garments, diaper pants, swim diapers, feminine care articles and the like. In one suitable embodiment, the diaper20is a disposable absorbent article. As used herein, the term “disposable absorbent article” refers to articles which absorb and contain body exudates and which are intended to be discarded after a limited period of use. The articles are not intended to be laundered or otherwise restored for reuse. The articles can be placed against or in proximity to the body of a wearer to absorb and contain various exudates discharged from the body. It is understood that in other suitable embodiments, the diaper20(or more broadly, the “absorbent article”) can be reusable. That is, the absorbent article can be intended for multiple uses without departing from some aspects of this disclosure. The diaper20, as seen inFIGS.1and2, has a front waist region22, a back waist region24, and a crotch region26disposed longitudinally between and interconnecting the front and back waist regions. The diaper20also has a pair of laterally opposite side edges28and a pair of longitudinally opposite waist edges, respectively designated front waist edge30and back waist edge32. In the illustrated embodiment, the side edges28are arcuately shaped to provide the diaper20with a more body conforming shape. The front waist region22is contiguous with the front waist edge30, and the back waist region24is contiguous with the back waist edge32. As seen inFIG.2, the diaper20defines a longitudinal direction34and a transverse direction36perpendicular to the longitudinal direction. The diaper20includes a body-facing side38(i.e., the side of the diaper20that faces the body of a wearer when worn) and a garment-facing side40(i.e., the side of the diaper20that faces away from the body of a wearer when worn). The diaper20also includes a liquid impermeable backsheet42, a topsheet44, and an absorbent assembly, indicated generally at46, disposed between the backsheet and the topsheet. The illustrated absorbent assembly46extends longitudinally from the front waist region22through the crotch region26to the back waist region24. As seen inFIG.2, the backsheet.42, topsheet.44, and absorbent assembly46are arranged in a superposed relation by suitable means including, but not limited to, adhesives, ultrasonic bonds, pressure bonds, thermal bonds, and combinations thereof. The absorbent assembly46also includes a pair of containment flaps48for inhibiting the lateral flow of body exudates. Suitably, the backsheet42prevents waste material from wetting articles, such as bed sheets and clothing, as well as the wearer and caregiver. The backsheet may comprise a variety of suitable materials including, for example and without limitation, a material which is substantially liquid impermeable. The backsheet42can be a single layer of liquid impermeable material, or may comprise a multi-layered laminate structure in which at least one of the layers is liquid impermeable. The backsheet42may also comprise a liquid permeable material. The backsheet42may also be stretchable, and more suitably elastic. In particular, the backsheet42is suitably stretchable and more suitably elastic in at least the transverse, or circumferential direction36of the diaper20. The backsheet42may also be stretchable, and more suitably elastic, in both the transverse and the longitudinal directions34and36. The topsheet44is suitably compliant, soft-feeling, and non-irritating to the wearer's skin. The topsheet44is also sufficiently liquid permeable to permit liquid body exudates to readily penetrate through its thickness to the absorbent assembly46. The topsheet44may comprise a variety of suitable materials including, for example and without limitation, porous foams, reticulated foams, apertured plastic films, woven and nonwoven webs, and combinations thereof. The topsheet44may also be stretchable, and more suitably it may be elastomeric. The absorbent assembly46is suitably compressible, conformable, non-irritating to a wearer's skin, and capable of absorbing and retaining liquids and certain body wastes. For example, the absorbent assembly46may comprise cellulosic fibers (e.g., wood pulp fibers), other natural fibers, synthetic fibers, woven or nonwoven sheets, scrim netting or other stabilizing structures, superabsorbent material, binder materials, surfactants, selected hydrophobic materials, pigments, lotions, odor control agents or the like, as well as combinations thereof. The absorbent assembly46may be stretchable so as not to inhibit the stretchability of other components to which the absorbent structure may be adhered, such as the backsheet42and topsheet44. After being formed or cut to a desired shape, the absorbent assembly46may be wrapped or encompassed by a suitable wrap (not shown) that aids in maintaining the integrity and shape of the absorbent structure. The absorbent assembly46may also include a surge management layer (not shown) located adjacent the absorbent assembly46(e.g., between the absorbent assembly46and the topsheet44) to decelerate and diffuse surges or gushes of liquid that may be rapidly introduced into the absorbent assembly46of the diaper20by the wearer. Examples of suitable surge management layers are described in U.S. Pat. No. 5,486,166 issued Jan. 23, 1996 to Bishop et al.; U.S. Pat. No. 5,490,846 issued Feb. 13, 1996 to Ellis et al.; and U.S. Pat. No. 5,820,973 issued Oct. 13, 1998 to Dodge, II et al., the disclosures of which are hereby incorporated by reference. As seen inFIG.1, the front waist region22of the diaper20can be selectively joined to the back waist region24via a pair of refastenable side seams50to define a fastened or wear configuration of the diaper having a waist opening, indicated at52, and two leg openings, indicated at54. The illustrated refastening seams50are defined by first fastening components56(e.g., a loop-type fastener) selectively engageable with second fastening components58(e.g., hook-type fasteners). The fastening components56,58may include any suitable complementary refastenable fasteners including, for example and without limitation, hook- and loop-type fasteners, other types of mechanical fasteners, adhesive fasteners, cohesive fasteners, and combinations thereof. In some suitable embodiments, the fastening components56,58may be pre-fastened during the manufacturing process of the diaper20such that the diaper20is supplied to the user in the fastened configuration. WhileFIG.1illustrates the front and back regions22,24being joined together via refastenable seams50, it is understood that the front and back regions can be joined together via non-refastenable, bonded seams (e.g., by adhesive bonding, ultrasonic bonding, pressure bonding, thermal bonding). With reference still toFIGS.1and2, the illustrated diaper20also includes front and rear waist elastic members60configured to form a gasket around the waist opening52. The waist elastic members60can be formed of any suitable elastic material including, for example and without limitation, sheets, strands or ribbons of natural rubber, synthetic rubber, or thermoplastic elastomeric polymers. Other suitable elastic materials from which the waist elastic members60can be formed, and suitable methods of incorporating waist elastic members into an absorbent article are described in U.S. Pat. No. 9,820,889 filed Oct. 31, 2013 by Sina et al., and U.S. Pat. No. 9,265,669 filed Oct. 31, 2013 by Bennett et al., the disclosures of which are hereby incorporated by reference. As best seen inFIG.2, the illustrated diaper20also includes a pair of profiled leg cuffs or discrete parts62disposed proximate the side edges28of the diaper20to create a gasket and to reduce or inhibit leakage of body exudates around the leg openings54. The leg cuffs62can be formed from a variety of suitable elastic materials including, for example and without limitation, sheets, strands or ribbons of natural rubber, synthetic rubber, or thermoplastic elastomeric polymers. The illustrated leg cuffs62include at least one elastic element (e.g., an elastic strand) adhered to the topsheet44. Suitably, the leg cuffs62can be cut and formed from a continuous ribbon of elastic material, and applied to the diaper20as a discrete segment utilizing the apparatus and methods described in more detail herein. Particular examples of suitable elastic materials for leg cuffs62include, without limitation, dry-spun coalesced multifilament spandex elastomeric threads sold under the trade name LYCRA® and available from Invista of Wichita, Kansas, U.S.A., vertical filament laminate (VFL) materials, an example of which is described in U.S. Pat. No. 6,916,750 to Thomas et al., which is hereby incorporated by reference; elastic nonwoven composites having an apertured elastic film laminated to one or more nonwoven web materials, examples of which are described in U.S. Pat. No. 7,803,244 issued Sep. 28, 2010 to Siqueira et al., and U.S. Pat. No. 8,361,913 issued Jan. 29, 2013 to Siqueira et al., both of which are hereby incorporated by reference; and other elastic laminates such as single- and dual-faced spandex laminates, stretch-bonded laminates (SBL), and continuous filament stretch-bonded laminates (CFSBL), examples of which are described in U.S. Pat. No. 5,385,775 issued Jan. 31, 1995 to Wright; U.S. Pat. No. 6,057,024 issued May 2, 2000 to Mleziva et al.; and U.S. Pat. No. 6,969,441 issued Nov. 29, 2005 to Welch et al., all of which are hereby incorporated by reference. In the illustrated embodiment, the leg cuffs62are attached to the body-facing side38of the topsheet44. In other suitable embodiments, the leg cuffs62may be attached to the garment-facing side40of topsheet44. In yet other suitable embodiments, it is contemplated that the leg cuffs62can be attached to the body-facing side38of the backsheet42in addition to, or instead of, the leg cuffs62being attached to the topsheet44. That is, in one suitable embodiment, the leg cuffs62can be attached to both the body-facing and garment-facing sides38,40of the topsheet44. As shown inFIG.2, the leg cuffs62of the illustrated embodiment are profiled and, more specifically curved (i.e., nonlinear), to provide a more formfitting, comfortable gasket around the leg openings54of the diaper20. In particular, the leg cuffs62are shaped to provide improved leakage protection and a more appealing aesthetic appearance. More specifically, at least a portion of each leg cuff62has a radius of curvature R of less than about 40 inches, and more suitably less than about 10 inches, along at least a portion of its length. FIG.3schematically illustrates a portion of one suitable embodiment of a process100for making the absorbent articles20illustrated inFIGS.1and2.FIG.4is a perspective view of the process100for making the absorbent articles20illustrated inFIGS.1and2.FIG.5is a perspective side view of the process100for making the absorbent articles20illustrated inFIGS.1and2. As seen inFIG.3, at least one supply of a web102is used to form the leg cuffs62of the absorbent article20and is provided from suitable supply sources (e.g., supply rolls104). As shown inFIG.3, the process100includes two supplies of web102and two supply rolls104to simultaneously apply the leg cuffs62to the absorbent article20. However, the process100may include only a single supply of the web102and a single supply roll104. The process100includes at least one applicator106, a perforator108, and a web treatment apparatus110. The applicator106applies a hot melt adhesive (not shown) to the web102, and the hot melt adhesive adheres the leg cuffs62to the absorbent articles20. The applicator106may include, but is not limited to only including, a spray, a slot coat, a drag bead, and/or any other suitable type of adhesive applicator. The web102is fed to the web treatment apparatus110to assemble at least a portion of the absorbent article20. Specifically, the treatment apparatus110receives the web102as it is traveling in a first direction, represented by arrow112. In this embodiment, the web102includes two continuous ribbons of elastic material106. In another suitable embodiment including only a single supply of the web102and a single supply roll104, the web102includes a continuous ribbon of elastic material106that is separated into separated, discrete leg cuffs62. In the illustrated embodiment, the perforator108at least partially perforates the continuous ribbon of elastic material106. More specifically, in this embodiment, the perforator108partially perforates the continuous ribbon of elastic material106such that the continuous ribbon of elastic material106is weakened, but does not separate into separate leg cuffs62. Rather, and as described below in more detail, the treatment apparatus110separates the continuous ribbon of elastic material106into separate leg cuffs62. In another suitable embodiment, the web102includes leg cuffs62that are separated by preformed perforations or other suitable lines of weakness. It is contemplated, however, that pre-separated leg cuffs62can be fed to the treatment apparatus110. It is also contemplated that the web102can be cut into separate leg cuffs62after the web102is fed to the treatment apparatus110. In one embodiment, the treatment apparatus110includes a drive assembly114configured to rotate about a drive axis116, and a plurality of transfer segments118that are coupled to and extend outwardly from the drive assembly. The drive assembly114includes one or more drive sources including, for example, servo motors, and/or camboxes, that are coupled to each transfer segment118. The drive assembly114is configured to rotate each transfer segment118about the drive axis116between a pick-up location, indicated generally at120, and an application location, indicated generally at122. As illustrated inFIG.3, the transfer segment118is configured to receive the web102including the leg cuffs62at the pick-up location120, and convey the leg cuffs62to the application location122. In the illustrated configuration, each of the leg cuffs62is separated from an adjacent leg cuff62along the perforation (or other line of weakness) formed by the perforator108as the web102is conveyed by the treatment apparatus110. More specifically, and as described below in more detail, each of the leg cuffs62is received by one of the transfer segments118. During rotation by the drive assembly114, each of the adjacent transfer segments118of the treatment apparatus110moves apart thereby causing the web102of leg cuffs62to rupture (i.e., separate) about the perforations. Thus, each of the transfer segments118is adapted to carry the leg cuffs62of one of the absorbent articles20. In a suitable embodiment, the web treatment apparatus110is an oscillating cam adjusted roller as is disclosed in U.S. Pat. Nos. 5,716,478, 5,759,340, and 6,139,004, all of which are assigned to Kimberly-Clark Worldwide, Inc., and the entire disclosures of all of which are hereby incorporated herein by reference. Each of the transfer segments118includes a support arm124extending radially outwardly from the drive assembly114, and a transfer puck assembly126coupled to the support arm124. The transfer puck assembly126includes a puck support125and at least one puck assembly127attached to the puck support. In this embodiment, the transfer puck assembly126includes two puck assemblies127. The support arm124includes a first end128, which is coupled to the drive assembly114, and an opposite second end130, which is coupled to the puck support125of the transfer puck assembly126. The support arm124extends between the first end128and the second end130along a radial axis132. In one suitable embodiment, the first end128of the support arm124is coupled to the drive assembly114such that each transfer puck assembly126is independently rotatable about the drive axis116of the treatment apparatus110(as indicated by arrow134ofFIGS.3and10) and at least one puck segment138of a plurality of puck segments138of each puck assembly127is translatable along an axial direction (as indicated by arrow136ofFIG.6A). As illustrated inFIGS.6A,6B, and7, each puck assembly127includes the plurality of puck segments138that define a leading edge140, a trailing edge142, and a platform144of the transfer puck assembly126. The platform144extends between the leading edge140and the trailing edge142and is sized and shaped to receive the leg cuffs62from the web102, and release the leg cuffs62to apply the leg cuffs62to the absorbent article20. Specifically, as shown inFIG.7, the platform144has a curved shape that matches a curved outer contour146of the apparatus110. As mentioned above, the puck segments138of the puck assembly127are translatable in the axial direction136to curve a curved end170of the leg cuffs62prior to applying the leg cuffs62to the absorbent article20. More specifically, at least one puck segment138of each puck assembly127is movable between a first position, indicated generally at148inFIG.6A, wherein the puck assembly is oriented to receive the leg cuffs62at the pick-up location120and a second position, indicated generally at150inFIG.6B, wherein the puck assembly127is oriented to apply the leg cuffs62to the absorbent article20at the application location122. In one suitable embodiment, the web102of leg cuffs62is traveling at a first speed in the first direction112, and the absorbent article20is traveling at a second speed in a second direction152that is different than the first speed. The drive assembly114is adapted to rotate each transfer puck assembly126about the drive axis116such that the surface speed of each puck assembly127is approximately equal to the speed of the web102as the leg cuffs62are received by the platforms144of the puck assembly127at the pick-up location120. In the illustrated embodiment, the drive assembly114accelerates each transfer puck assembly126such that the speed of the puck assembly127is approximately equal to the speed of the absorbent article20as the leg cuffs62are applied to the absorbent article20by the puck assembly127at the application location122. Additionally, accelerating the transfer puck assemblies126separates the puck assemblies127such that the web102is separated into the leg cuffs62along the perforations (or other line of weakness) prior to applying the leg cuffs62to the absorbent articles20. In one embodiment, at least one puck segment138of each of the puck assemblies127is translated along axial direction136. A cylinder or barrel cam174causes at least one puck segment138of each puck assembly127to translate along axial direction136between the pick-up location120and the application location122. In one suitable embodiment, the barrel cam174is configured to selectively adjust a translation distance of at least one puck segment138of each puck assembly127, as at least one puck segment138of each puck assembly127is translated between the pick-up location120and the application location122. More specifically, the barrel cam174selectively translates at least one puck segment138of each puck assembly127from the first position148to the second position150from the pick-up location120to the application location122such that an outer edge131of each puck segment138is translated from a first location133to a second location135. The distance between the first location133of the first position148and the second location135of the second position150defines a translation distance154traveled by the puck segment138. In one suitable embodiment, the apparatus110can be used to simultaneously apply first and second leg cuffs156,158to a continuously moving product web including at least one portion of the absorbent article20. In the illustrated embodiment, the translation distance154of the first and second leg cuffs156,158is the same. In alternative embodiments, the translation distance154of the first and second leg cuffs156,158is different. FIG.6Ais a top view of the transfer puck assembly126of the manufacturing process100in the first position148, andFIG.6Bis a top view of the transfer puck assembly seen inFIG.6Amoved to the second position150. In the illustrated embodiment, the transfer puck assembly126includes a first puck assembly161and a second puck assembly163. The first and second puck assemblies161and163each include a base puck segment160and a translating puck segment162,164. Specifically, the first puck assembly161includes a first translating puck segment162, and the second puck assembly163includes a second translating puck segment164. The barrel cam174is configured to translate the first translating puck segment162along axial direction136in a first translation direction, represented by arrow166inFIG.6B, and to translate the second translating puck segment164in a second translation direction, represented by arrow168inFIG.6B, that is opposite the first direction. The translating puck segments162,164may be disposed on or connected to linear bearings or the like to ensure accurate linear movement. Translating the first and second translating puck segments162,164curves the curved end170of the first and second leg cuffs156,158prior to adhering the first and second leg cuffs156,158to the absorbent article20. Additionally, a straight end171of the first and second leg cuffs156,158is maintained in position as the curved end170is translated along the axial direction136. That is, only a portion of the first and second leg cuffs156,158is translated along the axial direction136, while another portion of the first and second leg cuffs is maintained in position. The first puck assembly161conveys the first leg cuff156, and the second puck assembly163conveys the second leg cuff158. The first translating puck segment162is translated in the first translation direction166, and the second translating puck segment164is translated in the second translation direction168such that the curved end170of the first leg cuff156is spaced from the curved end170of the second leg cuff158. In the embodiment illustrated inFIGS.6A and6B, each of the first and second translating puck segments162,164is translated such that the curved end170of the first and second leg cuffs156,158are applied to the absorbent article20with the radius of curvature R. In another embodiment, each of the first and second translating puck segments162,164is translated to different translation distances154such that the curved end170of the first and second leg cuffs156,158are applied at different radius of curvatures R. More specifically, each of the first and second translating puck segments162,164is translated to different translation distances154such that the curved end170of the first leg cuff156is applied at a first radius of curvature R1and the curved end170of the second leg cuff158is applied at a second radius of curvature R2that is different than the first radius of curvature R1. In one suitable embodiment, the second leg cuff158is applied at the second radius of curvature R2that is equal to, and opposite from, the first radius of curvature R1. By applying the first and second leg cuffs156,158at opposing, curved orientations, the apparatus110can manufacture the absorbent article20ofFIGS.1and2. In one suitable embodiment illustrated inFIG.8, the cylinder or barrel cam174is coupled to each puck assembly127to translate the respective puck segments138of each transfer puck assembly126along the axial direction136. The barrel cam174includes a radial outer surface176and a cam track178defined along the radial outer surface. As illustrated inFIGS.11A and11B, each transfer puck assembly126includes a cam arm180, a cam follower182coupled to the cam arm180, a first cam pivot181also coupled to the cam arm180, a second cam pivot183, and a cam belt185coupled to both of the first and second cam pivots. The cam follower182is positioned within the cam track178and moves from a first position187illustrated inFIG.11Ato a second position189illustrated inFIG.11B. Specifically, the cam track178has a curved shape, and the cam follower182follows the curved shape of the cam track. The cam arm180is attached to the cam follower182and rotates as the cam follower moves between the first position187and the second position189. The cam arm180is also attached to the first cam pivot181and rotates the first cam pivot. The first cam pivot181rotates the cam belt185which rotates the second cam pivot183. The second cam pivot183is coupled to the first and second translating puck segments162,164, and includes a pivot point184. In one embodiment, the apparatus110includes a first translation segment186associated with the first translating puck segment162and a second translation segment188associated with the second translating puck segment164. The second cam pivot183is coupled to the first and second translation segments186and188such that rotation of the second cam pivot translates the first and second translating puck segments162,164along the axial direction136. The cam follower182is adapted to engage the cam track178to facilitate selectively translating the first and second translating puck segments162,164along the axial direction136. More specifically, the cam follower182rotates the cam arm180, the cam arm rotates the first cam pivot181, the first cam pivot rotates the cam belt185, the cam belt rotates the second cam pivot183about the pivot point184, and the second cam pivot translates the first and second translation segments186and188and the first and second translating puck segments162,164as each transfer puck assembly126rotates about the drive axis116. Through connection with the translation segments186,188, the rotation of the cam arm180causes translation of the first and second translation segments186and188and the first and second translating puck segments162,164along the axial direction136. It should be understood that many other options exist for converting the rotational motion of the cam arm180into the translation motion of the puck segments162,164. Accordingly, the specific mechanism shown inFIGS.11A,11Bshould not be viewed as limiting. For example, the process100may include other mechanisms for translating puck segments162and164such as: (1) two linear servos (not shown), one attached to each puck segment, that each translate at least one of first and second puck segments along axial direction136; (2) a single linear servo260(shown inFIGS.23A and23B) that actuates a rack and pinion system262(shown inFIGS.23A and23B) that translates first and second puck segments along axial direction136; (3) two rib cams270(shown inFIGS.24A and24B), one attached to each puck segment, that each translate first and second puck segments along axial direction136; and/or (4) any other mechanism that translates first and second puck segments along axial direction136as described herein. Specifically, in the alternative embodiment illustrated inFIGS.23A and23B, each transfer puck assembly126may include the linear servo260and the rack and pinion system262attached to the linear servo for translating first and second puck segments along axial direction136. The rack and pinion system262includes a pinion264, a first rack266attached to the first puck segment162and movably attached to the pinion, and a second rack268attached to the second puck segment164and movably attached to the pinion. The first rack266is also slidably attached to the linear servo260. Rotation of the transfer segment118actuates the linear servo260, and the linear servo translates the first rack266and the first puck segment162along axial direction136as described herein. Translation of the first rack266also rotates the pinion264. Rotation of the pinion264translates the second rack268and the second puck segment164along axial direction136as described herein. Additionally, in the alternative embodiment illustrated inFIGS.24A and24B, each transfer puck assembly126may include the two rib cams270, one attached to each puck segment162and164, that each translate first and second puck segments along axial direction136. Each rib cam270includes a rib272extending from the radial outer surface176of the barrel cam174, a cam follower274movably attached to the rib272, and a cam arm276attached to the cam follower274and the first and second puck segments162and164. The cam followers274are positioned on the ribs272, and the ribs272have a curved shape similar to the cam track178. The cam followers274follow the curved shape of the ribs272, and the cam arms180translate the first and second puck segments162and164as the cam followers and the cam arms follow the curved shape of the ribs. FIGS.9and10are schematic views of a portion of one suitable embodiment of the drive assembly114. As mentioned above, the apparatus110includes a plurality of transfer puck assemblies126each comprising at least the first translating puck segment162and the second translating puck segment164. The illustrated drive assembly114is configured to rotate each transfer puck assemblies126about the drive axis116and translate the first and second translating puck segments162,164such that the curved ends170of the first and second leg cuffs156,158are curved away from each other. As seen inFIGS.9and10, the drive assembly114includes a drive ring assembly190and a cam plate assembly192. The drive ring assembly190and cam plate assembly194are each coupled to each transfer segment118to rotate the transfer segments about the drive axis116. The drive ring assembly190includes a drive ring194. In another embodiment, the drive ring assembly190includes a plurality of drive rings (not shown). As illustrated inFIG.9, the cam plate assembly194includes a cam plate195including the cam track178. In one embodiment, the drive ring194and the cam track178are coupled to each transfer segment118. The drive ring194rotates each transfer segment118about drive axis116, and the cam track178engages cam follower182to translate the puck segments138along axial direction136as the transfer segments118are rotated about drive axis116. Referring to again toFIGS.3-5, in a suitable embodiment, the apparatus110includes a vacuum assembly196that is coupled to each puck support125by a vacuum hose197to selectively apply a vacuum suction to the platform144through the puck support125to enable the transfer puck assembly126to selectively receive, hold and release the respective leg cuffs62. More specifically, as shown inFIG.12, the puck segments138define a plurality of vacuum holes198that are fluidly connected to the vacuum assembly196. The vacuum assembly196selectively applies a vacuum suction through the vacuum hose197, the puck support125, the platform144, and the vacuum holes198. A control system200is coupled in operative control communication with the drive assembly114and with vacuum assembly196to operate the drive assembly114and the vacuum assembly196to convey the first and second leg cuffs156,158from the web102, and to apply the first and second leg cuffs156,158to the absorbent article20. The control system200includes a controller202that is coupled to the drive assembly114, the vacuum assembly196, and one or more sensors204. Each sensor204senses various parameters relative to the operation of the drive assembly114, the transfer segments118, and/or the vacuum assembly196. The sensors204may include, but are not limited to only including, position sensors, angular speed sensors, proximity sensors, and/or any other sensors that sense various parameters relative to the operation of the apparatus110. The sensors204can be any suitable sensors such as, for example, encoders, reed switches, reed sensors, infra-red type sensors, and/or photo-eye sensors. Alternatively, any sensors that enable operation of the apparatus110, as described herein may be used. In one embodiment, the controller202includes a processor206and a memory device208. The processor206includes any suitable programmable circuit which may include one or more systems and microcontrollers, microprocessors, reduced instruction set circuits (RISC), application specific integrated circuits (ASIC), programmable logic circuits (PLC), field programmable gate arrays (FPGA), and any other circuit capable of executing the functions described herein. The above examples are exemplary only, and thus are not intended to limit in any way the definition and/or meaning of the term “processor.” Memory device208includes a computer readable medium, such as, without limitation, random access memory (RAM), flash memory, a hard disk drive, a solid state drive, a diskette, a flash drive, a compact disc, a digital video disc, and/or any suitable device that enables processor206to store, retrieve, and/or execute instructions and/or data. In one embodiment, the control system200is configured to control a position of a rotary valve or vacuum slug (not shown) to selectively apply a vacuum suction to the platform144of the transfer puck assembly126. Specifically, when the puck segment138is at the pick-up location120adjacent the web102, the rotary valve permits the vacuum assembly196to apply a vacuum suction through the vacuum holes198to cause the web102to adhere to the platform144of the transfer puck assembly126. When the puck segment138is at the application location122adjacent the absorbent article20, the rotary valve cuts off fluid communication between the vacuum assembly196and the transfer puck assembly126to release the respective first and second leg cuffs156,158from the platform144of the transfer puck assembly126to enable the transfer puck assembly126to release and thereby apply the first and second leg cuffs156,158to the absorbent article20. FIGS.12and13illustrate the first puck assembly161of the transfer puck assembly126arranged in a first transfer puck assembly arrangement210.FIGS.14-18illustrate the first puck assembly161of the transfer puck assembly126arranged in a second transfer puck assembly arrangement254.FIGS.20-22illustrate the first puck assembly161of the transfer puck assembly126arranged in a third transfer puck assembly arrangement246. As best seen inFIGS.14-18illustrating the first puck assembly161of the transfer puck assembly126arranged in the second transfer puck assembly arrangement254, the first puck assembly161includes a first puck segment212, a second puck segment214, a third puck segment216, and a fourth puck segment or base puck segment218arranged such that the transfer puck assembly126has a rectangular shape. However, the transfer puck assembly126may include any number of puck segments that enable the transfer puck assembly126to operate as described herein. Specifically, each puck segment212-218has a length220and a width222and each puck also defines a rectangular shape. In the illustrated embodiment, the width222of each puck segment212-218is the same, and the length220of the first, second, and third puck segments212-216are also the same. The length220of the fourth puck segment218is greater than the length220of the first, second, and third puck segments212-216. More specifically, in this embodiment, the width222of each puck segment212-218is about 0.25 inches to about 4.0 inches, the length220of the fourth puck segment218is about 1.0 inches to about 6.0 inches, and the length220of the first, second, and third puck segments212-216is about 0.25 inches to about 4.0 inches. The radius of curvature R of the first and second leg cuffs156,158is at least partially determined by the length110of the puck segments212-218. Additionally, each puck segment212-218has a first side edge224, a second side edge226, a puck leading edge228, and a puck trailing edge230. As shown inFIGS.12-16, the puck segments212-218are arranged linearly such that the first puck segment212is slidably positioned next to the second puck segment214, the second puck segment214is slidably positioned next to the third puck segment216, and the third puck segment216is slidably positioned next to the fourth puck segment218. Specifically, the puck trailing edge230of the first puck segment212is positioned next to the puck leading edge228of the second puck segment214, the puck trailing edge230of the second puck segment214is positioned next to the puck leading edge228of the third puck segment216, and the puck trailing edge230of the third puck segment216is positioned next to the puck leading edge228of the fourth puck segment218. The puck segments212-218each include a joint assembly (not shown) that allows the puck segments to slide or translate along axial direction136without separating from each other. For example, the joint assembly may include a tongue and groove assembly that enables the puck segments212-218to slide or translate along axial direction136without separating from each other. Specifically, the puck leading edges228of the second, third, and fourth puck segments214-218may each include a ridge (not shown), and the puck trailing edges230of the first, second, and third puck segments212-216may each include a groove or slot (not shown) that has a shape and size that corresponds to a shape and size of the ridges of the first, second, and third puck segments. The ridges of the second, third, and fourth puck segments214-218are positioned within the grooves of the first, second, and third puck segments212-216and retain a position of the puck segments212-218relative to each other in a circumferential direction232as the puck segments slide or translate in the axial direction136. In alternative embodiments, the puck segments212-218may include joint assembly that enables the transfer puck assembly126to operate as described herein. In an alternative embodiment illustrated inFIGS.12and13, the first transfer puck assembly arrangement210only includes the first puck segment212and the second, third, and fourth puck segments214-218are combined into a fifth puck256. In the illustrated embodiment, the length220of the fifth puck256is equivalent to the combined lengths220of the second, third, and fourth puck segments214-218. As described below, the first and fifth puck segments212and256operate in manner consistent with the operation of the transfer puck assembly126illustrated inFIGS.12-16. As described above, the puck segments212-218each define vacuum holes198fluidly connected to the vacuum assembly196, and the vacuum assembly196selectively applies a vacuum suction through the vacuum holes198, retaining the leg cuffs62on the transfer puck assembly126. The vacuum holes198each define a vacuum hole diameter234and are arranged in rows236and columns238. In the second transfer puck assembly arrangement254, each puck segment.212-218includes five columns238of vacuum holes198, the fourth puck segment218includes 17 rows236of vacuum holes198, the second and third puck segments214and216each include seven rows236of vacuum holes198, and the first puck segment212includes six rows236of vacuum holes198. In alternative embodiments, the puck segments212-218may each include any number of rows236and columns238of vacuum holes198that enable the transfer puck assembly126to operate as described herein. In the first transfer puck assembly arrangement210illustrated inFIG.12, the first puck segment212includes six rows236of vacuum holes198, and the fifth puck256includes 31 rows236of vacuum holes198. Additionally, in the second transfer puck assembly arrangement254, the vacuum hole diameters234of each of the vacuum holes198are the same. In alternative embodiments, the vacuum hole diameters234of each of the vacuum holes198are different. In the illustrated embodiment, the vacuum hole diameter234of each of the vacuum holes198is about 0.06 inches to about 0.15 inches. In alternative embodiments, the vacuum hole diameter234of each of the vacuum holes198may be any size that enables the transfer puck assembly126to operate as described herein. As shown inFIGS.14and15, in the second transfer puck assembly arrangement254, when the transfer puck assembly126is in the first position148, oriented to receive the leg cuffs62at the pick-up location120, the puck segments212-218are arranged such that the transfer puck assembly has a rectangular shape. Specifically, in the first position148, the puck segments212-218are arranged such that the first side edges224of the puck segments are aligned, and the second side edges226of the puck segments are aligned, forming the rectangular shape of the transfer puck assembly126. Additionally, the columns238of vacuum holes198of each puck segment212-218are aligned in a linear arrangement. In the first transfer puck assembly arrangement210illustrated inFIG.12, the first puck segment212is aligned with the fifth puck256such that the first transfer puck assembly arrangement has a rectangular shape similar to the linear arrangement of the transfer puck assembly126illustrated inFIG.14. As shown inFIGS.16,17, and18, in the second transfer puck assembly arrangement254, when the transfer puck assembly126is in the second position150, oriented to apply the leg cuffs62to the absorbent article20at the application location122, one or more of the first, second, and third puck segments212-216are translated in the axial direction136to curve the leg cuffs62prior to applying the leg cuffs62to the absorbent article20. In the embodiment illustrated inFIG.14, only the first puck segment212is translated in the axial direction136. In the embodiments illustrated inFIGS.15and16, the first and second puck segments212and214and the first, second, and third puck segments212-216are translated in the axial direction136, respectively. Similarly, the first transfer puck assembly arrangement210illustrated inFIGS.12and13, the transfer puck assembly126is in the second position150, oriented to apply the leg cuffs62to the absorbent article20at the application location122, the first puck segment212is translated relative to the fifth puck256in the axial direction136to curve the leg cuffs62prior to applying the leg cuffs62to the absorbent article20. Specifically, in the embodiment illustrated inFIG.14, only the first puck segment212is translated a first translation distance240in the axial direction136to curve the leg cuffs62prior to applying the leg cuffs62to the absorbent article20. In the illustrated embodiment, the first translation distance240is about 0.5 inches to about 2.0 inches. In alternative embodiments, the first translation distance240may be any distance that enables the transfer puck assembly126to operate as described herein. In the embodiment illustrated inFIG.16, the first puck segment212is translated the first translation distance240in the axial direction136and the second puck segment214is translated a second translation distance242to curve the leg cuffs62prior to applying the leg cuffs62to the absorbent article20. In the illustrated embodiment, the first translation distance240is about 0.5 inches to about 2.0 inches, and the second translation distance242is about 0.25 inches to about 1.0 inches. Specifically, the first translation distance240is greater than the second translation distance242. In alternative embodiments, the first translation distance240and the second translation distance242may be any distance that enables the transfer puck assembly126to operate as described herein.In the embodiment illustrated inFIG.18, the first puck segment212is translated the first translation distance240in the axial direction136, the second puck segment214is translated a second translation distance242, and the third puck segment216is translated a third translation distance244to curve the leg cuffs62prior to applying the leg cuffs62to the absorbent article20. In the illustrated embodiment, the first translation distance240is about 0.75 inches to about 3.0 inches, the second translation distance242is about 0.5 inches to about 2.0 inches, and the third translation distance244is about 0.25 inches to about 1.0 inches. Specifically, the first translation distance240is greater than the second translation distance242and the third translation distance244, and the second translation distance242is greater than the third translation distance244. In alternative embodiments, the first, second, and third translation distances240-244may be any distance that enables the transfer puck assembly126to operate as described herein. As described above, the barrel cam174is coupled to each transfer puck assembly126to translate at least one of first, second, and third puck segments212-216of each transfer puck assembly126along the axial direction136. More specifically, as illustrated inFIGS.19A and19B, the apparatus110includes a plurality of first translation segments186associated with the first, second, and third puck segments212-216of the first translating puck segment162and a plurality of second translation segments188associated with the first, second, and third puck segments212-216of the second translating puck segment164. The cam follower182rotates the cam arm180about the pivot point184as each transfer puck assembly126rotates about the drive axis116. The cam arm180translates the first and second translation segments186and188and at least one of second, third, and fourth puck segments214-218along the axial direction136. As best seen inFIGS.20-22illustrating one side of the transfer puck assembly126arranged in the third transfer puck assembly arrangement246, the transfer puck assembly126includes the first, second, and fourth puck segments212,214, and218. Additionally, while the first and fourth puck segments212and218each include vacuum holes198arranged in rows236and columns238similar to the first and fourth puck segments212and218of the second transfer puck assembly arrangement254, the second puck segment214includes vacuum holes198arranged in rows236and curved columns248. More specifically, in the third transfer puck assembly arrangement246, the second puck segment214includes seven rows236of vacuum holes198and three curved columns248of vacuum holes198at least partially misaligned with the columns238of vacuum holes198of the first and fourth puck segments212and218. As shown inFIGS.20and21, in the third transfer puck assembly arrangement246, when the transfer puck assembly126is in the first position148, oriented to receive the leg cuffs62at the pick-up location120, the puck segments212,214, and218are arranged in a linear arrangement similar to the linear arrangement of the second transfer puck assembly arrangement254. Specifically, the columns238of vacuum holes198of the first and fourth puck segments212and218are aligned in a linear arrangement, but the curvature of the curved columns248causes the curved columns248of vacuum holes198of the second puck segment214to be at least partially misaligned with the columns238of vacuum holes198of the first and fourth puck segments212and218. As shown inFIG.21, in the third transfer puck assembly arrangement246, when the transfer puck assembly126is in the second position150, oriented to apply the leg cuffs62to the absorbent article20at the application location122, only the first puck segment212is translated in the axial direction136to curve the leg cuffs62prior to applying the leg cuffs62to the absorbent article20. Specifically, only the first puck segment212is translated a fourth translation distance252causing a portion250of the leg cuff62covering the second puck segment.214to also translate in the axial direction136. Translation of the portion250of the leg cuff62covering the second puck segment214causes the leg cuff62to assume a curved shape corresponding to the curvature of the curved columns248of the second puck segment214. In the illustrated embodiment, the fourth translation distance252is about 0.5 inches to about 2.0 inches. In alternative embodiments, the fourth translation distance252may be any distance that enables the transfer puck assembly126to operate as described herein. The curved hole pattern of the curved columns248of the second puck segment214reduces friction and enables the radius of curvature R of the first and second leg cuffs156,158to be controlled. Accordingly, the curvature of the curved columns248of the third transfer puck assembly arrangement246enables the transfer puck assembly126to control the radius of curvature R of the first and second leg cuffs156,158and reduces friction between the first and second leg cuffs156,158and the puck segments212,214, and218. When introducing elements of the present invention or the preferred embodiment(s) thereof, the articles “a”, “an”, “the”, and “said” are intended to mean that there are one or more of the elements. The terms “comprising,” “including”, and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. | 49,463 |
11857399 | DETAILED DESCRIPTION It is to be understood that the drawings are schematic and that individual components, such as the material and the respective rolls are not necessarily drawn to scale. The cutting roll, anvil roll and the transport vacuum transport roll may also be differently arranged in relation to each other than in the drawings. With reference toFIG.1, a method of transferring cut-out nonwoven material members1a,1b,1cfrom a cutting station2is schematically shown. The cut-out nonwoven material members are Carded Air Through Bonded nonwoven material members, Carded Spunlace nonwoven material members or Carded Needle punched nonwoven material members. In a first step a continuous web of a Carded Air Through Bonded, a Carded Spunlace or a Carded Needle punched nonwoven material1is fed in a machine direction MD and towards the cutting station2. The cutting station2includes a rotating cutter roll4with a circumferential outer surface4aand a rotating anvil roll5with a smooth circumferential outer surface5a. The continuous web of nonwoven material1is passed in a nip3formed between the rotating cutter roll4and the anvil roll5. The rotating cutter roll4includes knives6a,6bprotruding from the outer circumferential surface4aof the cutter roll4. The knives6a,6beach has a cutting edge7a,7bwith a first outline shape S1. In the cutting station2, individual nonwoven material members1a,1b,1care cut out from the continuous web of nonwoven material1by passing the continuous web1between the rotating cutter roll4and the anvil roll5. The resulting nonwoven material member1a,1b,1ceach has a second outline shape S2corresponding to the first outline shape S1of the respective cutting edge7a,7bof the one or more knives6a,6b. The respective cutting edge7a,7bmay each have the same outline shape S1. After cutting of the continuous web of nonwoven material1in the cutting station2, the cut-out nonwoven material members1a,1b,1care separated from the trim waste11and transferred from the cutting station2to a vacuum transfer roll8. The trim waste resulting from the cutting station may for example be pulled away from the cut-out nonwoven material members1a,1b,1cby means of vacuum. To synchronize the cutting station2with the vacuum transfer roll8, the cutter roll4and the anvil roll5rotates at a first rotational speed V1 and the vacuum transfer roll8rotates at a second rotational speed V2, and wherein the first rotational speed V1 and second rotational speed V2 are synchronized such that upon transfer of the one or more cut-out nonwoven material members1a,1b,1cto the vacuum transfer roll8, the one or more vacuum port pattern units10a,10bwill each coincide with one of the one or more cut-out nonwoven material members1a,1b,1c. The vacuum transfer roll8has an outer circumferential surface8aincluding a plurality of vacuum ports9. The vacuum ports9are arranged in one or more vacuum port pattern units10a,10b,10c. The vacuum port pattern units10a,10beach has a third outline shape S3matching with the outer contour of the second outline shape S2of the one or more cut-out nonwoven material members1a,1b. As illustrated inFIG.1, and which may also be seen inFIGS.2and3, a total area of the vacuum ports9of the respective vacuum port pattern units10a,10b,10cin the vacuum transfer roll outer circumferential surface8acorresponds to from 10% to 30% of the area of a respective of the one or more cut-out nonwoven material members1a,1b,1cwhen being transferred to the vacuum transfer roll. In the vacuum transfer roll8illustrated inFIGS.1-3, the number of vacuum ports9is higher in a leading half section12aof each of the third outline shape S3of the respective vacuum port pattern units10a,10b,10cthan in a trailing half section12bof each of the third outline shape S3of the respective vacuum port pattern units10a,10b,10c, as seen in the machine direction MD. The leading half section12ahas a higher number of vacuum ports9and a greater open area than the trailing half section12b, therefore the vacuum pressure applied to the one or more cut-out nonwoven material members1a,1b,1cis higher in the leading half section12aof the cut-out nonwoven material members1a,1b,1cthan to the trailing half section12bthereof. InFIG.2, the vacuum transfer roll8is provided with vacuum port pattern units10a,10b,10ceach having a third outline shape S3matching with second outline shape S2of the one or more cut-out nonwoven material members1a,1b,1c(shown inFIG.1and illustrated with a dotted contour line). In the leading half section12aof the second outline shape S2the number of vacuum ports9are higher than in the trailing half section12b. The ports9are also distributed along the entire contour of the leading half section12aand only along parts of the contour in the trailing half section12b, or at least with a greater distance between adjacent points in the trailing half section12b. InFIG.3, the vacuum transfer roll8is provided with vacuum port pattern units10a,10b,10ceach having a third outline shape S3matching with second outline shape S2in the leading half sections12a. The trailing half sections12bof the respective vacuum port pattern units10a,10b,10care free from vacuum ports9. | 5,203 |
11857400 | DETAILED DESCRIPTION OF THE INVENTION Definitions “Disposable,” in reference to absorbent articles, means that the absorbent articles are generally not intended to be laundered or otherwise restored or reused as absorbent articles (i.e., they are intended to be discarded after a single use and, preferably, to be recycled, composted or otherwise discarded in an environmentally compatible manner). “Absorbent article” refers to devices which absorb and contain body exudates and, more specifically, refers to devices which are placed against or in proximity to the body of the wearer to absorb and contain the various exudates discharged from the body. Exemplary absorbent articles include diapers, training pants, pull-on pant-type diapers (i.e., a diaper having a pre-formed waist opening and leg openings such as illustrated in U.S. Pat. No. 6,120,487), refastenable diapers or pant-type diapers, incontinence briefs and undergarments, diaper holders and liners, feminine hygiene garments such as panty liners, absorbent inserts, and the like. “Proximal” and “Distal” refer respectively to the location of an element relatively near to or far from the longitudinal or lateral centerline of a structure (e.g., the proximal edge of a longitudinally extending element is located nearer to the longitudinal centerline than the distal edge of the same element is located relative to the same longitudinal centerline). “Body-facing” and “garment-facing” refer respectively to the relative location of an element or a surface of an element or group of elements. “Body-facing” implies the element or surface is nearer to the wearer during wear than some other element or surface. “Garment-facing” implies the element or surface is more remote from the wearer during wear than some other element or surface (i.e., element or surface is proximate to the wearer's garments that may be worn over the disposable absorbent article). “Longitudinal” refers to a direction running substantially perpendicular from a waist edge to an opposing waist edge of the article and generally parallel to the maximum linear dimension of the article. Directions within 45 degrees of the longitudinal direction are considered to be “longitudinal.” Longitudinal distances are measured between points disposed along the same longitudinal line. “Lateral” refers to a direction running from a longitudinal edge to an opposing longitudinal edge of the article and generally at a right angle to the longitudinal direction. Directions within 45 degrees of the lateral direction are considered to be “lateral.” Lateral distances are measured between points disposed along the same lateral line. “Disposed” refers to an element being located in a particular place or position. “Joined” refers to configurations whereby an element is directly secured to another element by affixing the element directly to the other element and to configurations whereby an element is indirectly secured to another element by affixing the element to intermediate member(s) which in turn are affixed to the other element. “Film” refers to a sheet-like material wherein the length and width of the material far exceed the thickness of the material. Typically, films have a thickness of about 0.5 mm or less. “Water-permeable” and “water-impermeable” refer to the penetrability of materials in the context of the intended usage of disposable absorbent articles. Specifically, the term “water-permeable” refers to a layer or a layered structure having pores, openings, and/or interconnected void spaces that permit liquid water, urine, or synthetic urine to pass through its thickness in the absence of a forcing pressure. Conversely, the term “water-impermeable” refers to a layer or a layered structure through the thickness of which liquid water, urine, or synthetic urine cannot pass in the absence of a forcing pressure (aside from natural forces such as gravity). A layer or a layered structure that is water-impermeable according to this definition may be permeable to water vapor, i.e., may be “vapor-permeable.” “Elongatable,” “extensible,” or “stretchable” are used interchangeably and refer to a material that, upon application of a biasing force, can stretch to an elongated length of at least about 110% of its relaxed, original length (i.e. can stretch to 10 percent more than its original length), without rupture or breakage, and upon release of the applied force, shows little recovery, less than about 20% of its elongation without complete rupture or breakage as measured by EDANA method 20.2-89. In the event such an elongatable material recovers at least 40% of its elongation upon release of the applied force, the elongatable material will be considered to be “elastic” or “elastomeric.” For example, an elastic material that has an initial length of 100 mm can extend at least to 150 mm, and upon removal of the force retracts to a length of at least 130 mm (i.e., exhibiting a 40% recovery). In the event the material recovers less than 40% of its elongation upon release of the applied force, the elongatable material will be considered to be “substantially non-elastic” or “substantially non-elastomeric”. For example, an elongatable material that has an initial length of 100 mm can extend at least to 150 mm, and upon removal of the force retracts to a length of at least 145 mm (i.e., exhibiting a 10% recovery). Elastomeric materials may include elastomeric films (including but not limited to films derived from rubber and/or other polymeric materials), polyurethane films, elastomeric foams, scrims, elastic nonwovens, synthetic fibers such as LYCRA® and other sheet-like structures. An elastic member comprises elastomeric material. “Pant” refers to disposable absorbent articles having a pre-formed waist and leg openings. A pant may be donned by inserting a wearer's legs into the leg openings and sliding the pant into position about the wearer's lower torso. Pants are also commonly referred to as “closed diapers”, “prefastened diapers”, “pull-on diapers”, “training pants” and “diaper-pants.” “Adjacent” as it refers to elastic members or sets of elastic members herein means that there are no elastic members disposed between said adjacent elastic members or between said adjacent sets of elastic members. Overview The present invention is directed to a disposable absorbent article with features that improve comfort, fit, ease of use and/or appearance. In embodiments, the chassis may comprise a maximum width in the front waist region, such that the front waist region is wider than the remaining portions of the article. In further embodiments, the article comprises an elasticized region having two elastic members proximate to one another and comprising different properties, such as different strain levels, different attachment patterns, and/or different contraction region lengths and/or attachment starting points and/or ending points positioned on different axes. In a further embodiment, the article comprises an array of elastic members in a waist region, wherein the elastic members are selected such that their relative contractive forces and/or relative moments of force compensate for changes in stiffness and/or bendability of surrounding materials in the article. Absorbent Article FIG.1is a plan view of an exemplary, non-limiting embodiment of an absorbent article20of the present invention in a flat, uncontracted state. The body-facing surface115of the absorbent article20is facing the viewer. The absorbent article20includes a longitudinal centerline100and a lateral centerline110. The absorbent article20comprises a chassis22. The absorbent article20and chassis22are shown to have a first waist region36, a second waist region38opposed to the first waist region36, and a crotch region37located between the first waist region36and the second waist region38. The waist regions36and38generally comprise those portions of the absorbent article20which, when worn, encircle the waist of the wearer. The waist regions36and38may include elastic members210wsuch that they gather about the waist of the wearer to provide improved fit and containment. The crotch region37is the portion of the absorbent article20which, when the absorbent article20is worn, is generally positioned between the legs of the wearer. The chassis22may comprise a liquid permeable topsheet24, a backsheet26, and an absorbent core28between the topsheet24and the backsheet26. In embodiments that include one or more opacity strengthening patches80, the chassis22also comprises the opacity strengthening patch(s)80. The absorbent core28may have a body-facing surface and a garment-facing surface. The backsheet26may have a body-facing side26aand a garment-facing side26b. The topsheet24may be joined to the core28and/or the backsheet26. The backsheet26may be joined to the core28and/or the topsheet24. It should be recognized that other structures, elements, or substrates may be positioned between the core28and the topsheet24and/or backsheet26. In some embodiments, an acquisition-distribution system is disposed between the topsheet26and the absorbent core28. In certain embodiments, the chassis22comprises the main structure of the absorbent article20with other features added to form the composite absorbent article structure. While the topsheet24, the backsheet26, and the absorbent core28may be assembled in a variety of well-known configurations, absorbent article configurations are described generally in U.S. Pat. Nos. 3,860,003; 5,151,092; 5,221,274; 5,554,145; 5,569,234; 5,580,411; and 6,004,306. Topsheet The topsheet24is generally a portion of the absorbent article20that may be positioned at least in partial contact or close proximity to a wearer. Suitable topsheets24may be manufactured from a wide range of materials, such as porous foams; reticulated foams; apertured plastic films; or woven or nonwoven webs of natural fibers (e.g., wood or cotton fibers), synthetic fibers (e.g., polyester or polypropylene fibers), or a combination of natural and synthetic fibers. The topsheet24is generally supple, soft feeling, and non-irritating to a wearer's skin. Generally, at least a portion of the topsheet24is liquid pervious, permitting liquid to readily penetrate through the thickness of the topsheet24. One topsheet24useful herein is available from BBA Fiberweb, Brentwood, TN as supplier code 055SLPV09U. The topsheet24may be apertured. Any portion of the topsheet24may be coated with a lotion or skin care composition as is known in the art. Non-limiting examples of suitable lotions include those described in U.S. Pat. Nos. 5,607,760; 5,609,587; 5,635,191; and 5,643,588. The specific examples are not limiting, as any lotion or skin care composition known in the art may be utilized. The topsheet24may be fully or partially elasticized or may be foreshortened so as to provide a void space between the topsheet24and the core28. Exemplary structures including elasticized or foreshortened topsheets are described in more detail in U.S. Pat. Nos. 4,892,536; 4,990,147; 5,037,416; and 5,269,775. Absorbent Core The absorbent core28may comprise a wide variety of liquid-absorbent materials commonly used in disposable diapers and other absorbent articles. Examples of suitable absorbent materials include comminuted wood pulp, which is generally referred to as air felt creped cellulose wadding; melt blown polymers, including co-form; chemically stiffened, modified or cross-linked cellulosic fibers; tissue, including tissue wraps and tissue laminates; absorbent foams; absorbent sponges; superabsorbent polymers; absorbent gelling materials; or any other known absorbent material or combinations of materials. In one embodiment, at least a portion of the absorbent core is substantially cellulose free and contains less than 10% by weight cellulosic fibers, less than 5% cellulosic fibers, less than 1% cellulosic fibers, no more than an immaterial amount of cellulosic fibers or no cellulosic fibers. It should be understood that an immaterial amount of cellulosic material does not materially affect at least one of the thinness, flexibility, and absorbency of the portion of the absorbent core that is substantially cellulose free. Among other benefits, it is believed that when at least a portion of the absorbent core is substantially cellulose free, this portion of the absorbent core is significantly thinner and more flexible than a similar absorbent core that includes more than 10% by weight of cellulosic fibers. The amount of absorbent material, such as absorbent particulate polymer material present in the absorbent core may vary, but in certain embodiments, is present in the absorbent core in an amount greater than about 80% by weight of the absorbent core, or greater than about 85% by weight of the absorbent core, or greater than about 90% by weight of the absorbent core, or greater than about 95% by weight of the core. In some embodiments, the absorbent core may comprise one or more channels, wherein said channels are substantially free of absorbent particulate polymer material. The channels may extend longitudinally or laterally. The absorbent core may further comprise two or more channels. In one nonlimiting example, two channels are symmetrically disposed about the longitudinal axis. Exemplary absorbent structures for use as the absorbent core28are described in U.S. Pat. Nos. 4,610,678; 4,673,402; 4,834,735; 4,888,231; 5,137,537; 5,147,345; 5,342,338; 5,260,345; 5,387,207; 5,397,316; and 5,625,222. Backsheet The backsheet26is generally positioned such that it may be at least a portion of the garment-facing surface120of the absorbent article20. Backsheet26may be designed to prevent the exudates absorbed by and contained within the absorbent article20from soiling articles that may contact the absorbent article20, such as bed sheets and undergarments. In certain embodiments, the backsheet26is substantially water-impermeable. Suitable backsheet26materials include films such as those manufactured by Tredegar Industries Inc. of Terre Haute, IN and sold under the trade names X15306, X10962, and X10964. Other suitable backsheet26materials may include breathable materials that permit vapors to escape from the absorbent article20while still preventing exudates from passing through the backsheet26. Exemplary breathable materials may include materials such as woven webs, nonwoven webs, composite materials such as film-coated nonwoven webs, and microporous films such as manufactured by Mitsui Toatsu Co., of Japan under the designation ESPOIR NO and by EXXON Chemical Co., of Bay City, TX, under the designation EXXAIRE. Suitable breathable composite materials comprising polymer blends are available from Clopay Corporation, Cincinnati, OH under the name HYTREL blend P18-3097. Such breathable composite materials are described in greater detail in PCT Application No. WO 95/16746 and U.S. Pat. No. 5,865,823. Other breathable backsheets including nonwoven webs and apertured formed films are described in U.S. Pat. No. 5,571,096. An exemplary, suitable backsheet is disclosed in U.S. Pat. No. 6,107,537. Other suitable materials and/or manufacturing techniques may be used to provide a suitable backsheet26including, but not limited to, surface treatments, particular film selections and processing, particular filament selections and processing, etc. Backsheet26may also consist of more than one layer. The backsheet26may comprise an outer cover and an inner layer. The outer cover may be made of a soft, non-woven material. The inner layer may be made of a substantially liquid-impermeable film, such as a polymeric film. The outer cover and an inner layer may be joined together by adhesive or any other suitable material or method. A particularly suitable outer cover is available from Corovin GmbH, Peine, Germany as supplier code A18AH0, and a particularly suitable inner layer is available from RKW Gronau GmbH, Gronau, Germany as supplier code PGBR4WPR. While a variety of backsheet configurations are contemplated herein, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. Ears/Fasteners The absorbent article20may include front ears40and/or back ears42. The ears40,42may be extensible, inextensible, elastic, or inelastic. The ears40,42may be formed from nonwoven webs, woven webs, knitted fabrics, polymeric and elastomeric films, apertured films, sponges, foams, scrims, and combinations and laminates thereof. In some embodiments, the ear40,42may include elastomers (e.g., elastic strands, LYCRA® fibers), such that the ear is stretchable. In certain embodiments, the ears40,42may be formed of a stretch laminate such as a nonwoven/elastomeric material laminate or a nonwoven/elastomeric material/nonwoven laminate, which also results in the ear being stretchable. Stretch laminates may be formed by any method known in the art. For example, the ears40,42may be formed as a zero strain stretch laminate, which includes at least a layer of non-woven material and an elastomeric element. The elastomeric element is attached to the layer of non-woven material while in a relaxed or substantially relaxed state, and the resulting laminate is made stretchable (or more stretchable over a further range) by subjecting the laminate to an activation process which elongates the nonwoven layer permanently, but the elastomeric element temporarily. The nonwoven layer may be integral with at least a portion of the chassis22, in which case the elastomeric element may be attached to the nonwoven layer and the non-woven/elastomeric element laminate is subsequently activated. Alternatively, the nonwoven layer may be a separate component, in which case the elastomeric element is attached to the nonwoven layer to form the laminate, which is then coupled to the main portion. If one or more layers of the ear40,42are provided separately, the laminate may be activated either before or after attachment to the main portion. Zero strain activation processes are further disclosed in U.S. Pat. Nos. 5,167,897 and 5,156,793. A suitable elastic ear may be an activated laminate comprising an elastomeric film (such as is available from Tredegar Corp, Richmond, VA, as supplier code X25007) disposed between two nonwoven layers (such as is available from BBA Fiberweb, Brentwood, TN as supplier code FPN332). An ear40,42may be highly extensible wherein the ear40,42is capable of extending up to 150%. It is believed that highly extensible ears40,42allow an absorbent article20to expand to comfortably fit a range of wearers who vary in shape and/or weight. Suitable highly extensible ears40,42are described in U.S. Pat. Nos. 4,116,892, 4,834,741, 5,143,679; 5,156,793; 5,167,897; and 5,422,172; and 5,518,801; PCT App. No. WO 2005/110731; and U.S. App. Nos. US 2004/0181200 and US 2004/0193133. In an embodiment, the ears40,42may be discrete. A discrete ear is formed as separate element which is joined to the chassis22. The absorbent article20may also include a fastening system44. When fastened, the fastening system44interconnects the first waist region36and the rear waist region38resulting in a waist circumference that may encircle the wearer during wear of the absorbent article20. The fastening system44may comprise a fastener46such as tape tabs, hook and loop fastening components, interlocking fasteners such as tabs & slots, buckles, buttons, snaps, and/or hermaphroditic fastening components, although any other known fastening means are generally acceptable. Some exemplary surface fastening systems are disclosed in U.S. Pat. Nos. 3,848,594; 4,662,875; 4,846,815; 4,894,060; 4,946,527; 5,151,092; and 5,221,274. An exemplary interlocking fastening system is disclosed in U.S. Pat. No. 6,432,098. The fastening system44may also provide a means for holding the article in a disposal configuration as disclosed in U.S. Pat. No. 4,963,140. The fastening system44may also include primary and secondary fastening systems, as disclosed in U.S. Pat. No. 4,699,622. The fastening system44may be constructed to reduce shifting of overlapped portions or to improve fit as disclosed in U.S. Pat. Nos. 5,242,436; 5,499,978; 5,507,736; and 5,591,152. In some embodiments, the fastening system44and/or the fastener46is foldable. The fastening system44may be joined to any suitable portion of the article20by any suitable means. In some embodiments, the fastening system is joined to the ear40,42. In one nonlimiting example, the fastening system44and/or the fastener46is mechanically bonded to the ear40,42through one or more mechanical bonds. In one nonlimiting example, the ear40,42comprises a first fastener bond400disposed inboard and a second fastener bond402disposed outboard as shown inFIG.1. The first and/or second fastener bond400,402may be mechanical. The article20may comprise a landing zone47disposed in the first waist region36(as shown inFIG.1A). The fastener46may attach to the first waist region36in the landing zone47, or the fastening system44may be otherwise capable of joining the waist regions by connecting at the landing zone47. In one nonlimiting example, the landing zone47is partially disposed on the longitudinal centerline100. In another nonlimiting example, the landing zone47is disposed about 2 mm or less from the longitudinal centerline100, or about 1 mm or less from the longitudinal centerline100. The landing zone may comprise fastening components (e.g., mechanical closure elements comprising hook and loop fastening materials, adhesive, or other known means). Chassis Design The outer periphery30of the chassis22is defined by longitudinal edges12and waist edges (first waist edge13in first waist region36and second waist edge14in second waist region38). The longitudinal edges12may be subdivided into a front longitudinal edge12a, which is the portion of the longitudinal edge12in the first waist region36, and a rear longitudinal edge12b, which is the portion of the longitudinal edge12in the rear waist region38. The chassis22may have opposing longitudinal edges12that are oriented generally parallel to the longitudinal centerline100. However, for better fit, longitudinal edges12may be curved or angled to produce, for example, an “hourglass” shape article21when viewed in a plan view as shown inFIGS.1-3A, for example. The chassis22may have opposing lateral edges13,14(i.e., the first waist edge13and second waist edge14) that are oriented generally parallel to the lateral centerline110. In an embodiment depicted inFIG.2, the chassis periphery30comprises a varying width, Wv. (FIG.2is a schematic view of the chassis with the garment-facing side120facing the viewer.) The varying width, Wv, may comprise multiple zones having different widths between the longitudinal edges12. In one nonlimiting example, the chassis periphery comprises a first maximum width zone32disposed in the first waist region36. The first maximum width zone32is a section in the first waist region36having a first maximum width, W1, extending between the longitudinal edges12in the first waist region36. The first maximum width, W1, is the largest width dimension in the chassis periphery30. The first maximum width, W1, may be from about 150 mm to about 400 mm, or from 200 mm to about 380 mm, or from about 250 mm to about 360 mm, reciting for each range every 10 mm interval therebetween. In a further nonlimiting example, the chassis periphery30comprises a minimum width, Wmin, disposed in the crotch region37. The minimum width, Wmin, is the smallest width dimension in the chassis periphery30. The minimum width, Wmin, may be from about 90 mm to about 180 mm, from about 100 mm to about 175 mm, or from about 140 mm to about 170 mm, reciting for each range every 10 mm interval therebetween. The chassis periphery30may further comprise a first maximum width to minimum width ratio, W1:Wmin, of from about 1.4 to about 2.7, or from about 1.6 to about 2.4, or from about 1.8 to about 2.2, reciting for each range every 0.1 interval therebetween. In another nonlimiting example, the chassis periphery30comprises a second maximum width, W2, disposed in the second waist region38. The second maximum width, W2, is the maximum width between the longitudinal edges12in the second waist region38. The second maximum width, W2, may be less than the first maximum width, W1. The chassis periphery30may further comprise a first maximum width to second maximum width ratio, W1:W2of from about 1.1 to about 1.7, reciting for said range every 0.1 interval therebetween. To date, manufacturers have made taped diaper chassis with symmetric front and back waist regions or with back waist regions that have a greater maximum width than the maximum width of the front region. However, various benefits may be achieved by providing a wider first waist region36, such as (i) the wide front may cover more skin around the front and side waist regions, signaling comfort and proper fit; (ii) rough fastening elements may be prevented from directly contacting the skin, thereby reducing skin irritation and abrasion; and/or (iii) the front waist region may be easier to find and grasp, reducing the time and effort required to apply an absorbent article. Further, sufficient overlap of the front waist region36and back waist region38around the wearer's waist can improve fit, reducing sagging and gapping about the waist and legs. In addition, sufficient overlap of these regions36,38may increase the garment-like appearance of the article20during use. In an embodiment, the width of a waist edge, WE, is less than the first maximum width, W1. In one nonlimiting example, both waist edges,13,14comprise the same waist width, WE. The backsheet26may comprise a material periphery34defined by the outermost longitudinal and lateral edges of one or more layers of the backsheet26. In an embodiment, the backsheet material periphery34may be coterminous with the chassis periphery30as illustrated inFIGS.2and3A. In one nonlimiting example, the backsheet26comprises the first maximum width, W1, in the front waist region36, the minimum width, Wmin, in the crotch region37and the second maximum width, W2, in the second waist region38. The second maximum width, W2, can be less than the first maximum width, W1. It is desirable for the backsheet material periphery34to define the chassis periphery30to prevent the appearance of loose material edges or seams and thereby create a higher quality impression. In such embodiment, the chassis22may be shaped by providing the backsheet26at a continuous first maximum width, W1, and subsequently trimming the backsheet26to define narrower widths outside of the first maximum width zone32. The backsheet26may be joined to the absorbent core28and/or topsheet24before, during or after the trimming process. The formation of the material periphery34or chassis periphery30may be achieved by any known means, including but not limited to die cutting, stamping, shear cutting, or the like. In a further embodiment, the chassis periphery30continually slopes outside of the first maximum width zone32. By “continually slopes”, it is meant that the longitudinal edges are shaped such that the lateral distance between the longitudinal edge12and the longitudinal centerline100continually changes except within the first maximum width zone32. That is, any two adjacent points P1, P2along a longitudinal edge12outside of the first maximum width zone32are disposed at different lateral distances, DP1and DP2, from the longitudinal centerline100. In one nonlimiting example, the angle α between (i) any straight span,12SP, on the longitudinal edge12outside of the maximum width zone32and (ii) the longitudinal centerline100is at least about 2 degrees. Where the chassis22is formed from a starting material having a continuous width equal to the first maximum width, W1, the continual slope outside of the first maximum width zone32permits the chassis22to be formed without die cut spans that are parallel to the centerline100; such parallel spans are known to impact the die-tool life negatively by causing repetitive wear in the same areas resulting in shorter die life, increased maintenance costs, decreased line efficiency and/or increased manufacturing costs. In a further embodiment, the article20may comprise two leg gasketing systems70disposed on opposite longitudinal sides (seeFIG.1). In such nonlimiting example, the article20may comprise a maximum cuff width, Wcuff, such dimension being the maximum lateral distance between the outer cuff edges77. In an embodiment, the maximum cuff width, Wcuff, may be greater than the minimum chassis periphery width, Wmin, by at least about 10 mm or at least about 15 mm. Leg gasketing systems70are discussed in more detail below. In another embodiment shown inFIG.3A, the backsheet26may comprise a polymeric film layer261having a maximum lateral width, Wpoly, which is the maximum lateral dimension of the polymeric film layer. (FIG.3schematically depicts the body-facing side26aof the backsheet26.) In one nonlimiting example, the polymeric film maximum lateral width, Wpoly, is less than the minimum chassis width, Wmin, as illustrated inFIG.3A. The polymeric film maximum lateral width, Wpoly, may be less than the minimum chassis periphery width, Wmin, by at least about 5 mm or at least about 8 mm, or at least about 10 mm; and/or the polymeric film maximum lateral width, Wpoly, may be less than the minimum chassis periphery width, Wmin, by at least about 2.5 mm on each longitudinal side262of the polymeric layer261, or at least about 5 mm on each longitudinal side262. The polymeric film layer261may be positioned such that both of the layer's longitudinal edges262are disposed inboard of the backsheet material periphery34and/or inboard of the chassis longitudinal edges12. In one nonlimiting example, the material periphery34is coterminous with the chassis periphery30as discussed above. In another nonlimiting example, the polymeric film maximum width, Wpoly, is greater than the minimum chassis width, Wmin. The polymeric film maximum width, Wpoly, may greater than the minimum chassis periphery width, Wmin, by at least about 10 mm, or at least about 15 mm, or at least about 20 mm, or at least about 5 mm on each longitudinal side12of the chassis at the minimum width, Wmin, or at least about 10 mm on each longitudinal side12of the chassis at the minimum width, Wmin. The polymeric film maximum width, Wpoly, may be less than the first maximum width, W1, or less than the second maximum width, W2. An ear42, having any of the features described above, may be included in the second waist region38as shown inFIG.3A. The back ear42may be stretchable42a, such as an ear42formed from a zero strain stretch laminate or other elastomeric material. Further, the stretchable back ear42amay be highly extensible. In embodiments with stretchable ears42a, it may be preferable to join a discrete back ear42due to the cost of materials utilized for stretchable ears42aversus the cost of materials used to form the backsheet26and remaining chassis22components. Where the chassis22is shaped by trimming the backsheet26, the back ear42may be joined to the chassis22before, after or during the trimming process. The discrete ear42may be joined to any suitable layer of the chassis22, and to any side of the chosen layer, at an ear attachment site41. The ear42may be joined by any means known in the art. In a nonlimiting example, the discrete ear42is joined to the body-facing side26aof the backsheet26as shown inFIGS.3B and3D. In another nonlimiting example, the discrete ear42is joined to the garment-facing side26bof the backsheet26as shown inFIGS.3A,3C and3E. In another nonlimiting example, the ear42is joined to the body-facing side of the opacity strengthening patch80as shown inFIG.8. Alternatively, the ear42may also be attached to the leg gasketing system70. Returning toFIG.3A, a fastening system44comprising a fastener46, as described above, may be disposed on the ear42. The fastener46may comprise an inboard fastener edge48which is disposed on the body-facing side43of the ear42and is the longitudinal edge of the fastener46closest to the longitudinal centerline100. The fastener46may be foldable such that is partially disposed on the body-facing side43of the ear and partially disposed on the garment-facing side45of the ear (see, e.g.,FIGS.3B-3E). As depicted inFIGS.3D and3E, the inboard fastener edge48may be disposed such that the minimum lateral distance, DLE-FE, between on the longitudinal edge12band the fastener edge48(measured between any two parallel points on those edges, said points being disposed along on an imaginary lateral line) is about 0 mm or greater, or from about 0 mm to about 40 mm, or from about 1 mm to about 30 mm, or from about 2 mm to about 20 mm, or about 6 mm, or about 4 mm, reciting for each range every 1 mm interval therebetween. The minimum lateral distance, DLE-FE, is measured from the longitudinal edge12boutboard, such that the ranges provided herein result in the chassis periphery30being coterminous with or inboard of the inboard fastener edge at the minimum lateral distance, DLE-FE. In this way, the fastener edge becomes easier to access when the ear42is attached to the garment-facing side26bof the backsheet26, or the garment-side120of the chassis22. The fastener edge48may be substantially straight, curvilinear, or combinations thereof. When the first maximum width, W1, is greater than the second maximum, W2, accessibility of the fastener edge48can be further enhanced. Where the second maximum width, W2, is greater than or equal to the first maximum width W1(as it is in known articles), issues can arise. For example, if W2were greater or equal to W1and the ear were joined to the garment-facing side120,26bof a layer of the chassis22, the fastener edge48may be covered between the ear42and the chassis22and thus difficult to find during application, as shown inFIG.3C. If, in this width scenario (W2≥W1), the ear42were alternatively joined to the body-facing side of a chassis layer (e.g., the body-facing side of the backsheet26a), then an excess, loose portion of chassis22material may remain outboard of the attachment site41of the ear42as shown inFIG.3B. The excess portion may look unsightly to an end-user. Further, including stretchable ears42ain the second region38in such scenario could result in (i) the article's waist area being too large for a given weight range of users and/or (ii) the ears being otherwise inadequate for their desired purpose. When the second maximum width, W2, is less than the first maximum width, W1, these issues are avoided as shown inFIGS.3D and3E. The fastener edge48is visible and easier to engage and little to no excess material remains outboard the attachment site41, without having to increase ear and/or bond site dimensions (either one of which could lead to extra costs and production inefficiencies). Moreover, stretchable ears may be more optimally utilized. Elasticized Regions The article20may comprise one or more elasticized regions200as shown for example inFIGS.4A through5B. Elasticized regions200may be disposed in leg cuffs71, waist regions36,38, waist gasketing elements81disposed in waist regions, ears40,42, and/or other portions of the article20as is known in the art. For purposes of this section, the location in which the elasticized region is found will be referred to as the component500. The component500comprises an outermost edge502(e.g., cuff edge, waist edge, waist gasketing element edge, ear edge), which may be a folded edge503. The elasticized region200may comprise an array240of elastic members210, which may comprise different properties including but not limited to different strain levels and/or different attachment profiles. The array240may be longitudinal or lateral depending on the structure of the component500and contraction requirements. In some embodiments, elastic members210in the array240run generally parallel to the component outermost edge502. The elastic members210may be elastomeric fibers, such as LYCRA® fibers available from IN VISTA of Wichita, KS in various decitex levels. The skilled person may select the appropriate decitex based on the desired contraction and other principles discussed herein. Other suitable elastics can be made from natural rubber, such as elastic tape sold under the trademark Fulflex 9411 by Fulflex Company of Middletown, R.I. The elastic members210may also comprise any heat shrinkable elastic material as is well known in the art. In addition, elastic members210may take a multitude of configurations. For example, the width may be varied; a single strand or several parallel or non-parallel strands of elastic material may be used; or a variety of shapes may be used including rectilinear and curvilinear; or a variety of cross sectional shapes can be used (circular, rectangular, square, etc.). In one embodiment, adjacent elastic members210a,210bare spaced at least 3.5 mm apart from one edge of the member to the other edge of the member, optionally at least 4 mm apart; optionally at least 4.5 mm apart; optionally at least 5 mm apart; optionally at least 5.5 mm apart; optionally at least 6 mm apart; optionally at least 6.5 mm apart; optionally at least 7 mm apart; optionally at least 7.5 mm apart; optionally at least 8 mm apart; optionally at least 8.5 mm apart; optionally at least 9 mm apart; optionally at least 9.5 mm apart; optionally at least 10 mm apart; optionally at least 10.5 mm apart; optionally at least 11 mm apart; optionally at least 11.5 mm apart; optionally at least 12 mm apart. The spacing is measured in the direction perpendicular to the direction of extension (i.e., if the elastic members are longitudinally extending, the spacing is a lateral measurement). Elastic members210may be sandwiched (i) between discrete layers of the component500, (ii) between the component500and the backsheet26or other portion of the article20, and/or (iii) between a continuous piece of material folded about itself to form layers of the component500. Alternatively, elastic members210may be joined to an outer side of the component500such that the elastic members are not sandwiched between layers. The elastic members210may be joined to the component500or one or more of said layers by glue bond, heat bond, pressure bond, mechanical bonds, ultrasonic or any other bonding method known in the art. In an embodiment, one or more of the elastic members210are joined to the component by strand coating. The array240may comprise a first elastic member214and a second elastic member216. The first elastic member214may be disposed between (i) the component's outermost edge502and (ii) the second elastic member216, as shown for example inFIG.4A. The first and second elastic members214,216may run generally parallel to the component edge502. In an embodiment, the first elastic member214comprises a first elastic strain, ε1, and the second elastic member216comprises a second elastic strain, ε2. Strain may be determined by the Strain Test Method herein. The second elastic strain, ε2, is different from the first elastic strain, ε1. In one nonlimiting example, the first and second elastic strains, ε1, ε2, differ by at least about 50%, or from about 75% to about 200%, or about 100% to about 150%, reciting for each range every 10% increment therein, when said elastic members are joined to the component500and/or chassis22. In another nonlimiting example, the second elastic strain, ε2, is greater than the first elastic strain, ε1. In a further nonlimiting example, at time installing the elastics, the second elastic strain, ε2, is greater than the first elastic strain, ε1, by at least about 50%, or from about 75% to about 200%, or about 100% to about 150%, reciting for each range every 10% increment therein. One of skill in the art will recognize that the magnitude of strain differences in comparative elastic members210during manufacturing may be different than the magnitude of the strain differences of those same comparative elastic members210in the final product; however, the relationship between the elastic members' strain (i.e., one is greater than the other) may remain apparent in the final article20. The article20may comprise additional elastic members210which may comprise strain levels that are different from the first strain, ε1, and/or different from the second strain, ε2. In a further embodiment shown inFIG.4B, the article20may comprise a first set of elastic members214S and a second set of elastic members216S, where the first set214S is disposed between (i) the outermost edge502and (ii) the second set216S. The first set214S comprises a first aggregate strain (i.e., the sum of the strain levels of the elastic members in the set; each strain level being determined by the Strain Test Method herein), Σε1, and the second set216S comprises a second aggregate strain, Σε2. The second aggregate strain, Σε2, is different than the first aggregate strain, Σε1. The second aggregate strain, Σε2, may be greater than the first aggregate strain, Σε1. It is believed that, in use, the higher strained elastic members (e.g.,216,216S) seek to wrap about the smallest possible circumference which represents the path length most closely matching their initial pre-stretched length and the lowest possible energy state the elastic member210can achieve. By increasing the strain of an elastic member216(or set of elastic members) that is further from the edge502, said elastic member216seeks to fit the wearer at a smaller circumference than the elastic member closer to the edge502. The increased strain on the inside elastic member216causes the outermost edge502to curve away wearer as shown in an exemplary leg gasketing system schematically depicted inFIG.4C. The curvature allows a side portion506of the component500to contact the wearer's skin. In known constructions, the outermost edge502contacts the wearer's skin. The present invention allows for increased contact area between the article20and the skin in the elasticized region200, which reduces localized, effective pressure on the skin and skin redness, pressure marks and/or irritation caused by such localized, effective pressure. Moreover, the differential strain causes fewer larger gathers at a larger wavelength towards the edge502where there is less contractive force and more consolidation of gathers away from the edge (towards the inside portion of the elasticized component) where there is more contractive force. Gathers are a result of the contraction of elastic members210, where an elastic member210is contracted from a stretched length to a relaxed length that is shorter than the stretched length. This contraction creates a contraction force (F) that is exerted on the component500. The contraction force F causes the component500to have a reaction force (FR) that results in the creation of gathers that contain the physical characteristics of waves—oscillations that have a wavelength, amplitude, and frequency within a given phase. Wave Function:y(t)=Asin(wt+Δ),where A=amplitude, w=frequency, A=phase or length (l). The fewer, larger outer gathers at larger wavelengths reduces the number of ridges at the component's outermost edge502; such ridges are known to irritate a wearer's skin. Returning toFIGS.4A and4B, in some embodiments, the array240may comprise adjacent elastic members210each joined in a different manner to the component500in an attachment zone218. The attachment zone218is an area of the component500where the elastic members210in the array240are joined to the component500and/or to the chassis22. In the attachment zone, the first elastic member214can be joined to the component500and/or chassis22at two attachment intervals219. The two attachment intervals219are separated by an unattached span222. The second elastic member216may be adjacent to the first elastic member214, and the second elastic member216can be continuously joined to the component500and/or chassis22in the attachment zone218. Said differently, the elastic member214closest to the edge502is joined to the component500and/or chassis22at two intervals separated by an unattached span and an adjacent elastic member216(disposed further away from the edge502) is continuously joined to the component and/or chassis22. Alternatively, the first elastic member214can be joined to the component and/or to the chassis22continuously in the attachment zone218and the second elastic member216may be joined to the component500and/or chassis22at two intervals separated by an unattached span. Further to the above, an unattached span222may comprise a length of from about 10 mm to about 60 mm, or at least about 20 mm, or at least about 30 mm or at least about 50 mm. In one nonlimiting example, glue212is applied in the first attachment interval221and in the second attachment interval223, where said intervals are separated by an unglued span222. The first attachment interval221may comprise the same shape, length, width, bonding material, bond strength, volume and/or density of bonding material (e.g., glue), and combinations thereof as the second attachment interval223. Alternatively, the first and second intervals may differ in one or more of the above-mentioned characteristics. In a further nonlimiting example, at least one attachment interval219comprises a length of at least about 15 mm, or about 20 mm to about 100 mm, or about 30 mm, or about 40 mm, or about 60 mm, or about 80 mm, reciting for each range every 5 mm increment therein. In another nonlimiting example, at least one attachment interval219comprises glue add-on rate of from about 0.0175 g/m to about 0.0525 g/m, or from about 0.020 g/m to about 0.050 g/m, or from about 0.025 g/m to about 0.045 g/m, or from about 0.030 g/m to about 0.040 g/m, or about 0.035 g/m, reciting for each range every 0.005 g/m interval therebetween. The length of the attachment interval219may change based on the add-on rate and vice versa. The mentioned length and add-on rates have been shown to increase the likelihood of a partially glued elastic member210maintaining its initial bond strength and/or bond dimensions over time. In one nonlimiting example, the attachment interval219comprises about a length of about 30 mm and an add-on rate of about 0.035 g/m. Length in this paragraph is measured in the direction that elastic member210extends (e.g., longitudinal or lateral). By differently joining adjacent elastic members in this way, it is believed that the potential for friction and/or pressure between the wearer's skin and the article20is reduced. The absence of bonds, such as glue bonds, along the span of the first elastic member214reduces the amount of contractive force on the component edge502and/or the edge of the article20closest and substantially parallel to the elastic member214. Further, the lack of bonding reduces stiffness and sharpness of said edges. Moreover, when said component edge502or the closest, parallel article edge is folded, the lack of bonding may cause a rounded, balloon-like effect wherein the elastic member210or portions of the elastic member210may be free to move within the folded edge503. As noted, the elastic members210may be joined to the chassis22and/or component500by any suitable means. In one embodiment, the elastic members210are joined to the component500and/or chassis22with one or more adhesive bonds212. The adhesive bonds212may be applied using strand coating techniques, such as applying glue directly to the elastic members210with one or more glue applicators, such as slot glue applicator. In one nonlimiting example, a glue applicator with independently controlled zones is utilized. The two zones may be programmed to start and stop at different time intervals, such that discrete glue intervals are applied to the first elastic member214in the attachment zone218and glue is continuously applied to the second elastic member216in the attachment zone218. Alternatively, discrete glue intervals can be applied to the second elastic member216in the attachment zone218and glue can be continuously applied to the first elastic member214in the attachment zone218. In another embodiment shown inFIG.4D, an additional adhesive253may be applied. The additional adhesive253may disposed in the unattached span222. If the adhesive253is applied in the unattached span222, portions of the elastic member210will be attached to surrounding material in that span222and portions will remain unattached. In one nonlimiting example, the additional adhesive253is applied through patterned slot coating techniques as taught in U.S. Pat. Pub. Nos. 2014/0148323, 2014/0148773, 2014/0148774 and 2014/0144579. In such embodiment, the first elastic member214may comprise an attachment pattern220and may be joined to the surrounding material by more than two attachment intervals219.FIGS.4D and4Eprovide exemplary patterns220but numerous patterns are contemplated. By attachment pattern, it is meant a predetermined design comprising one or more shapes and/or lines; in a given pattern, at least one shape or line may repeat. Turning toFIGS.5A and5B, in an embodiment, an elastic member210is joined to the component500and/or chassis22at both a contraction starting point224and a contraction ending point226. A contraction region225extends between the starting point224and ending point226. Further, the elastic member210may be unattached and cut to release tension in the snap back areas213, which are disposed outside of the contraction region225. In the snap back areas213, the elastic member210is free to snap back to its original unstretched length without contracting the surrounding material. Each starting point224may be disposed along a start axis, and each ending point226may be disposed along an end axis. Axis, with respect contraction starting and ending points, means an imaginary line intersecting the respective starting point or ending point and running perpendicular to the direction of extension of the elastic members210. Each elastic member210in the array240may have a contraction region225extending between a contraction starting point and a contraction ending point. All of the contraction regions225for the elastic members210in the array240are disposed within the attachment zone218. Snap-back regions213may be disposed outside of the attachment zone218. In known absorbent articles, the attachment starting points of multiple elastics are typically linear, meaning that the corresponding mechanical or glue bonds for each elastic member is applied along the same axis (an axis that is perpendicular to the direction of the extension of the elastic members). Likewise, the ending points are disposed along one axis. This has largely been due to limitations of equipment technology that apply bonds at high speeds. If those starting points are located inboard of the chassis periphery, wrinkles to the chassis may be formed especially when the starting points are near other bonds (e.g., cuff tackdown bonds). The wrinkles create the impression of low quality and can contribute to the pulling down of the chassis during use. Other issues are created when the starting or ending points are disposed outboard of the chassis periphery. For instance, in leg cuffs, if starting points or ending points are located outboard of the chassis periphery, an uncontracted triangle shaped zone may be formed in the leg cuff system (between a contoured chassis periphery and the imaginary lateral line created by the attachment starting points). That uncontracted triangle shaped zone creates a gap between the wearer and the leg cuff system, precluding proper fit and creating an impression of inadequate leakage protection. By independently selecting the starting or ending points of elastic members210in the array240, one or more of these issues may be avoided. In one embodiment shown inFIG.5A, a first elastic member214has first contraction starting point224F disposed on a first start axis228that runs substantially perpendicular to the direction of extension of the elastic members210in the array240. In such embodiment, a second elastic member216has a second contraction starting point224S disposed on a second start axis229, where the second start axis229also runs substantially perpendicular to the direction of extension of the elastic members210in the array. The first and second starting axes228,229may be different (i.e., not overlapping). By way of nonlimiting example, two longitudinally extending elastic members may have contraction starting points disposed on two different lateral axes. In a further embodiment, the first elastic member214has a first contraction ending point226F disposed on a first end axis230, and the second elastic member216has a second contraction ending point226S disposed on a second end axis231. The first and second end axes230,231each run substantially perpendicular to the direction of extension of the elastic members210and may be different (i.e., not overlapping). In some embodiments, the first elastic member may comprise a first contraction region225F and the second elastic member may comprise a second contraction region225S. The second contraction region225S may be different than the first contraction region225F. In one nonlimiting example, the contraction regions225F,225S differ in length (as shown inFIG.5Aand measured in the direction parallel to the direction of extension of the elastic members). Additional nonlimiting examples of differences in the contraction regions225F,225S include the amount of contraction, bonding material, bond strength and bond dimensions. In a further embodiment shown inFIG.5B, the array240comprises a first set of elastic members214S and a second set of elastic members216S. The first set214S comprises a first set of contraction starting points224F disposed on a first start axis228that runs substantially perpendicular to the direction of extension of the elastic members210in the array240. The second set216S comprises a second set of contraction starting points224S disposed on a second start axis229that also runs substantially perpendicular to the direction of extension of the elastic members210in the array240. The start axes228,229may be different. In a further embodiment, the sets214S,216S each comprise a set of contraction ending points226F,226S disposed on different axes230,231as shown inFIG.5B. In a further embodiment, the first set of elastic members214S may comprise one or more elastic members214having a first contraction region225F. The second set216S may comprise and one or more elastic members216having a second contraction region225S. The second contraction region225S may be different than the first contraction region225F. In one nonlimiting example, the contraction regions225F,225S differ in length (as shown inFIG.5Band measured in the direction parallel to the direction of extension of the elastic members). Additional nonlimiting examples of differences in the contraction regions225F,225S include the amount of contraction, bonding material, bond strength and bond dimensions. Varying the starting points, ending points and/or contraction regions of elastic members210in the array240can prevent defects like wrinkles, prevent fit problems such as gaps created in snap back areas213, and enhance fit by deliberating assigning contraction properties to the article at specific locations which may correspond to the article's contours. In one embodiment, at least one the starting points224F,224S and/or at least one of the ending points226F,226S are disposed on the chassis periphery30as shown inFIG.5Cin the context of an exemplary leg gasketing system70. In a further embodiment also shown inFIG.5C, at least one of the starting points224F,224S and/or at least one of the ending points226F,226S are disposed a distance, DCE, from 0 mm to 6 mm of the chassis periphery30as measured in the direction of extension of the elastic members from the respective elastic starting point or ending point to the nearest point on the chassis periphery in said direction of extension. In another embodiment shown inFIG.5D, the chassis periphery30comprises a first initial intersection point XF. The first initial intersection point XF is a point on the chassis periphery30where an imaginary line F intersects the chassis periphery, the line F being superimposed over the first elastic member214and extending in the direction that the first elastic member214extends as shown inFIG.5D. For ease of understanding, the component inFIG.5Dis shown to be coterminous with the chassis periphery along its outermost edge502and the sides that are adjacent to said edge. The chassis periphery30may further comprise a second initial intersection point XS. The second initial intersection point XS is a point on the chassis periphery30where an imaginary line S intersects the chassis periphery, the line S being superimposed over the second elastic member216and extending in the direction that the second elastic member216extends. In one nonlimiting example, the first starting point224F is disposed at an angle β with respect to the second starting point224S. The first initial intersection point XF can be disposed at substantially the same angle β with respect to the second initial intersection point XS. In an alternative nonlimiting example, the first initial intersection point XF is disposed at angle β±5 degrees with respect to the second initial intersection point XS. In another embodiment, the chassis periphery30comprises a first terminating intersection point YF defined by an imaginary line F intersecting the chassis periphery30and being superimposed on the first elastic member214and extending in the direction of extension of the first elastic member214. The chassis periphery30may further comprise a second terminating intersection point YS defined by an imaginary line S intersecting the chassis periphery30and being superimposed on the second elastic member216and extending in the direction of extension of the second elastic member216. In one nonlimiting example, the first end point226F is disposed at an angle γ with respect to the second ending point226S. In such example, the first terminating intersection point YF may be disposed at the same angle γ with respect to the second terminating intersection point YS. Alternatively, the first terminating intersection point YF may be disposed at an angle γ±5 degrees with respect to the second terminating intersection point YS. Returning toFIG.5A, in some embodiments, a first elastic member214is disposed a minimum distance D1-Efrom the component outermost edge502as measured perpendicularly to the direction of extension of the elastic members (i.e., if the elastic is longitudinally extending, the minimum distance of 3 mm is measured laterally). In one nonlimiting example, the minimum distance D1-Eis greater than about 3 mm. Known disposable absorbent articles attach elastic members within 2 mm or less of the component edge502, which enhances contact with the wearer but increases localized pressure on the skin and ridges near the edge502due to small, high frequency gathers at or near the edge502. Further, in embodiments where the edge is folded503and in embodiments where elastic members210are sandwiched between two layers each having edges that are coterminous with the component outermost edge502, a partially attached elastic member214nearest the edge502will tend to move into the edge502during wear, which can also increase localized pressure. This migration occurs because the elastic member214seeks the smallest circumference to wrap around in order to achieve its lowest energy state—the smallest circumference being the edge502in this case. A minimum distance D1-Eof at least about 3 mm between the attached portion of said elastic member214and the edge502causes the elastic member214to be sufficiently trapped away from the outermost edge502, reducing pressure and friction on the skin and allowing gathers to be felt by the wearer. To the extent that the elasticized region is located in waist region36or38, the elastic members210may be disposed such that the absorbent article20may lay substantially flat during application. Positioning and other components of this aspect of the invention are discussed below in the Waist Gasketing Element section. In embodiments involving sets of elastic members, a set may comprise differentially strained elastic members210and/or adjacent elastics210a,210bdifferently joined to the surrounding material as taught herein (see, for example,FIG.5B). With respect to all embodiments, the first elastic member214or first set of elastic members214S may be disposed between (i) the component edge502and (ii) the second elastic member216or second set of elastic members216S respectively. Leg Gasketing System The absorbent article20may comprise a leg gasketing system70attached to the chassis22, which may comprise an elasticized region200discussed more fully below. The leg gasketing system70comprises one or more cuffs71. The leg gasketing system70may be constructed as, and comprise one or more features, disclosed in commonly assigned U.S. App. No. 62/134,622. In an embodiment, the leg gasketing system70comprises an inner cuff72having an inner cuff edge73. The inner cuff edge73may comprise an inner cuff material edge74. Alternatively, the inner cuff material edge74may be folded such that the cuff edge73comprises a folded inner cuff edge75. The leg gasketing system70may further comprise an outer cuff76that comprises an outer cuff edge77. The outer cuff edge77may comprise the outer cuff material edge78. Alternatively, the outer cuff material edge78may be folded such that the outer cuff edge77comprises a folded outer cuff edge79. FIGS.6and7depict schematic cross sectional views of the exemplary leg gasketing systems ofFIG.1in a flat, uncontracted state, the views taken through the lateral centerline110(FIG.6is a schematic cross section of the left leg gasketing system, andFIG.7is a schematic cross section of both leg gasketing systems in relation to the topsheet). In one embodiment, each leg gasketing system70comprises a single, continuous web of material. In other embodiments, the leg gasketing system70may be formed from more than one web of material (e.g., multiple webs of material that are joined together to become one web of material, or multiple distinct webs of material that are separate from the disposable absorbent article chassis and form part of the leg gasketing system). Herein, locations (e.g., folded edge, material edge, etc.) on the leg gasketing system70are detailed in reference to “a web of material” or “a portion of the web of material.” The recitations of “a web of material” or “the web of material” refer to leg gasketing system embodiments that may be formed from a single, continuous web of material, multiple webs of material that are joined together to become one web of material, or multiple distinct webs of material that are separate from the disposable absorbent article chassis and form part of the leg gasketing system. All such embodiments are contemplated. In some embodiments, the web of material is folded laterally inward (toward the longitudinal centerline100of the absorbent article20) to form the outer cuff folded edge79and folded laterally outward (away from the longitudinal centerline100of the absorbent article20) to form the inner cuff folded edge75. The cuffs71may be attached to the chassis22and/or each other72,76by any suitable means. In an embodiment, the outer cuff76is attached to the chassis22through one or more cuff attachment bonds52as illustrated inFIG.7. Further, a cuff attachment bond52may attach at least portion of web material in the outer cuff76to the opacity strengthening patch80in at least a portion of the first waist region36and at least a portion of the second waist region38as shown inFIG.8. The opacity strengthening patch80may be attached to the inner layer of the backsheet26by at least one OSP bond53. In an embodiment, the inner cuff edge73comprises a folded edge75and the outer cuff edge77comprises a folded outer cuff edge79. In such embodiment, at least a portion of the web material between the inner cuff folded edge75and the outer cuff folded edge79can be attached to at least a portion of the web of material between the outer cuff folded edge79and the outer cuff material edge78in at least the crotch region37and the first waist region36. The attachment of the web of material between the inner cuff folded edge75and the outer cuff folded edge79to the web of material between the outer cuff folded edge79and the outer cuff material edge78in at least the crotch region37and the first waist region36is made through utilization of one or more cuff separation bonds54(seeFIG.7). The leg gasketing system70may further comprise a pocket55arising from the web of material between the inner cuff folded edge75and the outer cuff folded edge79being unattached to the web of material between the outer cuff folded edge79and the outer cuff material edge78in one of the waist regions36,38as shown inFIG.8. The pocket55may provide additional void volume within the leg gasketing system70to receive exudates to help isolate fecal material from the wearer's skin as well as contain exudates between the layers of the leg gasketing system70to prevent leakage. The pocket55may comprise an opening56created by a break in the cuff separation bond54or a series of breaks in the cuff separation bond54. The pocket and opening can occur in the first waist region36, the second waist region38or the crotch region37as needed for the specific type of exudates and particular situation where leakage prevention is desired. Attachment of the outer cuff76, the opacity patch80and/or inner cuff72and/or formation of the pocket55may be accomplished in accordance with the disclosure of commonly assigned U.S. Patent App. No. 62/134,622. The pocket55may be free from elastics210. In one embodiment shown inFIG.9, one or more attachment bonds52can comprise a tackdown bond58which may be disposed in a waist region36,38and may extend longitudinally in a continuous or substantially continuous manner in the waist region36,38. Attachment bonds52,58, OSP bonds53and/or cuff separation bonds54may take the form of glue, heat bond, pressure bond, mechanical bonds, ultrasonic or any other bonding method known in the art. In one nonlimiting example, the tackdown bond58takes the form of a glue bond60. The leg gasketing system70may comprise one or more elasticized regions200comprising one or more longitudinally extending elastic members210as can be seen inFIGS.5C-7. The elastic members210may be joined to the web material by any suitable means including mechanical bonds and/or adhesive bonds212. In an embodiment illustrated inFIG.5C, an elastic member210is joined to the leg gasketing system70at both a contraction starting point and a contraction ending point. In such embodiment, the elastic member210is contracted between the starting point and ending point, forming a contraction region225. In a nonlimiting example, the longitudinal length of the contraction region225of a first elastic member214is different than the length of the contraction region225of a second elastic member216. In a further nonlimiting example, the longitudinal length of the contraction region225of the first elastic member214is greater than the longitudinal length of the contraction region225of the second elastic member216. In another nonlimiting example, the contraction starting points may be disposed on different lateral axes and/or the contraction ending points may be disposed on different lateral axes as shown inFIG.5C. Additional discussion of the contraction starting and ending points is included in the Elasticized Region section above. As illustrated inFIGS.6-7and9, the inner cuff72may comprise an inner cuff elasticized region200ICcomprising one or more longitudinally-extending elastic members210IC. The inner cuff elastic members210ICmay run substantially parallel to the inner cuff edge73. In one nonlimiting example, the elastic members210ICmay be disposed between the inner cuff folded edge75and the outer cuff material edge78. In an embodiment, the inner cuff elasticized region200ICcomprises a first inner cuff elastic member214ICdisposed outboard of the inner cuff edge73as shown in the flat, uncontracted state in, for example,FIGS.6-7. The inner cuff elasticized region200ICmay further comprise a second inner cuff elastic member216ICdisposed outboard the first inner cuff elastic member214ICin the flat, uncontracted state. In some embodiments, the first inner cuff elastic member214ICmay be adjacent to the second inner cuff elastic member216IC. In one nonlimiting example, the first inner cuff elastic member214ICis disposed a minimum lateral distance, DI1-I2, from the second inner cuff elastic member216ICas depicted inFIG.6. The minimum lateral distance, DI1-I2, may be from about 3.5 mm to about 10 mm. In an embodiment, the first inner cuff elastic member214ICand the second inner cuff elastic member216ICmay be differentially strained as discussed in more detail in the Elasticized Region section above. The first inner cuff elastic member214ICcomprises a first inner elastic strain, ε1ic, and the second inner cuff elastic member216ICcomprises a second inner elastic strain ε2ic. Strain may be determined by the Strain Test Method herein. The first inner elastic strain, ε1ic, may be different than the second inner elastic strain, ε2ic. In a nonlimiting example, the second inner elastic strain, ε2ic, is greater than the first inner elastic strain, ε1ic. In a further embodiment shown inFIG.9, the leg gasketing system70comprises an inner cuff elastic attachment zone218ICin which adjacent elastics210ICmay be joined to the leg gasketing system70differently (which is discussed more completely above in the Elasticized Region section). In such embodiment, the inner cuff edge73is the outermost edge503of the component, the component being the inner cuff72. In one nonlimiting example, the first inner cuff elastic member214ICis joined to the leg gasketing system70at a first inner attachment interval221ICand at a second inner attachment interval223IC. The first inner attachment interval221ICmay be at least partially disposed in the first waist region36, and the second inner attachment interval223ICmay be at least partially disposed in the second waist region38. The attachment intervals221IC,223ICare separated by an unattached span222IC, which may be disposed in the crotch region37. In such example, the second inner cuff elastic member216ICis continuously joined to the leg gasketing system70in the attachment zone218IC. In a further nonlimiting example, the second elastic member216ICis continuously joined to the leg gasketing system70in the crotch region37. In a further nonlimiting example, the elastic members214IC,216ICare joined the web material in the inner cuff72using one or more adhesive bonds212, and the unattached span222ICcomprises an unglued span222IC. It is also contemplated that the second inner elastic member216ICmay be joined at two attachment intervals219separated by an unattached span222, where the unattached span is disposed in the crotch region37and the attachment intervals are partially disposed in waist regions36,38, and the first inner elastic member214ICmay be continuously joined to the leg gasketing system70within the attachment zone218IC. In another embodiment, the outer cuff76may comprise an outer cuff elasticized region200OCcomprising one or more longitudinally-extending elastic members210OC. The outer cuff elastic members210OCmay run substantially parallel to the outer cuff edge77. In one nonlimiting example, the elastic members210OCmay be disposed between the outer cuff folded edge79and the inner cuff material edge74. In an embodiment, the outer cuff elasticized region200OCcomprises a first outer cuff elastic member214OCdisposed inboard of the outer cuff edge77as shown in the flat, uncontracted state inFIGS.6-7. The outer cuff elasticized region200OCmay further comprise a second outer cuff elastic member216OCdisposed inboard of the first outer cuff elastic member214OC. In some embodiments, the first outer cuff elastic member214OCmay be adjacent to the second outer cuff elastic member216OC. In one nonlimiting example, the first outer cuff elastic member214OCis disposed a minimum lateral distance, DO1-O2, from the second outer cuff elastic member216OCas depicted inFIG.6. The minimum lateral distance, DO1-O2, may be from about 3.5 mm to about 10 mm. In an embodiment, the first outer cuff elastic member214OCand the second outer cuff elastic member216OCmay be differentially strained as discussed in more detail in the Elasticized Region section above. The first outer cuff elastic member214OCcomprises a first outer elastic strain, ε1oc, and the second outer cuff elastic member216OCcomprises a second outer elastic strain, ε2oc. The first outer elastic strain, ε1oc, may be different than the second outer elastic strain, ε2oc. In a nonlimiting example, the second outer elastic strain, ε2oc, is greater than the first outer elastic strain, ε1oc. Strain may be determined by the Strain Test Method herein. In a further embodiment shown inFIG.9, the leg gasketing system70comprises an outer cuff elastic attachment zone218OCin which the first outer cuff elastic member214OCand the second outer cuff elastic member214OCmay be joined to the leg gasketing system70differently (which is discussed more completely above in the Elasticized Region section). In one nonlimiting example, the first outer cuff elastic member214OCis joined to the leg gasketing system70at a first outer attachment interval221OCand a second outer attachment interval223OC. The first outer attachment interval221OCmay be at least partially disposed in the first waist region36, and the second outer attachment interval223OCmay be at least partially disposed in the second waist region38. The attachment intervals221OC,223OCare separated by an unattached span222OC, which may be disposed in the crotch region37. In such example, the second outer cuff elastic member216OCis continuously joined to the leg gasketing system70in the attachment zone218OC. In a further nonlimiting example, the elastic members214OC,216OCare joined the web material in the outer cuff76using one or more adhesive bonds212, and the unattached span222OCcomprises an unglued span222OC. While described above in terms of the second elastic member being continuously joined to the leg gasketing system70and the first outer cuff elastic member being attached at two intervals219separated by an unattached span222, it is also contemplated that the second outer elastic member216OCmay be joined at two attachment intervals219separated by an unattached span222and the first elastic member214OCmay be continuously joined to the leg gasketing system70within the attachment zone218OC. The inner cuff72and/or outer cuff76may comprise additional cuff elastic members210. The inner cuff72may comprise at least one elastic member210, at least two elastic members210, at least three elastic members210, at least four elastic members210, or at least five elastic members210. The outer cuff76may comprise at least two elastic members210, at least three elastic members210, at least four elastic members210, at least five elastic members210, or at least six elastic members210. In one embodiment, the inner cuff72comprises an array of elastic members positioned between the inner cuff folded edge75and the inner cuff material edge74. The elastic members210ICmay be attached to the portion of the web of material that forms the inner cuff72by elastics adhesive212. In such an embodiment, the elastics210ICare positioned between i) the portion of the web of material between the inner cuff folded edge75and the inner cuff material edge74, and ii) the portion of the web material between the inner cuff folded edge75and the outer cuff folded edge79. Likewise, the outer cuff76may comprise elastic members210OCpositioned in a lateral array between the outer cuff folded edge79and outer cuff material edge78. The elastics210OCmay be attached to the portion of the web of material that forms the outer cuff by elastics adhesive212. In such an embodiment, the elastic members210OCare positioned between i) the portion of the web of material between the outer cuff folded edge79and the outer cuff material edge78, and ii) the portion of the web material between the outer cuff folded edge79and the inner cuff folded edge75. In an embodiment, any elastic members210ICin the inner cuff72and/or any elastic members210OCin the outer cuff76may be differentially strained. Strain levels in the outer cuff76may be the same as or different than strain levels in the inner cuff72. In a further embodiment, the first inner elastic strain, ε1ic, is different than the first outer elastic strain, ε1oc. In one nonlimiting example, the first inner elastic strain, ε1ic, is greater than the first outer elastic strain, ε1oc. In another nonlimiting example, the first inner elastic strain, ε1ic, is less than the first outer elastic strain, ε1oc. In another embodiment, the second inner elastic strain, ε2ic, is different than the second outer elastic strain, ε2oc. In one nonlimiting example, the second inner elastic strain, ε2ic, is greater than the second outer elastic strain, ε2oc. In another nonlimiting example, the second inner elastic strain, ε2ic, is less than the second outer elastic strain, ε2oc. In still another embodiment, any adjacent elastic members210ICin the inner cuff72and/or any adjacent elastic members210OCin the outer cuff76may be differently joined to the leg gasketing system70in the respective attachment zones218IC,218OC. In a further embodiment, adjacent elastic members210OCin the outer cuff76may be attached differently than adjacent elastics210ICin the inner cuff72. In one nonlimiting example, the first inner elastic member214ICis joined to the leg gasketing system in IC attachment pattern220ICand the first outer elastic member214OCis joined to the leg gasketing system70in an OC attachment pattern220OC. The IC attachment pattern220ICmay be different from the OC attachment pattern220OC. Alternatively, the IC attachment pattern220ICmay be the same as the OC attachment pattern220IC. The attachment patterns220may be formed by pattern slot coating. In one embodiment, the outer cuff76and inner cuff72are the same color. In one embodiment, the outer cuff76and inner cuff72are different colors. In one embodiment, there is an additional printing on one or more of the cuffs71of the leg gasketing system70. In embodiments with printing on both the inner72and outer cuffs76, the printing may be the same or different on each cuff71. In some embodiments, the outer cuff edge77extends outboard of the chassis periphery30in the crotch region37to form an exposed outer cuff76E as shown inFIGS.5C and9. In one nonlimiting example, the backsheet26and/or polymeric film layer261may be spaced laterally inward of the outer cuff edge77by about 10 mm; optionally about 20 mm; optionally about 30 mm; optionally about 40 mm. In another nonlimiting example, the outer cuff edge77extends outboard of the chassis periphery30for a maximum longitudinal distance, Lexp, of from about 10 mm to about 35 mm, or from about 15 mm to about 20 mm, as measured between intersection points C and D where the outer cuff edge77intersects the chassis periphery30as shown inFIG.9. In a further nonlimiting example, the lateral distance, DO1-OE, between the first outer cuff elastic member214OCand the outer cuff edge77may be about 5% to about 55%, or from about 6% to about 50% of the maximum longitudinal distance, Lexp, for each range reciting every 5% increment therein. The outer cuff edge77may comprise a folded outer cuff edge79in such example. Alternatively, the outer cuff edge77may comprise two or more layers that have edges coterminous with the outer cuff edge77in such example. In another nonlimiting example, the lateral distance, DO2-OE, between the second outer cuff elastic member216OCand the cuff edge77may be about 30% or greater of the maximum longitudinal distance, Lexp, or from about 35% to about 95% of the maximum longitudinal distance, Lexp, for each range reciting each 5% increment therebetween. In such nonlimiting example, the cuff edge77may comprise a folded cuff edge79or the cuff edge77may be coterminous with the edges of two or more layers of the outer cuff76. In these embodiments, it is believed that the first elastic member214OCwill resist the tendency to move into the cuff edge77as discussed more completely in the Elasticized Region section. In one embodiment, the leg gasketing system70is spaced laterally inward of the chassis longitudinal edge12by about 10 mm, optionally about 20 mm, optionally about 30 mm, optionally about 60 mm or more. In another embodiment, at least a portion of the lateral edge of the outer cuff76extends to the laterally outboard edge13,14of the chassis22as shown, for example, inFIG.9. In still another embodiment, at least a portion of the lateral edge of the outer cuff76is disposed longitudinally inboard of the laterally outboard edge13,14of the chassis22. In one embodiment, the outboard edge77of the leg gasketing system70is disposed laterally inboard of at least a portion of the longitudinal edge of the article20in at least one of the waist regions36,38. Thus, in one embodiment, the front ears40and/or back ears42extend past the leg gasketing system70. As shown inFIG.10, the outer cuff76has an outer cuff height, HOC, and the inner cuff72has an inner cuff height, HIC. In an embodiment, the inner cuff height, HIC, is less than the outer cuff height, HOC. In alternative embodiments, the outer cuff height, HOC, and the inner cuff height, HIC, are substantially equivalent or the inner cuff height, HIC, is greater than the outer cuff height, HOC. In one embodiment, the height of the inner cuff, HIC, is at least about 10 mm, at least about 20 mm, at least about 30 mm, at least about 32 mm, at least about 35 mm, or at least about 38 mm. In one embodiment, the outer cuff height, HOC, is at least about 15 mm, at least about 23 mm, at least about 25 mm, at least about 27 mm, or at least about 30 mm. The inner cuff height, HIC, is measured along a lateral line from inner cuff edge73to the first point of connection to the chassis20in the crotch region37. The outer cuff height is measured along a lateral line from the outer cuff edge77to the first point of connection to the chassis20in the crotch region37. In one nonlimiting example, the height of the inner cuff is measured along a lateral line from inner cuff folded edge75to the first point of connection to a material beyond the inner cuff material edge74in the crotch region. Further, the outer cuff height is measured along a lateral line from the outer cuff folded edge75to the first point of connection the inner cuff72has to a material beyond the inner cuff material edge73in the crotch region37. Thus, in such example, the inner and outer cuffs are measured from their respective folded edges to the point where the inner cuff is connected to the first material beyond the inner cuff material edge74. Where the outer cuff height, HOC, is greater than or appears greater than the inner cuff height, HIC, in the contracted state, the intended function of the outer cuff (as a secondary barrier) is indicated to the user. In some embodiments, the inner cuff elastic members comprise an aggregate strain level that is higher than the aggregate strain of the outer cuff elastics. In this way, the path length of the inner cuff elastic members in the contracted state is shorter than the path length of the outer cuff elastic members, and consequently, the outer cuff may appear to have a greater height than the inner cuff. In such embodiments, the outer cuff height, HOC, may actually be greater than the inner cuff height, HIC. In embodiments where the cuff edge73,77comprises a folded cuff edge75,79and/or in embodiments where more than one layers has an edge coterminous with the cuff edge73,77, the first elastic member214may be disposed a lateral distance, D1-E, of at least about 3 mm from the cuff edge73,77. In this way, the first elastic member214will resist the tendency to be move into the edge73,77as discussed more completely above in the Elasticized Region section. The inner and/or outer cuff72,76may comprise sets of elastic members214S,216S and any of the embodiments taught with respect to sets in the Elasticized Region section herein. Further, one or more of the cuffs71may be constructed of N-fiber as discussed below. Waist Gasketing Element The disposable absorbent article20may include at least one waist gasketing element81attached to the chassis22. The waist gasketing element81may be disposed on the body facing side115of the chassis or a body-facing side of a layer of the chassis22. In an embodiment, the waist gasketing element81comprises an elasticized waistband94as shown inFIG.1. In another embodiment, the waist gasketing element81comprises a waist gasketing element pocket93as shown inFIG.11. The pocket93may be formed from a portion of the waist gasketing element81that is unattached from the chassis22. Waist gasketing elements81may be joined to the chassis22in the first waist region36and/or in the second waist region38. In one nonlimiting example, the waist gasketing element81is disposed in the second waist region38. In one embodiment, the at least one waist gasketing element81comprises a single, continuous web of material. In other embodiments, the waist gasketing element(s)81may be formed from more than one web of material (e.g., multiple webs of material that are joined together to become one web of material, or multiple distinct webs of material that are separate from the disposable absorbent article chassis and form part of the waist gasketing element). Herein, locations (e.g., folded edge, material edge, etc.) on the waist gasketing element81are detailed in reference to “a web of material”, “a portion of the web of material” or “waist material.” The recitations of “a web of material” or “the web of material” or “waist material” refer to waist gasketing element embodiments that may be formed from a single, continuous web of material, multiple webs of material that are joined together to become one web of material, a single material that is folded to form multiple layers of the same material, a single material that is slit apart and rejoined together, or multiple distinct webs of material that are separate from the disposable absorbent article chassis and form part of the waist gasketing element81. All such embodiments are contemplated. In one embodiment, the waist gasketing element81includes an inboard lateral edge82, an outboard lateral edge83, and two longitudinal edges84. The outboard lateral edge83may be coterminous with a waist edge13,14. Alternatively, the outboard lateral edge83may be disposed longitudinally inward of the waist edge13,14. In some embodiments, the web of material forming the waist gasketing element81is folded longitudinally outward (away from the lateral centerline110of the absorbent article20) to form the inboard lateral edge82. In such embodiments, the inboard lateral edge82is also the location of the waist gasketing element folded edge89and the outboard lateral edge83is also the location of the waist gasketing element first material edge90and the waist gasketing element second material edge91. Although an embodiment depicting a waist gasketing element81with one folded edge89and two material edges90,91is shown inFIG.11, alternate constructions of useful waist gasketing elements are contemplated. For example, an alternate waist gasketing element81may include two distinct webs of material and therefore have four material edges (two on the inboard lateral edge82, and two on the outboard lateral edge83). As another example, an alternate waist gasketing element may have a continuous web material that is formed into having two folded edges (one on the inboard lateral edge82, and one on the outboard lateral edge83) and two material edges. In a further embodiment, the waist gasketing element81may be used in conjunction with a leg gasketing system70as shown inFIG.11. In such embodiment, the waist gasketing element81is attached to: 1) the chassis22and 2) the leg gasketing system70, such that at least a portion of the outboard lateral edge83of the waist gasketing element81is attached to the chassis22and at least a portion of the outboard lateral edge83of the waist gasketing element81is attached to the web of material of the leg gasketing system70. The inboard lateral edge82of the waist gasketing element81may be unattached, partially unattached or fully attached to the chassis22of the disposable absorbent article20. In embodiments that include a waist gasketing element81that has a waist gasketing element folded edge89, a waist gasketing element first material edge90, and a waist gasketing element second material edge91, at least a portion of the web of material between the waist gasketing element folded edge89and waist gasketing element second material edge91is attached to the topsheet24and/or backsheet26of the chassis22. The attachment of the waist gasketing element81to the chassis22is made through utilization of one or more outboard lateral edge bonds85(see, for example, the rear waist gasketing element onFIG.11). The outboard lateral edge bond85attaches at least a portion of the waist gasketing element's web of material between the waist gasketing element folded edge89and the waist gasketing element second material edge91to the topsheet24. In one embodiment, the attachment bond85is at the second waist edge14of the chassis22; in other embodiments, the attachment bond is placed at least 2 mm inboard from the waist edge of the chassis; at least 10 mm inboard from the waist edge of the chassis; at least 20 mm inboard from the waist edge of the chassis; at least 50 mm inboard from the waist edge of the chassis; or any range or distance within the range of about 2 mm to about 50 mm inboard from the waist edge of the chassis. The outboard lateral edge bond85may take the form of glue, heat bond, pressure bond, mechanical bonds, or any other bonding method known in the art. In the exemplary embodiment ofFIG.11, the outboard lateral edge bond85takes the form of a glue bond. In embodiments that include a waist gasketing element81that has a waist gasketing element folded edge89, a waist gasketing element first material edge90, and a waist gasketing element second material edge91, at least a portion of the web of material between the waist gasketing element folded edge89and waist gasketing element second material edge91is attached to the web of material forming the leg gasketing system70. The attachment of the waist gasketing element81to the web of material forming the leg gasketing system70is made through utilization of one or more longitudinal edge bond(s)86. As seen in the embodiment ofFIG.11(see the rear waist gasketing element), the longitudinal edge bonds86attach at least a portion of the waist gasketing element's web of material between the waist gasketing element folded edge89and the waist gasketing element second material edge91to the web of material forming the leg gasketing system70. The longitudinal edge bonds86can be located adjacent to the longitudinal edges84of the waist gasketing element81(or may be coterminous therewith). In another embodiment, the longitudinal edge bonds86are located adjacent to the inner cuff folded edge75of the leg gasketing system70(or may be coterminous therewith). The waist gasketing element81may be attached to the leg gasketing system70over substantially the entire area that the leg gasketing system70overlaps with the waist gasketing element81. In some embodiments, the waist gasketing element81is attached to the leg gasketing system70over more than about 50%, more than about 60%, more than about 70%, more than about 80%, more than about 90%, or more than about 95%, of the entire area that the leg gasketing system70overlaps with the waist gasketing element81. The longitudinal edge bonds86may take the form of glue, heat bond, pressure bond, mechanical bonds, or any other bonding method known in the art. In the exemplary embodiment ofFIG.11, the longitudinal edge bonds86take the form of a glue bond. In one nonlimiting example, the combination of the longitudinal edge bonds86, the lateral outward edge bond85and unattached portion of the inboard lateral edge82of the waist gasketing element81(i.e., unattached from the chassis22) forms a pocket93. When the wearer moves, a portion of the bodily exudates will migrate into the waist gasketing element pocket93for containment and be held/trapped between two layers of nonwoven before it can leak out in an area between the wearer's back and the back waist region38of the absorbent article20. In addition, the waist gasketing element pocket93provides additional void volume within the waist region to receive the fecal material which helps in isolating the fecal material from wearer's skin. The waist gasketing element81and its attachment to the chassis22may be in accordance with U.S. Patent App. No. 62/134,622. A waist region36,38may comprise an elasticized region200comprising one or more laterally extending elastic members210. The waist elastic members210may be disposed in an array240. In one nonlimiting example, the waist elasticized region200Wis disposed in a waist gasketing element81that is disposed within a waist region36,38. In the waist elasticized region200W, one or more elastic members210Wmay be joined to the chassis22in the waist region and/or joined to the web of waist material. The elastic members210Wmay be joined to the chassis22and/or waist gasketing element81by any suitable means including mechanical bonds and/or adhesive bonds212. In one nonlimiting example, the elastics may be positioned between i) the portion of the web of material between a waist gasketing element folded edge89and the waist gasketing element first material edge90, and ii) the portion of the web material between the waist gasketing element folded edge89and the waist gasketing element second material edge91. In an embodiment, an elastic member210Wcan be joined to the chassis and/or to the waist gasketing element81at both a contraction starting point and a contraction ending point, forming a contraction region225therebetween. In one nonlimiting example shown inFIG.12, the longitudinal edges84of the waist gasketing element81are coterminous with the longitudinal edges of the chassis in the waist region12a,12b. (FIG.12schematically depicts the first waist region but is equally applicable to embodiments where the second waist region comprises an elasticized region200w.) In a further embodiment, the lateral length of the contraction region225WFof a first waist elastic member214wmay be different than the length of the contraction region225WSof a second waist elastic member216w. The contraction starting points224FW,224SWof the first and second waist elastic members214w,216wmay be disposed on different longitudinal axes228W,229W. Likewise, the contraction ending points226FW,226SWmay be disposed on different longitudinal axes230W,231W. Additional discussion of the contraction starting and ending points is included in the Elasticized Region section above. Returning toFIG.11, the first waist region36and/or second waist region38may comprise an elasticized region200whaving an array240of waist elastic members210w. In one embodiment, the first waist region36comprises a first waist elasticized region200w1comprising a first waist elastic member214wand a second waist elastic member216w. The first waist elastic member214wmay be disposed between (i) the waist edge13and (ii) the second waist elastic member216w. In some embodiments, the first waist elastic member214wis adjacent to the second waist elastic member216w. In one nonlimiting example, the first and second waist elastic members214w,216ware disposed a longitudinal distance, Lw1-w2, apart from about 3.5 mm to about 10 mm. In another embodiment, the second waist region38comprises a second waist elasticized region200W2comprising a first back waist elastic member215wand a second back waist elastic member217w. The first back waist elastic member215wmay be disposed between (i) the waist edge14and (ii) the second back waist elastic member217w. In some embodiments, the first back waist elastic member215wis adjacent to the second back waist elastic member217w. In one nonlimiting example, the first and second back waist elastic members215w,217ware disposed a longitudinal distance, Lw3-w4, apart of from about 3.5 mm to about 10 mm. In another embodiment, waist elastic members210win the array240may be differentially strained as discussed in more detail in the Elasticized Region section above. In one embodiment, the first waist elastic member214wcomprises a first waist elastic strain, ε1w, and the second waist elastic member216wcomprises a second waist elastic strain, ε2w. The first waist elastic strain, ε1w, may be different than the second waist elastic strain, ε2w. In one nonlimiting example, the second waist elastic strain, ε2w, is greater than the first waist elastic strain, ε1w. In another embodiment, the first back waist elastic member215wcomprises a first back waist elastic strain, εw3, and the second back waist elastic member217wcomprises a second back waist elastic strain, εw4. The first back waist strain, εw3, may be different than the second back waist elastic strain, εw4. In one nonlimiting example, the second back waist strain, εw4, is greater than the first back waist strain, εw3. In a further embodiment, the waist elasticized region200wcomprises adjacent waist elastic members joined to the waist gasketing element81differently. In such embodiment, the first waist elastic member214wmay be adjacent to the second waist elastic member216wand/or the first back waist elastic member215wmay be adjacent to the second back waist elastic member217w. In one nonlimiting example, the first waist elastic member214wis joined to the waist gasketing element81at first and second front waist attachment intervals221w1,223w1. The attachment intervals221w1,223w1are separated by an unattached span222w1. The first waist attachment interval221w1can be disposed proximate to or touch a longitudinal edge12, and the second waist attachment interval223w1can be disposed proximate to or touch the opposite longitudinal edge12as shown inFIGS.11-12. In such example, the second waist elastic member216wis continuously joined to the waist gasketing element81. It is also contemplated that the second waist elastic member214wmay be joined at two attachment intervals219separated by an unattached span222and the first waist elastic member214wmay be continuously joined to the waist gasketing element81with the attachment zone218w1. In another nonlimiting example, the first back waist elastic member215wis joined to the waist gasketing element81at first back and second back waist attachment intervals221w3,223w3. The first back waist attachment interval221w3can be disposed proximate to or touch a longitudinal edge12, and the second back waist attachment interval223w3can be disposed proximate to or touch the opposite longitudinal edge12as shown inFIGS.11-12. In such example, the second back waist elastic member217wis continuously joined to the waist gasketing element81. The elastic members210wmay be joined to the waist gasketing element81by one or more adhesive bonds212, and the unattached span222w3may comprise an unglued span222w3. It is also contemplated that the second back waist elastic member217wmay be joined at two attachment intervals219separated by an unattached span222and the first back waist elastic member215wmay be continuously joined to the waist gasketing element81with the attachment zone218w2. Elasticized regions in the first and/or the second waist region may comprise additional waist elastic members210w. In an embodiment, the waist elasticized region200wmay comprise at least two waist elastic members210w, at least three waist elastic members210w, at least four elastic members210w, at least five elastic members210w, at least six waist elastic members210w, at least seven waist elastic members210w, at least eight waist elastic members210w, at least nine waist elastic members210w, at least ten waist elastic members210w, at least eleven waist elastic members210w, or at least twelve waist elastic members210w. In an embodiment, any waist elastic members210win the first waist region36and/or any waist elastic members210win the second waist region38may be differentially strained. Further, strain levels in the first waist region36may be the same as or different than strain levels in the second waist region38. In a further embodiment, the first waist elastic strain, εW1, is different than the first back waist elastic strain, εW3. In one nonlimiting example, the first waist elastic strain, εW1, is greater than the first back waist elastic strain, εW3. In another nonlimiting example, the first waist elastic strain, εW1, is less than the first back waist elastic strain, εW3. In another embodiment, the second waist strain, εW2, is different than the second back waist elastic strain, ε4W. In one nonlimiting example, the second waist strain, εW2, is greater than the second back waist elastic strain, ε4W. In another nonlimiting example, the second waist strain, εW2, is less than the second back waist elastic strain, ε4W. In still another embodiment, any adjacent elastic members210win the first waist region36and/or any adjacent elastic members210win the second waist region38may be differently joined to the waist gasketing element81in the respective attachment zones218w1,218w2. In a further embodiment, adjacent elastic members210win the first waist region36may be attached differently than adjacent elastics210win the second waist region38. In one nonlimiting example, the first waist elastic member214Wis joined to the waist gasketing element81in first region attachment pattern220W1and the first back waist elastic member215Wis joined to the waist gasketing element81in a second region attachment pattern220W3. The first region attachment pattern220W1may be different from the second region attachment pattern220W3. Alternatively, the first region attachment pattern220W1may be the same as the second region attachment pattern220W3. The attachment patterns220W1,220W3may be formed by pattern slot coating. The waist elasticized region200wis used to the contract the article in the waist region36,38to enhance fit about the wearer. While not intending to be bound by theory, the contractive forces in the elastic members210wcause the contraction of the portion of the article20where the elastic members210ware disposed. However, identical elastic members210w(e.g., size, decitex, etc.) under identical strain levels disposed in the elasticized region200wcan each provide a different level of contraction on surrounding materials depending on their respective locations and the stiffness and/or rigidity of the materials to which the elastics210ware attached or are otherwise in close proximity. By way of example, where the core28is disposed inboard of the waist edge (as shown inFIGS.13A and13B), an elastic member210wdisposed over the core28(and other layers joined to the core28) and applied at a given condition may exhibit less contraction than an identical elastic member210wapplied at the same given condition but disposed within the topsheet and backsheet laminate alone. Likewise, an elastic member210wdisposed further from the waist edge (and thus being surrounded by more material) will exhibit less contraction than an identical elastic member210wdisposed closer to the waist edge. As a result of the different contraction in individual elastic members210w, the respective surrounding materials (i.e., the materials immediately surrounding each elastic member210wwhether above, below or adjacent) will also experience a difference in contraction. Essentially, the rigid, stiffer materials counteract an elastic member's210wcontractive force, causing the force equilibrium to be reached at a lower contraction level than if the elastic member210wwere placed over less stiff, more flexible materials. The contraction causes the waist region where the elasticized region200wis disposed to bend towards the waist edge—that is, in a convex manner with respect to the less stiff, more bendable area, which is closer to the waist edge. The convex shape precludes the article from lying flat and/or causes the lateral edge of the article to curve inwards while lying flat. Each issue makes it harder to find fasteners on the article because (i) the fasteners46are disposed at an angle as opposed to linearly, (ii) the lateral distance of the waist region is shorter and the fasteners46are therefore less visible when the article is disposed around or under the wearer during application, and (iii) the raising and contraction of the material may cause the waist region to bend even further inward when the wearer is laid upon the article, hiding the fastening system44. Moreover, the fasteners46are not as easily secured to the intended landing zones47due to the undesired curvature of the waist region in the elasticized region200w. The inventors have found that the tendency to bend is reduced or eliminated by increasing the actual contractive force of elastic members210wdisposed inboard (i.e., closer to the core28) relative to the actual contractive force of the elastic members210wdisposed outboard (i.e., closer to the waist edge). The difference in force between inboard and outboard elastics may be determined using the Tensile Test Method for Force Differential of Waist Gasketing Element as detailed herein. Nonlimiting examples of ways by which the elastic force differential is created include greater applied strain levels on the inboard elastic member(s), greater decitex of the inboard elastic member(s), greater diameter of the inboard elastic member(s), different base materials between inboard and outboard elastic members (i.e., such that an inboard elastic member has a higher Young's modulus or stiffness), more elastic members disposed inboard than outboard, and closer longitudinal spacing between adjacent elastic members210wthat are inboard versus elastic members disposed more outboard. In some embodiments, the waist gasket element may have a Force Ratio of at least about 1.1, or from about 1.1 to about 1.5, reciting every 0.01 increment therein. In one embodiment shown inFIG.13A, the elasticized waist region200wcomprises a longitudinal array of waist elastic members240. In a contracted state (i.e., when the waist gasketing element is not being stretched), an inner elastic member242,243or244is substantially equal in lateral width or is shorter (less wide) than the outermost elastic member241. (FIG.13Aschematically depicts an elasticized waist region). Stated differently, a primary outboard elastic member241may comprise a primary lateral width, Wprim, and a secondary inboard elastic member242may comprise a secondary lateral width, Wsec. Said widths may be measured by projection against the lateral centerline110. The primary lateral width, Wprim, may be greater than or equal to the secondary lateral width, Wsec. In this way, the waist region can be made to remain substantially flat during application of the article20. In another embodiment, the array240comprises a primary waist elastic member241comprising a primary force, FP, and a secondary waist elastic member242comprising a secondary force, FS. The secondary waist member is disposed inboard of the primary waist member241. The secondary FS may be greater than the primary force FP as determined by the Tensile Test Method for Force Differential of Waist Gasketing Element as detailed herein. In one nonlimiting example, the primary waist elastic member241comprises a primary decitex, DP, and the secondary elastic member242comprises a secondary decitex, DS. The secondary decitex, DS, may be greater than the primary decitex, DP. In another nonlimiting example, the primary waist elastic member241comprises a primary diameter, dP, and the secondary elastic member242comprises a secondary diameter, dS. The secondary diameter, dS, may be greater than the primary diameter, dP. In yet another nonlimiting example, the primary waist elastic member241comprises a primary waist elastic strain, εwp, and the secondary elastic member242comprises a secondary waist elastic strain, εws. Strain may be determined in accordance with the Strain Test Method herein. The secondary waist elastic strain, εws, may be greater than the primary waist elastic strain, εwp. It is believed that any of these examples can result in an article20having higher contractive elastic force on an inboard elastic242resulting in greater contraction of the area immediately surrounding the inboard elastic member242than if the elastic members241,242comprised the same levels of the above-referenced factors. In still another nonlimiting example, the array240may comprise additional elastic members210wincluding a tertiary elastic member243disposed inboard of the secondary elastic member242and a quaternary elastic member244disposed inboard of the tertiary elastic member243. The tertiary elastic member243may comprise a tertiary force FT that may be greater than the primary force FP or greater than the secondary force FS. In one nonlimiting example, the tertiary member243may comprise a tertiary waist strain, εwt, that is greater than the secondary waist strain, εwsand/or greater than the primary waist strain, εwp. Further, the tertiary member243may comprise a tertiary decitex, DT, that may be greater than the secondary decitex, DS or greater than the primary decitex, DP. In another nonlimiting example, the tertiary member243may comprise a tertiary diameter, dT, that may be greater than the secondary diameter, dS, or greater than the primary diameter, dP. The quaternary elastic member244may comprise a quaternary force, FQ, that may be greater than the primary force, FP, or greater than the secondary force, FS, or greater than the tertiary force, FT. Further, the quaternary elastic member244may comprise a quaternary waist strain, εwq, that may be greater than the primary waist strain, εwp, or greater than the secondary waist strain, εws, or greater than the tertiary waist strain, εwt. The quaternary member244may comprise a quaternary decitex, DQ, that may be greater than the primary decitex, DP, or greater than the secondary decitex, DS, or greater than the tertiary decitex, DT. In another nonlimiting example, the quaternary member244may comprise a quaternary diameter, dQ, that may be greater than the secondary diameter, dS, or greater than the primary diameter, dP, or greater than the tertiary diameter, dT. In a further embodiment, the primary waist elastic member241may be disposed a minimum longitudinal distance A from the waist edge13,14or from outboard edge83of the waist gasketing element81. In one nonlimiting example, the minimum longitudinal distance A is at least about 3 mm and the edge comprises a folded edge15,89. The secondary waist elastic member242may be disposed a minimum longitudinal distance B from the primary waist elastic member241. The tertiary elastic member243may be disposed a minimum longitudinal distance C from the secondary waist elastic member242, and B may be greater than C. In this way, the contraction inboard is greater than the contraction outboard. The quaternary elastic member244may be disposed a minimum longitudinal distance D from the tertiary waist elastic member243, and C may be greater than D. It is believed that the above embodiments (relating to force, strain, diameter, decitex, spacing) can result in an increase in the contraction of the inboard portion of the elasticized waist region200wmore than would be otherwise achieved without making the above-referenced provisions. All embodiments are contemplated that can increase the ability of the inboard portion of the elasticized region200to contract at the same or higher level than the outboard portion despite the relative stiffer materials in the inboard portion and the tendency of those relatively stiffer materials to resist contraction. Other nonlimiting examples include weakening the materials in or near the inboard portion, using additional materials to increase contractive forces of the elastic members (such as elasticized nonwovens, films) in the inboard portion, corrugating materials near or in the inboard portion, removing materials in the inboard portion, and combinations thereof. All of these embodiments aim to achieve the goal of reducing the convex curvature toward the waist edge of the article20, and therefore allowing the elasticized region to lay flat. The same principles may be applied to a set of elastic members (i.e., one or more elastic members, or at least two elastic members) as illustrated inFIG.13B. In other words, in the contracted state, an outboard set241S can comprise substantially the same lateral width or a greater lateral width than an inboard set of elastic members242S. Likewise, the array240may comprise a primary set of elastic members241S having an aggregate primary force ΣFP, defined as the sum of the force values for each elastic member in the primary set241S. The array240may further comprise a secondary set of elastic members242S having an aggregate secondary force ΣFS, defined as the sum of the force values for each elastic member in the secondary set242S. The aggregate secondary force ΣFS may be greater than the aggregate primary force ΣFP as determined by the Tensile Test Method for Force Differential of Waist Gasketing Element herein. In some embodiments, the Force Ratio (as determined by the Tensile Test Method for Force Differential) may be at least about 1.1, or from about 1.1 to about 1.5, reciting every 0.01 increment therein. A greater aggregate force may be achieved by having (i) an aggregate secondary elastic strain Σεwsthat is greater than the aggregate primary elastic strain, (ii) an aggregate secondary decitex ΣDS that is greater than the aggregate primary decitex, ΣDP, (iii) an aggregate secondary diameter ΣdS that is greater than the aggregate primary diameter ΣdP, (iv) a greater number of secondary elastic members242in the secondary set242S than primary elastic members241in the primary set241S, (v) closer longitudinal spacing between adjacent elastic members242in the secondary set than the longitudinal spacing between adjacent primary elastic members241in the primary set241S and/or (vi) any of the other embodiments taught with reference to primary241and secondary242elastic members above. In a further nonlimiting example, the array240may include additional elastic members210wincluding a tertiary set of elastic members243S. The tertiary set243S may comprise an aggregate tertiary force ΣFT greater than the aggregate primary force, ΣFP, or greater than the aggregate secondary force, ΣFS. The force differential may be created in accordance with the teachings herein and other known methods. The force differential may be determined in accordance with the Tensile Test Method for Force Differential of Waist Gasketing Element herein. Further, the minimum longitudinal distance between sets may be such that inboard sets are spaced closer together than outboard sets (i.e., the minimum longitudinal distance between sets being the minimum longitudinal distance between adjacent elastic members belonging to different sets). In one nonlimiting example, the primary set241S and secondary set242S are separated by a minimum longitudinal distance of Bs, and the secondary set242S and tertiary set243S are separated by a minimum longitudinal distance Cs. In such example, Bsmay be greater Cs. In another nonlimiting example, adjacent elastics241a,241bwithin the primary set241S are separated by a primary minimum longitudinal distance Asetand adjacent elastic members242a,242bwithin the secondary set242S are separated by a secondary minimum longitudinal distance Bset. Asetmay be greater than Bset. In yet another nonlimiting example, the secondary set242S comprises a greater number of elastic members210wthan the first set241S. The primary set241S may comprise n primary elastic members241, and the secondary set may comprise at least n+1 secondary elastic members242. In another embodiment, the elasticized region200wis disposed in a waist gasketing element81that comprises a pocket93as shown inFIGS.13C and13D. An array240may include a first outboard pocket elastic member246disposed inboard of the outboard lateral edge83and having a first outboard pocket force, FOP. The array may further comprise a second inboard pocket elastic member248, disposed inboard of the first outboard pocket elastic246and having a second inboard pocket force SIP. The second inboard pocket force, SIP, may be greater than the first outboard pocket force FOP. In this way, a greater amount of void volume may be created. The difference in forces can be determined by the Tensile Test Method for Force Differential herein. In one nonlimiting example, the Force Ratio in a waist element having a pocket93as determined by the Tensile Test Method for Force Differential herein is at least about 1.1, or from about 1.1 to about 1.5, reciting each 0.01 increment therein. In a further nonlimiting example, the first outboard pocket elastic246comprises an outboard pocket elastic decitex, DOP, and the second inboard pocket elastic248comprises an inboard pocket elastic decitex, DIP. The second inboard pocket elastic decitex, DIP, may be greater than the first outboard pocket elastic decitex, DOP. In another nonlimiting example, the first outboard pocket elastic246comprises an outboard pocket strain, εwop, and the secondary inboard pocket elastic248comprises an inboard pocket strain, εwip. Again, strain may be determined by the Strain Test Method herein. The inboard pocket strain, εwip, may be greater than the outboard pocket strain, εwop. As explained in detail above and illustrated inFIG.13C, the array240wmay comprise additional elastic members210wwhich may comprise differential spacing such that inboard elastic members210ware more closely spaced than outboard elastic members. Likewise, an embodiment may include sets of elastics (as depicted inFIG.13D) that vary by aggregate force, including but not limited to aggregate strain, aggregate decitex, aggregate diameter, the number of elastic members in a set, longitudinal spacing and/or other nonlimiting examples described herein. In embodiments where the waist gasketing element81comprises a pocket93, it is believed that a higher inboard contraction level cay be achieved via equal inboard and outboard forces because the unattached portion of the pocket (described above) has less surrounding material counteracting the contraction of elastic member(s)248disposed closer to the unattached portion. Therefore, under the same actual contractive force, the inboard pocket elastic member(s)248can contract more than the outboard elastic member(s)246. However, by creating an even higher inboard elastic force using the teachings and embodiments herein, the pocket93may comprise greater void volume for the capture and containment of exudates. Turning toFIGS.14A and14B, the article20may comprise a lateral bending line206in a waist region36,38. The lateral bending line206is the lateral line in the article20where the article tends to bend in the waist region36,38once an elasticized waist region200wis included; the article20will bend in a z-direction bending line (a line perpendicular to the majority of the surface of article20and intersects the lateral bending line206) and/or the article will bend upwards towards the edge13,14of the respective waist region36,38. The lateral bending line206is determined by finding the lateral line where an elastic member210wexhibits a change in contraction of at least 8%. The lateral bending line206separates a rigid region202and a bendable region204. In one nonlimiting embodiment, the lateral bending line206is coterminous with the lateral edge of the core28, where the core28is disposed in the rigid region202. An elasticized waist region200wmay be disposed between the waist edge13,14and the lateral bending line206as shown inFIG.14B. Alternatively, the elasticized waist region200wmay overlay by the lateral bending line206as shown inFIG.14A. When elastic members210ware symmetrically spaced on either side of the bending line206and exhibit the same actual contractive force F, the article20will tend to bend in a generally convex manner about the bendable region204. This is because the elastic members210win the bendable region204can contract farther before reaching the force equilibrium with the surrounding materials than in the more rigid region202(i.e., the force has a greater effect on the less stiff, more bendable materials in the bendable region204). Stated differently, the elastic members210win the rigid region202will be subject to a dampening effect, c, which dampens said elastic member's actual contractive force. The inventors have found that adjusting the forces of the waist elastic members210wwill reduce the tendency of the waist gasketing element81to bend. The moment of force is defined by the equation: Momenti=ri×Ficiwhere:momentiis the moment of force for a waist elastic member210i;ciis the dampening effect on actual contractive force of waist elastic member210i;riis the perpendicular distance between Fiand the bending line206; andFiis the actual contractive force of the waist elastic member210i. The skilled person will recognize that elastic members210wdisposed in a rigid region202will exhibit a dampening coefficient, c, of less than 1. The actual value of the dampening coefficient can be empirically determined by the skilled person. Likewise, the skilled person will recognize that elastic members210wdisposed in a bendable region204will exhibit a dampening coefficient, c, that is equal to 1 (i.e., there is no dampening effect). Further, the skilled person will recognize that in the context of disposable absorbent articles, changes in force will have more of an effect on the moment than changes in radius. This is because the area within the elasticized region200wis generally limited and only permits small changes in radius. The aggregate moment of force is the sum of the moments of force for the individual elastic members in a given area (e.g., outboard of the line206, inboard of the line206). In some embodiments, the aggregate moment of force of elastic members in a given portion of the elasticized region may be greater than aggregate moment of elastic members in another portion in order to compensate for the effect of surrounding materials on the elastic members' contractive forces. Said differently, when the inboard and outboard portions of an elasticized region200wcontract the same amount, the summation of both the contractive forces and the compression resisting forces (in the material) in the outboard portion should counterbalance the summation of both the contractive forces and the compression resisting forces in the inboard portion (i.e., the sums should zero out). Adjusting the aggregate moments of force may achieve this state. In one nonlimiting example, where the elasticized region200wis disposed between the bending line and the waist edge as shown inFIG.14B, the tendency to bend is reduced or eliminated by ensuring that the aggregate moment of force of waist elastic members256closer to the bending line206is greater than the aggregate moment of force of waist elastic members254closer to the waist edge in the region in which the elasticized region is disposed (i.e., the first waist edge13if the elasticized region is disposed in the first waist region36, the second waist edge14if the elasticized region is in the second waist region38). A greater aggregate moment of force may be achieved by a greater aggregate force and/or a greater aggregate radius. As taught above, the aggregate force ΣFaxis of the inboard elastic members256closer to the bending line206may be greater than the aggregate force ΣFedge of elastic members closer to the waist edge by (i) a greater aggregate inboard strain than aggregate outboard strain, (ii) a greater aggregate inboard decitex than aggregate outboard decitex, (iii) a greater aggregate inboard diameter than aggregate outboard diameter, (iv) a greater number of elastic members210win the inboard set256than in the outboard set254, (iv) closer longitudinal spacing between adjacent inboard elastic members256than the longitudinal spacing between adjacent outboard elastic members254, and/or (v) any other nonlimiting examples disclosed herein. Differences in force may be determined by the Tensile Test Method for Force Differential herein. In some embodiments, the Force Ratio created by inboard elastic members and outboard elastic members is at least about 1.1, or from about 1.1 to about 1.5, reciting each 0.01 increment therein. In another nonlimiting example, where the elasticized region200woverlays the bending line206as shown inFIG.14A, the tendency to bend is reduced or eliminated by ensuring the aggregate moment of force, ΣMin, of the waist elastic members252disposed inboard of the bending line206is greater than the aggregate moment of force, ΣMout, of the waist elastic members250disposed outboard of the bending line206. In a further nonlimiting example, a primary outboard set of waist elastic members250is disposed outboard of the bending line206. The primary outboard set of waist elastic members250comprises one or more elastic members210w, or at least two elastic members210w, disposed between the waist edge and the bending line206. The primary set of outboard waist elastic members250comprises a primary aggregate moment of force ΣMP, which is the sum of the moments of force for each elastic member210win the set250. The elasticized region200wmay further comprise a secondary inboard set of elastic members252disposed inboard of the bending line206. Where the elasticized region200wis disposed in a waist gasketing element81, the secondary inboard set of waist elastic members252is disposed between the bending line206and the inboard lateral edge82of the element81. The secondary set of inboard waist elastic members252comprises one or more elastic members210w, or at least two elastic members210w. The secondary inboard set of elastic members252also comprises a secondary aggregate moment of force ΣMs, which is the sum of the moments of force for each elastic member in the secondary inboard set252. The secondary aggregate moment of force ΣMs may be greater than the aggregate primary moment of force, ΣMp. A greater aggregate moment of force may be achieved by a greater aggregate force and/or a greater aggregate radius. As taught above, the aggregate force ΣFin of the secondary set of inboard elastic members252may be greater than the aggregate primary outboard force ΣFout by (i) a greater aggregate secondary inboard strain Σεinwthan aggregate primary outboard strain Σεoutw, (ii) a greater aggregate secondary decitex, ΣDin, than aggregate primary outboard decitex, ΣDout, (iii) a greater aggregate secondary diameter, Σdin, than aggregate primary outboard diameter, Σdout, (iv) a greater number of elastic members210win the second inboard set252than in the primary outboard set250, (iv) closer longitudinal spacing between adjacent secondary inboard elastic members252than the longitudinal spacing between adjacent primary outboard elastic members250, and/or (v) any other nonlimiting examples disclosed herein. Differences in force may be determined by the Tensile Test Method for Force Differential herein. In some embodiments, the Force Ratio created by inboard elastic members and outboard elastic members is at least about 1.1, or from about 1.1 to about 1.5, reciting each 0.01 increment therein. In an embodiment, the waist gasketing element81may comprise N-fiber. Opacity Strengthening Patch In some embodiments of the disposable absorbent articles detailed herein, an opacity strengthening patch80may be included as part of the chassis22. The opacity strengthening patch80is an additional layer of material. The opacity strengthening patch80may be connected to the leg gasketing system70, the polymeric film layer261, and/or the backsheet26. The opacity strengthening patch80may be disposed between the backsheet26and leg gasketing system70in either the first waist region36, the second waist region38, or both the first waist region36and the second waist region38of the article; the opacity strengthening patch80may overlap at least one of the leg gasketing system70and/or the polymeric film layer261(i.e., inner layer of the backsheet26). The opacity strengthening patch80may be attached to one or both of the leg gasketing system70or the polymer film layer using any suitable means such as glue, mechanical bonds, thermal bonds, or the like, so that loads generated during the application process or during wear can be transferred from the lateral edge of the article to the leg gasketing system70and/or the polymeric film layer. The opacity strengthening patch is useful in providing the strength needed to prevent the article from extending excessively during application and wearing; it also may provide opacity at the sides and waist to prevent the skin of the user from showing through the article. Thus, the patch80may be located at any portion of the chassis22where strength and opacity is desirable. Materials suitable to act as the opacity strengthening patch include materials having a basis weight of at least about 10 gsm, at least about 15 gsm, at least about 25 gsm. An opacity strengthening patch useful herein may exhibit the following tensile properties in the cross direction: at 2% engineering strain for a 1 inch wide sample, 0.4N; at 5% engineering strain for a 1 inch wide sample, 1.25N; at 10% engineering strain for a 1 inch wide sample, 2.5N. One opacity strengthening patch useful herein is available from Pegas, Znojmo, CZ, as supplier number 803968. In one embodiment, the opacity strengthening patch80is discrete and is located in the front and back waist regions of the article. In one embodiment, the opacity strengthening patch is about 70 mm long in the front, optionally about 90 mm long in the front; optionally about 120 mm long in the front. In one embodiment, the opacity strengthening patch is about 70 mm long in the back, optionally about 100 mm long in the back, optionally about 140 mm long in the back. In one embodiment, the opacity strengthening patch is continuous and spans the entire length of the product. In one embodiment, the opacity strengthening patch has a hunter color opacity of greater than about 15%, optionally greater than about 25%, optionally greater than about 40%, optionally greater than 60%. In one embodiment the opacity strengthening patch is laterally outboard of the polymeric film layer. In one embodiment, the opacity strengthening patch overlaps the polymeric film layer in the lateral direction such that it can be affixed to the polymeric film in order to transmit laterally directed application and wearing forces from the opacity strengthening patch to the polymeric film layer. Any suitable bonding means known in the art may be used to affix the opacity strengthening patch to the polymeric film layer. In one embodiment, the opacity strengthening patch overlaps the polymeric film layer by about 5 mm, optionally about 10 mm, optionally about 15 mm, optionally about 20 mm, optionally less than about 30 mm. In one embodiment, there is a lateral gap between the opacity strengthening patch and the polymeric film layer and the opacity strengthening patch is affixed by any suitable bonding means to the leg gasketing system, and the leg gasketing system is affixed to the polymeric film layer by any suitable bonding means such that application and wearing loads can transmit from the opacity strengthening patch to the gasketing system and then from the gasketing system to the polymeric film layer. In this embodiment, the gap is preferably less than 30 mm, more preferably less than 20 mm, more preferably less than 10 mm. In one embodiment, there is a lateral gap between the opacity strengthening patch and the polymeric film layer; the opacity strengthening patch may be affixed by any suitable bonding means to the leg gasketing system and the body facing and garment facing sides of the leg gasketing system may be affixed together by any suitable bonding means so that the loads from the opacity strengthening patch are shared by both layers of the leg gasketing system. The leg gasketing system may be affixed to the polymeric film layer by any suitable bonding means such that application and wearing loads can transmit from the opacity strengthening patch to the leg gasketing system and then from the leg gasketing system to the polymeric film layer. In one embodiment, the opacity strengthening patch overlaps the leg gasketing system in the lateral direction such that it can be affixed securely to the opacity strengthening patch layer by any suitable bonding means as a way to transmit application and wearing forces from the opacity strengthening patch to the leg gasketing system. In this embodiment, the opacity strengthening patch may overlap the leg gasketing system by about 5 mm, optionally about 10 mm, optionally less than about 15 mm, optionally less than about 25 mm. In one embodiment the leg gasketing system has about the same lateral tensile strength properties as the opacity strengthening patch. In one embodiment the combined properties of the leg gasketing system and the backsheet nonwoven outer cover has about the same lateral tensile strength as the opacity strengthening patch. In another embodiment the outercover nonwoven has very low lateral strength between about 0% and about 10% engineering strain. In one embodiment, the outercover nonwoven may exhibit the following tensile properties: at 10% engineering strain for a 1 inch wide sample, 0.4N. Construction Materials It is recognized that there are many combinations of material lateral tensile properties that could form a substantially suitable force transmission pathway in the waist region or the article without excessive lateral stretch in the waist region, and that the material force pathways may go from the opacity strengthening patch directly into the polymeric film layer or into the polymeric film layer through a variety of other layers in the region immediately outboard the polymeric film layer. These layers may include the topsheet, backsheet nonwoven, cuff, absorbent assembly, leg gasketing system, or any other layer that is located in a region adjacent to the polymeric film layer. In one embodiment, the material of the leg gasketing system70is made from a substantially liquid impervious material. The material may be selected from the group consisting of an SMS nonwoven, SMMS nonwoven material, or a nonwoven component layer comprising “N-fibers”. Various nonwoven fabric webs may comprise spunbond, meltblown, spunbond (“SMS”) webs comprising outer layers of spunbond thermoplastics (e.g., polyolefins) and an interior layer of meltblown thermoplastics. In one embodiment of the present invention, the leg gasketing system70comprises a nonwoven component layer having fine fibers (“N-fibers”) with an average diameter of less than 1 micron (an “N-fiber layer”) may be added to, or otherwise incorporated with, other nonwoven component layers to form a nonwoven web of material. In some embodiments, the N-fiber layer may be used to produce a SNS nonwoven web or SMNS nonwoven web, for example. The leg gasketing cuff70may comprise a first nonwoven component layer comprising fibers having an average diameter in the range of about 8 microns to about 30 microns, a second nonwoven component layer comprising fibers having a number-average diameter of less than about 1 micron, a mass-average diameter of less than about 1.5 microns, and a ratio of the mass-average diameter to the number-average diameter less than about 2, and a third nonwoven component layer comprising fibers having an average diameter in the range of about 8 microns to about 30 microns. The second nonwoven component layer is disposed intermediate the first nonwoven component layer and the third nonwoven component layer. The N-fibers may be comprised of a polymer, e.g., selected from polyesters, including PET and PBT, polylactic acid (PLA), alkyds, polyolefins, including polypropylene (PP), polyethylene (PE), and polybutylene (PB), olefinic copolymers from ethylene and propylene, elastomeric polymers including thermoplastic polyurethanes (TPU) and styrenic block-copolymers (linear and radial di- and tri-block copolymers such as various types of Kraton), polystyrenes, polyamides, PHA (polyhydroxyalkanoates) and e.g. PHB (polyhydroxubutyrate), and starch-based compositions including thermoplastic starch, for example. The above polymers may be used as homopolymers, copolymers, e.g., copolymers of ethylene and propylene, blends, and alloys thereof. The N-fiber layer may be bonded to the other nonwoven component layers by any suitable bonding technique, such as the calender bond process, for example, also called thermal point bonding. In some embodiments, the use of an N-fiber layer in a nonwoven web may provide a low surface tension barrier that is as high as other nonwoven webs that have been treated with a hydrophobic coating or a hydrophobic melt-additive, and still maintain a low basis weight (e.g., less than 15 gsm or, alternatively, less than 13 gsm). The use of the N-fiber layer may also provide a soft and breathable (i.e., air permeable) nonwoven material that, at least in some embodiments, may be used in single web layer configurations in applications which previously used double web layer configurations. Furthermore, in some embodiments, the use of the N-fiber layer may at least reduce the undesirable migration of hydrophilic surfactants toward the web and, therefore, may ultimately result in better leak protection for an associated absorbent article. Also, when compared to an SMS web having a similar basis weight, the use of a nonwoven web comprising the N-fiber layer may decrease the number of defects (i.e., holes or pinholes through the mechanical bond site) created during the mechanical bonding process. N-fibers are further discussed in WO 2005/095700 and U.S. patent application Ser. No. 13/024,844. In one embodiment, the inner cuff72web of material has a hydrostatic head of greater than about 2 mbar, greater than about 3 mbar, greater than about 4 mbar. In one embodiment, the outer cuff76web of material has a hydrostatic head of less than about 200 mbar, less than about 100 mbar, less than about 75 mbar, less than about 50 mbar, less than about 25 mbar, less than about 15 mbar. In one embodiment, the folded outer cuff web of material has a basis weight of 10 gsm; optionally 13 gsm; optionally 15 gsm; optionally 18 gsm. In one embodiment, the inner cuff72web of material has an opacity of from about 15% to about 50% hunter opacity; optionally from about 20% to about 45% hunter opacity. In one embodiment, the outer cuff76web of material has an opacity of from about 45% to about 75% hunter opacity; optionally from about 50% to about 70% hunter opacity; optionally less than about 75% hunter opacity; optionally less than about 70% hunter opacity. In one embodiment, the inner cuff72web of material has an air permeability of less than about 50 m3/m2/min; optionally less than about 45 m3/m2/min. In one embodiment, the outer cuff76web of material has an air permeability of greater than about 5 m3/m2/min; optionally greater than about 10 m3/m2/min; optionally greater than about 15 m3/m2/min; optionally greater than about 20 m3/m2/min. In one embodiment, the inner cuff72web of material has a WVTR of less than about 5500 g/m2/24 hrs; optionally less than about 5400 g/m2/24 hrs. In one embodiment, the outer cuff76web of material has a WVTR of greater than about 4250 g/m2/24 hrs; optionally greater than about 4500 g/m2/24 hrs; optionally greater than about 5000 g/m2/24 hrs; optionally greater than about 5250 g/m2/24 hrs; optionally greater than about 5500 g/m2/24 hrs. The gasketing cuffs70may be substantially inelastic or may be elastically extensible to dynamically fit at the wearer's leg. The gasketing cuff70may be formed by one or more elastic members210(such as elastic strands) operatively joined to the topsheet24, backsheet26, or any other suitable substrate used in the formation of the absorbent article20. Suitable gasketing cuff construction is further described in U.S. Pat. No. 3,860,003. The inner cuff72may span the entire longitudinal length of the absorbent article20. The inner cuff72may be formed by a flap and an elastic member78(such as elastic strands). The inner cuff72may be a continuous extension of any of the existing materials or elements that form the absorbent article20. The inner cuff72may comprise a variety of substrates such as plastic films and woven or nonwoven webs of natural fibers (e.g., wood or cotton fibers), synthetic fibers (e.g., polyester or polypropylene fibers), or a combination of natural and synthetic fibers. In certain embodiments, the flap may comprise a nonwoven web such as spunbond webs, meltblown webs, carded webs, and combinations thereof (e.g., spunbond-meltblown composites and variants). Laminates of the aforementioned substrates may also be used to form the flap. A particularly suitable flap may comprise a nonwoven available from BBA Fiberweb, Brentwood, TN as supplier code 30926. A particularly suitable elastic member is available from Invista, Wichita, KS as supplier code T262P. Further description of diapers having inner cuffs and suitable construction of such cuffs may be found in U.S. Pat. Nos. 4,808,178 and 4,909,803. The elastic member210may span the longitudinal length of the inner cuff72. In other embodiments, the elastic member210may span at least the longitudinal length of the inner cuff72within the crotch region37. It is desirable that the elastic member210exhibits sufficient elasticity such that the inner cuff72remains in contact with the wearer during normal wear, thereby enhancing the barrier properties of the inner cuff72. The elastic member210may be connected to the flap at opposing longitudinal ends. In certain embodiments, the flap may be folded over onto itself so as to encircle the elastic member210. The inner cuff72and/or outer cuff76may be treated, in full or in part, with a lotion, as described above with regard to topsheets, or may be fully or partially coated with a hydrophobic surface coating as detailed in U.S. application Ser. No. 11/055,743, which was filed Feb. 10, 2005. Hydrophobic surface coatings usefully herein may include a nonaqueous, solventless, multicomponent silicone composition. The silicone composition includes at least one silicone polymer and is substantially free of aminosilicones. A particularly suitable hydrophobic surface coating is available from Dow Corning MI, Salzburg as supplier code 0010024820. EXAMPLES Air32 dyneOpacityPermeabilityWVTRHydroheadStrikethrough%m3/m2/ming/m2/24 hrsmbarSecOuterInnerOuterInnerOuterInnerOuterInnerOuterInnerProductLot No.CuffCuffCuffCuffCuffCuffCuffCuffCuffCuffPrototypeNA58.7 ±37.6 ±26.8 ±36.9 ±5905 ±5224 ±16.8 ±12.3 ±21.0±9.2 ±N-Fiber2.23.25.64.6129872.11.33.51.5PrototypeNA65.8 ±39.0 ±65.6 ±38.5 ±5748 ±5193 ±16.3 ±10.0 ±15.6 ±7.6 ±SMS1.81.011.53.82761451.81.71.91.4Pampers0089U01139042280.1 ±38.8 ±2.1 ±56.1 ±4063 ±5252 ±>2006.7 ±>10010.1 ±BabyDry0.43.81.06.3671570.80.5Luvs1047U01139051885.3 ±36.4 ±3.1 ±90.2 ±304 ±5244 ±>2006.5 ±>10011.8 ±1.23.41.99.3144261.01.4HuggiesBI006912B80.1 ±45.4 ±2.6 ±45.0 ±3673 ±5581 ±>2008.3 ±>10014.3 ±Little1.04.20.415.7190901.33.5MoversHuggiesNM1275U1F075572.7 ±53.6 ±4.4 ±145.2 ±375 ±5688 ±>2009.2 ±>10014.6 ±Supreme2.22.31.123.277851.83.1* Results are expressed as the average ± one standard deviation* Prototype N-Fiber is a 13 gsm SMNS available from Polymer Group Inc* Prototype SMS is a 15 gsm SMS (Spunbonded-Meltblown-Spunbonded) nonwoven available from Fibertex under the Comfort Line Package Turning toFIG.15, a disposable absorbent article20having any of the above-disclosed features may be provided in a package1000comprising about 5 or more articles20, or about 8 or more, or about 10 or more articles20. Combination of Embodiments While embodiments are described separately herein for brevity and clarity, combinations of the various embodiments are contemplated and within the scope of the present disclosure. For example, the combination of differently joined and different strained elastic members, where the outermost elastic member comprises an unattached span between two attachment intervals and is disposed at least 3 mm from the edge, would result in an enhancement of various benefits described herein. Test Methods Strain Test Method Strain is measured individually for each elastic member in a waist gasketing element. Linear measurements are made with a steel ruler traceable to NIST or similar standards organization. All testing is performed in a room controlled at 23° C.±3° C. and 50%±2% relative humidity. Open the article and place it, backsheet down, on a lab bench. Identify the waist gasketing element and carefully remove from the article in a non-destructive manner. For example, a minimal amount of cryogenic spray can be applied through the outermost layer of the article to remove the waist gasketing element. Cut two longitudinal lines perpendicular to the waist element lateral edge immediately inboard of the shortest elastic member for both the left and right side of the waist element. Cut the specimen in the lateral direction, midway between each elastic member, to isolate the individual elastic members within the waist gasketing element. Carefully label each strip to denote its position in the original waist gasketing element (e.g. top to bottom, position 1 through position n). Submerge a specimen strip in an appropriate solvent, such as tetrahydrofuran, that will dissolve the adhesives but not the nonwovens or elastic member. After the components have separated, remove each component from the solvent and place on a flat bench within a ventilated hood to allow the solvent to dry. Arrange the elastic member on the bench in a substantially linear configuration in a relaxed state and measure and record its length to the nearest 0.1 mm. Likewise, arrange the nonwoven strip flat on the bench, extended to its full dimension without stretching and measure the length to the nearest 0.1 mm. If the elastic member is sandwiched between two nonwovens, measure the length of both nonwoven strips and report the nonwoven length as their average to the nearest 0.1 mm. Calculate the Elastic Member Strain as the [Nonwoven Length (mm)−Elastic Member Length (mm)]/Elastic Member Length (mm)×100 and report to the nearest 0.1%. Repeat for each strip isolated from that waist gasketing element. The measure is performed for a total of five replicate waist gasketing elements. An average Elastic Member Strain is then calculated for each position (1 through n) and reported to the nearest 0.1%. Tensile Test Method for Force Differential of Waist Gasketing Element The tensile properties of an elasticized sample are measured on a constant rate of extension tensile tester with computer interface (a suitable instrument is the MTS Alliance using Testworks 4.0 Software, as available from MTS Systems Corp., Eden Prairie, MN) using a load cell for which the forces measured are within 10% to 90% of the limit of the cell. The load cell is calibrated per the vendor instructions prior to testing. Both the movable (upper) and stationary (lower) pneumatic jaws are fitted with rubber faced grips that are 15 mm wide by 8 mm tall. Linear measurements are made with a steel ruler traceable to NIST or similar standards organization. All testing is performed in a room controlled at 23° C.±3° C. and 50%±2% relative humidity. Open the article and place it, backsheet down, on a lab bench. Identify the Outboard Lateral Edge and Inboard Lateral Edge of the waist gasketing element. Mark the chassis at the four corners of the waist gasketing element. Carefully remove the waist gasketing element from the article in a non-destructive manner. For example, a minimal amount of cryogenic spray can be applied through the outermost layer of the article to remove the waist gasketing element. Mark the waist gasketing element at both of its longitudinal edges 7.5 mm up from the Inboard Lateral Edge and 7.5 mm down from the Outboard Lateral Edge. Repeat for both the left and right longitudinal edges. After the waist gasketing elements have been removed from the article, they are conditioned at 23° C.±3° C. and 50%±2% relative humidity two hours prior to testing. In like fashion, prepare three waist gasketing elements from three replicate articles. Fully extend the back region of the chassis where the waist gasketing element was removed and secure to the bench. Measure the distance between the marks on the chassis corresponding to the Outboard Lateral Edge (OBLE extension) and then the distance corresponding to the Inboard Lateral Edge position (IBLE extension) and record to the nearest 0.1 mm. Subtract 16.0 mm from the OBLE extension to give the Final OBLE extension. Likewise subtract 16.0 mm from the IBLE extension to give the Final IBLE extension. Take the waist gasketing element and measure the lateral width at the marks closest to the Outboard Lateral Edge (OBLE gage) and the lateral width at the marks closest to the Inboard Lateral Edge (IBLE gage) and record both to the nearest 0.1 mm. Subtract 16.0 mm from the OBLE gage to give the Final OBLE gage. Likewise subtract 16.0 mm from the IBLE gage to give the Final IBLE gage. Program the tensile tester to perform an extension test. From the original gage move the crosshead at 100 mm/min to the final extension endpoint and then return the crosshead to its original position. Force and extension data are collected at a rate of 100 Hz. The gage length and extension endpoint are entered manually for each specimen and test location. Set the gage length between grip faces to the Final OBLE Gage and zero the crosshead. Set the final extension equal to the Final OBLE Extension (mm). Insert the specimen into the upper grips, aligning it vertically within the upper and lower jaws. Align the top of the grip face flush with the left longitudinal edge of the specimen and centered at the mark proximal to the Outboard Lateral Edge. Close the upper grips. Insert the specimen into the lower grips with the grip face centered at the mark proximal to the Outboard Lateral Edge and close. The specimen should be under enough tension to eliminate any slack, but less than 0.05 N of force on the load cell. Start the test and collect force and extension data. Remove the specimen and allow to condition for 15 minutes. In like fashion repeat the tensile experiment for the Inboard Lateral Edge using the Final IBLE Gage length and Final IBLE Extension. The analysis is repeated in like fashion for a total of 3 replicate waist gasketing element specimens. From the paired force (N) vs extension (mm) curves, record the force at the Final OBLE Extension (N) and Final IBLE Extension (N) to the nearest 0.001 N. Calculate the Force Ratio as Force at Final IBLE Extension divided by Force at Final OBLE Extension for each of the 3 replicate specimens and report the arithmetic mean to the nearest 0.001. Opacity Method Opacity is measured using a 0° illumination/45° detection, circumferential optical geometry, spectrophotometer with a computer interface such as the HunterLab LabScan XE running Universal Software (available from Hunter Associates Laboratory Inc., Reston, VA) or equivalent instrument. Instrument calibration and measurements are made using the standard white and black calibration plates provided by the vendor. All testing is performed in a room maintained at 23±2° C. and 50±2% relative humidity. The spectrophotometer is conFIG.d for the XYZ color scale, D65 illuminant, 10° standard observer, with UV filter set to nominal. The instrument is standardized according to the manufacturer's procedures using the 0.7 inch port size and 0.5 inch area view. After calibration, the software is set to the Y opacity procedure which prompts the operator to cover the sample with either the white or black calibration tile during the measurement. Articles are pre-conditioned at 23° C.±2° C. and 50%±2% relative humidity for two hours prior to testing. To obtain a specimen, the article is stretched flat on a bench, body facing surface upward, and the total longitudinal length of the article is measured. A testing site on the inner and outer cuffs is selected at the longitudinal midpoint of the article. Using scissors, a test specimen is cut 60 mm long by the entire height of the inner cuff centered at the longitudinal midpoint of the left cuff. Next, a second test specimen is cut, this time from the outer cuff, 60 mm long by the entire height of the outer cuff, centered at the longitudinal midpoint of the left outer cuff. In like fashion, inner and outer cuff specimens are prepared from the cuffs on the right side of the article. The specimen is placed over the measurement port. The specimen should completely cover the port with the surface corresponding to the inner-facing surface of the cuff directed toward the port. The specimen is gently extended until taut in its longitudinal direction so that the cuff lies flat against the port plate. Adhesive tape is applied to secure the cuff to the port plate in its extended state for testing. Tape should not cover any portion of the measurement port. The specimen is then covered with the white standard plate. A reading is taken, then the white tile is removed and replaced with the black standard tile without moving the specimen. A second reading is taken, and the opacity is calculated as follows: Opacity=(Yvalue(black backing)/Yvalue(white backing))×100 Specimens from five identical articles (10 inner cuff (5 left and 5 right) and 10 outer cuff (5 left and 5 right)) are analyzed and their opacity results recorded. The average opacity for the inner cuffs and the outer cuffs are calculated and report separately, each to the nearest 0.01%. Water Vapor Transmission Rate Method Water Vapor Transmission Rate (WVTR) is measured using the wet cup approach. A cylindrical cup is filled with water, maintaining a constant headspace between the water surface and a specimen sealed over the cup's upper opening. The vapor loss is measured gravimetrically after heating the assembled cup for a specified time in an oven. All testing is performed in a room maintained at 23° C.±2° C. and 50%±2% relative humidity. Articles are preconditioned at 23° C.±2° C. and 50%±2% relative humidity for two hours prior to testing. The article stretched flat on a bench, body facing surface upward, and the total longitudinal length of the article is measured. A testing site on the inner and outer cuffs is selected at the longitudinal midpoint of the article. Using scissors, a test specimen is cut 60 mm long by the entire height of the inner cuff centered at the longitudinal midpoint of the left cuff. Next, a second test specimen is cut, this time from the outer cuff, 60 mm long by the entire height of the outer cuff, centered at the longitudinal midpoint of the left outer cuff. In like fashion, inner and outer cuff specimens from the cuffs on the right side of the article are prepared. Glass straight walled, cylindrical vials, 95 mm tall with a 17.8 mm internal diameter at the opening are used as WVTR test vials. Each test vial is filled with distilled water accurately to a level 25.0 mm±0.1 mm from the upper lip of the vial's opening. The specimen is placed, inner-facing surface of the cuff downward, over the vial's opening. The specimen is gently pulled taut and secured around the vial's circumference with an elastic band. The specimen is further sealed by wrapping Teflon tape around the vial's circumference. A preferred Teflon tape is a thread sealant tape 0.25″ wide available from McMaster Can (cat. No. 4591K11) or equivalent. The Teflon tape is applied up to the top edge of the vial but should not cover any portion of the vial's opening. The mass of the vial assembly (vial+specimen+sealing tape) is weighed to the nearest 0.0001 gram. This is the starting mass. The vial assemblies are placed upright in a mechanical convection oven (e.g. Lindberg/BlueM oven available from ThermoScientific or equivalent) maintained at 38±1° C. for 24 hours, taking care to avoid contact between the water in the vials and the specimens. After 24 hours has elapsed, the vial assemblies are removed from the oven and allowed to come to room temperature. The mass of each vial assembly is measured to the nearest 0.0001 gram. This is the final mass. The WVTR is calculated using the following equation: WVTR (g/m2/24 hrs)=([starting mass (g)−final mass (g)]/surface area (m2))/24 hrs Specimens from five identical articles (10 inner cuff (5 left and 5 right) and 10 outer cuff (5 left and 5 right)) are analyzed and their WVTR results recorded. The average WVTR for the inner cuffs and the outer cuffs are each reported separately to the nearest 1 g/m2/24 hrs. Air Permeability Test Air permeability is tested using a TexTest FX3300 Air Permeability Tester (available from Advanced Testing Instruments, Greer, SC) with a custom made 1 cm2circular aperture (also available from Advanced Testing Instruments) or equivalent instrument. The instrument is calibrated according to the manufacturer's procedures. All testing is performed in a room maintained at 23° C.±2° C. and 50%±2% relative humidity. The articles are pre-conditioned at 23° C.±2° C. and 50%±2% relative humidity for two hours prior to testing. To obtain a specimen, the article is stretched flat on a bench, body facing surface upward, and the total longitudinal length of the article is measured. A testing site on the inner and outer cuffs is selected at the longitudinal midpoint of the article. Using scissors, a test specimen is cut 60 mm long by the entire height of the inner cuff centered at the longitudinal midpoint of the left cuff. Next, a second test specimen is cut, this time from the outer cuff, 60 mm long by the entire height of the outer cuff, centered at the longitudinal midpoint of the left outer cuff. In like fashion, inner and outer cuff specimens are prepared from the cuffs on the right side of the article. The specimen is centered over the measurement port. The specimen should completely cover the port with the surface corresponding to the inward-facing surface of the cuff directed toward the port. The specimen is gently extended in its longitudinal direction until taut so that the cuff lies flat across the port. Adhesive tape is applied to secure the cuff across the port in its extended state for testing. Tape should not cover any portion of the measurement port. The test pressure is set to allow air to pass through the specimen. For non-woven cuffs the pressure is typically set for 125 Pa and for cuffs containing films typically 2125 Pa is used. The sample ring is closed and the measuring range is adjusted until the range indicator shows green to indicate that the measurement is within the accepted limits of the instrument. The air permeability is recorded to the nearest 0.1 m3/m2/min. Hydrostatic Head Test Hydrostatic head is tested using a TexTest FX3000 Hydrostatic Head Tester (available from Advanced Testing Instruments, Greer, SC) with a custom made 1.5 cm2circular measurement port (also available from Advanced Testing Instruments). Two annular sleeve rings, the same dimensions as the gaskets around the measurement ports, are cut from the standard protective sleeves for fine nonwovens (part FX3000-NWH, available from Advanced Testing Instruments). The sleeve rings are then adhered with two-sided adhesive tape to the sample facing surfaces of the upper and lower gaskets of the TexTest instrument to protect the specimen during clamping. Standardize the instrument according to the manufacturer's procedures. All testing is performed in a room maintained at about 23° C.±2° C. and about 50%±2% relative humidity. Precondition the articles at about 23° C.±2° C. and about 50%±2% relative humidity for two hours prior to testing. To obtain a specimen, lay the article stretched flat on a bench, body facing surface upward, and measure the total longitudinal length of the article. Select a testing site on the inner and outer cuffs, at the longitudinal midpoint of the article. Using scissors cut a test specimen 70 mm long by the entire height of the inner cuff centered at the longitudinal midpoint of the left cuff. Next cut a second test specimen, this time from the outer cuff, 70 mm long by the entire height of the outer cuff, centered at the longitudinal midpoint of the left outer cuff. In like fashion, prepare inner and outer cuff specimens from the cuffs on the right side of the article. Place the specimen centered over the port of the upper test head. The specimen should completely cover the port with the surface corresponding to the outward-facing surface of the cuff directed toward the port (inner-facing surface will then be facing the water). Gently extend the specimen taut in its longitudinal direction so that the cuff lies flat against the upper test plate. Adhesive tape is applied to secure the cuff to the test plate in its extended state for testing. Tape should not cover any portion of the measurement port. Fill the TexTest syringe with distilled water, adding the water through the measurement port of the lower test plate. The water level should be filled to the top of the lower gasket. Mount the upper test head onto the instrument and lower the test head to make a seal around the specimen. The test speed is set to 3 mbar/min for samples that have a hydrostatic head of 50 mbar or less and a speed of 60 mbar/min for samples with a hydrostatic head above 50 mbar. Start the test and observe the specimen surface to detect water droplets penetrating the surface. The test is terminated when one drop is detected on the surface of the specimen or the pressure exceeds 200 mbar. Record the pressure to the nearest 0.5 mbar or record as >200 mbar if there was no penetration detected. A total of five identical articles (10 inner cuff and 10 outer cuff specimens) are analyzed and their hydrostatic head results recorded. Calculate and report the average hydrostatic head for the inner cuffs and the outer cuffs and report each to the nearest 0.1 mbar. Low Surface Tension Fluid Strikethrough Time Test The low surface tension fluid strikethrough time test is used to determine the amount of time it takes a specified quantity of a low surface tension fluid, discharged at a prescribed rate, to fully penetrate a sample of a web (and other comparable barrier materials) which is placed on a reference absorbent pad. For this test, the reference absorbent pad is 5 plies of Ahlstrom grade 989 filter paper (10 cm×10 cm) and the test fluid is a 32 mN/m low surface tension fluid. This test is designed to characterize the low surface tension fluid strikethrough performance (in seconds) of webs intended to provide a barrier to low surface tension fluids, such as runny BM, for example. Lister Strikethrough Tester: The instrumentation is like described in EDANA ERT 153.0-02 section 6 with the following exception: the strike-through plate has a star-shaped orifice of 3 slots angled at 60 degrees with the narrow slots having a 10.0 mm length and a 1.2 mm slot width. This equipment is available from Lenzing Instruments (Austria) and from W. Fritz Metzger Corp (USA). The unit needs to be set up such that it does not time out after 100 seconds. Reference Absorbent Pad: Ahlstrom Grade 989 filter paper, in 10 cm×10 cm areas, is used. The average strikethrough time is 3.3+0.5 seconds for 5 plies of filter paper using the 32 mN/m test fluid and without the web sample. The filter paper may be purchased from Empirical Manufacturing Company, Inc. (EMC) 7616 Reinhold Drive Cincinnati, OH 45237. Test Fluid: The 32 mN/m surface tension fluid is prepared with distilled water and 0.42+/−0.001 g/liter Triton-X 100. All fluids are kept at ambient conditions. Electrode-Rinsing Liquid: 0.9% sodium chloride (CAS 7647-14-5) aqueous solution (9 g NaCl per 1 L of distilled water) is used. Test Procedure All testing is performed in a room maintained at about 23° C.±2° C. and about 50%±2% relative humidity. The Ahlstrom filter paper and test articles are conditioned in this controlled environment for 24 hours and 2 hours before testing.Ensure that the surface tension is 32 mN/m+/−1 mN/m. Otherwise remake the test fluid.Prepare the 0.9% NaCl aqueous electrode rinsing liquid.Ensure that the strikethrough target (3.3+/−0.5 seconds) for the Reference Absorbent Pad is met by testing 5 plies with the 32 mN/m test fluid as follows:Neatly stack 5 plies of the Reference Absorbent Pad onto the base plate of the strikethrough tester.Place the strikethrough plate over the 5 plies and ensure that the center of the plate is over the center of the paper. Center this assembly under the dispensing funnel.Ensure that the upper assembly of the strikethrough tester is lowered to the pre-set stop point.Ensure that the electrodes are connected to the timer.Turn the strikethrough tester “on” and zero the timer.Using the 5 mL fixed volume pipette and tip, dispense 5 mL of the 32 mN/m test fluid into the funnel.Open the magnetic valve of the funnel (by depressing a button on the unit, for example) to discharge the 5 mL of test fluid. The initial flow of the fluid will complete the electrical circuit and start the timer. The timer will stop when the fluid has penetrated into the Reference Absorbent Pad and fallen below the level of the electrodes in the strikethrough plate.Record the time indicated on the electronic timer.Remove the test assembly and discard the used Reference Absorbent Pad. Rinse the electrodes with the 0.9% NaCl aqueous solution to “prime” them for the next test. Dry the depression above the electrodes and the back of the strikethrough plate, as well as wipe off the dispenser exit orifice and the bottom plate or table surface upon which the filter paper is laid.Repeat this test procedure for a minimum of 3 replicates to ensure the strikethrough target of the Reference Absorbent Pad is met. If the target is not met, the Reference Absorbent Pad may be out of spec and should not be used.After the Reference Absorbent Pad performance has been verified, nonwoven web samples may be tested.Precondition the test articles at about 23° C.±2° C. and about 50%±2% relative humidity for two hours prior to testing. To obtain a specimen, lay the article stretched flat on a bench, body facing surface upward, and measure the total longitudinal length of the article. Select a testing site on the inner and outer cuffs, at the longitudinal midpoint of the article. Using scissors cut a test specimen 70 mm long by the entire height of the inner cuff centered at the longitudinal midpoint of the left cuff. Next cut a second test specimen, this time from the outer cuff, 70 mm long by the entire height of the outer cuff, centered at the longitudinal midpoint of the left outer cuff. In like fashion, prepare inner and outer cuff specimens from the cuffs on the right side of the article.Place the specimen centered over the port of the strike through plate. The specimen should completely cover the port with the surface corresponding to the body-facing surface of the cuff directed toward the port. Gently extend the specimen taut in its longitudinal direction so that the cuff lies flat against the upper test plate. Adhesive tape is applied to secure the cuff to the test plate in its extended state for testing. Tape should not cover any portion of the measurement port.Ensure that the upper assembly of the strikethrough tester is lowered to the pre-set stop point.Ensure that the electrodes are connected to the timer. Turn the strikethrough tester “on” and zero the timer.Run as described above.Repeat this procedure for three articles. Average the six values and report as the 32 mN/m low surface tension strikethrough time to the nearest 0.1 seconds. The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as “40 mm” is intended to mean “about 40 mm.” Every document cited herein, including any cross referenced or related patent or application and any patent application or patent to which this application claims priority or benefit thereof, is hereby incorporated herein by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with respect to any invention disclosed or claimed herein or that it alone, or in any combination with any other reference or references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern. While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention. | 170,988 |
11857401 | DETAILED DESCRIPTION OF THE INVENTION “Pull-on garment” or “pant” means articles of wear which have a defined waist opening and a pair of leg openings and which are pulled onto the body of the wearer by inserting the legs into the leg openings and pulling the article up over the waist. “Disposable” means garments, which are not intended to be laundered or otherwise restored or reused as a garment (i.e., they are intended to be discarded after a single use and to be recycled, composted or otherwise disposed of in an environmentally compatible manner). The pull-on garment may be “absorbent” such that it absorbs and contains the various exudates discharged from the body. “Closed form” means opposing waist regions are joined to form a continuous waist opening and leg openings. SeeFIGS.6,7, and15-17. “Array” means a display of packages comprising disposable articles of different sizes having like article constructions (e.g., same elastomeric materials [compositionally and/or structurally] in the flaps, graphic elements) said packages having the same brand and/or sub-brand, and said packages oriented in proximity to each other in a given area of a retail store. An array is marketed as a line-up of products normally having like packaging elements (e.g., packaging material type, film, paper, dominant color, design theme, etc.) that convey to consumers that the different individual packages are part of a larger line-up. Arrays often have the same brand, for example, “Huggies,” and same sub-brand, for example, “GoodNites.” A different array may have the brand “Huggies” and the sub-brand “Pull-Ups.” The differences between the “GoodNites” array and the “Pull-Ups” arrays may include for example different side seams, where “Good Nights” comprises a permanently closed side and “Pull-Ups” comprises a refastenable side seam. Furthermore, the packaging is distinctly different in that “GoodNites” is packaged in a predominately blue, film bag for boys and a predominantly pink, film bag for girls and “Pull-Ups” is packaged in a predominately blue, film bag for boys and a predominantly pink, film bag for girls. The key differences are the wearers displayed on the packaging wherein GoodNites packaging has older children displayed on it relative to the children on the Pull-Ups packaging. Arrays also often have the same trademarks, including trademarks of the brand, sub-brand, and/or features and/or benefits across the line-up. “On-line Array” means an “Array” distributed by a common on-line source. “Hip Circumference” means the circumference of the body at the level of the maximum posterior protuberance of buttocks. SeeFIG.1. “Hip Width” means the horizontal distance at the front of the body at the hips, where the hips are defined at the same level as the maximum prominent point of the buttocks as seen from the side. SeeFIG.3. “Side Length” means the vertical distance from the navel to the level of the hip (where the hips are defined at the maximum prominent point of the buttocks as seen from the side. SeeFIG.3. “Hip Circumference-to-Side Length Ratio” means the Hip Circumference (mm) divided by the Side Length (mm). SeeFIG.1. “Body Hip-to-Side Silhouette” means the Hip Width (mm) divided by the Side Length (mm). SeeFIG.3. “Product Hip-to-Side Silhouette” means Relaxed Product Hip Width (301) (mm) divided by the Relaxed Product Side Length (303) (mm). SeeFIGS.6and7. “Array Average Product Hip-to-Side Silhouette” means the average Product Hip-to-Side Silhouette of each size offered in a product array. “Relaxed Product Length” means the longitudinal distance between the longitudinally distal most point in the crotch region and the longitudinally distal most point along the front waist edge. The longitudinal distance is measured parallel to the longitudinal axis of the product. Refer toFIGS.6and7. “Relaxed Product Hip Width” means the lateral distance from the laterally distal most point of the left side edge of the product at the upper edge of the left leg opening to the laterally distal most point of the right side edge of the product at the upper edge of the right leg opening. Refer toFIGS.6and7. The lateral distance is measured perpendicular to the longitudinal axis of the product. “Relaxed Product Waist Width” means the lateral distance from the distal most point at the right side of the front waist edge to the distal most point at the left side of the front waist edge. The lateral distance is measured perpendicular to the longitudinal axis of the product. Refer toFIGS.6and7. “Relaxed Product Side Length” means the linear distance from the point of intersection between the waist edge and the side edge of the product to the point of intersection between the top of the leg opening and the same side edge of the product. The relaxed product side length measurement is the average of the measurements from the left and right sides of the product. Refer toFIGS.6and7. “Target Waist Range” means the waist range as defined on each product package. For example, the Depend for Women Moderate Absorbency S/M package indicates a waist of 28-40 in (71-102 cm). “Average Targeted Waist” means the average of the Target Waist Range. For example, the Depend for Women Moderate Absorbency S/M has a Target Waist Range (as defined on its package) of 71-102 cm. The Average Targeted Waist for this product is 86.5 cm. Consumers who are urinary incontinent especially those who are suffering from nocturnal enuresis often are traumatized by the condition. Many aspects of the condition contribute to the trauma, like the fear of having an incontinent event in public. Even when wearing an absorbent article, there is still the fear of leaking, and the fear of their absorbent article being noticeable under their clothes. As such providing a product experience that helps normalize the condition by providing a more underwear-like, thin and body conforming structure across the entire weight/age range is one of the objects of the present disclosure. FIG.8illustrates a variety of specific shapes that may exist within each weight range: rectangle (also known as cylindrical), hourglass, pear, and apple. The higher the weight, the further to the right (toward the apple) a wearer typically is on this body shape scale. The prevalence of these shapes differs among weight ranges, for instance, higher weight wearers have a higher probability of being apple or pear shaped. Absorbent articles may be marketed to wearers of a particular body shape, such as apple, rather than focusing on exact weight values (which may be off-putting to a consumer), in order to match a wearer with the article that will best fit their unique body shape or size. It may be desirable to link the Product Hip-to-Side Silhouette to that of the targeted consumers Body Hip-to-Side Silhouette in order to achieve a better fitting, better conforming, better gasketing product. This may increase the wearing comfort for each consumer while reducing leakage. Additionally, a product array where the Product Hip-to-Side Silhouette of each subsequently larger size follows the same general trend as the Body Hip-to-Side Silhouette for each subsequently larger size may also deliver a better fitting, better conforming article to each consumer regardless of their respective weight. The anthropometric measures of Hip Circumference and Side Length are illustrated inFIG.1. The relationship between the ratio of Hip Circumference to Side Length versus Body Weight is illustrated inFIG.2. The projected body shape measures Hip Width and Side Length are illustrated inFIG.3. The relationship of Body Hip-to-Side Silhouette versus Body Weight is illustrated inFIG.5.FIGS.2and5illustrate that there is a correlation between Body Hip Circumference to Side Length versus Body Weight, and the Body Hip-to-Side Silhouette versus Body Weight. Absorbent Article The absorbent articles of the present disclosure are generally designed and configured to manage bodily exudates such as urine, menses, feces or other vaginal discharges. In one embodiment, an absorbent article may comprise a chassis comprising a topsheet, a backsheet, and an absorbent core disposed at least partially between the topsheet and the backsheet. The absorbent chassis may comprise a waistband, leg cuffs and or elastic strands. In various embodiments, referring toFIGS.12, an example absorbent article10is shown in its flat uncontracted state prior to joining the side seams, in some cases the side seams are formed by fastening components53aandb. In one embodiment, referring toFIG.12, one end portion of the absorbent article10may be configured as a front waist region36and the longitudinally opposing end portion may be configured as a back waist region38. An intermediate portion of the absorbent article10extending longitudinally between the front waist region36and the back waist region38may be configured as a crotch region37. The length of each of the front waist region36, the back waist region38and the crotch region37may be about ⅓ of the length of the absorbent article10, for example, as illustrated inFIGS.13and14(versus coinciding with the front and back belts as illustrated inFIG.12. In other embodiments, the length of each of the front waist region36, the back waist region38, and the crotch region37may have other dimensions. In various embodiments, the absorbent article10may have a laterally extending front waist end edge136in the front waist region36and a longitudinally opposing and laterally extending back waist end edge138in the back waist region38. In one embodiment, referring toFIG.12, a chassis100of the absorbent article10may comprise a first longitudinally extending side edge137aand a laterally opposing and second longitudinally extending side edge137b. Both of the side edges137may extend longitudinally between the front waist end edge136and the back waist end edge138. The chassis100may form a portion of the laterally extending front waist end edge136in the front waist region36and a portion of the longitudinally opposing and laterally extending back waist end edge138in the back waist region38. Furthermore, the chassis100may comprise an interior surface102, an exterior surface104, a longitudinal axis42, and a lateral axis44. The longitudinal axis42may extend through a midpoint of the front waist end edge136and through a midpoint of the back waist end edge138, while the lateral axis44may extend through a midpoint of the first side edge137aand through a midpoint of the second side edge137b. In various embodiments, a portion of or the whole absorbent article10may be made to be laterally extensible. The extensibility of the absorbent article10may be desirable in order to allow the absorbent article10to conform to a body of a wearer during movement by the wearer. The extensibility may also be desirable, for example, in order to allow the caregiver to extend the front waist region36, the back waist region38, the crotch region37, and/or the chassis100to provide additional body coverage for wearers of differing size, i.e., to tailor the absorbent article10to the individual wearer. Such extension may provide the absorbent article10with a generally hourglass shape, so long as the crotch region37is extended to a relatively lesser degree than the waist regions36and/or38. This extension may also impart a tailored appearance to the absorbent article10during use. Many current pull-on pant absorbent articles have a brief style design, dimensionally similar to full cut brief underwear. Such brief style articles are designed to fit in the waist at the navel of the wearer and along the legs and sides at the level of the hip. All of these products have side seams which have a length that is substantially less than the folded length of the article as measured along the longitudinal centerline. That means the hoop that supports the article only anchors the upper portion of the article and the remainder of the article disposed primarily in the crotch has no lateral support and as such can shift and move with the wearer's movements. In addition, the weight of the center chassis, when loaded, also imparts a force having a vector that is substantially perpendicular to the force vector of the hoop which can contribute to degradation of the overall fit of the article leading to sagging and gapping of gasketing elements and degradation of article performance. In order to overcome this perpendicular degradation force the force of the hoop would have to be so high that it would be detrimental to the comfort of the wearer, resulting in poor fit, increased skin marking and difficulty of application, etc. The stabilization benefits of a longitudinally longer elasticized belt structure described herein are enabled by a product design having a lower Product Hip to Side silhouette. The lower Product Hip to Side Silhouette is a result of a longer side seam length for a given size absorbent article. The resultant Product Hip to Side Silhouette ratio of these absorbent articles range from about 0.5 to about 1.8. The lower Product Hip to Side Silhouette results in product designs that are similar to boy boxer brief and girl boy-short style underwear. The boxer brief/boy-short silhouette absorbent articles of the present disclosure are designed to fit at the waist at or adjacent the navel and along the legs below the hip closer to the level of the bottom of the crotch of the center chassis. Such designs have side seams that are closer to the folded length of the article as measured along the longitudinal centerline. This style of fit minimizes the impact of the dynamic forces imparted by movements of the wearer on the center chassis in the crotch by providing lateral stabilization along the legs thereby helping to maintain contact and position of all of the gasketing elements of the center chassis. In addition, having more of the absorbent core within the hoop created by the longer elasticized belt portion of the article also helps increase absorbent to body contact thereby improving fluid uptake and leakage prevention. In certain embodiments, the side seam length is preferably >60% and <100% of the relaxed product length of the article as measured along the longitudinal centerline. In other embodiments, the side seam length is preferably >70% and <100% of the relaxed product length of the article as measured along the longitudinal centerline. In yet another embodiment, the side seam length is preferably >80% and <100% of the relaxed product length of the article as measured along the longitudinal centerline. In another embodiment, the side seam length is preferably >90% and <100% of the relaxed product length of the article as measured along the longitudinal centerline. The elastic features described herein enhance the dynamic fit of the absorbent article about the wearer in those zones that undergo dynamic changes caused by the wearer's movements. In an especially preferred embodiment, the absorbent article is provided with elastic waist features, elastic lea cuffs, and elastic side/hip panels that provide elastic extensibility to provide greater freedom of movement for the wearer and a more comfortable and contouring fit by initially conformably fitting the diaper to the wearer and by sustaining this fit during use. Due to the increased size and coverage of the elastic belt structures, these structures may t have differential extensibility along the longitudinal axis when stretched in the lateral direction. The differential extensibility allows portions to laterally expand to a greater degree than other portions along the longitudinal axis. This differential extensibility provides a belt having both an abdominally compliant front elastic portion as well as an elastically compliant hip/leg portion that can expand differentially providing distinctive shape, dimensions and forces targeted to adapt to the specific wearer movements of those regions as the wearer moves, sits, and stands. Any or all portions of the absorbent article may comprise a bacteriophage composition as described in U.S. Ser. No. 61/931,229, titled DISPOSABLE ABSORBENT ARTICLES COMPRISING BACTERIOPHAGES AND RELATED METHODS, and filed on Jan. 24, 2014. Topsheet In one embodiment, referring toFIGS.4a,4b,12and19, the absorbent article10may comprise a topsheet81. The topsheet81may be compliant, soft feeling, and non-irritating to the wearer's skin and may be elastically stretchable in one or more directions. Further, the topsheet81may be liquid pervious, permitting liquids (e.g., menses, urine, and/or runny feces) to penetrate through its thickness. Various topsheets may also comprise a hydrophilic material, for example, which is configured to draw bodily fluids into an absorbent core of the chassis100when these fluids are expelled from the body. A suitable topsheet81may be manufactured from a wide range of materials, such as woven and nonwoven materials, apertured or hydroformed thermoplastic films, apertured nonwovens, porous foams, reticulated foams, reticulated thermoplastic films, and/or thermoplastic scrims, for example. Suitable apertured films may comprise those described in U.S. Pat. Nos. 3,929,135, 4,324,246, 4,342,314, 4,463,045, 5,006,394, 5,628,097, 5,916,661, 6,545,197, and 6,107,539. Apertured film or nonwoven topsheets typically may be pervious to bodily exudates, yet non-absorbent, and have a reduced tendency to allow fluids to pass back through and rewet the wearer's skin. Suitable woven and nonwoven materials may comprise natural fibers, such as, for example, wood or cotton fibers, synthetic fibers, such as, for example, polyester, polypropylene, or polyethylene fibers, or combinations thereof. If the topsheet81comprises fibers, the fibers may be spunbond, carded, wet-laid, meltblown, hydroentangled, or otherwise processed, for example, as is generally known in the art. The topsheet may comprise a skin care lotion. Examples of suitable lotions include, but are not limited to, those described in U.S. Pat. Nos. 5,607,760; 5,609,587; 5,635,191; 5,643,588; and 5,968,025, and as described in U.S. application Ser. No. 61/391,353. In one embodiment, the topsheet may comprise graphics (e.g.,116inFIG.15) such that depth perception is created as described in U.S. Pat. No. 7,163,528. Backsheet In one embodiment, referring toFIGS.4a,4b,18and19, for example, the absorbent article10may comprise a backsheet83. The backsheet83may be impervious, or at least partially impervious, to fluids or body exudates (e.g., menses, urine, and/or runny feces) and may be manufactured from a thin plastic film, although other flexible liquid impervious materials may also be used. The backsheet83may prevent the body exudates or fluids absorbed and contained in an absorbent core of the absorbent article10from wetting articles which contact the absorbent article10, such as bedsheets, pajamas, clothes, and/or undergarments. The backsheet83may comprise a woven or nonwoven material, polymeric films such as thermoplastic films of polyethylene or polypropylene, and/or a multi-layer or composite materials comprising a film and a nonwoven material (e.g., having an inner film layer and an outer nonwoven layer). A suitable backsheet may comprise a polyethylene film having a thickness of from about 0.012 mm (0.5 mils) to about 0.051 mm (2.0 mils). Examples of polyethylene films are manufactured by Clopay Corporation of Cincinnati, Ohio, under the designation BR-120 and BR-121, and by Tredegar Film Products of Terre Haute, Ind., under the designation XP-39385. One suitable material for the backsheet can be a liquid impervious thermoplastic film having a thickness of from about 0.012 mm (0.50 mil) to about 0.051 mm (2.0 mils), for example including polyethylene or polypropylene. Typically, the backsheet can have a basis weight of from about 5 g/m2to about 35 g/m2. The backsheet can be typically positioned adjacent the outer-facing surface of the absorbent core and can be joined thereto. For example, the backsheet may be secured to the absorbent core by a uniform continuous layer of adhesive, a patterned layer of adhesive, or an array of separate lines, spirals, or spots of adhesive. Illustrative, but non-limiting adhesives, include adhesives manufactured by H. B. Fuller Company of St. Paul, Minn., U.S.A., and marketed as HL-1358J. An example of a suitable attachment device including an open pattern network of filaments of adhesive is disclosed in U.S. Pat. No. 4,573,986. Another suitable attachment device including several lines of adhesive filaments swirled into a spiral pattern is illustrated by the apparatus and methods shown in U.S. Pat. Nos. 3,911,173; 4,785,996; and 4,842,666. Alternatively, the attachment device may include heat bonds, pressure bonds, ultrasonic bonds, dynamic mechanical bonds, or any other suitable attachment device or combinations of these attachment devices. In one embodiment, the backsheet83may be embossed and/or matte-finished to provide a more cloth-like appearance. Further, the backsheet83may permit vapors to escape from the absorbent core of the absorbent article10(i.e., the backsheet83is breathable) while still preventing, or at least inhibiting, fluids or body exudates from passing through the backsheet83. In one embodiment, the size of the backsheet83may be dictated by the size of the absorbent article10and the design or configuration of the absorbent article10to be formed, for example. Absorbent Core In various embodiments, referring toFIGS.4a,4b,18and19, the absorbent article10may comprise an absorbent core (also referred to as an “absorbent member” or “absorbent assembly” or “absorbent structure” or “absorbent composite”)200that is disposed between the topsheet81and the backsheet83. The absorbent core200may comprise a laterally extending front edge236in the front waist region36, a longitudinally opposing and laterally extending back edge238in the back waist region38, a first longitudinally extending side edge237a, and a laterally opposing and second longitudinally extending side edge237b. Both of the side edges237may extend longitudinally between the front edge236and the back edge238. In one embodiment, more than one absorbent core200or more than one absorbent core layer may be provided in an absorbent article10, for example. The absorbent core200may be any suitable size or shape that is compatible with the absorbent article10. Example absorbent structures for use as the absorbent core200of the present disclosure that have achieved acceptance and commercial success are described in U.S. Pat. Nos. 4,610,678; 4,673,402; 4,888,231; and 4,834,735. In one embodiment, suitable absorbent cores may comprise cellulosic airfelt material. For instance, such absorbent cores may comprise less than about 40%, 30%, 20%, 10%, 5%, or even 1% of the cellulosic airfelt material as determined by weight. Additionally, such an absorbent core may be primarily comprised of an absorbent gelling material in amounts of at least about 60%, 70%, 80%, 85%, 90%, 95%, or even about 100% as determined by weight. Furthermore, a portion of the absorbent core may comprise a microfiber glue (if applicable). Such absorbent cores, microfiber glues, and absorbent gelling materials are described in U.S. Pat. Nos. 5,599,335; 5,562,646; 5,669,894; 6,790,798; and 7,521,587 and in U.S. Pat. Publ. No. 2004/0158212. In one embodiment, the core, including multiple layers making up the core system, may be printed and embossed as described in U.S. Pat. No. 8,536,401. In one embodiment, the core may be separable from the chassis as disclosed in U.S. Pat. Nos. 6,989,006; 7,381,202; 7,175,613; 7,824,386; 7,766,887; and 6,989,005. In such embodiments, the measurements described in this disclosure may be made to the chassis alone or may be made to the chassis in combination with the separable core/absorbent assembly. In one embodiment, the absorbent article of the present disclosure, and particularly, a portion where the absorbent member is disposed, may have a body fluid absorption rate greater than 3 g/sec according to U.S. Pat. No. 6,649,810. According to U.S. Pat. No. 6,649,810, the expression “the portion (of the absorbent article) where the absorbent member is disposed” is intended to mean the portion occupied by the absorbent member when the absorbent article is flatly unfolded and seen in its plan view. In one embodiment, the absorbent structure may have an intake factor greater than 3 according to U.S. Pat. No. 7,073,373, wherein the intake factor is defined as the absorbent core permeability divided by the normalized retention capacity (which is defined by the Retention Capacity Test—also according to U.S. Pat. No. 7,073,373). In one embodiment, the absorbent composite has a body fluid absorption greater than 75 g/100 cm2, according to U.S. Pat. No. 6,649,810. In one embodiment, a target location of the absorbent article may have a wicking value greater than 36%, according to U.S. Pat. No. 6,383,960. In one embodiment, the absorbent article may have a bending stiffness between 0.05-1.0 gf, according to U.S. Pat. No. 5,810,796. In one embodiment, the absorbent article may have a crotch fluid absorption rate greater than 3 g/sec according to U.S. Pat. No. 6,649,810. In one embodiment, a freeze-dried composite of the absorbent composite may have an intake rate of at least about 1.9 cubic centimeters (cc) of liquid/second at 80% composite saturation according to U.S. Pat. No. 6,689,934. Leg Cuffs In one embodiment, referring toFIGS.13and14, the chassis100of the absorbent article10may comprise longitudinally extending and laterally opposing leg cuffs147aand147bthat are disposed on the interior surface of the chassis100that faces inwardly toward the wearer and contacts the wearer. The leg cuffs147aand147bmay comprise one or more elastic gathering members disposed at or adjacent the proximal edge of one or both of the leg cuffs147. In addition, the elastic gathering members of the leg cuff may also comprise one or more elastic strands146disposed at or adjacent the distal edge of one or both of the leg cuffs147. The elasticized leg cuffs147may comprise several embodiments for reducing the leakage of body exudates or fluids in the leg regions. The elasticized leg cuffs147are sometimes referred to as leg bands, barrier cuffs, elastic cuffs, or gasketing cuffs. Suitable elasticized leg cuffs147may comprise those described in U.S. Pat. Nos. 3,860,003, 4,909,803, 4,695,278, 4,795,454, 4,704,115, and 4,909,803, and U.S. Pat. Publ. No. 2009/0312730. The leg cuffs147may be formed by folding portions of the chassis100laterally inward, i.e., toward the longitudinal axis42, to form both the respective leg cuffs147and the side edges137aandbof the chassis100. In other embodiments, the leg cuffs147may be formed by attaching an additional layer or layers to the chassis100at or adjacent to each of the respective side edges137aand137bof the chassis100. In one embodiment, the chassis100may also comprise other elastics disposed adjacent the side edges137which may cause the article10to form into a “U” shape when allowed to relax thereby pulling the interior surface102of the front waist region36toward the interior surface102of the back waist region38. In one embodiment, each leg cuff147may comprise a proximal edge157aand157b. These edges157aand157bare positioned proximate to the longitudinal axis42compared to distal edges139aand139b. The leg cuffs147may overlap the absorbent core200, i.e., the proximal edges157aand157blie laterally inward of the respective side edges237aand237bof the absorbent core200. Such an overlapped configuration may be desirable in order to impart a more finished appearance to the absorbent article10than that imparted by a non-overlapped configuration. In other embodiments, the leg cuffs147may not overlap the absorbent core200. In one embodiment, each leg cuff147may be attached to the interior surface102of the chassis100in a leg cuff attachment zone (not shown) adjacent to the front waist end edge136and in a longitudinally opposing leg cuff attachment zone (not shown) adjacent to the back waist end edge138. In one embodiment, between the leg cuff attachment zones, the proximal edge157of the leg cuff147remains free, i.e., not attached to the interior surface102of the chassis100or to the absorbent core200. Also, between the longitudinally opposing leg cuff attachment zones, each leg cuff147may comprise one or more (specifically including one, two, three, or four elastic strands per leg cuff147) longitudinally extensible cuff elastic gathering members159that may be disposed at or adjacent to the proximal edge157of the leg cuff147by any suitable methods. Each of such cuff elastic gathering members159may be attached over the leg cuff's entire length or over only a portion of the leg cuff's length. For example, such cuff elastic gathering members159may be attached only at or near the leg cuff's longitudinally opposing ends and may be unattached at the middle of the leg cuff's length. Such cuff elastic gathering members159may be disposed in the crotch region37and may extend into one or both of the front waist region36and the back waist region38. For example, an elastic gathering member159may be attached at or adjacent to the proximal edge157of each of the leg cuffs147and extends into both the front waist region36and the back waist region38. In various embodiments, each cuff elastic gathering member159may be enclosed inside a folded hem for example. In various embodiments, the cuff elastic gathering members159may be sandwiched between two layers forming the leg cuff147, by two layers of the chassis100, or may be attached on a surface of the chassis100or the leg cuff147and remain exposed. In one embodiment, when stretched, the cuff elastic gathering member159disposed adjacent to each leg cuff's proximal edge157allows the leg cuff proximal edge157to extend to the flat uncontracted length of the chassis100, e.g., the length of the chassis100. When allowed to relax, the cuff elastic gathering member159contracts to pull the front waist region36and the back waist region38toward each other and, thereby, bend the article10into a “U” shape in which the interior of the “U” shape may be formed by the portions of the article10that are intended to be placed toward the body of the wearer (i.e., interior surface102). Because each of the proximal edges157remains free between the longitudinally oriented leg cuff attachment zones, the contractive force of the elastic gathering member159may lift the proximal edge157of the leg cuff147away from the interior surface102of the chassis100. This lifting of the proximal edges157when the article10is in the relaxed condition lifts the leg cuffs147into a position to serve as side barriers to prevent, or at least inhibit, leakage of bodily exudates. Waistband In one embodiment, referring toFIG.14, the article10may comprise an elasticized waistband112aandb. The elasticized waistband may provide improved fit and containment and may be configured to elastically expand and contract laterally to dynamically fit a wearer's waist. The elasticized waistband may extend longitudinally outwardly from the waist edge of the absorbent article10toward the waist edge of the absorbent core200. In one embodiment, the absorbent article10may have two elasticized waistbands, one positioned in the back waist region38and one positioned in the front waist region36, although other pant embodiments may be constructed with a single elasticized waistband. The elasticized waistband may be constructed in a number of different configurations including those described in U.S. Pat. Nos. 4,515,595 and 5,151,092. In one embodiment, the elasticized waistbands may comprise materials that have been “prestrained” or “mechanically prestrained” (i.e., subjected to some degree of localized pattern mechanical stretching to permanently elongate the material). The materials may be prestrained using suitable deep embossing techniques. In other embodiments, the materials may be prestrained by directing the material through an incremental mechanical stretching system as described in U.S. Pat. No. 5,330,458. The materials may then be allowed to return to their substantially untensioned condition, thus forming a zero strain stretch material that is extensible, at least up to the point of initial stretching. Examples of zero strain materials are disclosed in U.S. Pat. Nos. 2,075,189, 3,025,199, 4,107,364, 4,209,563, 4,834,741, and 5,151,092. Flaps The flaps189(a-d) may be discrete from or integral with the chassis100. A discrete flap is formed as separate element, which is joined to the chassis100. In some embodiments, this includes a plurality of flaps, e.g. 2 or 4 (often referred to as ear panels or side flaps) being joined to the side edges137aandbof the chassis in the front and/or rear waist regions36and38(seeFIGS.12-17). In other embodiments this may include a front and/or back belt-like flaps (“belts”) being joined across the front and back (or rear) waist regions of the chassis100, at least across end edges of the chassis136and138(seeFIGS.4a,4b,12and19). In some embodiments the waistbands112can overlap the flaps to create a continuous belt-like structure (seeFIG.14). The belt-like flaps and may comprise an inner nonwoven layer and an outer nonwoven layer and elastics there between. The inner and outer nonwoven layers may be joined using adhesive or thermoplastic bonds. Various suitable belt-like flap configurations can be found in U.S. Pub. No. 2013-0211363.FIG.11illustrates belt flaps in the front and back waist regions that are discrete and that have a relatively small distance between the front and back belt flaps such that only a small portion of the chassis hangs below the belts (seeFIG.7). An integral flap is a portion, one or more layers, of the chassis that projects laterally outward from the longitudinal edge. The integral flap may be formed by cutting the chassis to include the shape of the flap projection. While many of the embodiments illustrated in this application having belt-like flaps are pant articles, taped articles may have belt-like flaps disposed in one or both waist regions as well. The structure of flaps play an important role in the functionality of the absorbent article and are fundamentally different than the elastics used in underwear. As mentioned above, incontinence events, such as SUI and UUI, can result in a high flow rate and/or a full bladder release. The amounts of urine expelled during the incontinence events can vary wildly given the type of urinary incontinence as well as other circumstances such as time since last bathroom visit, amount of fluid intake, day or night, etc. Loadings can range from as low as a few drops of urine to loadings as high as 600 mls. It is not unusual to have single loadings as high as 300, 400 and even 500 mls. These levels of loading present a significant downward force associated with the loading which can be a pound or more. This downward force must be compensated for by the absorbent article chassis in order to minimize sagging, gapping and leakage. In order to sustain the fit of the article even after loading the article comprises elastomeric element(s)146, including films (including apertured films) and/or strands) that are disposed proximate to and along the side seams280aandb(see, for example,FIG.15, where the elastomeric elements146terminate proximate to and along the length of the seams280aandb) of the article and extend laterally from one side toward the other. Each of the elastomeric elements146may extend continuously from side seam280ato side seam280bin the front and the back belts along the longitudinal distance from the belt waist edges136,138to the opposite belt end edges (versus being cut as illustrated inFIGS.4a,4b,12, and15), such that one or more of the elastomeric elements146overlap with the absorbent core200; it may be desirable for 3 or more elastic elements146to overlap with the core in the front and/or back waist regions36and38. These elastomeric element(s) should create a normal force against the body sufficient to anchor the article. The location of the elastomeric element(s), as well as the forces exerted by the elastomeric element(s) can be varied to ensure proper anchoring at the hips and along the body specifically across the front waist region and in the back waist region. One form of anchoring beneficial for sustaining the fit of a loaded article is disclosed in U.S. Pat. No. 5,358,500 Absorbent Articles Providing Sustained Dynamic Fit issued Oct. 25, 1994 to LaVon, et al. It should also be noted that regular underwear with elastic along the waist edge and leg edges would not typically provide sufficient support to sustain the fit of the underwear if a weight of 300-600 grams was applied to the crotch region of the underwear. Fastening System The absorbent article may also include a fastening system. When fastened, the fastening system interconnects the front waist region36and the rear waist region38resulting in a waist circumference that may encircle the wearer during wear of the absorbent article10. This may be accomplished by flaps189aandbin the back waist region interconnecting with flaps189canddin the front waist region or by flaps in the back waist region interconnecting with the chassis100in the front waist region. The fastening system may comprises a fastener53aandbsuch as tape tabs, hook and loop fastening components, interlocking fasteners such as tabs & slots, buckles, buttons, snaps, and/or hermaphroditic fastening components, although any other known fastening means are generally acceptable. The fasteners may releasably engage with a landing zone118, which may be a woven or nonwoven. Some exemplary surface fastening systems are disclosed in U.S. Pat. Nos. 3,848,594; 4,662,875; 4,846,815; 4,894,060; 4,946,527; 5,151,092; and 5,221,274. An exemplary interlocking fastening system is disclosed in U.S. Pat. No. 6,432,098. The fastening system may also provide a means for holding the article in a disposal configuration as disclosed in U.S. Pat. No. 4,963,140. The fastening system may also include primary and secondary fastening systems, as disclosed in U.S. Pat. No. 4,699,622. The fastening system may be constructed to reduce shifting of overlapped portions or to improve fit as disclosed in U.S. Pat. Nos. 5,242,436; 5,499,978; 5,507,736; and 5,591,152. Identical or Substantially Identical Chassis As disclosed in U.S. Pub. No. 2013-0211355, it may be desirable to offer an array of packages for fitting different sized wearers, but comprising identical or substantially identical chassis. For instance, an array may comprise a first package comprising a first size of absorbent articles and a second package may comprise a second size of absorbent articles, where the first and second packages comprise identical or substantially identical chassis as described in U.S. Pub. No. 2013-0211355. More particularly, the first package may comprise a first chassis and the second package may comprise a second chassis, where each of the first and second chassis comprise the same dimensions of one or more of: core width at the lateral centerline, core width at one of the front or rear core end, a distance from a left outer cuff distal edge to a right outer cuff distal edge, a distance from a left inner cuff distal edge to a left outer cuff distal edge, a distance from a left inner cuff proximal edge to a right inner cuff proximal edge, a distance from a left inner cuff proximal edge to a left outer cuff distal edge, a free height of the inner cuff, inner cuff hem fold width, inner cuff elastics length, outer cuff elastics length, core length, and backsheet width. Further, each of the first and second chassis may comprise identical chemical compositions of one or more of a topsheet, backsheet film, backsheet nonwoven, core super absorbent polymers, core pulp, core nonwoven, core tissue, leg cuff film, leg cuff nonwoven, super absorbent polymer adhesive, core nonwoven adhesive, leg cuff elastic adhesive, and backsheet nonwoven/film adhesive. And, each of the first and second chassis may comprise the same basis weight of one or more of the topsheet, backsheet film, backsheet nonwoven, core super absorbent polymers, core pulp, leg cuff nonwoven, leg cuff film, super absorbent polymer adhesive, leg cuff adhesive, and backsheet nonwoven/film adhesive. And, each of the first and second chassis may comprise compositionally identical core super absorbent polymers. The first and second chassis may have identical component cross sectional order and disposition in at least one of the front waist region, back waist region, and crotch region. The inner leg cuffs of the first and second chassis may be composed of the compositionally identical materials. And, the core adhesives of the first and second chassis may be the same adhesive(s). The first and second chassis may comprise core super absorbent polymers that are in the same chemical class and subclass. And, each of the first and second chassis may comprise first and second wetness indicators, respectively, and wherein the first and second wetness indicators are compositionally identical. Further, the inner leg cuffs of the first and second chassis may have identical component cross sectional order and disposition in at least one of the front waist region, back waist region, and crotch region. The distance from the left outer cuff distal edge to a right outer cuff distal edge may the same. The distance from the left inner cuff proximal edge to left outer cuff distal edge may be the same. The distance from the left inner cuff proximal edge to the right inner cuff proximal edge is the same. The lengths of the inner and outer cuffs are the same. In some embodiments, different size offerings in an array may have identical or substantially identical chassis as the flaps or belts may be used to enable the absorbent article to fit different sized wearers. For example, first and second absorbent articles may have identical chassis (compositionally, dimensionally, cross-sectionally), but the first article may have a different length due to disposition of the belts, such that the first article may be targeted to fit a smaller wearer than the second article. As a second example, first and second absorbent articles may have identical chassis (compositionally, dimensionally, cross-sectionally), but the first article may have a different length and/or width due to the size of the belts, such that the first article may be targeted to fit a smaller wearer than the second article. In some embodiments, first and second absorbent articles may have identical chassis compositionally, but not dimensionally, and not cross-sectionally. In some embodiments, first and second absorbent articles may have identical chassis dimensionally, but not compositionally, and not cross-sectionally. In some embodiments, first and second absorbent articles may have identical chassis cross-sectionally, but not dimensionally, and not compositionally. In still other embodiments, first and second absorbent articles may have two, but not three of (1) compositionally, (2) dimensionally, and (3) cross-sectionally identical chassis. TABLE 1aExamples of Existing Product ArraysArrayArrayArraySide SeamAverageAverageAverageAverageRelaxedRelaxedRelaxedProductLength toProductProductProductTargetedProductProductProductHip-to-SideRelaxedHip-to-SideLength-to-SideLength-to-HipWeightLengthHip WidthSide LengthSilhouetteProductSilhouetteSilhouetteSilhouette(kg)(mm)(mm)(mm)(mm/mm)Length(mm/mm)(mm/mm)(mm/mm)PampersUnderJamssize S/M232282221211.83253%1.9521.9781.014size L/XL332412411162.07348%HuggiesGoodNitesPull Upssize S/M232342621391.88759%1.9931.7490.879size L/XL422482871372.09855%WallgreensWellBeginningsSleepsize S/M232522711362.00254%1.9961.8700.937size L/XL422562711361.99153%TargetUp and UpNighttimesize S/M232302281311.73957%1.8301.7970.983size L/XL422542651381.92054%Parents ChoiceNight Timesize S/M252562671341.99052%1.9591.9040.972size L/XL422582621361.92853%Kroger ComfortNight Pantssize S/M232362491391.78959%1.9271.7620.916size L/XL422492811362.06555%MeijerNight Timesize S/M232322461401.76060%1.8531.7300.934size L/XL422522711391.94655% TABLE 1bExamples of Existing Product ArraysArrayArrayArraySide SeamAverageAverageAverageAverageRelaxedRelaxedRelaxedProductLength toProductProductProductTargetedProductProductProductHip-to-SideRelaxedHip-to-SideLength-to-SideLength-to-HipWeightLengthHip WidthSide LengthSilhouetteProductSilhouetteSilhouetteSilhouette(kg)(mm)(mm)(mm)(mm/mm)Length(mm/mm)(mm/mm)(mm/mm)DependFit-FlexUnderwearfor WomenModeratesize S/M693352631791.46854%1.4961.9691.317size L983712742021.35355%size XL1133852911751.66645%DependSilhouetteActive FitBriefsfor WomenModeratesize S/M692653601302.76949%2.4241.9270.805size L/XL983453951902.07955%AlwaysDiscreetClassic CutUnderwearMaximumsize S/M693202951951.51361%1.6051.6501.030size L983403302001.65059%size XL1143703802301.65262%AlwaysDiscreetLower RiseUnderwearModeratesize S/M692803151751.80063%1.7551.6550.944size L983253251901.71158% TABLE 2Examples of Inventive Product ArraysArrayArrayArraySide SeamAverageAverageAverageAverageRelaxedRelaxedRelaxedProductLength toProductProductProductTargetedProductProductProductHip-to-SideRelaxedHip-to-SideLength-to-SideLength-to-HipWeightLengthHip WidthSide LengthSilhouetteProductSilhouetteSilhouetteSilhouette(kg)(mm)(mm)(mm)(mm/mm)Length(mm/mm)(mm/mm)(mm/mm)1stInventiveArray(2 packagearray)1stPackage203233012151.40067%1.3931.4341.029in Array2ndPackage26.53503552561.38773%in Array2ndInventiveArray(3 packagearray)1stPackage202802802551.09891%1.0611.0450.984in Array2ndPackage303003052851.07095%in Array3rdPackage40.53203303251.015102%in Array3rdInventiveArray(4 packagearray)1stPackage18.52062932321.263113%1.1820.8290.702in Array2ndPackage26.52203192651.204120%in Array3rdPackage34.52403433041.128127%in Array4thPackage41.52503503091.133124%in Array It may be desirable to link the Product Hip-to-Side Silhouette to the Body Hip-to-Side Silhouette in order to deliver a more boxer or boyshort-like product shape relative to the body shape. Boxer and boyshort-like underwear exhibit Product Hip-to-Side Silhouettes that are less than the Body Hip-to-Side Silhouettes. Tables 1a and 1b detail some of today's marketed product arrays.FIG.9shows how the Product Hip-to-Side Silhouettes of these arrays compare to the Body Hip-to-Side Silhouettes. It can be seen that today's product arrays do not provide Product Hip-to-Side Silhouettes less than Body Hip-to-Side Silhouettes. Table 2 illustrates several inventive arrays of 2, 3, and 4 packages, whose Product Hip-to-Side Silhouettes are less than the Body Hip-to-Side Silhouettes and provide more boxer and boyshort-like products. These inventive arrays are provided simply as non-limiting examples. Other inventive Hip-to-Side Silhouette arrays are possible within the scope of this disclosure. These inventive arrays are also shown inFIG.10. It may be desirable to have an absorbent article having a Product Hip-to-Side Silhouette value of from about 0.5 to about 1.8, or from about 0.5 to about 1.4, or from about 0.5 to about 1.3, or from about 1 to about 1.3, or from about 1 to about 1.5. It may be desirable to have an absorbent article having a Product Hip-to-Side Silhouette value from about 0.5, about 0.75, about 1, or about 1.5 to about 1.3, about 1.4, about 1.5, or about 1.8, and any combination thereof. It may be desirable to have an absorbent article having a Relaxed Product Side Length greater than about 65%, about 75%, about 85%, about 95%, about 100%, about 105%, about 110%, or about 115%, but less than about 100%, about 115%, about 125%, about 130%, about 135%, about 140%, or about 150%, of the Relaxed Product Length. For example,FIG.7Ashows a front view of a boxer pant product in closed form in its relaxed state wherein the Relaxed Product Side Length is greater than the Relaxed Product Length. It may be desirable to have an absorbent article within an array, the array comprising two or more absorbent articles, where one or more absorbent articles in the array has a Product Hip-to-Side Silhouette value of from about 0.5 to about 1.8, or from about 0.5 to about 1.4, or from about 0.5 to about 1.3, or from about 1 to about 1.3, or from about 1 to about 1.5. Further, it may be desirable to have an Array Average a Product Hip-to-Side Silhouette value of from about 0.5 to about 1.8, or from about 0.5 to about 1.4, or from about 0.5 to about 1.3, or from about 1 to about 1.3, or from about 1 to about 1.5. It may be desirable to have an absorbent article within an array, the array comprising two or more absorbent articles, where one or more absorbent articles in the array has a Relaxed Product Side Length less than about 40%, 35%, 30%, or 25% of the Relaxed Product Length. Test Methods Product Measurement Preparation All measurements are conducted at 22° C. +/−2° and 50% RH +/−20%. Purpose This method is used to prepare pant type products for subsequent dimensional measurement. The method provides a consistent means of opening a product that has been removed from a bag. This method is applicable to all forms of pant products. A constant rate of extension tensile testing machine with computer interface is used. A load cell is chosen so that the load cell capacity ensures accuracy of a 5 N load to within 0.1 N. Sample Holder Apparatus “C” (304) and “O” (305) Bar attachments each with a rod radius of 9.50 mm that extend longer than the length of the longest side seam. Refer toFIG.20. The bars are mounted horizontally in the tensile tester with their longitudinal axes in the same vertical plane and with upper bar mounted directly above the lower bar. Equipment Set Up Calibrate tensile tester equipment according to the instrument manufacturer's recommendations. The initial gauge length is determined by removing 10 sample products from the bag, unfolding the pant products (307) and laying them flat as illustrated inFIG.21, below and measuring the distance between the sides of the pant at the waist as shown (306). The average of the waist measurement will be used as the initial gauge length for the specific set of specimens. The initial gauge length is the distance from the uppermost edge of the upper bar to the lowermost edge of the lower bar. Apply the whole product (307) to the bars as shown inFIG.22while minimizing manipulation of the specimen. Pull Sample to 5 N Force then hold for 10 seconds. Return to initial gauge length.Crosshead Speed=254.0 mm/min, Data acquisition rate=50 Hz.Cycles=1 Remove the specimen from the bars while minimizing manipulation. Lay the specimen flat with the front side facing upward as shown inFIG.6. Repeat for all 10 specimens Physical Measurements Each of the measurements below is to be conducted on 10 separate like specimens and the average of the 10 separate like specimens is considered to be the measurement for that specific specimen set. Relaxed Product Length (300) Relaxed Product Length is the longitudinal distance between the longitudinally distal most point in the crotch region and the longitudinally distal most point along the front waist edge. The longitudinal distance is measured parallel to the longitudinal axis of the product. Refer toFIGS.6and7. Relaxed Product Hip Width (301) Relaxed Product Hip Width is the lateral distance from the laterally distal most point of the left side edge of the product at the upper edge of the left leg opening to the laterally distal most point of the right side edge of the product at the upper edge of the right leg opening. Refer toFIGS.6and7. The lateral distance is measured perpendicular to the longitudinal axis of the product. Relaxed Product Waist Width (302) Relaxed Product Waist Width is the lateral distance from the distal most point at the right side of the front waist edge to the distal most point at the left side of the front waist edge. The lateral distance is measured perpendicular to the longitudinal axis of the product. Refer toFIGS.6and7. Relaxed Product Side Length (303) Relaxed Product Side Length is the linear distance from the point of intersection between the waist edge and the side edge of the product to the point of intersection between the top of the leg opening and the same side edge of the product. The relaxed product side length measurement is the average of the measurements from the left and right sides of the product. Refer toFIGS.6and7. Each of the measurements above is recorded to within +/−1.0 mm | 52,804 |
11857402 | DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part thereof, and within which are shown by way of illustration specific embodiments by which the invention may be practiced. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from the scope of the invention. As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the context clearly dictates otherwise. It is an object of the current invention to provide a sanitary device that prevents or reduces leaks, odors, and infections resulting from bacterial and fungal growth; is simple and easy to install in traditional pads or underwear; is re-useable and washable; is small in size; is low in cost; and is easy to store or dispose of. In an embodiment, the current invention is a sanitary device that can be used to prevent or reduce leaks, odors, and infections during female menstrual cycles. In an embodiment, the sanitary device can absorb discharged fluids from the body due to bladder leaks in men, women, and children. As depicted inFIGS.1A and1B, sanitary device10comprises absorbent sponge20, adhesive strips30, and collection bag40. Sanitary device10is smaller in overall size and lower in cost compared to conventional sanitary devices15on the market. Conventional sanitary devices15include tampons, sanitary napkins, sanitary towels, menstrual pads, or other devices for absorbing fluids discharged from the human body (seeFIGS.4A and4B). In certain embodiments, conventional sanitary devices15may further include absorbent underwear, diapers, and adult diapers (seeFIG.4C). During use, sanitary device10is positioned centrally over the vaginal opening with upper portion22of absorbent sponge20pressed against the labia. Absorbent sponge20may be a variety of geometric shapes and configurations, including rectangular, square, and circular. When absorbent sponge20becomes saturated with fluids during menstruation, as depicted inFIG.2A, the fluids drain in collection bag40through drainage aperture29disposed within the body of absorbent sponge20. Drainage aperture29may be a single drainage aperture29or may include one or more drainage apertures29arranged in a pattern or randomly spaced apart from one another about absorbent sponge20. Collection bag40is disposed in underlying relation to absorbent sponge20and secured thereto using an adhesive, stitching, or other known coupling methods. At least a portion of absorbent sponge20may reside within collection bag40, as depicted inFIG.2B. For cost, impermeability, reusability, and durability reasons, collection bag40is ideally constructed from plastic. However, one of ordinary skill in the art would appreciate that collection bag40may be constructed from nylon, synthetic fiber, elastane, rubber, polyester, or other material and/or combination of materials suitable for containing fluids within reservoir42. Collection bag40may include discharge mechanism44(e.g., plug), configured to drain the fluids within reservoir42once the reservoir is filled with fluids. In an embodiment, collection bag40of sanitary device10is configured to reside within the deepest groove of conventional sanitary pad15. The groove is sized and shaped to receive collection bag40and prevent the collection bag from being displaced horizontally causing misalignment or discomfort. The osmotic process dictates that a solution with a higher chemical potential will spontaneously diffuse into a solution with a lower chemical potential to achieve homeostasis. Further, the laws of physics dictate that a fluid will always seek and take the path of least resistance. Thus, absorbent sponge20is laced with an amount of salt. The salt allows for the migration of menstrual fluids—which have a higher chemical potential—to the salt-laced sponge having a lower chemical potential. This migration of fluids away from the vagina is quicker than that of conventional sanitary devices as a result of the chemical potential created by the salty environment. The rapid migration of menstrual fluids away from the opening of the vagina significantly reduces the potential for infection and other adverse medical conditions. A healthy vagina has a large number of bacterial cells, while only a small number of yeast cells. The most common bacteria,Lactobacillus acidophilus, helps to keep various organisms, such as yeast cells, in check. Several medical issues, including vaginal yeast infections, can arise as the result of unchecked yeast growth. For example, a vaginal yeast infection is an indication that an overabundance of yeast cells are growing in or around the vagina. The chance of contracting a vagina yeast infection increases during menstrual periods as females are currently required to use convention sanitary pads. The use of conventional sanitary devices results in a warm and bloody environment close to the opening of the vagina, which facilitates bacteria and yeast colonization that leads to a number of adverse medical conditions. In an embodiment, an amount of alcohol and/or odor masking compound may saturate absorbent sponge20to prevent the build-up bacteria and yeast colonization. In such embodiments, alcohol sanitizes and kills both bacterial and yeast cells upon the absorption of menstrual fluids by the sponge. The odor masking compound may be sodium bicarbonate or other similar compounds configured to remove an odor given off by menstrual or other bodily fluids. The combination of salt and alcohol destroys bacteria and yeast cells before they have the opportunity to colonize and reenter the vagina. Reentry into the vagina can result in an imbalance of bacteria within or around the vagina and potentially results in medical conditions, such as bacterial vaginosis. Further, an excess of bacteria and yeast on and around the labia can form a rash or build-up of yeast resulting in uncomfortable vaginal itching. FIGS.3A and3Bdepict an embodiment having semi-permeable membrane24disposed over absorbent sponge20. Semi-permeable membrane24prevents the salt distributed within absorbent sponge20from contacting the epidermis of the wearer. Pores formed within semi-permeable membrane24are sized small enough that the salt particles are unable to pass through, but large enough to permit the passage of fluids through semi-permeable membrane24. As shown inFIG.3A, slit26may be formed within semi-permeable membrane24to allow larger particles—such as vaginal tissue or clotted blood—to pass through the membrane and into reservoir42of collection bag40. Now referring toFIG.4A, sanitary device10is coupled to conventional sanitary device15—especially during times of heavy flow—using adhesive strips30to provide triple protection against leakage and store menstrual fluid discharge away from the opening of the vagina. During periods of lighter flow, sanitary device10is directly attached to underwear, panty-liners, incontinence pads. In an embodiment, sanitary device10may be used without the need for conventional sanitary device15and coupled directly to the epidermis of the wearer. Additional embodiments of sanitary device10are contemplated in which sanitary device10may be used as an emergency urination bag for adult males, females, and children when a restroom is not readily accessible as depicted inFIGS.4B and4C. As depicted inFIGS.5-6, adhesive strips30are disposed in underlying relation to absorbent sponge20and include first set of adhesive strips30aand second set of adhesive strips30b. Each of the first set30aand second set30b(seeFIG.6) of adhesive strips have a plurality of adhesive portions36, each separated by impermeable layer32. Impermeable layer32functions to prevent each adhesive portion36from adhering to an adjacent adhesive portion36. To adhere adhesive strips30to either conventional sanitary pad15or the epidermis of the wearer, impermeable membrane32is removed to expose an adhesive lining on at least a portion of the adhesive strips30. In an embodiment, sanitary device10is coupled to conventional sanitary device15(e.g., incontinence underwear) and includes pocket17configured to receive collection bag40, when sanitary device10is coupled to conventional sanitary device15. To remove sanitary device10from conventional sanitary device15, the user simply pulls up on adhesive strips30, which in turn detaches from the surface of conventional sanitary device15. Adhesive strips30facilitate the removal of sanitary device10from conventional sanitary device15without contacting the soiled portion of collection bag40. To prevent fluids from leaking from collection bag40during storage, adhesive strips30may be disposed over drainage aperture29, as shown inFIG.6. After removal, soiled collection bag40is easily stored and placed in an opaque storage bag for disposal in the garbage or a purse to carry home for washing and re-use (e.g., for cost or environmental reasons). Sanitary device10is reused by washing absorbent sponge20and collection bag40during the cleaning process. When collection bag40and absorbent sponge20are cleaned, impermeable layer16prevents the adhesive from being washed away from adhesive portion36. After washing, absorbent sponge20is then re-laced with salt, alcohol, and/or an odor-masking compound. These products are usually stored in most homes or easily purchased at a local supermarket and drug store. To re-lace the absorbent sponge20with salt, the absorbent sponge is soaked or sprayed with a solution containing salt water or saline until absorbent sponge20is saturated with the solution. Absorbent sponge20is then dried to evaporate the water from the solution. To re-lace absorbent sponge20with alcohol, absorbent sponge20is soaked or sprayed with a solution containing the alcohol until absorbent sponge20is saturated with the solution. Absorbent sponge20is then dried to evaporate the water from the solution. In an embodiment, the alcohol may be isopropyl alcohol. To re-lace absorbent sponge20with an odor-masking compound, absorbent sponge20is soaked or sprayed with a solution containing odor-masking compound until absorbent sponge20is saturated with the solution. Absorbent sponge20is then dried to evaporate the water from the solution. In an embodiment, the odor-masking compound may be sodium bicarbonate or another odor-masking compound. Further, sodium bi-carbonate aids in the balancing of the pH level of female genitals. Because absorbent sponge20is laced with odor-masking compound34, absorbent sponge20does not emit an odor or an odor given off by absorbent sponge20is otherwise minimized during storage, disposal, and transport. The advantages set forth above, and those made apparent from the foregoing description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween. | 11,653 |
11857403 | DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention comprises the provision and use of a novel surgical mesh which provides a skirt or rim of surgical mesh about the outer perimeter of a base layer of surgical mesh but which allows the skirt or rim of surgical mesh to be pulled upward without distorting the smooth planar configuration of the base layer of surgical mesh. More particularly, and looking now atFIGS.7-10, the present invention comprises the provision and use of a novel segmented skirted surgical mesh105. Novel segmented skirted surgical mesh105comprises a base layer110of surgical mesh terminating in an outer edge112, and a segmented continuous skirt or rim115of surgical mesh terminating in an outer edge117and an inner edge118which defines a central opening119. Segmented continuous skirt or rim115overlies the outer portion of base layer110(e.g., so that outer edge117of segmented continuous skirt or rim115is substantially aligned with outer edge112of base layer110), and segmented continuous skirt or rim115is secured to base layer110only at or adjacent to outer edge117of segmented continuous skirt or rim115, such that the inner portions of segmented continuous skirt or rim115(i.e., the portions adjacent to inner edge118) can be lifted away from base layer110when desired. The segmented continuous skirt or rim115of surgical mesh is segmented by providing a plurality of breaks or cuts or slits122in the continuity of segmented continuous skirt or rim115of surgical mesh105, whereby to form a plurality of segments or flaps123A,123B,123C, etc. of the segmented continuous skirt or rim115. In one preferred form of the invention, there are at least three breaks or cuts or slits122in the continuity of segmented continuous skirt or rim115of surgical mesh105, whereby to form at least three segments or flaps123A,123B,123C, etc. Each of the segments or flaps123A,123B,123C, etc. of segmented continuous skirt or rim115provides an easily accessed section of surgical mesh which facilitates fixation of segmented skirted surgical mesh105to the soft tissue, i.e., by fixing the various segments or flaps123A,123B,123C, etc. of segmented continuous skirt or rim115to the edges of the soft tissue defect using conventional suture or tack fixation. By providing segmented skirted surgical mesh5with the segmented continuous skirt or rim115of surgical mesh, when segmented skirted surgical mesh105is being secured to the soft tissue, the sharp ends of the fixation elements (e.g., the suture needle or tack) are isolated from the delicate internal organs of the patient by base layer110of segmented skirted surgical mesh105, whereby to prevent inadvertent damage to the delicate internal organs of the patient. At the same time, and significantly, by providing a segmented continuous skirt or rim115of surgical mesh, where the segmented continuous skirt or rim115is segmented (through the provision of breaks or cuts or slits122) into a plurality of segments or flaps123A,123B,123C, etc., distortion of base layer110of segmented skirted surgical mesh105can be reduced or eliminated when segmented continuous skirt or rim115is pulled upward, since then only the surgical mesh of a particular segment or flap123A,123B,123C, etc. is pulled upward—the remainder of the segments or flaps123A,123B,123C, etc. of the segmented continuous skirt or rim115are unaffected, which results in reduced distortion of base layer110of segmented skirted surgical mesh105. By way of example but not limitation, having three or four evenly-spaced breaks or cuts or slits122in segmented continuous skirt or rim115of a small oval or circular segmented skirted surgical mesh105keeps base layer110of segmented skirted surgical mesh105substantially flat even when some or all of segments or flaps123A,123B,123C, etc. of the segmented continuous skirt or rim115is lifted up from base layer110of segmented skirted surgical mesh105(FIGS.7-10), since then only the surgical mesh of a particular segment or flap123A,123B,123C, etc. is pulled upward—the remainder of the segments or flaps123A,123B,123C, etc. are unaffected, which results in reduced distortion of base layer110of segmented skirted surgical mesh105. In larger constructions, an oval configuration (FIGS.7-10) is typically used, inasmuch as defects in a body wall cavity (e.g., an abdominal hernia) are typically oblong in shape (due to the stress orientation in the soft tissue). These oval configurations have opposing tight end radii125which benefit even more than circular configurations by providing breaks or cuts or slits122in segmented continuous skirt or rim115. FIGS.11and12show a segmented skirted surgical mesh105having a circular configuration. Note that the segmented continuous skirt or rim115of segmented skirted surgical mesh105ofFIGS.11and12has three breaks or cuts or slits122, whereby to provide three segments or flaps123A,123B and123C. The breaks or cuts or slits122in segmented continuous skirt or rim115of segmented skirted surgical mesh105are preferably accomplished by cutting through segmented continuous skirt or rim115, preferably starting at inner edge118of segmented continuous skirt or rim115and extending radially outwardly, and preferably terminating just short of the outer edge117of segmented continuous skirt or rim115. In one preferred embodiment, breaks or cuts or slits122extend at an angle of 90 degrees to the adjacent inner edge118of segmented continuous skirt or rim115. Alternatively, the breaks or cuts or slits122in segmented continuous skirt or rim115may be made at varying angles to inner edge118of segmented continuous skirt or rim115so as to further minimize distortion in base layer110of segmented skirted surgical mesh105when segments or flaps123A,123B,123C, etc. are subjected to lifting away from base layer110. FIGS.13-15show another segmented skirted surgical mesh formed in accordance with the present invention. AndFIGS.16-18show still another segmented skirted surgical mesh formed in accordance with the present invention. Note that with the segmented skirted surgical meshes ofFIGS.13-15andFIGS.16-18, segmented continuous skirt or rim115is modified so as to provide different sized central openings119. The breaks or cuts or slits122in segmented continuous skirt or rim115preferably extend almost all the way to outer edge117of segmented continuous skirt or rim115, although the breaks or cuts or slits may also extend all the way to outer edge117if desired, or may terminate intermediate of segmented continuous skirt or rim115if desired. The number of cuts or breaks or slits122formed in segmented continuous skirt or rim115of segmented skirted surgical mesh105, and the placement of those breaks or cuts or slits122, may be optimized so as to (i) minimize distortion of base layer110when a segment or flap123A,123B,123C, etc. is pulled upward, and (ii) minimize the overall number of segments or flaps123A,123B,123C, etc. that the segmented continuous skirt or rim115is divided into (since “too many segments or flaps” has the potential to complicate the fixation process for the surgeon). In practice, it is generally preferred to make three or four cuts or breaks or slits122in the segmented continuous skirt or rim115of segmented skirted surgical mesh105, whereby to provide three or four segments or flaps123A,123B,123C, etc. in segmented continuous skirt or rim115of segmented skirted surgical mesh105, since providing less than three cuts or breaks or slits122in segmented continuous skirt or rim115makes it difficult to lift the segments or flaps of continuous segmented skirt or rim115away from base layer110without distorting base layer110. It should also be appreciated that, if desired, outer edge117of segmented continuous skirt or rim115could terminate inboard of outer edge112of base layer110. Alternatively, outer edge117of segmented continuous skirt or rim115could overlap outer edge112of base layer110(e.g., outer edge117of segmented continuous skirt or rim115could be folded over edge112of base layer110). By minimizing the distortion of base layer110of segmented skirted surgical mesh105when one or more of the segments or flaps123A,123B,123C, etc. of segmented continuous skirt or rim115is lifted up during fixation, the fixation itself is facilitated, i.e., the fixation will take less time and the final repair geometry is controlled so that there are no gathered areas that might lead to potential sites of discomfort for the patient. Thus, the segmented skirted surgical mesh of the present invention benefits both the surgeon (through facilitated fixation) and the patient (by producing a more cosmetic and comfortable reconstruction). MODIFICATIONS OF THE PREFERRED EMBODIMENTS It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention. | 9,087 |
11857404 | DETAILED DESCRIPTION The following detailed description and the appended drawings describe and illustrate various example embodiments of storage devices, loading devices, delivery systems, kits, and methods. The description and illustration of these examples are provided to enable one skilled in the art to make and use a storage device, a loading device, a delivery system, to make a kit, and to practice a method. They are not intended to limit the scope of the claims in any manner. As used herein, the term “diameter” refers to the length of a straight line passing from side to side through the center of a body, element, or feature, and does not impart any structural configuration on the body, element, or feature. As used herein, the term “circumferential” refers to an enclosing boundary of a body, element, or feature, and does not impart any structural configuration on the body, element, or feature. FIGS.1,2, and3illustrate a first example storage device10that includes a storage member12, a first cap14, and a second cap16. In the illustrated embodiment, each of the first cap14and the second cap16is releasably attached to the storage member12. The storage member12has a lengthwise axis13, a first end20, a second end22, and a main body24that defines a circumferential wall26, a first opening28, a second opening30, a passageway32, a separating wall34, and a plurality of holes36. The passageway32extends through the storage member12from the first opening28to the second opening30and has a first portion38that extends from the first end20to the separating wall34and a second portion40that extends from the second end22to the separating wall34. The first portion38has a first inside diameter39. The second portion40has a second inside diameter41at the separating wall34that is less than the first inside diameter39and a third inside diameter43at the second end22that is equal to the first inside diameter39such that the second portion40tapers from the second end22to the separating wall34(e.g., creating a partial cone). In the illustrated embodiment, the second portion40is sized and configured to house an implantable medical device, as described in more detail herein. The separating wall34extends into the passageway32at a location between the first end20and the second end22that is positioned closer to the first end20. The separating wall34defines a through hole42that has inside diameter45that is less than the second inside diameter41of the second portion40. Each hole of the plurality of holes36extends through the separating wall34and provides access between the first portion38of the passageway32and the second portion40of the passageway32such that a fluid passed through the storage member12can pass over the outside and inside surfaces of a medical device disposed within the second portion of the passageway40. Each hole of the plurality of holes36is equally spaced from an adjacent hole of the plurality of holes36and is disposed the same distance from the circumferential wall26relative to the other holes of the plurality of holes36. While the storage member12has been illustrated as having a particular structural arrangement, a storage member can have any suitable structural arrangement and selection of a suitable structural arrangement for a storage member can be based on various considerations, including the type of implantable medical device intended to be stored within the storage member. For example, while the passageway32has been illustrated as having a first portion38and a second portion40, a passageway defined by a main body of a storage member can have any suitable number of portions, such as one, at least one, two, a plurality, three, four, and any other number considered suitable for a particular embodiment. While the second portion40has been illustrated as having a second inside diameter41at the separating wall34that is less than the first inside diameter39and a third inside diameter43at the second end22that is equal to the first inside diameter39, a second portion can have any suitable inside diameters. For example, a second portion can have a second inside diameter at the separating wall that is equal to, less than, greater than, or about a first inside diameter of a first portion and/or a third inside diameter at a second end that is equal to, less than, greater than, or about the first inside diameter. While the separating wall34has been illustrated as positioned closer to the first end20, a separating wall can be positioned at any suitable location between the first and second ends of a storage member. For example, a separating wall can be disposed in the center of a storage member between first and second ends, or positioned closer to a second end of a storage member. While the storage member12has been illustrated as defining a plurality of holes36such that each hole of the plurality of holes36is equally spaced from an adjacent hole of the plurality of holes36and is disposed the same distance from the circumferential wall26relative to the other holes of the plurality of holes36, a storage member can include any suitable number of holes positioned in any suitable orientation. Examples of numbers of holes considered suitable for a main body of a storage member to define on a separating wall include one, at least one, two, a plurality, three, four, five, more than five, more than ten, and any other number considered suitable for a particular embodiment. Examples of positions considered suitable to locate a plurality of holes include such that each hole of a plurality of holes is equally spaced, or irregularly spaced, from an adjacent hole of the plurality of holes and is disposed the same distance, or a varied distance, from a circumferential wall relative to the other holes of the plurality of holes. Each of the first cap14and the second cap16is sized and configured to be releasably attached to the storage member12. The first cap14is releasably attached to the first end20of the storage member12and the second cap16is releasably attached to the second end22of the storage member. When attached to the storage member12, each of the first cap14and the second cap16seals the passageway32defined by the storage member12. In the illustrated embodiment, each of the first cap14and the second cap16defines threads that mate with threads defined by the storage member12to achieve releasable attachment between the storage member12and the first and second caps14,16. While the first cap14has been illustrated as being threadably attached to the storage member12and the second cap16has been illustrated as being threadably attached to the storage member12, a first cap and a second cap can be attached to a storage member using any suitable technique or method of attachment and selection of a suitable technique or method of attachment between the cap and a storage member can be based on various considerations, including the material(s) that forms the cap and/or storage member. Examples of techniques and methods of attachment considered suitable between a cap and a storage member include using threaded connections, threaded connections using a thread disposed on an exterior surface of a storage member to avoid rotation of the storage member (e.g., to avoid disruption of an implantable medical device stored in the storage device during attachment of a cap), snap fit attachments, using one or more connectors, one or more mating slots and projections, one or more sealed unions, tapered attachments (e.g., morse taper), and any other technique or method of attachment considered suitable for a particular application. FIGS.4and5illustrate another example storage device110. The storage device110is similar to the storage device10illustrated inFIGS.1,2, and3and described above, except as detailed below. The storage device110includes a storage member112, a first cap114, and a second cap116. In the illustrated embodiment, each of the first cap114and the second cap116defines structure that mates with structure defined by the storage member112to achieve a releasable snap fit attachment between the storage member112and the first and second caps114,116. In the illustrated embodiment, the storage member112includes a port121extending from the main body124and a first two-way valve123attached to the port121. In addition, the second cap116defines a passageway125that extends through the main body of the second cap116that is in communication with a second two-way valve127. This structural arrangement provides a mechanism for sterilizing and/or rinsing an implantable medical device stored in the storage device110, decreasing the complexity of sterilizing, storing, rinsing, and/or loading an implantable medical device, and minimizing the risk associated with handling an implantable medical device that is intended to be positioned within the storage device. In an alternative embodiment, the port121, the first two-way valve123, the passageway125, and/or the second two-way valve127can be omitted. In the illustrated embodiment, the first cap114comprises a device guard146that is releasably attached to the first end120of the storage member112and partially extends into the passageway132defined by the storage member112. The device guard146has a lengthwise axis147, a first end148, a second end150, and a main body152that defines a base154, a first projection156, a second projection158, and a recess160. The base154is disposed between the first end148and the second end150and is sized and configured to be releasably attached within the passageway132of the storage member112. In the illustrated embodiment, the base154has an outside diameter155, a first side162, a second side164, and is sized and configured to be releasably attached to the storage member112within the passageway132using a snap fit attachment between the device guard146and the storage member112. Thus, the storage member112and the device guard146define mating structure that achieves a releasable snap fit attachment between the storage member112and the device guard146. The first projection156extends from the first side162to the first end148and the second projection158extends from the second side164to the second end150. The first projection156has an outside diameter157that tapers from the base154to the first end148, which provides a mechanism for positioning an implantable medical device between the first projection156and the storage member112. The second projection158has a first outside diameter149at the base154, a second outside diameter151between the base154and the second end150, and a third outside diameter153at the second end150. The second outside diameter151is less than the first outside diameter149and the third outside diameter153is less than the second outside diameter151. The recess160extends from the first end148toward the second end150to a recess base166and is sized and configured to receive a portion of a delivery system, as described in more detail herein. The recess160has a first portion168, a second portion170, and a third portion172. The first portion168has an inside diameter167that increases from the first end148to the second portion170. The second portion170has an inside diameter169that tapers from the first portion168to the third portion172. The third portion172has an inside diameter171that is less than the inside diameter169of the second portion170. Each of the first portion168and the second portion170has a partial conical configuration and the third portion172is sized and configured to mate with a portion of a delivery system (e.g., tip1516) such that the portion of the delivery system is rotationally fixed relative to the device guard146when disposed within the third portion172, as described in more detail herein. In the illustrated embodiment, the third portion172defines a planar surface173that extends from the second portion170to the recess base166that is sized and configured to mate with a portion of a tip (e.g., planar surface1572of tip1516) of a delivery system, as described in more detail herein. When attached to the storage member112, the device guard146is positioned such that the first projection156extends through the through hole142of the separating wall134. During use, the device guard146acts as a mechanical stop to advancement of a delivery system through a storage member, as described in more detail herein. While the device guard146has been illustrated as having a particular structural arrangement, a device guard can have any suitable structural arrangement and selection of a suitable structural arrangement for a device guard can be based on various considerations, including the type of implantable medical device intended to be implanted using a storage device of which the device guard is a component. For example, while the device guard146has been illustrated as a single component, a device guard can be formed as multiple components (e.g., base, first projection, second projection) releasably attached, or fixedly attached, to one another, a first projection can have a constant outside diameter along its length, a second projection can have a constant outside diameter along its length, and/or a first portion can have an inside diameter that is constant from first end to second portion. While each of the first portion168and the second portion170has been illustrated as having a partial conical configuration and the third portion172has been illustrated as having a planar surface173that extends from the second portion170to the recess base166, a recess defined by a device guard can have any suitable configuration. For example, a recess can define any structural arrangement that is sized and configured to receive any suitable portion of a delivery system (e.g., portion of a tip, entire tip) and/or rotationally fix a portion of a delivery system when disposed within the device guard. While device guard146has been illustrated as being releasably attached to storage member112, any suitable device guard, such as those described herein (e.g., device guard715, device guard1714), can be releasably attached to a storage member. FIGS.6and7illustrate another example storage device210. The storage device210is similar to the storage device10illustrated inFIGS.1,2, and3and described above, except as detailed below. The storage device210includes a storage member212, a first cap214, and a second cap216. In the illustrated embodiment, the second portion240has a second inside diameter241at the separating wall234that is equal to the first inside diameter239such that the second portion240has a constant inside diameter241from the separating wall234to the second end222(e.g., creating a cylinder). In addition, each hole of the plurality of holes236defined by the main body224of the storage member212is not equally spaced from an adjacent hole of the plurality of holes236and is disposed a different distance from the circumferential wall226relative to the other holes of the plurality of holes236. The main body224of the storage member212defines first and second projections276,278that extend from the circumferential wall226, a first passageway280that extends through the first projection276, and a second passageway282that extends through the second projection278. The projections276,278and the passageways280,282are sized and configured to mate with a loading member and/or guide member, as described in more detail herein, such that the storage member212can be releasably attached to the loading member and/or guide member. While the storage member212has been illustrated as including a specific structural arrangement to accomplish releasable attachment to a loading member and/or guide member, any suitable structure can be used to accomplish such a releasable attachment. Any embodiment of a storage member described herein can optionally include one or more projections (e.g., projections276,278) and one or more passageways (e.g., passageways280,282) such that the storage member can releasably attached to a loading member and/or guide member and be used with a guide system, as described in more detail herein. In the illustrated embodiment, the second cap216is releasably attached to the second end222of the storage member212. The second cap216has a lengthwise axis283, a first end284, a second end286, and a main body288that defines a passageway290that extends through the second cap216. The passageway290has a first portion292, a second portion294, and a third portion296. The first portion292extends from the first end284toward the second end286and has a first inside diameter291. The second portion294extends from the first portion292to the third portion296and has a second inside diameter293that tapers from the first portion292to the third portion296. FIGS.8,9,10,11,12,13, and14illustrate another example storage device310. The storage device310is similar to the storage device210illustrated inFIGS.6and7and described above, except as detailed below. The storage device310includes a storage member312, a first cap314, a second cap316, a first one-way valve410, a second one-way valve412, and a diffuser414. In the illustrated embodiment, the inside diameter of the second portion340of the storage member312has a second inside diameter341at the separating wall334that positions the circumferential wall326in the second portion340such that it partially obstructs the plurality of holes336. As shownFIGS.10,11, and12the main body324of the storage member312defines a plurality of recesses416. Each recess of the plurality of recesses416extends into the circumferential wall326to a recess base418and extends from the separating wall334toward the second end322. In the illustrated embodiment, each recess of the plurality of recesses416extends to the second end322. Each recess of the plurality of recesses416is in communication with a hole of the plurality of holes336and has a first width415at the separating wall334at the recess base418and a second width417between the separating wall334and the second end322at the recess base418that is greater than the first width415. By positioning each recess of the plurality of recesses416such that it is adjacent to and in communication with a hole of the plurality of holes336, fluid passed through the storage member312from the first one-way valve410toward the second one-way valve412can flow through the plurality of holes336and within the plurality of recesses416to increase the amount of fluid that contacts any implantable medical device disposed within the storage member312. The through hole342defined by the main body324of the storage member312is sized and configured to receive a portion of the diffuser414, as described in more detail herein. While each recess of the plurality of recesses416has been illustrated as extending from the separating wall334to the second322, as being in communication with a hole of the plurality of holes336, and having a first width415at the separating wall334at the recess base418and a second width417between the separating wall334and the second end322at the recess base418that is greater than the first width415, each recess can have any suitable structural arrangement. Selection of a suitable structural arrangement for each recess included in a storage member can be based on various considerations, including the structural arrangement of an implantable medical device intended to be disposed within the storage member. For example, a storage member can define any suitable number of recesses, such as one, at least one, two, a plurality, three, four, five, more than five, more than ten, and any other number considered suitable for a particular embodiment. A recess included on a storage member can extend any suitable length of a storage member. For example, a recess, or each recess of a plurality of recesses, can extend from a separating wall to a second end of a storage member, from a separating wall to a location between the separating wall and the second end, from a location between a separating wall and a second end to the second end, from a first location between a separating wall and a second end to a second location between the first location and the second end, and any other length of a storage member considered suitable for a particular embodiment. A recess included on a storage member can have any suitable width along its length. For example, a recess, or each recess of a plurality of recesses, can have a first width at a first end (e.g., at a separating wall) at a recess base and a second width at a second end (e.g., between a separating wall and a second end) at a recess base that is greater than, less than, equal to, or about the first width. A recess included on a storage member can have any suitable structural arrangement, such as curved, cuboidal, prismatic, and any other structural arrangement considered suitable for a particular embodiment. In the illustrated embodiment, the second cap316is releasably attached to the second end322of the storage member312. The passageway390of the second cap316has a first portion392, a second portion394, a third portion396, and a fourth portion398. The first portion392extends from the first end384toward the second end386and has a first inside diameter391. The second portion394extends from the first portion392to the third portion396and has a second inside diameter393that tapers from the first portion392to the third portion396. The third portion396extends from the second portion394to the fourth portion398and has an inside diameter395that tapers from the second portion394to the fourth portion398. The fourth portion398extends from the third portion396to the second end386and has an inside diameter397that is sized and configured to allow fluid to pass through the passageway390to the second one-way valve412, as described in more detail herein. In the illustrated embodiment, the first cap314has a first end420, a second end422, and a main body424that defines a passageway426and a recess428. The passageway426extends from the first end420to the recess428and is sized and configured to allow fluid to pass through the passageway426. The first one-way valve410is releasably attached to the first end420of the first cap314and the second one-way valve412is releasably attached to the second end386of the second cap316. Each of the first and second one-way valves410,412has a first opening430, a second opening432, and is adapted to allow fluid to pass through the valve in one direction. In the illustrated embodiment, the first one-way valve410is adapted to allow fluid to pass through the valve from the first opening430to the second opening432and the second one-way valve412is adapted to allow fluid to pass through the valve from the second opening432to the first opening430. In alternative embodiments, a first one-way valve and/or second one-way valve can be omitted from a storage device and/or loading device, as described in more detail herein, and a first cap can define a recess and omit the inclusion of a passageway, a second cap can define a recess and omit the inclusion of a passageway, and/or a loading member can define a recess and omit the inclusion of a passageway. Alternatively, a first one-way valve and/or second one-way valve can be omitted from a storage device and/or loading device, as described in more detail herein, and a cap can be disposed on a first end of a first cap, a second end of a second cap, and/or a second end of a loading member to seal the passageway defined by the first cap, the passageway defined by the second cap, and/or the passageway defined by the loading member such that fluid cannot pass through the passageway(s). Alternatively, a first one-way valve and/or second one-way valve can be omitted from a storage device and/or loading device, as described in more detail herein, and a first two-way valve and/or second two-way valve can be included in the storage device and/or loading device in place of any one-way valves. Alternatively, a first one-way valve and/or second one-way valve included in a storage device can be permanently fixed to a cap, disposed within a recess defined by a cap, or other component, of the storage device. The diffuser414is releasably disposed within the first portion338of the passageway332and the through hole342of the separating wall334. As shown inFIGS.13and14, the diffuser414has a first end434, a second end436, a base438, and a frame440. The base438extends from the second end436toward the first end434to the frame440and is sized and configured to be received by the through hole342of the separating wall334. The base438has an outside diameter439that is equal to the inside diameter345of the through hole342. Alternative embodiments, however, can include a diffuser that has a base with an outside diameter that is less than, greater than, or about, an inside diameter of a through hole. The storage member312and the diffuser414define mating structure that achieves a snap-fit attachment between the base438of the diffuser414and the separating wall334of the storage member312. The frame440extends from the base438to the first end434and has a plurality of struts442that define a plurality of openings446that are sized and configured to allow a fluid to pass through the frame432during use. The diffuser414provides a mechanism for dispersing a fluid passed through the storage member312during use such that the fluid can pass through the plurality of holes336and/or through the through hole342in embodiments in which the base438of the diffuser414does not seal the through hole342. In alternative embodiments, a diffuser can be omitted from a storage device and/or loading device, as described in more detail herein. While the diffuser414has been illustrated as having a particular structural arrangement and as being releasably disposed within a first portion of a storage member, a diffuser can have any suitable structural arrangement and can be positioned within a storage member in any suitable technique. Selection of a suitable structural arrangement for a diffuser and of a suitable technique to position a diffuser within a storage member can be based on various considerations, including the structural arrangement of a storage member within which the diffuser is disposed. Examples of suitable techniques for positioning a diffuser within a storage member include such that a diffuser is releasably disposed within a first portion of a storage device, releasably disposed within a second portion of a storage device, permanently, or releasably, attached to a cap (e.g., first cap, second cap) of a storage device, permanently, or releasably, attached to a storage member (e.g., within a first portion of a passageway, within a second portion of a passageway), and any other technique considered suitable for a particular embodiment. The storage device310provides a mechanism for decreasing the complexity of sterilizing, storing, rinsing, and/or loading an implantable medical device and minimizing the risk associated with handling an implantable medical device that is intended for implantation. For example, the storage device310provides a mechanism for sterilizing, storing, rinsing, and/or loading an implantable medical device using a closed system that reduces the interaction with the implantable medical device during sterilization, storing, rinsing, and/or loading. FIGS.15,16, and16Aillustrate another example storage device510. The storage device510is similar to the storage device310illustrated inFIGS.8,9,10,11,12,13, and14and described above, except as detailed below. The storage device510includes a storage member512, a first cap514, a second cap516, a first one-way valve610, a second one-way valve612, a diffuser614, an implantable medical device650, and a loading puller652. In the illustrated embodiment, the implantable member device650comprises a frame654and a material656attached to the frame654. The implantable medical device650is disposed within the second portion540of the storage member512such that a fluid can pass over the outside and inside surfaces of the implantable medical device650when the fluid is passed through the first portion538of the storage member512and into the second portion540via the plurality of holes536and the through hole542of the separating wall534. In the illustrated embodiment, the loading puller652is releasably attached to the implantable medical device650and is partially disposed within each of the storage member512and the second cap516. The loading puller652has a lengthwise axis657, a first end658, a second end660, a length661, and main body662that defines a first bend664, a second bend666, a third bend668, and a fourth bend670. The first bend664is positioned near the first end658between the first end658and the second bend666and the fourth bend670is positioned near the second end660between the second end660and the third bend668such that the loading puller defines two hooked ends672,674that partially surround a portion of the frame654of the implantable medical device650when the loading puller652is releasably attached to the implantable medical device650. The first hooked end672is opposably positioned from the second hooked end674relative to a lengthwise axis657of the loading puller652. The second bend666is disposed between the first bend664and the third bend668and the third bend668is disposed between the second bend666and the fourth bend670such that the loading puller652defines a u-shaped member676. The loading puller652is moveable between a first, uncompressed configuration and a second, compressed configuration. In the compressed configuration, the loading puller652has a width disposed between the hooked end672,674that is less than the outside diameter of an implantable medical device such that the loading puller652can be releasably attached to the implantable medical device. In the compressed configuration, a portion of the loading puller652(e.g., hooked ends672,674) is disposed within one or more openings651defined by a frame of an implantable medical device650, such that the loading puller652is capable of applying axial force on the implantable medical device650when axial force is applied to the loading puller652, as shown inFIG.16B. In the uncompressed configuration, the loading puller652has a width disposed between the hooked ends672,674that is greater than the outside diameter of the implantable medical device such that the loading puller is free of the implantable medical device. While the loading puller652has been illustrated as having a particular structural arrangement, a loading puller can have any suitable structural arrangement capable of providing releasable attachment to an implantable medical device and advancing the implantable medical device through a storage device and/or loading device, as described in more detail herein. Selection of a suitable structural arrangement for a loading puller can be based on various considerations, such as the structural arrangement of an implantable medical device to which the loading puller is intended to be attached. For example, while loading puller652has been illustrated as having a first hooked end672that is opposably positioned from a second hooked end674relative to the lengthwise axis657of the loading puller652, a first hooked end can be positioned at any suitable location relative to a second hooked end relative to a lengthwise axis of the loading puller. While the loading puller652has been illustrated as defining four bends, a loading puller can define any suitable number of bends. Examples of numbers of bends considered suitable for a loading puller to define include one, at least one, two, a plurality, three, four, five, more than five, and any other number considered suitable for a particular embodiment. For example, a loading puller can define only first and second bends to define first and second hooked ends and can include a curve defined between the first bend and the second bend such that the first hooked end is opposably positioned from the second hooked end. Alternatively, a loading puller can define only first, second, and third bends to define first and second hooked ends and the third bend can be defined between the first bend and the second bend such that the first hooked end is opposably positioned from the second hooked end. A loading puller652can be formed of any suitable material and using any suitable method of manufacture and selection of a suitable material and method of manufacture can be based on various considerations, including the material forming an implantable medical device to which the loading puller is intended to be releasably attached. Examples of materials considered suitable to form a loading puller include biocompatible materials, materials that can be made biocompatible, metals, shape memory alloys, Nitinol, plastics, and any other material considered suitable for a particular embodiment. In the illustrated embodiment, the loading puller is formed of Nitinol. FIG.17illustrates an example loading device710. The loading device710includes a loading member712, a first cap714, a second cap716, an implantable medical device718, and a loading puller720. The implantable medical device718is similar to the implantable medical device650illustrated inFIGS.15and16and described above, except as detailed below. The loading puller720is similar to the loading puller652illustrated inFIGS.15and16and described above, except as detailed below. In the illustrated embodiment, the loading member712has a lengthwise axis721, a first end722, a second end724, and a main body726that defines a first opening728, a second opening730, and a passageway732. The passageway732extends from the first opening728to the second opening730and has a first portion734, a second portion736, a third portion738, and a fourth portion740. The passageway732is sized and configured to house the implantable medical device718. The first portion734extends from the first end722to the second portion736and has an inside diameter735. The second portion736extends from the first portion734to the third portion738and has an inside diameter737that tapers from the first portion734to the third portion738. The third portion738extends from the second portion736to the second end724and has an inside diameter739that is less than the inside diameter735of the first portion734. The fourth portion740extends from the third portion738to the second end724and has a width741that is greater than the inside diameter739of the third portion738. In use, when the loading puller720is pulled through the passageway732the loading puller720is in its compressed configuration and the implantable medical device718is in its compressed configuration as its moves through the second portion736of the passageway732. When the loading puller720reaches the fourth portion740of the passageway732it expands to its uncompressed configuration while the implantable medical device718remains in its compressed configuration. While the implantable medical device718is illustrated as being disposed within the first portion734of the passageway732, an implantable medical device can be disposed within any suitable portion of a loading member. Depending on the structural arrangement of an implantable medical device intended to be positioned within a loading device, a first portion of a passageway can have a constant inside diameter along the length of the first portion, an inside diameter that varies along the length of the first portion (e.g., tapers from the first end toward the second end, defines a shoulder within the first portion such that a first inside diameter is between the first end and the shoulder and a second inside diameter is between the shoulder and the second end that is greater than the first inside diameter), or any other arrangement considered suitable for a particular embodiment. The second cap716is releasably attached to the second end724of the loading member712and has a first end742, a second end,744, and a main body746that defines a recess748and a recess base750. The recess748has a first portion752and a second portion754. The first portion752has a first inside diameter753and the second portion754has a second inside diameter755that is less than the first inside diameter753of the first portion752. The second portion754is sized and configured to receive a portion of the loading puller720. The second cap716and the loading member712define mating structure that achieves a snap-fit attachment between the second cap716and the loading member712. In the illustrated embodiment, the first cap714comprises a device guard715that is releasably attached to the first end722of the loading member712and partially extends into the passageway732defined by the loading member712. The device guard715has a first end756, a second end758, and a main body760that defines a base762, a sidewall764, a projection766, and a recess768that extends into the projection766. The base762and the sidewall764cooperatively define a cavity770that is sized and configured to receive a portion of the loading member712. The projection766extends from the base762, through the cavity770, and to an environment exterior to the cavity770. The recess768extends from the second end758toward the first end756to a recess base769. The recess768is sized and configured to receive a portion of a delivery system, as described in more detail herein. While device guard715has been illustrated as being releasably attached to loading member712, any suitable device guard, such as those described herein (e.g., device guard146, device guard1714), or cap, such as those described herein (e.g., cap14), can be releasably attached to a loading member. Alternative embodiments can include a device guard that includes a projection that has a length that is greater than, or equal to, a tip of a delivery system or that defines an opening on a first end or a hollowed extension that is sized and configured to receive a portion of a tip of a delivery system. In the illustrated embodiment, the loading puller720is releasably attached to the implantable medical device718and is partially disposed within each of the loading member712and the second cap716. Optionally, a loading device can include a port (e.g., port121), a first two-way valve (e.g., valve123), a passageway defined on a second cap (e.g., passageway125), and a second two-way valve (e.g., valve127). In these embodiments, an implantable medical device can be positioned within the loading member (e.g., first portion of passageway) and the caps can be positioned on the loading member as described, Subsequently, if not already sterilized, a sterilizing material can be passed through the loading member using the port to sterilize the implantable medical device using the first and second two-way valves and any suitable components attached to the valves to pass the sterilizing material through the loading member. After sterilization, a rinsing material can be passed through the loading member using the port to rinse the implantable medical device using the first and second two-way valves and any suitable components attached to the valves to pass the rinsing material through the loading member. Optionally, a holding material can be passed through the loading member using the port to store the implantable medical device using the first and second two-way valves and any suitable components attached to the valves to pass the holding material through the loading member. This structural arrangement provides a mechanism for sterilizing, rinsing, and storing an implantable medical device such that the implantable medical device is not contacted by any component until a delivery system, as described herein, is used to deliver the implantable medical device. The loading device710provides a mechanism for decreasing the complexity of sterilizing, storing, rinsing, and/or loading an implantable medical device and minimizing the risk associated with handling an implantable medical device that is intended for implantation. For example, the loading device710provides a mechanism for sterilizing, storing, rinsing, and/or loading an implantable medical device using a closed system that reduces the interaction with the implantable medical device during sterilization, storing, rinsing, and/or loading. FIGS.18,19,20,21,22,23,24,25, and26illustrate another example loading device810. The loading device810includes a storage member812, a first cap814, a first one-way valve910, a second one-way valve912, a diffuser914, a loading member1012, a second cap1014, a connector1016, and a loading puller1020. Each of the storage member812, the first cap814, the first one-way valve910, the second one-way valve912, and the diffuser914is similar respectively to the storage member312, the first cap314, the first one-way valve410, the second one-way valve412, and the diffuser414illustrated inFIGS.8,9,10,11,12,13, and14and described above, except as detailed below. Each of the loading member1012and the second cap1014is similar respectively to the loading member712and cap714illustrated inFIG.17and described above, except as detailed below. As shown inFIGS.19and24, the main body824of the storage member812defines first and second posts1074,1076, protuberances1078, and a recess1079. Each of the first and second posts1074,1076extends from the first end820and away from the second end822to an end1073. Each of the posts1074,1076has a first outside diameter1075at the end1073of the post and a second outside diameter1077between the end of the post and the first end820of the first cap812. The second outside diameter is less than the first outside diameter. Each protuberance1078extends from the second end822and away from the first end820and is sized and configured to be received by a recess1098defined by the loading member1012, as shown inFIG.21. The recess1079extends into the main body824from an exterior surface and toward the lengthwise axis813of the storage member812. The recess1079is sized and configured to receive a portion of the connector1016, as described in more detail herein. As shown inFIGS.19and25, the diffuser914is permanently attached to the first cap814, the first one-way valve is permanently attached to the first cap814, and the first cap814defines first and second openings1080,1082that are each sized and configured to receive a portion of a post1074,1076defined by the storage member812. Each opening1080,1082has a first portion1084sized and configured to receive the portion of a post1074,1076that has the first outside diameter1075and a second portion1086that is sized and configured to receive the portion of a post1074,1076that has the second outside diameter1077. In use, the first cap814is positioned on the storage member812such that the first post1074is disposed within the first opening1080and the second post1076is disposed within the second opening1082. After the posts1074,1076have been positioned within the openings1080,1082, the first cap814is rotated relative to the storage member812about the lengthwise axis813of the storage member812to achieve releasable attachment between the storage member812and the first cap814. In the illustrated embodiment, the loading member1012is releasably attached to the storage member812using the connector1016and the main body1026of the loading member1012defines a plurality of recesses1088, a first track1090, a second track1092, first and second posts1094,1096, a plurality of recesses1098, and recess1099. Each recess of the of the plurality of recesses1088extends from the first end1022of the loading member1012toward the second end1024and terminates at the junction between the first portion1034and the second portion1036of the passageway1032. Each recess of the plurality of recesses1088has a first width1087at the first end1022of the loading member1012and a second width1089between the first end1022and the second end1024. The first width1087is greater than the second width1089such that each recess of the plurality of recesses tapers from the first end1022toward the second end1024. Each of the first track1090and the second track1092extends from the first end1022of the loading member1012to the second end1024of the loading member1012and is sized and configured to receive a portion of the loading puller1020. Each of the first and second tracks1090,1092provides a mechanism to guide the loading puller1020through the loading member1012during use. Each of the first and second posts1094,1096extends from the second end1024of the loading member1012and away from the first end1022to an end1093. Each of the posts1094,1096has a first outside diameter1095at the end1093of the post and a second outside diameter1097between the end1093of the post and the second end1024of the loading member1012. The second outside diameter1097is less than the first outside diameter1095. Each recess1098extends from the first end1022, into the main body1026of the loading member1012, and is sized and configured to receive a protuberance1078defined by the storage member812. When the protuberances1078are received within the recesses1098, the plurality of recesses916defined by the storage member812is aligned with the plurality of recesses1088defined by the loading member1012. The recess1099extends into the main body1026from an exterior surface and toward the lengthwise axis1021of the loading member1012. The recess1099is sized and configured to receive a portion of the connector1016, as described in more detail herein. While each recess of the plurality of recesses1088has been illustrated as extending from the first end1022of the loading member1012toward the second end1024and terminating at the junction between the first portion1034and the second portion1036of the passageway1032and as having a first width1087at the first end1022of the loading member1012and a second width1089between the first end1022and the second end1024that is less than the first width1087, each recess can have any suitable structural arrangement. Selection of a suitable structural arrangement for each recess included in a loading member can be based on various considerations, including the structural arrangement of an implantable medical device intended to be passed through a loading member. For example, a loading member can define any suitable number of recesses, such as one, at least one, two, a plurality, three, four, five, more than five, more than ten, and any other number considered suitable for a particular embodiment. A recess included on a loading member can extend any suitable length of a loading member. For example, a recess, or each recess of a plurality of recesses, can extend from a first end to a second end of a loading member, from a first end to a location between the first end and the second end of a loading member, from a location between a first end and a second end to the second end of the loading member, from a first location between a first end and a second end to a second location between the first location and the second end of a loading member, and any other length of a loading member considered suitable for a particular embodiment. A recess included on a loading member can have any suitable width along its length. For example, a recess, or each recess of a plurality of recesses, can have a first width at a first end (e.g., at a first end of a loading member) and a second width at a second end (e.g., between a first end and a second end of a loading member) that is greater than, less than, equal to, or about the first width. A recess included on a loading member can have any suitable structural arrangement, such as curved, cuboidal, prismatic, and any other structural arrangement considered suitable for a particular embodiment. In the illustrated embodiment, the second cap1014is releasably attached to the second end1024of the loading member1012and the second one-way valve912is permanently attached to the second end1044of the second cap1014. Alternative embodiment, however, can include a cap that incorporates a one-way or two-way valve within the cap such that a separate component attached to the cap is not needed. The main body1046of the second cap1014defines a passageway1102that extends through the second end1044and provides access to the recess1048. As shown inFIG.23, the second cap1014defines first and second openings1104,1106that are each sized and configured to receive a portion of a post1094,1096defined by the loading member1012. Each opening1104,1106has a first portion1108sized and configured to receive the portion of a post1094,1096that has the first outside diameter1095and a second portion1110that is sized and configured to receive the portion of a post1094,1096that has the second outside diameter1097. In use, the second cap1014is positioned on the loading member1012such that the first post1094is disposed within the first opening1104and the second post1096is disposed within the second opening1106. After the posts1094,1096have been positioned within the openings1104,1106, the second cap1014is rotated relative to the loading member1012about the lengthwise axis1021of the loading member1012to achieve releasable attachment between the loading member1012and the second cap1014. The connector1016is releasably attached to the storage member812and the loading member1012. The connector1016has a lengthwise axis1113, a first end1114, a second end1116, and a main body1118that defines a first projection1120and a second projection1122. Each of the first projection1120and the second projection1122extends from the main body1118and toward the lengthwise axis1113of the connector1016. The first projection1120is sized and configured to be received by the recess1079defined by the storage member812and the second projection1122is sized and configured to be received by the recess1099defined by the loading member1012. The connector1016provides releasable attachment between the storage member812and the loading member1012. In an alternative embodiment, a connector can be omitted and a storage member can be directly attached to a loading member using any suitable method or technique that achieves releasable attachment, such as those described herein. Alternatively, a connector can be permanently attached to a storage member and a loading member (e.g., using a crimp connection). Any of the storage devices and/or loading devices described herein can optionally include an implantable medical device housed within a second portion of a storage member. Any suitable implantable medical device can be included in a storage member and selection of a suitable implantable medical device can be based on various considerations, including the treatment intended to be performed. Examples of implantable medical devices considered suitable to include in a storage member include implantable medical devices that include a frame, such as a support frame, implantable medical devices that include a frame and a material attached to the frame, venous valves, heart valves, stents, occluders that include a frame along with leaflets that are sewn or otherwise attached to each other to permanently close an associated valve orifice or a graft material that lacks an orifice, and any other implantable medical device considered suitable for a particular embodiment. Examples of frames considered suitable to include on an implantable medical device include those that comprise an expandable frame having radially compressed and radially expanded configurations. Such a frame can be implanted at a point of treatment within a body vessel by minimally invasive techniques, such as delivery and deployment with a delivery system, such as those described herein, that is sized and configured for navigation within the body vessel. It is noted, though, that implantable medical devices, such as frames, regardless of the type and/or nature of the frame, can be implanted within a body vessel at a desired point of treatment using conventional minimally-invasive techniques, such as by delivery with an associated delivery system, such as those described herein, by surgical techniques, or by any other suitable technique for placing a frame or medical device at a point of treatment within a body vessel. A frame can be self-expandable or can require an input of force to affect expansion, such as a balloon expandable frame. A frame can provide a stenting function, i.e., exert a radially outward force on the interior wall of a vessel in which the frame, or implantable medical device including the frame, is implanted. By including a frame that exerts such a force, an implantable medical device can provide multiple functions, such as a stenting and a valving function, at a point of treatment within a body vessel, which may be desirable in certain situations, such as when a degree of vessel stenosis, occlusion, and/or weakening is present. A frame of an implantable medical device can include any suitable structural elements, such as struts and bends, conventional structural features that facilitate anchoring of the frame at a point of treatment within a body vessel, such as barbs and/or microbarbs, and structural features, such as radiopaque markers, that facilitate visualization of the frame in conventional or other medical visualization techniques, such as radiography, fluoroscopy, and other techniques. Furthermore, a frame can include structural features, such as eyelets, barbs, fillets and other suitable structures, that provide attachment points for grafts and other materials. A frame can be made from any suitable material and selection of an appropriate material for use in a frame according to a particular embodiment can be based on various considerations, including any desired flexibility and visualization characteristics. The material selected for a frame need only be biocompatible or be able to be made biocompatible. Examples of suitable materials include, without limitation, stainless steel, nickel titanium (NiTi) alloys, e.g., Nitinol, other shape memory and/or superelastic materials, molybdenum alloys, tantalum alloys, titanium alloys, precious metal alloys, nickel chromium alloys, cobalt chromium alloys, nickel cobalt chromium alloys, nickel cobalt chromium molybdenum alloys, nickel titanium chromium alloys, linear elastic Nitinol wires, polymeric materials, and composite materials. Absorbable and bioremodellable materials can also be used to form a frame. As used herein, the term “absorbable” refers to the ability of a material to degrade and to be absorbed into a tissue and/or body fluid upon contact with the tissue and/or body fluid. A number of absorbable materials are known in the art, and any suitable absorbable material can be used. Examples of suitable types of absorbable materials include absorbable homopolymers, copolymers, or blends of absorbable polymers. Specific examples of suitable absorbable materials include poly-alpha hydroxy acids such as polylactic acid, polylactide, polyglycolic acid (PGA), or polyglycolide; trimethylene carbonate; polycaprolactone; poly-beta hydroxy acids such as polyhydroxybutyrate or polyhydroxyvalerate; or other polymers such as polyphosphazines, polyorganophosphazines, polyanhydrides, polyesteramides, polyorthoesters, polyethylene oxide, polyester-ethers (e.g., polydioxanone) or polyamino acids (e.g., poly-L-glutamic acid or poly-L-lysine). There are also a number of naturally derived absorbable polymers that may be suitable, including modified polysaccharides, such as cellulose, chitin, and dextran, and modified proteins, such as fibrin and casein. Stainless steel and nitinol are currently considered suitable materials for use in a frame of an implantable medical device due at least to their biocompatibility, shapeability, and well-characterized nature. Also, cold drawn cobalt chromium alloys, such as ASTM F562 and ASTM F1058 (commercial examples of which include MP35N™ and Elgiloy™, both of which are available from Fort Wayne Metals, Fort Wayne, IN; MP35N is a registered trademark of SPS Technologies, Inc. (Jenkintown, PA, USA); Elgiloy is a registered trademark of Combined Metals of Chicago LLC (Elk Grove Village, IL, USA)), are currently considered suitable materials for frames at least because they are non-magnetic materials that provide beneficial magnetic resonance imaging (MRI) compatibility and avoid MRI artifacts typically associated with some other materials, such as stainless steel. A frame can be fabricated in any suitable manner and by any suitable technique and selection of an appropriate manner and/or technique for fabricating a frame can be based on various considerations, including the nature of the material from which the frame is being fabricated. Examples of suitable techniques include forming a frame from wire, such as by wrapping a suitable wire around a suitable mandrel, by cutting the frame from a tubular section of an appropriate material, such as by laser-cutting the support frame from a metal tubular member, and by forming the desired structure of the frame in sheet form, such as by vapor deposition or other suitable technique, configuring the sheet into tubular form, such as by rolling or other suitable technique, and fixing the frame in tubular form, such as by laser-welding or other suitable technique. If an implantable medical device includes a frame and a material attached to the frame, the material attached to the frame can form any suitable structure and selection of a suitable structure for a material attached to a frame to form can be based on various considerations, including the treatment intended to be performed. Any suitable material can be attached to the frame to form an implantable medical device and selection of an appropriate material for use with a frame in an implantable medical device can be based on various considerations, including the intended use and desired function of the implantable medical device. For valve devices, such as venous valves, heart valves, or any other valve device, one or more leaflets, each having a free edge, can be attached to a frame and comprise a section of material, such as a sheet, that is attached to the frame along a respective attachment pathway. The leaflets can be formed of any suitable material, and need only be biocompatible or be able to be made biocompatible. The material can be formed of a flexible material. Examples of suitable materials for use as leaflets in implantable medical devices include natural materials, synthetic materials, and combinations of natural and synthetic materials. Examples of suitable natural materials include extracellular matrix (ECM) materials, such as small intestine submucosa (SIS), and other bioremodelable materials, such as bovine pericardium. Other examples of suitable ECM materials that can be used include stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater. Other examples of suitable natural materials include renal capsule matrix, abdominal fascia, parenchyma, such as abdominal parenchyma, connective tissue, pulmonary or lung ligament, tissue laminates, and natural valve leaflets with or without adjacent vessel wall. Pleura is also considered a suitable natural material, including visceral pleura. Fixed tissues are also considered suitable, including fixed SIS, fixed pericardium, fixed pulmonary or lung ligament, and any other suitable fixed natural tissue. When fixed tissue is used, any suitable fixation technique and/or procedure can be used, including chemical fixatives, such as aldehydes, e.g., formaldehyde, glutaraldehyde, and formalin, and carbodiimides, such as ethyl dimethylaminopropyl carbodiimide, dicyclohexylcarbodiimide. Physical fixation techniques and/or procedures can also be used, including exposure to heat and/or radiation. Lyophilized preparations and chemically-dried preparations of these natural materials are also considered suitable. Examples of suitable synthetic materials include polymeric materials, such as expanded polytetrafluoroethylene, polyurethane, polyurethane urea, polycarbonate, and polyesters. Any materials attached to a frame can have any suitable size, shape and configuration. For example, valve devices can include one, two or more leaflets that are sheet-like sections of material attached to a frame. Another example of a material that can be attached to a frame is a tubular structure that is attached around the outer circumference of the frame. Indeed, a tubular structure and one, two or more leaflets can be attached to a frame to form a valve device having an outer sleeve. Any material and/or elements attached to a frame can be attached to the frame in any suitable manner and with any suitable structure and/or substance. For example, leaflets can be attached to a frame in a valve device using sutures, tissue welding, adhesive(s), mechanical attachment(s), a combination of these approaches, and any other suitable structure and/or substance. The loading device810provides a mechanism for decreasing the complexity of sterilizing, storing, rinsing, and/or loading an implantable medical device and minimizing the risk associated with handling an implantable medical device that is intended for implantation. For example, the loading device810provides a mechanism for sterilizing, storing, rinsing, and/or loading an implantable medical device using a closed system that reduces the interaction with the implantable medical device during sterilization, storing, rinsing, and/or loading. FIGS.27and28illustrate an example delivery system1210. The delivery system1210includes a sheath1212, an elongate member1214, and a tip1216. The sheath1212has a first end1220, a second end1222, a length1223, and a main body1224that defines a lumen1226that extends through the entire length1223and is sized and configured to receive a portion of the elongate member1214, a portion of the tip1216, and a portion of an implantable medical device. The elongate member1214(e.g., cannula) has a lengthwise axis1229, a first end1230, a second end1232, and a main body1234that defines an outer surface1236, an inner surface1238, a lumen1240, and a notch1242. The lumen1240extends through the entire length of the elongate member1214and is sized and configured to receive a portion of a wire guide, or another medical device. The notch1242extends into the main body1234of the elongate member1214from the outer surface1236to the inner surface1238, toward the lengthwise axis1229, and toward the second end1232of the elongate member1214at an angle1243. In the illustrated embodiment, the angle1243is greater than zero degrees relative to the lengthwise axis1229of the elongate member1214. A notch can be defined at any suitable angle such as angles equal to, less than, greater than, or about 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 75 degrees relative to the lengthwise axis of an elongate member. The notch1242is sized and configured to receive a portion of a loading puller, as described in more detail herein. In the illustrated embodiment, the angle1243is equal to about 45 degrees relative to the lengthwise axis1229of the elongate member1214. While the elongate member1214has been illustrated as defining an inner surface1238and a lumen1240, an alternative embodiment can include an elongate member that comprises a solid piece of material that does not include an inner surface that defines a lumen. In this alternative embodiment, a notch can be defined in the main body the elongate member as described above with respect to elongate member1214. The tip1216is disposed on the second end1232of the elongate member1214and has a first end1246, a second end1248, and a main body1250that defines a lumen1251, a first portion1252, a second portion1254, and a third portion1256. The tip1216is sized and configured to be partially disposed within the sheath1212and to receive an implantable medical device thereon such that the implantable medical device can be delivered to a point of treatment. In the illustrated embodiment, the first portion1252is sized and configured to be disposed within the sheath1212. The notch1242is positioned from the first end1246of the tip1216a distance1257that is greater than the length of a loading puller such that the loading puller can be disposed within the notch and releasably attached to an implantable medical device that is disposed between the notch1242and the tip1216or disposed on the tip1216. While the tip1216has been illustrated as defining a lumen1251, an alternative embodiment can include a tip that comprises a solid piece of material that omits a lumen. FIG.29illustrates another example delivery system1310. The delivery system1310is similar to the delivery system1210illustrated inFIGS.27and28and described above, except as detailed below. The delivery system1310includes a sheath1312, an elongate member1314, a tip1316, and a gripping member1360. In the illustrated embodiment, the elongate member1314has a lengthwise axis1329, a first end1330, a second end1332, and a main body1334that defines an outer surface1336. The gripping member1360is attached to the elongate member1314between the first end1330of the elongate member1314and the first end1346of the tip1316. The gripping member1360has a first end1362, a second end1364, a length1365, and a main body1366. In use, the gripping member1360is sized and configured to be disposed within the lumen1326defined by the sheath1312and within a lumen defined by an implantable medical device disposed within a storage member. The gripping member1360provides a friction force between the frame of an implantable medical device and the sheath1312and assists with a controlled release of the implantable medical device during delivery such that jumping of the implantable medical device is prevented when being released from the sheath1312. In embodiments in which a balloon is included on a delivery system, the balloon can be positioned between a tip and a gripping member, or be considered the tip and positioned distal to a gripping member. In these embodiments, the elongate member can define an inflation lumen that is in fluid communication with a balloon chamber and extends to an inflation port defined distal to a sheath. A gripping member can be formed of any suitable material and have any suitable structural arrangement and selection of a suitable material and structural arrangement for a gripping member can be based on various considerations, including the intended use of a delivery system of which the gripping member is included. Examples of materials considered suitable for a gripping member include any material that has a coefficient of friction greater than the coefficient of friction of a material that forms an elongate member to which the gripping member is attached, polymers, silicone, polyurethane, rubbers, and any other material considered suitable for a particular embodiment. FIG.30illustrates another example delivery system1410. The delivery system1410is similar to the delivery system1210illustrated inFIGS.27and28and described above, except as detailed below. The delivery system1410includes a sheath1412, an elongate member1414, a tip1416, and a gripping member1460. In the illustrated embodiment, the delivery system includes a gripping member1460that is attached to the elongate member1414between the notch1442and the first end1446of the tip1416. The gripping member1460has a first end1462, a second end1464, a length1465, and a main body1466. In use, the gripping member1460is sized and configured to be disposed within the lumen1426defined by the sheath1412and within a lumen defined by an implantable medical device disposed within a storage member. In the illustrated embodiment, the gripping member1460is positioned from the notch1442a distance that is greater than the length of a pulling member intended to be used with the delivery system1410. Optionally, a delivery system can include an inner pusher catheter disposed within a sheath and over an elongate member that can be used to assist with delivery of an implantable medical device. In addition, a delivery system can include one or more kerfs disposed between a notch and a proximal end of an elongate member. FIGS.31and32illustrate an alternative tip1516that can be disposed the second end of an elongate member of an example delivery system. The tip1516is similar to the tip1216illustrated inFIG.27and described above, except as detailed below. In the illustrated embodiment, the main body1550of the tip1516defines shoulder1570and a planar surface1572. The shoulder1570is disposed between the first end1546of the tip1516and the second end1548of the tip1516. The planar surface1572extends from the shoulder1570toward the second end1548to a location between the shoulder1570and the second end1548. The inclusion of a shoulder1570and a planar surface1572provides a mechanism for orienting the tip1516and an attached elongate member relative to another component (e.g., loading member, storage member, device guard, planar surface of device guard), such as those described herein. FIGS.32A and32Billustrate an alternative tip1516′ that can be disposed the second end of an elongate member of an example delivery system. The tip1516′ is similar to the tip1216illustrated inFIG.27and described above, except as detailed below. In the illustrated embodiment, the main body1550′ of the tip1516′ defines a first recess1570′ and a second recess1572′. Each of the first recess1570′ and the second recess1572′ extends from the first end1546′ toward the second end1548′ and is sized and configured to receive a portion of a device guard or cap such that the tip1516′ and an attached elongate member can be oriented relative to another component (e.g., loading member, storage member, device guard, planar surface of device guard), such as those described herein. In the illustrated embodiment, the first recess1570′ is disposed on a plane that extends through the lengthwise axis of the tip1516′. However, alternative embodiments can include a first recess that is disposed on a first plane that extends through a lengthwise axis of a tip and a second recess that is disposed on a second plane that extends through the lengthwise axis of the tip at any suitable angle relative to the first plane (e.g., 45 degrees). While a first recess1570′ and a second recess1572′ have been illustrated, a main body of a tip can define any suitable number of recesses to assist with orienting the tip relative to a portion of a storage device and/or loading device and selection of a suitable number of recesses for a main body of a tip to define can be based on various considerations, such as the type of material forming a tip. Examples of suitable numbers of recesses for a main body of a tip to define include one, two, a plurality, three, four, five, more than five, and any other number considered suitable for a particular embodiment. FIGS.32C and32Dillustrate an alternative first cap114′ that can be releasably attached to a storage member of an example storage device or loading member of an example loading device. The first cap114′ is similar to the first cap114illustrated inFIGS.4and5and described above, except as detailed below. In the illustrated embodiment, the first cap114′ comprises a device guard146′ that can be releasably attached to a first end of a storage member or a loading member. The device guard146′ has a lengthwise axis147′, a first end148′, a second end150′, and a main body152′ that defines a base154′, a first projection156′, a recess160′, a first projection161′, and a second projection163′. The base154′ extends from the first end148′ toward the second end150′ and is sized and configured to be releasably attached within a passageway of a storage member. In the illustrated embodiment, the base154′ has an outside diameter155′, a first side162′, a second side164′, and is sized and configured to be releasably attached to a storage member within a passageway using a snap fit attachment between the device guard146′ and the storage member. The first projection156′ extends from the second side164′ to the second end150′. The first projection156′ has an outside diameter157′ that tapers from between the base154′ and the second end150′. The recess160′ extends from the first end148′ toward the second end150′ to a recess base166′ and is sized and configured to receive a portion of a delivery system (e.g., tip1516′), as described in more detail herein. The recess160′ has a first portion168′ and a second portion170′. The first portion168′ has an inside diameter167′ that is constant from the first end148′ to the second portion170′. The second portion170′ has an inside diameter169′ that tapers from the first portion168′ to the recess base166′. The first portion168′ has a cylindrical configuration and the second portion170′ has a conical configuration. Each of the first projection161′ and the second projection163′ extends into the recess160′ and is sized and configured to mate and be disposed within a recess defined by a tip (e.g., recess1570′, recess1572′) such that the delivery system is rotationally fixed relative to the device guard146′ when the projections161′,163′ are disposed within the recesses defined by the tip of the delivery system. While a first projection161′ and a second projection163′ have been illustrated, a main body of a device guard can define any suitable number of projections to assist with orienting a tip relative to a portion of a storage device and/or loading device and selection of a suitable number of projections for a main body of a device guard to define can be based on various considerations, such as the type of material forming a tip. Examples of suitable numbers of projections for a main body of a device guard to define include one, two, a plurality, three, four, five, more than five, and any other number considered suitable for a particular embodiment. FIGS.33,34,35, and36illustrate an example guide system1610. The guide system1610includes a guide board1612, a loading member1614, and a guide member1616. The loading member1614is similar to the loading member712illustrated inFIG.17and described above, except as detailed below. The guide system1610can be used with any suitable storage device described herein, such as storage device10, storage device110, storage device210, storage device310, and/or storage device510. The guide board1612has a first end1620, a second end1622, a first side1624, a second side1626, a top surface1628, a bottom surface1630, and a main body1632that defines a notch1634and a plurality of apertures1636. The notch1634extends from the first end1620to the second end1622and is sized and configured to receive the loading member1614, the guide member1616, and a storage member or a storage member that includes an attached device guard, as described herein. A first set of apertures1638of the plurality of apertures1636is disposed near the first end1620and a second set of apertures1640of the plurality of apertures1636is disposed between the first set of apertures1638and the second end1622. In the illustrated embodiment, the loading member1614is disposed within the notch1634and is releasably attachable to the guide board1612using mounting pins (not shown). A first portion of the loading member1614has been illustrated for clarity in each ofFIGS.33and35. However, the loading member1614includes a second portion that is identical to the first portion and is releasably attached to the first portion using mounting pins and such that it is rotated 90 degrees relative to the lengthwise axis1644of the loading member, as described in more detail herein. The loading member1614has a lengthwise axis1644, a first end1646, a second end1648, and a main body1650that defines a first opening1652, a second opening1654, a passageway1656, a first track1658(cooperatively defined with the second portion), a second track1660, a third track1662(cooperatively defined with the second portion), a fourth track (not shown but defined on the second portion of the loading member), a plurality of mounting passageways1663, and guide pins1665. The passageway1656extends from the first opening1652to the second opening1654and has a first portion1666, a second portion1668, a third portion1670, and a fourth portion1672. The passageway1656is sized and configured to receive an implantable medical device, a loading puller, and a portion of a delivery system, such as those described herein. The first portion1666extends from the first end1646to the second portion1668and has an inside diameter1667that tapers from the first end1646to the second portion1668. The second portion1668extends from the first portion1666to the third portion1670and has an inside diameter1669that is less than the inside diameter1667of the first portion1666at the first end1646. The second portion1668is sized and configured to receive a portion of an implantable medical device, a loading puller, and a portion of a delivery system (e.g., gripping member). The third portion1670extends from the second portion1668to the fourth portion1672and has a width1671that is greater than the inside diameter1669of the second portion1668. The third portion1670is sized and configured to receive a portion of a loading puller in the expanded, or partially expanded, configuration, as described in more detail herein. The fourth portion1672extends from the third portion1670to the second end1648and has an inside diameter1673that is less than the width1671of the third portion and greater than the inside diameter1669of the second portion1668. The fourth portion1672is sized and configured to receive a portion of a sheath of a delivery system, as described in more detail herein. The decrease in diameter between the fourth portion1672and the third portion1670creates a shoulder1674that acts as a mechanical stop to advancement of a sheath of delivery system through the passageway1656. In use, when a loading puller is pulled through the passageway1656the loading puller is compressed as its moves through the first portion1666of the passageway1656and then expands when it reaches the third portion1670of the passageway1656. Each of the tracks1658,1660,1662, fourth track (not shown) extends from the first end1646to the second end1648. Each of the first track1658and third track1662is sized and configured to receive a portion of a loading puller and provides a mechanism to guide the loading puller through the loading member1614during use. Each of the second track1660and fourth track (not shown) is sized and configured to receive a portion of an implantable medical device. For example, in embodiments in which the implantable medical device includes a frame that has a portion that extends outwardly from the lengthwise axis of the frame (e.g., one or more markers, one or more barbs), one of, or each of, the second track and fourth track provides a mechanism to guide the implantable medical device through the loading member1614during use. Each aperture of the plurality of mounting passageways1663is sized and configured to align with the second set of apertures1640of the guide board1612such that one or more alignment pins (not shown) can be positioned within the apertures to maintain the position of the loading member1614relative to the guide board1612. Each of the guide pins1665is sized and configured to be received by a passageway (e.g., passageway280, passageway282) defined by a storage member to achieve alignment between the storage member and the loading member1614. The guide member1616is disposed within the notch1634and is releasably attachable to the guide board1612using mounting pins (not shown). The guide member1616has a lengthwise axis1675, a first end1676, a second end1678, and a main body1680that defines a first opening1682, a second opening1684, a passageway1686, and a plurality of mounting passageways1688. The passageway1686extends from the first opening1682to the second opening1684and is sized and configured to receive a portion of a delivery system (e.g., sheath), such as those described herein. The guide member1616provides a mechanism to maintain the position of a delivery system while loading an implantable medical device, as described in more detail herein. Each aperture of the plurality of mounting passageways1688is sized and configured to align with the first set of apertures1638of the guide board1612such that one or more mounting pins (not shown) can be positioned within the apertures to maintain the position of the guide member1616relative to the guide board1612. While the guide board1612, loading member1614, and guide member1616have been illustrated as separate elements, a guide board can be an integrated component with a loading member and/or a guide member. For example, a guide member can be permanently attached to a guide board. FIG.37illustrates an example kit1710that includes a storage device1712according to an embodiment; a device guard1714according to an embodiment; a delivery system1716according to an embodiment; a guide system1718according to an embodiment; instructions for use1720; and a storage container1722. Any suitable storage device, device guard, delivery system, loading member, and guide system can be included in a kit and selection of a suitable storage device, device guard, delivery system, loading member, and guide system to include in a kit can be based on various considerations, including the type of implantable medical device intended to be implanted using the kit. Examples of storage devices considered suitable to include in a kit include storage device storage device110, storage device210, storage device310, storage device510, variations of the storage devices described herein, and any other storage device according to an embodiment. Examples of device guards considered suitable to include in a kit include device guard146, device guard715, device guard1714, variations of the device guards described herein, and any other device guard according to an embodiment. Examples of delivery systems considered suitable to include in a kit include delivery system1210, delivery system1310, delivery system1410, variations of the delivery systems described herein, and any other delivery system according to an embodiment. Examples of loading members considered suitable to include in a kit include loading member712, loading member1012, loading member1614, variations of the loading members described herein, and any other loading member according to an embodiment. Examples of guide systems considered suitable to include in a kit include guide system1610, variations of the guide systems described herein, and any other guide system according to an embodiment. In the illustrated embodiment, the kit1710includes storage device510, as shown inFIGS.15,16, and16A, delivery system1410, as shown inFIG.30, and guide system1610, as shown inFIGS.33,34,35, and36. In the illustrated embodiment, the device guard1714is similar to the device guard715illustrated inFIG.17and described above, except as detailed below. The device guard1716is releasably attachable to the first end520of the storage member512and the main body1760of the device guard1714defines a base1762, a sidewall1764, a projection1766, a first opening1768, a second opening1770, and a passageway1772. The base1762and the sidewall1764cooperatively define a cavity1770that is sized and configured to receive a portion of the storage member512. The projection1766extends from the base1762, through the cavity1770, and to an environment exterior to the cavity1770. The passageway1772extends from the first opening1768to the second opening1770and is sized and configured to receive a portion of a delivery system, as described in more detail herein. While the kit1710has been illustrated as including a single a storage device510, a single device guard1714, a single delivery system1310, and a single guide system1610, any suitable number, and type, of storage devices, device guards, delivery systems, loading members, and/or guide systems can be included in a kit, such as those described herein. Selection of a suitable number of storage devices, device guards, delivery systems, loading members, and/or guide systems to include in a kit according to a particular embodiment can be based on various considerations, such as the type of implantable medical device intended to be implanted using the kit. Examples of suitable numbers of storage devices, device guards, delivery systems, loading members, and/or guide systems to include in a kit include at least one, one, two, a plurality, three, four and any other number considered suitable for a particular embodiment. While the kit1710has been illustrated as including only a storage device1712, a device guard1714, a delivery system1716, a guide system1718, instructions for use1720, and a storage container1720, a kit can include any suitable number of optional components. Examples of numbers of optional components considered suitable to include in a kit, such as an implantable medical device, include one, at least one, two, a plurality, three, four, five, more than five, and any other number considered suitable for a particular embodiment. Examples of optional components and/or devices considered suitable to include in a kit include containers, or bags (e.g., I.V. bag), filled with saline, lubricant, a rinsing solution, or a flushing solution, tubing, bowls, guide wires, catheters, syringes, and/or any other component and/or device considered suitable for a particular embodiment. A storage container included in a kit can have any suitable structural arrangement and be formed of any suitable material and selection of a suitable structural arrangement and material to form a storage container can be based on various considerations, including the number of storage devices, device guards, delivery systems, loading members, and/or guide systems included in a kit. Examples of structural arrangements considered suitable to form a storage container include boxes, boxes that include a lid, boxes that include a lid attached to the box (e.g., pivotably attached), bags, and any other structural arrangement considered suitable for a particular embodiment. Examples of materials considered suitable to form a storage container include metals, plastics, glass, combinations of the materials described herein, and any other material considered suitable for a particular embodiment. In the illustrated embodiment, the storage container1722is a box1723formed of a rigid plastic. FIG.38illustrates an example kit1810that includes a loading device1812according to an embodiment; a device guard1814according to an embodiment; a delivery system1816according to an embodiment; instructions for use1818; and a storage container1820. Any suitable loading device, device guard, and delivery system can be included in a kit and selection of a suitable storage device, device guard, and delivery system to include in a kit can be based on various considerations, including the type of implantable medical device intended to be implanted using the kit. Examples of loading devices considered suitable to include in a kit include loading device710, loading device810, variations of the loading devices described herein, and any other loading device according to an embodiment. Examples of device guards considered suitable to include in a kit include device guard146, device guard715, device guard1714, variations of the device guards described herein, and any other device guard according to an embodiment. Examples of delivery systems considered suitable to include in a kit include delivery system1210, delivery system1310, delivery system1410, variations of the delivery systems described herein, and any other delivery system according to an embodiment. In the illustrated embodiment, the kit1810includes loading device810, as shown inFIGS.18,19,20,21,22,23,24,25, and26, and delivery system1410, as shown inFIG.30. While the kit1810has been illustrated as including a single a loading device1812, a single device guard1814, and a single delivery system1816, any suitable number, and type, of loading devices, device guards, and/or delivery systems can be included in a kit, such as those described herein. Selection of a suitable number of loading devices, device guards, and/or delivery systems to include in a kit according to a particular embodiment can be based on various considerations, such as the type of implantable medical device intended to be implanted using the kit. Examples of suitable numbers of loading devices, device guards, and/or delivery systems to include in a kit include at least one, one, two, a plurality, three, four and any other number considered suitable for a particular embodiment. While the kit1810has been illustrated as including only a loading device1812, a device guard1814, a delivery system1816, instructions for use1818, and a storage container1820, a kit can include any suitable number of optional components. Examples of numbers of optional components considered suitable to include in a kit, such as an implantable medical device, include one, at least one, two, a plurality, three, four, five, more than five, and any other number considered suitable for a particular embodiment. Examples of optional components and/or devices considered suitable to include in a kit include containers, or bags (e.g., I.V. bag), filled with saline, lubricant, a rinsing solution, or a flushing solution, tubing, bowls, guide wires, catheters, syringes, and/or any other component and/or device considered suitable for a particular embodiment. A storage member, a cap, a device guard, a one-way valve, a diffuser, a loading member, a loading puller, a connector, a catheter, an elongate member, a tip, a guide board, and a guide member of the embodiments described herein can be formed of any suitable material and using any suitable method of manufacture. Selection of a suitable material and method of manufacture can be based on various considerations, including the intended use of the device, component, element, or feature. Examples of materials considered suitable to form a storage member, a cap, a device guard, a one-way valve, a diffuser, a loading member, a loading puller, a connector, a catheter, an elongate member, a tip, a guide board, and a guide member of the embodiments described herein include biocompatible materials, materials that can be made biocompatible, metals, plastics, polymers, transparent materials, opaque materials, and any other material considered suitable for a particular embodiment. Optionally, any of the storage member, a cap, a device guard, a one-way valve, a diffuser, a loading member, a loading puller, a connector, a catheter, an elongate member, a tip, a guide board, and a guide member of the embodiments described herein can include a gasket (e.g., o-ring) disposed between it and another element to which it is attached. Any attachment between a storage member, a cap, a device guard, a one-way valve, a diffuser, a loading member, a connector, a catheter, an elongate member, a tip, a guide board, and a guide member and another element described herein cap can utilize any suitable technique or method of attachment between the elements. Selection of a suitable technique or method of attachment between two elements can be based on various considerations, including the material(s) that forms the elements. Examples of techniques and methods of attachment considered suitable between two elements described herein include those illustrated, using threaded connections, snap fit attachments, using one or more connectors, one or more mating slots and projections, pierceable membranes between the elements, releasable attachments, permanent attachments, and any other technique or method of attachment considered suitable for a particular application. Various methods of treatment are described herein. While the methods described herein are shown and described as a series of acts, it is to be understood and appreciated that the methods are not limited by the order of acts, as some acts may in accordance with these methods, occur in the order shown and/or described, in different orders, and/or concurrently with other acts described herein. FIG.39is a schematic illustration of an example method1900of sterilizing an implantable medical device. A step1902comprises inserting an implantable medical device into a storage member. Another step1904comprises attaching a first cap to the storage member. Another step1906comprises introducing a sterilizing material into the storage member. Another step1908comprises introducing a holding material into the storage member such that the sterilizing material is removed from the storage member. Another step1910comprises attaching a second cap to the storage member. Step1902can be accomplished using any suitable implantable medical device, such as those described herein. In the illustrated embodiment, the example method of sterilizing an implantable medical device1900comprises a method of sterilizing a valve device. Step1902can be accomplished by applying an axial force on the implantable medical device along the lengthwise axis of a storage member and toward the second end of the storage member until the implantable medical device is disposed within the second portion of the passageway defined by the storage member. Any suitable storage member can be used to complete method1900, such as the storage members described herein. An optional step that can be completed prior to, or subsequent to, step1902comprises releasably attaching a loading puller to the implantable medical device. Step1904can be accomplished using any suitable cap, such as the caps described herein. Alternatively, step1904can comprise attaching a loading member to a storage member and can be accomplished using any suitable loading member, such as the loading members described herein. Step1906can be accomplished using any suitable method or technique of introducing a sterilizing material into storage member (e.g., using a syringe) and by passing the sterilizing material through the first opening of the storage member such that it accumulates within the passageway defined by the storage member (e.g., within only the second portion of the passageway, within both the first portion and the second portion of the passageway), or passes through the passageway. Any suitable sterilizing material can be introduced into a storage member and selection of a suitable sterilizing material can be based on various considerations, including the type of implantable medical device disposed within the storage member. Examples of sterilizing materials include glutaraldehyde, formaldehyde, alcohol, and any other sterilizing material considered suitable for a particular embodiment. An optional step comprises removing the sterilizing material from the storage member. Optionally, step1906can be accomplished prior to step1904. Step1908can be accomplished using any suitable method or technique of introducing a holding material into storage member (e.g., using a syringe) and by passing the holding material through the first opening of the storage member such that it accumulates within the passageway defined by the storage member (e.g., within only the second portion of the passageway, within both the first portion and the second portion of the passageway), or passes through the passageway, and replaces any sterilizing material in the storage member. Any suitable holding material can be introduced into a storage member and selection of a suitable holding material can be based on various considerations, including the type of implantable medical device disposed within the storage member. Examples of holding materials include glutaraldehyde, saline, formaldehyde, phosphate buffers, phosphate buffered saline (PB S), agents, biological agents, coatings, absorbable coatings, drugs, quenching solutions, quenching solutions that may include an amino acid, anti-calcification materials, rinsing fluids, flushing fluids, and any other holding material considered suitable for a particular embodiment. Optionally, step1908can be completed multiple times (e.g., two times, three times). Optionally, step1908can be accomplished prior to step1904and after step1906. Step1910can be accomplished using any suitable cap, such as the caps described herein. In an alternative embodiment, step1904can comprise attaching a cap to the storage member and step1910can comprise attaching a loading member to a storage member.FIG.40illustrates an implantable medical device1912stored within an example storage member1914. While various steps, alternative steps, and optional steps have been described above with respect to the example method1900, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the method, steps, alternative steps, and/or optional steps described herein with respect to the example method2000, example method2100, example method2200, example method2300, and/or example method2400. FIG.41is a schematic illustration of another example method2000of sterilizing an implantable medical device. A step2002comprises inserting an implantable medical device into a storage member. Another step2004comprises attaching a first cap to the storage member. Another step2006comprises attaching a second cap to the storage member. Another step2008comprises introducing a sterilizing material into the storage member. Another step2010comprises introducing a holding material into the storage member such that the sterilizing material is removed from the storage member. Step2002can be accomplished as described above with respect to step1902. Step2004can be accomplished using any suitable cap, such as the caps described herein. Alternatively, step2004can comprise attaching a loading member to a storage member and can be accomplished using any suitable loading member, such as the loading members described herein. Step2006can be accomplished using any suitable cap, such as the caps described herein. Step2008can be accomplished using any suitable method or technique of introducing a sterilizing material into storage member such that the sterilizing material is passed through the first opening of the storage member and accumulates within the passageway defined by the storage member (e.g., within only the second portion of the passageway, within both the first portion and the second portion of the passageway), or passes through the passageway. For example, a syringe or a line connected to a bag containing a sterilizing material can be attached to a first one-way valve and be utilized to introduce the sterilizing fluid into the storage member such that the sterilizing material is contained within the storage member and does not pass through the second one-way valve. Alternatively, a syringe or a line connected to a bag can be used to pass the sterilizing fluid through the second one-way valve and into the storage member, or through the first one-way valve, the storage member, and the second one-way valve, or through the second one-way valve, the storage member, and the first one-way valve. Any suitable sterilizing material can be introduced into a storage member, such as those described herein. An optional step comprises removing the syringe or line from the one-way valve. Step2010can be accomplished using any suitable method or technique of introducing a holding material into storage member such that the holding material is passed through the first opening of the storage member and accumulates within the passageway defined by the storage member (e.g., within only the second portion of the passageway, within both the first portion and the second portion of the passageway), or passes through the passageway. For example, a syringe or a line connected to a bag containing a holding material can be attached to a first one-way valve and be utilized to introduce the holding fluid into the storage member such that the holding material is contained within the storage member and does not pass through the second one-way valve. Alternatively, a syringe or a line connected to a bag can be used to pass the holding fluid through the second one-way valve and into the storage member, or through the first one-way valve, the storage member, and the second one-way valve, or through the second one-way valve, the storage member, and the first one-way valve. An optional step comprises removing the syringe or line from the one-way valve. Any suitable holding material can be introduced into a storage member, such as those described herein. Optionally, step2010can be completed multiple times (e.g., two times, three times). Each time step2010is completed, it can be completed for a particular period of time (e.g., 1 minute, 5 minutes) and/or until a specified volume of holding fluid has been passed through storage member.FIG.42illustrates an implantable medical device2012stored within an example storage member2014and a loading puller2016that defines only first and second bends and a curve between the first and second bends. While various steps, alternative steps, and optional steps have been described above with respect to the example method2000, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the method, steps, alternative steps, and/or optional steps described herein with respect to the example method1900, example method2100, example method2200, example method2300, and/or example method2400. FIG.43is a schematic illustration of an example method2100of storing an implantable medical device. A step2102comprises inserting a sterilized implantable medical device into a storage member. Another step2104comprises attaching a first cap to the storage member. Another step2106comprises introducing a holding material into the storage member. Another step2108comprises attaching a second cap to the storage member. Step2102can be accomplished as described above with respect to step1902. Optional steps that can be completed prior to step2102include: sterilizing the implantable medical device; rinsing the implantable medical device; and/or attaching a loading puller to the implantable medical device. These optional steps can be accomplished using conventional sterilization and/or rinsing methods or those described herein. Step2104can be accomplished using any suitable cap, such as the caps described herein. Alternatively, step2104can comprise attaching a loading member to a storage member and can be accomplished using any suitable loading member, such as the loading members described herein. Step2106can be accomplished using any suitable method or technique of introducing a holding material into storage member (e.g., using a syringe) and by passing the holding material through the first opening of the storage member such that it accumulates within the passageway defined by the storage member (e.g., within only the second portion of the passageway, within both the first portion and the second portion of the passageway), or passes through the passageway. Any suitable holding material can be introduced into a storage member, such as those described herein. Optionally, step2106can be completed multiple times (e.g., two times, three times). Optionally, step2106can be accomplished prior to step2104or subsequent to step2108. In embodiments in which step2106is accomplished subsequent to step2108, step2106can be accomplished using any suitable method or technique of introducing a holding material into storage member such that the holding material is passed through the first opening of the storage member and accumulates within the passageway defined by the storage member (e.g., within only the second portion of the passageway, within both the first portion and the second portion of the passageway), or passes through the passageway. For example, a syringe containing a holding material can be attached to a first one-way valve and be utilized to introduce the holding fluid into the storage member such that the holding material is contained within the storage member and does not pass through the second one-way valve. Alternatively, a syringe can be used to pass the holding fluid through the second one-way valve and into the storage member, or through the first one-way valve, the storage member, and the second one-way valve, or through the second one-way valve, the storage member, and the first one-way valve. In this embodiment, step2106can be completed multiple times (e.g., two times, three times). Each time step2106is completed, it can be completed for a particular period of time (e.g., 1 minute, 5 minutes) and/or until a specified volume of holding fluid has been passed through storage member. An optional step comprises removing the syringe or line from the one-way valve. Step2108can be accomplished using any suitable cap, such as the caps described herein. While various steps, alternative steps, and optional steps have been described above with respect to the example method2100, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the method, steps, alternative steps, and/or optional steps described herein with respect to the example method1900, example method2000, example method2200, example method2300, and/or example method2400. FIG.44is a schematic illustration of an example method2200of rinsing an implantable medical device. A step2202comprises attaching a device that includes a rinsing material to a one-way valve of a storage device. Another step2204comprises introducing the rinsing material into the storage device such that it passes through the storage device. Another step2206comprises stopping the step of introducing the rinsing material into the storage device. Step2202can be accomplished using any suitable method or technique of attachment and using any suitable device that includes a rinsing material, such as syringe, a line attached to a bag that includes a rinsing material, and any other device considered suitable for a particular embodiment. Any suitable rinsing material can be included in a device and selection of a suitable rinsing material can be based on various considerations, including the type of implantable medical device disposed within a storage member. Examples of rinsing materials include saline, agents, biological agents, coatings, absorbable coatings, drugs, phosphate buffers, phosphate buffered saline (PBS), and any other rinsing material considered suitable for a particular embodiment. In the embodiment described, a device is attached to a first one-way valve of a storage device. However, alternative embodiments can include a device that is attached to a second one-way valve of a storage device. While step2202has been described as being completed by attaching a device to a storage device, an alternative embodiment can include attaching a device to a loading device. Step2202can be accomplished by attaching the device to a first one-way valve of a storage device and/or loading device or a second one-way valve of a storage device and/or loading device. Step2204can be accomplished using any suitable method or technique of introducing a rinsing material into storage device such that the rinsing material is passed through the first opening of the storage member and accumulates within the passageway defined by the storage member (e.g., within only the second portion of the passageway, within both the first portion and the second portion of the passageway), or passes through the passageway. Alternatively, a syringe can be used to pass the rinsing fluid through the second one-way valve and into the storage member, or through the first one-way valve, the storage member, and the second one-way valve, or through the second one-way valve, the storage member, and the first one-way valve. Alternatively, a syringe containing a rinsing material can be attached to a first one-way valve and be utilized to introduce the rinsing fluid into the storage member such that the rinsing material is contained within the storage member and does not pass through the second one-way valve. Step2204can be completed multiple times (e.g., two times, three times). Each time step2204is completed, it can be completed for a particular period of time (e.g., 1 minute, 5 minutes) and/or until a specified volume of rinsing fluid has been passed through storage member. Optionally, steps2202,2204,2206can be repeating one or more times using a second rinsing fluid that is different than the rinsing fluid initially passed through the storage member. An optional step comprises agitating the storage member during step2204or subsequent to the completion of step2204. While method2200has been described as being accomplished using a one-way valve, other embodiments can include a storage device and/or loading device that omits the inclusion of one or more one-way valves. In these embodiments, method2200can include the steps of: removing a first cap, a second cap, a first one-way valve, and/or a second one-way valve; immersing the storage member in a rinsing material; optionally agitating the storage member; and removing the storage member from the rinsing material. While various steps, alternative steps, and optional steps have been described above with respect to the example method2200, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the method, steps, alternative steps, and/or optional steps described herein with respect to the example method1900, example method2000, example method2100, example method2300, and/or example method2400. FIG.45is a schematic illustration of an example method2300of loading an implantable medical device onto a delivery system. A step2302comprises removing a first cap from a storage member containing an implantable medical device. Another step2304comprises removing a diffuser from the storage member. Another step2306comprises attaching a device guard to the storage member. Another step2308comprises removing a second cap from the storage member. Another step2310comprises attaching the storage member to a loading member of a guide system. Another step2312comprises applying an axial force on a portion of a delivery system such that it is passed through the storage member and partially disposed within the device guard. Another step2314comprises positioning a loading puller within a notch defined by a cannula of the delivery system. Another step2316comprises applying an axial force on the cannula of the delivery system away from the storage member until the loading puller moves to its uncompressed configuration and is free of the implantable medical device. Another step2318comprises removing the loading puller from the delivery system and loading member. Another step2320comprises applying an axial force on a sheath of the delivery system toward the loading member while maintaining the position of the cannula until the sheath contacts the loading member. Another step2322comprises applying an axial force on the cannula while maintaining the position of the sheath such that the cannula is withdrawn from the loading member and the medical device is advanced into the sheath. Another step2324comprises removing the delivery system from the loading member. Step2304can be accomplished in any suitable manner, such as by applying a force on a diffuser away from a storage member in embodiments in which the diffuser is releasably disposed within a storage member. Alternatively, in embodiments in which a diffuser is permanently attached, or releasably attached, to a cap, step2304can be accomplished concurrently with step2302. Step2306can be accomplished using any suitable device guard, such as the device guards described herein. In an alternative embodiment, step2306can be omitted from a method of loading an implantable medical device onto a delivery system. Step2312can be accomplished using any suitable delivery system, such as the delivery systems described herein.FIG.46illustrates a storage member2330attached to a loading member2332of a guide system2334.FIG.47illustrates a delivery system2336partially disposed within the device guard2338and the loading puller2340disposed within the notch2342defined by the cannula2344.FIG.48illustrates the loading puller2340in the uncompressed configuration.FIG.49illustrates the sheath2346advanced toward the loading member such that it contacts the loading member. An optional step comprises implanting the implantable medical device with a body of a patient. Another optional step comprises orienting the tip of the delivery system relative to the implantable medical device using the device guard. Step2322can optionally be accomplished using structure attached to, or separate from, a loading member that provides for a releasable attachment between the loading member and a sheath during use such that the position of the sheath can be maintained while the cannula is being retracted into the sheath. For example, a loading member can include a collet, or flexible flaps, that extend into the passageway defined by the loading member that are sized and configured to mate with a sheath and maintain the position of the sheath until an axial force is applied to the sheath to remove it from the loading member. While various steps, alternative steps, and optional steps have been described above with respect to the example method2300, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the method, steps, alternative steps, and/or optional steps described herein with respect to the example method1900, example method2000, example method2100, example method2200, and/or example method2400. FIG.50is a schematic illustration of another example method2400of loading an implantable medical device onto a delivery system. A step2402comprises removing a cap from a storage member containing an implantable medical device. Another step2404comprises removing a diffuser from the storage member. Another step2406comprises attaching a device guard to the storage member. Another step2408comprises applying an axial force on a portion of a delivery system such that it is passed through the storage member and partially disposed within the device guard. Another step2410comprises positioning a loading puller within a notch defined by a cannula of the delivery system. Another step2412comprises applying an axial force on the cannula of the delivery system until the loading puller moves to its uncompressed configuration and is free of the implantable medical device. Another step2414comprises removing the loading puller from the delivery system and loading member. Another step2416comprises applying an axial force on a sheath of the delivery system toward the loading member while maintaining the position of the cannula until the sheath contacts the loading member. Another step2418comprises applying an axial force on the cannula while maintaining the position of the sheath such that the cannula is withdrawn from the loading member and the medical device is advanced into the sheath. Another step2420comprises removing the delivery system from the loading member. Step2404can be accomplished as described above with respect to step2304. Step2406can be accomplished using any suitable device guard, such as the device guards described herein. In an alternative embodiment, step2406can be omitted from a method of loading an implantable medical device onto a delivery system. Step2408can be accomplished using any suitable delivery system, such as the delivery systems described herein. Depending on the arrangement of the storage member being used in a method of loading an implantable medical device onto a delivery system, an implantable medical device can be wet during the loading process.FIGS.51and51Aillustrate a delivery system2422partially disposed within the device guard2424and the loading puller2426disposed within the notch2428defined by the cannula2430.FIGS.52and52Aillustrate the loading puller2426in the uncompressed configuration.FIGS.53and53Aillustrate the sheath2432advanced toward the loading member2434such that it contacts the loading member2434. When disposed within a delivery system, an implantable medical device can be partially disposed on a gripping member and entirely disposed proximal to a tip. An optional step comprises implanting the implantable medical device with a body of a patient. Another optional step comprises orienting the tip of the delivery system relative to the implantable medical device using the device guard. Another optional step comprises removing a second cap from the loading member to expose the loading puller. While various steps, alternative steps, and optional steps have been described above with respect to the example method2400, these steps, alternative steps, and optional steps can be included in, accomplished concurrently with, and/or accomplished in the alternative to, the method, steps, alternative steps, and/or optional steps described herein with respect to the example method1900, example method2000, example method2100, example method2200, and/or example method2300. The example storage devices, loading devices, guide systems, delivery systems, and methods described herein provide a mechanism for decreasing the complexity of sterilizing, storing, rinsing, and/or loading implantable medical devices and minimizing the risk associated with handling an implantable medical device that is intended for implantation. For example, the example storage devices, loading devices, guide systems, delivery systems, and methods described herein provide a mechanism for sterilizing, storing, rinsing, and/or loading an implantable medical device using a closed system that reduces the interaction with the implantable medical device during sterilization, storing, rinsing, and/or loading. Those with ordinary skill in the art will appreciate that various modifications and alternatives for the described and illustrated embodiments can be developed in light of the overall teachings of the disclosure. Accordingly, the particular arrangements disclosed are intended to be illustrative only and not limiting as to the scope of the invention, which is to be given the full breadth of the appended claims and any and all equivalents thereof. | 118,887 |
11857405 | B) EXAMPLE 1: PREPARATION OF AN IMPLANT a) Preparation of BNC Tube: A device and reactor as shown and described in FIG. 1 of WO2013/113675A1 is used for preparation of a BNC tube. To prepare the products, several rod shaped templates are arranged in a clamping and inserted into the moving means of the device. The reactor is then closed and sterilized. After sterilization of the entire reactor the reservoir of the reactor is filled under sterile conditions with a mixture of cellulose producing microorganisms and separately sterilized culture solution filled. Then, the engine of the device is started, and following steps performed:dipping the templates into the mixture of cellulose producing microorganisms and culture solution in the reservoir, thereby contacting the surface of the templatesremoving the templates from the reservoir, thereby interrupting of the contact between the template and the mixture, wherein on the surface of the template, a liquid film remains comprising the liquid culture medium and the microorganismcontacting of the liquid films on templates with the oxygen-containing atmosphere inside of the device and formation of microbial cellulose in and/or on the liquid film. In this step, the templates are rotated around at least two rotational axes, in order to reach a defined and preferably equal distribution of the film The above sequence of steps is repeated several times until the BNC tube on the template has assumed a desired shape a desired wall thickness of about 1-3 mm. The length and inner diameter of each BNC tube is determined by the dimensions of the corresponding rod-shaped template. At the end of the process, the tubes are stripped from the templates, purified and stored wet, preferably in deionized water. The BNC tube had a length of approximately 80-150 mm, an inner diameter of approximately 2-4 mm and an outer diameter of approximately 4-10 mm. The number of distinct BNC layers in the tube is about 5-7. An obtained BNC-tube1is shown in a cross section inFIG.1. The BNC tube1is placed onto the template8, which is a metal rod. L is the longitudinal axis of the BNC tube1. L extends in the viewing direction. The BNC tube1is composed of three layers5,6,7, wherein layer5is an inner layer,6a middle layer and7the outer layer. More than the shown layer6between the outer layer7and the inner layer5can be present. The layers5,6,7are concentric or substantially concentric to a longitudinal axis (L) of the tube1. The inner surface of the lumen of the BNC tube1is designated as3, and the outer surface is 4. An exemplary layer structure in a Scanning electron micrograph is shown in FIG. 3 of WO2013/113675A1. The layers5,6,7of microbial cellulose are made of fibers. Exemplary structures are shown in FIGS. 4, 5, and 6 of WO2013/113675A1. b) Combining BNC Tube and Stent A biliary stent (8.5 Fr Biliary Drainage Tube Set/Olympus, Tokyo, Japan) with a length of 50-120 mm, a diameter of 8.5 Fr was slit into the tube until the stent protruded both ends of the BNC tube in symmetrical manner. The obtained implant100is shown in appendedFIG.2. The microbial cellulose tube1comprises a wall2with the inner surface3and the outer surface4. The wall2is composed of the BNC layers5,6,7that are shown inFIG.1. The tubular stent9is placed inside of the microbial cellulose tube1. The outer surface10of the stent contacts the inner surface3of the microbial cellulose tube1. As shown inFIG.2, the length12of the stent9is longer than the length l1of the BNC tube1. The tubular stent9protrudes from the microbial cellulose tube at a first end11of the microbial cellulose tube1and a second end12of the microbial cellulose tube1. In the example ofFIG.2, the outer diameter of the stent9may be higher than the inner diameter of the BNC tube1(without stent9). In this case, the tube1is expanded in radial direction. Exemplary directions of expansion are designated with arrows R. It is to be understood that expansion will in this example occur also in other radial directions, since the stent9and the tube1are circular. A more or less symmetric expansion occurs, thereby increasing the inner diameter of the tube1. C) EXAMPLE 2: INSERTION OF THE IMPLANT INTO ANIMAL TO REGENERATE A BILE DUCT Comparative example: In a first experiment, only a BNC tube, without stent, was used as an implant. Implantation was done after resection of a bile duct segment in a pig, having a length of 3 cm. The BNC tube was interposed after length adjustment in end-to-end manner using 6/0-Prolene sutures. In a second experiment an implant as shown inFIG.2was used.FIG.3shows the implant100in a pig in a schematic view. Reference signs correspond to reference signs inFIG.2, as far as the implant100is concerned. FIG.3shows a part of a pig's liver13with a first bile duct section, or bile duct end,14and a part of the duodenum15with a second bile duct section, or bile duct end,16. In the first bile duct section14, a first protruding part of the stent9was introduced. In the second bile duct section16, a second protruding part of the stent9was introduced. The BNC tube1is placed between the bile duct sections14,16. A connection between the BNC tube1and the bile duct sections14,16is made by sutures17,18. After insertion of the implant100in a pig as shown inFIG.3the implant100was left for four or eight weeks in the animal. Following results were obtained: The BNC tube was still placed in the bile duct, i.e. between the bile duct sections14,16but was not grown together with the bile duct sections14,16. New bile duct epithelium was continuously formed on the surface4of the BNC tube, as shown by histologic analysis. In result, the bile duct sections14,16were connected by new bile duct epithelium. The anastomosis was sufficient, in a sense that an anastomosis ring could be observed. No badly healed or insufficient anastomosis were observed. The actual anastomosis was not existent any more since the interponate, i.e. the BNC tube, was repelled. The implant100, i.e. the BNC tube1and the stent4could be removed from the bile duct sections14,16and the newly created bile duct epithelium. The stent9was removed through the duodenum15. Thereby, the BNC tube1was also removed. The BNC tube1disassociated from the new bile duct epithelium which was grown on its surface. | 6,325 |
11857406 | DETAILED DESCRIPTION OF THE INVENTION While the invention has been disclosed with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt to a particular situation or material to the teachings of the invention without departing from its scope. Throughout the specification and claims, the following terms take the meanings explicitly associated herein unless the context clearly dictates otherwise. The meaning of “a”, “an”, and “the” include plural references. The meaning of “in” includes “in” and “on.” Referring to the drawings, like numbers indicate like parts throughout the views. Additionally, a reference to the singular includes a reference to the plural unless otherwise stated or inconsistent with the disclosure herein. The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” is not necessarily to be construed as advantageous over other implementations. Disclosed are methods and devices for regulating fluid flow to and from a region of a patient's lung, such as to achieve a desired fluid flow dynamic to a lung region during respiration and/or to induce collapse in one or more lung regions. Pursuant to an exemplary procedure, an identified region of the lung (referred to herein as the “targeted lung region”) is targeted for treatment. The targeted lung region is then bronchially isolated to regulate airflow into and/or out of the targeted lung region through one or more bronchial passageways that feed air to the targeted lung region. As shown inFIG.1, the bronchial isolation of the targeted lung region is accomplished by implanting a flow control device110(sometimes referred to as a bronchial isolation device) into a bronchial passageway115that feeds air to a targeted lung region120. The flow control device110regulates fluid flow through the bronchial passageway115in which the flow control device110is implanted. The flow control device110can regulate airflow through the bronchial passageway115using a valve that permits fluid flow in a first direction (e.g., the exhalation direction) while limiting or preventing fluid flow in a second direction (e.g., the inhalation direction). The valve includes coaptation regions that are moveable toward and away from one another so as to define an opening through which fluid can flow. When exposed to fluid flow with sufficient pressure in the first direction (e.g., the exhalation direction), the coaptation regions are urged away from one another permit fluid flow through the valve. When exposed to fluid flow in the second direction (e.g., the inhalation direction), the coaptation regions are urged toward one another to decrease the size of and/or completely close the opening to decrease and/or completely prevent fluid flow through the valve. Flow through the valve is completely prevented when the coaptation regions are completely shut such that there is no opening for fluid to flow through the valve. As described in detail below, the flow control device110can include a valve that is closed in a default state such that there is no gap or opening between the coaptation regions of the valve. The coaptation regions separate from one another to form an opening for fluid flow in the first direction when the valve cracking pressure is exceeded. For such a valve, there is a tendency for the coaptation regions, such as the valve lips, to stick together so as to resist opening and thereby increase the valve cracking pressure. The sticking force between the coaptation regions can be stronger when the valve is implanted in a lung, as mucous can coat the valve lips and form surface tension that must be overcome to separate the lips and open the valve. Throughout this disclosure, reference is made to the term “lung region”. As used herein, the term “lung region” refers to a defined division or portion of a lung. For purposes of example, lung regions are described herein with reference to human lungs, wherein some exemplary lung regions include lung lobes and lung segments. Thus, the term “lung region” as used herein can refer, for example, to a lung lobe or a lung segment. Such nomenclature conform to nomenclature for portions of the lungs that are known to those skilled in the art. However, it should be appreciated that the term “lung region” does not necessarily refer to a lung lobe or a lung segment, but can refer to some other defined division or portion of a human or nonhuman lung. FIG.2shows an anterior view of a pair of human lungs210,215and a bronchial tree220that provides a fluid pathway into and out of the lungs210,215from a trachea225, as will be known to those skilled in the art. As used herein, the term “fluid” can refer to a gas, a liquid, or a combination of gas(es) and liquid(s). For clarity of illustration,FIG.2shows only a portion of the bronchial tree220, which is described in more detail below with reference toFIG.5. Throughout this description, certain terms are used that refer to relative directions or locations along a path defined from an entryway into the patient's body (e.g., the mouth or nose) to the patient's lungs. The path of airflow into the lungs generally begins at the patient's mouth or nose, travels through the trachea into one or more bronchial passageways, and terminates at some point in the patient's lungs. For example,FIG.2shows a path202that travels through the trachea225and through a bronchial passageway into a location in the right lung210. The term “proximal direction” refers to the direction along such a path202that points toward the patient's mouth or nose and away from the patient's lungs. In other words, the proximal direction is generally the same as the expiration direction when the patient breathes. The arrow204inFIG.2points in the proximal or expiratory direction. The term “distal direction” refers to the direction along such a path202that points toward the patient's lung and away from the mouth or nose. The distal direction is generally the same as the inhalation or inspiratory direction when the patient breathes. The arrow206inFIG.2points in the distal or inhalation direction. The lungs include a right lung210and a left lung215. The right lung210includes lung regions comprised of three lobes, including a right upper lobe230, a right middle lobe235, and a right lower lobe240. The lobes230,235,240are separated by two interlobar fissures, including a right oblique fissure226and a right transverse fissure228. The right oblique fissure226separates the right lower lobe240from the right upper lobe230and from the right middle lobe235. The right transverse fissure228separates the right upper lobe230from the right middle lobe235. As shown inFIG.2, the left lung215includes lung regions comprised of two lobes, including the left upper lobe250and the left lower lobe255. An interlobar fissure comprised of a left oblique fissure245of the left lung215separates the left upper lobe250from the left lower lobe255. The lobes230,235,240,250,255are directly supplied air via respective lobar bronchi, as described in detail below. FIG.3Ais a lateral view of the right lung210. The right lung210is subdivided into lung regions comprised of a plurality of bronchopulmonary segments. Each bronchopulmonary segment is directly supplied air by a corresponding segmental tertiary bronchus, as described below. The bronchopulmonary segments of the right lung210include a right apical segment310, a right posterior segment320, and a right anterior segment330, all of which are disposed in the right upper lobe230. The right lung bronchopulmonary segments further include a right lateral segment340and a right medial segment350, which are disposed in the right middle lobe235. The right lower lobe240includes bronchopulmonary segments comprised of a right superior segment360, a right medial basal segment (which cannot be seen from the lateral view and is not shown inFIG.3A), a right anterior basal segment380, a right lateral basal segment390, and a right posterior basal segment395. FIG.3Bshows a lateral view of the left lung215, which is subdivided into lung regions comprised of a plurality of bronchopulmonary segments. The bronchopulmonary segments include a left apical segment410, a left posterior segment420, a left anterior segment430, a left superior segment440, and a left inferior segment450, which are disposed in the left lung upper lobe250. The lower15lobe225of the left lung215includes bronchopulmonary segments comprised of a left superior segment460, a left medial basal segment (which cannot be seen from the lateral view and is not shown inFIG.3B), a left anterior basal segment480, a left lateral basal segment490, and a left posterior basal segment495. FIG.4shows an anterior view of the trachea225and a portion of the bronchial tree220, which includes a network of bronchial passageways, as described below. In the context of describing the lung, the terms “pathway” and “lumen” are used interchangeably herein. The trachea225divides at a lower end into two bronchial passageways comprised of primary bronchi, including a right primary bronchus510that provides direct air flow to the right lung210, and a left primary bronchus515that provides direct air flow to the left lung215. Each primary bronchus510,515divides into a next generation of bronchial passageways comprised of a plurality of lobar bronchi. The right primary bronchus510divides into a right upper lobar bronchus517, a right middle lobar bronchus520, and a right lower lobar bronchus522. The left primary bronchus515divides into a left upper lobar bronchus525and a left lower lobar bronchus530. Each lobar bronchus,517,520,522,525,530directly feeds fluid to a respective lung lobe, as indicated by the respective names of the lobar bronchi. The lobar bronchi each divide into yet another generation of bronchial passageways comprised of segmental bronchi, which provide air flow to the bronchopulmonary segments discussed above. As is known to those skilled in the art, a bronchial passageway defines an internal lumen through which fluid can flow to and from a lung or lung region. The diameter of the internal lumen for a specific bronchial passageway can vary based on the bronchial passageway's location in the bronchial tree (such as whether the bronchial passageway is a lobar bronchus or a segmental bronchus) and can also vary from patient to patient. However, the internal diameter of a bronchial passageway is generally in the range of 3 millimeters (mm) to 10 mm, although the internal diameter of a bronchial passageway can be outside of this range. For example, a bronchial passageway can have an internal diameter of well below 1 mm at locations deep within the lung. Flow Control Device. Some of the breathing patterns that are characteristic of patients with severe emphysema are that the patients are able to inhale very easily and yet exhale with great difficulty. The destruction of lung parenchyma in the diseased regions of the lung leads to a loss of elastic recoil for the diseased lung region. The resulting imbalance in elastic recoil between diseased and healthier lung regions results in the diseased lung regions filling with air easily and first during inspiration. However, the diseased regions empty last and with great difficulty during expiration, as there is little or no elastic recoil remaining in the diseased lung regions to assist in the expelling of air. Adding to this difficulty, the distal airways in the diseased lung regions collapse during exhalation due to the loss of tethering forces that hold the airways open during exhalation in normal lung regions. As pleural pressure increases at the beginning of expiration, these distal airways partially or fully collapse, thus decreasing the exhalation flow, and increasing the work and time required for the patient to fully exhale. To help ease the symptoms of emphysema and to improve breathing mechanics, implantation of one-way flow control devices or valve bronchial isolation devices has been employed, as described in several prior U.S. patent applications, including “Methods and Devices for use in Performing Pulmonary Procedures”, Ser. No. 09/797,910, filed Mar. 2, 2001, “Bronchial Flow Control Devices and Methods of Use”, Ser. No. 10/270,792, filed Oct. 10, 2002, and “Implanted Bronchial Isolation Devices And Methods”, Ser. No. 12/885,199, filed Sep. 17, 2010 which are incorporated herein by reference. FIGS.5A-6Bshow an exemplary embodiment of a flow control device110that generally includes a valve, a frame or anchor, and a seal member for sealing against a wall of a bronchial passageway. It should be appreciated that the flow control device110shown inFIGS.5A-6Bis exemplary and that the frame, seal member, and valve can vary in structure. The flow control device110has a general outer shape and contour that permits the flow control device110to fit entirely or at least partially within a body passageway, such as within a bronchial passageway. The valve is configured to regulate fluid flow through a bronchial passageway in which the device110is implanted. The valve opens and vents fluid (such as gas or liquid, including mucous) when the pressure across the valve due to flow in a first direction, such as the exhalation direction, exceeds the rated cracking pressure of the valve. Thus, the valve opens in response to fluid flow in the first direction. The valve moves towards a closed configuration in response to fluid flow in a second, opposite direction such as the inhalation direction. With reference toFIGS.5A-6B, the flow control device110extends generally along a central axis605(shown inFIGS.5B and6B). The flow control device110includes a main body that defines an interior lumen610through which fluid can flow along a flow path. The dimensions of the flow control device110can vary based upon the bronchial passageway in which the flow control device110is configured to be implanted. The valve does not have to be precisely sized for the bronchial passageway it is to be placed within. Generally, the diameter D (shown inFIG.6A) of the flow control device110in the uncompressed state is larger than the inner diameter of the bronchial passageway in which the flow control device110will be placed. This will permit the flow control device110to be compressed prior to insertion in the bronchial passageway and then expand upon insertion in the bronchial passageway, which will provide for a secure fit between the flow control device110and the bronchial passageway. The flow of fluid through the interior lumen610is controlled by a valve612that is disposed at a location along the interior lumen such that fluid must flow through the valve612in order to flow through the interior lumen610. It should be appreciated that the valve612could be positioned at various locations along the interior lumen610. The valve612can be made of a biocompatible material, such as a biocompatible polymer, such as silicone. As discussed in more detail below, the configuration of the valve612can vary based on a variety of factors, such as the desired cracking pressure of the valve612. The valve612can be configured to permit fluid to flow in only one-direction through the interior lumen610, to permit regulated flow in two-directions through the interior lumen610, or to prevent fluid flow in either direction. With reference still toFIGS.5A-6B, the flow control device110includes a seal member615that provides a seal with the internal walls of a body passageway when the flow control device is implanted into the body passageway. The seal member615is manufactured of a deformable material, such as silicone or a deformable elastomer. The flow control device110also includes an anchor member or frame625that functions to anchor the flow control device110within a body passageway. As shown inFIGS.5A-6B, the seal member615can includes a series of radially-extending, circular flanges620that surround the outer circumference of the flow control device110. The configuration of the flanges can vary. For example, as shown inFIG.6B, the radial length of each flange620can vary. It should be appreciated that the radial length could be equal for all of the flanges620or that the radial length of each flange could vary in some other manner. In addition, the flanges620can be oriented at a variety of angles relative to the longitudinal axis605of the flow control device. As mentioned, the anchor member625functions to anchor the flow control device110in place when the flow control device is implanted within a body passageway, such as within a bronchial passageway. The anchor member625has a structure that can contract and expand in size (in a radial direction and/or in a longitudinal direction) so that the anchor member can expand to grip the interior walls of a body passageway in which the flow control device is positioned. In one embodiment, as shown inFIGS.5A-6B, the anchor member625comprises an annular frame that surrounds the flow control device110. The frame625can be formed from a super-elastic material, such as Nickel Titanium (also known as Nitinol), such as by cutting the frame out of a tube of Nitinol or by forming the frame out of Nitinol wire. The super-elastic properties of Nitinol can result in the frame exerting a radial force against the interior walls of a bronchial passageway sufficient to anchor the flow control device110in place. It should be appreciated that the configurations, including the sizes and shapes, of the frame625and the seal member615can vary from those shown in the figures. The seal615and/or the frame625can contract or expand in size, particularly in a radial direction. The default state is an expanded size, such that the flow control device110will have a maximum diameter (which is defined by either the seal615or the frame625) when the flow control device110is in the default state. The flow control device110can be radially contracted in size during insertion into a bronchial passageway, so that once the flow control device110is inserted into the passageway, it expands within the passageway. At least a portion of the valve612is optionally surrounded by a rigid or semirigid valve protector member637(shown inFIGS.5B and6B), which is a tubular member or annular wall that is contained inside the seal member615. In another embodiment, the valve protector can comprise a coil of wire or a ring of wire that provides some level of structural support to the flow control device. The valve protector637can be concentrically located within the seal member615. Alternately, the valve612can be completely molded within the seal member615such that the material of the seal member615completely surrounds the valve protector. The valve protector has sufficient rigidity to maintain the shape of the valve member against compression. In one embodiment, the valve protector member637has two or more windows639comprising holes that extend through the valve protector member, as shown inFIG.6B. The windows639can provide a location where a removal device, such as graspers or forceps, can be inserted in order to facilitate removal of the flow control device110from a bronchial passageway. As mentioned, the structural configuration of the flow control device can vary. For example,FIG.7shows a perspective view of another embodiment of a flow control device110that includes a frame625, a valve612mounted in the frame625, and a membrane627. The frame625and the membrane627can collectively or individually seal with an internal wall of a bronchial passageway. The device110inFIG.7includes an elastically expandable frame625that is covered with an elastomeric membrane627. In one embodiment, the device has an expanded frame laser-cut from nitinol tubing that has been expanded and heat treated to set it in the shape shown. The frame625is dipped in a silicone dispersion so that all outer surfaces are covered in a thin silicone membrane. When the device is compressed into a delivery catheter, it may be delivered through the trachea, using any of a number of well-known delivery methods, to the target bronchial lumen, and released from the catheter. Once released, the device expands and grips the walls of the bronchial lumen, and due to the silicone membrane, blocks fluid (gas and liquid) flow through the lumen in both the inhalation and exhalation directions. The frame625can have points or prongs on the distal end to prevent migration of the device in the distal or inhalation direction. Of course, the frame may be made of other materials and take other shapes, may be deformable or heat expandable rather than spring resilient, and the membrane may be formed from other materials (such as urethane) and may be manufactured using methods other than dipping. This particular device is compact enough to fit into a delivery catheter that can fit through the working channel of a bronchoscope that has an internal diameter of 2.2 mm, however it may be delivered using other methods. As discussed above, exemplary implantable one-way valve flow control devices are shown inFIG.5A-7. A valve of a flow control device includes regions (referred to herein as coaptation regions) that contact one another to block flow through the valve, and separate from one another to allow flow through the valve. The coaptation regions can contact one another along their entire length or area such that there is no gap between therebetween and the valve is completely closed. The valve coaptation regions may be in full contact with one another in a default state, such as when there is no pressure differential across the valve. That is, the coaptation regions are in contact with one another such that there is no opening for fluid to flow through. As mentioned, the default state is the state of the valve when exposed to no fluid flow and, therefore, no pressure differential across the valve. When a valve is “closed” the valve coaptation regions contact one another so as to block flow through the valve when there is no pressure differential across the valve. The valve member612can be any type of fluid valve, and preferably is a valve that enables the cracking pressures described herein. The valve member612can have a smaller diameter than the frame625so that compression or deformation of the frame625in both a radial and axial direction will have little or no impact on the structure of the valve member612. In the embodiment shown inFIGS.5-7, the valve member612comprises a duckbill valve that includes two flaps631(shown inFIGS.5B and6B) that are oriented at an angle with respect to one another and that can open and close with respect to one another so as to form an opening at a lip801(FIG.6B) where the flaps631touch one another. The duckbill valve allows fluid flow in a first direction and prevents fluid flow in a second direction that is opposed to the first direction. For example,FIG.8Ashows a schematic side-view of a duckbill valve in a closed state, wherein the flaps631touch one another at the lip801. In the closed state, the duckbill valve prevents fluid flow in a first direction, which is represented by the arrow A inFIG.8A. However, when exposed to fluid flow with sufficient pressure in a second direction (represented by arrow B inFIG.8B) that is opposed to the first direction, the flaps631separate from one another to form an opening between the flaps631that permits flow in the second direction, as shown inFIG.8B. The cracking pressure is defined as the minimum fluid pressure necessary to open the one-way valve member in a certain direction, such as in the distal-to-proximal direction. Given that the valve member of the flow control device110will be implanted in a bronchial lumen of the human lung, the flow control device110will likely be coated with mucus and fluid at all times. For this reason, the cracking pressure of the valve is desirably tested in a wet condition that simulates the conditions of a bronchial lumen. A representative way of testing the valve member is to use a small amount of a water based lubricant to coat the valve mouth. The testing procedure for a duckbill valve is as follows: 1. Manually open the mouth of the valve member, such as by pinching the sides of the valve together, and place a drop of a dilute water based lubricant between the lips of the valve. 2. Wipe excess lubricant off of the valve, and force 1 cubic centimeter of air through the valve in the forward direction to push out any excess lubricant from the inside of the valve. 3. Connect the distal side of the valve to an air pressure source, and slowly raise the pressure. The pressure is increased from a starting pressure of 0 inches H2O up to a maximum of 10 inches H2O over a period of time (such as 3 seconds), and the peak pressure is recorded. This peak pressure represents the cracking pressure of the valve. The cracking pressure of the valve member can vary based on various physiological conditions. For example, the cracking pressure could be set relative to a coughing pressure, a forced expiration pressure, or a normal respiration pressure. For example, the cracking pressure could be set so that it is higher than normal respiration pressure and lower than a coughing pressure (approximately 25 inches H2O). In this regard, the normal or coughing respiration pressure can be determined based on a particular patient, or it could be determined based on average normal or coughing respiration pressures. In one embodiment, the cracking pressure of the valve member is in the range of approximately 5-25 inches H2O. In another embodiment, the cracking pressure of the valve is in the range of approximately 7-9 inches H2O. In yet another embodiment, the cracking pressure of the valve is in the range of approximately 11-24 inches H2O. The cracking pressure of the valve may be set also be set above 25 inches H2O. In an embodiment, the cracking pressure of the valve is in the range of approximately 26-120 inches H2O. The cracking pressure of the valve may also be set above 120 inches H2O. In an embodiment the cracking pressure of the valve is in the range of approximately 121-160 inches H2O. The cracking pressure of the valve may also be set above 160 inches H2O. It may be desirable to have a valve with a cracking pressure above normal breathing pressures in order to reduce the risk of the targeted lung region collapsing too quickly. Thus, the cracking pressure may be set such that the valve will not open with an exhale but will open with a cough or forced exhalation. Such a valve will act like a plug during normal breathing but will allow mucus to pass during a cough or forced exhalation. An example of a valve with a cracking pressure above normal breathing pressures is shown inFIG.9. The valve912comprises a duckbill valve that includes two opposed, inclined walls or flaps931that are oriented at an angle913with respect to one another and lips910configured to be parallel with respect to one another in the closed configuration. The flaps931can open and close with respect to one another so as to form an opening between the lips910. The relative positions of the lips910determines the size of the opening in the valve912. When the lips910are in full contact with one another, there is no opening between the coaptation regions. In an embodiment, the inclined walls or flaps931are oriented at an angle relative to the longitudinal axis905of the valve while in the closed configuration. The lips may be configured to be parallel with the longitudinal axis905of the valve while in the closed configuration. Various characteristics of the valve912may be varied to increase (or decrease) the cracking pressure of the valve912. For example, the smaller the duckbill valve, the higher the cracking pressure that is generally required to open the valve. In addition, increasing the thickness932of a wall of the valve912will increase the cracking pressure. A longer parallel lip length911will also increase the cracking pressure of the valve912. Increasing the angle913between the inclined walls or flaps931will increase the cracking pressure of the valve912. In an embodiment, the angle913between the inclined walls or flaps931is in the range of approximately 70 to 110 degrees. The cracking pressure is also increased by orienting the valve912more orthogonal to the direction of flow. In an embodiment the valve912is oriented at an angle with respect to the direction of air flow through the bronchial passageway. Additionally, the cracking pressure may be increased by narrowing the opening slit cut between the parallel lips910. FIGS.10A-12Eshow various embodiments of valves with cracking pressures above normal breathing. The valves1012,1112,1212comprise inclined walls or flaps1031,1131,1231that are oriented at an angle with respect to one another and lips1010,1110,1210configured to be parallel with respect to one another in the closed configuration. The flaps1031,1131,1231can open and close with respect to one another so as to form an opening between the lips1010,1110,1210. The relative positions of the lips1010,1110,1210determines the size of the opening in the valve1012,1112,1212. When the lips1010,1110,1210are in full contact with one another, there is no opening between the coaptation regions. In some embodiments a length of parallel and contacted lips1010,1110,1210extending longitudinally beyond the inclined flaps1031,1131,1231is at least 30% as long as a length of the inclined flaps1031,1131,1231. In other embodiments a length of parallel and contacted lips1010,1110,1210extending longitudinally beyond the inclined flaps1031,1131,1231is at least 40% or 50% as long as a length of the inclined flaps1031,1131,1231. While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims. | 30,256 |
11857407 | Like reference numbers and designations in the various drawings indicate like elements. DETAILED DESCRIPTION This document provides implantable intraluminal medical devices. For example, this document provides stent graft devices that can be implanted in bodily conduits. In some embodiments, the stent graft devices provided herein are suited for implantation in bodily conduits that have side branches. In some embodiments, the stent graft devices provided herein operably allow the flow of fluids between the primary conduit and the side branches through flow channels disposed at the peripheral wall of the stent graft devices. With reference toFIG.1A, an example stent graft device10includes multiple tubular segments40,42,44,46, and48. Each tubular segment40,42,44,46, and48includes an individual annular stent member20,22,24,26, and28, respectively, and a tubular membrane30,32,34,36, and38, respectively. Adjacent segments of the tubular segments40,42,44,46, and48are partially nested within each other and are connected to one another by one or more axial reinforcement members50. While the example stent graft10is composed of five (5) tubular segments40,42,44,46, and48, some embodiments of the stent graft devices provided herein have fewer than five (5) segments (e.g., four (4), three (3), or two (2)). Some embodiments of the stent graft devices provided herein have more than five (5) segments (e.g., six (6), seven (7), eight (8), nine (9), ten (10), or more). Stent graft devices having any appropriate number of segments are envisioned within the scope of this document. Stent graft10includes a first end12and a second end14. Stent graft10is configured to conduct fluid flow between the first end12and the second end14. As used herein, fluid flow within the lumen of a stent graft and between the first and second ends of the stent graft may be referred to as “axial” flow. Connecting the first end12and the second end14is a substantially cylindrical tunnel. The peripheral wall of the tunnel is defined by the annular stents20,22,24,26, and28, and the tubular membranes30,32,34,36, and38. Stent graft device10is also configured to facilitate flow through the peripheral wall of stent graft device10, from the exterior to the interior of stent graft device10. Said differently, in some embodiments, stent graft device10is configured to facilitate inward radial flow. As used herein, “radial” flow refers to any fluid flow between the exterior and interior of the stent graft that is conducted through flow channels70disposed at the peripheral wall of the stent grafts provided herein. Such radial flow is to be distinguished from axial flow as described above. While the term radial flow is used, it is not intended to be limiting in terms of the specific geometry or angle of the fluid flow path. That is, any flow between the interior and exterior (in either direction) through the peripheral wall of the stent grafts provided herein may be described herein as radial flow, even if a portion of such flow may be substantially parallel to the axis of the stent graft. The radial flow capabilities of the stent grafts provided herein can facilitate flow between one or more side branches and a primary conduit containing a stent graft, as will be described further below. In some embodiments, axial reinforcement members can function like a “backbone” of the stent graft devices provided herein. That is, axial reinforcement members can help the stent graft maintain a desired physical configuration. For example, axial reinforcement member50links together segments40,42,44,46, and48, and assists in defining the spacing between the segments. Axial reinforcement member50defines the overall length of example stent graft device10. In some embodiments, an axial reinforcement member is adhered to portions of the outer wall surface of the stent graft device. In some embodiments, an axial reinforcement member is adhered to the inner wall surface of the stent graft device. In some embodiments, an axial reinforcement member is adhered to both the inner and outer wall surfaces of the stent graft device. In some embodiments, the axial reinforcement members are strips of biocompatible membrane material that are adhered to portions of the stents and membranes of the segments. In some embodiments, other materials, such as metallic or polymeric wires, can be used for the axial reinforcement member. In some embodiments, tubular membrane segments can be linked together by having discrete bondable areas on the tubular membranes30,32,34,36, and38. The discrete bondable areas adhere portions of adjacent tubular membrane segments together. In those embodiments, an additional axial reinforcement member may not be needed. In some embodiments, a combination of discrete bondable areas and additional axial reinforcement members are used to link adjacent tubular membrane segments. Axial reinforcement members can have any suitable width. For example, in some embodiments axial reinforcement members made from membranous material can be about ¼″ wide. Membranous axial reinforcement members with any other suitable width are also envisioned. Any suitable quantity of axial reinforcement members can be included in a stent graft device. For example, in some embodiments, one (1) axial reinforcement member is included. In some embodiments, two (2) axial reinforcement members are included. In some embodiments, three (3) or more axial reinforcement members are included. In some implementations where more than one axial reinforcement member is used, the axial reinforcement members may be approximately equally spaced around a circumference of the device, for example. In some implementations where more than one axial reinforcement member is used, the axial reinforcement members are not equally spaced around a circumference of the device. In some embodiments, the tubular membranes30,32,34,36, and38are comprised of a membranous material that inhibits or reduces passage of blood and other bodily fluids. In some embodiments, the tubular membranes30,32,34,36, and38have a material composition and configuration that inhibits or prevents tissue ingrowth to the membrane. In some embodiments, the tubular membranes30,32,34,36, and38, or portions thereof, have a microporous structure that provides a tissue ingrowth scaffold for durable occlusion and supplemental anchoring strength of the stent graft device. Some embodiments of the tubular membranes30,32,34,36, and38comprise a fluoropolymer, such as an expanded polytetrafluoroethylene (ePTFE) polymer. In some embodiments, the tubular membranes30,32,34,36, and38comprise a polyester, a silicone, a urethane, or another biocompatible polymer, or combinations and subcombinations thereof. In some embodiments, the tubular membranes30,32,34,36, and38may be formed of a copolymer. In some embodiments, a first portion of the tubular membranes30,32,34,36, and38is formed of a first material and a second portion of the tubular membranes30,32,34,36, and38is formed of a second material. For example, the portion of the tubular membranes30,32,34,36, and38near the stent members20,22,24,26, and28may be formed of a first material, and the remainder of the tubular membranes30,32,34,36, and38may be formed of a second material. In some embodiments, portions of the membrane have one or more radiopaque markers attached thereto to enhance in vivo radiographic visualization. In general, the stent members of a stent graft device provide a structural framework for the stent graft device. Whereas the membranous covering of a stent graft by itself may tend to be relatively flaccid, the stent members can provide desired structural strength and rigidity to the stent graft device. The stent members can provide structure that is useful during the deployment process. In general, the stent graft devices provided herein can be deployed using transcatheter techniques. Stent members can be attached to membranous coverings in a variety of suitable manners well known to those of ordinary skill in the art. For example, in some embodiments, the stent members are sewn to the membranous covering. In some embodiments, the stent members are glued to the membranous covering. In some embodiments, the stent members are sandwiched between layers of membranous covering. In some embodiments, portions of the stent members have one or more radiopaque markers attached thereto to enhance in vivo radiographic visualization. In some embodiments, the materials of the stent members themselves are constructed to enhance in vivo radiographic visualization of the stent members. For example, in some embodiments the stent members can be at least partially hollow and radiopaque material can be inserted within the hollow portions of the stent members. In some embodiments, the stent members are self-expanding to thereby intrinsically provide radial force that can bear against the wall of a bodily lumen or cavity. Self-expanding stent members are often comprised of super elastic shape-memory Nitinol (NiTi) material. In some embodiments, a secondary device such as a balloon is used to provide a temporary supplemental radial force to help expand the stent members into contact with the wall of a bodily lumen or cavity and to expand a constricted area of the lumen or cavity. Such stent members may be comprised of stainless steel or other materials. Stent members can be fabricated in various manners, such as by forming a wire, or by laser cutting a tube, and the like. These and all other variations of stent member types, material compositions, material treatments, configurations, fabrication techniques, and methods for attaching stents to membranous coverings are envisioned and within the scope of the stent graft devices provided herein. Stent members20,22,24,26, and28of example stent graft10are depicted as NiTi wire rings that have been heat-set into a sinusoidal wave pattern. Each segment,40,42,44,46, and48includes an individual stent member20,22,24,26, and28, respectively. With the exception of segment48, which serves as a unique end segment, the stent members20,22,24, and26are located asymmetrically in relation to the segmented tubular membranes30,32,34, and36. That is, stent members20,22,24, and26are located off-center and nearer to one of the edges of their respective membranes30,32,34, and36. As a result of the asymmetrical location of the stent members20,22,24, and26, one end portion of each membrane30,32,34, and36is supported by a stent member, while the other end portion of each membrane30,32,34, and36is not supported by a stent member. Therefore, one end portion of each segment40,42,44, and46is supported by a stent member, but the other end portion of each segment40,42,44, and46is unsupported and relatively flaccid, compared to the supported end portion. Segment40can be used to illustrate the previous point. Segment40includes a supported edge portion52and an unsupported edge portion54. The supported edge portion52is supported by stent member20, whereas the unsupported edge portion54has no such supplemental support from a stent member. Instead, unsupported edge portion54is comprised of tubular membrane30without supplemental support from a stent member. Unsupported edges may also be referred to herein as “free” edges, and the unsupported edge portions of the membrane may be referred to herein as “flaps” or “tails.” Unsupported edge portion54is relatively flaccid and compliant as compared to the supported edge portion52. That is, unsupported edge portion54exhibits the flexibility and compliance of the unsupported tubular membrane30, and therefore unsupported edge portion54may provide relatively little resistance to being deflected in an inward radial direction, for example. The resistance of the unsupported edge portions to deflection, or flexibility, can be engineered by manipulating one or more stent graft design parameters. For example, design parameters such as the material composition of the membrane, the thickness of the membrane, the length of the segment, the diameter of the segment, the number of axial reinforcement members, the length of the stent members, the flexibility of the stent members, and the like, can have an effect on the flexibility of an unsupported edge portion. Those design parameters can be selected and established so as to create a stent graft with the desired characteristics for the flexibility of the unsupported edge portions. As will be described further below, the flexibility of the unsupported edge portions is a feature that facilitates or regulates radial flow between the exterior and interior of the stent graft, e.g., the flow that occurs between a side branch and primary conduit where a stent graft is placed. Still referring toFIG.1A, unsupported edge portion54of segment40is nested within the supported edge portion56of segment42. Since unsupported edge portion54is relatively flaccid, whereas supported edge portion56is more rigid, a fluid flow path or channel exists between the unsupported edge portion54and the supported edge portion56. The configuration of example stent graft10facilitates radial flow in the direction from the exterior of the stent graft10to the interior of the stent graft10, as represented by flow arrows60. In general, the fluid flow path may exist generally around the circumference of the device, for example in the overlap areas between the one or more axial reinforcement members50. In some embodiments, when the fluid pressure at the exterior of the stent graft10is higher than the fluid pressure within the interior of the stent graft10, the pressure differential can cause the unsupported edge portion54to be deflected in an inward radial direction, while the supported edge portion56remains substantially stationary. In that case, fluid flow can occur in a flow channel70between the outer periphery of unsupported edge portion54and the inner periphery of supported edge portion56. Such flow can be directed from the exterior of the stent graft10to the interior of stent graft10. Such flow can be described as inward radial flow through a flow channel70within the peripheral wall of stent graft10. In some embodiments, inward radial flow can occur through the flow channels70existing between each of the adjacent segments of the stent graft device10. The amount of differential pressure required to induce deflection of the unsupported edge54can depend upon various stent graft design parameters, as described above. In some embodiments, the unsupported edge54can be optimized to inhibit outward radial flow. For example, the amount that an unsupported edge overlaps a supported edge can be selected to inhibit outward radial flow. While in some implementations the stent graft device is implanted to remain indefinitely, in some implementations it is desirable to implant the stent graft for a temporary period of time. For example, in some applications, it is desirable to implant a stent graft for a period of about one (1) year to remodel a conduit, and then to remove the stent graft. For example, as described further below, treatment of chronic pancreatitis or intrahepatic strictures using a stent graft are applications for which it is desirable to implant a stent graft for a finite period of time. In some applications, the desired finite period of time can be more than or less than one (1) year. In some cases, the clinician implanting the stent graft may not have a pre-conceived period of time that the stent graft is intended to be implanted. For implementations where the stent graft is to be later removed, it may in some embodiments be desirable to configure the stent graft to inhibit or reduce tissue encapsulation of the device, including inhibition or reduction of tissue ingrowth, tissue bridging, and/or endothelialization. Inhibition of encapsulation can help facilitate the removal process. One of the design parameters of the stent grafts provided herein that can affect tissue encapsulation is the configuration of the flow channels70that exist between the supported edge portions and the unsupported edge portions of the membranous covering. Minimizing or inhibiting tissue encapsulation may be desirable as well to minimize a risk of occlusion or blockage of a fluid flow path70caused by excess tissue ingrowth, whether or not the device is intended to be later removed. In general, openings in the wall of traditional stent grafts can have the potential, in some scenarios, to allow tissue encapsulation. To understand this better, consider bare metal stents as an example. Bare metal stents (stents with substantial wall openings because of having no membranous covering) are, in some cases, generally associated with substantial epithelial hyperplasia and endothelialization. Bare metal stents can allow tissue to grow and engulf or entangle portions of the bare stent framework, in some cases. That propensity for tissue encapsulation is at least partially attributable to the fact that tissue has little distance to travel to bridge the bare stent's frame members, i.e., to engulf portions of the stent frame. The flow channels70of the stent graft devices provided herein can be configured to inhibit or reduce tissue encapsulation, despite providing openings in the wall of the stent graft to permit fluid flow. For example, in some embodiments, configuring flow channels that are longer, rather than shorter, can inhibit or reduce tissue encapsulation because longer flow channels may require tissue to grow a greater distance to engulf a stent graft device. The size of the flow channel openings can also be configured to inhibit or reduce tissue encapsulation of the stent graft devices provided herein. For instance, the use of smaller openings rather than larger openings may inhibit or reduce tissue encapsulation. In some embodiments, the use of membranous materials with a known low foreign body response (e.g., ePTFE) can also inhibit or reduce tissue encapsulation. In some embodiments, the lengths of the flow channels70of the stent grafts provided herein are established by the distance that the adjacent segments nest or overlap with each other. That is, the unsupported edge portions of a segment (or a wind, in reference toFIGS.2A and2B, described below) can be configured to overlap the supported edge portions of the adjacent segment by a particular distance. For example, in example stent graft10, the edge of unsupported edge portion54of segment40extends just beyond the stent member22of segment42. The distance that the unsupported edge portion overlaps with an adjacent segment can be configured to be any suitable distance. For example, in some embodiments, the edge of the unsupported edge portion extends beyond the stent member of the adjacent segment. In some embodiments, the edge of the unsupported edge portion extends to about the farthest end of the stent member of the adjacent segment. In some embodiments, the unsupported edge extends to a distance between the ends of the stent member of the adjacent segment. With reference toFIG.1B, an example stent graft device100includes multiple tubular segments140,142,144,146, and148. Each tubular segment140,142,144,146, and148includes at least one individual annular stent member120,122,124,126,128and129, respectively, and a tubular membrane130,132,134,136, and138, respectively. Unique end segment148includes two (2) annular stent members128and129. Adjacent segments of the tubular segments140,142,144,146, and148are partially nested within each other and are connected to one another by one or more axial reinforcement members150. While example stent graft100is composed of five (5) segments140,142,144,146, and148, some embodiments have fewer than five (5) segments (e.g., four (4), three (3), or two (2)). Some embodiments have more than five (5) segments (e.g., six (6), seven (7), eight (8), nine (9), ten (10), or more). Stent grafts having any appropriate number of segments are envisioned within the scope of this document. Stent graft100includes a first end112and a second end114. Connecting the first end112and the second end114is a substantially cylindrical tunnel. The peripheral wall of the tunnel is defined by the annular stents120,122,124,126,128, and129, and the tubular membranes130,132,134,136, and138. Stent graft100is configured to conduct axial fluid flow within the tunnel (or lumen) between the first end112and the second end114, in either direction. Stent graft device100is also configured to facilitate flow through flow channels170at the peripheral wall of stent graft device100from the interior to the exterior of the stent graft device100. Said differently, stent graft device100is configured to facilitate outward radial flow. The radial flow capability of stent graft100can, for example, facilitate flow between a primary conduit containing the stent graft100and one or more side branches or ducts with anastomoses intersecting with the conduit containing stent graft100. In some embodiments, the flow channels170at the peripheral wall can be optimized to inhibit inward radial flow. For example, the amount that an unsupported edge overlaps a supported edge can be selected to inhibit inward radial flow. Stent graft100includes one or more axial reinforcement members150. Axial reinforcement members150link segments140,142,144,146, and148together, and assist in defining the desired spacing between the segments. Axial reinforcement members150define the overall length of example stent graft device100. Tubular membranes130,132,134,136, and138are comprised of a membranous material as described above in reference to tubular membranes30,32,34,36, and38of example stent graft10. In some embodiments, stent members120,122,124,126,128, and129of example stent graft100are equivalent to stent members20,22,24,26, and28, as described above in reference to example stent graft10. Each segment,140,142,144,146, and148includes at least one individual stent member120,122,124,126, and128, respectively. End segment148includes two (2) annular stent members128and129. With the exception of end segment148, which serves as a unique end segment, the stent members120,122,124, and126are located asymmetrically in relation to the segmented tubular membranes130,132,134, and136. That is, stent members120,122,124, and126are located off-center and nearer to one of the edges of their respective membranes130,132,134, and136. As a result of the asymmetrical location of the stent members120,122,124, and126, one edge portion of each membrane130,132,134, and136is supported by a stent member, while the other edge portion of each membrane130,132,134, and136is not supported by a stent member. Therefore, one edge portion of each segment140,142,144, and146is supported by a stent member, but the other edge portion of each segment140,142,144, and146is unsupported and relatively flaccid, compared to the supported edge portion. Segment140can be used to illustrate the previous point. Segment140includes a supported edge portion152and an unsupported edge portion154. The supported edge portion152is supported by stent member120, whereas the unsupported edge portion154has no such supplemental support from a stent member. Instead, unsupported edge portion154is comprised of tubular membrane130without supplemental support from a stent member. As such, unsupported edge portion154is relatively flaccid and compliant, as compared to the supported edge portion152. That is, unsupported edge portion154exhibits the flexibility of the unsupported tubular membrane130, and therefore unsupported edge portion154may provide relatively little resistance to being deflected in an outward radial direction. The unsupported edge portion154of segment140is nested over the outer periphery of the supported edge portion156of segment142. Since unsupported edge portion154is relatively flaccid, whereas supported edge portion156is more rigid, a fluid flow channel170exists between them. The configuration of example stent graft100can facilitate radial flow in the direction from the interior of the stent graft100to the exterior of the stent graft100through flow channels170. In general, the fluid flow path may exist generally around the circumference of the device, for example in the overlap areas between the one or more axial reinforcement members150. In some embodiments, when the fluid pressure within the interior of the stent graft100is higher than the fluid pressure at the exterior of the stent graft100, the pressure differential can cause the unsupported edge portion154to be deflected in an outward radial direction, while the supported edge portion156remains substantially stationary. In that case, fluid flow can occur in a flow channel170between the inner periphery of unsupported edge portion154and the outer periphery of supported edge portion156. Such flow is directed from the interior of the stent graft100to the exterior of stent graft100, and can be described as outward radial flow through a flow channel within the peripheral wall of stent graft100. Outward radial flow can occur through the flow channels170existing between each of the adjacent segments of the stent graft device100, in some embodiments. With reference toFIG.2A, an example stent graft device200includes a continuous helical stent member220, a continuous helical membranous covering230, and one or more axial reinforcement members250. The one or more axial reinforcement members250may be equivalent to the axial reinforcement members50and150described above in reference toFIGS.1A and1B. Stent graft200includes a first end212and a second end214. Between the first end212and the second end214is a substantially cylindrical tunnel. The peripheral wall of the tunnel is defined by the continuous helical stent member220and the continuous helical membranous covering230. Stent graft200is configured to conduct fluid flow axially within the tunnel (or lumen) from the first end212toward the second end214. Stent graft device200is also configured to facilitate flow through flow channels260at the peripheral wall of stent graft device200from the exterior of the stent graft device200to the interior of the stent graft device200. Said differently, stent graft device200is configured to facilitate inward radial flow. The radial flow capability of stent graft200can, for example, facilitate flow between one or more side branches or ducts with anastomoses intersecting with stent graft200and a primary conduit containing the stent graft200. In contrast to the stent graft devices10and100described above, the stent frame of example stent graft device200is not comprised of multiple individual annular stent rings. Rather, the stent frame of example stent graft device200is a single continuous helically wound or arranged stent member220. The stent frame member of example stent graft device200is depicted as a single wire formed in a sinusoidal wave pattern, but any suitable configuration of a stent frame member is envisioned as within the scope of the devices discussed herein. In contrast to the stent graft devices10and100described above, the membrane of example stent graft device200is not comprised of multiple individual tubular segments. Rather, the membrane of example stent graft device200is a continuous helically wound or arranged membranous covering230. The continuous helical membranous covering230is wound or arranged in a helical configuration. For example, example stent graft device200has about five (5) winds. Stent grafts having any suitable number of winds are envisioned as within the scope of this document (e.g., two (2), three (2), four (4), six (6), seven (7), eight (8), nine (9), ten (10), or more). The continuous helical stent member220and the continuous helical membranous covering230can be attached to each other as described above. In some embodiments, the continuous helical stent member220is attached so as to be approximately abutting an edge of the continuous helical membranous covering230, i.e., in an asymmetrical manner. As a result of the asymmetrical placement of the continuous helical stent member220on the continuous helical membranous covering230, one edge portion of the continuous helical membranous covering230is supported by a stent member but the other edge portion of continuous helical membranous covering230is unsupported by a stent member. For example, continuous helical membranous covering230includes a supported edge252and an unsupported edge254. In order to keepFIG.2Auncluttered and easier to understand, the literal edge of the unsupported edge254is not shown. The unsupported edge254of each wind is nested within the supported edge252of the adjacent wind. As described above in reference to example stent grafts10and100, the overlap distance of the unsupported edge254with the supported edge252can be any suitable distance including beyond the edge of the stent member220. Longer overlaps can tend to reduce the potential for endothelialization, tissue ingrowth, or tissue bridging in some implementations. As described above, supported edge252may be relatively rigid, while unsupported edge254may be relatively flaccid. Since unsupported edge254is relatively flaccid, whereas supported edge252is more rigid, a fluid flow channel260exists between them. The configuration of example stent graft200can facilitate radial flow in the direction from the exterior of the stent graft200to the interior of the stent graft200through flow channels260. In general, the fluid flow path may exist generally helically around the circumference of the device in the overlap areas, for example in the areas between the one or more axial reinforcement members250. In some embodiments, when the fluid pressure at the exterior of the stent graft200is higher than the fluid pressure within the interior of the stent graft200, the pressure differential causes the unsupported edge254to be deflected in an inward radial direction, while the supported edge252remains substantially stationary. In that case, fluid flow can occur in a flow channel260between the outer periphery of unsupported edge254and the inner periphery of supported edge252. Such flow can be directed from the exterior of stent graft200to the interior of stent graft200, and can be described as inward radial flow through a flow channel within the peripheral wall of stent graft200. Inward radial flow can occur through the flow channels260existing between each of the adjacent winds of the stent graft device200, in some embodiments. With reference toFIG.2B, an example stent graft device270includes a continuous helical stent member280, a continuous helical membranous covering290, and one or more axial reinforcement members272. The one or more axial reinforcement members272may be equivalent to the axial reinforcement members50,150, and250described above in reference toFIGS.1A,1B, and2A. Stent graft270includes a first end282and a second end284. Between the first end282and the second end284is a substantially cylindrical tunnel. The peripheral wall of the tunnel is defined by the continuous helical stent member280and the continuous helical membranous covering290. Stent graft270is configured to conduct fluid flow axially through the tunnel (or lumen) between the first end282and the second end284, in either direction. Stent graft device270is also configured to facilitate flow through flow channels260at the peripheral wall of stent graft device270, from the interior of the stent graft device270to the exterior of the stent graft device270. Said differently, stent graft device270is configured to facilitate outward radial flow. The radial flow capability of stent graft270can, for example, facilitate flow between a primary conduit containing the stent graft270and one or more side branches with anastomoses intersecting with stent graft270. In contrast to the stent graft devices10and100described above, the stent frame of example stent graft device270is not comprised of multiple individual annular stent rings. Rather, the stent frame of example stent graft device270is a single continuous helically wound or arranged stent member280. The stent frame member of example stent graft device270is depicted as a single wire formed in a sinusoidal wave pattern, but any suitable configuration of a stent frame member can be incorporated. In contrast to the stent graft devices10and100described above, the membrane of example stent graft device270is not comprised of multiple individual segments. Rather, the membrane of example stent graft device270is a continuous helically wound or arranged membranous covering290. The continuous helically membranous covering290is wound or arranged in a helical configuration. For example, example stent graft device270has about five (5) winds. Stent grafts having any suitable number of winds are envisioned as within the scope of this document (e.g., two (2), three (2), four (4), six (6), seven (7), eight (8), nine (9), ten (10), or more). The continuous helical stent member280and the continuous helical membranous covering290can be attached to each other as described above. In some embodiments, the continuous helical stent member280is attached so as to be approximately abutting an edge of the continuous helical membranous covering290in an asymmetrical manner. As a result of the asymmetrical placement of the continuous helical stent member280on the continuous helical membranous covering290, one edge of the continuous helical membranous covering290is supported by a stent member but the other edge of continuous helical membranous covering290is unsupported by a stent member. For example, continuous helical membranous covering290includes a supported edge292and an unsupported edge294. In order to keepFIG.2Buncluttered and easier to understand, the literal edge of the supported edge292is not shown. The supported edge292of each wind is nested within the unsupported edge294of the adjacent wind. As described in reference to example stent grafts10and100, the overlap distance of the unsupported edge294with the supported edge292can be any suitable distance, including beyond the edge of the stent member280. Longer overlaps can tend to reduce the potential for endothelialization or tissue ingrowth, in some implementations. As described above, supported edge292may be relatively rigid while unsupported edge294may be relatively flaccid. Since unsupported edge294is relatively flaccid, whereas supported edge292is more rigid, a fluid flow channel260exists between them. The configuration of example stent graft270facilitates radial flow in the direction from the interior of the stent graft270to the exterior of the stent graft270through glow channels260. In general, the fluid flow path may exist generally helically around the circumference of the device in the overlap areas, for example in the areas between the one or more axial reinforcement members272. In some embodiments, when the fluid pressure in the interior of the stent graft270is higher than the fluid pressure at the exterior of the stent graft270, the pressure differential causes the unsupported edge294to be deflected in an outward radial direction, while the supported edge292remains substantially stationary. In that case, fluid flow can occur in a flow channel260between outer periphery of supported edge292and the inner periphery of unsupported edge294. Such flow can be directed from the interior of the stent graft270to the exterior of stent graft270, and can be described as outward radial flow through a flow channel260within the peripheral wall of stent graft270. Outward radial flow can occur through the flow channels260existing between each of the adjacent winds of the stent graft device270, in some embodiments. With reference toFIG.3A, a human pancreas300with an example intraluminal stent graft device310deployed in a main pancreatic duct302is depicted. The pancreatic ductal system includes, in addition to the main pancreatic duct302, multiple side branches304. FIG.3Adepicts an example implementation of some embodiments of the stent graft devices provided herein. That is, some embodiments of the stent graft devices provided herein can be used as an interventional treatment for pancreatitis, i.e., to facilitate patency of the main pancreatic duct. In doing so, the stent graft devices provided herein can also facilitate flow of pancreatic enzymes and juices from the side branches304into the main pancreatic duct302. Pancreatitis can result when digestive enzymes generated in the pancreas are prevented, as by a stricture, from flowing through the pancreatic ductal system and into the duodenum portion of the small intestine. Pancreatic damage can occur as a result of cellular necrosis and apoptosis mechanisms that are triggered following activation of co-localized digestive enzymes before secretion from the pancreas. Blockage of the pancreatic ductal system can be a result of stones, fibrotic tissue, or other strictures in the main pancreatic duct. Some embodiments of the stent grafts provided herein are suited to treating strictures in the main pancreatic duct. That is, the stent grafts provided herein can be implanted to open up a flow path through the main pancreatic duct. The stent grafts provided herein can also facilitate flow from side branches of the pancreatic ductal system into the main pancreatic duct. In addition, some embodiments of the stent grafts provided herein are suitable for later removal, and are resistive to endothelialization or tissue ingrowth. Such a feature can be beneficial because stents that are left in the main pancreatic duct can become occluded, for example, due to tissue encapsulation or clogging, thereby blocking flow and requiring removal. The treatment of main pancreatic duct strictures due to chronic pancreatitis by deploying a stent graft in the main pancreatic duct can be a suitable implementation of stent graft embodiments that include radial inflow capability. As shown in the enlarged view, pancreatic enzymes flow from the side branches304into the main pancreatic duct302, as depicted by arrows312. Stent graft embodiments with radial inflow capability can facilitate the flow from the side branches304into the main pancreatic duct302. For example, the stent graft embodiments10and200, described above in reference toFIGS.1A and2A, include such radial inflow capability. In some embodiments, the radial inflow or outflow capabilities of the stent grafts provided herein can exist along substantially the entire axial length of the stent graft device body. Such a feature can be desirable because the side branch anatomies of human patients can vary significantly, and the stent graft embodiments provided herein can thereby accommodate variation in side branch anatomies. That is, since radial inflow or outflow can occur along the entire axial length of the stent graft device body, it may generally not matter where the anastomoses of the side branches are in relation to the primary conduit, or in relation to particular portions of the stent graft device body. Hence, the stent graft devices provided herein may provide versatility for use in a wide variety of patients, without customization of the stent graft device to accommodate differing ductal system anatomies. With reference toFIG.3B, a human pancreas300with an example intraluminal stent graft device330deployed in a main pancreatic duct302across the major papilla308and into the duodenal intestine320is depicted.FIG.3Bdepicts another example implementation of some embodiments of the stent graft devices provided herein. That is, some embodiments of the stent graft devices provided herein can be used as an interventional treatment for strictures due to chronic pancreatitis, i.e., to facilitate patency of the major papilla and main pancreatic duct of the pancreas. In doing so, the stent graft devices provided herein can also facilitate radial inflow of bile from the common bile duct306into the main pancreatic duct302. For example, stent graft embodiments10and200described above in reference toFIGS.1A and2A, which facilitate radial inflow, may be appropriate configurations for this implementation. In some implementations, it may be desirable for a portion of the stent graft330to protrude from the major papilla308into the duodenal intestine320. In some implementations, some embodiments of the stent graft devices provided herein are deployed within the bile duct306. With reference toFIG.3C, a human liver340with an example intraluminal stent graft device350deployed in the intrahepatic ductal system342is depicted. Some embodiments of the stent graft devices provided herein can be used as an interventional treatment for intrahepatic biliary strictures, i.e., to facilitate patency of the common hepatic duct306and/or the intrahepatic ductal system342of the liver340. In doing so, the stent graft devices provided herein can also facilitate radial inflow of bile from the intrahepatic ductal system342into the common hepatic duct306. For example, stent graft embodiments10and200described above in reference toFIGS.1A and2A, which facilitate radial inflow, may be appropriate configurations for this implementation. With reference toFIG.4, a portion of a human aorta400including an aortic arch402with an example intraluminal stent graft device420installed therein is depicted. The aortic arch402is depicted as having an aneurysm410. This example implementation of the stent graft devices provided herein represents the treatment of an aneurysm in the wall of a vessel. The aortic arch402has secondary arteries404,406, and408branching off from the aortic arch402. An example secondary stent graft device430is depicted in the middle secondary artery406. This illustrates the capability of some embodiments of the stent graft devices provided herein to allow one or more other devices to be deployed through or within the flow channels in the wall of the stent graft devices provided herein. In addition to using the flow channels to deploy a secondary stent430, other usages are envisioned. For example, catheters can be routed through the flow channels to deploy other devices or to perform various treatments within or via the side branches. In some implementations, it can be desirable to allow radial flow through some portions of the wall of the stent graft but not through other portions of the wall of the stent graft. For example, in reference to stent graft device420, it may be desirable to allow radial flow through the wall to supply the secondary arteries404,406, and408, but it may not be desirable to allow radial flow through the wall in the area of the aneurysm410. Some embodiments of the stent graft devices provided herein can be configured to allow radial flow through portions of the stent graft wall while restricting radial flow through other portions of the stent graft wall. In some embodiments, this localized restricting capability can be created during device construction, or by the doctor just prior to implantation, or after deployment of the device. In some implementations, it is desirable to allow radial inflow through some portions of the wall of the stent graft, and to allow radial outflow through other portions of the wall. Some implementations of the stent graft devices provided herein can be configured to allow radial inflow through some portions of the wall of the stent graft, and to allow radial outflow through other portions of the wall. With reference toFIG.5, an exemplary process500for fabricating an intraluminal stent graft device560is schematically illustrated. The progressive steps of process500are illustrated generally, beginning with the view of the top of the sheet, continuing with the view in the middle, and ending with the finished stent graft560at the bottom of the sheet. Process500is provided as an exemplary process for fabricating an intraluminal stent graft device that has multiple discrete tubular segments such as stent graft embodiments10and100, described above in reference toFIGS.1A and1B. However, other processes, sub-processes, and techniques for fabricating an intraluminal stent graft device with multiple discrete tubular segments are also envisioned within the scope of this document. Process500will be described as fabricating a stent graft device560from certain exemplary types of materials. However, the use of other types of materials to fabricate stent graft devices with multiple discrete tubular segments is also envisioned within the scope of this document. Although an intraluminal stent graft device with five (5) segments is used to illustrate process500, a stent graft device with virtually any number of tubular segments can be fabricated using process500. As shown in the view at the top ofFIG.5, a membrane530with a plurality of attached stent members520,522,524,526, and528is formed to surround a cylindrical mandrel510. The mandrel510is used as a form from which to build up a stent graft560. The mandrel510can be comprised of any suitable mandrel material, e.g., stainless steel, tool steel, or aluminum. The diameter of mandrel510substantially determines the inner diameter of the stent graft560. As such, an appropriately sized mandrel510should be selected in accordance with the size of the stent graft desired. For example, a smaller diameter mandrel should be used to form a small stent graft for a pancreatic duct implementation, as compared to a larger diameter mandrel for forming a larger stent graft for an aortic arch implementation. The length of mandrel510will be at least as long as the desired length of the stent graft to be fabricated, and the mandrel510may be substantially longer than the stent graft to be fabricated. In some embodiments of process500, a cushion tube (not shown) is included as a liner over the mandrel510surface. The cushion tube can be a suitable compressible material, e.g., an ePTFE tube or tape wrap. In some embodiments, a thin, heat resistant, non-stick liner made from a material such as a Kapton® is wrapped over the cushion tube. A base layer of membrane530is wrapped around mandrel510over the cushion tube and non-stick liner. In some embodiments, a film-like, ePTFE membrane material is used. Other suitable materials, such as woven or knitted polyester, and the like, can also be used. In some embodiments, the ePTFE membrane530has a surface layer of fluorinated ethylene propylene (FEP) material on one side of the ePTFE membrane530. The side of the membrane530with the FEP layer is oriented outward, i.e., away from the mandrel510. FEP is a heat activated adhesive that, as described further below, can be used to bond layers of membrane. In some embodiments, the ePTFE membrane does not include a FEP layer. In such cases, a separate FEP film can be wrapped onto the ePTFE membrane. In some embodiments, a second layer of ePTFE membrane530is wrapped onto the ePTFE and FEP already on the mandrel510. In some embodiments, the second layer of ePTFE membrane530is a spiral wrap with about a fifty percent (50%) overlap. The second layer of ePTFE membrane530can also have a FEP layer on one side of the membrane530. The side with the FEP layer should be oriented down onto the first layer of membrane530, i.e., no FEP should be exposed in the area of the channel flaps after the addition of the second layer of ePTFE membrane530. In some embodiments, the first two (2) layers of ePTFE membrane530make up the base membrane530. In some embodiments, other constructions can make up the base membrane. For example, in some embodiments, more than two (2) layers of ePTFE membrane are included. In some embodiments, only one (1) layer of ePTFE membrane is included. Stent members520,522,524,526, and528are added on top of the layers of membrane530. In this embodiment, ring-like annular stent members are used. In some embodiments, stent members are wrapped around the membrane in another configuration, such as helically as described below in reference toFIG.6. The annular stent members520,522,524,526, and528are to be placed on the mandrel510at locations in relation to the membrane530such that the desired axial lengths of the unsupported membrane (the flap length) will be created. In some embodiments, a layer of ePTFE with FEP (oriented downward) is added over the stent members520,522,524,526, and528. In some embodiments, this additional ePTFE is only wrapped over the individual stent members520,522,524,526, and528, and is not wrapped over the entire length of the membrane530. That is, each discrete stent member520,522,524,526, and528can be wrapped individually by a strand of ePTFE with FEP. The strands of ePTFE with FEP can be a little wider than the individual stent members520,522,524,526, and528, so that the stent members520,522,524,526, and528will be fully laminated within the membrane material. In some embodiments, the additional ePTFE is wrapped over the entire length of the membrane530. A hot iron or other heat source is applied to all areas of the strands of ePTFE with FEP that cover the stent members520,522,524,526, and528. The hot iron can be used to trace around the stent members520,522,524,526, and528. The hot iron, with a temperature of about 670-720° F., for example, will activate the FEP and cause the strands of ePTFE to bond to the stent members520,522,524,526, and528and to the base membrane530. The use of the hot iron causes the stent members520,522,524,526, and528to become firmly laminated between the strands of ePTFE and the base membrane530, such that substantially all portions of the stent members520,522,524,526, and528are covered by ePTFE material. In some embodiments, the mandrel510, membrane530, and stent members520,522,524,526, and528are then heated in an oven to activate the FEP adhesive, e.g., the FEP between the first two layers of membrane530. Any suitable time and temperature profile can be used. For example, in some embodiments of process500, the heating takes place at about 320° C. for about twelve (12) minutes. After heating, and subsequent cooling, the non-stick liner can be removed from the mandrel510. The membrane530with the stent members520,522,524,526, and528can also be removed from the mandrel510. In some embodiments, the membrane530is circumferentially cut at lines570,572,574, and576to create discrete cylindrical segments540,542,544,546, and548. The cutting is performed so as to create discrete cylindrical segments540,542,544, and546with stent members520,522,524, and526that are asymmetrically located on the discrete cylindrical segments540,542,544, and546(see middle view ofFIG.5). In this example, the end segment548is unique, and its stent member528may be located in a suitable location that is different than the other discrete cylindrical segments540,542,544, and546. The asymmetrical location of the stent members520,522,524, and526causes the discrete cylindrical segments540,542,544, and546to each have a supported edge portion and an unsupported edge portion (a flap or tail), as described above in reference to stent graft embodiments10and100. Segment540can be used to illustrate the previous point. Segment540includes a supported edge portion552and an unsupported edge portion554. The supported edge portion552is supported by stent member520, whereas the unsupported edge portion554has no such supplemental support from a stent member. Instead, unsupported edge portion554is comprised of tubular membrane530without supplemental support from a stent member. The discrete cylindrical segments540,542,544,546, and548are then placed again on mandrel510(or on a different mandrel), in some examples with a cushion tube and non-stick liner, and configured in relation to each other (nested together) as desired. That is, the tails of cylindrical segments are placed interior of, or exterior of, the supported edge of an adjacent cylindrical segment. As shown in the bottom view ofFIG.5, in some embodiments, the tails are placed interior of the supported edge portion of an adjacent cylindrical segment. For example, the tail554of cylindrical segment540is located within the supported edge portion556of the adjacent cylindrical segment542. In some embodiments, the tails are placed over the exterior of the supported edge portion of an adjacent cylindrical segment (see, e.g., stent graft100ofFIG.1B). In some embodiments, a combination of interior and exterior placements of the tails in relation to the supported edges of the adjacent cylindrical segments can be created. The configuration of the tails in relation to the adjacent cylindrical segment can effect whether that portion of the stent graft device is configured for inward radial flow or outward radial flow. One or more axial reinforcement members550are attached to the nested cylindrical segments540,542,544,546, and548. In some embodiments, the axial reinforcement members550are strips of ePTFE that have a FEP layer on one side. In such embodiments, the strips of ePTFE with a FEP layer are attached to the cylindrical segments540,542,544,546, and548by applying a hot iron on the surface of the ePTFE strip. The heat from the hot iron will activate the FEP to cause the ePTFE strip to adhere to the cylindrical segments540,542,544,546, and548. The axial reinforcement members550can be of any suitable width. In some embodiments, the axial reinforcement members550are about ¼″ wide. Any suitable number of axial reinforcement members550can be used. In some embodiments, one (1), two (2), three (3), or more than three (3) axial reinforcement members550are used. In some embodiments, one or both of the ends of stent graft560are reinforced by the addition of circumferential end reinforcement members580and582, for example. In some embodiments, the end reinforcement members580and582are strips of ePTFE that have a FEP layer on one side. In such embodiments, end reinforcement members580and582are attached to the end cylindrical segments540and548by applying a hot iron on the surface of the ePTFE strip. The heat from the hot iron, for example at a temperature of about 670-720° F., will activate the FEP to cause the ePTFE strip to adhere to the cylindrical segments540and548. The end reinforcement members580and582can be of any suitable width. In some embodiments, the end reinforcement members580and582are about ¼″ wide. In some embodiments the end reinforcement members580and582are wrapped about a single circumference around cylindrical segments540and548. In some embodiments, two (2) or more wraps of end reinforcement members580and582are made around cylindrical segments540and548. The stent graft560on the mandrel510can then be heated in an oven to ensure all FEP adhesive has been activated. Any suitable time and temperature profile can be used. For example, in some embodiments of process500, the heating can take place at about 320° C. for about twelve (12) minutes. The non-stick liner and the stent graft560can then be removed from the mandrel510. The flow channels575between the tails and the supported edges can be checked to ensure that the channels are operable to be opened as desired. If any flow channels575are adhered together they can be gently separated using an appropriate tool, e.g., one of the tips of a pair of tweezers. With reference toFIG.6, an exemplary process600for fabricating an intraluminal stent graft device660is schematically illustrated. The progressive steps of process600are illustrated generally, beginning with the view of the top of the sheet, continuing with the view in the middle, and concluding with the finished stent graft660at the bottom of the sheet. Process600is provided as an example process for fabricating an intraluminal stent with a helically arranged membranous strip and a helically arranged support member attached to the helically arranged membranous strip, such as, for example, stent graft embodiments200and270as described above in reference toFIGS.2A and2B. The helically arranged membranous strip and the helically arranged support member are configured to comprise a plurality of turns or winds. However, other processes, sub-processes, and techniques for fabricating an intraluminal stent comprising a helically arranged membranous strip are also envisioned within the scope of this document. Process600will be described as fabricating a stent graft device660from certain exemplary types of materials. However, the use of other types of materials to fabricate stent graft devices with a helically arranged membranous strip is also envisioned within the scope of this document. Although an intraluminal stent graft device with five (5) turns (or winds) is used to describe process600, a stent graft device with virtually any number of turns can be fabricated using process600. As shown in the view at the top ofFIG.6, a membrane630with a helically arranged support member620is formed to surround a cylindrical mandrel610. The mandrel610is used as a form from which to build up a stent graft660. The mandrel610can be comprised of any suitable mandrel material, e.g., stainless steel, tool steel or aluminum. For process600, the diameter of mandrel610is oversized in comparison to the desired final inner diameter of the stent graft660. For example, to fabricate a stent graft660with a final inner diameter of about ten (10) millimeters, a mandrel610with a diameter of about thirteen (13) millimeters can be used. As such, an appropriately oversized mandrel610should be selected in accordance with the final inner diameter of the stent graft660desired. The length of mandrel610will be longer than the desired length of the stent graft to be fabricated, and the mandrel610may be substantially longer than the stent graft to be fabricated. In some embodiments of process600, a cushion tube (not shown) is included as a liner over the mandrel610surface. The cushion tube can be a suitable compressible material, e.g., an ePTFE tube or tape wrap. In some embodiments, a thin, heat resistant, non-stick liner made from a material such as a Kapton® is wrapped over the cushion tube. A base layer of membrane630is wrapped around mandrel610over the cushion tube and non-stick liner. In some embodiments, a film-like, ePTFE membrane material is used. Other suitable materials, such as woven or knitted polyester, and the like, can also be used. In some embodiments, the ePTFE membrane630has a surface layer of fluorinated ethylene propylene (FEP) material on one side of the ePTFE membrane. The side of the membrane630with the FEP layer is oriented outward, i.e., away from the mandrel610. The FEP is a heat activated adhesive that, as described further below, can be used to bond layers of membrane. In some embodiments, the ePTFE membrane does not include a FEP layer. In such cases, a separate FEP film can be wrapped onto the ePTFE membrane. In some embodiments, a second layer of ePTFE membrane630is wrapped onto the ePTFE and FEP already on the mandrel610. In some embodiments, the second layer of ePTFE membrane630is spiral wrap with about a fifty percent (50%) overlap. The second layer of ePTFE membrane630can also have a FEP layer on one side of the membrane630. The side with the FEP layer should be oriented down onto the first layer of membrane630, i.e., no FEP should be exposed in the area of the channel flaps after the addition of the second layer of ePTFE membrane630. In some embodiments, the first two (2) layers of ePTFE membrane630make up the base membrane630. In some embodiments, other constructions can make up the base membrane. For example, in some embodiments, more than two (2) layers of ePTFE membrane are included. In some embodiments, only one (1) layer of ePTFE membrane is included. Stent member620is added on top of the layers of membrane630. In this exemplary embodiment, a single helically arranged stent member is used. The stent member620is helically wound on the mandrel610with a spacing between turns of stent members620that is greater than the desired spacing between the turns of stent members620in the final stent graft660. For example, in some embodiments, a spacing of about ten (10) millimeters between the turns of stent members620is made on the mandrel610, and a spacing of about two (2) millimeters between the turns of stent members620is made in the final product. In some embodiments, a layer of ePTFE with FEP (oriented downward) is added over the stent member620. In some embodiments, this additional ePTFE is only helically wrapped over the stent member620, and is not wrapped over the entire length of the membrane630. The strand of ePTFE with FEP may be a little wider than the stent member620so that the stent member620will be fully laminated within the membrane material. In some embodiments, the additional ePTFE is wrapped over the entire length of the membrane630. A hot iron or other heat source is applied to all areas of the strand of ePTFE with FEP that covers the stent members620. The hot iron can be used to trace around the stent member620. The hot iron, with a temperature of about 670-720° F., for example, will activate the FEP and cause the strand of ePTFE to bond to the stent member620and to the base membrane630. The use of the hot iron causes the stent member620to become firmly laminated between the strand of ePTFE and the base membrane630, such that substantially all portions of the stent member620are covered by ePTFE material. In some embodiments, the mandrel610, membrane630, and stent member620are then heated in an oven to activate the FEP adhesive, e.g., the FEP between the first two layers of membrane630. Any suitable time and temperature profile can be used. For example, in some embodiments of process600, the heating takes place at about 320° C. for about twelve (12) minutes. After heating, and subsequent cooling, the non-stick liner can be removed from the mandrel610. The membrane630with the stent member620can also be removed from the mandrel610. In some embodiments, the membrane630is cut in a helical pattern along line670. The cutting is performed so as to create a helical strip of membrane630with stent member620asymmetrically located on the helical strip of membrane630(see middle view ofFIG.6). The asymmetrical location of the stent member620will cause the final configuration of stent graft660to have a supported edge and an unsupported edge at each turn, as described above in reference to stent graft embodiments200and270. That is, the helical strip of membrane630has lengthwise side regions (or margins), and one of the side regions is supported by stent member620while the other side region is unsupported. The helical strip of membrane630with stent member620is then placed on an undersized mandrel, in some cases with a cushion tube and non-stick liner. For example, for a stent graft with about a ten (10) millimeter final inner diameter, a mandrel with about an eight (8) millimeter diameter can be used. The turns of the helical strip of membrane630are then configured in relation to each other (nested together) as desired. That is, the unsupported side region (tails) of the turns are placed interior of, or the exterior of, the supported side region of adjacent turns. As shown in the bottom view ofFIG.6, in some embodiments, the tails are placed interior of the supported side region of an adjacent cylindrical segment. In some embodiments, the tails are placed over the exterior of the supported side region of an adjacent cylindrical segment (see, e.g., stent graft270ofFIG.2B). The configuration of the tails in relation to the adjacent cylindrical segment can effect whether that portion of the stent graft device is configured for inward radial flow or outward radial flow. In some embodiments, one or more axial reinforcement members650are attached to the helical strip of membrane630with stent member620. In some embodiments, the axial reinforcement members650are strips of ePTFE that have a FEP layer on one side. In such embodiments, the strips of ePTFE with a FEP layer are attached to the turns of the helical strip of membrane630with stent member620by applying a hot iron on the surface of the ePTFE strip. The heat from the hot iron will activate the FEP to cause the ePTFE strip to adhere to the helical strip of membrane630with stent member620. The axial reinforcement members650can be of any suitable width. In some embodiments, the axial reinforcement members650are about ¼″ wide. Any suitable number of axial reinforcement members650can be used. In some embodiments, one (1), two (2), three (3), or more than three (3) axial reinforcement members650are used. In some embodiments, one or both of the ends of stent graft660are reinforced by the addition of circumferential end reinforcement members680and682, for example. In some embodiments, the end reinforcement members680and682are strips of ePTFE that have a FEP layer on one side. In such embodiments, end reinforcement members680and682are attached to the ends of the helical strip of membrane630with stent member620by applying a hot iron on the surface of the ePTFE strip. The heat from the hot iron, for example at a temperature of about 670-720° F., will activate the FEP to cause the ePTFE strip to adhere to the membrane630. The end reinforcement members680and682can be of any suitable width. In some embodiments, the end reinforcement members680and682are about ¼″ wide. In some embodiments the end reinforcement members680and682are wrapped about a single circumference around membrane630. In some embodiments, two (2) or more wraps of end reinforcement members680and682are made around the membrane630. The stent graft660on the mandrel can then be heated in an oven to ensure all FEP adhesive has been activated. Any suitable time and temperature profile can be used. For example, in some embodiments of process600, the heating can take place at about 320° C. for about twelve (12) minutes. The non-stick liner and the stent graft660can then be removed from the mandrel. The flow channels675between the tails and the supported edges can be checked to ensure that the channels675are operable to be opened as desired. If any flow channels675are adhered together they can be gently separated using an appropriate tool, e.g., one of the tips of a pair of tweezers. FIG.7is a flowchart of an exemplary process700for fabricating a stent graft device with discrete cylindrical segments arranged in a nested configuration as provided herein. For example, process700can be used to fabricate stent graft embodiments10and100ofFIGS.1A and1B. Process700also corresponds to some embodiments of the process depicted inFIG.5, for example. At operation710, membranous material is arranged on a mandrel. The mandrel can be sized corresponding to an inner diameter of the stent graft to be fabricated. As described above, in some embodiments ePTFE is used for the membranous material. In some embodiments, a FEP layer is included on one surface of the ePTFE. In some embodiments, two (2) or more layers of film material comprise the membranous material as a laminate. In some embodiments, woven or knitted membranes are used. At operation720, a plurality of individual ring-like annular support members are arranged over the membranous material. In some embodiments, the individual ring-like annular support members are stent members. In some embodiments, the stent members are formed wires or laser cut lattice rings. The stent members are placed over the membranous material in locations that will result in the desired asymmetrical stent placement configuration as described above in reference toFIGS.1A and1B. Strips of membrane material can be placed over the support members and laminated to the membranous material so as to attach and laminate the stent members onto the membranous material. In some embodiments a hot iron can be used to adhere the strips of membrane material to the membranous material to thereby laminate the support members with membranous material. In some embodiments, the mandrel with the partially completed stent graft device is then heated in an oven to activate the FEP. The activation of FEP bonds the layers of membranous material together. At operation730, after removing the partially completed stent graft from the mandrel, the base membrane can be cut to produce a plurality of cylindrical segments. The cuts are made in locations on the base membrane near the edges of stent members. The locations of the stent members are thereby located axially asymmetrical on the segments. That is, one edge of the cylindrical segments has support from a stent member but the other edge does not (it is the tail portion). At operation740the plurality of cylindrical segments are again placed on the mandrel, or another mandrel, and arranged in a nested configuration in accordance with the type of stent graft device desired, such as a radial inflow stent graft device or a radial outflow stent graft device. If a radial inflow stent graft is desired, the tails of the cylindrical segments are placed interior of (i.e., closer to the mandrel) the supported edges of the adjacent cylindrical segments. If a radial outflow stent graft is desired, the tails of the cylindrical segments are placed exterior of (i.e., further from the mandrel) the supported edges of the adjacent cylindrical segments. At operation750, reinforcing members are applied to the cylindrical segments that are arranged in the nested configuration. One or more axial reinforcement members can be applied. In some embodiments, end reinforcement members can also be applied to one or both ends of the stent graft device. In some embodiments, the reinforcement members are strips of ePTFE membrane with a FEP layer. In some embodiments, the strips are about ¼″ wide. The reinforcement members may be of any suitable width. In some embodiments, the mandrel with the completed stent graft device is once again heated in an oven to activate the FEP. The activation of FEP bonds the layers of membranous material together to create a completed stent graft device. FIG.8is a flowchart of an example process800for fabricating a stent graft device with a helically arranged membrane, wherein the turns of the helix overlap to create a nested configuration. For example, process800can be used to fabricate stent graft embodiments200and270ofFIGS.2A and2B. Process800also corresponds to some embodiments of the process depicted inFIG.6, for example. At operation810, membranous material is arranged on a mandrel. In some embodiments, the mandrel is over-sized for the inner diameter of the stent graft to be fabricated. For example, to fabricate a stent graft with a final inner diameter of about ten (10) millimeters, a mandrel with a diameter of about thirteen (13) millimeters can be selected. As described above, in some embodiments ePTFE is used for the membranous material. In some embodiments, a FEP layer is included on one surface of the ePTFE. In some embodiments, two (2) or more layers of film material can comprise the membranous material as a laminate. In some embodiments, woven or knitted membranes are used. At operation820, a single continuous support member is helically arranged over the membranous material. In some embodiments, the helically arranged support member is a stent member. In some embodiments, the stent member is made of a formed wire or a laser cut lattice strip. The stent member is placed over the membranous material in a location that will result in the desired asymmetrical stent placement configuration, as described above in reference toFIGS.2A and2B. A strip of membrane material can be placed over the support member and laminated to the base membrane, so as to attach and laminate the stent member within the membranous material. In some embodiments a hot iron can be used to adhere the strip of membranous material to the base material to thereby laminate the support member within membranous material. In some embodiments, the mandrel with the partially completed stent graft device is then heated in an oven to activate the FEP. The activation of FEP bonds the layers of membrane material together. At operation830, after removing the partially completed stent graft from the mandrel, the base membrane can be cut to produce a helical strip of membranous material with an asymmetrically located support member. The helical cut is made on the base membrane near the edges of the stent member. The stent member is thereby located asymmetrically on the helical strip of membranous material. At operation840, in some embodiments, the plurality of cylindrical segments are placed on an undersized mandrel. For example, for a stent graft with about a ten (10) millimeter final inner diameter, a mandrel with about an eight (8) millimeter diameter can be used. The turns of the helical strip of membranous material are then arranged in a nested configuration in accordance with the type of stent graft device desired, such as a radial inflow stent graft device or a radial outflow stent graft device. If a radial inflow stent graft device is desired, the tails of the turns are placed interior of (i.e., closer to the mandrel) the supported edge of the adjacent turn. If a radial outflow stent graft is desired, the tails of the turns are placed exterior of (i.e., further from the mandrel) the supported edge of the adjacent turn. At operation850, reinforcing members are applied to the cylindrical segments that are arranged in the nested configuration. One or more axial reinforcement members can be applied. In some embodiments, end reinforcement members can be applied to one or both ends of the stent graft device. In some embodiments, the reinforcement members are strips of ePTFE membrane with a FEP layer. In some embodiments, the strips are about ¼″ wide. The reinforcement members may be of any suitable width. In some embodiments, the mandrel with the completed stent graft device is once again heated in an oven to activate the FEP. The activation of FEP bonds the layers of membrane material together to create a completed stent graft device. While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any devices, methods, and systems discussed herein, but rather as descriptions of features that may be specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination. Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. | 75,193 |
11857408 | DETAILED DESCRIPTION Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. As a result, to the extent one exemplary embodiment of a surgical implant management device includes a particular feature, a person skilled in the art would be able to incorporate that feature into other surgical implant management devices, including in the various embodiments of devices provided for herein, as well as in other devices and the like used to manage implants that are known to those skilled in the art. In the present disclosure, like-numbered components of the embodiments generally have similar features and/or purposes. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the implant management devices, and the components associated therewith, can depend at least in part on the anatomy of the subject in which the implants will be used, the sizes and shapes of the components with which the implant management devices will be used, and the methods and procedures in which the systems and devices will be used. To the extent features are described herein as being a “first feature” or a “second feature,” such numerical ordering is generally arbitrary, and thus such numbering can be interchangeable. The figures provided herein are not necessarily to scale. Further, to the extent arrows are used to describe a direction a component can be tensioned or pulled, these arrows are illustrative and in no way limit the direction the respective component can be tensioned or pulled. A person skilled in the art will recognize other ways and directions for creating the desired tension or movement. Likewise, while in some embodiments movement of one component is described with respect to another, a person skilled in the art will recognize that other movements are possible. Additionally, a number of terms may be used throughout the disclosure interchangeably but will be understood by a person skilled in the art. By way of non-limiting example, the terms “suture” and “filament” and “flexed” and “folded” may be used interchangeably. The present disclosure generally relates to a surgical implant management device for selectively retaining a surgical implant or other construct. The management device can be used both to hold the components of the implant prior to use of the implant in a surgical procedure, and it can be used to help prepare for the surgical procedure, at least due in part to some of the features provided for as part of the device. For example, as described in further detail below, the device can include features that allow for a user to easily mark particular distances on the device, the implant, and/or a ligament graft associated therewith to help the user better know the location of the implant and ligament graft during a surgical procedure. The device can include features incorporated therewith, such as measurement indicia on a surface of the device, such that additional devices, for example rulers, are not needed to determine particular distances or lengths. Still further, the various configurations provided for herein can make it easier to keep various filaments of the implant from getting tangled, to more easily identify the filaments, and in general, can make it easier to use the implant and perform the procedures associated therewith. Surgical Implant While the disclosure provided for herein can be used in conjunction with a variety of implants, two non-limiting exemplary embodiments are illustrated inFIGS.1A and1B. Each of the implants10,10′ generally includes an implantable body12,12′ associated with one or more filaments in which at least one filament forms one or more adjustable coils or loops14,14′. More particularly,FIG.1Aillustrates an implant10that includes a body12having thru-holes formed therein and a first suture filament11associated therewith. The first filament11, sometimes referred to as a graft-holding suture, can be coupled to or otherwise associated with the body12and configured to hold a ligament graft for implantation. In the illustrated embodiment, a portion of the first filament11is formed into a plurality of adjustable coils or loops14defined by a self-locking knot13disposed on a top side12tof the body12, with the loops14primarily being disposed on a bottom side12bof the body12. The filament11can include at least one adjustable limb or tail, as shown a first adjustable limb15aand a second adjustable limb15b, extending from the knot13, and the limbs15a,15bcan be operable to adjust a size of one or more openings14oformed by one or more of the loops14when tension is applied thereto. One or more additional filaments can be removably associated with the body12to help control the implant during a surgical procedure. As shown, a second filament16, sometimes referred to herein as a shuttle suture or filament or a leading suture or filament, is disposed in a thru-hole located in a first end of the body12, and a third filament18, sometimes referred to herein as a trailing or toggle suture or filament, is disposed in a thru-hole located in a second end of the body12. These two filaments16,18, collectively referred to as guide filaments, can be used to help position and set the implant10, and thus the ligament graft associated therewith, at a desired implant location. In the illustrated embodiment, a first limb16aand a second limb16bof the second filament16extend from opposed sides of one thru-hole, and a first limb18aand a second limb18bof the third filament18extend from opposed sides of another thru-hole. Further, in some exemplary embodiments, each limb16a,16bcan include a receiving portion17a,17bconfigured to receive respective portions of the first and second adjustable limbs15a,15b. Disposing the limbs15a,15bwithin the receiving portions17a,17bcan assist in filament management, as well as provide a convenient way to help insure that any cutting of the first and second adjustable limbs15a,15bis not to the detriment of the integrity of the self-locking knot13. More particularly, a portion of the limbs15a,15bdisposed within the receiving portions17a,17bcan be trimmed to maintain the integrity of the knot13. A person having skill in the art will recognize that the integrity of the knot13, and thus the strength of the implant10, can be compromised when the limbs15a,15bare cut too close to the body12. Further details about implants of the nature illustrated inFIG.1Aare provided in U.S. Pat. No. 10,405,968, entitled “Implant Having Filament Limbs of an Adjustable Loop Disposed in a Shuttle Suture,” filed Dec. 11, 2013, the content of which is incorporated by reference herein in its entirety. The implant ofFIG.1Bis another exemplary embodiment of an implant10′ that can be used in conjunction with the implant management devices and surgical methods provided for herein. As shown, the implant10′ is similar to the implant10ofFIG.1A, except that it provides for an alternative configuration for protecting the integrity of a knot of a first filament. Similar to the implant10, the implant10′ includes a body12′ having thru-holes formed therein, a first filament11′ coupled to or otherwise associated with the body12′, and second and third filaments16′,18′ removably coupled to opposed thru-holes of the body12′. A portion of the first filament11′ can be formed into a plurality of adjustable coils or loops14′ defined by a self-locking knot13′ disposed on a top side12t′ of the body12′, with the loops14′ primarily being disposed on a bottom side12b′ of the body12′. The filament11′ can include at least one adjustable limb or tail, as shown a first adjustable limb15a′ and a second adjustable limb15b′, extending from the knot13′, and the limbs15a′,15b′ can be operable to adjust a size of one or more openings14o′ formed by one or more of the loops14′ when tension is applied thereto. The second and third filaments16′,18′ can serve as leading and trailing filaments, with first and second limbs16a′,16b′ of the second filament16′ extending from opposed sides of one thru-hole d, and first and second limbs18a′,18b′ of the third filament18′ extending from opposed sides of another thru-hole. Unlike the embodiment ofFIG.1A, the second filament16′ does not receive portions of the adjustable limbs15a′,15b′. Instead, a sleeve or spacer19′ is disposed over a portion of the first and second adjustable limbs15a′,15b′ on the top side12t′ of the body12′, adjacent to a top surface of the body12′. More particularly, as illustrated, the sleeve19′ is a single suture filament having a plurality of bores formed therein to receive first and second adjustable limbs15a′,15b′. The sleeve19′ can be disposed around a portion of the first limb15a′ on the top side12t′, wrap around a bottom surface of the body12′, and then wrap back around to the top side12t′ so it can be disposed around a portion of the second limb12b′. Wrapping the sleeve19′ around the bottom surface of the body12′ can help minimize proximal movement of the sleeve19′, towards terminal ends15ti′,15t2′ of the adjustable limbs15a′,15b′, when the limbs15a′,15b′ are tightened. The first terminal end15ti′ can pass into the sleeve19′ at a first bore19a′ and out of the sleeve19′ at a second bore19b′, while the second terminal end15t2′ can pass into the sleeve19′ at a third bore19c′ and out of the sleeve19′ at a fourth bore19d′. Similar to the receiving portions17of the implant10, the sleeve19′ can assist in preventing a surgeon from cutting the limbs15a′,15b′ too close to the body12′. More particularly with respect to this embodiment, the sleeve19′ can generally have elastic properties such that it bunches as compressive forces are applied, and a surgeon can then cut the limbs15a′,15b′ at a location proximate to the bores19b′,19d′. Further details about an implant of the nature illustrated inFIG.1Bare provided in U.S. Pat. No. 9,974,643, entitled “Implant Having Adjustable Filament Coils,” filed Mar. 11, 2013, the content of which is incorporated by reference herein in its entirety. A variety of other configurations of implants of the nature provided for herein, as well as other types of implants, can be used in conjunction with the disclosures provided herein pertaining to implant management devices and methods. By way of non-limiting example, in some embodiments, one or more loops associated with an implant body can be fixed as opposed to adjustable, and one or more limb(s) extending therefrom can be configured for other purposes besides adjusting a size of the loops, such purposes being known to those skilled in the art. Implant Management Device FIGS.2A and2Billustrate one exemplary embodiment of a surgical implant management device100, sometimes referred to herein as an implant management card. The card100in its unfolded state is shown inFIG.2A, while a configuration of the card100in a folded state, sometimes referred to herein as a compact configuration, is shown inFIG.2B. More particularly,FIG.2Bresults from folding a second portion128of the card100underneath the illustrated top side or surface112, i.e., towards a bottom side or surface114(FIG.2D) of the card100. This results in indicia136formed on the second portion128, as shown inFIG.2A, being visible on the bottom side114of the card100, as shown inFIG.2D. In the folded or compact configuration, the second portion128, and in particular the indicia136formed thereon, can, for all intents and purposes, become part of the bottom surface114. While a body102of the card100itself can have a variety of shapes and configurations, some of which are illustrated herein and many others of which are derivable based on the present disclosure, in the illustrated embodiment the body102has a generally rectangular shape defined by a first end104, a second end106, and opposed walls108,110extending between the two ends104,106. The device also includes a top side or surface112, sometimes referred to as a first side or surface, and a bottom side or surface114, sometimes referred to as a second side or surface. A central longitudinal axis L can extend the length of the body102, and can be located approximately equidistant from the two opposed sides108,110. For ease of reference, the central longitudinal axis L will be used in each embodiment described herein, even when the other reference numerals change. The body102can generally be defined as having a length, a width, and a thickness(not labeled, but extending between the top surface112and the bottom surface114). Depending on configuration of the card100, any of the length, the width, and the thicknesscan change when the card100is moved from an unfolded configuration to a folded configuration. Although the body102is described as being generally rectangular in shape, a person skilled in the art will see that the first and second ends104,106are not singular straight lines that are perpendicular to the central longitudinal axis L as in a typical rectangle. Instead each end104,106is tapered toward a midpoint104M,106M thereof, thus creating symmetrical ends. As discussed below, the first and second ends104,106can have a variety of other shapes, depending, at least in part, on the other features, shapes, and dimensions of the cards, without departing from the spirit of the present disclosure. In exemplary embodiments, the lengthin the unfolded configuration can be approximately in the range of about 100 millimeters to about 250 millimeters, in the folded configuration it can be approximate in the range of about 80 millimeters to about 220 millimeters, the widthin the folded or unfolded configuration can be approximately in the range of about 35 millimeters to about 80 millimeters, and the thickness tin the unfolded configuration can be approximately in the range of about 0.01 millimeters to about 1 millimeters, with the thicknesschanging for portions of the card in the folded configuration based on the amount of folding that occurs, such thickness changes being easily determinable by a person skilled in the art. In one exemplary embodiment, the lengthin the unfolded configuration can be approximately 160 millimeters, the lengthin the folded configuration can be approximately 130 millimeters, the widthcan be approximately 55 millimeters, and the thickness tin the unfolded configuration can be approximately 0.5 millimeters. The surgical implant management device100includes a number of different features that improve a user's ability to manage the filaments before and during a surgical procedure. One such feature is an implantable body retainer116. As shown, the implantable body retainer includes two staggered, opposed tabs118,120configured to grasp opposite ends of an implantable body. The tabs118,120can be configured to hold the body at a particular location consistent with indicia134,136formed on the device100. Accordingly, the first tab118can be adjacent to a 0 millimeter indicia line and the second tab120can be a distance apart from the location of the first tab118, closer to the first end104than the first tab118is. Both tabs118,120can be configured to pivot at their respective bases118b,120bso that the ends118e,120eof the tabs118,120can be moved out of a plane that extends substantially through the top surface112. As designed, both tabs118,120can pivot out of the page, as shown inFIG.2C, thus allowing an implant body to be tucked underneath the tabs118,120and be supported by other portions of the top surface112. Thus, in the illustrated embodiment, the tabs118,120operate to retain an implant body on the top surface112of the implant management device100. While the tabs118,120of the implantable body retainer116can have a variety of shapes and sizes, depending, at least in part, on the size and shape of the other portions of the implant management device and the implant itself, in the illustrated embodiment the two tabs118,120have a finger-like shape that can be also be described as being elongate and semi-elliptical. A length of each tab118,120is such that the base118b,120bextends on one side of the central longitudinal axis L, while the terminal end118d,120eof the same tab118,120extends on the opposite side of the central longitudinal axis L. This geometry can help secure an implant body to the surface112in use. Another feature of the device100can be a filament loop engaging region122, sometimes referred to herein as a first filament receiving region, which can be used to retain and tension one or more filament loops that extend below a bottom side of an implant body. The filament loop engaging region122can have many different configurations. In the embodiment illustrated inFIG.2B, the filament loop engaging region122includes at least one protruding feature, as shown two prongs124, around which the filament loops can be disposed. As a result, all of the loops of the implant can be held together, in a tensioned state, by a single component. The prongs124can be formed by folding a portion of the device100along a fold126formed in the body102. More particularly, a second portion128of the device100, which as shown is the portion of the device100disposed between the fold126and the second end106, can be folded toward a bottom surface114, i.e., into the page as illustrated. As a result, a combination of the opposed cutouts or openings130formed through the body102and a central cut-out or opening132also formed through the body, can form the opposed prongs124. In the illustrated embodiment, the opposed openings130have a generally triangular shape, although a variety of other shapes can also be used to form the opposed openings. Further, as shown, the fold126intersects and substantially bisects the triangularly-shaped cutouts130. The taper formed by sides of the triangularly-shaped cutouts130can help prevent the loop(s) from slipping off the prongs124. The fold126can extend across the widthof the body102, between the opposed walls108,110. A person skilled in the art will recognize that a location of the fold126, and thus the end of the prongs124, can depend on a variety of factors, including the implant being used in conjunction with the implant management device, and the type of procedure in which the implant is being used. In some exemplary embodiments, the fold126is generally located to allow the loops to have a tension applied thereto as a result of engaging the prongs124. In some implant embodiments, the size of the loops can be adjusted using filament limbs so that the loops can be appropriately tensioned on the prongs124. Although the prongs124that form the filament loop engaging region122illustrated inFIG.2Bare formed by folding over a portion of the body102, other configurations can be used to engage filament loops extending from an implant body. For example, in some instances the filament loop engaging region122can be pre-formed on the device100such that no folding or other changes to the initial configuration are necessary to form the filament loop engaging region122. Thus, in some embodiments prongs124can be pre-formed at the second end106of the device100. The opening132that forms the part of the prongs124can also be used to receive a ligament graft. As shown, at least a portion of the graft-receiving opening132can be disposed between the implantable body retainer116and the prongs124so that when a ligament graft is passed through the opening132, it is passed through at least one of the openings of the filament loop(s) of an implant, as described in further detail below. In the illustrated embodiment, the opening132is more proximate to the second end106than the first end104. The opening132can have any number of shapes and sizes, but in the illustrated embodiment it is symmetrical along the central longitudinal axis L. The opening132can also be bisected by the fold126, and thus can be symmetrical with respect to the fold126. As a result, when the second portion128is folded toward the bottom side114, the resulting configuration is one in which one half of the opening132is substantially aligned with the other half of the opening132. In the illustrated embodiment, the approximate shape of the opening132in the unfolded configuration can be similar to a dumbbell. Once folded, the larger portion132aof the dumbbell-shaped opening132can be large enough to receive a ligament graft, while the smaller portion132bof the opening132can help to form the shape of the prongs124. In particular, the portion of the device100disposed between the smaller portion132band the opposed openings130forms the prongs124of the filament loop engaging region122. As shown inFIG.2B, a space124sbetween the two prongs124can form an open pathway to the remainder of the opening132. In other embodiments, material can be disposed between the two prongs124, thereby eliminating the open pathway. Another feature of the device100can be first indicia134formed on the top side112. The first indicia134can be used for a variety of reasons, but in one exemplary embodiment they can assist a user in marking particular measurements on loops of an implant coupled to the device100. In some instances, the first indicia134can be used in marking particular measurements on a ligament graft. In the illustrated embodiment, the first indicia134begins proximate to the first tab118at 0 millimeters and extend to 50 millimeters, which is located approximately at the fold126. Each indicia line extends substantially parallel to the fold126. Each solid indicia line denotes an increment of 10 millimeters, and each dotted indicia line denotes an increment of 5 millimeters between each 10 millimeter indicia line. Other indicia are also permitted on the top surface of the device. For example, second indicia136can also be provided on the top side112between the fold126and the second end106. As shown, an additional 30 millimeters are marked off in 5 millimeter increments between the fold126and the second end106. The second indicia136can be used to assist in marking particular measurements on a ligament graft associated with an implant, or on filaments of the implant, depending on the implant and implant management device configurations. A receiving slit138can be formed in the body102for receiving the second end106when it is folded toward the bottom side114. As shown inFIG.2A, the receiving slit138can be disposed between the fold126and the first end104, and can extend substantially parallel to the fold126. In the illustrated embodiment the receiving slit138is actually between the implantable body retainer116and the fold126. The location of the receiving slit138, however, can generally be dependent on the shape and length of the second end106that is folded over toward the bottom side114. Accordingly, a length between the fold126and the receiving slit138can be approximately the same as the length of the second portion128. The length and shape of the slit138can correspond to the shape of the second end106that the slit is configured to receive. Another feature that can be incorporated into the device100is an alignment opening140for associating the device100with a graft preparation device. In the illustrated embodiment, the alignment opening140is located adjacent to the implantable body retainer116, between the implantable body retainer116and the fold126. The hole140can have a variety of shapes and sizes adapted to receive a post of a graft preparation device. A person skilled in the art will recognize that a graft preparation device can be used with ligament grafts so that appropriate notations can be made on the ligament grafts, as well as on implant management devices, in view of the disclosures provided for herein. An example of a graft preparation device is discussed below, and a person having skill in the art will recognize a variety of graft preparation devices configurations with which the implant management device100can be adapted for use. The alignment opening140can be generally elongate, and in the illustrated embodiment is generally teardrop shaped. A first end140aof the opening140can be configured to be complementary to the size of a post of the graft preparation device, while a second end140bcan have a bigger diameter than the first end140to make it easier to initially receive the post and position the implant management device100such that the post engages the device100at the first end140a. A number of features to help manage limbs and other filaments extending generally from the top side of the implant can also be included as features of the device100. These features can generally be referred to as filament retention features, and the location of at least some of these features on the device100can sometimes be referred to as a second filament receiving region142. In addition to retaining filament associated with the implant, at least some of these features can apply tension to the filament to help keep the filament out of the way. One example of a filament retention feature is shown inFIGS.2A and2Bas opposed tabs144,146formed between the implantable body retainer116and the first end104. As shown, the tabs144,146can be spaced approximately equidistant from the central longitudinal axis L, and can be described as being horizontally-disposed with respect to the central longitudinal axis L. Each tab144,146can include two folds144b,144cand146b,146c. A first, more centrally-disposed fold144b,146bcan be formed between the tab144,146and the body102, thereby allowing the tab144,146to be moved out of a plane extending substantially through the body102. In the illustrated embodiment, as shown inFIG.2D, the tabs144,146can be configured to move in an opposite direction of the implantable body retainer tabs118,120, and thus can extend into the page when folded. Each tab144,146can be folded along the second fold144c,146cto provide a receiving region144r,146ralong which filaments can be wound. As shown inFIG.2D, end portions144e,146eof the tab144,146can be substantially parallel to the plane extending substantially through the body102. Any and all portions of any filament associated with the implant can be wrapped around the tabs144,146, as described in greater detail below. The tabs144,146can help to keep the various filaments organized, and can also decrease the likelihood that any filaments will become tangled. The filaments can also be kept in a tensioned state once they are wrapped around the tabs144,146. A centrally disposed slit148can be formed in the first end104and extend towards the tabs144,146. The slit148can serve as an access point for filament to be disposed prior to winding it around the tabs144,146. As shown, the slit148terminates at a bore150extending through the body102. A portion of the filament can be disposed in the bore150prior to winding it around the tabs144,146. Another feature for retaining filament is provided by way of a bore152extending through the body102and configured to receive any and all of the filaments. The bore152can be disposed in the second filament receiving region142, proximate to the first end104, between the centrally disposed slit148and one of the first and second opposed walls108,110. A slit154can be in communication with the bore152and can extend to the opposed wall nearest to the bore152, as shown the first wall108. As shown byFIGS.2C and2D, filament can wrap around the tabs144,146, extend from the tabs144,146toward the bore152, and can be slid through the slit154to enter the bore152. In addition to the tabs144,146maintaining a tensioned state in the filaments, in some embodiments, the bore152can also help to maintain tension in the filaments, for instance when the bore152has a diameter similar to the total diameter of filaments disposed therein. A retention tab156can be provided as a further feature to assist with filament retention and management. As shown, the retention tab156can be located along one of the opposed walls108,110, as shown the first wall108, and can be more centrally disposed along the wall108than the bore152and slit154. In particular, the retention tab156can be disposed along the length e of the body102between the opposed tabs144,146and the implantable body retainer116. The retention tab156can be formed by two slits158,160extending from the wall108and toward the central longitudinal axis L, approximately parallel to the fold126, and can include two folds156b,156cformed therein, approximately perpendicular to the two slits158,160. The folds156b,156can allow the tab156to form a sleeve for receiving filament, and at least in some instances, can apply tension to and/or maintain a tension in the filament disposed therein. The more centrally disposed fold156bcan be formed between the body102and the tab156so that the tab156can extend into or out of the page. The second fold156ccan allow an end156eof the tab156to be folded over back toward the body102to form a sleeve, as shown inFIGS.2C and2D. By keeping filaments toward an edge of the device100, users can more easily view the implant loops, ligament graft, and the indicia134,136without filament impairing the view. FIGS.2C and2Dillustrate the device100having the implant10associated therewith. As shown, the body12of the implant10can be held at a desired location by the implantable body retainer116such that the start of the loops14extending from the bottom side12bis approximately at the 0 millimeter indicia line. The loops can extend towards the filament loop engaging region122and can be held in place in a tensioned state by the prongs124. As a result, the opening132for receiving the ligament graft is framed by the loops14. Each of the adjustable limbs15a,15b, as well as the two guide filaments16,18also associated with the body12, can extend from the body12towards the first end104. The limbs15a,15band guide filaments16,18can extend through the slit148to the centrally disposed bore150, and then can be wrapped around the tabs144,146below the bottom side114of the device100. The limbs15a,15band guide filaments16,18can extend towards the first wall108, where they can be disposed in the side slit154to access the bore152. The limbs15a,15band guide filaments16,18can then extend towards the filament loop engaging region122, and can be grasped by the sleeve formed by the retention tab156, before eventually terminating. Further details regarding techniques for attaching an implant to a device or card are described in greater detail below with respect toFIGS.15L-S. As shown, the first indicia134can be used to mark measurements on the loops14because the 0 millimeter indicia line coincides with the approximate starting point of the loops14with respect to the body12. The second indicia136can be used in one of two manners. As shown inFIG.2D, the second indicia136are located on the bottom side114of the device. In one exemplary embodiment, the second end106can be removed from the receiving slit138and returned approximately to its location in the unfolded configuration. Then a ligament graft disposed in the loops14and extending away from the prongs, in a direction A, can have measurements marked thereon using the second indicia136, as described in greater detail below. Alternatively, a ligament graft can be associated with the loops and then extended towards the first end104, along the bottom side114, so that the second indicia136can be used to mark measurements on the ligament graft when the body102is in the folded configuration. Alternative Embodiments of Implant Management Devices FIGS.3A-13provide for various other embodiments of implant management devices. The features illustrated by these embodiments include some of the same features described with respect to the device ofFIGS.2A-2Din combination with other features and/or alternative embodiments of the same features of the device ofFIGS.2A-2D. A person skilled in the art will recognize that to the extent these embodiments include features in one embodiment but not in other embodiments, each and every embodiment is generally capable of being modified to include or exclude particular features without departing from the spirit of the disclosure. Further, to the extent some features are illustrated in multiple embodiments, such features may not be described in each embodiment for efficiency purposes. A person skilled in the art will recognize how these illustrated features are configured and capable of being used in light of the entirety of the present disclosure and the knowledge of the skilled person. Generally, features that have a similar configuration between different embodiments are numbered alike (e.g.,198,298,398), while features that serve a similar purpose but have a different configuration are numbered alike but have prime designations (e.g.,198,298′,398″). FIGS.3A and3Billustrate an implant management device or card200in an unfolded configuration and a folded or compact configuration, respectively. The device200is similar to the device ofFIGS.2A-2Din that it has body202having a generally rectangular shape defined by a first end204, a second end206, and opposed walls208,210extending between the two ends204,206, has a central longitudinal axis L extending a length of the body202, and that it also includes a top side or surface212and a bottom side or surface214(not shown). The device further includes features such as an implantable body retainer216, an alignment opening240, prongs224formed as part of a filament loop engaging region222that results from folding a second portion228along a fold226and inserting the second end206into a retention slit238, opposed openings230, a graft-receiving opening232, first indicia234, second indicia236, and filament retention features formed in a second filament receiving region242, for example horizontally-disposed filament retention tabs244,246, a plurality of bores250,252and slits248,254, and a retention tab256. Despite having many similar features, the device200ofFIGS.3A and3Bis significantly longer than the device100ofFIGS.2A-2D. As shown, in the unfolded configuration a lengthof the device is approximately 220 millimeters, and in the folded configuration the lengthis approximately 160 millimeters. The longer device200can allow for longer measurements to be designated on loops of an implant associated therewith because the fold226is approximately 80 millimeters away from the implantable body retainer216. Longer devices can be useful for collateral ligament repairs, e.g., a medial collateral ligament (“MCL”) or a medial patellofemoral ligament (“MPFL”) repair, in which a length of an implant loop is typically larger, in the range of about 80 millimeters to about 120 millimeters. In some embodiments, a length of an implant loop can be about 80 millimeters, and in some other embodiments a length of an implant loop can be about 90 millimeters. Shorter devices like the device100can be useful for cruciate ligament repairs, e.g., an ACL or a posterior cruciate ligament (“PCL”) repair, in which a length of an implant loop is typically no more than about 50 millimeters to about 70 millimeters. In some embodiments, a length of an implant loop can be about 60 millimeters. Another feature included as part of the device200is an instructional marking, as shown an arrow262. The arrow262can be located adjacent to the graft receiving opening232, thereby indicating to a user that, in use, the ligament graft should be disposed in the opening232. Other instructional markings can also be provided for on the top and bottom surfaces212,214, and some further, non-limiting examples of such markings are provided for in other embodiments. The instructional markings can be particularly useful when the device comes pre-packaged so a user can easily identify the various features and functionalities of the device. Similar to the device100, the retention slit238for receiving the second end206can be disposed between the first end204and the start of the graft-receiving opening232. However, because in the illustrated embodiment the length of the second portion228is substantially similar to the length of the second portion128in the first device100, but the length between the first end204and the fold226is substantially longer than in the device100, the slit238is located further from the implantable body retainer216than is the comparable slit138. FIGS.4-8provide further alternative configurations of an implant management device. Unlike the previous two embodiments, these embodiments do not illustrate both an unfolded configuration and a folded or compact configuration. Although only a compact configuration is illustrated in the devices ofFIGS.4-8, the illustrated configurations can be the result of folding using techniques described herein or otherwise known to those skilled in the art. Alternatively, the illustrated configurations can be the only configurations of the body provided for, thus requiring no folding to result in the illustrated configurations. Each of these alternative configurations ofFIGS.4-8is for an implant management device300,400,500,600,700that has a body302,402,502,602,702having a generally rectangular shape defined by a first end304,404,504,604,704, a second end306,406,506,606,706, and opposed walls308and310,408and410,508and510,608and610,708and710extending between the two ends304and306,404and406,504and506,604and606,704and706. Each also includes a top side or surface312,412,512,612,712and a bottom side or surface314,414,514,614,714, and has a central longitudinal axis L extending a length of the body302,402,502,602,702, the location of the axis L having being previously defined with respect to other embodiments. Because the illustrated embodiments are in a compact configuration, the second end306,406,506,606,706is illustrated as being located at the portion in the earlier embodiments identified as the fold126,226. Such identification does not preclude an unfolded configuration for the devices300,400,500,600,700having a second end that is retained in a retention slit as described with respect to the devices100,200. In the implant management device300ofFIG.4, the device300includes a filament loop engaging region322, e.g., prongs324, located at the second end306, a graft-receiving opening332, and indicia334′ located on the top surface312. The illustrated embodiment does not include an implantable body retainer. Instead, a user can hold an implant at the 0 millimeter indicia line to mark loops and ligament grafts as desired. Additionally, as shown, the indicia334′ can be slightly angled as compared to an approximate straight line formed by the first end304. The angled lines can allow for a more true representation of the anatomy of the loop being marked. However, it was found that in most instances any difference in the accuracy of making markings using straight lines versus angled lines for the indicia was negligible. The implant management device includes a plurality of filament retention features for retaining filaments extending from the implant, e.g., adjustable limbs, a leading filament, and a trailing filament. The features can be formed in a second filament receiving region342of the body302, and can include, for example, a pair of opposed tabs344′,346′. The tabs344′,346′ in this embodiment are different than the tabs144,146and244,246both because they are formed differently and disposed in a different location. The tabs344′,346′ are formed only from a single fold344b′,346b′. The tabs344′,346′ can be bent to extend into or out of the page, and filaments can then be wrapped around the tabs344′,346′, proximate to the folds344b′,346b′. Regarding their location, both tabs344′,346′ can be centrally disposed on the device300such that the central longitudinal axis L substantially bisects the tabs344′,346′. Tabs extending in this direction can be referred to herein as being vertically-disposed with respect to the central longitudinal axis L. As shown, the two tabs344′,346′ are approximately equidistant from the 0 millimeter indicia line, although other locations are certainly possible, including some locations that are provided for herein. In some instances, filament that is wrapped around the tabs344′,346′ can help to maintain a location of an implant body in the absence of an implantable body retainer. Although there is no slit extending from one of the walls and towards the tabs344′,346′, like the slit148,248of the devices100,200, such a slit can be included in alternative configurations of the device300. The second filament receiving region342can also include a plurality of bores formed therein, as shown three bores352a,352b,352c, with each bore352a,352b,352chaving a slit354a,354b,354cassociated therewith extending from the first end304. Each bore352a,352b,352ccan be used to retain a different filament. For example, the first bore352acan be used to hold the adjustable limbs, the second bore352bcan be used to hold the leading suture, and the third bore352ccan be used to hold the trailing suture. By using each bore to hold a different filament, it can improve the ability for a user to distinguish between the various filaments, and can also help reduce the possibility of tangling between the filaments. In the illustrated embodiment, the third bore352chas a diameter that is larger than the diameters of the first and second bores352a,352b, although any combination of diameter sizes, and any number of bores, can be used, depending, at least in part, on the number and size of the filaments associated with the implant. The device400illustrated inFIG.5is similar to the device300ofFIG.4except that it includes an implantable body retainer416′, as well as an alignment opening440′ for integration with a graft preparation device. Further, the indicia434′,436′ provided for on the top surface412can be used in both directions. Features of the device such as the filament loop engaging region422, e.g., prongs424, the graft-receiving opening432, and filament retention features formed in a second filament receiving region442, for example the vertically-disposed filament retention tabs444′,446′ and the bores452a,452b,452cand slits454a,454b,454c, can be of a nature as described herein with respect toFIG.4and other disclosed embodiments. The implantable body retainer416′ allows a body of an implant to extend approximately horizontally with respect to the central longitudinal axis L, i.e., a horizontal orientation. The previously described embodiments held the implant body in a vertical orientation. The tab of the implantable body retainer416′ can be configured to fold into or out of the paper along a fold416b′ to allow the implant body to be tucked underneath the tab. Further, in some embodiments, the tab can include one or more fingers416fconfigured to make it easier for the user to grasp the tab416′. The alignment opening440′ provided for inFIG.5is substantially circular, as opposed to the more elongate configuration illustrated for the alignment openings140,240of the devices100,200. A person skilled in the art will recognize that a variety of other shapes can be used to help integrate an implant management device with a graft preparation device, depending, at least in part, on the shape and size of a corresponding post on the graft preparation device. The indicia434′,436′ on the top surface412are different than indicia of any of the previously described embodiments because they are both disposed in the same location and configured to allow for easy use in both directions on the same side of the device without needing to unfold the device400. As shown, the first indicia434′ starts at 0 millimeters at the location of the implantable body retainer416′ and goes to 50 millimeters at a location proximate to the prongs424, and the second indicia436′ starts at 0 millimeters at a location proximate to the prongs424and goes to 50 millimeters at the location of the implantable body retainer416′. Providing the second indicia436′ at this location can allow for ligament graft measurements to be easily made based on indicia located on the top surface412in the compact configuration because the starting place for such measurements can generally occur at or near the second end406. FIG.6illustrates another embodiment of an implant management device500. The device500is similar to the device400ofFIG.5in that it includes an implantable body retainer516′, an alignment opening540′, a graft-receiving opening532, prongs524formed as part of a filament loop engaging region522, first and second indicia534′,536′, and filament retention features formed in a second filament receiving region542, for example vertically-disposed filament retention tabs544′,546′. Further, bores550,552and slits548,554′ similar to the bores150,152and slits148,154of the device100ofFIGS.2A-2Dare also provided as filament retention features. Although the filament retention tabs544′,546′ of the device500are vertically disposed like the equivalent tabs444′,446′ of the device400, they are disposed at a different location. Further, the device500provides for additional examples of instructional markings provided on the top surface512. As shown, filament retention tabs544′,546′ are still opposed to each other and a longitudinal axis L′ that bisects the tabs544′,546′ is substantially parallel to the central longitudinal axis L, however, they are not centrally disposed on the device500as the tabs444′,446′ are in the device400. Instead the tabs544′,546′ are offset to one side of the central longitudinal axis L, as shown at a location that is more proximate to the first wall508than the second wall510. Further, a length e of the device is substantially longer than a length of the device400, which allows for the filament retention tabs544′,546′ to be spaced a distance apart from the indicia534′,536′ formed on the top surface512. As a result, it can be easier to view the indicia534′,536′ when filament is disposed around the filament retention tabs544′,546′ due to the wrapped filament not being disposed directly on any portion of the indicia534′,536′. The slit548and bore550can be used to assist in disposing filament around the filament retention tabs544′,546′. The slit548can be formed in the first end504, centrally disposed on the body502such that it extends a portion of the length of the central longitudinal axis L, substantially parallel to one terminal end of the tabs544′,546′. The slit548can extend towards the filament retention tabs544′,546′, terminating at the bore550extending through the body502. A portion of the filament can be passed through the slit548and disposed in the bore550prior to winding the filament around the tabs544′,546′. The second slit554′ and bore552combination can be formed along an edge of the body502to receive filament after it has been wound around the filament retention tabs544′,546′. As shown, the second slit554′ can be formed in the first wall508, proximate to a corner of the body502. The slit554′ can extend diagonally with respect to the central longitudinal axis L, and can terminate at the second bore552. Filament extending from the filament retention tabs544′,546′ can be passed through the slit554′ and disposed in the bore552to help manage the filament. Because the second slit554′ and bore552are disposed near the edge of the body502, they help keep the filament out of the way of the user's view so the loop, ligament graft, and indicia534′,536′ can be more easily viewed. The device ofFIG.6further illustrates two additional instructional markings disposed on the top surface512. One such marking is an alternative embodiment of an arrow562′ indicating to a user the location at which the ligament graft should be disposed. The arrow562′ serves a similar purpose as the arrow262of the device200, but has a different look. A person skilled in the art will recognize a variety of other arrow types, and other types of instructions, that can be used to indicate where ligament grafts, or portions of the implant itself, should be disposed or otherwise placed when using the devices provided for herein. The second such marking is an image564of a writing instrument. The image564indicates to a user that this side of the device500, i.e., the top side512, can be used to mark indicators on any and all of the device itself, the implant, and the ligament graft. A further embodiment of an implant management device600is shown inFIG.7. The device600includes some of the previously discussed features, including an implantable body retainer616, a graft-receiving opening632, prongs624formed as part of a filament loop engaging region622, indicia634, and filament retention features in a second filament receiving region642, for example vertically-disposed filament retention tabs644′,646′ and bores650,652and slits648,654, although the slit654is formed in the second wall610and the associated bore652is located proximate to the second wall610. The vertically-disposed filament retention tabs644′,646′ are disposed centrally such that the central longitudinal axis L bisects the two tabs644′,646′, and they are spaced a distance apart from the indicia634. The device further includes an additional filament management feature666located between the implantable body retainer616and the filament loop engaging region622. As shown, the feature666can include two staggered, opposed tabs668,670, similar to the tabs118,120of the implantable body retainer116of the device100. The tabs668,670can be located between the implantable body retainer616and the graft-receiving bore632. Both tabs668,670can be configured to pivot at their respective bases668b,670bso that ends668e,670eof the tabs668,670can be moved out of a plane that extends substantially through the body602. As designed, both tabs668,670pivot out of the page, thus allowing a portion of loops extending from a bottom side of an implant associated with the implantable body retainer616to be tucked underneath the tabs668,670and held in place proximate to the top surface612. The loops can then extend from the tabs668,670and towards the prongs624, still framing the graft-receiving opening632so that the loops can receive a ligament graft. The tabs668,670can help prevent the various loops from becoming tangled with each other, and can help insure that each loop that is supposed to receive the ligament graft is properly positioned to do so. In the illustrated embodiment, the tabs668,670are approximately centrally disposed such that they are substantially bisected by the longitudinal axis L. Further, as shown, the tabs668,670can be substantially aligned longitudinally such that the base668bof one tab668is approximately aligned with the end670eof the other tab670. In other embodiments the tabs668,670can be aligned longitudinally such that the end670eof the tab670terminates prior to the base668bof the tab668, similar to the alignment of the tabs118and120of the implantable body retainer116of the device100. The second slit654and second bore652are positioned on the body602such that they are aligned with a base646b′ of the tab646′. As a result, a filament that is wrapped around the tabs644′,646′ can extend horizontally across the base of the tab646′ and directly into the second slit654, and then into the second bore652, for retention near the edge of the body602. This alignment can help to alleviate undesirable tension in the filament while still keeping the filament out of the way of the user. Yet a further configuration of an implant management device700is shown inFIG.8. The device700includes some of the previously discussed features, including an implantable body retainer716, a graft-receiving opening732, prongs724formed as part of a filament loop engaging region722, indicia734, instructional markings such as an arrow762, and filament retention features formed in a second filament receiving region742, for example vertically-disposed filament retention tabs744″,746″ and bores750a,752aand slits748a,754a. The vertically-disposed filament retention tabs744″,746″ are different than in previous embodiments in that they are opposed but offset from each other. As shown, each tab744″,746″ can include a first wall744a″,746a″ and a second wall744b″,746b″, with the second wall744b″ of the first tab744″ being close to vertically aligned with the first wall746a″ of the second tab746″. As also shown, the second wall746b″ of the second tab746″ can be approximately aligned with the central longitudinal axis L. Additionally, a width744w″,746w″ of the tabs744″,746″ can be smaller than a width of the comparable filament retention tabs in the previously described embodiments, e.g., filament retention tabs144,146and644′,646′. As shown, the width744w″,746w″ of each of the first and second tabs744″,746″ is approximately half the width of the comparable filament retention tabs in the previously described embodiments. However, because the tabs are offset from each other, the width formed by the distance between the first wall744a″ of the first tab744″ and the second wall746b″ of the second tab746″ can be approximately equal to a width of the comparable filament retention tabs of the previously described embodiments. As shown, two folds744b″,744c″ and746b″,746c″ can be formed in each tab744″,746″, with the folds744b″,744c″ and746b″,746c″ operating similar to the folds144b,144cand146b,146cof the tabs144,146of the device100. The two slits748a,754aand bores750a,752aformed in the body702can operate in conjunction with the filament retention tabs744″,746″ to guide and/or maintain filament extending from a top side of an implant body associated with the device700. The centrally-disposed slit748aand bore750acan be in substantial vertical alignment with the second wall746b″ of the second tab746″. The second slit754aand bore752acan be of a similar construction as the slit748aand bore750a, but as shown can be in substantial vertical alignment with the first wall744a″ of the first tab744″. Accordingly, a portion of filament can be passed through the centrally-disposed slit748aand disposed in the bore750aprior to winding the filament around the tabs744″,746″, and then another portion of the filament can be passed through the second slit754aand disposed in the second bore752aafter winding the filament around the tabs744″,746″. The substantial vertical alignment of the slits748a,754aand bores750a,752awith the walls746b″ and744a″ can help prevent filament entanglement, as well as reduce unwanted tension in the filament. Further, because the second tab746″ intersects with a portion of the indicia734, the reduced size of the tab746″, and the fact that it is offset with respect to the center of the body702, can reduce any visual impairment caused by folding the tab746″ downward (into the page) in use. This configuration can also help reduce any visual impairment that results to indicia formed on a bottom side of the body702, for instance indicia to assist in making measurements on a ligament graft. FIGS.9and10Aprovide for two alternative implant management devices800,900in an unfolded configuration that illustrate non-limiting examples of differently shaped second ends806′,906″, respectively. Generally, the devices800,900include many of the same features illustrated with respect to the devices100,200ofFIGS.2A-2D and3A-3B. Thus, as shown, the devices800,900both have a body802,902having a generally rectangular shape defined by a first end804,904, a second end806′,906″, and opposed walls808,810and908,910extending between the two ends804,806′ and904,906″, respectively. Each device800,900further includes a central longitudinal axis L extending a length of the body802,902, and further includes a top side or surface812,912and a bottom side or surface814,914(not shown). Additional features provided for in the devices can include an implantable body retainer816,916having opposed tabs818,820and918,920, an alignment opening840,940, a second portion828,928configured to be folded along a fold826,926toward the bottom side814,914, i.e., into the page, to form a filament loop engaging region that includes prongs, opposed openings830,930, a graft-receiving opening832,932, first indicia834,934, second indicia836,936, and filament retention features formed in a second filament receiving region842,942, for example horizontally-disposed filament retention tabs844,846and944,946, a plurality of bores850,852and950,952and slits848,854and948,954, and a retention tab856,956having slits858,860and958,960. As shown inFIG.9, in one alternative embodiment, the second end can include a U-shaped cut-out872. Two tapered edges806a′,806b′ can extend from terminal ends872tof the cut-out872and to the opposed walls808,810. When the body802is folded along the fold826such that the second portion828moves into the page, towards the bottom side814, the two tapered edges806a′,806b′ can be disposed in complementary retention slits838a′,838b′ formed in the body802between the fold826and the first end804. As shown, the retention slits838a′,838b′ are disposed in-line with a portion of the alignment opening840, proximate to the implantable body retainer816because the length of the second portion828is almost the same length as the length extending from the 0 millimeter indicia line to the fold826. The U-shaped cut-out872helps prevent the body802from interfering with a graft preparation device by allowing the alignment opening840to be unobstructed. Thus, this configuration can be useful when the indicia826on the second portion828are provided for a length that is long enough to interfere with other features of the device800, implant, or other structures used in conjunction with the same, e.g., a graft preparation device. The alternative embodiment ofFIG.10Aprovides for a second end906″ that has a jagged shape. In the illustrated embodiment the second end906″ has an M-shape or W-shape such that three terminal peaks906a″,906c″,906e″ and two terminal valleys906b″,906d″ exist. A retention slit938formed between the fold926and the first end904can be configured to receive a portion of the second end906″ extending between the two terminal valleys906b″,906d″, including the central terminal peak906c″. Again, the location of the slit938can depend on the length of the second portion928folded towards the bottom side914, i.e., into the page. In the illustrated embodiment, the retention slit938is more proximate to a terminal end940tof the alignment opening940than a terminal end932tof the graft-receiving opening932. FIG.10Bprovides an alternative embodiment of a device900′ that is generally configured like the device900ofFIG.10A, but includes a differently configured implantable body retainer916′ and a differently configured filament retention feature, more particularly retention tabs956a′,956b′, which are differently configured than the retention tab956ofFIG.10A. As shown, opposed tabs918′,920′ of the implantable body retainer916′ ofFIG.10Bhave a larger surface area than the tabs916,918of the device900ofFIG.10A. These larger tabs918′,920′ allow for a larger implant body to be more easily retained by the device900′. A larger implant body can be used for surgeries requiring larger bone holes, or alternatively, in instances in which a surgeon drills a bone hole larger than originally anticipated. In such instances a length or diameter of the implant body can be configured to be larger than the diameter of the bone hole, and thus preventing the implant body from falling into the bone hole and the implant from losing its implant location. The retention tabs956a′,956b′ serve a similar purpose as the retention tab956, and thus can retain excess filament that extends from a top side of an implant body. While many configurations can be used to retain a filament, in the illustrated embodiment the tabs956a′,956b′ are configured in a manner similar to opposed tabs of implantable body retainers provided for herein, e.g., the opposed tabs918,920ofFIG.10Aor the opposed tabs668,670ofFIG.7. As shown, the tabs956a′,956b′ are located proximate to a wall908′ of the body902′, thereby keeping the filament disposed away from indicia934′ formed on a top surface912′ of the body902′, and are staggered with respect to each other. Both tabs956a′,956b′ can be configured to pivot at their respective bases956ab′,956bb′ so that ends956ae′,956be′ of the tabs956a′,956b′ can be moved out of a plane that extends substantially through the body902′. As designed, both tabs956a′,956b′ pivot out of the page, thus allowing filament to be tucked underneath the tabs956a′,956b′ and be supported by other portions of the top surface912′. In the illustrated embodiment, the tabs956a′,956b′ are substantially aligned longitudinally such that the base956ab′ of one tab956a′ is approximately aligned with the end956be′ of the other tab956b′. Likewise, the base956bb′ tab956b′ is approximately aligned with the end956ae′ of the tab956a′. In other embodiments the tabs956a′,956b′ can be aligned longitudinally such that an end of one tab, such as the end956be′ of the tab956b′, terminates prior to a base of the other tab, such as the base956ab′ of the tab956a′. FIG.11illustrates another embodiment of an implant management device or card1000in an unfolded configuration. This card1000is particularly designed to provide instructions on the card itself to assist a user in transforming the unfolded card into a folded card having an implant stored thereon and a ligament graft associated therewith. In particular, an increasing number of dots1076,1078,1080, and1082are provided for on a top surface1012to indicate the order of steps to be performed by the user to fold the card1000, add an implant, add a ligament graft, and store filaments associated with the implant on the card1000. As shown, the card1000has a body1002having a generally rectangular shape defined by a first end1004′, a second end1006, and opposed walls1008,1010extending between the two ends1004′,1006. The card1000has a central longitudinal axis L extending a length of the body1002, and also includes a top surface1012and a bottom surface1014(not shown). A pair of folds1025,1026are provided that extend substantially horizontal to the central longitudinal axis L, dividing the unfolded configuration into a first section1074a, a second section1074b, and a third section1074c. A first dot1076is provided proximate to an implantable body retainer1016″, which itself is located approximately centrally on the second section1074b. The implantable body retainer1016″ in the illustrated embodiment is configured differently than previously described implantable body retainers. As shown, the implantable body retainer1016″ is a single vertical slit that extends substantially in-line with the central longitudinal axis L. The first step indicated by the first dot1076can include passing an implant body through the slit of the implantable body retainer1016″, from the top side1012to the bottom side1014, while keeping at least a portion of the filament extending therefrom on the top side1012. The filament that forms the loops of the implant can extend from the implant body through a first bore1015″ formed at a terminal end of the vertical slit, and filament from adjustable limb(s), a leading suture, and a trailing suture can extend from the implant body through a second bore1017″ formed at an opposite terminal end of the vertical slit. This configuration can thus hold an implant in place on the card1000. In the illustrated embodiment, the second bore1017″ has a larger diameter than a diameter of the first bore1015″ because the second bore1017″ can be configured to hold a greater thickness of filament therein, although other sizes of bores can be used depending, at least in part, on the type, number, and thickness of the filaments associated with the implant. The location of the implant body once situated on the card1000can typically be such that the portion of the loop closest to the implant body is substantially aligned with the 0 millimeter indicia line to insure accurate markings on the device, ligament graft, and/or implant. In the illustrated embodiment, the indicia1034′ on the top surface1012extend diagonally with respect to the central longitudinal axis L. Additionally, as shown, an instructional marking of an image1064of a writing instrument is provided to illustrate that a user can use the indicia1034′ to mark indicators on any and all of the device itself, the implant, and the ligament graft. Two dots1078can be located on the second portion1074b, proximate to the fold1026. The two dots1078could just as easily be located on the third portion1074c, proximate to the fold1026. An arrow1084can be located next to the two dots1078, and can be configured to illustrate that the second step includes folding the third portion1074ctowards the bottom side1014, i.e., into the page in the illustrated embodiment. As a result, indicia1036on the third portion1074c, which as shown are substantially perpendicular to the longitudinal axis L, are disposed on the bottom surface1014for purposes as described elsewhere herein. The second end1006, which is part of the third portion1074c, can include a central flap1007having a rounded edge that is configured to be received by a receiving slit1038formed on the second portion1074b. Similar to other embodiments, the receiving slit1038can be disposed between a graft-receiving opening1032and the first end1004′. In this embodiment, the slit1038is actually located between the second bore1017″ and the second fold1025because the length of the third portion1074cis so long. The first fold1026can substantially bisect the graft-receiving opening1032, and thus folding the third portion1074conto the second portion1074bresults in an opening similar to the openings described in other embodiments herein. Unlike previously described embodiments, however, there are not two triangularly-shaped openings also bisected by the fold1026. Instead, opposed, matching openings1030′ formed equidistant from the central longitudinal axis L terminate at the fold1026such that when the third portion1074cis folded onto the second portion1074b, a portion of the third portion1074cobstructs the openings1030′ from the bottom side1014. Nevertheless, loops from an implant can still be disposed on the two prongs1024that are formed as a result of folding the third portion1074conto the second portion1074bat least because of the pliable nature of the card1000. The prongs1024can hold the loops in a tensioned state and the illustrated configuration allows the loops to receive a ligament graft disposed in the graft-receiving opening1032. Three dots1080can be located on the third portion1074c, adjacent to an arrow1062′ that points towards the graft-receiving opening1032. The three dots1080can indicate that the third step is to dispose a ligament graft through the graft-receiving opening1032, thus being received by loops of the implant being tensioned by the prongs1024. An image of a ligament graft1086can also be provided on the top surface1012to help illustrate the purpose of the arrow1062′. Filaments extending from a top side of an implant body, which can include adjustable limb(s), a leading suture, and a trailing suture, can be configured to extend from the implantable body retainer1016″ and towards the first portion1074a. The first portion1074acan include one or more filament retention features. As shown, filament retention features of the card1000include a centrally disposed slit1048and bore1050, as well as two opposed, substantially V-shaped cutouts1088formed in first and second walls1008,1010of the body1002. The filaments can be passed through the slit1048and a portion thereof can be held in the bore1050, and then a remaining portion of the filament can be wrapped around the two V-shaped cutouts1088in a direction substantially perpendicular to the central longitudinal axis L. Four dots1082can be located on the second portion1074b, proximate to the fold1025. The four dots1082could just as easily be located on the first portion1074a, proximate to the fold1025. An arrow1090can be located next to the four dots1082, and can be configured to illustrate that the fourth step includes folding the first portion1074atowards the bottom side1014, i.e., into the page in the illustrated embodiment. Alternatively, the first portion1074acould be folded towards the top side1012, i.e., out of the page in the illustrated embodiment. The first end1004′ can include a central flap1005′ having a rounded edge that is configured to be received by a second receiving slit1039′ formed on the second portion1074b. As shown, the second receiving slit1039′ can be proximate to the first receiving slit1038, although the location of both slits can be dependent on the size of the first and third portions1074a,1074cthat they are configured to receive. By folding over the first portion1074a, a portion of the filaments wrapped around the V-shaped cutouts1088can be protected from unintended fraying or cutting because a portion of the filaments is disposed between the two portions1074a,1074b. A centrally located diamond-shaped opening1092can be provided between the first and second portions1074a,1074b, which becomes a V-shaped opening when the first portion1074ais folded onto the second portion1074b. The diamond-shaped opening1092can help provide a desired amount of tension to the filaments as they are moved closer to the implant body when the first portion1074ais folded towards the second portion1074b. As a result, the filaments do not loosen undesirably and get in the way of the user during operation. A person skilled in the art will recognize that instructions of the nature described with respect to the card1000can be applied to devices and cards having a variety of configurations and a variety of different features, e.g., bores, openings, slits, tabs, without departing from the spirit of the present disclosure. Further, a person skilled in the art will recognize that the number, amount, and type of instructions can change depending, at least in part, on the configuration of the card and the type of procedure with which the card is being used, and thus instructions that include more, fewer, or different steps can be derived from the disclosures contained herein. The teachings of instructions provided for herein can easily be adapted for any and all of the device and card configurations disclosed herein, derivable therefrom, or for other configurations of implant management devices and cards known to those skilled in the art. FIG.12is another example of an implant management device1100in an unfolded configuration that can be folded to protect at least a portion of the implant. Protecting portions of the implant can be useful when packaging the implant and implant management device for distribution and sale, or alternatively, at the location of a surgical procedure prior to and during the procedure to prevent unintended fraying or cutting of filaments associated with the implant. As shown, the implant1100has a body1102having a generally rectangular shape defined by a first end1104, a second end1106, and opposed walls1108′,1110′ extending therebetween. The body1102includes two portions1102a′ and1102b′ divided by a fold1109′. As shown, the fold1109′ extends substantially parallel to the central longitudinal axis L, with the central longitudinal axis L in this embodiment being disposed centrally through the first portion1102a′. The second section1102b′ can be folded toward a bottom side1114(not shown) of the first section1102a′, i.e., into the page, such that filament wrapped around vertically-disposed filament retention tabs1144′,1146′ can be protected between the first and second sections1102a′,1102b′. First and second locking slits1194a,1194bcan be formed in the first and second walls1108′,1110′, respectively, to allow the second portion1102b′ to be secured to the first portion1102a′. As shown, the first locking slits1194aextend substantially perpendicularly to the central longitudinal axis L and the second locking slits1194bextend substantially diagonally with respect to the central longitudinal axis L. One of the portions1102a′,1102b′ can be twisted at the location of the slits1194a,1194bto allow one slit to engage the other, thereby forming a secure, interlocking connection. A person skilled in the art will recognize other ways by which a locking connection can be formed between two portions1102a′,1102b′. Additionally, the device1100can include some of the same features described in previous embodiments, including a filament loop engaging region1122, e.g., prongs1124, located at the second end1106, a graft-receiving opening1132, indicia1134located on a top surface1112of the body1102, and filament retention features, for example vertically-disposed filament retention tabs1144′,1146′ and bores1150a,1152aand slits1148a,1154a. The implant management device1200ofFIG.13provides yet another embodiment of a device that can be folded to protect at least a portion of the implant. The device1200as shown has a body1202having a generally rectangular shape defined by a first end1204, a second end1206, opposed walls1208,1210extending between the two ends1204,1206, a central longitudinal axis L extending a length of the body1202, and a top side or surface1212and a bottom side or surface1214(not shown). As shown, the body1202includes two portions1202a″ and1202b″ divided by a fold1226, and the fold1226extends substantially perpendicular to the central longitudinal axis L. The second section1202b″ can be folded toward the bottom side1214, i.e., into the page, such that the second end1206is located proximate to the first end1204. A first locking slit1294acan be formed in each of the first and second walls1208,1210of the first portion1202a″, and a second locking slit1294bcan also be formed in each of the first and second walls1208,1210of the second portion1202b″. The locking slits1294a,1294bcan operate in a manner similar to the locking slits1194a,1194bof the device1100, thereby forming a secure, interlocking connection between the first and second portions1202a″ and1202b″. As a result, any filament stored on the bottom side1214of the first portion1202a″ can be protected by the second portion1202b″. Features such as an implantable body retainer1216′, a graft-receiving opening1232, a filament loop engaging region1222that includes prongs1224and opposed openings1230, first and second indicia1234,1236, and instructional markings, such as an arrow1262′ and an image1286of a ligament graft, can be similar to those features previously described. The device1200also includes filament retention features. In the illustrated embodiment, the filament retention features include a centrally disposed slit1248terminating in a centrally disposed bore1250, and a second centrally disposed bore1251, proximate to the implantable body retainer1216′. As discussed in further detail below with respect toFIG.14B, the bore1251can be used in conjunction with a filament management device1400to help retain excess filament. The slit1248and bore1250can be used in a manner as described with respect to other embodiments to help retain and direct excess filament toward the filament retention feature resulting from using the bore1251in conjunction with the filament management device1400ofFIG.14B. In alternative embodiments, the excess filament can be retained only by slit1248and bore1250and/or excess filament can remain relatively free while being disposed between the first and second portions1202a″,1202b″. Although the illustrated embodiments of implant management devices are described as having a generally rectangular shape, a person skilled in the art will recognize other shapes that can be used to include the various device features provided for herein. Further, any and all of the implant management devices provided for herein can be made from a variety of different materials. In some exemplary embodiments, the devices are formed from a polymer, such as polyolefin or high density polyethylene because of its water-proof nature. Other non-limiting examples of materials that can be used to form implant management devices include metals, paper-based materials (e.g., paperboard, cardboard), and bio-compatible materials. Optionally, the device can be coated with one or more water-proof materials. One exemplary, non-limiting method for forming the implant management device is to die-cut a sheet of polyethylene. A weight of the implant management device itself can be approximately in the range of about 0.05 ounces to about 1.0 ounces. This amount of weight provides a desired amount of stability during the graft preparation stages. Further, a variety of different techniques and types of materials can be used to mark or otherwise provide indicia, instructions, or other markings on the implant management devices. By way of non-limiting examples, techniques for providing indicia, instructions, or other markings can include printing using ink, etching, embossing, and providing laser markings. For embodiments that include printing on the implant management devices, various inks, including waterproof inks such as Tampapur TPU 980 2-part epoxy ink from Marabu GmbH & Co. KG of Tamm, Germany, or other medical grade and/or bio-compatible inks can be used. Filament Management Devices FIG.14Aillustrates one exemplary embodiment of a filament management device1300that can be used in conjunction with the implant management devices provided for herein or otherwise known in the art. The device can be used to retain filament(s) extending from an implant, as well as to align terminal ends of the implant filament(s) so that the various filaments can be moved and/or trimmed to desired length(s). The filament management device1300ofFIG.14Ahas a body1302that is generally circular in shape and has a top surface1312and a bottom surface1314(not shown). The device1300can also include a slit1348extending from a perimeter of the body1302to a bore1350located at an approximate center of the circular body1302. Filament, such as the illustrated adjustable limbs1315a,1315b, limbs1316a,1316bof a leading suture1316, and limbs1318a,1318bof a trailing suture1318, can be passed through the slit1348and disposed in the bore1350. The filament management device1300can then be used to move and/or trim the limbs of the filaments to complementary lengths. Complementary lengths can mean equal lengths, or it can mean desired unequal lengths, depending, at least in part, on the filaments with which the filament management device is being used and the type of procedure in which the filaments are being used. For example, in an instance in which a user desires all of the filaments extending from an implant body to have equal lengths, the filaments can be tensioned and the device1300can be slid along a length of the filaments until the device1300is proximate to what would become the terminal ends of the filaments at the desired length. The filaments can then be trimmed to the desired length. In instances in which the device1300is used for trimming the lengths of filament, the device1300can be disassociated from the filament. Alternatively, the device1300can remain associated with the filaments to help manage them, for instance by making it easier to keep track of the various filaments and by preventing them from becoming tangled. In some embodiments, one or more instructional markings can be provided on at least one of the top or bottom surfaces1312,1314to inform a user that filaments associated with an implant can be disposed in the bore1350. For example, an illustration of the adjustable limbs1315a,1315b, the limbs1316a,1316bof the leading suture1316, and the limbs1318a,1318bof the trailing suture1318can be formed on the top surface1312. Filaments can be associated with the filament management device1300immediately prior to removing an implant from an implant management device. As a result, filament previously associated with filament retention features of the implant management devices can be held by the filament management device1300. This can prevent the filament from becoming tangled or damaged as the implant is moved from a location at which the ligament graft was being prepared, for instance a location of the graft preparation device, to a patient's body. The filament management device1300can then be disassociated from the filaments immediately prior to the filaments being disposed in the body. Alternatively, the filament management device1300can be used for a period of time while the implant is still associated with the implant management device. For example, a user may use the filament management device1300to form the complementary limb lengths while the implant is still coupled to or otherwise associated with the implant management device. The device1400illustrated inFIG.14Bprovides a different, non-limiting example of an alternative configuration of a filament management device. In one exemplary embodiment, the device1400can be used in conjunction with the implant management device1200. As shown, the device1400has a body1402that is generally circular in shape and has a top surface1412and a bottom surface1414(not shown). The device1400can also include a bore1450located at an approximate center of the circular body1402. The bore1450can be configured to mate with the bore1251of the implant management device1200such that the top surface1412is approximately parallel to the top surface1212. While a person having skill in the art will recognize a variety of components that can be used to mate the filament management device1400to the implant management device1200, in one exemplary embodiment a cylindrically-shaped grommet (not illustrated) can be disposed between the two devices1200,1400, with respective bores1251,1450of the devices1200,1400receiving opposed bases of the grommet. The bases of the grommet can be open or closed. The resulting configuration can resemble a spool, with the devices1200,1400serving as the ends of the spool and a cylindrical wall extending between the two bases of the grommet serving as the surface around which the excess filament(s) can be disposed. A second bore1452can also be formed through the body1402, a distance away from the center. A slit1454can extend from the perimeter of the circular body1402to the second bore1452, providing an access point to pass filament into the bore1452. The second bore1452can be used to help manage filament by making it easier to keep track of various filaments and by preventing filaments from becoming tangled. For example, terminal ends of filament that has been wrapped around a grommet extending between the implant management device1200and the filament management device1400can be disposed through the slit1454and into the bore1452. By having the second bore1452a distance away from the center, it can be easier to pass filaments into the bore1452and remove them from the bore1452than when a bore is centrally disposed because the filaments have a shorter distance to travel and thus have a decreased possibility of becoming caught in the slit1454as they travel therethrough. Similar to the device1300, in some embodiments, one or more markings can be made on one or both of the top and bottom surfaces1412,1414to indicate particular purposes of features of the device1400. The devices1300,1400can be sized and shaped to be complementary to the sizes and shapes of the implant management device and implant. Any of the materials suitable for forming the implant management devices are also suitable for forming the filament management devices1300,1400. A grommet used in conjunction with the device1400, or other component that serves a similar purpose as a grommet, can be made of any of the materials suitable for forming the implant management devices, including but not limited to a metal or plastic. Attaching Surgical Implant to Implant Management Device FIGS.15A-15Sillustrate one exemplary embodiment for placing an implant management device, as shown the device900ofFIG.10A, in a compact configuration. As shown inFIG.15A, the device900can come in a flat, die cut configuration having the indicia934,936formed on its top surface912and the graft-receiving opening932, opposed openings930, alignment opening940, and the plurality of bores950,954(FIG.15B) and slits938,948,954(FIG.15B),958,960that serve as filament retention features already formed therein. The implantable body retainer916, the fold926that is used to form the prongs924of the filament loop engaging region922, the horizontally-disposed filament retention tabs944,946, and the retention tab956can start in their unformed configurations. The second portion928can be folded toward the bottom surface914of the body902, as shown inFIG.15B, and the second end906can be disposed in the retention slit938, as shown inFIG.15C. The resulting configuration is shown inFIG.15D, in which the second portion928is held in place, adjacent to the bottom surface914, so that the indicia936on the second portion928are visible when viewing the bottom surface914. Additionally, the graft-receiving opening932and the opposed openings930form the prongs924of the filament loop engaging region922. They also form a new terminal end of the body902when in the compact configuration. As shown inFIG.15E, the opposed tabs918,920(920is hidden from view inFIG.15E) that form the implantable body retainer916can be flexed or folded so that they are no longer flush with a plane that extends substantially through the top surface912.FIG.15Eillustrates the tab918being flexed away from the body902, towards the top surface912(as opposed to towards the bottom surface914). The other tab920can be flexed in a similar manner, towards the top surface912. The horizontally-disposed filament retention tabs944,946can also be flexed or folded so that they are no longer flush with the plane that extends substantially through the top surface912. As shown inFIG.15F, the second tab946can be folded at a first fold946b, towards the top surface912(as opposed to towards the bottom surface914), so it is out of the aforementioned plane. The tab946can then be flexed back down toward the bottom surface914along the fold946bso that the tab946ends up being disposed below the bottom surface914. In alternative embodiments, the tab946can just be flexed down towards the bottom surface914. The second tab946can also be folded at a second fold946c, back towards the body902, as shown inFIG.15G. As a result, an end portion946eof the tab946can be substantially parallel to the aforementioned plane, as shown inFIG.15H.FIGS.15F-15Halso illustrate that these same flexing or folding maneuvers were applied to the first tab944. The retention tab956disposed in the first wall908can also be flexed or folded so it is configured to be at least partially disposed around filament.FIG.15Iillustrates that the tab956can be folded along a more centrally disposed fold956c, towards the top surface912. Then the tab956can be folded along a second fold956b, back towards the body902, as shown inFIG.15J. This results in the formation of a sleeve in which filament can be disposed, as described in greater detail herein. After all of the folding and flexing is completed, the implant management device900can look like the device as illustrated inFIG.15K. A person skilled in the art will recognize that the various steps leading up to this configuration can generally be performed in any order without departing from the spirit of the present disclosure. Accordingly, by way of non-limiting example, the horizontally-disposed retention tabs944,946can be formed after the retention tab956, or alternatively, before the second portion928is folded towards the bottom surface914. FIG.15Lillustrates one option for a beginning step to associate the implant10ofFIG.1Awith the implant management device900. As shown, the loops14are disposed around the prongs924and the remaining portion of the implant10is moved toward the first end904. It can be helpful to keep all of the loops14aligned so that they are not twisted or crossed, and so that each frames the graft-receiving opening932, as more clearly illustrated inFIG.15M. FIG.15Malso illustrates the implant body12being associated with the tabs918,920of the implantable body retainer916. The tab916that is more proximate to the 0 millimeter indicia line can be flexed towards the second wall910to allow the body12to pass under it, and then it can be flexed back towards the body902to help secure one end of the body12to the device900. The other tab920can then be flexed towards the first wall908, and subsequently back towards the body902after the body12is disposed thereunder, to help secure the other end of the body12to the device900. The terminal end of the body12associated with the more proximate tab918can typically be located approximately at the 0 millimeter indicia line to help insure accurate usage, such as when a user is making markings on the top surface912or the loops14. As shown inFIG.15N, the filaments extending from the top side12tof the body12, i.e., the adjustable limbs15a,15b, the leading suture16, and the trailing suture18, can be pulled tight to confirm secure placement of the implant body12with respect to the device900. After the body12is secured by the implantable body retainer916, the adjustable limbs15a,15b, leading suture16, and trailing suture18can be inserted through the central slit948and disposed in the bore950at which the slit948terminates, as shown inFIG.15O. A tension can be applied to each of the limbs15a,15band sutures16,18to insure that loose filament does not interfere with viewing the top surface912and implant10. While maintaining the tension, as shown inFIG.15P, the limbs15a,15band sutures16,18can be wrapped around the horizontally-disposed filament retention tabs944,946. More particularly, the limbs15a,15band sutures16,18can be wrapped around receiving regions944r,946rof the tabs944,946until the remaining portions of limbs15a,15band sutures16,18are at desired lengths.FIG.15Qillustrates one example of limbs15a,15band sutures16,18at desired lengths, in which the remaining portions of the filaments15a,15b,16,18can be retained by the other filament retention features, but is not so much that excess filament will get in the way of the user. In one exemplary embodiment, the filaments15a,15b,16,18are wrapped around the tabs944,946for approximately three full rotations before the remaining portions are directed to additional filament retention features. As shown inFIG.15R, the limbs15a,15band sutures16,18can be moved towards the slit954formed in the first wall908. The limbs15a,15band sutures16,18can be passed through the slit954and enter the bore952to be retained therein. The excess portions of the limbs15a,15band sutures16,18can then be advanced towards the retention tab956. As shown inFIG.15S, the retention tab956can engage the limbs15a,15band sutures16,18to secure their location along the edge of the body902. Excess portions of the limbs15a,15band sutures16,18can extend from the retention tab956, towards the filament loop engaging region922, although it can be preferable that this amount not be enough so as to interfere with the user's vision of the top surface912or with preparation steps performed leading up to a surgical procedure. The method described with respect toFIGS.15A-15Scan be performed by a user on location, e.g., a surgery room, or alternatively, the implant10can be associated with the implant management device900at a manufacturing facility prior to shipping and packaging the combination of the device900and implant10. Further, a person having skill in the art will recognize a variety of other ways by which an implant can be associated with an implant management device in view of the disclosures provided for herein, depending, at least in part, on the configurations of the implant management device and the implant, and the type of procedure with which the device and implant are being used. Graft Preparation Device Once an implant is coupled to the implant management device, the device can be used in conjunction with a graft preparation device or board to assist in making measurements. Graft preparation devices are generally known to those skilled in the art, and thus only a general description of such a device is provided for herein. As illustrated inFIG.16, a graft preparation device2000can include a platform2002having a first retention element2004and an opposed second retention element2006extending from the platform2002. The retention elements2004,2006can generally be configured to grasp opposed terminal ends3000a,300bof a ligament graft3000. In the illustrated embodiment, the retention elements2004,2006include jaws2008,2010and2012,2014, respectively, for grasping the terminal ends3000a,3000bof the ligament graft3000, although a variety of other techniques can be used to secure a location of the ligament graft3000with respect to the preparation device2000. A tensioning element2016can be in mechanical cooperation with the first retention element2004and it can be operable to supply tension to the ligament graft by linearly displacing the first grasping element2004along a length of the platform2002. As shown, a sliding threaded shaft2018can extend between the tensioning element2016and the first retention element2004to assist in the linear displacement. Indicia2020can be provided on the platform2002to help read the length of the ligament graft, or to make markings or indicators on the ligament graft. Further details about graft preparation devices are provided in U.S. Pat. No. 6,796,977 of Yap et al., the content of which is incorporated by reference herein in its entirety. FIGS.17A and17Billustrate an alternative embodiment of a graft preparation device or board2000′ being used in conjunction with the implant management device900and implant10ofFIG.15S. The graft preparation device2000′ can include a platform2002′ and first and second retention elements2004′,2006′ extending therefrom. As shown, the first retention element2004′ includes jaws2008′,2010′ for grasping a ligament graft3000′, and the second retention element2006′ includes a post2022′ configured to receive the alignment opening940of the implant management device900. The ligament graft3000′, which as shown is disposed through the graft-receiving opening932and is thus coupled to the loops14, can extend from the implant management device900and towards the first retention element2004′. In the illustrated embodiment, the ligament graft3000′ is not long enough to reach first retention element2004′, and thus one or more free limbs of suture3002′ can be whip-stitched onto both terminal ends3000a′,3000b′ of the ligament graft3000′. The suture3002′ can then be wrapped around the first retention element2004′ to secure the suture3002′ with respect to the first retention element2004′ and apply tension to the ligament graft3000′. As tension is supplied by a tensioning element2016′ to the first retention element2004′, via a sliding thread shaft2018′, the tension translates through the suture3002′ and to the ligament graft3000′. As the ligament graft3000′ is moved away from the post2022′, tension in the ligament graft3000′ increases. A person skilled in the art will recognize a variety of other ways by which the implant device900, and the ligament graft3000′, can be associated with graft preparation devices to supply the desired tension. As shown inFIG.17B, because of the configuration of the implant management device900, and in particular the indicia934,936provided for on the top surface912, when the desired tension is supplied to the ligament graft3000′, markings or indicators can be made on the device900, the implant10, e.g., the loops14, and/or the ligament graft3000′ without relying on a separate measurement instrument, such as a ruler or indicia formed on a graft preparation device. The indicators can then be used by a surgeon during a surgical procedure to provide valuable feedback about the location of the implant10, and graft3000′. The second portion928of the device900can actually be returned to the unfolded configuration so that measurements related to the ligament graft3000′ can be made, as shown. A person skilled in the art will recognize that a variety of measurements and related indicators can be made using this set-up, depending, at least in part, on the devices being used and the type of procedure being performed. By way of non-limiting example, in some surgical procedures, such as an ACL repair, a tunnel can be formed having two different diameters. The implant10can be configured to have a final implant location in the tunnel with the smaller diameter while the ligament graft3000′ can have a final implant location in the tunnel having a larger diameter. The user can measure the depths of the tunnel and use the indicia934,936to mark the loops14and ligament graft3000′ so that the user knows when the implant10and the ligament graft3000′ are at desired locations. A working example of the types of measurements that can be made during an ACL repair are provided below with respect toFIGS.18A-18F. ACL Repair Using Indicators Made on Implant and Ligament Graft As illustrated inFIG.18A, a knee4000can be prepared for an ACL repair procedure by forming the necessary tunnels4020,4022in the femur4002and tibia4004. Techniques known to those skilled in the art can be used to form these tunnels. The femoral tunnel4022can include both a main channel4024and a passing channel4026, with the passing channel4026having a smaller diameter than the main channel4024. The tibial tunnel4020can be situated such that components passed from the tibial tunnel4020can easily pass through joint space4006between the tibia4004and femur4002and into the main channel4024of the femoral tunnel4022. The depths of the various tunnels can be measured and those measurements can be indicated by making markings or indicators on any of the implant management device, implant10, and ligament graft3000′. In some embodiments, marking the indicators on the device, implant, and ligament graft can occur in conjunction with, i.e., simultaneously with, the tunnel formation in the bone. This can eliminate separate bone tunnel measuring. Further, if a first person forms the bone tunnel while a second person makes the markings or indicators indicative of the bone tunnel depths at the same time, it can make for a more accurate and efficient process than previous surgical procedures. The implant10, device900, and ligament graft3000′ can be prepared in advance of marking indicators on at least one of these components. While some of the specifics of the preparation steps are discussed above with respect toFIGS.15A-15SandFIGS.17A-17B, generally the implant can be coupled to the device900if it did not already come pre-packaged as such and the ligament graft3000′ can be prepared for coupling to loops14of the implant. The ligament graft3000′ can be cleaned by removing any excess tissue, and then the free limbs of suture3002′ can be whip-stitched on both terminal ends3000a′,3000b′ of the ligament graft3000′. The ligament graft3000′ can be passed through the graft-receiving opening such that an approximate center portion of the ligament graft3000′ engages the implant filament loops14and the terminal ends3000a′,3000b′ are on opposite sides of the loops14, approximately adjacent to each other. The free limbs of suture3002′ can then be coupled to the first retention element2004′, and the post2022′ can engage the alignment opening940of the device900. Tension can be applied to the free limbs of suture3002′ to position the device900, implant10, and ligament graft3000′ in a suitable position for marking. In one exemplary embodiment, a full depth of the femoral tunnel4022can be marked on the loops14of the implant10. This measurement can sometimes be referred to as a total bone stock depth. In such an embodiment, if the depth of the femoral tunnel4022is 40 millimeters, then a user can place one or more indicators14don the loops14, for instance on both a first side14fand a second side14gof the loops14as shown inFIG.18B, 40 millimeters away from the implant body12. By keeping the implant10on the device900, a user can rely on the indicia934disposed between the implantable body retainer916and the prongs924to mark the indicators14don the loops14. The surgeon can then rely on the indicators14dduring the procedure, as discussed in greater detail below. Further, a depth of just the main channel4022can be marked on the ligament graft3000′. This measurement can sometimes be referred to as a graft-in-tunnel depth. In such an embodiment, if the depth of the main channel4022is 25 millimeters, then a user can place one or more markings or indicators3000d′ on the ligament graft3000′, for instance on both a first side3000fand a second side3000g′ of the ligament graft3000′ as shown inFIG.18B, 25 millimeters away from the location at which the ligament graft3000′ is in contact with loops14of the implant10. By keeping the implant10on the device900, a user can rely on the indicia936disposed on the second portion928to mark indicators3000d′ on the graft3000′. The surgeon can then rely on the indicators3000d′ during the procedure, as discussed in greater detail below. After the indicators14d,3000d′ have been made on the implant14and the ligament graft3000′, the implant10can be decoupled or otherwise disassociated from the implant management device900. In some procedures, the implant10can be removed from the device900in the opposite order by which the implant10was originally associated with the device900. Thus, the adjustable limbs15a,15b, leading suture16, and trailing suture18can be pulled out of the retention tab956and bore952and slit954, and then unwound from the horizontally-disposed filament retention tabs944,946. The limbs15a,15band sutures16,18can then be pulled out of the bore950and slit948, the implant body12can be removed from the implantable body retainer916, and the loops14can be pulled away from the prongs924. The resulting configuration of the implant10disassociated from the device900is illustrated inFIG.18B. As shown, the ligament graft3000′ is disposed within the loops14, and the ligament graft indicators3000d′ are formed on the first and second sides3000f,3000g′ of the ligament graft3000′ and the loop indicators14dare formed on the first and second sides14f,14gof the loop14. The implant10further includes limbs16a,16bof the leading suture16, limbs18a,18bof the trailing suture18, and the adjustable limbs15a,15bthat can collapse the loop14, which as shown can extend into the receiving portions17a,17bof the leading suture limbs16a,16b. Further, the free limbs of suture3002′ are associated with the terminal ends3002a′,3002b′ of the ligament graft3000′ to help apply tension to, and otherwise control, the ligament graft3000′ when using the graft preparation device and during the surgical procedure. As shown inFIG.18C, a passing loop suture or shuttle suture3004′ can be used to help initially pull the implant10through the tibial and femoral tunnels4020,4022. Passing loop sutures or shuttle sutures are known to those skilled in the art, but in the illustrated embodiment, it includes a first end3004a′ having a loop3006′ formed therein for receiving filaments and a second end3004b′ that is a limb3008′ that can be grasped by a surgeon to move the loop3006′. A portion of each of the leading suture16, the trailing suture18, and the adjustable limbs15a,15bcan be inserted through the loop3006′, and then travel with the passing loop suture3004′ as it passes from the tibial tunnel4020, through the joint space4006, and into and through the femoral tunnel4022. In some embodiments, approximately no more than about 7 centimeters to about 10 centimeters of each of the leading suture16, trailing suture18, and adjustable limbs15a,15bshould be passed through the tunnels4020,4022with the passing loop suture3004′ so that the filaments15a,15b,16,18do not get caught in the tunnels4020,4022. Once the implant body12is in the joint space4006, a portion of each of the leading suture16, the trailing suture18, and the adjustable limbs15a,15bcan be disposed through the femoral tunnel4022so that they can be grasped by a surgeon outside of the tunnel4022. The implant body12can be viewed in the joint space4006using a number of techniques known to those skilled in the art, but in some embodiments a surgeon can insert an endoscope or other viewing device into the joint space4006. The implant body12can then be pulled into the femoral tunnel4022by applying a majority of the tension to the leading suture16. At the same time, it can be helpful to maintain adequate tension on the trailing suture18, as well as the adjustable limbs15a,15bto the extent they are not being tensioned by the tension applied to the leading suture16, such that the trailing suture18and adjustable limbs15a,15bare at least taut. Further, tension can also be applied to the ligament graft3000′ that extends through the tibial tunnel4020, or to the free limbs of suture3002′ associated therewith, the tension being applied in a direction M, moving away from the femoral tunnel4022and toward the tibial tunnel4020. The direction M is illustrated inFIG.18D, which is described in further detail below. As the implant body12is pulled through the femoral tunnel4022, it can be helpful to know once the implant body12has passed through the entirety of the tunnel, including through the passing channel4026, so the surgeon can know that the body12is in a position to be flipped or otherwise situated against the femoral cortex4008to set the implanted location of the body12. It may not be easy for a surgeon to know that the implant body12has exited the passing channel because resistance provided by tissue and other body parts surrounding the femoral cortex4008can be similar to the resistance that existed when the implant was disposed in the femoral tunnel4022. Further, it can be more difficult to dispose a viewing device such as an endoscope near the femoral cortex4008, as opposed to the joint space4006, because of the tissue and other components proximate to the femoral cortex4008. Thus, without knowing if the implant has exited the femoral tunnel4022, a surgeon may continue to try and pull the implant body12through the femoral tunnel4022, only to discover that he or she is actually pulling the implant body12through tissue or other portions of the body, and in turn damaging the implant, the graft, and/or the tissue or other portions of the body. The indicators14don the loops14, however, can remedy the problem of not knowing when the implant has excited the femoral tunnel4022. Using the endoscope or other viewing device disposed in the joint space4006, the surgeon can view the entrance to the main channel4024to observe a location of the indicators14dwith respect to the main channel4024. When the indicators14dare no longer visible in the joint space4006because they are disposed in the main channel4024, the surgeon knows that the implant body10has exited the passing channel4026because the location of the indicators14dis representative of the length of the femoral tunnel4022. The surgeon then knows that he or she can flip or otherwise situate the implant body12against the femoral cortex4008. While a variety of techniques known to those skilled in the art can be used to flip or reorient the body12against the femoral cortex4008, in the illustrated embodiment ofFIG.18D, the leading and trailing sutures16,18are manipulated such that a bottom surface12cof the implant body12rests against the cortex4008. Alternatively, or additionally, a force can be selectively applied to the ligament graft3000′ in an approximate direction M to tension the ligament graft3000′ and help manipulate the body12into the desired position by “flipping” it. Once the surgeon has oriented the implant body12as desired, the surgeon can confirm its location as lying flat on the femoral cortex4008, directly adjacent to the femoral tunnel4022, using a variety of techniques, including by using tactile feedback received from pulling the leading and trailing sutures16,18and the ligament graft3000′, and/or using visual aids. Once the body12is disposed at its desired location, tension can be applied in a direction N to the adjustable limbs15a,15bto decrease the circumference of the loops14, thereby drawing the ligament graft3000′ associated therewith further into the main channel4024. The tension can be applied in a variety of manners, including simply by pulling in the direction N. In some embodiments, as shown inFIG.18E, the adjustable limbs15a,15bcan be wrapped around an object, as shown a tool3010′, to assist with achieving the desired tension. Downward tension in the direction M on the ligament graft3000′ can also be applied while applying tension to the adjustable limbs15a,15bso that the ligament graft3000′ and free limbs of suture3002′ associated therewith are not jerked too quickly in the direction N. As the ligament graft3000′ is advanced through the main channel4024and toward the passing channel426, it can be helpful to know once the ligament graft3000′ is disposed directly adjacent to the passing channel4026. Otherwise, the surgeon may continue to try and pull the ligament graft3000′ through the passing channel4026even though the passing channel4026is not generally configured to have a ligament graft disposed therein. Trying to pull the ligament graft3000′ into the passing channel4026can cause undesirable harm to the implant10, the ligament graft3000′, and/or the knee4000. The indicators3000d′ on the ligament graft3000′, however, can remedy the problem of not knowing when the ligament graft3000′ is directly adjacent to the passing channel4026. Again using the endoscope or other viewing device disposed in the joint space4006, the surgeon can view the entrance to the main channel4024to observe a location of the indicators3000d′ with respect to the main channel4024. When the3000d′ are no long visible in the joint space4006because they are disposed in the main channel4024, the surgeon knows that the ligament graft3000′ is located directly adjacent to the passing channel4026because the location of the indicators3000d′ is representative of the length of the main channel4024. The surgeon thus knows that the ligament graft3000′ does not need to be pulled any further through the femoral tunnel4022, otherwise it may be undesirably pulled into the passing channel4026. The configuration that results from the body12being disposed on the femoral cortex4008and the ligament graft3000′ being disposed directly adjacent to the passing channel4026is illustrated inFIG.18F. Once the implant10and ligament graft3000′ are secure, the knee4000can be cycled as desired to remove excess laxity from the system. Subsequently, the adjustable limbs15a,15bcan be re-tensioned to insure the desired location of the ligament graft3000′. Tibial fixation can then be commenced, using techniques known to those skilled in the art. Further, the adjustable limbs15a,15bcan be trimmed so that there are not excess limbs disposed at the surgical site. The limbs15a,15bshould generally be trimmed in a manner that does not sacrifice the integrity of the loops14and their connection to the implant body12, which is aided by the limbs15a,15bbeing disposed in the receiving portions17a,17bof the leading suture16. Further, both the leading and trailing sutures16,18can be disassociated from the implant body12after the body is desirably positioned. They can be removed either by pulling them out or by cutting and pulling them out, depending on the manner in which they are initially associated with the implant body12. MPFL Repair FIGS.19A and19Billustrate portions of an MPFL repair procedure that can be performed in view of the disclosures provided for herein. As shown inFIG.19A, a femoral bone tunnel5022can be formed in the femur5002, with the tunnel5022including both a main channel5024and a passing channel5026, the passing channel5026having a smaller diameter than the main channel5024. An implant, implant management device, and ligament graft can be prepared in manners as described earlier, and they can be inserted into the tunnel5022using techniques described herein or otherwise known to those skilled in the art. In one exemplary embodiment, an implant10″ and ligament graft3000′ are passed into, and for some portions thereof, through the main channel5024and the passing channel5026using techniques described with respect toFIGS.18A-18F. The implant10″ can have previously been associated with any of the embodiments of a surgical implant management device as described herein or derivable therefrom, including the device900. A configuration that results during a portion of the procedure described above with respect toFIGS.18A-18Fis provided inFIG.19B, in which a body12″ of the implant10″ rests against the femoral cortex5008, adjacent to an opening in the passing channel5026, the loops14″ being disposed substantially in the passing channel5026, and the graft3000′ being disposed in the main channel5024. As shown, the free limbs of suture3002′ are associated with the graft3000′ on one side of the knee5000, and a limbs15″ and sutures16″,18″ are associated with the implant body12″ on the other side of the knee4000, although at least any of the free limbs of suture3002′ and sutures16″,18″ can be disassociated with the respective graft3000′ and implant body12″ to complete the implant procedure. In the illustrated embodiment, the implant10″ includes a single adjustable limb15″ associated with the loops14″ to adjust a diameter of the loops14″, the leading suture16″ includes a single limb extending from the body12″ to help guide the body12″ through the femoral tunnel5022, and the trailing suture18″ includes two limbs to also assist in guiding and placing the body12″ during the procedure. Thus, this implant10″ represents another, non-limiting example of an implant for use in conjunction with the disclosures herein. In the illustrated embodiment, the adjustable limb15″ and leading suture16″ can be disassociated from the body12″ by cutting or trimming them to a desired length, and the trailing suture18″ can be disassociated with the body12″ entirely. In other embodiments, the leading suture16″ can also be completely disassociated from the body12″ and/or the trailing suture18″ can also include a single limb. The ACL and MPFL repair methods provided for herein are just two examples of surgical procedures that can be performed using the implant management device900and implant10provided for herein. A person skilled in the art will recognize a variety of other surgical procedures, including variations on cruciate and collateral ligament repairs, with which the implant management device900and/or the implant10, and the other implant management devices and implants provided for herein or otherwise known to those skilled in the art, can be used without departing from the spirit of the present disclosure. Some, non-limiting exemplary embodiments of methods for using implants of the nature provided for herein are disclosed in U.S. Pat. No. 9,974,643 and U.S. patent application Ser. No. 10/405,968, the contents of each which have already been incorporated by reference in their entireties. Still further, a person skilled in the art will recognize that many other approaches can be taken for making particular markings or indicators on any of the implant management device, implant, and ligament graft without departing from the spirit of the present disclosure. By way of non-limiting example, instead of the indicators on the ligament graft being made such that their disappearance from view indicates that the ligament graft has reached the desired location, the indicators can instead be configured such that their appearance into a view indicates that the ligament graft has reached the desired location. In such an instance, rather than marking the depth of the main channel on the ligament graft, instead the depth of the main channel plus the distance extending between the femoral tunnel and the tibial tunnel can be marked on the ligament graft. Then, once the indicators exit the tibial tunnel and are visible in the joint space, the surgeon will know that the ligament graft is at the desired location. In still further embodiments, the indicators can be made such that they are still indicative of desired locations, but are visible outside of the knee, and thus not in the joint space. A variety of other indicator configurations can be derived from the disclosures provided for herein without departing from the spirit of the present disclosure. One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. For example, although the embodiments of an implant management device provided for herein are configured for use with an implant having a cortical button, the various devices, and features thereof, can be adapted for use with other types of implants, such as all different types of suture anchors. Likewise, the present disclosure provides a few variations of a particular feature, e.g., an implantable body retainer, but a person skilled in the art will recognize other configurations that can achieve similar results. Thus, by way of non-limiting example, other configurations for maintaining a location of an implant body on a device, e.g., sutures to hold the body on the device, can be utilized without departing from the spirit of the present disclosure. Still further, while various features described herein are provided for at particular locations, a person skilled in the art will recognize that in many instances those features can be located elsewhere on the device without negatively impacting the performance of the device. For example, some of the slits and bores used for filament retention can be disposed in alternate locations. All publications and references cited herein are expressly incorporated herein by reference in their entirety. | 119,493 |
11857409 | DETAILED DESCRIPTION Aspects of the present disclosure are described in greater detail below. The terms and definitions as used and clarified herein are intended to represent the meaning within the present disclosure. The terms and definitions provided herein control, if in conflict with terms and/or definitions incorporated by reference. The singular forms “a,” “an,” and “the” include plural reference unless the context dictates otherwise. The terms “approximately” and “about” refer to being nearly the same as a referenced number or value. As used herein, the terms “approximately” and “about” generally should be understood to encompass ±5% of a specified amount or value. As used herein, the term “posterior” refers to the backside of a patient, and the term “anterior” refers to front of a patient. Thus, the posterior side of a breast implant is the side of the implant facing the chest wall, while the anterior side is the opposite side closest to the skin. Similarly, the posterior side of a gluteal or buttock implant is the side closest to the skin, and the anterior side is the opposite side facing the pelvis. As used herein, the term “proximal” refers to a direction or location closer to a patient (e.g., the posterior side of a breast implant closest to the chest wall), whereas the term “distal” refers to a direction or location farther from the patient (e.g., the anterior surface of a breast implant closest to the skin). The present disclosure generally relates to medical implants, their features, and methods of producing and customizing such implants. Various aspects of the present disclosure may be used with and/or include one or more features disclosed in U.S. Provisional Application No. 62/313,218, entitled “Sensors for Implantable Medical Devices and Methods of Use Thereof,” filed on Mar. 25, 2016; U.S. Provisional Application No. 62/318,402, entitled “Medical Imaging Systems, Devices, and Methods,” filed on Apr. 5, 2016; U.S. Provisional Application No. 62/323,160, entitled “Minimally-Invasive Apparatus for the Implantation of Medical Devices and Methods of Use Thereof,” filed on Apr. 15, 2016; U.S. Provisional Application No. 62/334,667, entitled “Implant Surface Technologies and Elements of Formation,” filed on May 11, 2016; U.S. Application Publication No. 2015/0282926; U.S. Application Publication No. 2014/0081398; and/or U.S. Application Publication No. 2014/0078013. Implantable medical devices having a substantially uniform or otherwise controlled surface topography and materials suitable for such devices are disclosed herein. For example, the implant surfaces disclosed herein may exhibit a consistent texture on at least a portion or all outer surfaces/sides of the implant. In some aspects, the implants disclosed herein may include uniform surface features on the order of nanometers to micrometers. Further disclosed herein are implants comprising portions with different surface textures or roughness characteristics. The implants herein may include one or more features or properties to assist in biocompatibility, fixation, positioning, tracking, and/or identification. Also disclosed herein are processes to manufacture such implants. Although aspects of the present disclosure may be described in the context of a given type of medical implant, such as, for example, a breast prosthesis, embodiments of the present disclosure may be, and/or may be applied to, a variety of medical implants and instruments. Non-limiting examples include, e.g., coatings for electro-stimulation implants (e.g., pacemakers, spinal cord stimulators), drug delivery reservoirs, catheters, indwelling catheters, injection ports, drug delivery ports, inner and/or outer surfaces of gastric balloons, gastric bands, body contour implants such as gluteal, calf, testicular, and penile implants, etc. Medical implants may be described or characterized by various parameters. For example, the surface of an implantable medical device may have a specified texture, hydrophobicity or hydrophilicity, and elasticity, among other physical and chemical properties. With respect to texture, for example, surface topography may be described by roughness, kurtosis, and/or skewness values, e.g., based on the shapes, sizes, and/or distribution of topographical projections (peaks) and recesses (valleys), discussed below According to some aspects of the present disclosure, it may be desirable to provide the outer surface of an implant with controlled physical and/or chemical characteristics, e.g., to assist in patient safety and/or comfort. Implants having controlled surface features may improve implant biocompatibility, and therefore improve clinical outcomes. Without intending to be bound by theory, it is believed that the implant surfaces prepared according to the present disclosure may help to reduce adverse physiological reactions, including cellular responses such as fibroblast activity, and/or may reduce immune response to implants that may lead to the formation of reactive tissue capsules around the implant (e.g., capsular contracture). According to further aspects of the present disclosure, methods of manufacturing implant surfaces with consistent, controlled physical and/or chemical characteristics may be desired, e.g., to allow for reproducibility in implant manufacturing, and predictability and uniformity in implant surface characteristics. Moreover, the methods herein may produce implant surfaces with controlled physical and/or chemical characteristics, while also minimizing or eliminating extraneous particulate matter or other debris on the implant surfaces. This lack of debris on the surface may, for example, reduce or avoid irritation of patient tissue associated with the debris. Without intending to be bound by theory, it is believed that methods of preparing implant surfaces disclosed herein may allow for consistent, reproducible implants and implant surfaces having controlled physical and/or chemical properties, and may result in implant surfaces carrying little or no debris, such as salt particles or other abrasive particulate matter used in other surface texturizing methods. Further, for example, the implants having the physical and/or chemical surface characteristics disclosed herein may provide benefits in biocompatibility of the implants, leading to more stable thin capsules around the implants and/or less foreign body reaction. FIGS.1A and1Bdepict views of an exemplary implant100, which may embody one or more aspects of the disclosure herein.FIG.1Adepicts a cross-sectional side view of implant100. Implant100may have a shell102that encloses or surrounds a filling114. Shell102may comprise a single-layer or may be multi-layered. As shown, for example, shell102may have an outer surface104and an inner surface106. When the shell102comprises multiple layers, the shell102may include one or more layers108between the inner and outer surfaces104,106. Shell102may have a proximal or posterior side110, which may comprise a patch112useful for introducing the filling114into the implant100. Implant100may have a variety of shapes and sizes suitable for implantation in the body. For example, implant100may be a breast implant having a size and shape suitable for implantation during a breast augmentation or reconstruction surgery. Shell102of implant100may be a single or multi-layered shell, made of one or more biocompatible materials suitable for the implant. For example, shell102may comprise a series of successive layers of silicone, which may be cross-linked or otherwise attached together. One or more layers of shell102may comprise, for example, one or more siloxane polymer elastomers. When the shell102comprises multiple layers, each layer may have the same or different compositions and/or elasticity characteristics. For example, polymer or copolymer dispersions with different viscosities may be used to prepare the layers of a multilayered shell102. Patch112of posterior side110may be a single or multilayered patch of a biocompatible material. For example, patch112may comprise silicone. In some embodiments, patch112may be contiguous with shell102. In further embodiments, patch112may be a single- or multi-layered patch (e.g., made of layers of a silicone dispersion) constructed separately from shell102, and affixed to shell102via, for example, adhesion or vulcanization of patch112to implant100. In some embodiments, patch112may cover an aperture in shell102. In some embodiments, patch112may comprise a material or texture that is different from the texture of shell102. In further embodiments, patch112may not be located on posterior side110, and may instead be located on another side of implant100. In yet further embodiments, implant100may not have a patch112. The filling114of implant100may comprise any material or combination of materials suitable for an implant. For example, in a breast prosthesis, filling114may comprise a biocompatible liquid or gel filler material, such as a saline liquid or a silicone gel. Reference will now be made to characteristics of surfaces of implants according to the present disclosure. While certain principles or features are described in the context of implant100as an example, the present disclosure is not limited to implants of the type illustrated inFIGS.1A-1B. The concepts disclosed herein may be used for any suitable medical implants. Implant surface texture may be at least partially characterized by deviations in the surface from a hypothetical, perfectly flat surface. Such deviations may be on a macro level, e.g., visible to the naked eye, and/or on a microscopic level, e.g., via a suitable analytical technique. Surface texture implicates a combination of features and materials that may contribute to the visual and/or tactile properties of a surface. As such, surface texture may be characterized by one or several parameters or dimensions such as roughness, skewness, kurtosis, peak and valley heights/depths, and/or the number of peaks per unit area. “Roughness” in the present disclosure generally refers to the coarseness or unevenness of a surface, e.g., from projections/peaks, recesses/valleys, irregularities, and/or breaks in the surface. Roughness may be characterized, for example, by peaks and valleys that provide for a textured surface. If such variations in a surface are relatively large, then the surface may be characterized as “rougher” than a surface in which such variations are relatively small. Roughness of a surface may be described mathematically by an average roughness value Raand/or average root mean square roughness value Rq: Ra=1l∫0l❘"\[LeftBracketingBar]"z(x)❘"\[RightBracketingBar]"dxEquation1Rq=1l∫0l(z(x))2¯dxEquation2 where l is the surface length and z(x) is the surface profile along the x-axis. In three dimensions, the average roughness value Saand average root mean square roughness value Sqmay be determined as follows: Sa=1A∫∫A❘"\[LeftBracketingBar]"z(x,y)❘"\[RightBracketingBar]"dxdyEquation3Sq=1A∫∫A(z(x,y))2dxdyEquation4 where A is the surface area and z(x,y) is the surface profile along the x-axis and y-axis. Roughness of a surface may be measured by, for example, using a profilometer, such as an optical 3D microscope, a contact profilometer, or a non-contact profilometer. The measurements may provide a two-dimensional and/or three-dimensional profile of the surface from which roughness may be quantified. Kurtosis generally refers to a numerical characterization of the sharpness of the distribution of peak heights and valley depths of a surface, relative to a mean line of the surface. The kurtosis value of a surface may be calculated based on the measured surface roughness, e.g., via a profilometer. Kurtosis in two dimensions (Rku) and three dimensions (Sku) may be determined mathematically as follows: Rku=1Rq4(1l∫l0(z(x))4dx)Equation5Sku=1Sq4(1A∫∫A(z(x,y))4dxdy)Equation6 FIG.2depicts three exemplary curves to illustrate the kurtosis values of three different surfaces. If the surface heights and depths of peaks and valleys, respectively, of a textured surface are normally distributed (e.g., forming the shape of a bell such as curve204), then the kurtosis value is 3 or close to 3. A kurtosis value of 3 describes a surface having a Gaussian distribution of peak heights and valley depths. A textured surface having peaks and valleys that exhibit more deviations from the surface's mean peak heights and valley depths may generally have a kurtosis value less than 3, as represented by curve206. For example, a textured surface having few, varied peaks and/or the appearance of a series of rolling hills (e.g., a “bumpy” surface profile), may have a kurtosis value less than 3. A textured surface having more centrally distributed peak heights and valley depths, i.e., less variation and more uniformity in peak heights and valley depths, as represented by curve202, may have a kurtosis value that is greater or considerably greater than 3. Within the context of this disclosure, the term “kurtosis” refers to the kurtosis value normalized about 3, in which a value of 3 indicates a surface having a Gaussian distribution of peak heights and valley depths. Kurtosis values may be adjusted in some cases (e.g., by certain instruments used to measure surface characteristics) so that a value of 0 describes a normal distribution of peak heights and valley depths, instead of a value of 3. This may be done by calculating the kurtosis value (e.g., using Equation 5 or Equation 6), and then subtracting 3 in order to normalize the value about 0. Using this nomenclature, a value of 0 indicates a surface having a Gaussian distribution of peak heights and valley depths, a value less than 0 indicates a surface having peak heights and valley depths exhibiting more deviations from mean peak heights and valley depths, and a value greater than 0 indicates a surface having more centrally distributed peak heights and valley depths, i.e., more uniformity in peak height and valley depth. Within the context of this disclosure, the term “normalized kurtosis” refers to the kurtosis value normalized about 0, in which a value of 0 indicates a surface having a Gaussian distribution of peak heights and valley depths. In the present disclosure, the term “skewness” may be used to describe a numerical characterization of a symmetry or asymmetry/irregularity of height distribution of a surface, such as whether peaks or valleys predominate as compared to a mean line of the surface. The skewness value of a surface may be calculated based on the measured surface roughness, e.g., via a profilometer. Skewness in two dimensions (Rsk) and three dimensions (Ssk) may be determined mathematically as follows: Rsk=1Rq3(1l∫0l(z(x))3dx)Equation7Ssk=1Sq3(1A∫∫A(z(x,y))3dxdy)Equation8 A skewness value of 0 indicates that neither peaks nor valleys predominate in a surface. A positive skewness may indicate a predominance of peaks over a mean line of the surface. A negative skewness, in contrast, may indicate a predominance of valleys. For example, if the average height of peaks is equal to the average depth of valleys across the surface, then the skewness of the surface is 0. In some aspects of the present disclosure, the implants may have surface features with size dimensions on the order of nanometers and/or microns. For example, the surface features (e.g., peak heights and/or valley depths) may have dimensions ranging from about 5 μm to about 100 μm, such as from about 10 μm to about 100 μm, from about 5 μm to about 50 μm, from about 5 μm to about 25 μm, from about 10 μm to about 25 μm, from about 10 μm to about 18 μm, from about 10 μm to about 12 μm, from about 15 μm to about 35 μm, from about 10 μm to about 26 μm, or from about 10 μm to about 15 μm. In some examples, the implant surface may have an average peak height and/or an average valley depth of about 5 μm, about 10 μm, about 12 μm, about 15 μm, about 18 about 20 μm, about 22 μm, about 25 μm, about 26 μm, about 28 μm, about 30 μm, about 32 μm, about 35 μm, about 40 μm, or about 50 μm, See also Table 1 below. The average peak height may be the same or different than the average valley depth. FIG.3depicts two-dimensional cross-sectional characterizations of five exemplary surfaces (A-E) with different surface textures, meaning that each surface has a different combination of surface characteristics, e.g., roughness (as measured by the root mean square height of surface roughness) (Rq), skewness (Rsk), and kurtosis (Rku). For each surface, a horizontal line indicates the mean line of the surface profile, wherein peaks are above the mean line (the height of a peak being measured from the mean line to the highest point of the peak), and valleys are below the mean line (the depth of a valley being measured from the mean line to the lowest point of the valley). For example, surface A has a roughness value of 3 μm (indicating a relatively smooth surface), a skewness value of 0 (a predominance of neither peaks nor valleys), and a kurtosis value of 3 (a normal distribution of peak and valley heights). Surface B has a roughness value of 12 μm (indicating a relatively rough surface), a skewness value of −1 (indicating a predominance of valleys under the mean surface line), and a kurtosis value of 8 (indicating that the valleys are “spiky” or sharper than a Gaussian surface). Surface C has roughness and kurtosis values equivalent to those of surface B, but with a skewness of 1, indicating a predominance of peaks, instead of valleys, over the mean surface line. Surface D has a roughness value of 4 μm (indicating a somewhat smooth surface), a skewness value of 0 (indicating that neither peaks nor valleys predominate), and a kurtosis value of 1.5, indicating a less spiky and more rolling surface texture. Surface E has roughness and skewness values equivalent to those of surface D, but with a kurtosis of 10, indicating that the surface comprises sharp peaks and valleys as opposed to rolling bumps. As illustrated byFIG.3, two surfaces having the same roughness value may not have other surface characteristics that are the same. For example, surfaces B and C have the same roughness value but different surface profiles as shown and as indicated by the skewness value. Similarly, surfaces D and E have the same roughness value but different surface profiles as shown and as indicated by the kurtosis value. The implants herein may have a controlled surface texture with a combination of surface characteristics (not just a given surface roughness) that may provide benefits for implantation in a patient, as discussed herein. Implant surfaces according to some aspects of the present disclosure may have a kurtosis value (Sku) between about 2.5 and about 3.0 or greater than 3.0. For example, the kurtosis value may range from about 3.0 to about 7.0, such as from about 3.0 to about 5.0, from about 3.0 to about 4.0, from about 3.5 to about 5.0, from about 3.0 to about 5.5, from about 3.5 to about 4.5, or from about 4.0 to about 7.0. In some examples, the kurtosis value of the outermost surface(s) of an implant (the surface(s) of the implant in contact with bodily tissues) may range from about 3.0 to about 5.0, e.g., a kurtosis value of about 3.0, about 3.1, about 3.2, about 3.3, about 3.4, about 3.5, about 3.6, about 3.7, about 3.8, about 3.9, about 4.0, about 4.1, about 4.2, about 4.3, about 4.4, about 4.5, about 4.6, about 4.7, about 4.8, about 4.9, or about 5.0. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a kurtosis value of 3.5±0.5. In some embodiments, implant surfaces according to the present disclosure may have a kurtosis value of approximately 3.0, e.g., representing a relatively equal distribution of peaks and valleys with similar scale heights. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a kurtosis value of 3.1±0.4. In some embodiments, at least a portion of the implant surface may have a kurtosis value greater than 3.0, e.g., a kurtosis value of 4.0±0.5, or 4.5±0.5. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a kurtosis value ranging from about 4.7 to about 4.8. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a kurtosis value ranging from about 4.5 to about 4.6. Further, implant surfaces according to the present disclosure may have a skewness value (Ssk) ranging from about −0.2 to about 2.0, such as from 0 to about 0.4, from about 0.2 to about 0.6, from about 0.5 to about 1, from about 0.6 to about 2.0, or from about 0.4 to about 0.8, e.g., a skewness value of about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, or about 1.0. In some aspects, the skewness value of a surface may be approximately zero or a positive value, e.g., a slightly positive value such as 0.1, 0.2, 0.3, 0.4, or 0.5. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a skewness value ranging from about 0.4 to about 0.5. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a skewness value ranging from 0 to about 0.3. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a skewness value ranging from about 0.4 to about 0.5. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have a skewness value ranging from about 0.8 to about 0.9. Further, in some aspects, implant surfaces of the present disclosure may have an average roughness (Sa) ranging from about 2 μm to about 6 μm, such as from about 2.2 μm to about 5.8 μm, from about 2.5 μm to about 5.5 μm, from about 3.0 μm to about 5.0 μm, or from about 3.5 μm to about 4.5 μm. For example, the average roughness (Sa) of an implant surface may be about 2.5 μm, about 3.0 μm, about 3.5 μm, about 4.0 μm, about 4.5 μm, about 5.0 μm, about 5.5 μm, or about 6.0 μm. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have an average roughness (Sa) of about 3.1 μm or about 3.4 μm. In some examples of the present disclosure, the implant surface may have an average roughness (Ra) ranging from about 2 μm to about 20 μm, such as from about 4 μm to about 18 μm, from about 5 μm to about 15 μm, from about 16 μm to about 18 μm, or from about 10 μm to about 20 μm. In at least one example, a portion of, or an entirety of, the outermost surface of the implant may have an average roughness (Ra) of 3.9±0.5 μm. In some embodiments of the present disclosure, the implant surface may have a density of contact points in the range of about 2,500 peaks/cm2to about 65,000 peaks/cm2, such as a density of contact points ranging from about 5,000 peaks/cm2to about 15,000 peaks/cm2, from about 5,000 peaks/cm2to about 10,000 peaks/cm2, from about 10,000 peaks/cm2to about 20,000 peaks/cm2, or from about 10,000 peaks/cm2to about 15,000 peaks/cm2, from about 20,000 peaks/cm2to about 65,000 peaks/cm2, from about 20,000 peaks/cm2to about 60,000 peaks/cm2, from about 30,000 peaks/cm2to about 60,000 peaks/cm2, from about 12,000 peaks/cm2to about 50,000 peaks/cm2, from about 30,000 peaks/cm2to about 50,000 peaks/cm2, from about 45,000 peaks/cm2to about 55,000 peaks/cm2, from about 40,000 peaks/cm2to about 50,000 peaks/cm2, from about 40,000 peaks/cm2to about 45,000 peaks/cm2, or from about 45,000 peaks/cm2to about 50,000 peaks/cm2. For example, the surface may have about 5,000 peaks/cm2, about 7,500 peaks/cm2, about 8,000 peaks/cm2, about 8,500 peaks/cm2, about 9,000 peaks/cm2, about 9,500 peaks/cm2, about 10,000 peaks/cm2, about 12,500 peaks/cm2, about 15,000 peaks/cm2, about 17,500 peaks/cm2, about 20,000 peaks/cm2, about 25,000 peaks/cm2, about 30,000 peaks/cm2, about 35,000 peaks/cm2, about 40,000 peaks/cm2, about 45,000 peaks/cm2, about 50,000 peaks/cm2, about 55,000 peaks/cm2, about 60,000 peaks/cm2, or about 65,000 peaks/cm2. The density of contact points of an implant surface may be measured using, for example, a 3D non-contact microscope. Other measurements may also be used to characterize implant surfaces according to the present disclosure, such as average peak and valley heights, and the number of peaks per unit area. Table 1 shows ranges of exemplary roughness, kurtosis, skewness, and other values that may characterize the surface texture of an implant (e.g., surface characteristics within a given sampling area, which may be the entire posterior and/or anterior implant surface or a portion thereof) according to some aspects of the present disclosure. As discussed above, peak height and valley depth are distances measured relative to a mean line of the surface profile. The maximum peak height (Sp) refers to the greatest distance above the mean line, and the maximum valley depth (Sv) refers to the greatest distance below the mean line, both peak heights and valley depths being absolute values. The total height of the surface profile refers to the combined value of the maximum peak height and maximum valley depth (Sp+Sv). The mean height of the surface profile refers to the average of the combined peak heights and valley depths across the surface. TABLE 1Surface CharacteristicExemplary RangeAvg. Roughness (Sa)4.0 μm ± 2 μmAvg. Root Mean Square4.5 μm ± 2 μmRoughness (Sq)Skewness (Ssk)0.6 ± 0.4Kurtosis (Sku)3.0 to 5.0Maximum Peak Height (Sp)14 μm ± 2 μmMaximum Valley Depth (Sv)12 μm ± 2 μmTotal Height of Surface Profile25 μm ± 4 μm(max. peak height + max. valley depth)Mean Height of Surface Profile13 μm ± 2 μm(average of peak heights +valley depths)Density of Contact Points (peaks/cm2)20,000 to 60,000 At least one exemplary implant surface of the present disclosure may exhibit, for example, an average roughness (Sa) of 3.1 μm, a skewness (Ssk) of 0.89, and a kurtosis (Sku) ranging from 4.7 to 4.8. Another exemplary implant surface of the present disclosure may exhibit, for example, an average roughness (Sa) of 3.4 μm, a skewness (Ssk) of 0.8, and a kurtosis (Sku) ranging from 4.5 to 4.6. Ina further example, the implant may comprise an outer surface having an average roughness (Ra) of 3.9±0.5 μm, a skewness (Ssk) of 0.4±0.1, and a kurtosis (Sku) of 3.1±0.4. In yet another example, the implant may comprise an outer surface having an average roughness (Ra) of 4.0±0.4 μm, a skewness (Ssk) of 0.1±0.2, and a kurtosis (Sku) of 2.6±0.2. The present disclosure encompasses surfaces that exhibit other exemplary ranges of these properties as well. For example, embodiments of the present disclosure may exhibit an average roughness (Sa) of 2.5 μm±1.0 μm or 6.0 μm±2.0 μm and/or a root mean square roughness (Sq) of 2.5 μm±1.0 μm or 6 μm±2.0 μm. Further, embodiments of the present disclosure may exhibit a skewness (Ssk) of, for example, 0.6±1.2, and/or a kurtosis (Sku) ranging from 2.5 to 6.0. Implant surfaces of the present disclosure may exhibit peak heights (Sp) of 25 μm±15 μm and/or valley depths (Sv) of 10 μm±5 μm or 20 μm±5 μm. In some examples, implant surfaces of the present disclosure may exhibit a contact point density ranging from 20,000 peaks cm2to 60,000 peaks/cm2, such as from 30,000 peaks/cm2to 55,000 peaks/cm2, or from 40,000 peaks/cm2to 50,000 peaks/cm2. In other examples, the surfaces herein may have an average roughness (Sa) of 4.0 μm±1.0 μm, a skewness (Ssk) of 0.4±0.2, a kurtosis (Sku) of 3.1±0.4, a maximum peak height of 14 μm±2.0 μm, an average peak height of 13 μm±2.0 μm, a valley depth of 12 μm±2.0 μm, and a contact point density ranging from 40,000 to 50,000 peaks/cm2. Further, the present disclosure contemplates that embodiments may have combinations of properties exhibiting any of these exemplary ranges, optionally in combination with properties exhibiting any of the exemplary ranges disclosed in Table 1. Implants may be prepared as discussed herein to achieve a combination of desired surface characteristics. FIG.4depicts images obtained by scanning electron microscopy (SEM) of two exemplary texturized silicone samples prepared according to the present disclosure, whose surfaces exhibit the properties described above. The surfaces were sputter-coated with gold-palladium and scanned using an SEM Hitachi 3700N. Relative hydrophobicity of an implant surface may also improve biocompatibility of an implant surface. An implant (e.g., a breast implant) having a relatively hydrophilic surface may adhere to water-rich tissue and cause undesirable stiction, or static friction, that must be overcome to enable relative movement between the implant surface and the tissue. In contrast, a relatively hydrophobic surface, when in contact with water-rich living tissue (e.g., tissue at the front of a patient's chest cavity), may generate less friction against the tissue. Hydrophobicity and hydrophilicity generally may be described in terms of the “wettability” of a surface, or the affinity of a liquid towards the surface. Measurements of contact angle (also referred to as wetting angle) may provide an indication of the hydrophobicity and wettability of a surface. The contact angle of a surface is measured as the angle between the surface and the edges of a liquid droplet (e.g., water droplet) on the surface. Thus, hydrophobic surfaces generally have contact angles greater than 90°, whereas hydrophilic surfaces generally have contact angles less than 90°. Wettability of a surface may be affected by the chemical composition and/or physical properties of the surface, such as topography, e.g., roughness. For example, increasing surface roughness may correspond to increasing discrete points of contact between the surface and a water droplet in contact with the surface. This in turn may allow for air pockets between the points of contact of the surface and the water droplet, e.g., increasing the relative hydrophobicity of the surface. However, as discussed herein, excessive roughness of an implant surface may cause tissue encapsulation and capsular contraction. Therefore, implant surfaces according to some aspects of the present disclosure may exhibit relative hydrophobicity without excessive roughness. Accordingly, implant surfaces according to some aspects of the present disclosure may exhibit a contact angle between about 90° and about 150°, such as between about 100° and about 130°, between about 110° and about 130°, between about 115° and about 125°, e.g., a contact angle of about 110°, about 115°, about 120°, or about 125°. FIG.6depicts images of three exemplary textured surface samples prepared according to the present disclosure during contact angle measurements (panels A, B, and C), each with a drop of water in contact with the surface, using a goniometer (ramé-hart CAM 200 system, ramé-hart instrument co, USA). The beaded appearance to the water droplets indicates that the surfaces are relatively hydrophobic (contact angles >90°). See also Example 3, below. As mentioned above, the surface characteristics described herein may be incorporated into the outermost surface of a medical implant. For example, outer surface104of implant shell102may have a surface texture as described herein. Additionally or alternatively, one or more surfaces of an implant shell patch, such as inner and/or outer surfaces of patch112of implant100, may have a surface texture as described herein. In some embodiments, surfaces other than the outermost surface of an implant may have a surface texture as described herein. For example, an inner surface of an implant shell, such as inner surface106of shell102, may have a surface texture as described herein. Such a texturized inner surface may have improved interactions (e.g., increased adhesion or grip) with one or more other components of the implant, such as an inner component of the implant (e.g., filling114). For example, a texturized inner surface (e.g., inner surface106) may exhibit increased adhesion to an inner component of the implant (e.g., filling114), thus preventing or reducing potential separation of the inner component from the texturized inner surface during manufacturing, sterilization, and/or implantation, and/or throughout the lifespan of the implant. Implants according to the present disclosure may include areas having different surface characteristics. For example, the outermost surface of an implant (e.g., outer surface104of implant100inFIGS.1A-1B) may have different surface characteristics than an inside surface of the implant (e.g., inner surface106). Methods of texturizing inner surfaces of shells are discussed below. In some embodiments, the implant surface may be prepared such that one or more select areas of the surface has different surface characteristics than other portions or a remainder of the surface. For example, the surface may include one or more areas having a higher average roughness value than other portions of the implant surface. When such areas with increased roughness are on the outermost surface of the implant, for example, they may provide a modest increase in implant immobility by increasing friction between the implant and patient tissue. Further, for example, select areas of the implant surface may be prepared by higher or lower kurtosis and/or skewness values, as compared to other portions of the implant surface. Referring toFIGS.1A-1B, for example, a portion of outer surface104of implant100may have different average roughness values than other portions of outer surface104. For example, the posterior side110of implant100may comprise one or more discrete areas or regions having a higher average surface roughness. Such rougher portions of outer surface104may provide for increased friction with the surrounding tissue, and thus may help to restrict migration of the implant. In some aspects of the present disclosure, such rougher portions may avoid having a rougher (and potentially less biocompatible) surface on the entirety or the majority of the implant. In some aspects, for example, the patch112may have a higher roughness value than the remaining outer surface104. FIGS.7A-7Gdepict several exemplary configurations or patterns of surface features of an implant useful for restricting movement of the implant after implantation. The configuration of the surfaces and/or the location of the surfaces relative to the surrounding tissue after implantation may limit or prevent movement of the implant relative to those tissues. For example, surfaces having a higher roughness may provide for increased friction against patient tissue that restricts movement of the implant. The combination of different surface textures may prevent the implant from rotating or otherwise migrating from its proper position when implanted. For example, the posterior and/or anterior side of an implant may include a plurality of surfaces of various sizes and shapes, e.g., forming a pattern of surface features for restricting movement of the implant. Referring to the implant100ofFIGS.1A-1B, for example, the outer surface104of the implant100may have different surface textures, e.g., such that the outer surface104includes a combination of two or more surfaces have different surface textures. In at least one example, an upper portion of the posterior side110of the implant100may be configured to create friction against the tissue of a patient's upper chest cavity when implanted, in order to restrict movement of the implant100. WhileFIGS.7A-7Grefer to the outer surface104of the posterior side110of the implant100ofFIGS.1A and1B, the configurations depicted inFIGS.7A-7Gand discussed herein are not limited to a breast implant, or to the posterior side of a medical implant. The combinations of surface features disclosed herein may be used on any surface (e.g., anterior and/or posterior surface) of any implant (e.g., breast implant, gluteal implant, calf implant, or other implant). InFIGS.7A-7G, each of the shaded areas (e.g.,702,708,710,712,714, and716, as well as the outer surface of patch112) represents a surface (a portion of the outer surface104of the shell102) having a particular surface texture or set of surface characteristics. Each surface702,708,710,712,714,716, and112may have the same or different surface texture than any other surface. In some aspects of the present disclosure, the implant may include one or more discrete surfaces having a higher surface roughness than an adjacent surface of the implant. In some aspects, the implant may include one or more discrete surfaces having a lower surface roughness than an adjacent surface of the implant. For example, one or more of the darker-shaded surfaces708,710,712,714, and/or716may have a surface texture different than the surface texture of the lighter-shaded surface702. Additionally or alternatively, each darker-shaded surface may have a surface texture that is the same or different than the surface texture of at least one other darker-shaded surface. The surfaces may have any suitable size and shape. For example, the surfaces may be curved (e.g., circular, oval, arched, or annular/ring-shaped), or geometric (e.g., triangular, square, rectangular, rhomboid, or trapezoidal), among other possible shapes. The implant may comprise a plurality of surfaces forming a symmetrical pattern, as shown, or a pattern that is not symmetrical. For example,FIG.7Adepicts the posterior side110of implant100having a first surface702that may have a first surface texture including a set of surface characteristics of roughness, skewness, kurtosis, peak height, valley depth, and/or contact point density as disclosed herein.FIG.7Aalso depicts patch112on outer surface104, which may exhibit surface characteristics that are the same as those of the first surface702, or that are different from those of first surface702. In some embodiments, for example, patch112may exhibit a higher average roughness value than that of the first surface702. Additional surfaces of the posterior side110implant100(surfaces708,710, and712) may also have differing surface characteristics from the first surface702. For example, a surface708having the shape of a ring surrounding the patch112and centered on the posterior side110may exhibit one or more surface characteristics that differ from the surface characteristic(s) of the first surface702. Similarly, a surface710having a generally arched shape near the upper edge of the posterior side110, and/or one or more generally circular surfaces712. As shown, the arched surface710has a center of curvature at or proximate the center of the posterior side110, however other locations and orientations are also contemplated herein. As shown, the different surfaces are arranged such that the posterior side110has an axis of symmetry (e.g., an axis through the center of the patch112, equidistant from the two circular surfaces712). One or more of these surfaces708,710, and/or712may, in some embodiments, have a higher roughness value than that of the first surface702, and/or may differ with regard to other surface characteristics (e.g., skewness, kurtosis, peak height, valley depth, and/or contact point density). That is, the surfaces708,710, and/or712may have a different surface texture than the surface texture of the surrounding surface702. As mentioned above, such rougher portions of the implant may advantageously provide increased friction at certain areas of contact between the implant and patient tissue. For example, the surface710having an arched shape may provide increased friction between the upper portion of the posterior side110of implant100and the upper portion of the patient's chest cavity. This friction may inhibit rotation and/or migration of the implant, and/or may reduce the risk of separation between the implant and the patient's chest cavity. Further, while such rougher surfaces may comprise the majority of, or all of, the posterior side110of the implant100, they need not do so. Rougher surfaces that comprise only parts of the posterior side110of the implant100(e.g., as illustrated inFIGS.7A-7G) may advantageously restrict movement of the implant100without substantial tissue irritation, e.g., due to friction between a rough implant surface and patient tissue. FIGS.7B-7Gdepict other exemplary combinations of surfaces in various shapes and sizes, including a first surface702and one or more other surfaces that may exhibit one or more surface characteristics that are the same or different than those of the first surface702. Each ofFIGS.7B-7Gincludes an arched surface710and a ring-shaped surface708of the same size and having the same location as shown inFIG.7A, although these surfaces may not be included in other examples.FIG.7Balso depicts a second, smaller arched surface714radially inward of, and spaced apart from, the larger arched surface710. Each of the arched surfaces710,714, independently may exhibit surface characteristics different from first surface702. The two arched surfaces710,714are located on the upper portion of the posterior side110of the implant100, such that the surfaces710,714contact an upper portion of the patient's chest cavity when implanted.FIG.7Balso illustrates a surface712having a generally circular shape opposite the arched surfaces710,714, proximate the lower edge of the posterior side110of the implant100. The three surfaces710,712,714may be aligned such that the posterior side110has an axis of symmetry as shown. FIG.7Cdepicts yet another exemplary implant surface including three circular surfaces712, as compared to the two circular surfaces712depicted inFIG.7A. The three circular surfaces712may have the same surface texture, or a different surface textures than one another. The three circular surfaces712all may have the same or substantially the same size (as shown inFIG.7C), or one of the circular surfaces712may be larger or smaller than at least one of the other circular surfaces712. Further, in some examples, one of the surfaces712may have a different shape than at least one of the other areas, e.g., a generally oval shape, arched shape, geometric shape, or any other shape. FIG.7Ddepicts a second arched surface716located on the lower portion of the posterior side110of the implant mirroring the arched surface710located on the upper portion of the posterior side110. The ends the two arched surfaces710,716may be close together, forming a nearly annular surface radially outward of the patch112, which may have one or more surface characteristics that are different from the surface characteristics of the first surface702.FIGS.7E,7F, and7Gdepict additional variations on the placement, size, and shape of various surfaces (e.g., surfaces708,710,712, and714discussed in reference toFIGS.7A-7D) of the posterior side110of the implant100that may exhibit surface textures different from the surface characteristics of the first surface702. In some examples, the implant100may include more or fewer discrete surfaces than those illustrated inFIGS.7A-7G. For example, the posterior side110of the implant100may have a configuration similar to any ofFIGS.7A-7G, further comprising a plurality of smaller, discrete surfaces distributed across the posterior surface110. Additional configurations are likewise contemplated herein. In some examples, the outer surface of the implant may include information useful in identifying and/or characterizing the implant. As shown inFIGS.7A-7G, for example, the outer surface104may include one or more labels706. For example, the label706may comprise text (e.g., letters, words, numbers, signs, and/or symbols) imprinted into a portion of the outer surface104, or may comprise a separate material adhered or otherwise affixed to a portion of the outer surface104. Such a label706may, for example, be imprinted into or embossed into the outer surface104, and may include identification markings (e.g., manufacturer, model number, size dimensions, date of manufacture, etc.) or any other information useful for identifying the implant100. The label(s)706may be located on any suitable portion of the implant100, such as the first surface702and/or another surface such as patch112, any of surfaces708,710,712, or714, or any other area of outer surface104. WhileFIGS.7A-7Gdepict several exemplary surface configurations or patterns, one of ordinary skill in the art will understand that many other configurations are possible and may be appropriate for a given implant based on the size, shape, and/or orientation of the implant relative to different tissues when implanted. The number, size, shape, and location of such surfaces of the implant may be tailored according to the needs of a specific patient and/or the type of implant. The different surface textures may be distributed across the implant surface to assist in restricting or preventing movement of the implant in one or more directions relative to the surrounding patient tissue (e.g., upwards movement, downwards movement, side-to-side movement, and/or rotation of the implant within the patient). In at least one example, the posterior and/or anterior surface of the implant may include at least one first surface having a first surface texture and at least one second surface having a second surface texture different than the first surface texture. For example, the second surface(s) may have an average roughness greater than the average roughness of the first surface(s). The surfaces may be integral portions of the implant (e.g., an integral part of the shell or other outermost surface of the implant) or may be defined by a material coupled to the implant surface. For example, one or more of the surfaces708,710,712,714, and/or716ofFIGS.7A-7Gmay be defined by the outer surface of a tab attached to the outer surface of the implant. Each surface may have the same chemical composition or a different chemical composition than another portion of the implant surface. Referring toFIG.7A, in one example, all of surfaces708,710, and712may be integral portions of the shell102of the implant100, having the same chemical composition. In another example, surface708may be an integral portion of the shell102, while surfaces710and712are defined by tabs coupled to the surface having the same chemical composition than the shell102. In yet another example, each surface708,710, and712may be defined by a tab having a different chemical composition than the shell102. Methods of preparing implants having different surface textures as integral portions of the implant are discussed below. Tabs also are discussed below. Surface characteristics described herein may be incorporated into a variety of medical implants. Any suitable biocompatible material may be used for the implant surface, including, e.g., biocompatible polymers and/or copolymers. The material may be rigid, semi-rigid, or flexible, depending on the desired characteristics of the implant. For example, some implants such as pacemakers and other electro-simulation implants may have portions that are rigid or semi-rigid, whereas other implants such as breast implants or gluteal implants may be flexible. In some embodiments, the surface characteristics described herein may be incorporated into breast implants having a flexible shell formed of a biocompatible polymer or copolymer, such as an elastomer. Exemplary materials include, but are not limited to, silicone materials. For example, the shell may be formed of one or more siloxane polymer elastomers or a siloxane polymer elastomer mixture. The composition of the silicone material may provide a high strength barrier and/or a higher elongation per unit force. In some embodiments, the composition of the silicone material may provide a barrier to prevent diffusion of a filling material from inside of the implant. For example, the silicone material may comprise a silicone elastomer comprising a polysiloxane backbone and having a minimum mole percentage of 10% of a substituted or pendant chemical group that retards permeation of silicone through the layer. In some examples, the silicone elastomer may be a polydimethylsiloxane and the pendant chemical group may be one of a phenyl or a fluorine group. In some embodiments, the shell may be formed with one or more siloxane polymer elastomers having a viscosity suitable for providing a high strength barrier, and another siloxane polymer elastomer having a viscosity suitable for providing a higher elongation per unit force. In some embodiments, the shell may be formed by layers of each of these siloxane polymer elastomers with different viscosities, so as to create a shell having both a high strength barrier and/or a barrier to prevent diffusion of filling material, and a higher elongation per unit force. In some embodiments, the shell may provide for at least +200% elongation as compared to other silicone materials used in medical implants, when measured using a tensile testing system (e.g., an Instron® static tensile testing system having a charged cell of 50 N). For example, some shells of the present disclosure may exhibit elongation values ranging from about 450% to about 750%, such as from about 500% to about 750%, from about 600% to about 750%, or from about 650% to about 750%. The elongation value may be measured according to standard ISO 37 of the International Organization for Standardization. Additionally or alternatively, the shell breaking strength (ultimate breaking force) of shells according to the present disclosure may range from about 11.0 N to about 45.0 N, such as from about 15.0 N to about 40.0 N, from about 20.0 N to about 30.0 N, or from about 25.0 N to about 35.0 N. The shell breaking strength may be measured according to standard ASTM F703-07. In some aspects of the present disclosure, the tear strength of the shell may range from about 8.0 N to about 18.0 N, such as from about 10.0 N to about 15.0 N, or from about 15.0 N to about 20.0 N. The tear strength may be measured according to standard ISO 34-1:2004, Method C. A silicone shell according to the present disclosure, in combination with an appropriate filling material, may allow an implant to be elongated, compacted, and loaded into introducer devices more efficiently, e.g., without compromising the integrity of the implant through rupture of the shell, leakage of filling material, loss of implant shape, and/or separation of filling material from the inner wall of the shell. Some implants according to the present disclosure may comprise a filling material, such as a liquid or gel. For example, the filling material may allow the implant to more closely simulate tissue, e.g., by temporarily deforming in response to pressure or due to gravity. Any of the features of the gravity-sensitive implants disclosed in U.S. Publication No. 2015/0282926, incorporated by reference herein, may be used in the present disclosure. In some examples, the implant may be a breast prosthesis comprising a shell that encloses a biocompatible liquid such as saline, or a biocompatible gel such as a silicone gel. In such embodiments, suitable gels for retaining biocompatibility and/or compatibility with other components of the implant may be used. For example, the implant may comprise a silicone gel with high elasticity and/or low viscosity, e.g., a visco-elastic silicone material. In some examples, the implant may comprise a silicone gel with a penetration value ranging from 1.0 to 6.0, such as from 2.0 to 5.0, or from 5.0 to 6.0. The penetration value is a factor that measures the firmness of a colloid, such as a silicone gel. In some examples, the implant may comprise a silicone gel attaining a value in the range of 2 mm to 29 mm protrusion in the cone cohesion test and that will not detach from the cone, according to the test previewed in ISO 14607:2009 (Non-active surgical implants—Mammary implants—Particular requirements) and ASTM F703 (Standard Specification for Implantable Breast Prostheses). Such materials may allow for more efficient compaction, elongation, and loading of the implant into an introducer device, such as those disclosed in U.S. Provisional Application No. 62/323,160, incorporated by reference herein. Moreover, such materials may facilitate insertion of the implants through a smaller incision in the patient, reducing common issues and risks associated with current surgical implantation methods, such as tearing of the shell, separation of the filling (gel) from the inner shell walls, or fracturing of the filling. The implants and surfaces thereof disclosed herein may be produced using any suitable manufacturing process. For example, shells of implantable medical products according to some aspects of the present disclosure, such as, e.g., shell102shown inFIGS.1A-1B, may be produced by dip-molding. Other exemplary methods of producing implant surfaces according to the present disclosure may include, for example, rotational molding, pour-molding, and casting. FIG.8depicts an exemplary mandrel800that may be used as a mold for an implant shell. The mandrel800may comprise a variety of materials, such as metals, metallic alloys, one or more polymers or copolymers, ceramic materials, wood, stone, coral, or any combination thereof. Exemplary metallic materials include, but are not limited to, aluminum and aluminum alloys. Exemplary polymer or co-polymer materials include, but are not limited to, polyoxymethylene (acetal copolymer), such as Delrin® acetal homopolymers produced by DuPont™. Any other polymer/copolymer materials suitable for providing a textured mold surface as discussed herein may be used. In some embodiments, a mirror image of a desired surface texture may be imparted onto the upper surface802of the mandrel800. Various techniques may be used to texturized the surface802. For example, mandrel surface802may be impacted (e.g., blasted or sandblasted) with an abrasive substance, such as a plurality of abrasive particles. Exemplary materials for the abrasive particles may include, but are not limited to, staurolite minerals, quartz, kyanite, titanium minerals and/or their alloys, zircon, heavy metals (e.g., cadmium, selenium, ferrous iron, and/or steel alloys such as tungsten alloys, chromium alloys, magnesium alloys, molybdenum alloys, and vanadium alloys). These are exemplary materials, and other materials having comparable low malleability and high hardness as to maintain their shape characteristics during a blasting process may also be used for the abrasive particles. In some examples, the abrasive particles may be generally non-spherical in shape, e.g., irregular-shaped particles. For example, the particles may have a granular, irregular shape. In other examples, the abrasive particles may be generally spherical, ovoid, or otherwise regular in shape. In some examples, the abrasive particles may have generally rounded surfaces. In at least one example, the abrasive particles may comprise quartz, and may have generally rounded surfaces clean from extraneous debris, e.g., having less than about 7.0%, less than about 5.0%, less than about 3.0% free silica, or less than about 1.0% free silica. The composition and shape of the particles may be selected based at least partially on the composition of the mandrel800, e.g., to provide for a difference in Mohs hardness between the abrasive particles and the mandrel800. In some examples, the abrasive particles may have a Mohs hardness ranging from 5.0 to 8.0, such as from 5.0 to 6.5, from 6.5 to 7.0, or from 7.0 to 8.0. For example, the abrasive particles may have a Mohs hardness that is 1-3 values greater than the material(s) of the mandrel800. In at least one example, abrasive particles having a Mohs hardness of 6.5 to 7.0 may be used with poly oxymethylene (e.g., a black acetal copolymer, e.g., Delrin®) mandrel. The average diameter of the abrasive particles may range from about 10 μm to about 500 μm, such as from about 50 μm to about 450 μm, from about 50 μm to about 250 μm, from about 50 μm to about 100 μm, or from about 75 μm to about 125 μm. In at least one example, the abrasive particles may comprise quartz with an average diameter ranging from about 50 μm to about 100 μm (e.g., a mesh screen size in the range of 50-100 μm). Thus, the blasting and sandblasting processes according to the present disclosure are distinct from shot blasting or shot peening, which is generally understood to use spherical metal particles >500 μm (e.g., shot particles on the order of several millimeters) to create spherical dents in the surface. Sandblasting, by contrast, produces a superior mold surface that results in medical implant surfaces of greater biocompatibility and having textures as discussed throughout this disclosure. Abrasive particles may be blasted at the mandrel surface802from, for example, a nozzle. The distance between the nozzle and the mandrel surface802may also be adjusted to affect the surface texture. The distance between the nozzle and the mandrel surface may range from about 2 cm to about 75 cm, such as from about 5 cm to about 50 cm, from about 5 cm to about 25 cm, from about 25 cm to about 50 cm, from about 10 cm to about 35 cm, or from about 10 cm to about 25 cm. In some embodiments, particles used to blast the mandrel surface802may be reused for subsequently blasting further mandrel surfaces. In such embodiments, the particles may be periodically replaced to ensure adequate consistency of particles used in multiple mandrel-blasting iterations. Following the treatment with abrasive particles, the mandrel surface802may include peaks and valleys that provide a mirror image of the desired surface texture for the implant. In some aspects of the present disclosure, a shell may be prepared by dip-molding, using mandrel800as a mold, wherein the mandrel surface802has been texturized. For example, the mandrel surface802may be dipped, e.g., at least partially or fully submerged in a thermoplastic or thermosetting material, such as a silicone dispersion, such that the silicone material at least partially or fully coats the surface802. The surface802may be repeatedly dipped in order to form a multilayered shell, such as shell102ofFIGS.1A-1B. In some examples, the surface802may be dipped at least twice, three times, or four times or more to form multiple layers. In some examples, the surface802may be dipped between five and six times. In other examples, the surface802may be dipped more than six times. The thickness of the shell may range from about 0.1 mm to about 1.2 mm, such as from about 0.2 mm to about 0.8 mm, from about 0.3 mm to about 1.1 mm, or from about 0.4 mm to about 0.6 mm. In some examples, the thickness of the shell may range from about 0.33 mm to 1.02 mm, e.g., a thickness of about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, or about 1.0 mm. As discussed above, each layer may have the same or different composition with respect to the other layer or layers. To prepare a shell comprising layers with different compositions, the mandrel surface802may be dipped in different materials, e.g., silicone dispersions having different viscosities and/or different types of additives. In some examples, the shell may include one or more barrier layers to inhibit or prevent the passage of liquid or gel materials through the shell. Exemplary materials suitable for the barrier layer(s) include, but are not limited to, diphenyl silicone elastomers, dimethyl silicone elastomers, diphenyldimethyl silicone elastomers, methylphenyl silicone elastomers, fluorinated silicone elastomers such as trifluoropropyl silicone elastomers, and combinations thereof. Such barrier layers may be colored, e.g., by adding one or more pigments to the material(s) forming the barrier layer(s), to facilitate examination of the continuity and/or integrity of the barrier layer(s). For example, the barrier layer(s) may comprise a metal-based, inorganic, and/or organic pigment to provide a barrier layer that is blue, green, yellow, red, orange, purple, or any combination or hue thereof. For example, the barrier layer(s) may comprise a pigment such as phthalocyanine blue (e.g., copper chlorophthalocyanine) to provide a blue color. In at least one example, the shell may comprise one or more barrier layers comprising a two-part silicone elastomer comprising a diphenyldimethyl polysiloxane polymer dispersed in xylene and copper chlorophthalocyanine pigment dispersed in a vinyl-functionalized silicone polymer. Any of the materials and/or features of a barrier layer disclosed in U.S. Application Publication No. 2015/0150675, incorporated by reference herein, may be used in the present disclosure. Once the appropriate number of layers have formed around the mandrel800, the material(s) may then be allowed to cure at an appropriate temperature. For example, the shell may be cured at a temperature ranging from about 100° C. to about 200° C., such as from about 125° C. to about 175° C., or from about 125° C. to about 150° C. In some examples, the curing temperature may range from about 125° C. to about 127° C., e.g., about 125° C., about 126° C., or about 127° C. In further examples, the curing temperature may be about 150° C. The cured shell may then be removed from the mandrel800and inverted or turned inside out. Thus, the surface of the shell formerly in contact with surface802of mandrel800forms the exterior surface of the shell having a texture that is a mirror image of the textured surface802of the mandrel800. Alternatively, the cured shell may be removed from the mandrel800and may not be turned inside out, resulting in a shell having a textured interior surface. Advantageously, imparting a mandrel or other mold with a texture that is the mirror image of a desired surface texture as described herein, and using the mandrel or other mold to create an implant with that surface texture, may allow for superior control over the characteristics of the implant surface as compared to other methods of texturizing a surface, such as rubbing an abrasive material across the surface. Additionally, the methods herein may allow for reproducibility in implant characteristics, and consistent production of multiple textured implant shells having the desired surface characteristics (e.g., roughness, kurtosis, skewness, peak heights, valley depths, peak density/distribution, contact angle, etc.). According to some aspects of the present disclosure, textured mold surfaces may be produced by rotational molding (also called rotomolding) processes. For example, the interior surface of a rotational mold may be impacted with an abrasive substance, such as a plurality of abrasive particles in a manner similar to the preparation of mandrel surface802described above. Thus, when thermoplastic or thermosetting material(s) (such as, e.g., silicone material(s)) are placed into the hollow textured rotational molding cavity—and the mold is rotated around—the material(s) may spread evenly over the interior surface. Once the material(s) are cured and the shell component is removed from the rotational mold, the surface of the shell component formerly in contact with the interior surface of the rotational mold may have a texture that is a mirror image of the textured surface of the interior surface of the mold. The textured surface of the shell may define the outer surface, such that the shell need not be inverted. In another exemplary process suitable for preparing the surface textures herein, a masking mold may be used. Molding masks may be useful, for example, in preparing integral surfaces having areas or regions with different surface characteristics, including the types of surfaces illustrated inFIGS.7A-7G. For example, a masking mold whose surface includes peaks and valleys having a desired micro-texture may be used in a controlled imprinting process to create an implant surface with select areas having greater or less roughness than other portions of the surface. Exemplary materials for the masking mold may include, but are not limited to, one or more metals, a metallic alloys, etchable polymers, etchable co-polymers, or a combination thereof. In at least one example, the masking mold may comprise an aluminum alloy. In some exemplary processes, a mandrel surface may be engraved with a label or other identifying marks (e.g., label706depicted inFIGS.7A-7G), before or after being blasted with particles or subjected to a masking mold. For example, a mandrel surface802may be engraved with a label prior to being blasted with particles, and the engraved portion of the surface may be protected by a masking material during the blasting process to preserve the label. In further exemplary processes, a masking mold may be used to imprint a mandrel surface with a label or other identifying marks, either before or after the application of other texturizing processes to the mandrel surface. The surface of the masking mold may be texturized by any of the methods disclosed herein, such as impacting the surface with abrasive particles to yield the desired roughness and/or other surface characteristics or parameters. The masking mold then may be constructed or cut into the size and shape of the area to have those surface characteristics. For example, the masking mold may be cut or constructed into one or more shapes as depicted on the implant surfaces pictured inFIGS.7A-7G. The masking mold shapes may then be affixed to the surface of an implant mold, e.g., surface802of mandrel800, by an adhesive or other suitable material or mechanism. The implant mold and masking mold affixed thereto then may be subjected to a controlled electro-chemical deposition process to etch (imprint) the micro-texture characteristics of the masking mold into the surface of the implant mold. After this treatment of the implant mold, an abrasive blasting process as discussed above may be performed to texturize other portions of the mold. Additionally or alternatively, an abrasive blasting process may be used to texturize the implant mold prior to imprinting specific areas of the implant mold with a specified surface texture, e.g., via an electro-chemical deposition process. Using a texturized mold in an implant manufacturing process may provide for a more consistent and uniform texture on any or all surfaces of the implant (e.g., top, sides, and base) as compared to prior methods of applying abrasive materials directly to the implant surface, and may yield less propensity towards embedding abrasive particles in the implant shell material. For example, the process described above for preparing a texturized mold surface may result in few to no residual abrasive particles detectable on the mold surface after the surface treatment, which in turn may result in few to no loose particles in or on a shell made using the mold. Further, the preparation of mold surfaces (e.g., texturizing the surface of a mandrel) may allow for control over the surface texture of an implant, such that desired surface texture properties (e.g., roughness, kurtosis, skewness, peak heights, valley depths, peak distributions, etc.) may be selected and imparted to the surface of the mold as desired. The preparation of texturized mold surfaces may also provide for uniformity in manufacturing implants with the same or similar surface characteristics, e.g., having surface characteristics of the desired value or falling within the desired range of values. Thus, for example, the methods herein may allow for molds having a set of fixed, consistent surface features on a desired scale (e.g., nanometers or micrometers) for manufacturing a shell having a surface with a hierarchical (i.e., controlled), nano- and/or micro-structured texture. As mentioned above, interior surfaces of an implant may be prepared with a surface texture. In some embodiments, for example, it may be desirable to impart texture to the interior of an implant shell, such as surface106of shell102ofFIGS.1A-1B. In some examples, the shell may be prepared such that both the interior and exterior surfaces, e.g., surfaces104,106of shell102, may have a surface texture as disclosed herein. For example, a roughened texture may help to maintain contact between the filling material and the shell, e.g., to reduce or eliminate potential separation between the implant shell and filling material, such as a gel filling, inside the shell. Texture may be imparted to the inner surface of a shell by abrading a not-yet-cured material layer that is to define the innermost surface of an implant shell. For example, in a shell created by a dip-molding process using a mandrel such as mandrel800, several layers of a shell material dispersion, such as a silicone elastomer dispersion, may be coated over the mold as discussed above. Texture may be applied to the outermost layer formed by the last dip. Before curing the shell, for example, particles comprising salt or other abrasive material may be sprayed, bombarded, or otherwise applied to the uncured final-dipped layer of the shell on the mold such that the salt sticks to the surface. The shell having the salt particles may be cured, and then the salt dissolved and washed away, or otherwise removed, to leave a rough or roughened surface. Upon removal of the particles from the shell, the shell may be removed from the mold and inverted such that the roughened surface created by the salts will be located on the interior of the shell. When the surface of the implant mold is texturized, both the inner and outer surfaces of the shell may have texture, e.g., wherein the surface characteristics of the inner and outer surfaces may be similar in some respects, or may be different. In some examples, the outer surface may be a hierarchical, nanostructured surface, and the inner surface may be a less controlled, rougher surface. That is, the texture of the outer surface may be more controlled and well-defined than the inner surface. In another exemplary embodiment, a texturized inner surface of a shell may be created by adjusting the solvent content of the solution used for the final-dipped layer of the shell and/or by increasing the cycle temperature used for curing. Alternately or additionally, the pressure (e.g., in a curing oven) used for curing the shell may be decreased. One or more of these changes may cause solvent in the final-dipped layer of the shell to boil as it cures, creating pits and craters that may increase the total surface area in this final-dipped layer of the shell. Upon removal of the cured shell from the mold and inversion of the shell, the pitted and cratered surface may define the interior surface (e.g., interior surface106of shell102inFIGS.1A-1B). In some examples, a combination of the above-described methods of texturizing the inner and outer surfaces of an implant shell may be used. For example, a biocompatible texture according to the present disclosure may be imparted on the outside of an implant shell with a texturized mandrel. For example, prior to dipping or otherwise coating the mandrel with a silicone dispersion (or other suitable thermoplastic or thermosetting material) to create the implant shell, the mandrel may be blasted with abrasive particles, e.g., uniformly-sized abrasive particles. Once the mandrel has been thus treated, layers of the shell material may be applied to the mandrel to build the shell. Then, the above-described texturizing processes may be applied to the final-dipped layer of the shell. The shell then may be removed from the mandrel and inverted, such that the outer surface has a biocompatible surface texture with specified roughness, kurtosis, and/or skewness values, and the inner surface also has texture. In some embodiments of the present disclosure, the inner surface texture may be markedly rougher and less consistent or controlled than the texture of the outer surface. As has been described above, some implants according to the present disclosure may include a shell, e.g., enclosing a filling material. Such implant shells, e.g., implant shell102shown inFIGS.1A-1B, may have an aperture or hole, which may be created during the implant shell molding process. A patch, such as patch112, may be affixed to the implant shell over the hole, to cover and “stopper” the hole. In further embodiments, a patch may be applied to a portion of a shell or other portion of an implant surface where there is no hole, e.g., to provide a different texture to that portion of the implant surface. Such patches may be texturized, for example, by preparing both a shell having an aperture, and a patch for covering the aperture, with surface textures in accordance with the present disclosure. By affixing the patch over the aperture of the shell, the entire exterior implant surface may have texture as disclosed herein. In some examples, the patch may be prepared with a higher roughness than the rest of the shell, which may help to provide increased friction between the surface of the implant and surrounding tissues, e.g., and thus decreased movement of the implant as a whole. To create a patch having a desired surface texture according to the present disclosure, a patch (e.g., patch112ofFIGS.1A and1B) may be prepared with an unvulcanized surface, and may be positioned into a hole of an implant shell, such as shell102, in which filling114may have been introduced. A vulcanizing foot of a heat vulcanizer may be blasted with an abrasive substance, such as the abrasive substances disclosed herein. The vulcanizer may then be used to compress the patch to the shell over the hole in the shell. During vulcanization, the textured, hot, vulcanizing foot may imprint the patch with the texture on the vulcanizer foot while the patch-to-shell connection is heat-cured. Upon removal from the vulcanizer, the patch area of the shell may have the desired texture surface. In another exemplary process, a flat sheet of patch material may be texturized using an imprinting mold that has been impacted with abrasive particles, as described above. Patches then may be punched or cut out of the sheet and applied to the shell using a suitable material, such as adhesives or “raw” (e.g., unvulcanized) sheeting material that may be placed in between a patch and a shell, and vulcanized to attach the patch to the shell, or by a suitable process such as a welding process using, e.g., ultraviolet (UV), infrared (IR), or other laser-generated light energy. As mentioned above, it is believed that the surface textures disclosed herein may contribute to the biocompatibility of medical implants including such textures. In some aspects, for example, implants with the surface characteristics disclosed herein may be associated with reduced inflammation of the surrounding tissue. Medical implants with surfaces prepared as described herein may increase implant biocompatibility, and/or may reduce or eliminate micro-ruptures of the implant, which may present safety risks to the patient and reduce the longevity of the implant. Without intending to be limited by theory, it is believed that medical implants having the surface characteristics discloses herein may help to reduce or eliminate adverse physiological response by the tissue surrounding the implant, such as double capsular contracture. For example, implants having surface textures as disclosed herein may provide for capsular contracture rates associated with secondary surgeries that are lower than 1.0%. Further, for example, implants with surface textures as disclosed herein may be implicated or associated with fewer implant ruptures, e.g., providing for a rupture rate lower than 1.0%. For example, the processes discussed above used to prepare the surface textures may minimize the creation of micro-fractures on the implant surface, which may help to reduce the incidence of rupture. The implants herein may include various features to assist in maintaining the location, position, and/or orientation of the implant over time. For example, in addition to, or in lieu of, the implant being formed with an integral surface texture, implants according to the present disclosure may include one or more tabs attached or otherwise coupled to a surface of the implant to assist in implant fixation. Each tab may have a surface texture with surface characteristics (e.g., roughness, skewness, kurtosis, peak height, valley depth, and/or contact point density) that is the same or different than the surface characteristics of another portion of the implant surface. Such tabs include, but are not limited to, reinforced tabs, such as silicone-reinforced tabs. For example, the outer surface104of implant100may include one or more silicone-reinforced tabs attached to the posterior side110of the implant100in a specified configuration or pattern. Exemplary configurations or patterns include those illustrated inFIGS.7A-7G, wherein the various areas708,710,712,714, may be defined by tabs as discussed above. Each tab may be positioned in a specific pre-determined location and orientation, e.g., for device fixation to restrict or prevent rotation or other movement of the device. Such tabs may be constructed as separate pieces of material that are attached to the larger body of the implant. In some aspects, the tabs may be configured to protrude outward from the surface of the implant, e.g., to increase the surface area of the implant in contact with the patient tissue. In further aspects, the tabs may be configured to rest flat against or flush with the surface of the implant. Such tabs may be attached to the body of the implant via, for example, a suitable adhesive or combination of adhesives, by welding techniques, and/or by fusion processes, which may be designed not to jeopardize the integrity of the implant (e.g., the integrity of an elastic shell) upon attachment of the tab(s). Such tabs may be formed with texturized surfaces, such as the texturized surfaces of the present disclosure. According to some aspects of the present disclosure, the implant may comprise one or more support elements in addition to, or as an alternative to, a texturized surface. Such support elements may extend outward from the implant for attachment to an anatomical feature of the patient to assist in implant fixation. In some embodiments, the support element may comprise a flexible strap and/or a fixation device. For example, one or more straps may extend from the implant surface to anchor the implant to a portion of the patient's anatomy. Such strap or straps may having a first end extending from the implant and a second end configured for attachment to an anatomical feature or structure of the patient. In some aspects, each strap may comprise a thin piece of elastic material, forming a suspension strap of a relatively thin diameter. Exemplary materials suitable for the strap(s) include, but are not limited to, biocompatible polymers, such as biocompatible reinforced polymer elastomeric materials compatible or integral with the shell material. The strap(s) may have a generally circular cross-section or may be substantially flat. In some aspects, the strap(s) may comprise a reinforced material, e.g., to provide the straps with rigidity to assist in anchoring. Referring to a breast implant, for example, the strap(s) may be attached to the upper posterior and/or anterior portion of the implant shell, e.g., the strap being molded or adhered directly into the shell, or formed as an integral extension of the shell. The strap(s) may be configured to attach to the clavicle or other internal structure of the patient, e.g., for fixation to bone. Upon implantation, for example, the strap(s) may extend upward through a relatively narrow subcutaneous tunnel to connect the implant to the clavicle. FIG.9illustrates, in schematic form, the positioning of an exemplary breast implant902having a support element in the form of a strap904and a fixation device906. The fixation device906may comprise any suitable fixation structure, such as one or more of a bone screw, suture, and/or staples, among other fixation devices and related mechanisms. Strap904may be elastically biased or deformable (e.g., similar to a rubber band) in the longitudinal direction, or may otherwise be flexible to allow some limited movement of the implant902while ensuring that the implant returns to its original position. In at least one example, strap904may be texturized, e.g., having surface characteristics with specific roughness, kurtosis, and/or skewness values as disclosed herein. Implants according to the present disclosure may include one or more features visible by imaging, e.g., to assist in monitoring the location, position, and/or orientation of the implant over time. For example, the implants may include one or more radiopaque markers. In some examples, the radiopaque markers may be in the shape of strips as illustrated inFIGS.10A and10B, or any other suitable shape. Each strip may have a particular orientation, e.g., in specific horizontal and/or vertical directions, to allow physicians to more easily determine movement, orientation, and/or position of the implant during and/or after implantation.FIG.10Adepicts, in schematic form, a configuration of radiopaque strips1001in an implant, such as a breast implant. In some embodiments, the implant may include a plurality of radiopaque markers, which may comprise the same or different materials.FIG.10Bdepicts, for example, a configuration of a vertical orientation radiopaque marker1002in an implant, and a horizontal orientation marker1004in the implant. The radiopaque markers1002,1004may comprise different materials, providing for two different radiopaque densities. Thus, for example, the markers1002,1004may be distinguishable from each other, e.g., to allow for measuring device rotation post-implantation. Additionally, or alternatively, implants according to the present disclosure may include one or more radiopaque salts or other radiopaque particulate materials to assist in monitoring location, position, and/or orientation of the implant. For example, radiopaque salts may added to a liquid or gel filling material before or after the filling material is introduced into the implant. Examples of radiopaque materials suitable for a filling material include, but are not limited to, barium sulfate, bismuth compounds, tungsten, tantalum, and platinum, among other radiopaque metals or metal alloys. In some aspects, the implants herein may comprise powered radiopaque materials. The implants herein may comprise from about 10% to about 45% of particulate radiopaque materials, by weight with respect to the weight of the implant, such as from about 15% to about 30% by weight, or from about 20% to about 25% by weight. In at least one example, the implant comprises a shell comprising a filling material such as a saline solution or a silicone gel and a radiopaque salt or a combination of radiopaque salts. For example, the amount of the radiopaque materials incorporated into the filling material may be selected so as to avoid altering and in order to not jeopardize the viscosity characteristics of the filling material. Such radiopaque features may not only allow the physician to assess movement, misalignment, and/or rotation of the implant, but also may indicate a breach in the shell allowing the filling material to seep through the shell into the surrounding tissue. For example, radiopaque materials escaping through a breached shell may give the appearance of a bleb or irregular extension of the surface of the implant in a radiograph. A physician may image a patient during a procedure and/or after a procedure (including during periodic check-ups) to verify the integrity of the implant over time. Implants according to the present disclosure may be, for example, single-use sterile implants. In some embodiments, implants according to the present disclosure may include a unique device identifier (UDI), such as a micro-transponder, for post-implantation device recognition and traceability. Any of the devices and features disclosed in U.S. Provisional Application No. 62/313,218, filed on Mar. 25, 2016, and/or U.S. Application Publication Nos. 2014/0081398 and/or 2014/0078013, each incorporated by reference herein, may be used in the present disclosure. As mentioned above, in some embodiments, the implant may comprise a shell configured to prevent or delay passage of a filling material through the shell to contact tissue. For example, the shell may comprise two or more different low viscosity, heat-curable silicone dispersions, wherein one of the silicone dispersions may form a barrier layer. Thus, for example, a first silicone dispersion may form a base of the layers of the shell, and a second silicone dispersion may comprise a barrier layer to prevent or delay the passage of filler through the shell to reach patient tissue. Optionally, additional silicone dispersions may form additional layers of the shell above or below the barrier layer. Implants according to the present disclosure may have a variety of different shapes, sizes, and/or volumes, depending on patient preference, anatomy, and/or need. In some aspects of the present disclosure, different parameters may be selected to produce a customized implant, such as a breast implant for breast augmentation and/or reconstruction surgery. Such parameters may include, for example, a surface texture having a set of pre-determined characteristics (e.g., roughness, kurtosis, skewness, peak height, valley depth, contact point density), and combinations of surface textures and characteristics as disclosed herein, as well as other implant parameters such as shape, volume, type of filling material, and viscosity of the filling material. Any features regarding customizing implants discussed in U.S. Provisional Application No. 62/318,402, incorporated by reference herein, may be used in the present disclosure. FIG.11depicts some exemplary shape and positioning parameters of implants which can be adjusted to create a custom-sized and custom-shaped implant. For example, an overall implant shape, such as a teardrop shape1102or an oval shape1104, may be selected. When viewed from an anterior or posterior viewpoint, the widest width of an implant having a teardrop shape1102may be located lower than a horizontal center line of the implant. In contrast, the widest width of an implant having an oval shape1104may be located at or substantially near the center line of the implant. An overall implant height1106and/or width1108may also be selected from, for example, a range of heights and/or widths designed to suit a variety of patients. A projection distance1110, representing the distance from the most anterior portion of the implant to the posterior portion (the portion to be placed closest to the patient's chest cavity), may also be customized. An apex position1112may also be selected to customize an implant. Apex position1112may represent, for example, a vertical positioning of the most anterior portion of the implant relative to the lowest portion of the implant.FIG.11depicts, for example, four different height options for apex position1112. Further, an upper pole location may also be customized for an implant. For example, selection of upper pole location1114would result in an implant having a more convex or linear shape from the top of the implant to the apex, or the most anterior portion of the implant when the implant is placed in a patient. Selection of upper pole location1116, in contrast, may provide for an implant having a more concave shape from the top of the implant to the apex. Such size and/or positioning parameters may be selected in combination with surface texture. For example, any combination of size and/or positioning parameters may be selected in combination with one or more surface textures prepared according to the present disclosure for the outer surface of an implant. In some examples, surface textures for both outer and inner surfaces of an implant shell may be selected in combination with size and/or positioning parameters. For example, a relatively rough-textured inner surface or an untextured inner surface may be selected in combination with an outer surface having a hierarchical nanostructure (e.g., controlled characteristics of roughness, kurtosis, and/or skewness as discussed above), and further in combination with one or more size and/or positioning parameters. In further examples, one of a variety of configurations of an outer surface texture (such as those depicted in, e.g.,FIGS.7A-7Gand others described herein) may also be selectable in combination with other selectable parameters. In further examples, a customized label (e.g., label706inFIGS.7A-7G) may also be selected in combination with outer surface textures, an inner surface texture, and/or other parameters. In some embodiments, one or more shell and/or filling materials may also be selected in combination with other implant parameters. For example, a shell having one or more colored or transparent barrier layers to inhibit or prevent the passage of liquid or gel through the shell may be selected in addition to other parameters. In further examples, a desired gel or other filling material may also be selected. In yet more embodiments, additional features may also be selected in combination with desired size, shape, positioning, surface texture, and other parameters. For example, one or more tabs and/or straps to aid in fixation may be selected, as well as sizes and positions of such tabs and/or straps. In further examples, one or more radiopaque materials may also be selected for addition to an implant, such as radiopaque salts to be added to the gel or filling material, and/or radiopaque markers. In some embodiments of the present disclosure, customized implant parameters, such those disclosed herein, may be selected prior to manufacturing an implant mold or mandrel, such as mandrel800. In some embodiments, mandrel800or another mold used to manufacture a customized implant as disclosed herein may be manufactured to be a particular size and/or shape using customized parameters selected by a particular patient, practitioner, or manufacturer. In some embodiments, a customized mandrel or mold may be, for example, three-dimensionally printed. In some embodiments, after initial manufacture or printing of a customized mold or mandrel, one or more surfaces of the mold or mandrel may be treated as disclosed herein (e.g., blasted with abrasive particles) in order to impart one or more desired surface textures to an implant of a desired custom shape and/or size, to be manufactured using the customized mold or mandrel. The following examples are intended to illustrate the present disclosure without, however, being limiting in nature. It is understood that the present disclosure encompasses additional embodiments consistent with the foregoing description and following examples. EXAMPLES Example 1 A breast implant is prepared as follows. The shell of the breast implant is prepared with a mandrel comprising Delrin® textured with a staurolite sand and mineral mix of particles having a diameter ranging from 50-420 μm, and a Mohs hardness ranging from 6.5-7. The texturized mandrel is dipped a total of five to six times into a dispersion of a siloxane polymer elastomer, until a coating having a total thickness of about 1.0 mm is achieved to form the uncured shell. The dipped mandrel is then cured at a temperature of 126° C. The cured shell is then removed from the mandrel and inverted, such that the surface formerly in contact with the texturized mandrel surface is the outermost surface of the shell. The shell then is filled with a silicone gel. Air is removed from the shell, the shell is sealed, and the silicone gel is cured. Surface properties including the average roughness, the skewness value, and the kurtosis value of the shell are measured using a confocal laser microscope or an optical profilometer. The shell measures an average roughness (Sa) of 3.1 μm, a skewness value of 0.89, and a kurtosis value of 4.76 (normalized kurtosis value of 1.76). A 3D non-contact microscope is used to measure the density of contact points of the shell surface. The shell surface has a density of contact points ranging from 40,000 peaks/cm2to 50,000 peaks/cm2. Example 2 Normalized kurtosis values were measured for the surfaces of several commercial breast implants (surfaces A-J), as summarized in Table 2. A Keyence confocal laser microscope (Keyence Corporation, USA) was used to measure surface roughness for each implant to determine the normalized kurtosis value. Measurements were processed using the Gwyddion program for modular scanning probe microscopy data visualization and analysis. Results are summarized in Table 2.1 below and shown inFIG.5. TABLE 2.1NormalizedkurtosisSurfaceProductvalueABiocell ® (Allergan)−0.6BPolytech−0.2CSebbin−0.4DCereform ® (Cereform Ltd.)0.1ESilimed0.45FSilkSurface ™-Gen 1 (Motiva)1.75GSiltex ® (Mentor)−0.25HVelvetSurface ™ (Motiva)−0.35IEurosilicone (GC Aesthetics)−0.45JMentor Smooth−0.70 Surface characteristics for SilkSurface™—Gen1 and VelvetSurface™ breast implants (Motiva, Establishment Labs) were measured and compared to the surface characteristics of breast implants prepared as described in Example 1. Results are shown in Table 2.2. Measurements were performed with a Dektak-XT stylus profiler, and surface characteristics were calculated according to standard ISO 4287:1997. TABLE 2.2SilkSurface ™-Surface characteristicGen1VelvetSurface ™Present disclosureAverage roughness (Sa)3.5 μm ± 0.1 μm17.0 μm ± 3.0 μm4.0 μm ± 1.0 μmSkewness (Ssk)0.60.1 ± 0.20.4 ± 0.2Kurtosis (Sku)2.72.6 ± 0.33.1 ± 0.4Maximum peak height7.9 μm ± 0.4 μm43.0 μm ± 9.0 μm14.0 μm ± 2.0 μmMaximum valley depth—41.0 μm ± 6.0 μm12.0 μm ± 2.0 μmTotal Height of Surface Profile15.0 μm ± 1.0 μm85.0 μm ± 12.0 μm25.0 μm ± 4.0 μm(max. peak height + valleydepth)Mean Height of Surface Profile—57.0 μm ± 15.0 μm13.0 μm ± 2.0 μm(avg. peak height + valleydepth)Contact point density——40,000-50,000(peaks/cm2) Without being bound by theory, it is believed that the combination of surface characteristics listed above for the surface according to the present disclosure exhibits superior biocompatibility properties, as compared to the other breast implants listed in Tables 2.1 and 2.2 above. For example, it is believed that a mean surface profile (the average of peak heights and valley depths across the surface profile) near the maximum peak height and maximum valley depth, combined with a kurtosis value above Gaussian distribution (indicating more uniformity in peak heights and valley depths), a positive, near-zero skewness value (indicating symmetry of peaks and valleys), and a high contact point density, provides for lower adverse physiological reactions, a reduction in immune response, and less capsular contracture. For example, Table 2.2 shows that the surface according to the present disclosure exhibited a greater peak height and greater total surface profile height as compared to the SilkSurface™—Gen1 breast implant. Implant surfaces according to the present disclosure are expected to provide greater biocompatibility, e.g., for fibroblast cell alignment. Example 3 Several silicone materials prepared according to the procedure of Example 1 were tested for hydrophobicity as an indicator of biocompatibility. A set of ten silicone shells having an average roughness value Raof ˜4 μm was prepared as described in Example 1. A scalpel was used to cut three rectangular pieces out of each shell, at the base (located on the posterior side of the shell as it would be implanted in a patient), the equator (located around the portion of the shell having the largest diameter), and the apex (located at the anterior-most point of the shell as it would be implanted in a patient). A total of 30 samples mounted onto slides were thus prepared. Pieces cut from the base and apex measured approximately 1 cm×2 cm in area, and pieces cut from the equator measured approximately 1 cm×3 cm. Samples from the equator of each shell were cut such that the long edge of each sample was oriented in the direction from the base of the shell to the apex. Each sample was loaded onto a microscope slide in substantially the same orientation as other samples from the same implant location. Contact angle measurements were performed at room temperature (20° C.) and ambient humidity (85%) using a ramé-hart goniometer CAM 200 system (ramé-hart instrument co., USA). For each measurement, a single drop of water having a volume between 0.5-1.0 μl was placed on the surface of the sample manually with a micropipette. Contact angle measurements were taken at t=0 and at t=10 minutes. This was repeated for three separate drops of water on the surface of each sample to avoid local effects caused by irregularities in a particular spot. Table 3 lists the average contact angles obtained for the samples, where “avg. initial CA” refers to the average contact angle measured at t=0, “avg. final CA” refers to the average contact angle measured at t=10 minutes, and “avg. CA” refers to the average of the measurements at t=0 and t=10 minutes. TABLE 3SampleAvg. InitialAvg. FinalAvg. CAlocationCA (°)CA (°)(°)Equator131 ± 3107 ± 8119Apex132.6 ± 3108.7 ± 8121Base129.2 ± 5105 ± 7117Combined*131 ± 2107 ± 4119 ± 2*Average contact angles of equator, apex, and base combined As shown by the difference between initial contact angle measurements and final contact angle measurements, the water droplets initially retained more of their shape (exhibited a higher contact angle with the surface), and then spread somewhat across the surfaces over time, by t=10 minutes. This was understood to relate to the types of forces between the water droplet and surface, e.g., an initial interaction driven primarily by physical forces (e.g., roughness, pore size, etc.) that are overshadowed by chemical forces (e.g., determined by the chemical properties of the implant material). Both the initial and final contact angle measurements demonstrate that the samples exhibit overall hydrophobicity, with higher initial hydrophobicity. Such hydrophobicity of the surface may provide for improved biocompatibility between implant surfaces and patient tissue. Any aspect or feature in any embodiment may be used with any other embodiment set forth herein. It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed implants, implant features, and processes without departing from the scope of the disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure disclosed herein. It is intended that the specification and examples be considered as exemplary only. | 99,246 |
11857410 | DETAILED DESCRIPTION Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. Although the embodiments herein may be described in connection with various principles and beliefs, the described embodiments should not be bound by theory. For example, embodiments are described herein in connection with prosthetic valves, more specifically cardiac prosthetic valves. However, embodiments within the scope of this disclosure can be applied toward any valve or mechanism of similar structure and/or function. Furthermore, embodiments within the scope of this disclosure can be applied in non-cardiac applications. Aspects of the present disclosure are directed toward heart suture guards. The heart suture guards are configured to facilitate implantation of the heart valve. The heart suture guards discussed herein facilitate placement and suturing of the heart valve into the native annulus, and, in certain embodiments, help prevent damage to the heart valve from mishandling of the heart valve during an implantation procedure. For example, the heart suture guards (also referred to herein as suture guards) discussed herein are configured to help prevent sutures from looping over or otherwise becoming entangled with the valve posts (also referred to herein as suture looping, shunt wrapping, and/or strut wrapping) during implantation. When suture is inadvertently looped around one or more valve posts and subsequently tightened, the looped suture can damage one or more portions of the valve structure, damage one or more valve leaflets, negatively impact the functionality of the valve and/or the leaflets inside the posts. The heart suture guard designs, consistent with various aspects of the present disclosure, are configured to lessen the opportunity for suture looping. In some embodiments, the suture guards are configured to engage the valve posts to deflect the valve posts radially inward toward a longitudinal axis of the prosthetic valve100. In some examples, this mechanism of deflecting the valve posts radially inward helps prepare the valve for insertion into the annulus. Moreover, in some examples, a deflection of the valve posts radially inward helps reduce a radial profile of the valve posts, which help reduce the likelihood of a suture becoming entangled with the valve post. In various embodiments, the suture guard may also operate to cover or at least extend over an outflow end of the valve post, as illustrated and described below. A suture guard that extends over an outflow end of the valve post can operate to deflect suture line running along an exterior of the valve from migrating to a position interior to a valve post. In some embodiments, the heart suture guards include ramping features that are configured to deflect suture away from the valve posts. In some examples, the suture guards help the suture land safely on a suture ring or sewing cuff on the prosthetic valve without getting entangled with the valve posts. FIGS.1A and1Bare outflow and inflow, respectfully, perspective views of a valve100in the form of a prosthetic heart valve, in accordance with an embodiment. The components of the valve100that are visible inFIGS.1A and1Binclude three flexible leaflets310, a leaflet frame200including three valve (commissure) posts210that has been covered with material, a base frame500that has been covered with material, and a sewing cuff600. The leaflet free edges312of the leaflets310come together at a coaptation region316in a Y-shaped pattern (when viewed from above) to close the valve100. The valve100closes in this fashion when the pressure of the blood on the outflow side (as viewed inFIG.1A) is greater than the pressure of the blood on the inflow side of the valve (as viewed inFIG.1B). The leaflet free edges312of the leaflets310move apart to open the valve100and to let blood flow through the valve100from the inflow side as viewed inFIG.1Bwhen the pressure of the blood on the inflow side of the valve100is greater than the pressure on the outflow side of the valve100. For purposes of this disclosure, it is to be understood that the inflow side or end of the heart valve100is considered “proximal” to the outflow side or end of the heart valve100, while the outflow side or end of the heart valve100is considered “distal” to the inflow side or end of the heart valve100. The leaflets310generally flex about the leaflet base325of the U-shaped portion as the leaflets310open and close. In an embodiment, when the valve100is closed, generally about half of each leaflet free edge312abuts an adjacent half of a leaflet free edge312of an adjacent leaflet310, as shown inFIG.1A. The three leaflets310of the embodiment ofFIG.1Ameet at a triple point348. The valve orifice150is occluded when the leaflets310are in the closed position stopping fluid flow during reverse flow. In accordance with other embodiments of the valve100, each leaflet310includes a central region329and two side regions328on opposite sides of the central region329. The central region329is defined by a shape substantially that of an isosceles trapezoid defined by two central region sides327, the leaflet base325and the leaflet free edge312. Each of the side regions328has a shape substantially that of a triangle and each are defined by one of the central region sides327, one of the leaflet sides323, and the leaflet free edge312. FIG.2Ais a side-by-side illustration of a suture guard202in accordance with an embodiment. The suture guard202includes a first (upper) portion204and a second (lower) portion206. The first portion204is configured to interface with a prosthetic heart valve100(as shown in further detail inFIGS.2B-G). The first portion204includes supports208that may be equal to a number of valve (commissure) posts210, shown inFIGS.1A-B. The supports208may interface with an internal portion of the valve (commissure) posts210. As described in further detail below, the supports208act as a surface to structurally support the valve (commissure) posts210when moved inwardly for delivery. More specifically, the suture guard202is configured to move, which may be by bending, one or more valve (commissure) posts210of the prosthetic valve100inwardly toward a longitudinal axis of the prosthetic valve100. In addition, the first portion204may also include tapered surfaces211that are carved out of the first portion204to avoid interference with the leaflets310. The first portion204may be arranged within an inflow side of the valve100. The first portion204of the suture guard202also includes fiber holding portions212that are arranged at a perimeter of the first portion204of the suture guard202. The fiber holding portions212include openings that a suture or fiber may be thread through in order to move the one or more valve (commissure) posts210of the prosthetic valve100inwardly toward a longitudinal axis of the prosthetic valve100. The second portion206of the suture guard202is arranged below or under the first portion204. The second portion206may be configured to apply the force used to move the one or more valve (commissure) posts210of the prosthetic valve100inwardly toward a longitudinal axis of the prosthetic valve100. The second portion206, for example, can apply tension via a linear motion to the fiber or suture. The second portion206withdraws the one or more fiber lines inwardly toward the second portion206of the suture guard202to move the one or more valve (commissure) posts210. In addition, this mechanism shortens the length of the suture guard202and the one or more valve (commissure) posts210as opposed to lengthening the assembly. As shown in detail with reference toFIGS.2C-G, the second portion206may interface with a suture or fiber such that the suture or fiber slides inside the second portion206, which pulls the suture or fiber. This action by the second portion206applies the force used to move the one or more valve (commissure) posts210of the prosthetic valve100inwardly toward a longitudinal axis of the prosthetic valve100. FIG.2Bis a first and second side view of the suture guard202, shown inFIG.2A, with a prosthetic heart valve100. The suture guard202is shown with the prosthetic heart valve100. The suture guard202does not alter the shape or otherwise move the prosthetic heart valve100at this point. The suture guard202is arranged within the inflow portion of the prosthetic heart valve100and may support the leaflets310during implantation. The suture guard202is shown in an initial (e.g., not tensioned) position. The suture guard202has not applied to tension to or otherwise altered the shape of the prosthetic heart valve100in the position shown inFIG.2B. To connect the first portion204and the second portion206, the second portion206is pressed into the first portion204. In certain embodiments, the second portion206connects by using a click-tight mechanism or pawl mechanism. The second portion206connects with the first portion204with one click, in certain embodiments. To align the suture guard202with the prosthetic valve100, the fiber holding portions212(or tabs) are aligned with the valve (commissure) posts210. The fiber holding portions212may be seated against the base of the prosthetic valve100, which may be facilitated by the tapered surfaces211of the first portion204of the suture guard202. FIG.2Cis a bottom view of the suture guard202and the prosthetic heart valve100, shown inFIGS.2A-B, with a fiber214. One end of the fiber214is wrapped through openings in the fiber holding portion212. The fiber214may be knotted at the through openings in the fiber holding portion212to tie the fiber214to the suture guard202. In certain embodiments, another fiber214is similarly routed through each of the fiber holding portions212. In other embodiments, a single fiber214is used. In certain embodiments, the fiber holding portions212are equal to the number of supports208in the first portion204of the suture guard202, which may be equal to a number of valve (commissure) posts210. The other end of the first fiber214is fed through the right hole in the fiber holding portions212, and through a sewing cuff600of the prosthetic heart valve100, in certain embodiments. The fibers214may be arranged from through a sewing cuff600to weave the fibers214between the inflow side and the outflow side of the prosthetic heart valve100. FIG.2Dis a first and second side view of the suture guard202, the prosthetic heart valve100, and the fiber214, as shown inFIGS.2A-C. After passing the fiber214through the sewing cuff (not shown), the fiber214is then passed through the valve (commissure) post210. The fiber214is routed along a side of the valve (commissure) posts210(e.g., a right side of the valve (commissure) posts210as shown on the left portion ofFIG.2D). The fiber214remains on an outer diameter of the prosthetic heart valve100and does not pass through the inner diameter of the prosthetic heart valve100at any point. The fiber214is passed through the valve (commissure) posts210to the left (as shown right portion ofFIG.2D) and engages with the prosthetic heart valve100in the same manner as the other valve (commissure) posts210but mirrored. FIG.2Eis top view (from the outflow side) of the suture guard202, the prosthetic heart valve100, and the fiber214, as shown inFIGS.2A-D. After arranging the fiber214as described with reference toFIG.2D, the fiber214may then be passed through the prosthetic heart valve100(e.g., through the sewing cuff) and through the left opening in the fiber holding portion212. The other two fibers214are then fed through their respective openings in the fiber holding portions (obstructed inFIG.2E) through the prosthetic heart valve100(e.g., through the sewing cuff), and through their respective valve (commissure) posts210, as described with reference to the first fiber214. In this embodiment, the three fibers214are fed through the prosthetic heart valve100and suture guard202. The fibers214each span two valve (commissure) posts210with one end of the fibers214attached to the fiber holding portions212of the suture guard202. Although the prosthetic heart valve100is shown as a tricuspid valve (e.g., three leaflets310), the prosthetic heart valve100may include any number of leaflets (e.g., one, two, four, five, six, and so on). In embodiments where the prosthetic heart valve100includes a different number of leaflets310, the number of leaflets310may correspond to an equal number of aspects on the suture guard202such as an equal number of fibers214, fiber holding portions212, supports208, and valve (commissure) posts210. FIG.2Fis a partial cross-sectional first view and second side view of the suture guard202, the prosthetic heart valve100, and the fiber(s)214as shown inFIGS.2A-E. The free end of each fiber214is then fed inside the suture guard202. More specifically, the fiber214may be fed into the second portion206of the suture guard202between cone shaped members216of the second portion206. The fibers214may enter the second portion through openings218. As shown inFIG.2F, the second portion206is shown engaged with the first portion204of the suture guard202. As compared toFIG.2G, the second portion206is outwardly extended from the first portion204. The second portion206may be threadedly engaged or engaged via a snap-fit (click-fit or pawl mechanism) connection to the first portion204. The second portion206is moved inwardly within the first portion204to adjust tension on the fibers214as shown inFIG.2G. The prosthetic valve100and suture guard202are packaged together and delivered to a physician for implantation in the configuration shown inFIG.2F. The physician engages the suture guard202by pressing (e.g., linearly actuating) the first portion204into the second portion206, which in turn, tensions the fiber(s)214causing the valve (commissure) posts210to deflect inward preparing the prosthetic valve100for insertion into the annulus. FIG.2Gis a partial cross-sectional first view and top view of the suture guard202, the prosthetic heart valve100, and the fiber(s)214as shown inFIGS.2A-F. The prosthetic valve100and the suture guard202are shown in an engaged state for implantation. With all the fibers214secured to the second portion206(e.g., inside cone shaped members216), the prosthetic heart valve100is ready for implantation (e.g., after packaging and sterilization). When a surgeon is ready to implant the prosthetic heart valve100, a handle (e.g., as shown inFIGS.4-5) is attached to the second portion206, then the second portion206is pressed into the first portion204pulling the three fibers214with it as shown by the arrows inFIG.2G. The length of the fibers214are fixed from end-to-end, thus, the tension resulting from pressing the second portion206into the first portion204(e.g., linear motion mechanism) deflects or moves, which may be by bending, the valve (commissure) posts210inwards. The fibers214may be arranged from through the sewing cuff600to weave the fibers214between the inflow side and the outflow side of the prosthetic heart valve100. To remove the suture guard202, the surgeon cuts each of the three fibers214in a designated area220(e.g., a cut slot as also shown inFIG.2C) which releases the tension in the fibers214allowing the valve (commissure) posts210held inward by the fibers214to return to the initial position when the suture guard202is released from the prosthetic valve100. The suture guard202is removed from the prosthetic heart valve100by pulling the suture guard202out and away from the prosthetic heart valve100. The handle may be removed prior to removing the suture guard202or the handle may be reattached to facilitate removal of the suture guard202. As the ends of each of the fibers214remain attached to the suture guard202after being cut, the cut ends of each fiber214unwind back through the prosthetic heart valve100as the suture guard202is retracted away from the heart valve100. Thus, removing the suture guard202also removes the fibers214from the prosthetic heart valve100. The suture guard202acts as a delivery tool to aide in the surgical process. As noted above, the suture guard202lessens the chance that sutures are entangled with for the valve (commissure) posts210and/or lessens the chance of suture wrapping around one or more of the leaflets310(shunt wrapping) during implantation of the prosthetic valve100at the target location. As discussed in detail above, the suture guard202is configured to ease of implantation, protect the anatomy, and prevent strut wrap. FIG.3Ais an exploded view of an example suture guard202and a prosthetic heart valve100, in accordance with an embodiment. The suture guard202includes a first (upper) portion204and a second (lower) portion206. The first portion204is configured to interface with a prosthetic heart valve100, as shown in further detail inFIG.3B. The suture guard202may also include an atraumatic dome320. The atraumatic dome320interfaces with the first portion204of the suture guard202. The first portion204may be arranged within the inflow section of the prosthetic heart valve100and the atraumatic dome320may be arranged within the outflow portion of the prosthetic heart valve100. The atraumatic dome320is configured to protect against injury to a portion of a heart. In addition, the atraumatic dome320is configured to create a ramp for sutures (used to attach the prosthetic valve100at an implant location) to slide over and past the valve (commissure) posts210of the prosthetic valve100to avoid suture entanglement with one or more leaflets of the valve (commissure) posts210. As shown inFIG.3A, the second portion206may be separable from the first portion204. In addition, the suture guard202includes a fiber214routed through the suture guard202. One end of the fiber214is routed through an opening in the first portion204(e.g., as shown above inFIGS.2A-G). The fiber214may be defined by one or more knotted portions322. In certain embodiments, the fiber214is routed through the valve (commissure) posts210of the prosthetic valve100as shown inFIG.3A. The valve (commissure) posts210may include an opening. The second portion206of the suture guard202is arranged below or under the first portion204of the suture guard202. The second portion206may be configured to apply the force used to move the one or more valve (commissure) posts210of the prosthetic valve100inwardly toward a longitudinal axis of the prosthetic valve100. The second portion206, for example, can apply a linear motion to the fiber214or fibers214. The second portion206withdraws the one or more fiber lines inwardly toward the second portion206of the suture guard202to move the one or more valve (commissure) posts210. In addition, this mechanism shortens the length of the suture guard202and the one or more valve (commissure) posts210as opposed to lengthening the assembly. As shown inFIG.3A, the second portion206includes one or more prong structures324that interface with the first portion204. The one or more prong structures324force the fiber214into the first portion204. This action by the second portion206applies the tension to the fiber214as shown in further detail with reference toFIG.3B. The second portion206can include a screw mechanism326configured to secure the second portion206to the first portion204. The screw mechanism326rotates relative to the second portion206. The screw mechanism326may facilitate applying tension to the fiber214and maintaining tension on the fiber214during delivery and implantation of the prosthetic valve100. FIG.3Bis another view of the suture guard202and the prosthetic heart valve100, as shown inFIG.3Awith the second portion206coupled with the first portion, and with portions removed for ease of understanding. As shown inFIG.3B, the prong structures324force the fiber214into the first portion204thereby applying tension to the fiber214. The fiber214is crimped up into the first portion204by the prong structures324. Because the fiber214is coupled to at least one of the one or more valve (commissure) posts210of the prosthetic valve100, the tension moves the valve (commissure) posts210inwardly toward a longitudinal axis of the prosthetic valve100. In certain embodiments, the fiber214is secured to each of the valve (commissure) posts210. In other embodiments, the suture guard202may include multiple fibers214(e.g., as described with reference toFIGS.2A-G). When a surgeon is ready to implant the prosthetic heart valve100, a handle (e.g., portions of which are shown inFIGS.4-5) is attached to the second portion206at the screw mechanism326. The handle may be used to actuate the screw mechanism326to apply tension to the fiber214. The atraumatic dome320and the screw mechanism326can include oppositely threaded portion such that the screw mechanism326can fix the first portion204and the second portion206of the suture guard202together. In addition, the handle can include oppositely threaded portions relative to the screw mechanism326in order to tighten the screw mechanism326and tension the fiber214. To remove the suture guard202, the surgeon cuts the fiber214in a designated area which releases the tension in the fiber214lines allowing the valve (commissure) posts210inwards to return to intended position. The suture guard202is removed from the prosthetic heart valve100by pulling the suture guard202out and away from the prosthetic heart valve100. The handle may be removed prior to removing the suture guard202, in other instances, the handle may be reattached to facilitate removal of the suture guard202.FIG.3Cis a bottom view of the suture guard202and the prosthetic heart valve100, as shown inFIGS.3A-B, without the atraumatic dome320 FIG.4Ais a partial cross-sectional view of an example suture guard202, a prosthetic heart valve100, and a delivery handle410, in accordance with an embodiment. The suture guard202shown inFIG.4Aincludes an atraumatic dome320having an internally threaded portion402. The atraumatic dome320includes deflection lobes404that are configured to interface and couple the atraumatic dome320to another portion of the suture guard202.FIG.4Aalso shows a sleeve400that is used to facilitate use of the delivery handle410. The sleeve400shown inFIG.4Aincludes an externally threaded portion406that is configured to thread into the internally threaded portion402of the atraumatic dome320. The externally threaded portion406is configured to interface with one or more fibers214that are arranged with one or more of the valve (commissure) posts210of the prosthetic valve100. The delivery handle410is configured to apply tension to the one or more fibers214. The externally threaded portion406rotates relative to the internally threaded portion402and applies tension to the fiber214due the externally threaded portion406and the internally threaded portion402moving apart. This maintains tension on the fiber214during implantation of the prosthetic valve100. Because the fiber214is coupled to at least one of the one or more valve (commissure) posts210of the prosthetic valve100, the handle410applies tension and moves the valve (commissure) posts210inwardly toward a longitudinal axis of the prosthetic valve100. The sleeve400includes tabs408that interface with the suture guard202. In addition, the delivery handle410that is configured to move relative to the sleeve400to apply tension to the fiber214. The delivery handle410is coupled to the externally threaded portion406.FIG.4-B show a portion of the delivery handle410. The delivery handle410is accessible to an operating physician and extends outside the body. In certain instances, the delivery handle410portion shown attaches to another handle. The delivery handle410shown may be disposable. FIG.4Bis a partial cross-sectional view of the suture guard202, the prosthetic heart valve100, and the sleeve400, as shown inFIG.4A, in another configuration. The sleeve400is separated from the suture guard202in the configuration shown inFIG.4B. As shown inFIG.4B, the illustrative valve (commissure) post210is moved inwardly compared to the configuration shown inFIG.4A. To facilitate release of the sleeve400from the suture guard202, the delivery handle410is dovetailed at the point of interface with the externally threaded portion406. As a result, the externally threaded portion410may be slid perpendicular to the externally threaded portion406to release from the externally threaded portion406. Thus, the delivery handle410and the sleeve400are uncoupled and released from the suture guard202. FIG.5is a partial cross-sectional view of an example valve holding200device, a prosthetic heart valve100, and another delivery handle505, in accordance with an embodiment. The suture guard202shown inFIG.5includes an atraumatic dome320having an internally threaded portion402. The delivery handle505is accessible to an operating physician and extends outside the body. In certain instances, the delivery handle505portion shown attaches to another handle. The delivery handle505shown may be disposable. The delivery handle505shown inFIG.5includes an externally threaded portion406that is configured to thread into the internally threaded portion402of the atraumatic dome320. The externally threaded portion406is configured to interface with one or more fibers214that are arranged with one or more of the valve (commissure) posts210of the prosthetic valve100. The delivery handle505is configured to control the suture guard202and apply tension to the one or more fibers214. The externally threaded portion406rotates relative to the internally threaded portion402and applies tension to the fiber214and maintains tension on the fiber214during delivery and implantation of the prosthetic valve100. Because the fiber214is coupled to at least one of the one or more valve (commissure) posts210of the prosthetic valve100, the handle505applies tension and moves the valve (commissure) posts210inwardly toward a longitudinal axis of the prosthetic valve100as shown inFIG.5. The delivery handle505configured to separate from the suture guard202by applying pressure at area506as indicated by the arrows. Applying pressure at the area506opens the delivery handle505at area508as indicated by the arrows. As a result, the delivery handle505releases the externally threaded portion406. Thus, the delivery handle505is uncoupled from the suture guard202. FIG.6is an illustration of an example suture guard202and a prosthetic heart valve100, in accordance with an embodiment. The holding device200shown inFIG.6is an everted tube. The everted tube holding device200is arranged through the inflow portion of the prosthetic valve100and folded over the valve (commissure) posts (for further detail regarding the everted tube holding device200, reference may be made toFIGS.18-20). The everted tube holding device200is secured in place by a fiber that is arranged through the prosthetic valve100in accordance with the examples discussed above. As shown, the everted tube holding device200is configured to cover the valve (commissure) posts to help minimize the potential for suture looping. For example, the everted tube holding device200operates to deflect suture line extending along and exterior of the valve from becoming entangled with one or more of the covered valve (commissure) posts during the implantation procedure. In some examples, the everted tube holding device200may be configured to engage the valve (commissure) posts to move the one or more valve (commissure) posts of the prosthetic valve100inwardly toward a longitudinal axis of the prosthetic valve100. For instance, to move the valve (commissure) posts inwardly, the everted tube holding device200may be configured to create a surface on which the fiber214or fibers214(as noted above, the number of fibers may be equal to the number of valve (commissure) posts) slide, as they are tensioned in relation to the valve (commissure) posts, which causes the valve (commissure) posts to be moved inward. Additionally or alternatively, the everted tube holding device200may provide cushioning to the valve (commissure) posts to further reduce likelihood of trauma during implantation. The everted tube holding device200may be removed from the prosthetic heart valve100by releasing the fiber214or fibers214, which releasing tension on the everted tube holding device200and the valve (commissure) posts. The everted tube holding device200may then be slid through the prosthetic valve100. Additional examples of suture guards that operate to cover one or more of the valve (commissure) posts are illustrated and described further below with regard toFIGS.29A-33B. FIG.7is an illustration of another example suture guard202and a prosthetic heart valve100, in accordance with an embodiment. The suture guard202includes one or more retractable arms700that cover valve (commissure) posts of the prosthetic heart valve100. The retractable arms700provide a soft barrier between the valve (commissure) posts of the prosthetic heart valve100and anatomical features, such as the interior walls of the heart, thereby reducing the likelihood of trauma. These arms also provide a ramping surface for fiber loops214to slide past the valve (commissure) posts of the prosthetic heart valve100. The retractable arms700can be retractable allowing for the prosthetic heart valve100to be removed from the upstream side of the prosthetic heart valve100. The suture guards discussed herein are configured to protect prosthetic heart valves during surgery, protect tissue during insertion, and provide room for suture placement and tying as discussed in detail above. The suture guards200are also configured to connect and disconnect to a delivery handle, and attach/detach from prosthetic heart valves100from the inflow direction. FIG.8is an illustration of example fiber pathway, in accordance with an embodiment. The fiber214may be routed across a surface800and through a trough802. The fiber214includes a non-adjustable direction804and an adjustable direction806. As shown inFIG.8, the fiber214is routed underneath itself resulting in the fiber214arranged in the trough802when the non-adjustable direction804is placed under tension. The surface800includes an area808on the back of the surface800, which can be a device as discussed herein, to facilitate removal of the fiber214by cutting the fiber214. The routing of the fiber214allows for one of the fiber to slip when pulled (in the adjustable direction806) while not allowing the other end of the fiber214to slip (in the non-adjustable direction804). The surface800may be a portion of the suture guard202shown and discussed herein. The surface800and corresponding features shown inFIG.8, for example, may be arranged at the perimeter of the suture guard202for the fiber214. Anywhere the fibers214are anchored (e.g., fiber holding portions shown inFIGS.2A-Gor knotted portions322shown inFIGS.3A-B) may utilize the aspects ofFIG.8. FIG.9is an illustration of example fiber wrapping pathway, in accordance with an embodiment. The fiber214may be routed through a device900. The device includes pathways902through which the fiber214may be routed. The fiber214includes a non-adjustable direction804and an adjustable direction806. As shown inFIG.9, the fiber214is routed onto itself. The pathways902are large enough to fit two fibers214as shown in the left portion ofFIG.9, but not for three fibers214. In certain embodiments, a release fiber904may be used to release the fiber214. The release fiber904acts as lock loop that can release the fiber214when pulled in a release direction906. As shown in the right portion ofFIG.9, the pathways902are large enough for 3 fibers but not for 4 fibers. The routing of the fiber214allows for one of the fiber to slip when pulled (in the adjustable direction806) while not allowing the other end of the fiber214to slip (in the non-adjustable direction804). The device900may be a portion of the suture guard202shown and discussed herein. The device900and corresponding features shown inFIG.9, for example, may be arranged at the perimeter of the suture guard202for the fiber214. Anywhere the fibers214are anchored (e.g., fiber holding portions shown inFIGS.2A-Gor knotted portions322shown inFIGS.3A-B) may utilize the aspects ofFIG.9. FIG.23is an illustration of an example handle2300, in accordance with an embodiment. The handle2300may be disposable and remotely actuatable to release fibers214from the suture guards202discussed herein. As shown inFIG.23, the handle2300includes a release fiber904. The release fiber904can be engaged with fibers214as shown inFIG.9. An end of the release fiber904may also be coupled to cap2302. The cap2302is removeable from the handle2300by pulling on the cap2302in the direction shown. In this manner, the release fiber904is removed through a catheter2304portion of the handle2300. As a result, the release fiber904unlocks the fiber214or fibers214, as shown inFIG.9. As noted above, upon application of linear motion by the suture guard202, the one or more fiber lines214are configured to apply tension to move one or more valve posts210of the prosthetic valve100inwardly toward a longitudinal axis of the prosthetic valve100. The release fiber906is coupled to the cap2302and configured to releasably lock the one or more fiber lines214with the suture guard202, as discussed with reference toFIG.9. Upon actuation and removal of the cap2302from the handle2300, the release fiber906releases the release fiber906from the pattern shown inFIG.9to unlock the one or more fiber lines214. FIGS.29A to33Bprovide illustration on an example system1000according to some embodiments. The system1000generally includes a suture guard2000that operates to protect one or more components of a heart valve100during an implantation procedure of the heart valve100. In various embodiments, the suture guard2000is configured to minimize a possibility for entanglement of suture line (or other deployment components) with one or more portions of the heart valve100. For instance, as mentioned above, in various implantation procedures, one or more suture lines are utilized to install or implant the prosthetic heart valve100into a native valve annulus. In certain implantation procedures, the heart valve100is translated along one or more suture lines toward the native valve annulus (see, e.g.,FIG.32). The suture guard2000operates to help minimize a possibility that the suture line will become entangled with one or more of the commissure posts210as the heart valve100is translated along the suture line by covering, for example, one or more commissure posts of the prosthetic heart valve100. It should be appreciated that the prosthetic heart valve100illustrated and described with reference toFIGS.29A-29E,32, and33A-1and33A-2is consistent in form and function with the heart valve100illustrated and described above. In some examples, the suture guard2000is configured such that it operates to deflect suture line such that the suture line does not cross from one side of a commissure post210to an opposing side of the commissure post radially inwardly of the commissure post210. For instance, in some examples, the suture guard2000is configured to extend over the commissure posts210of the heart valve100as shown inFIGS.29A-29E.FIG.32also provides an illustration of the suture guard2000deployed over a heart valve100with suture line3000extending along the exterior of the commissure posts210of the heart valve100. While not essential, in some embodiments, the suture guard2000may optionally be configured such that upon deployment of the suture guard2000, the suture guard2000engages the commissure posts210to cause a radially inward deflection thereof. It is also to be appreciated that the suture guard2000illustrated and described with regard toFIGS.29A-33Bmay be optionally used in combination with the various other suture guards illustrated and described herein. For instance, after utilizing suture guard202(e.g.,FIGS.2A-2G) to deflect the valve posts radially inward in preparing a heart valve100for insertion into the annulus, for example, the suture guard2000illustrated and described with regard toFIGS.29A-33Bmay be utilized to cover the commissure posts210the heart valve100to help deflect suture line extending along and exterior of the heart valve100from becoming entangled with the commissure posts210. Alternatively, the suture guard2000illustrated and described with regard toFIGS.29A-33Bmay be utilized in lieu of the various other suture guards illustrated and described herein, and does not require the commissure posts210of the heart valve100to be deflected radially inward. FIGS.29A-29Eprovide illustration of a system1000including an example suture guard2000and a prosthetic heart valve100, in accordance with an embodiment. The suture guard2000is shown inFIGS.29A-29Ein a deployed configuration in combination with a heart valve100, where the suture guard2000covers one or more portions of the commissure posts210of the heart valve100.FIGS.30A-30Cillustrate the suture guard2000in the deployed configuration with the heart valve100removed, for clarity. Conversely,FIGS.31A-31Billustrate the suture guard2000in the non-deployed configuration with the heart valve100removed, for clarity. In various embodiments, the suture guard2000generally includes a cover member and a base. In some examples, the cover member includes a frame element, and may optionally include a film element coupled to the frame element. For example, as shown inFIGS.29A-31B, the suture guard2000includes a cover member2100. In various examples, the cover member2100includes a frame element2200and a film element2306. In some examples, the frame element2200and the film element2306, collectively, define the cover member2100. However, in some examples, the cover member2100may include the frame element2200without also requiring the film element2306. In yet further examples, similar to those discussed above with respect toFIG.6, a suture guard may include a cover member without a frame element.FIG.29Dis a top view of the system1000consistent withFIG.29C, but with the film element2306highly transparent to illustrate the frame element2200extending into the base2400 The frame element2200may be formed of one or more elongate members (e.g., a wire). In the exemplary embodiments depicted inFIGS.29A-33B, the frame element2200is formed of a plurality of interrelated elongate members,2200A,2200B, and2200C, that collectively define a cover member2100having a triple petal configuration. It should be understood, however, that the depicted frame element2200is not the only frame element configuration envisioned within the scope of the disclosure. The frame element2200can differ from the embodiments depicted inFIGS.29A-33Bin numerous ways such as, but not limited to, the number of petals, the geometries of the interrelated elongate members, including the various curvatures and angles of the interrelated elongate members, collectively, and individually, the number of elongate members forming the frame element2200(e.g., 1, 2, 3, elongate members, such as a single continuous elongate member, or multiple discrete yet interrelated elongate members), and/or the diameter(s) of the elongate members. The elongate members2200A,2200B, and2200C may be formed of various materials and/or combinations of materials. In exemplary embodiments, nitinol (NiTi) is used as the material of the elongate members. However, other materials such as stainless steel, polymeric materials, polyamide, polyester, polyimide, biosorbable polymers, a cobalt, chromium, nickel alloy, or any other appropriate biocompatible material, and combinations thereof, may be used as the material of the elongate members. In various embodiments, the frame element2200is generally conformable, fatigue resistant, elastic, and distensible such that the frame element2200can transition between deployed and non-deployed configurations. In various embodiments, the frame element2200provides structure and shape for the cover member2100of the suture guard2000. In the embodiment depicted inFIGS.29A-33B, the frame element2200provides a supportive structural framework for the film element2306, which may otherwise be relatively flaccid and flexible. In various embodiments, the film element2306may attached to or otherwise coupled with at least a portion of the frame element2200. In some examples, the film element2306is attached to the frame element2200with an adhesive material, such as, for example, a silicone, a polyurethane, or fluorinated ethylene propylene (FEP). Silicone, for example, may be utilized as a bonding agent to adhere the film element2306to the frame element2200. The adhesive material may be applied to portions of the frame element2200or to all of the frame element2200. In some examples, some or all of the film element2306is disposed on both sides (e.g., a first side2202and a second side2204) of the frame element2200such that the elongate members—e.g., elongate members2200A,2200B, and2200C—are encapsulated by the film element2306. In some examples, the first side2202of the frame element2200corresponds to a portion of the cover member2100that faces the heart valve100when the suture guard2000is in the deployed configuration. This first side2202of the frame element2200may alternatively be referred to as the portion of the cover member2100exposed to an interior lumen of the base2400of the suture guard2000in the non-deployed configuration (also referred to herein as the delivery configuration). In some examples, the second side2204of the frame element2200corresponds to a portion of the cover member2100opposite the first side2202, and that faces away from the heart valve100when the suture guard2000is in the deployed configuration. In the deployed configuration, the first side2202can be understood to face in an outflow direction of the heart valve100, while the second side2204can be understood to face in an inflow direction of the heart valve100. In various examples, portions of the film element2306, such as those on opposing sides of the frame element2200, may be adhered to each other so as to encapsulate portions of or the entirety of the frame element2200. Stitching, lashing, banding, and/or clips may be alternatively used to attach the film element2306to the frame element2200. In some embodiments, a combination of techniques is used to attach the film element2306to the frame element2200. In various embodiments, the film element2306may be formed of a membranous material that inhibits or reduces the passage of blood and/or other bodily fluids and materials through the film element2306. In an exemplary embodiment, the film element2306is a polymer material, such as, for example, a fluoropolymer material. In at least one embodiment, the film element2306is an expanded polytetrafluoroethylene membrane. It is to be appreciated that the film element2306may be formed of other materials, such as, but not limited to a silicone, a urethane, a polyester (e.g., DACRON®), and combinations thereof. As shown inFIGS.29A-30C, when in the delivery configuration, the suture guard2000is configured such that the cover member2100extends radially outwardly from the base2400. As shown inFIGS.29A-29C, the cover member2100extends radially outwardly of an interior surface(s)222of the outflow end(s)224of the commissure post(s)210, distal to the outflow end(s)224of the commissure post(s)210. In some examples, the cover member2100extends radially outwardly of an exterior surface(s)226of the outflow end(s)224of the commissure post(s)210.FIG.33A-1is a cross sectional view of the system1000ofFIG.29Btaken along line33-33, with the film element2306removed for clarity. As shown inFIG.33A-1, the cover member2100, including the frame element2200extends radially outwardly of the commissure post210of the heart valve100. By extending radially outwardly of the commissure post210or otherwise covering the commissure post(s)210, the cover member2100operates to deflect suture line (such as suture line3000) extending along and exterior of the commissure post210such that the suture line does not become entangled with the commissure post210as the heart valve100is advanced along (and relative to) the suture line. In various embodiments, the cover member2100is configured to adopt a predetermined deployment shape once deployed from the base2400. In some example, the shape adopted by the cover member2100is dictated by a predetermined shape of the frame element2200. In some other examples, the shape adopted by the cover member2100is additionally or alternatively dictated by a predetermined shape of the film element2306. That is, in various embodiments, one or more of the materials of the cover member2100are configured with shape memory properties that operate to cause the cover member2100to adopt a predetermined deployment shape when the suture guard2000is transitioned to the deployed configuration. In various embodiments, the cover member2100is configured to evert as it is deployed from the base2400. For instance, as shown inFIGS.29A-30C, in the deployed configuration, a first portion2102of the cover member2100is everted relative to second portion2104of the cover member2100, with a transition region2106therebetween. Conversely, as shown inFIGS.31A-31Cin the non-deployed configuration (e.g., the delivery configuration), the first portion2102of the cover member2100is non-everted relative to the second portion2104of the cover member2100. Thus, in some examples, in the deployed configuration, the cover member2100includes an everted portion (e.g., first portion2102) and a non-everted portion (e.g., second portion2104). As shown, in the non-deployed configuration each of the first and second portions2102and2104extend in an outflow direction with the transition region2106therebetween, whereas in the deployed configuration, the first portion2102(e.g., the everted portion) is everted such that the first portion2102extends from the transition region2106in an inflow direction towards an inflow end2410of the base2400. Thus, an axial length of the cover member2100measured along the longitudinal axis of the suture guard is greater in the non-deployed configuration than in the deployed configuration. Moreover, a radial profile (e.g., a diameter of the cover member2100) is greater in the deployed configuration than in the non-deployed configuration. It should thus be appreciated that, when transitioning from the non-deployed configuration to the deployed configuration, a portion of the axial length of the cover member2100is converted into the radial dimension of the cover member2100. In other words, in various examples, in the non-deployed configuration the suture guard2000has a first axial length and a first diameter, whereas in the deployed configuration the suture guard has a second, shorter axial length and a second, greater diameter. Such a deployed configuration provides that the cover member2100is configured to adopt a delivered profile conducive for covering one or more portions of the heart valve100during implantation of the heart valve100to help minimize a potential for suture line entanglement. With reference toFIG.33A-2, it should be appreciated that, while the cover member2100is illustrated with the first portion2102of the cover member extending at an angle 0>θ>180 relative to a longitudinal axis of the system1000(e.g., angle θ is also representative of the relative angle between the longitudinal axis of the heart valve100and the first portion2102, and the relative angle between the longitudinal axis of the second portion2104of the cover member2100and the first portion2102), the angle θ may be equal to zero or one hundred eighty degrees (0≥θ≥180). Put differently, the first portion2102and the second portion2104may be parallel or non-parallel provided that that the cover member2100extends to a position radially outwardly of the interior surface(s)222of the outflow end(s)224of the commissure post(s)210. As mentioned above, the shape adopted by the cover member2100may be dictated by the properties of one or more of the frame element2200and the film element2306. For instance, in some examples, the frame element2200includes a plurality of elongate members (e.g.,2200A,2200B, and2200C), where the elongate members include shape memory properties that operate to bias the cover member2100such that the cover member2100adopts a predetermined profile when not otherwise constrained, such as by the base2400. As shown inFIGS.29C and29D, the various elongate members2200A,2200B, and2200C are shaped such that they collectively form a multi-petal geometry, where each petal is configured to cover or overlay a respective commissure post of a heart valve. The cover member2100shown inFIGS.29C and29Dincludes three petals,2110,2112, and2114. The first petal2110includes elongate members2200A and2200C. The second petal2112includes elongate members2200A and2200B. The third petal2114includes elongate members2200B and2200C. The elongate members2200A,2200B, and2200C may be bent or formed with one or more bend regions, and optionally one or more loop regions. For example, elongate member2200C includes a plurality of loop regions, including first loop region2206C and second loop region2208C, as well as a bend region2210C. As shown, the bend region2210C is situated between the first and second loop regions2206C and2208C. Situated between the bend region2210C and the first loop region2206C is a first length or strut2212C of elongate member2200C. Similarly, situated between the bend region2210C and the second loop region2208C is a second length or strut2214C of elongate member2200C. The elongate member2200C is configured such that, when the suture guard2000is in the non-deployed configuration, the first and second lengths2212C and2214C of the elongate member2200C are angled away from one another at a first angle. Conversely, when the suture guard2000is in the deployed configuration, the elongate member2200C is configured such that the first and second lengths2212C and2214C are angled away from one another at a second angle greater than the first angle. That is, an angle of the bend region2210C is configured to change as the suture guard is transitioned between the deployed and non-deployed configurations. In particular, as the suture guard2000is transitioned from the non-deployed configuration to the deployed configuration, the bend region2210C is configured such that the angle of bend region2210C increases, such that the elongate member2200C adopts the deployed profile illustrated inFIGS.29C and29D. In some examples, the angle of bend region2210C increases from an acute angle to an obtuse angle as the suture guard2000is transitioned from the non-deployed configuration to the deployed configuration. Conversely, as the suture guard2000is transitioned from the deployed configuration to the non-deployed configuration, the bend region2210C is configured such that the angle of bend region2210C decreases, causing the first and second lengths2212C and2214C of the elongate member2200C to be drawn closer to one another. In various examples, the elongate member2200C is shape set to adopt the deployed profile illustrated inFIGS.29C and29D. The elongate members2200A,2200B, and2200C may be shape set according to known methods. Accordingly, in such examples, when the suture guard2000is situated in the non-deployed configuration, the angle of the bend region2210C is reduced such that the material of the bend region2210C stores energy. As the suture guard2000is transitioned from the non-deployed configuration to the deployed configuration, this energy that is stored in the bend region2210C is converted to kinetic energy and helps transition the suture guard2000to the deployed configuration (e.g., helps the cover member adopt the deployed profile). In various examples, the first and second loop regions2206C and2208C of elongate member2200C help define, at least in part, the first and third petals2110and2114, respectively of the cover member2100. As shown, petal2114is defined, at least in part, by loop region2208C of elongate member2200C and by loop region2208B of elongate member2200C. Petals2110and2112are similarly defined, at least in part, by a plurality of loop regions of a plurality of elongate elements. While the cover member ofFIGS.29C and29Dis configured such that each petal includes a plurality of loop portions, such as from a plurality of elongate elements, it should be appreciated that elongate elements may alternatively be configured such that each petal of the cover member2100includes only one of the elongate elements. In various examples, opposing loop regions of a plurality of elongate elements that collectively define a petal of the cover member2100may be coupled together via the film element2306of the cover member2100. For example, as shown, the film element2306couples together the loop regions of the elongate members2200A and2200C at petal2110. Likewise, the film element2306couples together the loop regions of the elongate members2200A and2200B at petal2112. Likewise, the film element2306couples together the loop regions of the elongate members2200B and2200C at petal2114. It should also be appreciated that while the suture guard2000is illustrated inFIG.33A-1in the deployed configuration with a portion of the cover member2100(e.g., the first portion2102, or a portion thereof) extending proximal to the outflow end224of the commissure post(s)210, the suture guard2000may alternatively be configured such that cover member2100does not extend proximal to the outflow end(s)224of the commissure post(s)210, but instead extends radially outwardly of the interior surface(s)222of the commissure post(s) distal to the outflow end(s)224of the commissure post(s)210. The suture guard2000may configured such that the cover member2100is selectively deployable from the base2400, or may alternatively be configured such that the cover member2100automatically deploys from the base2400upon an activation of the base2400. That is, the cover member2100may deploy from the base2400to cover the commissure post(s) of the heart valve100without requiring manipulation of the cover member2100aside from activation of the base2400. For instance, in some examples, the base2400is comprised of a support element2402and a shaft element2404, where the shaft element2404is operable to translate (e.g., be advanced and/or retracted) relative to the support element2402. In some such examples, the support element2402includes a lumen2412through which the shaft element2404extends. In some examples, a cross-sectional profile of the shaft element2404taken transverse to a longitudinal axis of the base2400(referred to hereinafter as a transverse cross-sectional profile of the shaft element) is complimentary of a luminal profile of the lumen2412. In some examples, the shaft element2404includes one or more protrusions, such as protrusions2432extending along its longitudinal length that are complimentary to one or more features2434of the luminal profile of the support element2402, and that operate to constrain the shaft element2404against substantial rotational movement relative to the support element2402. As discussed in greater detail below, such protrusions may additionally or alternatively operate to bias or maintain the shaft element2404in one or more discrete positions (e.g., axial or angular) relative to the support element2402. In various examples, as the shaft element is advanced relative to the support element2402, the cover member2100is automatically deployed from an outflow end2406of the shaft element2404. In some examples, the shaft element2404includes a lumen2408extending through the shaft element2404and through which the cover member2100extends. Thus, in various examples, one or more of the frame element2200(including one or more of elongate members2200A,2200B, and2200C) and the film element2306extends through and is translatable (e.g., advanceable or retractable) relative to the shaft element2404of the base2400. In various examples, one or more of the frame element2200and the film element2306are operably coupled to one or more of the support element2402and the shaft element2404such that advancement of the shaft element2404relative to the support element2402causes advancement (e.g., translation in the outflow/distal direction) of the cover member2100relative to the shaft element2404, which causes the suture guard2000to transition to the deployed configuration, where the cover member2100extends radially outwardly of the lumen2408of the shaft element2404. Similarly, in various examples, one or more of the frame element2200and the film element2306are operably coupled to one or more of the support element2402and the shaft element2404such that retraction of the shaft element2404relative to the support element2402causes retraction (e.g., translation in the inflow/proximal direction) of the cover member2100relative to the shaft element2404, which causes the suture guard2000to transition to the non-deployed (e.g., delivery) configuration. Associating the deployment and retraction of the cover member2100of the suture guard2000with the activation of the base2400provides for minimizing a potential for mishandling of the suture guard2000, including premature deployment or retraction of the cover member2100. In addition to the discussion above, it should be appreciated that, in some examples, the suture guard2000is configured such that in the non-deployed (e.g., delivery) configuration the cover member2100is situated within the lumen2408of the base2400in a collapsed configuration. That is, in some examples, the suture guard2000is configured such that in the non-deployed configuration the cover member2100, including the frame element2200and/or the film element2306, is situated radially inwardly of the interior surface222of the outflow end224of the commissure post(s)210. It should also be appreciated that while the examples illustrated and described above involve a base2400that is configured such that a shaft element2404is translatable relative to a support element2402, in various other examples, the base2400may be alternatively configured such that the shaft element2404is additionally or alternative rotatably coupled to the support element2402. In such examples, in addition to or as an alternative to translation of the shaft element2404relative to the support element2402, the shaft element2404is rotatable relative to the support element2402, where such rotation and/or translation operates to cause the cover member2100to extend radially outwardly of the interior surface222of the outflow end(s)224of the commissure post(s)210. In some examples, one or more regions of the base2400, such as a wall of the lumen2408, operate as one or more bearing surfaces along which the cover member2100interacts as the cover member2100transitions between everted and non-everted configurations. Accordingly, in various examples, the base2400is configured to constrain the cover member2100in a collapsed configuration when the suture guard is in the non-deployed configuration. In some examples where the base2400includes components (e.g., support element2402and shaft element2404) that are configured to translate and/or rotate relative to one another to facilitate the extension of the cover member2100radially outwardly of the interior surface(s)222of the outflow end(s)224of the commissure post(s)210, the base2400may additionally include one or more features that operate to bias the shaft element2404into one or more discrete positions (e.g., axial or angular) relative to the support element2402. For example, as shown inFIG.33A-1, the shaft element2404includes biasing members2414A and2414B, which are each configured to interface with a flange2416of the support element2402. As shown, the suture guard2000is in the deployed configuration with the shaft element2404in a distally advanced position relative to the support element2402, where flange2416is situated between biasing member2414A and a flange2418of the shaft element2404. With the flange2416so positioned, the biasing member2414A and the flange2418operate to help maintain the suture guard2000in the deployed position by biasing the flange2416between biasing member2414A and a flange2418. In various examples, the biasing force of the biasing member2414A may be overcome by applying a proximally directed longitudinal force to the shaft element2404to deflect tab2420A radially inwardly of flange2416such that biasing member2414A can clear flange2416and shaft element2404can be proximally withdrawn relative to support element2402. In various examples the biasing member(s) (e.g.,2414A and/or2414B) may include one or more ramp features, such as ramp feature2422A, that help facilitate a deflection of the biasing member as longitudinal force is applied (e.g., proximally and/or distally) to the shaft element2404. Such ramp features may be configured as bearing surfaces that engage and slide along flange2416as the shaft element2404is translated relative to the support element2402. In some examples, one or more of the biasing members (e.g.,2414A and/or2414B) may include one or more stop features, that operates to obstruct translation of the shaft element2404beyond a designated axial position relative to the support element2402. For example, as shown inFIG.33B, biasing member2414B includes stop feature2424B, which is a portion of tab2420B, that is configured to engage flange2416to obstruct proximal translation of the shaft element2404beyond the position illustrated inFIG.33B, which is the position of the shaft element2404in the non-deployed configuration. It should be appreciated that heart valve100has been removed fromFIG.33Bfor clarity. Referring back toFIG.33A-1, in some examples, the flange2418of the shaft element2404may operate as a stop feature that functions to obstruct distal translation of the shaft element2404beyond the position illustrated inFIG.33A-1, which is the position of the shaft element2404in the deployed configuration. As shown inFIG.33B, the suture guard2000is in the non-deployed configuration with the shaft element2404in a proximally advanced position relative to the support element2402, where flange2416is situated between biasing member2414A and tab2420B. With the flange2416so positioned, the biasing member2414A and the tab2420B operate to help maintain the suture guard2000in the deployed position (e.g., a discrete position) by biasing the flange2416between biasing member2414A and the tab2420B. In some examples, the base2400may be configured to interface with any of the delivery handles herein illustrated and described. Accordingly, one or more of the delivery handles illustrated and/or described herein may be utilized to advance the suture guard2000, including the heart valve100to a target region within a patient's heart, and/or to cause the suture guard2000to transition between delivery and deployed configurations. Accordingly, it is to be appreciated that one or more of the delivery handles illustrated and/or described herein may include one or more mechanisms configured to cause the shaft element2404to be advanced relative to the support element2402. In some examples, the base2400may be configured to be coupleable to one or more regions of the heart valve100. For example, as shown inFIG.30A, the base2400includes a retention feature2426. Retention feature2426is a protrusion extending radially from a portion of the base2400, such as from a portion of the support element2402. In various examples, suture can be passed through the sewing cuff600of the heart valve100and looped around the retention feature2426to secure or otherwise couple the heart valve100to the suture guard2000. In some examples, the retention feature2424may include a guide2428that operates to retain engagement between the suture and the retention feature2424. For instance, as shown inFIG.30A, the guide2428includes a channel or groove, and inFIG.29E, a suture or fiber3002is shown extending within the channel or groove of guide2428. In some examples, the base2400may be further configured to include a cut slot2430, similar to the cut slot described above with respectFIG.2C. To decouple the suture guard2000from the heart valve100, the surgeon cuts the suture or fiber3002in the designated area of cut slot2430, which releases the suture or fiber extending through the sewing cuff600and looping around the retention feature2426, thereby allowing the heart valve100to be decoupled from the suture guard2000. While the cover member2100illustrated and described herein is shown with a tri-lobal or three petal configuration, it is to be appreciated that the cover member2100may be configured to include less than three petals, such as two petals, or alternatively more than three petals, such as four, five, six, or more than six petals. Indeed, in various examples, the cover member may comprise any number of petals provided that the cover member2100is operable to be deployed and retracted in accordance with the disclosure above. In some examples, in lieu of a petal or lobed design, the cover member2100may not include any petals, but may instead be configured as an evertable hood consistent with the profile illustrated and described above with respect toFIG.6. Moreover, while the cover member illustrated and described in association withFIGS.29A-33Bincludes a frame element2200having discrete elongate elements2200A,2200B, and2200C, it should be appreciated that the frame element2200may include a single continuous elongate element. The single continuous elongate element may be bent into the configuration illustrated and described above with respect toFIGS.29A-33B, or may alternatively be formed into alternative configurations. For instance, in some examples, the frame element2200may be helically shaped. Additionally, while the elongate elements2200A,2200B, and2200C, are illustrated and described as including a bend region, such as bend region2210C, it should be appreciated that the elongate element(s) may include a plurality of bend regions. The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents. | 67,124 |
11857411 | DETAILED DESCRIPTION FIGS.1-3show various views of a prosthetic heart valve10, according to one embodiment. The illustrated prosthetic valve is adapted to be implanted in the native aortic annulus, although in other embodiments it can be adapted to be implanted in the other native annuluses of the heart (e.g., the pulmonary, mitral, and tricuspid valves). The prosthetic valve can also be adapted to be implanted in other tubular organs or passageways in the body. The prosthetic valve10can have four main components: a stent or frame12, a valvular structure14, an inner skirt16, and a perivalvular sealing means or sealing member. The prosthetic valve10can have an inflow end portion15, an intermediate portion17, and an outflow end portion19. In the illustrated embodiment, the perivalvular sealing means comprises an outer skirt18(which can also be referred to as an outer sealing member). The valvular structure14can comprise three leaflets41, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, as best shown inFIG.2. The lower edge of leaflet structure14desirably has an undulating, curved scalloped shape (suture line154shown inFIG.21tracks the scalloped shape of the leaflet structure). By forming the leaflets with this scalloped geometry, stresses on the leaflets are reduced, which in turn improves durability of the prosthetic valve. Moreover, by virtue of the scalloped shape, folds and ripples at the belly of each leaflet (the central region of each leaflet), which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the prosthetic valve. The leaflets41can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Pat. No. 6,730,118, which is incorporated by reference in its entirety herein. The bare frame12is shown inFIG.4. The frame12can be formed with a plurality of circumferentially spaced slots, or commissure windows,20(three in the illustrated embodiment) that are adapted to connect the commissures of the valvular structure14to the frame, as described in greater detail below. The frame12can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel titanium alloy (NiTi), such as nitinol). When constructed of a plastically-expandable material, the frame12(and thus the prosthetic valve10) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame12(and thus the prosthetic valve10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size. Suitable plastically-expandable materials that can be used to form the frame12include, without limitation, stainless steel, a biocompatible, high-strength alloys (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular embodiments, frame12is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). MP35N® alloy/UNS R30035 alloy comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. When MP35N® alloy is used as the frame material, as compared to stainless steel, less material is needed to achieve the same or better performance in radial and crush force resistance, fatigue resistances, and corrosion resistance. Moreover, since less material is required, the crimped profile of the frame can be reduced, thereby providing a lower profile prosthetic valve assembly for percutaneous delivery to the treatment location in the body. Referring toFIGS.4and5, the frame12in the illustrated embodiment comprises a first, lower row I of angled struts22arranged end-to-end and extending circumferentially at the inflow end of the frame; a second row II of circumferentially extending, angled struts24; a third row III of circumferentially extending, angled struts26; a fourth row IV of circumferentially extending, angled struts28; and a fifth row V of circumferentially extending, angled struts32at the outflow end of the frame. A plurality of substantially straight axially extending struts34can be used to interconnect the struts22of the first row I with the struts24of the second row II. The fifth row V of angled struts32are connected to the fourth row IV of angled struts28by a plurality of axially extending window frame portions30(which define the commissure windows20) and a plurality of axially extending struts31. Each axial strut31and each frame portion30extends from a location defined by the convergence of the lower ends of two angled struts32to another location defined by the convergence of the upper ends of two angled struts28.FIGS.6,7,8,9, and10are enlarged views of the portions of the frame12identified by letters A, B, C, D, and E, respectively, inFIG.5. Each commissure window frame portion30connects to a respective commissure of the leaflet structure14. As can be seen each frame portion30is secured at its upper and lower ends to the adjacent rows of struts to provide a robust configuration that enhances fatigue resistance under cyclic loading of the prosthetic valve compared to cantilevered struts for supporting the commissures of the leaflet structure. This configuration enables a reduction in the frame wall thickness to achieve a smaller crimped diameter of the prosthetic valve. In particular embodiments, the thickness T of the frame12(FIG.4) measured between the inner diameter and outer diameter is about 0.48 mm or less. The struts and frame portions of the frame collectively define a plurality of open cells of the frame. At the inflow end of the frame12, struts22, struts24, and struts34define a lower row of cells defining openings36. The second, third, and fourth rows of struts24,26, and28define two intermediate rows of cells defining openings38. The fourth and fifth rows of struts28and32, along with frame portions30and struts31, define an upper row of cells defining openings40. The openings40are relatively large and are sized to allow portions of the leaflet structure14to protrude, or bulge, into and/or through the openings40when the frame12is crimped in order to minimize the crimping profile. As best shown inFIG.7, the lower end of the strut31is connected to two struts28at a node or junction44, and the upper end of the strut31is connected to two struts32at a node or junction46. The strut31can have a thickness51that is less than the thicknesses S2 of the junctions44,46. The junctions44,46, along with junctions64, prevent full closure of openings40.FIG.13shows the prosthetic valve10crimped on a balloon catheter. As can be seen, the geometry of the struts31, and junctions44,46, and64assists in creating enough space in openings40in the collapsed configuration to allow portions of the prosthetic leaflets to protrude or bulge outwardly through openings. This allows the prosthetic valve to be crimped to a relatively smaller diameter than if all of the leaflet material were constrained within the crimped frame. The frame12is configured to reduce, to prevent, or to minimize possible over-expansion of the prosthetic valve at a predetermined balloon pressure, especially at the outflow end portion of the frame, which supports the leaflet structure14. In one aspect, the frame is configured to have relatively larger angles42a,42b,42c,42d,42ebetween struts, as shown inFIG.5. The larger the angle, the greater the force required to open (expand) the frame. As such, the angles between the struts of the frame can be selected to limit radial expansion of the frame at a given opening pressure (e.g., inflation pressure of the balloon). In particular embodiments, these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and even more particularly these angles are up to about 120 degrees when the frame is expanded to its functional size. In addition, the inflow and outflow ends of a frame generally tend to over-expand more so than the middle portion of the frame due to the “dog-boning” effect of the balloon used to expand the prosthetic valve. To protect against over-expansion of the leaflet structure14, the leaflet structure desirably is secured to the frame12below the upper row of struts32, as best shown inFIG.1. Thus, in the event that the outflow end of the frame is over-expanded, the leaflet structure is positioned at a level below where over-expansion is likely to occur, thereby protecting the leaflet structure from over-expansion. In one type of prosthetic valve construction, portions of the leaflets protrude longitudinally beyond the outflow end of the frame when the prosthetic valve is crimped if the leaflets are connected too close to the distal end of the frame. If the delivery catheter on which the crimped prosthetic valve is mounted includes a pushing mechanism or stop member that pushes against or abuts the outflow end of the prosthetic valve (for example, to maintain the position of the crimped prosthetic valve on the delivery catheter), the pushing member or stop member can damage the portions of the exposed leaflets that extend beyond the outflow end of the frame. Another benefit of connecting the leaflets at a location spaced away from the outflow end of the frame is that when the prosthetic valve is crimped on a delivery catheter, the outflow end of the frame12rather than the leaflets41is the proximal-most component of the prosthetic valve10. As such, if the delivery catheter includes a pushing mechanism or stop member that pushes against or abuts the outflow end of the prosthetic valve, the pushing mechanism or stop member contacts the outflow end of the frame, and not leaflets41, so as to avoid damage to the leaflets. Also, as can be seen inFIG.5, the openings36of the lowermost row of openings in the frame are relatively larger than the openings38of the two intermediate rows of openings. This allows the frame, when crimped, to assume an overall tapered shape that tapers from a maximum diameter at the outflow end of the prosthetic valve to a minimum diameter at the inflow end of the prosthetic valve. When crimped, the frame12can have a reduced diameter region extending along a portion of the frame adjacent the inflow end of the frame that generally corresponds to the region of the frame covered by the outer skirt18. In some embodiments, the reduced diameter region is reduced compared to the diameter of the upper portion of the frame (which is not covered by the outer skirt) such that the outer skirt18does not increase the overall crimp profile of the prosthetic valve. When the prosthetic valve is deployed, the frame can expand to the generally cylindrical shape shown inFIG.4. In one example, the frame of a 26-mm prosthetic valve, when crimped, had a first diameter of 14 French at the outflow end of the prosthetic valve and a second diameter of 12 French at the inflow end of the prosthetic valve. The main functions of the inner skirt16are to assist in securing the valvular structure14to the frame12and to assist in forming a good seal between the prosthetic valve and the native annulus by blocking the flow of blood through the open cells of the frame12below the lower edge of the leaflets. The inner skirt16desirably comprises a tough, tear resistant material such as polyethylene terephthalate (PET), although various other synthetic materials or natural materials (e.g., pericardial tissue) can be used. The thickness of the skirt desirably is less than about 0.15 mm (about 6 mil), and desirably less than about 0.1 mm (about 4 mil), and even more desirably about 0.05 mm (about 2 mil). In particular embodiments, the skirt16can have a variable thickness, for example, the skirt can be thicker at least one of its edges than at its center. In one implementation, the skirt16can comprise a PET skirt having a thickness of about 0.07 mm at its edges and about 0.06 mm at its center. The thinner skirt can provide for better crimping performances while still providing good sealing. The skirt16can be secured to the inside of frame12via sutures70, as shown inFIG.21. Valvular structure14can be attached to the skirt via one or more reinforcing strips72(which collectively can form a sleeve), for example thin, PET reinforcing strips, discussed below, which enables a secure suturing and protects the pericardial tissue of the leaflet structure from tears. Valvular structure14can be sandwiched between skirt16and the thin PET strips72as shown inFIG.20. Sutures154, which secure the PET strip and the leaflet structure14to skirt16, can be any suitable suture, such as Ethibond Excel® PET suture (Johnson & Johnson, New Brunswick, New Jersey). Sutures154desirably track the curvature of the bottom edge of leaflet structure14, as described in more detail below. Some fabric skirts comprise a weave of warp and weft fibers that extend perpendicularly to each other and with one set of the fibers extending longitudinally between the upper and lower edges of the skirt. When the metal frame to which such a fabric skirt is secured is radially compressed, the overall axial length of the frame increases. However, a fabric skirt with limited elasticity cannot elongate along with the frame and therefore tends to deform the struts of the frame and to prevent uniform crimping. Referring toFIG.12, in one embodiment, the skirt16desirably is woven from a first set of fibers, or yarns or strands,78and a second set of fibers, or yarns or strands,80, both of which are non-perpendicular to the upper edge82and the lower edge84of the skirt. In particular embodiments, the first set of fibers78and the second set of fibers80extend at angles of about 45 degrees (e.g., 15-75 degrees or 30-60 degrees) relative to the upper and lower edges82,84. For example, the skirt16can be formed by weaving the fibers at 45 degree angles relative to the upper and lower edges of the fabric. Alternatively, the skirt16can be diagonally cut (cut on a bias) from a vertically woven fabric (where the fibers extend perpendicularly to the edges of the material) such that the fibers extend at 45 degree angles relative to the cut upper and lower edges of the skirt. As further shown inFIG.12, the opposing short edges86,88of the skirt desirably are non-perpendicular to the upper and lower edges82,84. For example, the short edges86,88desirably extend at angles of about 45 degrees relative to the upper and lower edges and therefore are aligned with the first set of fibers78. Therefore the overall general shape of the skirt can be that of a rhomboid or parallelogram. FIGS.14and15show the inner skirt16after opposing short edge portions90,92have been sewn together to form the annular shape of the skirt. As shown, the edge portion90can be placed in an overlapping relationship relative to the opposite edge portion92, and the two edge portions can be sewn together with a diagonally extending suture line94that is parallel to short edges86,88. The upper edge portion of the inner skirt16can be formed with a plurality of projections96that define an undulating shape that generally follows the shape or contour of the fourth row of struts28immediately adjacent the lower ends of axial struts31. In this manner, as best shown inFIG.16, the upper edge of the inner skirt16can be tightly secured to struts28with sutures70. The inner skirt16can also be formed with slits98to facilitate attachment of the skirt to the frame. Slits98can be dimensioned so as to allow an upper edge portion of the inner skirt16to be partially wrapped around struts28and to reduce stresses in the skirt during the attachment procedure. For example, in the illustrated embodiment, the inner skirt16is placed on the inside of frame12and an upper edge portion of the skirt is wrapped around the upper surfaces of struts28and secured in place with sutures70. Wrapping the upper edge portion of the inner skirt16around struts28in this manner provides for a stronger and more durable attachment of the skirt to the frame. The inner skirt16can also be secured to the first, second, and/or third rows of struts22,24, and26, respectively, with sutures70. Referring again toFIG.12, due to the angled orientation of the fibers relative to the upper and lower edges in this embodiment, the skirt can undergo greater elongation in the axial direction (i.e., in a direction from the upper edge82to the lower edge84). Thus, when the metal frame12is crimped (as shown inFIG.13), the inner skirt16can elongate in the axial direction along with the frame and therefore provide a more uniform and predictable crimping profile. Each cell of the metal frame in the illustrated embodiment includes at least four angled struts that rotate towards the axial direction on crimping (e.g., the angled struts become more aligned with the length of the frame). The angled struts of each cell function as a mechanism for rotating the fibers of the skirt in the same direction of the struts, allowing the skirt to elongate along the length of the struts. This allows for greater elongation of the skirt and avoids undesirable deformation of the struts when the prosthetic valve is crimped. In addition, the spacing between the woven fibers or yarns can be increased to facilitate elongation of the skirt in the axial direction. For example, for a PET inner skirt16formed from 20-denier yarn, the yarn density can be about 15% to about 30% lower than in a typical PET skirt. In some examples, the yarn spacing of the inner skirt16can be from about 60 yarns per cm (about 155 yarns per inch) to about 70 yarns per cm (about 180 yarns per inch), such as about 63 yarns per cm (about 160 yarns per inch), whereas in a typical PET skirt the yarn spacing can be from about 85 yarns per cm (about 217 yarns per inch) to about 97 yarns per cm (about 247 yarns per inch). The oblique edges86,88promote a uniform and even distribution of the fabric material along inner circumference of the frame during crimping so as to facilitate uniform crimping to the smallest possible diameter. Additionally, cutting diagonal sutures in a vertical manner may leave loose fringes along the cut edges. The oblique edges86,88help minimize this from occurring. In alternative embodiments, the skirt can be formed from woven elastic fibers that can stretch in the axial direction during crimping of the prosthetic valve. The warp and weft fibers can run perpendicularly and parallel to the upper and lower edges of the skirt, or alternatively, they can extend at angles between 0 and 90 degrees relative to the upper and lower edges of the skirt, as described above. The inner skirt16can be sutured to the frame12at locations away from the suture line154so that the skirt can be more pliable in that area. This configuration can avoid stress concentrations at the suture line154, which attaches the lower edges of the leaflets to the inner skirt16. As noted above, the leaflet structure14in the illustrated embodiment includes three flexible leaflets41(although a greater or a smaller number of leaflets can be used). Additional information regarding the leaflets, as well as additional information regarding skirt material, can be found, for example, in U.S. patent application Ser. No. 14/704,861, filed May 5, 2015, which is incorporated by reference in its entirety. The leaflets41can be secured to one another at their adjacent sides to form commissures122of the leaflet structure. A plurality of flexible connectors124(one of which is shown inFIG.17) can be used to interconnect pairs of adjacent sides of the leaflets and to connect the leaflets to the commissure window frame portions30(FIG.5). FIG.17shows the adjacent sides of two leaflets41interconnected by a flexible connector124. Three leaflets41can be secured to each other side-to-side using three flexible connectors124, as shown inFIG.18. Additional information regarding connecting the leaflets to each other, as well as connecting the leaflets to the frame, can be found, for example, in U.S. Patent Application Publication No. 2012/0123529, which is incorporated by reference herein in its entirety. As noted above, the inner skirt16can be used to assist in suturing the leaflet structure14to the frame. The inner skirt16can have an undulating temporary marking suture to guide the attachment of the lower edges of each leaflet41. The inner skirt16itself can be sutured to the struts of the frame12using sutures70, as noted above, before securing the leaflet structure14to the skirt16. The struts that intersect the marking suture desirably are not attached to the inner skirt16. This allows the inner skirt16to be more pliable in the areas not secured to the frame and minimizes stress concentrations along the suture line that secures the lower edges of the leaflets to the skirt. As noted above, when the skirt is secured to the frame, the fibers78,80of the skirt (seeFIG.12) generally align with the angled struts of the frame to promote uniform crimping and expansion of the frame. FIG.19shows one specific approach for securing the commissure portions122of the leaflet structure14to the commissure window frame portions30of the frame. In this approach, the flexible connector124(FIG.18) securing two adjacent sides of two leaflets is folded widthwise and the upper tab portions112are folded downwardly against the flexible connector. Each upper tab portion112is creased lengthwise (vertically) to assume an L-shape having an inner portion142folded against the inner surface of the leaflet and an outer portion144folded against the connector124. The outer portion144can then be sutured to the connector124along a suture line146. Next, the commissure tab assembly is inserted through the commissure window20of a corresponding window frame portion30, and the folds outside of the window frame portion30can be sutured to portions144. FIG.19also shows that the folded down upper tab portions112can form a double layer of leaflet material at the commissures. The inner portions142of the upper tab portions112are positioned flat against layers of the two leaflets41forming the commissures, such that each commissure comprises four layers of leaflet material just inside of the window frames30. This four-layered portion of the commissures can be more resistant to bending, or articulating, than the portion of the leaflets41just radially inward from the relatively more-rigid four-layered portion. This causes the leaflets41to articulate primarily at inner edges143of the folded-down inner portions142in response to blood flowing through the prosthetic valve during operation within the body, as opposed to articulating about or proximal to the axial struts of the window frames30. Because the leaflets articulate at a location spaced radially inwardly from the window frames30, the leaflets can avoid contact with and damage from the frame. However, under high forces, the four layered portion of the commissures can splay apart about a longitudinal axis adjacent to the window frame30, with each inner portion142folding out against the respective outer portion144. For example, this can occur when the prosthetic valve10is compressed and mounted onto a delivery shaft, allowing for a smaller crimped diameter. The four-layered portion of the commissures can also splay apart about the longitudinal axis when the balloon catheter is inflated during expansion of the prosthetic valve, which can relieve some of the pressure on the commissures caused by the balloon, reducing potential damage to the commissures during expansion. After all three commissure tab assemblies are secured to respective window frame portions30, the lower edges of the leaflets41between the commissure tab assemblies can be sutured to the inner skirt16. For example, as shown inFIG.20, each leaflet41can be sutured to the inner skirt16along suture line154using, for example, Ethibond Excel® PET thread. The sutures can be in-and-out sutures extending through each leaflet41, the inner skirt16, and each reinforcing strip72. Each leaflet41and respective reinforcing strip72can be sewn separately to the inner skirt16. In this manner, the lower edges of the leaflets are secured to the frame12via the inner skirt16. As shown inFIG.20, the leaflets can be further secured to the skirt with blanket sutures156that extend through each reinforcing strip72, leaflet41and the inner skirt16while looping around the edges of the reinforcing strips72and leaflets41. The blanket sutures156can be formed from PTFE suture material.FIG.21shows a side view of the frame12, leaflet structure14and the inner skirt16after securing the leaflet structure14and the inner skirt16to the frame12and the leaflet structure14to the inner skirt16. FIG.22shows a cross-sectional view of a patch or section of pericardial tissue200that can be formed into an alternative embodiment of an outer skirt. The pericardial tissue200can be bovine pericardium, porcine pericardium, equine pericardium, kangaroo pericardium, or pericardium from other sources. The pericardial tissue200has a rough or fibrous layer202having a rough surface206on one side and a smooth layer204having a smooth surface208on the opposite side that is relatively smoother and less fibrous than the rough surface206. The tissue200can be formed from a section of the parietal pericardial membrane comprising a fibrous parietal layer (the outermost layer of the pericardium) forming the rough layer202and a serous parietal layer (the outer serous layer) forming the smooth layer204. The tissue200can be harvested and prepared for use in an implant using those techniques and mechanisms known for processing pericardial tissue for heart valve leaflets. A process for preparing pericardial tissue for heart valve leaflets typically includes first obtaining a fresh pericardial sac from a source animal, and then cutting the sac open along predetermined anatomical landmarks to obtain a parietal pericardial membrane. The parietal pericardial membrane can be flattened and typically cleaned of excess fat and other impurities. After trimming obviously unusable areas, a window or patch of tissue can be fixed, typically by immersing in an aldehyde to cross-link the tissue. Rough edges of the tissue window can be removed and the tissue can be bio-sorted to result in a tissue section. The process of bio-sorting involves visually inspecting the window for unusable areas, and trimming the section therefrom. Further details regarding the process for processing pericardial tissue are disclosed in U.S. Pat. Nos. 8,846,390 and 9,358,107, which are incorporated herein by reference in their entirety. In the illustrated example ofFIG.22, following initial processing of the pericardial tissue as described in the preceding paragraph, the overall thickness of the parietal pericardial membrane can be reduced by removing a portion of the smooth layer204of the pericardial tissue200, such as by using a laser210in a laser milling process, until the pericardial tissue has a desired thickness T. In some embodiments, the final thickness T after milling is between 50-150 μm, and more preferably between 100-150 μm, with 100 μm being a specific example. Alternatively, the pericardial tissue200can be milled or otherwise formed to any other thickness T. After the tissue is processed, the pericardial tissue200has a smooth layer204, a rough layer202, a thickness T, and it can be formed into an outer skirt as discussed in connection withFIGS.23and26below. In addition to laser tissue removal described above, various mechanical devices for skiving or shaving tissue such as razor or planing devices may be used to remove some of the tissue. For instance, a device having a flat platen over which a planing razor or blade translates may be substituted for the linear laser configuration ofFIG.22. Other physical configurations for creating relative tissue/razor movement are contemplated, such as for instance using a lathe-like razor to smooth the outer surface of the tissue. Each of these devices may be automatically or computer-controlled using an optical surface measuring component to control the depth of cut. Abrasive tissue removal (e.g., sanding or rasping) can also be used, though the grit of the tool should be relatively fine. In other embodiments, a dermatome can be used for skiving or shaving of a portion of the smooth tissue layer204. Further details regarding the use of a dermatome for removing portions of tissue from pericardial tissue are disclosed in U.S. Pat. No. 8,846,390. In alternative embodiments, the thickness of the pericardial tissue200can be reduced by removing a portion of the fibrous parietal layer using any of the techniques described above in lieu of or in addition to removing a portion of the serous parietal layer. FIGS.23-24show various views of an exemplary outer skirt300formed from the pericardial tissue200ofFIG.22.FIG.23shows a flattened view of the outer skirt300prior to its attachment to a prosthetic heart valve.FIG.24shows the outer skirt300attached to the prosthetic heart valve10. Referring toFIG.23, the outer skirt300can comprise a first end portion302(i.e., the upper end portion as depicted inFIG.23; also the outflow end portion in the illustrated embodiment), a second end portion304(i.e., the lower end portion as depicted inFIG.23; also the inflow end portion in the illustrated embodiment), and an intermediate portion306disposed between the first and second end portions302,304. The first end portion302of the outer skirt300can include a plurality of alternating projections308and notches310, or castellations. In other embodiments, first end portion302can be formed without any projections308or notches310and instead can be substantially straight. Referring toFIG.24, the outer skirt300is attached to the prosthetic heart valve10. The projections308of the first end portion302can be attached to the inner skirt16and/or the frame12of the prosthetic heart valve10using sutures (as shown) and/or an adhesive. The lower end portion304can be attached to the inner skirt16and/or the frame12of the prosthetic heart valve10using sutures, adhesive, or any other suitable attachment means. In the illustrated example ofFIG.24, the outer skirt300is secured to the frame12with the rough surface206of the pericardial tissue200facing away from the frame12and the smooth surface208facing the frame12. As such, when the prosthetic heart valve10ofFIG.24having the outer skirt300is implanted in a patient, the rough surface206of the pericardium200faces the native tissue of the patient. The rough surface206facing or being in contact with the native tissue can help disturb antegrade blood flow between the outer skirt300and the native anatomy of the patient, which can enhance tissue ingrowth and proliferation and help seal any gaps between the prosthetic heart valve10and the native anatomy to reduce and/or eliminate perivalvular leakage. In addition, if the outer skirt300protrudes inwardly through the frame12during cycling or when the prosthetic heart valve10is crimped in a radially collapsed configuration, any contact between the valvular structure14and the outer skirt300will be with the smooth surface208of the pericardium200, which can be less abrasive than outer skirts made of PET or other fabrics and therefore the outer skirt300made from pericardium200can help protect the leaflets of the valvular structure14. It should be noted that while outer skirt300is illustrated as being attached somewhat loosely, that is, with some slack in the intermediate portion306of the outer skirt300, it can also be attached so as to fit more snugly against the outer surface of the frame12. FIGS.25-26show various views of another exemplary outer skirt400formed from the pericardial tissue200ofFIG.22.FIG.25shows a flattened view of the outer skirt400prior to its attachment to a prosthetic heart valve.FIG.26shows the outer skirt400attached to the prosthetic heart valve10. Referring toFIG.25, the outer skirt400can comprise a first end portion402(i.e., the upper end portion as depicted inFIG.25), a second end portion404(i.e., the lower end portion as depicted inFIG.25), and an intermediate portion406disposed between the first and second end portions402,404. The first end portion402of the outer skirt400can include a plurality of alternating projections408and notches410, or castellations. As noted previously, in other embodiments, first end portion402can be formed without any projections408or notches410and instead can be substantially straight The intermediate portion406can comprise a plurality of slits or openings414. The slits414can be cut or otherwise formed in a longitudinal direction (i.e., an axial direction when the outer skirt400is attached to the frame of a prosthetic heart valve). The slits414can be laser cut or formed by any other means. In the illustrated embodiment ofFIG.25, the slits414are elongated axially and are arranged in five rows422,424,426,428, and430. In other embodiments, the slits414can be arranged in more or less than five rows. In the illustrated embodiment ofFIG.25, the rows422,426, and430of slits414are circumferentially aligned with each other and are offset from rows424and428of slits414, which are circumferentially aligned with each other. In some embodiments, each slit414includes first and second opposing longitudinal sides432a,432b, respectively, that are spaced apart from each other to define a permanent open gap therebetween. In other embodiments, the longitudinal sides432a,432bof a slit414are in contact with each other (and do not define a permanent open gap therebetween) in the absence of hemodynamic forces, but can move away from each other under hemodynamic forces to allow blood to flow through the skirt via the slits414. In the illustrated embodiment ofFIG.25, the slits414are arranged in alternating axially extending columns420aand420b. The columns420acan each comprise three slits and the columns420bcan each comprise two slits. In other embodiments, the slits414can be arranged on the outer skirt400in any pattern including any number of rows and/or columns containing any number of slits or any other pattern not having a particular number of rows and/or columns. Alternatively, the slits414can be arranged on the outer skirt400in a way that does not have a particular pattern. In some examples, the slits or openings414can have any of various other shapes, such as circular, square, rectangular, triangular, or various combinations thereof. In some examples, the slits or openings414can be elongated circumferentially or at any other angle with respect to the orientation of the outer skirt400. Referring toFIG.26, the outer skirt400can be attached to the prosthetic heart valve10as previously described. As noted above, when the prosthetic valve10is implanted in a patient, the rough layer202of the pericardial tissue200can help to reduce and/or eliminate perivalvular leakage, as discussed above. Additionally, blood can flow through the slits414, which can slow the flow of antegrade blood and further enhance blood clotting and tissue ingrowth, which can further help to prevent perivalvular leakage. Furthermore, the longitudinal or axial direction of the slits414can help reduce stretching or deformation of the outer skirt during passage through a sheath as may be caused by friction between the outer skirt and the inner surface of the sheath. Again, it should be noted that while outer skirt400is illustrated as being attached somewhat loosely, that is, with some slack in the intermediate portion406of the outer skirt400, it can also be attached so as to fit more snugly against the outer surface of the frame12. FIGS.27-29show various ways of mounting an outer skirt (e.g., outer skirt300or outer skirt400) to the frame12of a prosthetic valve10. For purposes of illustration, reference number400is used to designate the outer skirt inFIGS.27-29, although it should be understood that the other outer skirts disclosed herein can be mounted to the frame12in the same manner. Referring toFIG.27, the inner skirt16comprises an upper edge portion48and a lower edge portion50. The upper edge portion48of the inner skirt16can be secured to the inside of the frame12such as via sutures70as previously described and as best shown inFIG.21. Alternatively, the upper edge portion48of the inner skirt16can be secured to the inside of frame12via adhesive and/or ultrasonic welding in addition to or in lieu of sutures70. The upper edge portion402of the outer skirt400can be secured to the frame12with sutures468. The upper edge portions48and402are shown loosely attached to the frame inFIG.27for purposes of illustration, but typically are tightly secured to the frame struts as depicted inFIG.1. The lower edge portion50of the inner skirt16can be wrapped around the inflow end portion15of the frame12and around the lower edge portion404of the outer skirt400. The lower edge portion404of the outer skirt400and the wrapped lower edge portion50of the inner skirt16can be secured together and/or secured to the frame12, such as with sutures470and/or an adhesive. Wrapping the lower edge portion50of the inner skirt16around the lower edge portion404of the outer skirt400can reinforce the lower edge portion404and the sutures470along the lower edge portion404. The lower edge portions50and404are shown loosely attached to the frame inFIG.27for purposes of illustration, but typically are tightly secured to the frame struts with the sutures470. FIGS.28-29show another way of mounting the outer skirt400to the frame12. The upper edge portion402of the outer skirt400can be mounted to the frame12with sutures468as previously described herein. A reinforcing strip448having a first edge portion450and a second edge portion452can be wrapped around the inflow end portion15of the frame12. The reinforcing strip448can be made of fabric material (e.g., PET) or natural tissue (e.g., pericardial tissue). In some embodiments, the reinforcing strip448can be used to secure the cusp portion of each leaflet41to the frame, as shown inFIG.29. Although not shown inFIGS.28-29, in some embodiments, an inner skirt16also can be mounted inside of the frame12. In some embodiments, the reinforcing strip448is part of an inner skirt that varies in height around the circumference of the inner skirt with a maximum height at the commissures of the leaflets (such as illustrated inFIG.27) and a minimum height at a location equidistant between two commissures (such as illustrated inFIG.28). Further details of a reinforcing strip that is used to attach the cusp portions of the leaflets to a frame and details of an inner skirt that has a maximum height at the commissures of the leaflets and a minimum height between the commissures are provided in U.S. Provisional Application No. 62/369,678, filed Aug. 1, 2016, which is incorporated herein by reference in its entirety. The first edge portion450of the reinforcing strip448can be positioned inside of the frame12while the second edge portion452can be positioned outside the frame12. The first and second edge portions450,452can be attached to each other and/or to the frame12, using sutures470and/or an adhesive. The edge portions450,452are shown loosely attached to the frame inFIGS.28-29for purposes of illustration, but typically are tightly secured to the frame. The second edge portion452of the reinforcing strip448can be wrapped around the lower edge portion404of the outer skirt400such that the lower edge portion404is between the frame12and the reinforcing strip448. The lower edge portion404of the outer skirt400can be secured to the frame12and the second edge portion452of the reinforcing strip448with the sutures470and/or an adhesive. As depicted inFIG.29, the lower cusp portion of each leaflet41can be secured between the frame12and the first edge portion450of the reinforcing strip448with sutures (e.g., with sutures472) and/or an adhesive. Referring toFIG.29, the outer skirt400is shown protruding inwardly through the frame12, which may occur during cycling and/or when the frame12is crimped to its radially collapsed configuration. When the outer skirt400protrudes through the frame12, it may contact one of the leaflets41. By having smooth surface208of the pericardial tissue facing inwards towards the frame12, any contact between any of the leaflets41and the outer skirt400will be with the smooth surface208of the pericardial tissue200that forms the outer skirt400, thereby preventing or minimizing abrasion of the leaflets41. FIG.30shows a prosthetic heart valve10having an outer skirt500, according to another embodiment. The outer skirt500in the illustrated embodiment comprises a main body or layer502of pericardial tissue and a plurality of strips504of material mounted on the outer surface of the main body502. The main body502can be the outer skirt300or the outer skirt400. The strips504desirably are made from a substantially non-elastic and non-stretchable material. For example, the strips504can be sutures, pieces of woven fabric (e.g., PET strips), pieces of non-woven fabric, or other types of fibrous material. In the illustrated embodiment ofFIG.30, the strips504are arranged to form a repeating U-shaped pattern around the main body502. Alternatively, the strips504can be arranged in any other pattern (e.g., the strips504can extend parallel to the longitudinal axis of the prosthetic valve). The strips502can facilitate passage of the prosthetic valve through an introducer sheath by reducing contact between the pericardial tissue forming the main body502and the inner surface of the sheath and by resisting stretching of the pericardial tissue caused by frictional contact with the inner surface of the sheath. Further, when formed from an absorbent material, such as fabric, the strips504can absorb blood to help enhance blood clotting and tissue ingrowth to further reduce perivalvular leakage. While outer skirt500is illustrated as being attached somewhat loosely, that is, with some slack in the main body502of the outer skirt300, it can also be attached so as to fit more snugly against the outer surface of the frame12. The prosthetic valve10can be configured for and mounted on a suitable delivery apparatus for implantation in a subject. Several catheter-based delivery apparatuses can be used; a non-limiting example of a suitable catheter-based delivery apparatus includes that disclosed in U.S. Patent Application Publication No. 2013/0030519, which is incorporated by reference herein in its entirety, and U.S. Patent Application Publication No. 2012/0123529. To implant a plastically-expandable prosthetic valve10within a patient, the prosthetic valve10including the outer skirt400(or alternatively, the outer skirt300or500) can be crimped on an elongated shaft180of a delivery apparatus, as best shown inFIG.13. The prosthetic valve, together with the delivery apparatus, can form a delivery assembly for implanting the prosthetic valve10in a patient's body. The shaft180comprises an inflatable balloon182for expanding the prosthetic valve within the body. With the balloon182deflated, the prosthetic valve10can then be percutaneously delivered to a desired implantation location (e.g., a native aortic valve region). Once the prosthetic valve10is delivered to the implantation site (e.g., the native aortic valve) inside the body, the prosthetic valve10can be radially expanded to its functional state by inflating the balloon182. Alternatively, a self-expanding prosthetic valve10can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by inserting the prosthetic valve10, including the outer skirt400, into a sheath or equivalent mechanism of a delivery catheter. The prosthetic valve10can then be percutaneously delivered to a desired implantation location. Once inside the body, the prosthetic valve10can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional state. FIGS.31-33and36show various implantation positions for a prosthetic heart valve10, including implantation within a dock or anchor placed inside the patient's body prior to valve implantation.FIG.31shows the prosthetic heart valve10implanted in the native aortic valve of a patient. FIG.32shows the prosthetic heart valve10implanted in the pulmonary artery of a patient for replacing or enhancing the function of a diseased pulmonary valve. Due to the variations in the size and shape of the native pulmonary valve and the pulmonary artery, the prosthetic valve10can be implanted within a radially expandable outer docking device600. The docking device600can comprise a radially expandable and compressible annular stent602and a sealing member604that covers all or a portion of the stent and can extend across the inner surface and/or outer surface of the stent. The docking device600is configured to engage the inner wall of the pulmonary artery and can accommodate variations in patient anatomy. The docking device600also can compensate for the expanded prosthetic heart valve10being much smaller than vessel in which it is placed. The docking device600also can be used to support a prosthetic valve in other areas of the patient's anatomy, such as, the inferior vena cava, superior vena cava, or the aorta. Further details of the docking device600and methods for implanting the docking device and a prosthetic valve are disclosed, for example, in co-pending U.S. application Ser. No. 15/422,354, filed Feb. 1, 2017, which is incorporated herein by reference in its entirety. FIG.33shows the prosthetic heart valve10implanted in the native mitral valve of a patient using a docking device in the form of a helical anchor700. The helical anchor700can include one or more coils702deployed in left atrium and one or more coils704deployed in the left ventricle and radially outside of the native mitral valve leaflets706. When the prosthetic valve10is deployed within the native valve, the native leaflets are compressed or pinched between the prosthetic valve10and the anchor700to retain the prosthetic valve in place. Further details of the helical anchor700and methods for implanting the anchor and a prosthetic valve are disclosed, for example, in U.S. Application No. 62/395,940, filed Sep. 16, 2016, which is incorporated herein by reference in its entirety. FIGS.34and35show a docking device800for a prosthetic heart valve, according to another embodiment. The docking device800can include a radially expandable and compressible frame802having an outer portion804, an inner portion806disposed coaxially within one end portion of the outer portion804, and a curved transition portion808extending between and connecting the inner portion806and the outer portion804. The docking device800can further include a sealing member810extending over the inner surface of the inner portion806, a portion of the outer surface of the outer portion804adjacent the inner portion806, and the transition portion808. FIG.36shows the docking device800implanted in a vessel820, which can be, for example, the inferior vena cava, superior vena cava, or the ascending aorta. As shown, a prosthetic valve10can be deployed within the inner portion806of the docking device800. Similar to the docking device600, the docking device800can compensate for the expanded prosthetic heart valve10being much smaller than vessel in which it is placed. The docking device800is particularly suited for implanting a prosthetic valve in the inferior vena cava for replacing or enhancing the function of the native tricuspid valve. Further details of the docking device800and methods for implanting the docking device and a prosthetic valve are disclosed, for example, in co-pending U.S. application Ser. No. 16/034,794, filed Jul. 13, 2018, which is incorporated herein by reference. General Considerations It should be understood that the disclosed valves can be implanted in any of the native annuluses of the heart (e.g., the pulmonary, mitral, and tricuspid annuluses), and can be used with any of various approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). The disclosed prostheses can also be implanted in other lumens of the body. Further, in addition to prosthetic valves, the delivery assembly embodiments described herein can be adapted to deliver and implant various other prosthetic devices such as stents and/or other prosthetic repair devices. For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved. For example, an outer skirt for a prosthetic heart valve can include one or more features disclosed with respect to skirt18, skirt300, skirt400, and/or skirt500. Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” As used herein, the term “and/or” used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase “A, B, and/or C” means “A”, “B”, “C”, “A and B”, “A and C”, “B and C”, or “A, B, and C”. As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device toward the user, while distal motion of the device is motion of the device away from the user. The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined. As used herein, the terms “coupled” and “associated” generally mean physically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, operations that occur “simultaneously” or “concurrently” occur generally at the same time as one another, although delays in the occurrence of one operation relative to the other due to, for example, spacing, play or backlash between components in a mechanical linkage such as threads, gears, etc., are expressly within the scope of the above terms, absent specific contrary language. In view of the many possible embodiments to which the principles disclosed herein may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is at least as broad as by the following claims. | 52,713 |
11857412 | Persons skilled in the art will readily appreciate the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated or represented schematically to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. DETAILED DESCRIPTION The present disclosure relates to prosthetic valves used for cardiac valve replacement (e.g., for treating a failing or otherwise defective aortic or mitral valve) or other applications associated with native valve or other valve orifices, and related systems, methods, and apparatuses. In some associated treatment methods, the prosthetic valve is utilized to treat valve stenosis (e.g., aortic valve stenosis) and/or valve insufficiency (e.g., aortic valve insufficiency). In various examples, the prosthetic valve is operable as a one-way prosthetic valve that defines a valve orifice into which leaflets open to permit flow and close so as to block or occlude the valve orifice and partially or entirely prevent flow in response to differential fluid pressure. In the instant disclosure, the examples are primarily described in association with transcatheter cardiac valve applications, although it should be readily appreciated features of such examples are equally applicable to prosthetic valves or mechanisms of similar structure and/or function, including surgically implanted valves. Moreover, prosthetic valves according to the instant disclosure can be applied in non-cardiac applications, such as respiratory or gastrointestinal tract applications. Implantable valve orifices include anatomical structures into which a prosthetic valve can be placed and include, but are not limited to, a location from which a cardiac valve may or may not have been surgically removed. Other anatomical structures that can receive a prosthetic valve include, but are not limited to, veins, arteries, ducts, and shunts, for example. In addition to native valve locations, a valve orifice or implant site may also refer to a location in a synthetic or biological conduit that may receive a prosthetic valve. Generally, the term “distal” is used in the disclosure to refer to the outflow end (distal end) or outflow direction of a prosthetic valve, and in turn the term “proximal” is used to refer to the inflow end of a prosthetic valve, or a direction opposite the direction of primary flow through the prosthetic valve. FIG.1is an isometric view of a prosthetic valve100andFIG.2is a side view of the prosthetic valve100, according to some embodiments. As shown, the prosthetic valve100includes a support structure102(also described as a frame assembly), a leaflet construct104(also described as a leaflet assembly), and a sealing construct106(also described as a sealing cuff). A variety of other features used with such types of prostheses, such as radiopaque marker bands (not shown), are also contemplated. As shown, the prosthetic valve100defines a central longitudinal axis Xv, an inner side108(FIG.1) corresponding to a central lumen and an outer side110(FIG.1) corresponding to the exterior of the prosthetic valve100and extends from a proximal end112(FIG.2) to a distal end114(FIG.2). The prosthetic valve100also has an inflow side Is(FIG.2) into which fluid (e.g., blood) flows and an outflow side Os(FIG.2) out of which blood flows. In terms of basic operation, the leaflet construct104of the prosthetic valve100has free edges that flatten together (e.g., in a Y-shaped pattern in the case of three leaflets when viewed from the top), which can also be described as coaptation of the leaflet construct104prosthetic valve100. In particular, as the free edges of the leaflet construct104come together the prosthetic valve100closes. The prosthetic valve100closes in this fashion when the pressure of the blood on the outflow side Os(FIG.2) is greater than the pressure of the blood on the inflow side Is(FIG.2) of the prosthetic valve100. The free edges of leaflet construct104move apart to open the prosthetic valve100and to let blood flow through the prosthetic valve100from the inflow side Iswhen the pressure of the blood on the inflow side Isof the prosthetic valve100is greater than the pressure on the outflow side Osof the prosthetic valve100. As shown, the support structure102of the prosthetic valve100includes a frame1102(also described as a framework), a cover1104(also described as an attachment element), and a plurality of constraint retainers1106(also described as constraint guides). In various examples, the support structure102serves to operatively support the leaflet construct104in a desired location within a patient (not shown), provides features for securing and maintaining the prosthetic valve100to a delivery system (not shown), and other additional or alternative features as desired. FIG.3is a side view of the frame1102of the support structure102at a first rotational orientation andFIG.4is a side view of the frame1102at a second rotational orientation, according to some embodiments. The frame1102, and thus the support structure102along with the leaflet construct104, is optionally collapsible to a reduced profile, delivery configuration and then expandable (e.g., self-expanding or expanded by the application of an internal force, such as by balloon expansion) in situ. As shown inFIG.2, the frame1102is optionally annular, defining a tapered cylinder (e.g., a cone), also described as a tapered cylindrical shape, and has a central longitudinal axis Xf, which corresponds to and is coaxial with the central longitudinal axis of the prosthetic valve Xv (FIG.2) and is described interchangeably as the central longitudinal axis Xf of the support structure102, according to some embodiments. As will be further described, the tapered shape of the frame1102may be beneficial for a variety of reasons. Although the frame1102generally defines a circular transverse cross-section in an unloaded state (e.g., when not under a transverse load), it should be understood that any variety of cross-sections (e.g., oval- or rectangular-shaped) are also contemplated. The frame1102has an inner side1110and an outer side1112opposite the inner side1110. The inner side1110faces toward the central longitudinal axis Xf, and the outer side1112faces outwardly, or away from the central longitudinal axis Xf. The frame1102extends from a distal end1114(also described as an outflow end) to a proximal end1116(also described as an inflow end), the distal end1114having a first diameter and the proximal end1116having a second larger diameter such that the frame1102has a diametric taper of decreasing diameter in a distal direction between the distal end1114and the proximal end1116, the diametric taper defining a taper angle1118relative to the central longitudinal axis Xf of the frame1102(as well as relative to a right angle cylinder) when the frame1102, and the prosthetic valve100, is in an unloaded state. As shown, the taper angle1118is relatively constant (linear), although non-constant tapers (e.g., varies with one or more curved or angled segments) are contemplated, as further described. As shown, the frame1102includes a plurality of commissure posts1120and a plurality of frame members1122. As shown, the plurality of commissure posts are generally located toward, and are configured to support a region of the leaflet construct104that coapts, or a coaptation region of the leaflet construct104. The plurality of frame members1122generally define a collapsible and expandable arrangement, and also serve to support one or more portions of the leaflet construct104as desired. In some embodiments, the plurality of commissure posts1120are spaced from one another, and arranged at desired locations around a circumference of the frame1102. As shown, the plurality of commissure posts1120are angled inwardly toward the central longitudinal axis Xf, following the taper angle1118, although other configurations (e.g., angled more inwardly, non-angled or angled outwardly from the central longitudinal axis Xf) are also contemplated. Although as best seen inFIG.4, three commissure posts1120are shown, any number of commissure posts are contemplated. The plurality of commissure posts1120define circumferentially-adjacent ones, or simply adjacent ones of the plurality of commissure posts1120moving about the perimeter of the frame1102. As shown, other than location and orientation, each of the commissure posts1120has a similar design, although examples where the commissure posts1120differ from one another in various respects are also contemplated. Regardless, for ease of understanding, the features of each of the commissure posts1120will be described in association with a first commissure post1120a, enlarged views of which is shown inFIGS.5and6. The features of the first commissure post1120awill generally be referenced with a numeral followed by an “a.” Similar features of a second commissure post may be subsequently referenced with the same numeral as the first commissure post, but followed by a “b.” Similar features of a third commissure post may be subsequently referenced with the same numeral as the first commissure post1120a, but followed by a “c.” Similarly, when features of each of the plurality of commissure posts1120are referenced collectively, those features are referenced with the same numeral as identified for the first commissure post1120a, but not followed by a letter. As shown inFIG.5, the first commissure post1120a, includes a first leg1130a, a second leg1132a, a first slot1134a, which can also be described as a first post slot, and a second slot1136a, which can also be described as a second post slot. The first slot1134aand the second slot1136aare each located between the first leg1130aand the second leg1132a. As shown, the first commissure post1120aalso includes an intermediate leg1138apositioned between the first leg1130aand the second leg1132a. The first commissure post1120adefines the first slot1134abetween the first leg1130aand the intermediate leg1138aand the second slot1136abetween the second leg1132aand the intermediate leg1138a. The first commissure post1120ahas an outer side corresponding to the frame outer side1112(FIG.3) and a post inner side corresponding to the frame inner side1110(FIG.3). As shown, the first leg1130aand the second leg1132aextend longitudinally, or in a longitudinal direction. As shown inFIG.6, the first leg1130aand the second leg1132a(FIG.5) extend in a longitudinal direction that is parallel to the taper angle1118of the frame1102(FIG.3). In other examples, the first leg1130aand the second leg1132aextend longitudinally, but at a different angular offset relative to the central longitudinal axis Xf (e.g., parallel, more inwardly offset, or more outwardly offset. As shown, each of the first slot1134aand the second slot1136aextends through a thickness of the first commissure post1120a, from the inner side1110of the frame1102to the outer side1112of the frame1102. The slots1134a,1136aare formed through the frame in a generally radial direction relative to a central longitudinal axis Xf (FIG.2) of the frame1102. In various examples, one or both of the first slot1134aand the second slot1136aextend in a longitudinal direction, although the first slot1134aand the second slot1136agenerally follow the taper angle1118. In other examples, one or both of the first slot1134aand the second slot1136aextend longitudinally, but at some offset relative (e.g., angularly offset relative to the taper angle1118and/or angularly offset transversely relative to the central longitudinal axis Xf). As shown, one or both of the first slot1134aand the second slot1136aare elongate in shape, with lengths, or heights, much greater than their widths (e.g., more than 2×, 5×, 10×, 20×, or 30×, although a variety of dimensions are suitable). In some examples, the first slot1134aextends from a first end1140ato a second end1142aand the second slot1136aextends from a first end1144ato a second end1146a. As shown, the first ends1140a,1144aare open and the second ends1142a,1146aare closed. For example, the first ends1140a,1144aare “open” in the sense that it opens to a much wider area in the frame1102(e.g., more than 5×, 10×, or 20×), whereas the second ends1142a,1146aare “closed” in the sense that it terminates at the width of the first slot1134aand the second slot1136a. The widths of the first slot1134aand the second slot1136aare generally selected to allow a desired number of passes or loops of leaflet material through the first slot1134aand the second slot1136a, as subsequently described. As shown inFIG.5, in some embodiments, the first commissure post1120adefines a distal end1150athat is rounded and otherwise configured to be atraumatic to tissue. The plurality of commissure posts120, and in particular the distal ends (e.g., distal end1150a) of the plurality of commissure posts1120also extend distally to define a commissure post distal boundary1152(FIG.4). In general terms, the commissure post distal boundary1152approximates a distal boundary of the leaflet construct104, which is attached to the commissure posts1120. In some embodiments, the plurality of frame members1122define a collapsible (e.g., elastically) and expandable (e.g., self-expanding or balloon expandable) framework, and also serve to support one or more portions of the leaflet construct104as desired. As shown inFIG.3, the plurality of frame members1122define a plurality of rows of frame members1224defining an undulating, alternating pattern of proximal-facing apices242pointing in a proximal direction and distal-facing apices238pointing in a distal direction. In some embodiments, the plurality of rows of frame members1224include a proximal row1230toward the proximal end1116of the frame1102a distal row1232toward the distal end1114of the frame1102, and at least one intermediate row1234positioned intermediate the distal row1232and proximal row1230. As shown inFIG.3, there are four rows of frame members1224, although greater or fewer numbers are contemplated (e.g., 2, 4, 12, 20). As shown, the distal row1232of the plurality of rows of frame members1224extends distally to define a frame member distal boundary1236. As shown, the commissure post distal boundary1152is located distal to the frame member distal boundary1236, with the plurality of commissure posts1120generally extending more distally than the plurality of rows of frame members1224. In some embodiments, such a configuration leaves portions of the leaflet construct104(FIG.1) outwardly exposed between the plurality of commissure posts120(e.g., the coaptation region), although other features may be incorporated to transversely “cover” or protect the leaflet construct104from inward tissue ingress, such as one or more posts or other distal projections (e.g., such as the atraumatic posts2120inFIG.23). Regardless, as shown inFIG.2, leaflet construct104extends distal to the frame member distal boundary1236. Such a feature may provide additional circumferential space for the plurality of commissure posts120to fit into when the prosthetic valve100is diametrically compacted into a reduced diameter, delivery configuration. The plurality of rows of frame members1224each define an undulating pattern of distal-facing apices238each having an apex angle240and proximal-facing apices242each having an apex angle244. For reference, the distal-facing apices238point in the distal direction and the proximal-facing apices242point in the proximal direction. In various examples, each of the apex angles240of each of the distal-facing apices238has a value that is approximately the same in more than one of the plurality of rows of frame members1224(e.g., the same approximate value in each of the distal row of frame members1232, the proximal row of frame members1230, and/or the intermediate row of frame members1234). For example, in some embodiments, each the apex angles240are within 10% of a common apex angle defined by the plurality of rows of distal-facing apices238. In other embodiments, each of the apex angles is within 5%, 15%, 20%, or some other value of a common apex angle. In some examples, the common apex angle is 30 degrees, although any of a variety of common apex angles is contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those vales). In various examples, each of the apex angles244of each of the proximal-facing apices242has a value that is approximately the same in more than one of the plurality of rows of frame members1224(e.g., the same approximate value in the distal row of frame members1232, the proximal row of frame members1230, and/or the intermediate row of frame members1234). For example, in some embodiments, each of the apex angles244are within 10% of a common apex angle defined by the plurality of rows of proximal-facing apices242. In other embodiments, each of the apex angles is within 5%, 15%, 20%, or some other value of a common apex angle. In some examples, the common apex angle is 30 degrees, although any of a variety of common apex angles is contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values). In some examples, the apex angles240and/or the apex angles244of one or more columns of closed cells1238defined by the plurality of frame members1224are approximately the same as another one of the columns of closed cells1238. For example, the apex angles of one or more columns is optionally within 10% of a common apex angle defined by the one or more columns of closed cells1238of proximal-facing apices242and/or distal-facing apices238. In other embodiments, each of the apex angles is within 5%, 15%, 20%, or some other value of a common apex angle. In some examples, the common apex angle is 30 degrees, although any of a variety of common apex angles is contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values). As shown inFIG.3, the frame1102also includes a plurality of rows of closed cells1240defined by the plurality of frame members1224. The plurality of rows of frame members1224generally intersect with one another at intersection locations P to define the plurality of rows of closed cells1240. As shown in the example ofFIG.4, each of the plurality of rows of closed cells1240has a proximal end1242, a distal end1244, and a cell height1246between the distal end1244and the proximal end1242and a cell width1248perpendicular to the cell height1246. Moreover, each of the plurality of rows of closed cells has a first lateral-facing apex250defining an apex angle252and a second lateral facing-apex254opposite the first lateral-facing apex250and defining an apex angle256. In a similar manner to the apex angles240and the apex angles244, in various examples, each of the apex angles252and/or apex angles256of has approximately the same value between one or more of the plurality of rows of closed cells1240and/or columns of closed cells1238(e.g., within 10% of a common apex angle, although other values such as values within 5%, 15%, 20%, or some other value of a common apex angle are contemplated). In some examples, the common apex angle is 30 degrees, although any of a variety of common apex angles is contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values). In some examples, the apex angles240and/or the apex angles244of one or more of the plurality of columns of closed cells1238and/or one or more of the plurality of rows of the closed cells1240are approximately the same as another one of the plurality of columns of closed cells1238and/or the plurality of rows of the closed cells1240(e.g., within 10% of a common apex angle, although other values such as values within 5%, 15%, 20%, or some other value of a common apex angle are contemplated). In some examples, the common apex angle is 30 degrees, although any of a variety of common apex angles is contemplated (e.g., 10, 15, 20, 30, 40, 45, 50, 60, 90 degrees and ranges between any of those values). As shown inFIG.3, the plurality of rows of closed cells1240includes a proximal row of closed cells1250at the proximal end1116of the frame portion1210, a distal row of closed cells1252toward the distal end1114of the frame portion1210, and at least one intermediate row of closed cells1253intermediate the distal row of closed cells1252and the proximal row of closed cells1250. Although three rows of closed cells1240are shown, greater or fewer numbers are contemplated (e.g., greater or few number of intermediate rows of closed cells1253). As shown, the cell heights1246of the distal row of closed cells1252are each less than the cell heights1246of the proximal row of closed cells1250. Additionally, each of the cell heights1246of the intermediate row of closed cells1253are less than the cell heights1246of the proximal row of closed cells1250and greater than the cell heights1246of the distal row of closed cells1252. As shown, the cell widths1248of the distal row of closed cells1252are each less than the cell widths1248of the proximal row of closed cells1250. Additionally, each of the cell widths1248of the intermediate row of closed cells1253are less than the cell widths1248of the proximal row of closed cells1250and greater than the cell widths1248of the distal row of closed cells1252. In various of the foregoing examples, by balancing the various apex angles (e.g., the apex angles240, the apex angles244, the apex angles252, and/or the apex angles256), such as by having the apex angles240be within 10% of one another, the apex angles244be within 10% of one another, the apex angles252be within 10% of one another, and the apex angles256be within about 10% of one another), while increasing the cell heights1246and increasing cell widths1248in a proximal direction helps balance compaction forces needed toward the proximal end1116relative to the compaction forces necessary at the distal end1114for diametrically compacting the prosthetic valve100to a compact delivery configuration. In some examples, the compaction forces required toward the proximal end1116are substantially the same as, or less than, the compaction forces required toward the distal end of the prosthetic valve100. FIG.7shows additional features for the frame1102of the support structure102, according to some embodiments. The foregoing description of the frame1102applies fully to the frame1102shown inFIG.7. For reference, the additional features shown for the frame1102inFIG.7include a more curved shape for the frame members1122as a result of a non-linear change in the cell widths1248along the cell heights1246(e.g., as compared to the straighter pattern shown inFIGS.3and4) and the diametric taper exhibited by the frame1102, which is shown to include three, distinct tapers, as opposed to a single taper shown inFIGS.3and4for the frame1102. From the foregoing, it should be readily understood that the previous description of the other features of the frame1102applies fully. For reference purposes, the apex angles240, the apex angles244, the apex angles252, and the apex angles256are determined by drawing straight lines between the various apices of the plurality of rows of closed cells1240. With the foregoing in mind, as shown inFIG.7, the frame1102includes a diametric taper in which the taper angle varies1118between the distal end1114and the proximal end1116relative to the central longitudinal axis Xf of the frame1102when the prosthetic valve100is in an unconstrained, or unloaded state. For example, the taper angle1118optionally includes a distal taper angle1300corresponding to the plurality of commissure posts1120, a proximal taper angle1302corresponding to the proximal row1230of the plurality of rows of frame members1224, and an intermediate taper angle1304between the distal taper angle1300and the proximal taper angle1302that is defined by the intermediate rows1234and the distal row1232, according to some embodiments. As shown, the distal taper angle1300is greater than the intermediate taper angle1304, and the intermediate taper angle1304is greater than the proximal taper angle1302. In some examples, one or more of the distal taper angle1300, the intermediate taper angle1304, and the proximal taper angle1302is the same. In some examples, the proximal taper angle is zero (e.g., parallel to the central longitudinal axis Xf of the frame1102). FIG.8is an end view of the frame1102from the distal end1114andFIG.9is a side view of the frame1102, both of which show the frame1102in a diametrically compacted, delivery state. Although other portions of the prosthetic valve100are not shown, it should be understood that the configuration shown inFIGS.8and9is illustrative of compaction of the prosthetic valve100, according to some embodiments. As shown, the taper angle1118(FIG.7) includes a more inward taper angle toward the central longitudinal axis Xf at both the distal end1114and/or the proximal end1116than the intermediate portion of the diametric taper as desired. Such proximally tapering designs can be particularly helpful in delivering the prosthetic valve100from a delivery system (not shown) when in a diametrically compacted state (e.g., from a sheath of a delivery system or otherwise constrained on a delivery catheter), including avoiding damage to the anatomy during delivery, snagging on the anatomy and/or delivery system, facilitating repositioning or retrieval, or other advantages. Such advantages may also be present when the prosthetic valve100is partially or fully deployed. And, a distally tapering design may also assist with such delivery and also help with retraction and/or reorientation of the prosthetic valve100, including when the prosthetic valve100is diametrically compacted and/or partially or fully deployed. The frame1102can be etched, cut, laser cut, stamped, three-dimensional printed or wire wound, among other suitable processes. The frame1102can include any metallic or polymeric material, such as an elastically (e.g., nitinol) or plastically (e.g., stainless steel) deformable metallic or polymeric material that is generally biocompatible. Other materials suitable for the frame1102include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloy, polypropylene, acetyl homopolymer, acetyl copolymer, a drawn filled tube (e.g., nitinol wire with a platinum core), other alloys or polymers, or any other material that is generally biocompatible having adequate physical and mechanical properties to function as a frame1102as described herein. The cover1104optionally includes one or more layers of material, such as a membrane, or film material, secured to the frame1102. In some examples, the cover includes of one or more layers of ePTFE material, although any of a variety of other suitable materials may be employed as desired, including fluoropolymer materials such as PTFE, ePTFE, FEP, and others. The cover1104optionally assists with sealing the prosthetic valve100to the surrounding conduit in which it is placed (e.g., valve orifice) and also with securing the leaflet construct104to the support structure102, as subsequently described. As shown inFIG.1, in some embodiments, the cover1104has one or more rows of apertures1270for receiving one or more constraints (such as the constraint1272shown in broken lines inFIG.1) associated with a transcatheter delivery system6000as shown inFIG.32. Examples of suitable transcatheter delivery systems for use as the transcatheter delivery system6000can also be found in U.S. Provisional Application Ser. No. 62/579,756, entitled “TRANSCATHETER DEPLOYMENT SYSTEMS AND ASSOCIATED METHODS,” filed by Applicant on Oct. 31, 2017, as well as U.S. Provisional Application Ser. No. 62/682,692, entitled “TRANSCATHETER DEPLOYMENT SYSTEMS AND ASSOCIATED METHODS,” filed by Applicant on Jun. 8, 2018. For reference, although only the constraint1272is shown, a plurality of constraints are optionally employed (e.g., as shown inFIG.32three constraints1272are generally indicated in broken lines at positions corresponding to the rows of apertures1270and the constraint retainers1106shown inFIG.1). For reference, constraints, such as the constraint1272, are optionally formed of a filamentary material (e.g., a filament, strand, wire, combinations thereof, and the like). In some embodiments, as shown inFIG.2, the prosthetic valve100also optionally includes one or more constraint retainers1106formed as a loop of material coupled to the support structure102(e.g., secured to one or more of the plurality of frame members1122). In some embodiments, the constraint retainers1106are each formed by one or more loops of material, such as polymeric material (e.g., ePTFE fiber), metallic material (e.g., nitinol), or any other material that is biocompatible and suitable for implantation with the prosthetic valve100. In some examples, the constraint retainers1106are formed of filamentary material, such as a filament, strand, or a wire (e.g., polymeric or metallic). In some examples, one or more of the constraint retainers1106are formed of a biocorridible or biodegradable material that biocorrodes or bioabsorbs over time following implantation. As shown, the constraint1272passes through the constraint retainers1106to help secure the constraint1272in place and help prevent the constraint1272from slipping off the distal end1114of the frame1102. Although some specific attachment examples are subsequently described, the leaflet construct104can be received within and coupled to the support structure102using any of a variety of techniques (e.g., bonding, adhering, sewing, and others). The location or position of the leaflet construct104along the length of the prosthetic valve100is referenced as a leaflet region or leaflet portion of the prosthetic valve100. The various embodiments described herein may utilize biological, such as bovine or porcine, or synthetic leaflets, such fluoropolymer leaflet constructs. Various embodiments have been found to be advantageous for use with synthetic leaflets, such as fluoropolymer constructs, including for wash out and reduced thrombosis, secure and reliable leaflet construct attachment, and others. Some examples of suitable leaflet constructs can also be found in US 2015/0224231 to Bruchman et al., published Aug. 13, 2015. FIG.10is an enlarged view of a portion of the support structure102between two adjacent commissure posts1120of the frame1102, according to some embodiments. Similar portions of the support structure102are defined between each of the adjacent plurality of commissure posts1120, according to some embodiments and thus are described collectively with reference toFIG.10. InFIG.10, the portion of the support structure102is represented in a flattened form for ease of illustration, although it should be understood that the support structure102is three-dimensional and generally annular. As shown, the support structure102defines a first leaflet attachment region1160abetween the first commissure post1120aand the second commissure post1120b, as well as leaflet attachment regions1160between the remaining commissure posts1120. The leaflet attachment frame members1170and the cover1104are arranged to support the leaflet construct104and to help define a leaflet shapes of the leaflet construct104. In some embodiments, the plurality of frame members1122of the frame1102include a plurality of leaflet attachment frame members1170, or simply leaflet attachment elements, that together with the cover1104define the leaflet attachment regions of the prosthetic valve100, including the first leaflet attachment region1160ashown inFIG.10. Each of the leaflet attachment regions is optionally substantially similar and thus are described collectively with regard to the first leaflet attachment region1160a. The first leaflet attachment region1160adefines a first side1162a, a second side1164a, and a base1166a, which is defined at least in part by the cover1104. As referenced, similar leaflet attachment regions are defined between each of the plurality of commissure posts1120, according to some embodiments. According to various examples, other than location and orientation, each of the plurality of leaflets1180has a similar design, although examples where the leaflets differ from one another in various respects are also contemplated. Regardless, for ease of understanding, the features of each of the leaflets1180will be described in association with a first leaflet1180a. The features of the first leaflet1180awill generally be referenced with a numeral followed by an “a.” Similar features of a second leaflet may be subsequently referenced with the same numeral as the first leaflet, but followed by a “b.” Similar features of a third leaflet may be subsequently referenced with the same numeral as the first leaflet1180a, but followed by a “c.” Similarly, when features of each of the leaflets are referenced collectively, those features are referenced with the same numeral, but not followed by a letter. Similarly, when features of each of the leaflets1180are referenced collectively, those features are referenced with the same numeral, but not followed by a letter. FIG.11is a flat view of the first leaflet1180aof the leaflet construct104. The first leaflet1180ais shown from a flattened, plan view prior to assembly with the support structure102. This flattened plan view can also be described as a cut pattern, or simply a leaflet pattern. FromFIG.11, for example, it should be understood that the leaflet construct104is folded and turned into a non-planar shape following attachment to portions of the support structure102, with each of the plurality of leaflets1180being attached circumferentially about the support structure102. As should be understood fromFIG.10, the plurality of leaflets1180are optionally formed as separate components, which are then separately assembled to the support structure102, although interconnected, continuous leaflet designs are also contemplated. As shown, the plurality of leaflets1180are spaced from one another, and arranged, or otherwise distributed at desired locations around a circumference of the leaflet construct104. Although three leaflets1180are shown inFIG.1, any number of leaflets is contemplated. Each of the leaflets1180define circumferentially-adjacent ones, or simply adjacent ones of the plurality of leaflets1180moving about the circumference of the leaflet construct104. The leaflet construct104can be formed in a variety of manners, including cutting a cylinder of polymer material into a desired shape, cutting a sheet of polymer material into a desired shape, and/or molding (e.g., compression or injection molding) the leaflet construct104with a desired shape. As indicated onFIG.11, the first leaflet1180aoptionally includes a body portion1190a, a plurality of attachment tabs1192aextending from the body portion1190a, a first commissure tab1194aextending from the body portion1190a, and a second commissure tab1196aextending from the body portion1190a. The body portion1190a, also described as a leaflet body, is bounded in broken lines for understanding purposes. The body portion1190aof the first leaflet1180ais the moving portion of the first leaflet1180ain the prosthetic valve100(FIG.1). It should be appreciated that when assembled to the support structure102, the boundaries of the body portion1190aare defined and the body portion1190atakes on a three dimensional shape, rather than the flat shape shown inFIG.11. As such, the broken lines are provided for general visualization purposes of the body portion1190a. In various examples, the shape of the body portion1190ais generally dictated by the lines, or areas of attachment to the support structure102. The edges of the body portion1190agenerally correspond to fold lines where the attachment tabs1192aand first commissure tab1194aand the second commissure tab1196aare secured to the support structure102. As will be described below, the leaflet construct104may be attached to the support structure102using cover1104(FIG.10), which in turn, may contribute to shape defined by the leaflet attachment regions1160and the ultimate shape of the body portion1190a. As shown inFIG.11, the body portion1190aof the first leaflet1180ahas the general shape of an isosceles trapezoid. Regardless of the exact shape, the body portion1190agenerally has a first side1200a, a second side1202a, a leaflet base1204a, and a free edge1206aopposite the leaflet base1204a. The body portion1190ais configured to facilitate coaptating of the first leaflet1180awith the other leaflets1180. In general terms, the shape of the body portion1190acorresponds to the sides and base of the first leaflet attachment region1160a(FIG.10). As shown, the two sides1200a,1202adiverge from the leaflet base1204a, and the leaflet base1204awill be substantially straight in a transverse plane relative to the central longitudinal axis Xf of the support structure102. In different terms, leaflet base1204acan be considered to be flat and to extend perpendicular to the central longitudinal axis Xf of the support structure102following assembly, although a variety of configurations are contemplated, including leaflet bases that are not flat in the transverse plane. Although the body portion1190ais shown to take on the general shape of an isosceles trapezoid, any number of shapes is contemplated, and the body portion1190aneed not be trapezoidal in overall appearance. For example, the body portion1190amay include a central region that defines a shape substantially that of an isosceles trapezoid, with side regions on each side that have a shape substantially that of a triangle. In still other embodiments, the body portion1190amay outline a shape that can be described as U-shaped or a V-shapes, depending on the geometric outline defined by the first leaflet attachment region1160a. The first leaflet1180agenerally defines a fold over portion1198a, also described as a fold over region, outside of the body portion1190a, as demarcated by the broken line inFIG.11. The fold over portion1198aof the first leaflet1180ais the portion that is used to secure the first leaflet1180ato the support structure102, where the remaining leaflets1180optionally include similar features for securing to the frame1102. The leaflet attachment frame members1170(FIG.10) fit into a fold that is formed between the body portion1190aand the fold over portion1198a. In general terms, the margin of the body portion1190aadjacent to the support structure102extends radially inward from the frame1102when coupled to the frame1102. The body portion1190aincludes enough material between the commissure posts1120of the frame1102so that the leaflet free edges can come together or coapt in the interior of the prosthetic valve100to close the prosthetic valve100. As shown, the plurality of attachment tabs1192alocated in the fold over portion1198aare positioned about a perimeter of the body portion1190aand are separated from one another by openings1208afor receiving frame members1122(e.g., leaflet attachment frame members1170) of the frame1102. As shown, one or more of the plurality of attachment tabs1192aoptionally includes apertures1199athrough the thickness of the attachment tabs1192a. The apertures1199amay assist with securing the attachment tabs1192ato the support structure102(e.g., to the frame1102and the cover1104) using adhesives or bonding (e.g., to provide additional surface area for adhesion/bonding), fastening elements (e.g., holes for sutures), or combinations thereof. In some examples, the apertures1199aare used for alignment purposes, such as to help align one attachment tab (e.g., one of the attachment tabs1192aof the first leaflet1180a) over another attachment tab of another leaflet (e.g., one of the attachment tabs1192bof the second leaflet1180b) when folding the attachment tabs onto the support structure102. Similar or additional apertures1199amay additionally or alternatively be incorporated to reduce mass of the material forming the leaflets1180, to increase mechanical entanglement of the material forming the leaflets1180and any bonding materials used to secure the leaflets1180to the support structure102, or for additional or alternative purposes as desired. In various examples, the first commissure tab1194aand the second commissure tab1196aassist with securing the first leaflet1180ato the first commissure post1120aand second commissure post1120b(FIG.2). As shown inFIG.11, the first commissure tab1194aextends from the first side1200aof the body portion1190aand the second commissure tab1196aextends from a second side1202aof the body portion1190a. The first commissure tab1194aextends from a first end1210a, also described as a leaflet end, to a terminal end1212a. Similarly, the second commissure tab1196aextends from a first end1214ato a terminal end1216a. The first commissure tab1194aand the second commissure tab1196aare shown as generally rectangular in shape, with a constant width, although tapers (e.g., toward the terminal ends1212a,1216a) are also contemplated. As shown inFIG.11, the first leaflet1180aincludes a plurality of first retaining elements1184aand a plurality of second retaining elements1186a. As shown inFIG.11, the first leaflet1180aincludes a plurality of first retaining elements1184a, and a plurality of second retaining elements1186a. As used herein, a retaining element includes one or more of a strand, filament, monofilament, multifilament (whether braided, woven, twisted or an otherwise associated group of filaments), a bead of material, a thread, a suture, a rolled film, a multilayer lay-up of material, a wire, an embossed or other feature providing the functionality described herein. The first retaining elements1184aand/or the second retaining elements1186acan be formed from polymeric or metallic materials, fluoropolymers, one or more of FEP, PEEK, ePTFE filament(s) (mono- or multi-), nitinol, stainless steel, multiple folds or layers of material (e.g., ePTFE film), combinations thereof, or any of a variety of features configured to resist movement relative to the slot(s). The first and second retaining elements1184a,1186aare optionally molded, heat bonded, or otherwise coupled to the leaflet construct104as desired. As used herein, couple means to join, connect, attach, adhere, affix, or bond, whether directly or indirectly, and whether permanently or temporarily. As shown, the first leaflet1180aincludes first retaining elements1184athat are located on each of the first commissure tab1194aand the second commissure tab1196a. As shown, the first leaflet1180aalso includes second retaining elements1186athat are located on each of the first commissure tab1194aand the second commissure tab1196a. In some examples, the first retaining elements1184aare spaced apart from their adjacent second retaining elements1186aa distance at least as wide as the thickness of a corresponding commissure post1120(e.g.,1120a) as measured from the inner side1110to the outer side1112of the frame1102. As previously referenced, the various retaining elements can take a variety of forms. In some examples, one or both of the first and second retaining elements1184,1186are formed as beads of material and/or fibers (e.g., coated fibers) on the commissure tabs of the leaflets1180. The various retaining elements are optionally bonded to the underlying material of the leaflets1180, such as by thermal bonding. FIG.12is illustrative of a leaflet attachment configuration between the plurality of leaflets1180and the plurality of commissure posts1120of the prosthetic valve100. In particular, althoughFIG.12shows the first commissure post1120a, with one side of the first leaflet1180aand one side of the second leaflet1180battached thereto, it should be understood that similar attachment methods are used to attach the remaining commissure tabs of the plurality of leaflets1180to respective ones of the remaining commissure posts1120. As shown inFIG.12, the first commissure tab1194aof the first leaflet1180aextends through the first slot1134aa plurality of times (also described as a plurality of passes) and the second commissure tab1196bof the second leaflet1180bextends through the second slot1136aof the first commissure post1120aa plurality of times (also described as a plurality of passes), with the first retaining elements1184a,1184bpositioned on the outer side1112of the frame1102, and thus on the outer side1112of the first commissure post1120a. The second retaining elements1186a,1186bare also positioned on the outer side1112of the frame1102, and thus the outer side of the first commissure post1120a. As shown, the second retaining elements1186a,1186band the plurality of passes of the first and second commissure tabs1194a,1196b, respectively, resist being pulled inwardly and outwardly relative to the frame1102. For example, the first retaining elements1184a,1184band the plurality of passes of the first and second commissure tabs1194a,1196b, respectively, cover the second retaining elements1186a,1186band help the assembly being pulled inwardly and outwardly relative to the frame1102. As shown, the first commissure tab1194aof the first leaflet1180adefines a first pass1250athrough the first slot1134a(inside-out relative to the first commissure post1120a) and a second pass1252athrough the first slot1134a(outside-in relative to the first commissure post1120a) to define a first loop1254athrough the first slot1134a. The second retaining element1186ais positioned within the first loop1254ato encircle the second retaining element1186aand form a widened cross-section for the first loop1254aon the outer side1112of the frame1102. The width of the first loop1254ais selected to resist, or be restrained from, pulling through the first slot1134a. The first commissure tab1194aof the first leaflet1180adefines a third pass1256aaround the outside of the first commissure post1120a, from the inner side1110around the first side1148ato the outer side1112and then back from the outer side1112to the first side1148ato define a fourth pass1259a, the third and fourth passes1256a,1259adefining a second loop1258apassing outside the first commissure post1120aon the first side1148a. The first retaining element1184ais positioned within the second loop1258ato encircle the first retaining element1184aand form a widened cross-section for the second loop1258aon the outer side1112of the frame1102. The width of the second loop1258ais selected as desired (e.g., to fit against the outer side1112between the first leaflet1180aand the second leaflet1180b. As shown, the first pass1250ais positioned adjacent, and opposite the second pass1252a, and the third pass1256aand fourth pass1259aare positioned adjacent each other. The second commissure tab1196bdefines a similar set of features to those of the first commissure tab1194a, which are labeled onFIG.12for reference. As shown, the second commissure tab1196bof the second leaflet1180bdefines a first pass1250bthrough the second slot1136a(inside-out relative to the first commissure post1120a) and a second pass1252bthrough the second slot1136a(outside-in relative to the first commissure post1120a) to define a first loop1254bthrough the second slot1136a. The second retaining element1186bis positioned within the first loop1254bto encircle the second retaining element1186band form a widened cross-section for the first loop1254bon the outer side1112of the frame1102. The width of the first loop1254bis selected to resist, or be restrained from, pulling through the second slot1136a. The second commissure tab1196bof the second leaflet1180bdefines a third pass1256baround the outside of the first commissure post1120a, from the inner side1110around the second side1149ato the outer side1112and then back from the outer side1112to the second side1149ato define a fourth pass1259b, the third and fourth passes1256b,1259bdefining a second loop1258bpassing outside the first commissure post1120aon the second side1149a. The first retaining element1184ais positioned within the second loop1258ato encircle the first retaining element1184aand form a widened cross-section for the second loop1258bon the outer side1112of the frame1102. The width of the second loop1258bis selected as desired (e.g., to fit against the outer side1112between the first leaflet1180aand the second leaflet1180b). As shown, the second retaining elements1186a,1186b, and thus the second loops1258a,1258bare secured together (e.g., with an adhesive or one or more fasteners, such as sutures or staples). For example, as shown on or more sutures or other filaments are optionally used to secure the second loops1258a,1258btogether. InFIG.12, a secondary coupler1290is shown in broken lines secured around the second retaining elements1186a,1186b. As shown, the secondary coupler1290is a filament, such as a suture or staple, for securing the second retaining elements1184a,1184btogether. In other examples, the secondary coupler1290includes coating(s) or layer(s) of material over molded or otherwise disposed on the exterior and/or interior side of the frame1102to help couple the first loops1254and the second loops1258to one another and the frame1102. Similarly, any of the other loop and post arrangements may be coupled with one or more secondary couplers (e.g., by one or more sutures, filaments, layers, and/or coatings). For example, one or more layers of tape may be overwrapped onto first loops1254and/or second loops1258, one or more jackets or covers of material may be placed over and secured to the first loops1254and/or second loops1258, or other techniques may be employed. Generally, such materials may be selected not only to secure the first loops1254and the second loops1258in place, but may also be employed to form a continuous surface without cracks or other defects, which may help avoid tissue ingrowth and/or thrombus formation where such avoidance is desirable. Similarly, any of the other loop and post arrangements provided in this disclosure may be coupled with one or more secondary couplers (e.g., by one or more sutures, filaments, layers, and/or coatings). With the arrangement shown the second loops1258a,1258bcan help prevent the first loops1254a,1254bfrom pulling outwardly (radial outward) from the first commissure post1120a. The first loops1254a,b, are optionally described as outer loops and the second loops1258a,bare also optionally described as outer loops. In some examples, one or more of the passes1250a,b,1252a,b,1256a,b,1259a,bare coupled to one another (e.g., by heat seating, adhesives, sutures, or other means). Whether bonded or unbonded, the passes can be inserted into the first slot1134aand second slot1136a, respectively, with the first retaining elements1184a,bon the outer side1112of the frame1102and the second retaining elements1186a,bon the outer side of the frame2102by sliding the first and second commissure tabs1194a,1196binto the first slot1134aand the second slot1136athrough open ends of the slots (not shown, but see the first commissure post1120afor an example). In some other examples, the first and second commissure tabs1194a,1196bare threaded through the slots1134a,1136aand around the sides1148a,1149a(e.g., rather than being slid up into the slots1134a,1136aand around the first and second legs1130a,1132a). Although the described number of passes are shown for each of the commissure tabs inFIG.12, fewer or greater passes are also contemplated. With the arrangement shown inFIG.12, none of the first retaining elements1184, second retaining elements1186, first loops1254, or second loops1258resides on the inner side1110of the frame1102. Thus, those features are outside of the flow field and generally do not interfere with blood flow through the prosthetic valve100. The remaining commissure tabs of the leaflets1180are secured to and supported from the remaining commissure posts1120. The relatively smooth turns and reinforcement provided by the first and second retaining elements1184,1186reduce stress concentrations at the commissure posts1120due to transverse loading of the leaflet construct104and help to reduce axial stress concentrations at the attachment interfaces between the commissure posts1120and the leaflets1180. Also, as shown, the first leaflet1180aand the second leaflet1180bare spaced from one another at the inner side1110of the frame1102, which can be described as the leaflets defining a commissure gap1260at the first commissure post1120a. In some embodiments, the prosthetic valve (e.g., prosthetic valve100) defines similar commissure gaps between each, circumferentially-adjacent leaflets1180of the prosthetic valve100. The commissure gap1260helps provide a limited amount of flow to pass between the first and second leaflets1180a,1180bnear the frame1102to help avoid thrombus formation at that location (e.g., whereas a lack of a gap such as the commissure gap1260may create a dead flow region susceptible to such thrombosis formation). FIG.13shows an overlay of portions of the prosthetic valve100illustrating parts of the frame1102, the cover1104, the first leaflet1180aand the second leaflet1180bof the leaflet construct104in an area of the first commissure post1120a, for understanding of assembly thereof, where similar concepts apply in assembling the remaining leaflets1180to the support structure102. As referenced above, the leaflet construct104(FIG.11) is attached to the support structure102using fold over portions, such as the fold over portion1198a(FIG.11) of the first leaflet1180a. Attachment tabs, such as the attachment tabs1192a,1192bof the first leaflet1180aand the second leaflet1180bare received through the plurality of rows of closed cells1240over portions of the frame1102and the cover1104and attached over the outer side1112of the frame1102and the cover1104to attach the leaflet construct104to the support structure102. As should be understood, the attachment tabs1192a,1192bare passed through the frame1102and folded onto the cover1104. For example, the lowermost attachment tab(s)1192amay be folded to a relatively flat area defined by the cover1104(e.g., the base1166ashown inFIG.10), to define the leaflet base1204ashown for the body portion1190ainFIG.11. In particular, in the case of the first leaflet1180a, the various attachment tabs are folded over at the first leaflet attachment region1160a, including the first side1162a, the second side1164a, and the base1166a(FIG.10). The fold over portions of each of the plurality of leaflets1180are then secured to the support structure102at each of the leaflet attachment regions1160between each of the plurality of commissure posts1120. The fold over portions can be secured in place using adhesives, sutures, sintering, or by other methods as desired. In some examples, apertures, such as the apertures1199aare used to assist with bonding (e.g., adhering) and/or to assist with aligning the attachment tabs at their proper positions. In some examples, the shapes of the fold over portions generally correspond to shapes of the plurality of rows of closed cells1240(FIG.7) to assist with proper visual alignment of the leaflet construct104onto the support structure. As shown inFIGS.1and2, the sealing construct106includes a sealing member1500having a secured portion1510that is coupled to the support structure102(e.g., to the cover1104) and an unsecured portion1512that is not coupled to the support structure102. The sealing member1500is optionally in the form of a continuous band of material extending about the circumference of the support structure102. For ease of illustration, the sealing construct106is not shown to extend fully to the proximal end112of the device, although it should be understood that the sealing construct106optionally extends along a desired portion of the prosthetic valve100, including to the proximal end112. The secured portion1510optionally includes a proximal region1520that is adhered, bonded or otherwise secured to the support structure102. As referenced above, the proximal region1520optionally extends proximally a desired amount, including to the proximal end112of the prosthetic valve100as desired. As indicated by the broken line, the proximal region1520(FIG.2) is optionally continuous and uninterrupted (e.g., a ring) around a circumference of the support structure102(e.g., forming a continuous area of attachment. In other examples, the proximal region1520is discontinuous. The secured portion1510also optionally includes one or more discrete regions1522(FIG.2) that are bonded, adhered, or otherwise secured to the support structure102. Moreover, the secured portion1510also optionally includes one or more securing tabs1524(FIG.2) that are secured to the support structure102and extend longitudinally (e.g., distally) from a distal-facing edge1532of the sealing member1500. The unsecured portion1512optionally includes a distal region1530(FIG.2) of the sealing member which extends to a distal-facing edge1532(FIG.2), at least a portion of which is not secured to the support structure102. In use, the distal-facing edge1532is free to billow, or deflect outwardly a limited amount (e.g., under positive blood pressure) to help the sealing member1500positively engage adjacent tissue. This feature may assist with the sealing function of the sealing member1500with adjacent tissue, including blocking blood flow and/or facilitating tissue ingrowth, for example. The discrete regions1522, securing tabs1524, or other additional or alternative features are optionally employed to help prevent the sealing member1500from inverting during deployment and/or in vivo during operation of the prosthetic valve100. In some examples, the distal-facing edge1532is secured to the support structure102at a plurality of locations (e.g., at the securing tabs1524) and remains unsecured from the support structure102at a plurality of locations where the distal-facing edge1532is free to billow, or deflect outwardly. FIGS.14to18show by way of example some of the advantages that are achieved with the tapered diametric profiles described above for the frame1102, and thus the prosthetic valve100. With reference toFIG.2, the leaflet bases of the leaflet construct104(e.g., such as the leaflet base1204ashown inFIG.11), are located at a first longitudinal location1600along the central longitudinal axis Xf of the support structure102, the frame1102defining a leaflet base level diameter at the first longitudinal location1600. In turn, each the leaflet construct104is coupled to the plurality of commissure posts1120at a second longitudinal location1650along the central longitudinal axis Xf of the support structure102that is distal to the first longitudinal location, the frame1102defining a commissure level diameter at the second longitudinal location1650. For reference, the prosthetic valve100generally defines a proximal portion1660proximal to the first longitudinal location1600and that proximal portion1660typically encounters a larger amount of the inward radial compressive load (e.g., a majority of the inward radial compressive load) when the prosthetic valve100is implanted in a native valve orifice, such as an aortic valve orifice. As illustrated inFIGS.14to18, the commissure level diameter is less than the leaflet base level diameter when the frame1102, and thus the prosthetic valve100, is in an unloaded state. The commissure level diameter is closer in value to the leaflet base diameter when the prosthetic valve100is in an operational state (e.g., under an inward radial compressive load) than when the prosthetic valve100is in the unloaded state. In particular, the operational state of the prosthetic valve100(e.g., following implantation at a native valve orifice) includes the prosthetic valve100being subjected to an inward radial compressive force on at least the proximal portion1660of the prosthetic valve100. FIG.14shows a deformation model for the frame1102under an inward radial compressive load F. In general terms, the load is modeled as a compressive force applied in the form of a right cylinder applied equally around an entire circumference of the frame1102along the entire length of the frame1102.FIG.14Ashows the frame1102in an unloaded condition.FIG.14Bshows the frame1102in a partially loaded condition under the inward radial compressive load F.FIG.14Cshows the frame1102under a fully loaded condition (e.g., as would be expected during operation following implantation). As shown, the commissure level diameter is closer in value to the leaflet base diameter after the prosthetic valve100is placed under full loading.FIGS.15and16help illustrate some advantages of this feature, for example when compared to a prosthetic valve with a frame that has the shape of a simple, right cylinder. FIG.15Ashows an example of a prosthetic valve2000with a frame2002having the shape of a right cylinder,FIG.15Bshows deformation of that prosthetic valve2000when placed under a simulated load corresponding to a native valve orifice (e.g., with a majority placed on a proximal portion of the prosthetic valve2000), andFIG.15Cshows the resulting performance of a leaflet construct2004of the prosthetic valve2000when placed under that inward radial compressive load. As shown, the leaflet construct2004shows wrinkling and less than optimal opening conditions as a result of the leaflet base diameter of the prosthetic valve2000being compressed inwardly a large amount so that it is relatively less than the commissure level diameter. FIG.16shows expected performance of the prosthetic valve100under similar conditions to those described above with regard to the prosthetic valve2000ofFIG.15.FIG.16Ashows the model of the prosthetic valve100with the diametric taper previously described.FIG.16Bshows the modeled performance of the prosthetic valve100under the same simulated load asFIG.15B. As shown inFIG.16B, the model shows the prosthetic valve100to take on a much less tapered, cylindrical shape under a similar operational state. As shown inFIG.16C, the model shows the prosthetic valve100to have a relatively wrinkle-free, optimal opening profile under the simulated inward radial compressive load. This enhanced operational performance may be attributed, at least in part, to the leaflet base diameter of the prosthetic valve100being compressed inwardly a lesser amount and the leaflet base diameter being relatively closer to the commissure level diameter when the prosthetic valve100is in the simulated, operational state. FIGS.17and18provide further visualization of potential advantages achieved by the tapered diametric profiles described herein.FIG.17shows the prosthetic valve2000ofFIG.15in a modeled aortic orifice. As shown, when subjected to the simulated forces encountered in the modeled aortic orifice, the prosthetic valve2000takes on an irregular diametric shape as shown inFIG.17Aand a relatively large proximal taper is imparted as shown inFIGS.17B and17C. In turn,FIG.18shows a modeled deformation of the prosthetic valve100when subjected to the simulated forces encountered in the same modeled aortic orifice. As shown, the prosthetic valve100has taken on a relatively regular, cylindrical shape with a reduced taper and a relatively circular diametric profile. It should be understood that this more regular, diametric profile is desirable for optimal valve performance, resulting in a more regular opening through the prosthetic valve100when transitioned to the open state. FIG.19shows the frame1102of the prosthetic valve100(FIG.1) with a constant diametric taper and commissure posts1120with modified features. In particular, the commissure post1120have been modified for attachment of leaflet construct104(not shown) to the frame1102by adhering and/or wrapping one or more portions of the leaflet construct to the commissure posts1120, for example. As shown inFIG.19, the commissure posts1120also have a rounded, atraumatic design. FIG.20shows another possible modification for the frame1102of the prosthetic valve100(FIG.1). As shown, one or more of the plurality of frame members1122may be modified with features for the frame1102usable for securing the constraints1272(FIG.1) to the prosthetic valve100. As shown inFIG.20, one or more of the plurality of rows of frame members1224(e.g., the proximal row1230and/or the distal row1232shown inFIGS.3and7) and/or one or more of the plurality of commissure posts1120(FIGS.3and7) optionally includes a plurality of circumferentially-oriented eyelets2024A. In some examples, the plurality of circumferentially-oriented eyelets2024A are formed one or more of the plurality of rows of frame members (e.g., at one or more of the apices previously described). Again, these features can additionally or alternatively be located elsewhere in the frame design. Various methods are usable to form the plurality of circumferentially-oriented eyelets2024A. For example, the plurality of circumferentially-oriented eyelets2024A are optionally formed using a circumferential lasing process, a circumferential drilling process, a casting process, combinations thereof and other technique as desired. FIGS.21and22are illustrative of formation of the plurality of circumferentially-oriented eyelets2024A using a further technique and show formation of one of the plurality of circumferentially-oriented eyelets2024A according toFIG.20. For example, as shown, the plurality of circumferentially-oriented eyelets2024A can optionally be formed by first forming a radially-oriented eyelet2024R in a radial direction (FIG.21) and then twisting the frame1102to re-orient the radially-oriented eyelet2024R circumferentially to define one of the plurality of circumferentially-oriented eyelets2024A (FIG.22). This, twisted form may be heat set, set by cold working, or set by any of a variety of methods as desired depending upon application and material used. FIG.23shows a plurality of radially-oriented eyelets2024R formed in the commissure posts1120. As shown, the radially-oriented eyelets2024R have smoothed edges (e.g., via electro polishing). In some examples, the constraint1272(FIG.1) is able to be woven through the radially-oriented eyelets to help provide guide for the constraint1272(FIG.1) as it extends about the frame1102. The radially-oriented eyelets2024R are optionally formed via lasing, or other manufacturing option as desired.FIG.23also illustrates an additional, optional feature. In particular, the frame1102is shown with a plurality of atraumatic posts2120between the plurality of commissure posts1120. The atraumatic posts2120are optionally employed to help protect the leaflet construct104, and in particular portions that extend above the frame member distal boundary1236(FIG.2). As shown, the atraumatic posts2120are relatively narrow, and fit well within the space between adjacent ones of the plurality of commissure posts1120to facilitate diametric compaction of the frame1102. Various advantages may be realized by securing one or more of the plurality of constraints1272using the circumferentially-oriented eyelets2024A and/or the radially-oriented eyelets2024R. For example, tension forces may be reduced via a reduction in friction forces (e.g., by reducing the amount of surface area contacted by a particular constraint). Moreover, surface profile may be reduced and reliability in deployment and compaction increased. Additionally or alternatively, either the circumferentially-oriented eyelets2024A or the radially-oriented eyelets2024R may be polished, or otherwise formed for reduced friction and may additionally or alternatively be treated with coatings or surface modifications to reduce friction. FIGS.24and25are illustrative of another possible feature for the frame1102of the prosthetic valve100. As shown, a distal-facing apex238A of one of the plurality of rows of distal-facing apices238defines an offset intersection location Po with a proximal-facing apex242A of one of the plurality of proximal-facing apices242. As shown, the offset intersection location Po is proximate one of the plurality of commissure posts1120. The offset intersection location Po results in two diagonal frame members3024D of the plurality of frame members1122defining a relatively straight line extending through the offset intersection location Po as illustrated by the relative comparison betweenFIG.26(not offset, intersection location P) andFIG.27(offset intersection location Po). As shown inFIG.25, the offset intersection location Po results in a closed cell3240adjacent the commissure post1120, and in particular the frame members1122defining the closed cell3240, to fold laterally and also proximally to fit under the commissure post1120(e.g., to effect a more efficient packing profile as shown inFIG.25) when the frame1102is diametrically compacted. Similar offset intersections Po are optionally employed next to each of the commissure posts1120of the frame1102as desired. FIG.28shows another modification for the frame1102for attaching the leaflet construct (FIG.1) to the frame1102andFIG.29is an enlarged view of a portion ofFIG.28. As shown inFIGS.28and29, the frame1102is modified with a plurality of leaflet frame projections4260for securing the leaflet construct104to the frame1102. As shown, the leaflet frame projections are disposed on the sides of the plurality of commissure posts1120as well as the leaflet attachment frame members1170(FIG.11). FIG.30shows a modification used for the plurality of leaflets1180, where each leaflet generally includes a plurality of leaflet apertures4308disposed about a leaflet attachment region4330(e.g., corresponding generally to the locations of the commissure tab(s) and/or attachment tab(s) previously described. In use, the leaflet attachment region4330is folded over or otherwise wrapped and/or wound about a portion of the frame1102with the plurality of leaflet apertures4308received over the plurality of leaflet frame projections4260. FIG.31is a top view of a leaflet retention feature4500. The leaflet retention feature4500includes a plurality of struts4512. As shown, the leaflet retention feature4500includes a body4502, a first end4504, a second end4506opposite the first end4504and a first side4508extending between the first and second ends4504,4506. The plurality of struts4512extend opposite from the first side4508. As shown inFIG.30, each of the plurality of struts4512include a free end4524that projects away from where the struts are coupled to the body4502. The leaflet retention feature4500includes a plurality of cells4514. As shown, a plurality of regions4518are defined between adjacently situated ones of the struts4512, each if which is laterally exposed or not otherwise enclosed (e.g., in the instance the leaflet retention feature4500is secured to the leaflet frame projections4260by sliding the leaflet frame projections4260laterally through the plurality of regions4518. As shown inFIG.29, each of the leaflet retention features4500is configured to be coupled onto (e.g., slidingly received onto) the leaflet frame projections4260such that the leaflet frame projections4260extend through gaps defined by cells4514between adjacent ones of the plurality of struts4512. In different terms, the leaflet frame projections4260extend into the cells4514of the leaflet retention feature4500. In various examples, the cells4514are narrower than the leaflet frame projections4260, such that the leaflet retention feature4500, and in particular the plurality of struts4512, is configured to form an interference fit with the leaflet frame projections4260that are each received in one of the plurality of cells4514. In some examples, the leaflet attachment region4330(FIG.30) is optionally placed onto, folded over, or wrapped and/or wound, about, or otherwise engaged with a portion of the frame1102including the leaflet frame projections4260with the plurality of leaflet apertures4308received over the plurality of leaflet frame projections4260. The leaflet retention feature4500is advanced along the leaflet frame projections4260toward the surface from which the leaflet frame projections4260extends to form an interference fit that secures the leaflet attachment region4330to the frame. Generally, the leaflet retention feature4500is advanced until the leaflet retention feature4500contacts the leaflet1180, and/or until the leaflet retention feature4500is advanced to a designated position to secure the leaflet retention feature4500over the leaflet1180to secure the leaflet1180to the frame1102. In some examples, the leaflet attachment region4330(whether wrapped about or otherwise engaged with the frame) is simply covered by the leaflet retention feature4500to secure the leaflet attachment region4330in place. Additionally or alternatively, as part of the attachment process, the leaflet attachment region4330is optionally placed over or under the leaflet retention feature4500and/or folded around the leaflet retention feature4500a desired number of times (e.g., such that the leaflet retention feature4500resides between one or more folds of the leaflet attachment region4330). In some examples, the leaflet retention feature4500is bonded to the leaflet attachment region4330prior to, or after the leaflet retention feature4500is secured to the leaflet frame projections4260. It should also be understood that multiple leaflet retention features similar to the leaflet retention feature4500are secured over the leaflet frame projections4260around portions of the frame1102to which the leaflet construct104is secured, with a similar process being repeated for each of the plurality of leaflets1180. Additionally, although the slots, and associated wrapping technique described in association withFIG.12is not shown, it should be understood that a combination of methods (e.g., wrapping through the first and second slots1134,1136and/or using retaining elements such as the first and second retaining elements1184,1186) are optionally employed. Additional examples of suitable attachment methods similar to those described above can also be found in U.S. patent application Ser. No. 14/973,589, published as U.S. Pub. 2016/0175096, filed Dec. 17, 2015, entitled “PROSTHETIC VALVES WITH MECHANICALLY COUPLED LEAFLETS,” filed by the Applicant hereof on even date herewith. FIGS.32to34show variations of the frame1102in which the distal row1232of the plurality of rows of frame members1224extends distally to define the frame member distal boundary1236either proximate to, at the same level as, or distal to the commissure post distal boundary1152. In these variations, the plurality of commissure posts1120do not extend beyond the frame member distal boundary1236. In further variations (not shown), the plurality of commissure posts do not extend as far beyond the frame member distal boundary1236as other variations (e.g.,FIG.7). In various examples, the distal row1232provides additional support to the commissure posts1120, and helps to reduce strain levels exhibited by flexing of the commissure posts1120. This feature may improve overall reliability and performance by reducing stress/strain concentrations in the frame1102(e.g., maximum alternating strains). In the examples ofFIGS.32to34, the attachment mechanism at the commissure posts1120can include T-shaped barbs or other retention features, such as the features shown inFIGS.28and29(leaflet frame projections4260). Namely, the frame1102is modified with a plurality of leaflet frame projections for securing the leaflet construct104to the frame1102. In the examples ofFIGS.32to34, leaflet frame projections are not shown on the sides of the plurality of commissure posts1120and the leaflet attachment frame members1170for ease of illustration and so that the features of the distal row1232of the plurality of rows of frame members1224may be more easily visualized. According to the example shown inFIG.32, the distal row1232of frame members1224projects distally beyond the commissure post distal boundary1152to define a frame member distal boundary1236that is also distal the commissure post distal boundary1152. The examples ofFIGS.32A to32Cutilize an alternative, inverted distal row approach to provide the additional structural support to the commissure posts1120while minimizing any increase in overall height of the frame1102, and thus the prosthetic valve100. For example, inFIG.32Aone or more closed cells (e.g., each closed cell) of the distal row of closed cells1252has two distal-facing apices238, as does the example ofFIG.32B. In the example ofFIG.32C, one or more closed cells (e.g., each closed cell) of the distal row of closed cells1252has three distal-facing apices238. These reversed, or inverted apex configurations facilitate enhanced rigidity at the distal row1232, and assist with reinforcing the commissure posts1120against stress/strain due to leaflet pressurization. FIGS.33and34show a similar arrangement to that ofFIG.32b, with offset intersections to assist with packing density of the frame and/or manufacturing considerations. In any of the foregoing examples, the distal row1232of the plurality of rows of frame members1224may include relatively thinner frame members1224(see, e.g.,FIG.34), which may assist with compacting the frame1102into a diametrically smaller delivery configuration while still achieving the reinforcing characteristic for the commissure posts1120. From the foregoing, it should be understood that the inverted, or reverse distal row1232configurations may be applied to any of the examples of the frame1102shown and/or described. FIGS.35and36illustrate constraint retention features for the prosthetic valve100that can be provided in addition to or as an alternative to the rows of apertures1270and constraint retainers1106, according to some examples. For example, as shown inFIG.35, the prosthetic valve100optionally includes a plurality of constraint guides5270, which may operate similarly to the constraint retainers1106to receive constraints1272for prosthetic valve100delivery and deployment. It should also be understood that any combination of constraint retention features is employed as desired and, as shown inFIG.35, the prosthetic valve100also optionally includes one or more constraint retainers1106formed as loops of material coupled to the support structure102(e.g., secured to one or more of the plurality of frame members1122) as previously described. Like the constraint retainers1106, the constraint guides5270help retain and guide one or more of the constraints1272to pass around the prosthetic valve100and not disengage or slip off (e.g., they are able to move axially, but are generally restrained in a longitudinal direction of the prosthetic valve16). The constraint guides5270can be described as tunnels, external bands, or belt loops, through which the constraints1272are able to be slidably or otherwise received. As shown, the constraint guides5270are formed by bands or layers of material that define spaces, gaps, or tunnels between layers of material (e.g., between layers of the cover1104). The constraints1272pass through these gaps and are retained between the layers of material. This type of arrangement can be contrasted to those in which constraint1272is threaded in-and-out of the rows of apertures1270, from the interior to the exterior of the prosthetic valve100. In different terms, as shown inFIG.35the constraint guides5270do not result in the constraint1272passing behind the cover1104into the interior of the prosthetic valve100. Generally, the approach implemented by the constraint guides5270is to embed, or retain the constraint1272within portions of the cover1104, rather than having the constraint1272simply wrapped around the periphery of the prosthetic valve100or laced through an interior and exterior path of the prosthetic valve100through the rows of aperture1270. The constraint guides5270can provide a variety of desirable features, including one of more of the following: reduced perivalvular leakage due to elimination of biopsies (e.g., openings or apertures) through the cover1104of prosthetic valve100(e.g., in contrast to some examples using the apertures1270); improved durability of the prosthetic valve100due to less perforations; improved deployment reliability (e.g., release and/or tensioning of the constraint1272) due to reduced friction between constraint1272and the prosthetic valve100; improved prosthetic valve100compatibility and reliability due to reduction of interference/interaction of vessel walls with the constraint1272; reduced likelihood of snagging/pinching the constraint1272as the constraint1272is not captured or otherwise trapped between portions of the frame1102(e.g., as can happen when the constraint1272is threaded in-and-out of the apertures1270and/or the frame1102); and improved durability of the constraint1272, due to less wear from the frame1102engaging the constraint1272(e.g., pinching the constraint1272) when the prosthetic valve100is compressed, or diametrically compacted. These are just a few examples of optional advantages according to various embodiments. Generally, the constraint guides5270receive (e.g., slidingly) one or more constraints1272that pass into and out of the constraint guides5270in a circumferential path extending around the frame1102. The one or more constraints1272are thus able to be used for retaining the frame1102, and thus the prosthetic valve100, in a diametrically compacted, delivery configuration and then permitting the prosthetic valve100to be transitioned to a diametrically enlarged, deployed configuration upon releasing tension in the one or more constraints1272using an associated delivery system (such as those previously or subsequently described). As shown inFIG.35, the prosthetic valve100includes a plurality of rows of the constraint guides5270, such as a proximal row of constraint guides5270a, one or more intermediate rows of constraint guides5270b, and a distal row of constraint guides5270c. Each of the rows of constraint guides5270is positioned as desired for a corresponding constraint1272to form a loop at a desired level along the prosthetic valve100. For example, the cover1104optionally includes a plurality of separate constraint guides5270each spaced circumferentially apart from one another about the circumference of the frame1102in a row, with one of the constraints1272passing through each of the plurality of constraint guides5270in a circumferentially-aligned row. Although, in some examples, each of a plurality of separate constraint guides5270in a row is circumferentially-aligned about the circumference of the frame1102, in other examples a row is not circumferentially-aligned, but instead is helically aligned, or defines another path about the circumference of the frame1102as desired. Generally, the proximal row of constraint guides5270aslidably receive a proximal constraint1272athat is passed through the proximal row of constraint guides5270aand which can be tensioned to collapse, or radially compress, the prosthetic valve100onto a delivery catheter as previously described. Similarly, the intermediate row of constraint guides5270band the distal row of constraint guides5270ceach slidably receive an intermediate constraint1272band a distal constraint1272c, respectively, that are each is passed through the constraint guides5270and which can be tensioned to collapse, or radially compress, the prosthetic valve100. As shown, the proximal constraint1272ais optionally passed through constraint retainers1106associated with the frame1102, for example. For reference, a single row (whether circumferential and parallel, helical, or otherwise) may include multiple constraint guide designs, such as designs consistent with constraint guide5270, constraint retainer1106, or apertures1270. FIG.36Ais an enlarged view of a portion of the prosthetic valve100including one of the constraint guides5270. As shown inFIG.36A, a manufacturing aid Maid is inserted through the constraint guide5270. Each of the constraint guides5270is optionally formed similarly to the constraint guide5270shown inFIG.36A. As shown inFIG.36A, the constraint guide5270includes an outer layer1104aof material and base layer1104bof material that combine to form a loop and define a tunnel1104c, or gap, extending between the outer layer1104aand the base layer1104bwithin a thickness of the cover1104. The tunnel1104cextends between a first opening1104dand a second opening1104ein the outer surface of the cover1104. As described below, the outer layer1104aand the base layer1104bare optionally formed as layers of the cover1104, where some methods of forming the constraint guides5270include making cut lines Cline through the outer layer1104aon either side of the tunnel1104c. In other embodiments, the outer layer1104ais formed as a discrete flap, or piece of material that is subsequently secured to the cover1104to define the tunnel1104c, as well as a portion of the outer surface of the cover1104. With additional reference toFIG.35, the frame1102generally defines a circumference extending along a transverse path around the central longitudinal axis Xf of the frame1102. As previously referenced, the cover1104is coupled to the frame1102and includes a plurality of constraint guides5270. In some examples, each constraint guide5270defines a tunnel1104c, such as that shown inFIG.36A, that extends transversely to the central longitudinal axis Xf of the frame1102between the first opening1104dand second opening1104ein the outer surface of the cover1104. FIG.36Billustrates two of the constraint retainers1106which have been formed by wrapping filaments around the frame members1122a plurality of times to secure the filaments to the frame members1122and to form one or more loops1106bsuitable for receiving one of the constraints1272. As previously described, the filaments of the constraint retainers1106can be metallic (e.g., nitinol) polymeric (e.g., ePTFE) or any other biocompatible material. In some examples, the filaments are formed of biocompatible, biocorrodible/biodegradable material such that the filaments degrade and are absorbed or pass out of the body after a desired time frame. If desired, the constraint retainers1106can also be bonded (e.g., in addition or as an alternative to the wrapping securement mechanism) to specific points on the frame members1122using a suitable adhesive or other bonding agent, for example. FIG.36Cillustrates a constraint retainer1106formed by wrapping a filament around an intersection location of the frame members1122, such as the intersection location P (FIG.26). The constraint retainer1106is formed by wrapping a filament around the frame members1122at the intersection P one or more times to secure the filament to the frame members1122and to form one or more loops1106csuitable for receiving one of the constraints1272. As previously described, the filaments of the constraint retainer1106can be metallic (e.g., nitinol) polymeric (e.g., ePTFE) or other material. In some examples, the filaments are formed of biocompatible, biocorrodible/biodegradable material such that the filaments degrade and are absorbed or pass out of the body after a desired time frame. If desired, the constraint retainers1106can be wrapped and bonded to specific points on the frame members1122(e.g., in addition or as an alternative to the wrapping securement mechanism) using a suitable adhesive or other bonding agent, for example. Some methods of forming the prosthetic valve100with constraint guides5270include one or more of the following steps:Applying one or more layers of inner cover material to form the base layer1104bonto a mandrel, where the inner cover material includes an outwardly-facing adhesive;Positioning the frame1102over the base layer1104b;Preparing one or more layers of outer cover material to form the outer layer1104a, where the outer cover material optionally includes an inwardly facing adhesive;Cutting the outer layer1104aalong the cut lines Cline on either side of the tunnel1104cthat will be formed at locations corresponding to each constraint guide5270;Positioning the outer layer1104aover the frame1102, the base layer1104band the outer layer1104acombining to form the cover1104, where the cut lines Cline, or holes through the outer layer1104aare positioned at the desired locations for the constraint guides5270;Obtaining a manufacturing aid Maid for placement through each of the tunnels1104c(i.e., through the cut lines Cline on either side of the tunnels1104c), where the manufacturing aid Maid should have a desired diameter to achieve an appropriate level of interference of the constraint1272with the constraint guide5270upon removal of the manufacturing aid Maid, may have a length corresponding to that of individual tunnels1104cor be longer, continuous element for placement through multiple tunnels1104c, should be able to withstand bonding temperatures of the base layer1104band the outer layer1104a, and should not bond to the base layer1104band/or outer layer1104a, or should otherwise be configured such that the manufacturing aid Maid is able to be effectively removed from the tunnel1104c(e.g., a potential manufacturing aid Maid may be a PEEK rod);Threading the manufacturing aid Maid through the tunnels1104cbetween the base layer1104band the outer layer1104a;Preparing the frame1102, base layer1104b, outer layer1104a, and manufacturing aid Maidfor bonding and bonding one or more of the foregoing (e.g., by overwrapping with a sacrificial compression layer and heating in an oven to reflow the adhesive(s) and/or sinter layer(s)); andRemoving the manufacturing aid Maidfrom the tunnel1104c. In some examples, the manufacturing aid Maidmay be loosened or freed from the tunnel1104cby using a slender rod (or needle) to trace the outer diameter of the manufacturing aid Maidto break the manufacturing aid Maidfree from the base layer1104band/or outer layer1104aprior to pulling the manufacturing aid Maidout of the tunnel1104c(e.g., with a tweezers). Generally, the same process may be used to form any number of the tunnels1104cas desired. In some examples, a method of forming a prosthetic valve with the constraint retainers1106includes the following steps: Obtaining a manufacturing aid Maidfor placement through each of the loops1106B or1106C, where the manufacturing aid Maidshould have a desired diameter to achieve an appropriate level of interference of the constraint1272with the constraint retainer1106upon removal of the manufacturing aid Maid, should be able to withstand bonding temperatures for any bonding agent used with the filament forming the loops1106bor1106c, and should not bond to the material forming the loops1106bor1106c, or should otherwise be configured such that the manufacturing aid Maidis able to be effectively removed from the loops1106bor1106c(e.g., a potential manufacturing aid Maidmay be a PEEK rod); Wrapping a filament around the frame members1122one or more times to secure the filament to the frame members1122and to form the loop1106B or1106C over the manufacturing aid Maid; Preparing the frame1102, filament, and manufacturing aid Maidfor optional bonding (e.g., by heating in an oven to reflow the adhesive(s) and/or sinter filament winding(s); and Removing the manufacturing aid Maidfrom the loop1106bor1106c. In some examples, the manufacturing aid Maidmay be loosened or freed from the loops1106bor1106cby using a slender rod (or needle) to trace the outer diameters of the manufacturing aid Maidto break the manufacturing aid Maidfree from the filament prior to pulling the manufacturing aid Maidout of the loops1106bor1106c(e.g., with a tweezers). Generally, the same process may be used to form any number of the loops1106bor1106cas desired. FIG.37shows additional, optional anchor member features of the frame1102of the prosthetic valve100. As shown, the frame1102includes a plurality of anchor members5700that project radially outward from the frame1102. In some examples, the plurality of anchor members5700are formed of the same material as the frame1102(e.g., by laser cutting the anchors from the same material as the remainder of the frame1102). Each of the anchor members5700is optionally biased (e.g., by shape memory) to extend radially outward, and thus to be radially actuable, to a desired angle from the frame (e.g., at an angle of greater than 15 degrees, 20 degrees, 45 degrees, or more) relative to the central longitudinal axis Xf of the frame1102. Any number of anchor members5700is contemplated at any of a variety of positions on the frame1102. As shown in the example ofFIG.37, one of the anchor members5700extends from a location on one of the frame members1122that is proximate to every other distal-facing apice238of the proximal row of closed cells1250. FIG.38shows an example of a possible compacted frame design for the frame1102including the anchor members5700. As shown inFIG.38, each of the anchor members5700includes a base5702where each of the anchor members5700extends from the frame1102, a body5704that projects radially outward from the frame1102upon deployment of the prosthetic valve100, and a tip5706that may be configured to penetration tissue. In various examples, the position for the intermediate constraint1272bcorresponds to a location that would extend across the anchor members5700when the frame1102, and the prosthetic valve100more generally, is in the diametrically compacted state. In this manner, the intermediate constraint1272bis optionally used to constrain the anchor members5700until the intermediate constraint1272bis released. Additionally, as shown, the anchor members5700are optionally configured to be interleaved in the spaces between adjacent frame members1122to facilitate a more compact design. In some examples, the anchor members5700are located to engage the base of the native leaflets and the native sinuses of a native valve. The anchor members5700may also be located at a position on the prosthetic valve100to displace or puncture native leaflets and reside in the native sinuses of a native valve structure. Finally, the anchor members5700are generally positioned and configured not to interfere with leaflet operation of the prosthetic valve100or other operational valve features according to various designs. FIG.39is an example of the assembled prosthetic valve100with the anchor members5700. As shown, the anchor members5700are free from the cover1104and are free to project outwardly and to radially actuate upon expansion of the prosthetic valve100from a diametrically compacted state (e.g.,FIG.38) to the diametrically expanded, delivery state shown inFIG.39. For reference, the design of the frame1102inFIG.39includes an extra row of closed cells (e.g., in comparison to the examples for the frame1102shown inFIGS.37and19). The anchor members5700are optionally positioned at locations on the prosthetic valve100that correspond to a desirable anchoring site in the anatomy. As shown schematically inFIG.40, upon deployment, the anchor members5700are optionally employed to help anchor or retain the prosthetic valve100at a location in the anatomy of a patient, including a valve orifice5800, such as a human or porcine native valve orifice (e.g., aortic valve orifice or a mitral valve orifice). Although the anchor members5700are shown in an intermediate position on the prosthetic valve100, alternative or additional locations for the anchor members5700(e.g., more proximally- or distally-located positions on the frame1102of the prosthetic valve100) are contemplated. In some associated methods of treatment, the anchor members5700assist with securing the prosthetic valve100in a native valve orifice that is exhibiting valve insufficiency (e.g., aortic or mitral valve insufficiency, for example). Valve insufficiency and associated regurgitation through the valve may be a result of weakened tissue associated with the valve. In such instances, the anchor members5700may be particularly useful for securing the prosthetic valve100in place. Some methods of treatment of valve insufficiency include positioning the prosthetic valve100at a desired treatment location within the body and securing the prosthetic valve100at the desired treatment location, including expanding the prosthetic valve at the desired treatment location such that the anchor members5700of the prosthetic valve100anchor the prosthetic valve100at the desired treatment location. In some examples, the desired treatment location can be a native aortic valve exhibiting aortic regurgitation and the method can include positioning the prosthetic valve at the native valve orifice and securing the prosthetic valve at the native valve orifice by engaging the anchor members5700with tissue associated with the native aortic valve. Positioning the prosthetic valve at the desired treatment location within the body can include constraining the prosthetic valve100in a diametrically compacted delivery profile with one or more of the constraints1272and positioning the prosthetic valve100at the desired treatment location within the body with the prosthetic valve100in the diametrically compacted delivery profile. The method can include radially actuating the anchor members5700by releasing one or more of the constraints1272and expanding the prosthetic valve100in the native valve orifice by releasing the one or more constraints1272such that the anchor members5700engage the tissue associated with the native aortic valve. Similarly to various embodiments, an inward radial compressive load may be applied to the prosthetic valve by the native valve orifice or associated tissue and the diametric taper exhibited by the prosthetic valve100may be reduced relative to when the prosthetic valve100is in an unloaded state. Prosthetic valve leaflets detaching from a support structure, or frame, constitute a high risk to a patient into which it is placed. One factor contributing to leaflet detachment can be peak stress in the leaflet at the commissure region when the prosthetic valve is closed and under fluid backpressure.FIGS.41and42show a commissure attachment region variation and associated leaflet closing profile at the outflow end that can be employed in any of the embodiments and examples previously described. Adjacent, diverging leaflet attachment regions, may provide beneficial overall stress profiles in the leaflet adjacent the commissure regions of the leaflets. As shown inFIG.41, the commissure attachment regions1134a,1136a(which correspond to a modified version of the slots1134a,1136aofFIG.5) of commissure post1120aare modified to provide means by which to preserve, if not shorten, prosthetic valve height with the capability of reducing the peak commissure stress in the leaflet at the commissure post without altering the leaflet material properties. FIG.42is illustrative of the leaflets1180of prosthetic valve100in a closed state with the diverging commissure attachment region modification. As shown, and as will be subsequently described, the diverging commissure attachment regions result in a closed profile with the leaflets1180having diverging free edges at the frame1102. As shown inFIG.41, the upper most portion of adjacent commissure attachment regions near the second ends1142a,1146ahave been modified from being non-divergent (e.g., parallel as shown inFIG.5) to being divergent. The adjacent commissure attachment regions of the commissure post1120aterminates by extending away from a middle axis Yf positioned centrally between each of the adjacent commissure attachment regions1134a,1136a, the pair diverging from a location below the commissure post tip (the distal end1150a) in the outflow direction. The adjacent commissure attachment regions1134a,1136amay diverge along their entire heights, or as shown may have base portions toward the first ends1140a,1144athat are parallel or otherwise non-diverging and terminal portions toward the second ends1142a,1146athat are diverging as shown. Each of the commissure posts1120may be similarly configured, resulting in a diverging leaflet profile as illustrated generally inFIG.42. FIG.43is a schematic view of one of the plurality of leaflets1180which can be referenced for further discussion of leaflet effects achieved using the diverging free-edge concept. As shown in the example ofFIG.43, the leaflet1180has body portion1190(also described as a cusp), free edge1206, and commissure regions1154. The free edge1206extends to two termini1156. The two termini1156are defined at an intersection of the leaflet free edge1206and the leaflet attachment region1143. The leaflet attachment regions1143of adjacent leaflets1180are configured to be coupled to the commissure posts1120at locations on the adjacent leaflets1180that are adjacent the termini1156of the adjacent leaflets1180. According to some examples (e.g.,FIG.11), the leaflet attachment region1143is at the outer margin of the leaflet1180and corresponds to the plurality of attachment tabs1192a, the first commissure tab1194a, and the second commissure tab1196a, where the first and second commissure tabs1194a,1196acorrespond to the portion of the leaflet attachment region1143coupled to the commissure post1120. In other examples (e.g.,FIG.30), the leaflet attachment regions4330corresponds to the correspond to the portion of the leaflet attachment region1143coupled to the commissure post1120. In those other examples, the diverging commissure post slots1134,1136are substituted with diverging leaflet frame projections4260for securing the leaflet construct104to the frame1102as previously described. As illustrated schematically inFIG.43, a (dashed) fold line defines an outer margin of the body portion1190and commissure regions1154used to secure the leaflet1180to the frame1102. A free edge region1158is that location of the leaflet1180including and adjacent to the leaflet free edge1206. The outer margin or leaflet attachment region1143of each leaflet1180is coupled to the frame1102, and the free edge1206of the leaflet1180extends across a cylindrical region defined by the frame1102. In various examples, the commissure regions1154of adjacent ones of the leaflets1180are operable to pass through the adjacent commissure attachment regions1134,1136(slots) in a side-by-side relationship (or be attached to diverging leaflet frame projections4260in a side-by-side relationship as previously referenced). Because the commissure post1120defines diverging commissure attachment regions1134,1136that diverge in the outflow direction towards the commissure post tip the commissure regions1134,1136of adjacent, respective leaflets1180will also diverge from a location away from the commissure post tip in the outflow direction when adjacent leaflets1180are in a closed, coapted position. Non-diverging commissure attachment regions (e.g.,FIG.5) may have a maximal stress at the region corresponding to the terminus1156when a leaflet is in the closed position. It turn, use of diverging commissure attachment regions (e.g., as shown inFIG.41), may help translate the region of maximal stress away from the termini1156of adjacent leaflets1180, to be distributed over a larger area, and to also have a reduced magnitude. For example, stress force vectors within the leaflets1180along diverging regions proximate the termini1156may be reduced relative to the same basic frame and leaflet arrangement but with non-diverging commissure attachment regions by a reduction of 41% of peak stress in the leaflets1180in the free edges1206at the termini1156for a given frame length. The stress within the leaflets1180along the diverging region (e.g., in the free edges1206at the termini1156) may be reduced more than 40% relative to a non-diverging attachment when exposed to peak closing pressures of about 135 mm Hg on the outflow faces (or distal faces) of the leaflets fora given frame length. It has been demonstrated that the location of maximum loaded stress can be moved to a predetermined and more favorable location and the magnitude and distribution of stress that a given region of the leaflet1180experiences can be changed by changing the geometry where the leaflets1180attach to the frame1102, and in particular by using diverging attachment regions for adjacent leaflets. Similar results are expected by modifying the divergence and curvature of the slots1134,1136of commissure posts1120or by modifying the divergence and curvature of the projections4260for securing the leaflet construct104to the frame1102. Although some examples have been provided, it should be understood that similar diverging attachment regions may be implemented with cut tube, wire frame, or any other type of frame (or frame material) as desired to achieve reduced, and more distributed stresses from the leaflet termini. The attachment configurations described above can be particularly advantageous when employed with polymeric (e.g., ePTFE-based) leaflets, although any of a variety of leaflet materials are contemplated. Transcatheter Delivery System In some embodiments, with reference toFIG.44, a transcatheter delivery system6000comprises a prosthetic valve6100(according to any of the examples previously described) having a diametrically compacted, or collapsed configuration, and an expanded operational configuration (as shown) and a delivery catheter6200, configured to deploy the prosthetic valve6100. The prosthetic valve6100can be mounted to an end of the delivery catheter6200for delivery through the vasculature and maintained in a collapsed state by a plurality of the constraints1272which are then released to permit expansion of the prosthetic valve6100. In order to hold the prosthetic valve6100in a collapsed configuration on the delivery catheter6200, the transcatheter delivery system6000may further comprise a removable sheath (not shown) or other type of constraint to closely fit over the prosthetic valve100. Some methods of delivery include the steps of radially compressing the prosthetic valve100(according to any of the examples previously described) into its collapsed configuration onto the end of the delivery catheter6200; delivering the prosthetic valve100to a desired treatment location, including a tissue orifice6400, such as a native valve orifice (e.g., aortic valve orifice or a mitral valve orifice), via a transfemoral or transapical route, and expanding the prosthetic valve100into the tissue orifice6400. The prosthetic valve100can be self-expanding and/or expansion can also be facilitated by expanding a balloon (not shown). In some examples, the method includes releasing the constraints1272, which are passed through one or more of the more rows of apertures1270, the plurality of constraint retainers1106, the circumferentially-oriented eyelets2024A, and/or the radially-oriented eyelets2024R as previously described. Surgical Embodiments It is appreciated that the prosthetic valve100(according to any of the examples previously described) may be surgically implanted rather than using transcatheter techniques. As shown inFIG.45, the prosthetic valve100(according to any of the examples previously described) may have a sewing cuff6300adjacent to the frame outer side. The sewing cuff6300, which may be of a type known in the art, is operable to provide structure that receives suture for coupling the prosthetic valve100to an implant site, such as the tissue orifice6400. The sewing cuff may comprise any suitable material, such as, but not limited to, double velour polyester. The sewing6300cuff may be located circumferentially around the frame of the prosthetic valve100, for example. Leaflet Materials In various examples, the leaflet construct104is formed of a biocompatible, synthetic material (e.g., including ePTFE and ePTFE composites, or other materials as desired). In other examples, the leaflet construct104is formed of a natural material, such as repurposed tissue, including bovine tissue, porcine tissue, or the like. As used herein, the term “elastomer” refers to a polymer or a mixture of polymers that has the ability to be stretched to at least 1.3 times its original length and to retract rapidly to approximately its original length when released. The term “elastomeric material” refers to a polymer or a mixture of polymers that displays stretch and recovery properties similar to an elastomer, although not necessarily to the same degree of stretch and/or recovery. The term “non-elastomeric material” refers to a polymer or a mixture of polymers that displays stretch and recovery properties not similar to either an elastomer or elastomeric material, that is, considered not an elastomer or elastomeric material. In accordance with some embodiments herein, the leaflet comprises a composite material having at least one porous synthetic polymer membrane layer having a plurality of pores and/or spaces and an elastomer and/or an elastomeric material and/or a non-elastomeric material filling the pores and/or spaces of the at least one synthetic polymer membrane layer. In accordance with other examples, the leaflet further comprises a layer of an elastomer and/or an elastomeric material and/or a non-elastomeric material on the composite material. In accordance with examples, the composite material comprises porous synthetic polymer membrane by weight in a range of about 10% to 90%. An example of a porous synthetic polymer membrane includes expanded fluoropolymer membrane having a node and fibril structure defining the pores and/or spaces. In some examples, the expanded fluoropolymer membrane is expanded polytetrafluoroethylene (ePTFE) membrane. Another example of porous synthetic polymer membrane includes microporous polyethylene membrane. Examples of an elastomer and/or an elastomeric material and/or a non-elastomeric material include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE/PMVE copolymer), (per)fluoroalkylvinylethers (PAVE), urethanes, silicones (organopolysiloxanes), copolymers of silicon-urethane, styrene/isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers and copolymers or mixtures of each of the foregoing. In some examples, the TFE/PMVE copolymer is an elastomer comprising essentially of between 60 and 20 weight percent tetrafluoroethylene and respectively between 40 and 80 weight percent perfluoromethyl vinyl ether. In some examples, the TFE/PMVE copolymer is an elastomeric material comprising essentially of between 67 and 61 weight percent tetrafluoroethylene and respectively between 33 and 39 weight percent perfluoromethyl vinyl ether. In some examples, the TFE/PMVE copolymer is a non-elastomeric material comprising essentially of between 73 and 68 weight percent tetrafluoroethylene and respectively between 27 and 32 weight percent perfluoromethyl vinyl ether. The TFE and PMVE components of the TFE-PMVE copolymer are presented in wt %. For reference, the wt % of PMVE of 40, 33-39, and 27-32 corresponds to a mol % of 29, 23-28, and 18-22, respectively. In some examples, the TFE-PMVE copolymer exhibits elastomer, elastomeric, and/or non-elastomeric properties. In some examples, the composite material further comprises a layer or coating of TFE-PMVE copolymer comprising from about 73 to about 68 weight percent tetrafluoroethylene and respectively from about 27 to about 32 weight percent perfluoromethyl vinyl ether. In some examples, the leaflet is an expanded polytetrafluoroethylene (ePTFE) membrane having been imbibed with TFE-PMVE copolymer comprising from about 60 to about 20 weight percent tetrafluoroethylene and respectively from about 40 to about 80 weight percent perfluoromethyl vinyl ether, the leaflet further including a coating of TFE-PMVE copolymer comprising from about 73 to about 68 weight percent tetrafluoroethylene and respectively about 27 to about 32 weight percent perfluoromethyl vinyl ether on the blood-contacting surfaces. As discussed above, the elastomer and/or an elastomeric material and/or a non-elastomeric material may be combined with the expanded fluoropolymer membrane such that the elastomer and/or the elastomeric material and/or the non-elastomeric material occupies substantially all of the void space or pores within the expanded fluoropolymer membrane. Some examples of suitable leaflet materials may be found in U.S. Pat. No. 8,961,599 to Bruchman et al. (“Durable High Strength Polymer Composite Suitable for Implant and Articles Produced Therefrom”); U.S. Pat. No. 8,945,212 to Bruchman et al. (“Durable Multi-Layer High Strength Polymer Composite Suitable for Implant and Articles Produced Therefrom”); U.S. Pat. No. 9,554,900 to Bruchman et al. (“Durable High Strength Polymer Composites Suitable for Implant and Articles Produced Therefrom”); and U.S. Pat. App. Pub. 2015/0224231 to Bruchman et al. (“Coherent Single Layer High Strength Synthetic Polymer Composites for Prosthetic Valves”). Frame Materials The frames can be etched, cut, laser cut, stamped, three-dimensional printed or wire wound, among other suitable processes. The frames can be self-expanding or balloon expandable (e.g., when configured for transcatheter implantation) or non-expandable (e.g., when configured for surgical implantation). The various frames can comprise materials, such as, but not limited to, any metallic or polymeric material, such as an elastically (e.g., nitinol) or plastically (e.g., stainless steel) deformable metallic or polymeric material that is generally biocompatible. Other materials suitable for any of the frames described herein include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloy, polypropylene, acetyl homopolymer, acetyl copolymer, a drawn filled tube (e.g., nitinol wire with a platinum core), other alloys or polymers, or any other material that is generally biocompatible having adequate physical and mechanical properties to function as a frame as described herein. Methods of Making Various methods of making prosthetic valves are contemplated for the various prosthetic valves described herein. Generally, the methods include providing a frame and a leaflet construct according to any of the above-described embodiments and securing the leaflet construct to the frame. In some methods of making prosthetic valves, the leaflet construct is at least partially coupled to the frame by a looped structure. For example, in some methods the commissure tabs of the leaflet construct define one or more loops that are passed through slots in the commissure posts of the frames, such as the commissure posts according to any of the frame embodiments previously described. In some examples, inner retaining elements pass through one or more of the loops to help widen the loops and help prevent the loop(s), or passes of material, from pulling outwardly through the slots in the commissure posts. Outer retaining elements additionally or alternatively help prevent the loop(s), or passes of material, from pulling inwardly through the slots in the commissure posts. In various examples, the loop(s) of material are optionally coupled to one another and/or to the frame (e.g., bonded or adhered by an outer wrap of film, sutured, or otherwise secured) to help secure the commissure tabs to the commissure posts. In various examples, the body portions of the leaflets are optionally attached to the frame using attachment tabs secured through and folded over the outer side of the frame and/or cover. In some methods, leaflet retention features are coupled onto (e.g., slidingly received onto) leaflet frame projections to secure the leaflets to the frame. These and other methods should be apparent from the foregoing disclosure. Numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications can be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts including combinations within the principles of the disclosure, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein. | 117,064 |
11857413 | DETAILED DESCRIPTION As referred to herein, stented transcatheter prosthetic heart valve can assume a wide variety of different configurations, such as a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic or tissue—engineered leaflets, and can be specifically configured for replacing any of the four valves of the human heart. In general terms, the stented prosthetic heart valves of the present disclosure include a stent or stent frame maintaining a valve structure tissue or synthetic), with the stent having a normal, expanded condition or arrangement and collapsible to a compressed condition or arrangement for loading within a delivery device. The stent frame is normally constructed to self-deploy or self-expand when released from the delivery device. For example, stents or stent frames are support structures that comprise a number of struts or wire segments arranged relative to each other to provide a desired compressibility and strength to the prosthetic heart valve. The struts or wire segments are arranged such that they are capable of self-transitioning from a compressed or collapsed condition to a normal, radially expanded condition. The struts or wire segments can be formed from a shape memory material, such as a nickel titanium alloy (e.g., Nitinol™). The stent frame can be laser-cut from a single piece of material, or can be assembled from a number of discrete components. With the above understanding in mind, one simplified, non-limiting example of a stented prosthetic heart valve20in accordance with principles of the present disclosure is illustrated inFIG.1A. As a point of reference, the prosthetic heart valve20is shown in a normal or expanded condition in the view ofFIG.1A;FIG.1Billustrates the prosthetic heart valve20in a compressed condition (e.g., when compressively retained within an outer catheter or sheath). The prosthetic heart valve20includes a stent or stent frame22and a valve structure24. The stent frame22can generally assume any of the forms mentioned above, and is generally constructed so as to be self-expandable from the compressed condition (FIG.1B)) to the normal, expanded condition (FIG.1A). In other embodiments, the stent frame22can be configured for expansion from the compressed condition to the expanded condition via operation of a separate tool, such as a balloon (i.e., the stent frame22can be a balloon-expandable stent frame as known in the art). The valve structure24can assume a variety of forms, and can be, for example, formed from one or more biocompatible synthetic materials, synthetic polymers, autograft tissue, homograft tissue, xenograft tissue, or one or more other suitable materials. In some embodiments, the valve structure24can be formed, for example, from bovine, porcine, equine, ovine and/or other suitable animal tissues. In some embodiments, the valve structure24can be formed, for example, from heart valve tissue, pericardium and/or other suitable tissue. In some embodiments, the valve structure24can include or form one or more leaflets26. For example, the valve structure24can be in the form of a tri-leaflet bovine pericardium valve, a bi-leaflet valve, or other suitable valve. In some constructions, the valve structure24can comprise two or three leaflets that are fastened together at enlarged lateral end regions to form commissural points28, with the unattached edges forming coaptation edges of the valve structure24. The leaflets26can be fastened to a skirt (not shown) that in turn is attached to the stent frame22. The upper ends of the commissural points28can define an inflow portion30corresponding to a first or inflow end32of the prosthesis20. The opposite end of the valve structure24can define an outflow portion34corresponding to a second or outflow end36of the prosthesis20. With the exemplary construction ofFIGS.1A and1B, the prosthetic heart valve20can be configured (e.g., sized and shaped) for replacing or repairing an aortic valve. Alternatively, other shapes are envisioned, adapted to mimic the specific anatomy of the valve to be repaired (e.g., the stented prosthetic heart valve of the present disclosure can alternatively be shaped and/or sized for replacing a native mitral, pulmonic, or tricuspid valve). The self-expanding stent frame22is configured to generate a high radially expansive force (alternatively referred to as a chronic outward force) when forced to the compressed condition ofFIG.1Bfor self-deployment, and exhibit high resistance to radial compression (alternatively referred to as a radial resistive force or force required to compress the stent frame22) once in the normal, expanded condition ofFIG.1A. It will be recognized that when implanted, the stent frame22will expand from the compressed condition toward the normal condition; however, the stent frame22will not fully attain the normal condition. Instead, the stent frame22is sized and shaped in accordance with the expected anatomy such that the stent frame22intimately contacts the native anatomy at a level of expansion less than the normal condition. In this way, the chronic outward force attribute of the stent frame22ensures that the stent frame22securely lodges or anchors against the native anatomy, with the stent frame22thus applying a force onto the native anatomy. This inherent characteristic of the stent frame22can also be referred to in terms of radial stiffness. With this in mind,FIG.2Aillustrates the stent frame22in isolation. The stent frame22has a lattice structure that provides a plurality of closed cells40(several of which are referenced inFIG.2A). The lattice structure collectively forms a tubular shape defining a circumference (best reflected by the schematic end view ofFIG.2B). The closed cells40are arranged about the circumference, and the lattice structure can be viewed as defining one or more circumferential bands of closed cells. For example, first, second and third circumferential bands50-54are identified inFIG.2A. The stent frame22is configured such that a radial stiffness exhibited along the first band50(in at least the normal, expanded condition) varies along the circumference as described below. The radial stiffness exhibited along the second and third bands52,54can be substantially uniform along an entirety of the circumference in some embodiments; alternatively, more than one circumferential band defined by the lattice structure of stent frame22have a varying radial stiffness along the circumference (e.g., the first and second bands50,52can have the varying radial stiffness attributes described below). Regardless, the variable radial stiffness embodied by at least the first circumferential band50is configured to impart minimal or reduced force on contacted tissue upon implant of the stent frame22, for example imparting less chronic outward force onto a native conduction fibers or bundle. The variable radial stiffness of the first band50can be characterized by regions of differing radial stiffness. For example, in the view ofFIG.2B, a first region60and a second region62are identified. As a point of reference,FIG.2Bis a schematic end view of the stent frame22from the inflow end32, illustrating the tubular nature of the stent frame22in the normal, expanded state, and generally reflects a location of the closed cells40along the first band50. With this in mind, each of the regions60,62consists of at least two circumferentially adjacent closed cells40. The stent frame22is constructed such that the radial stiffness along the first region60is less than the radial stiffness along the second region62. In this regard, the stent frame22can exhibit a constant radial stiffness along an entirety of the first region60or along an entirety of the second region62, or the radial stiffness within the regions60/62can vary slightly, respectively. Regardless, the minimum radial stiffness at any location along the second region62is greater than the maximum radial stiffness along any portion of the first region60. The elevated radial stiffness of the second region62(as compared to the radial stiffness of first region60) is akin to that provided at other longitudinal locations along the stent frame22and is conventionally sufficient for anchoring the stent frame22at a native valve site. A maximum radial stiffness along the first region60is sufficiently less than the radial stiffness along the second region62by a level sufficient to not induce conditions on to native tissue that would otherwise contribute to a need for a pacemaker. For example, a maximum radial stiffness along the first region60can be at least 10% less, alternatively at least 20% less, alternatively at least 40% less, alternatively at least 60% less than a minimum radial stiffness along the second region62. As reflected byFIG.2B, an arc angle of the second region62is greater than that of the first region60, with the second region62serving to promote robust anchoring of the stent frame22to the native valve anatomy (along the first band50). Thus, at least a majority of the closed cells40of the first band50are along the second region62. By way of one non-limiting example, with embodiments in which the first band50includes eighteen of the closed cells40, the second region62consists of at least ten, optionally at least twelve of the closed cells40. Conversely, the first region60includes no more than four of the closed cells40, alternatively two of the closed cells40. In some embodiments, the first band50can be further viewed as providing third and fourth regions64,66as identified inFIG.2B. The third and fourth regions64,66represent transitions in radial stiffness from the elevated radial stiffness second region62to the low radial stiffness first region60. The transition regions64,66thus exhibit a radial stiffness less than that of the second region62but greater than that of the first region60, and encompass a relatively small arc length or arc angle (as compared to the arc length or arc angle of the second region62). By way of one non-limiting example, the transition regions64,66can each consist of no more than four, alternatively two, of the closed cells40. The transition regions64,66minimize the possibility that the stent frame22will buckle or in-fold at the first region60. The low radial stiffness first region60can be generated in a variety of fashions. In more general terms, the closed cells40of the variable radial stiffness first band50are generally akin to, and follow the pattern of, other hands defined by the stent frame22. Thus, the closed cells40of the variable radial stiffness first band50are uniformly and equidistantly spaced from one another along the circumference. That is to say, the low radial stiffness first region60does not omit a portion or entirety of any of the closed cells40. In other embodiments, the variable radial stiffness first band50includes the same number of closed cells40as the immediately longitudinally adjacent second band52, with each of the closed cells40of the second band52being directly physically connected to a corresponding closed cell40of the first band50. By maintaining the closed cell pattern along an entirety of the circumference of the first band50, the first band50will have minimal negative impact, if any, on an overall fatigue strength of the stent frame22. In some embodiments, the low radial stiffness first region60is generated by altering or reducing, but not eliminating, a geometric attribute of one or more of the structures otherwise generating one or more of the closed cells40and/or connections between the closed cells40of the first region60. For example,FIG.3illustrates a portion of the stent frame22in a two-dimensional or “unwrapped” form (and in the compressed condition). For ease of explanation, the closed cells40, and corresponding components thereof, of the low radial stiffness first region50are identified with the suffix “L” (e.g., the closed cells40L), whereas the suffix “E” is utilized with structures of the second region62(e.g., the closed cells40E). Each of the closed cells40of the first band50arc connected to one another by a connector70. Further, each of the closed cells40is formed or defined by a plurality of struts72-78. For example, the closed cells40E of the elevated stiffness second region62are each defined by struts72E-78E. The first and second struts72E.74E are interconnected at a first node80E, and the third and fourth struts76E,78E are interconnected at a second node82E. A size and shape of each of the struts72E-78E of the elevated stiffness closed cells40E are identical or substantially identical (e.g., within 5% of a truly identical construction). The connectors70along the elevated radial stiffness second region62are also identical or substantially identical. While the closed cells40L of the low stiffness first region60are each defined by struts72L-78L interconnected by nodes80L,82L and are thus generally similar to the elevated stiffness cells40E, at least one of the components72L-78L,80L,82L, is not identical to the corresponding component72E-78E,80E,82E of the elevated radial stiffness cells40E. The low radial stiffness along the first region60is effectuated by altering a geometry of one or more of the struts72L-78L and/or nodes80L-82L of one or more of the cells40L, and/or one or more of the connectors70L, along the first region60. For example,FIG.4Aillustrates one of the struts72E of one of the elevated radial stiffness closed cells40E (FIG.3). The strut72E can be viewed as having or defining a leading segment90E, an intermediate segment92E, and a trailing segment94E. The leading segment90E defines a length LLEand a width WLE. The intermediate segment92E similarly defines a length LIEand a width WIE. The trailing segment94E has a length LTEand a width WTE; The leading segment90E extends from a connector70E (partially illustrated inFIG.3B), and can taper in width WLEto the intermediate segment92E. The width WIEof the intermediate segment92E can be substantially uniform in extension from the leading segment90E to the trailing segment94E. The trailing segment94E can have an increasing width WTEin extension from the intermediate segment92E to the corresponding node80E (shown in partially inFIG.4A). Finally, the node80E has a height HNEand a width WNE. With the above geometric attributes of the strut72E (or “elevated stiffness strut”) in mind,FIG.4Billustrates one non-limiting example of a strut72L (or “low stiffness strut”) of one of the low radial stiffness closed cells40L in accordance with principles of the present disclosure. As a point of reference, the low stiffness strut72L spatially corresponds with the elevated stiffness strut72E ofFIG.4A(i.e., the struts72E,72L are both at the lower left quadrant of the corresponding closed cell40E,40L inFIG.3). The low stiffness strut72E has the same general shape and size as the elevated stiffness strut72E, however a geometry of at least one of the segments90L-94L differs from the corresponding segment90E-94E of the elevated stiffness strut72E. For example, the width WLLof the leading segment90L is less than the corresponding leading segment width WLEof the elevated stiffness strut72E. The reduction in mass reduces the radial stiffness of the low stiffness strut72L (as compared to the radial stiffness associated with the elevated stiffness strut72E). As a point of reference, the reduction in the width is exaggerated inFIG.4Bfor ease of understanding. In actual practice, the leading segment width WLLneed only be slightly less than the normal width WLE. In other embodiments, the width WILof the low stiffness strut intermediate segment92E can be less than the corresponding intermediate segment width WIEof the elevated stiffness strut72E. Alternatively or in addition, the width WTLof the trailing segment94L of the low stiffness strut72L can be less than the width WTEof the trailing segment94E of the elevated stiffness strut72E. Another non-limiting embodiment of a low stiffness strut72L1in accordance with principles of the present disclosure is shown inFIG.4C. A comparison with the elevated stiffness strut72E ofFIG.4Areveals that the length LLL1of the leading segment90L1is less than the length LLEof the leading segment90E of the elevated stiffness strut72E, whereas the length LIL1of the intermediate segment92L1is greater than the length LIEof the elevated stiffness strut72E (such that an overall length of the low stiffness strut72L1is the same as the overall length of the elevated stiffness strut72E). The overall reduction in mass lessons the radial stiffness of the low stiffness strut72L1(as compared to the radial stiffness presented by the elevated stiffness strut72E). Alternatively or in addition, the length LIL1of the intermediate segment92L1can be less than that associated with the elevated stiffness strut72E, and the length LTL1of the low stiffness strut trailing segment94L1can be less or greater than that of the elevated stiffness strut72E. In yet other embodiments, the low stiffness struts of the present disclosure can incorporate both reduced width(s) and length(s). Moreover, and returning toFIG.3, one, two, or all of the struts72L-78L of the low radial stiffness cell(s)40L can incorporate any of the geometric reductions described above in comparison to the counterpart strut72E-78E of the elevated stiffness cells40E. FIG.4Dillustrates another embodiment low stiffness strut72L2in accordance with principles of the present disclosure and that again generally corresponds with the elevated stiffness strut72E ofFIG.4A. A comparison ofFIGS.4A and4Dreveals that the node80L2of the low stiffness strut72L2has a reduced height HNL2and width WNL2as compared to the height HNEand width WNEof the elevated stiffness strut72E. Alternatively, only one of the height HNL2or width WNL2can be reduced. Regardless, the reduction in mass of the node80L2effectuates a reduced radial stiffness (as compared to radial stiffness provided by the elevated stiffness strut72E). Returning toFIG.3, in yet other embodiments, the reduced radial stiffness of the first region60can be accomplished by forming the connector70L to have a size less than that associated with the connector70E of the elevated stiffness second region62. The low radial stiffness first region60can be generated by a combination of any of the features described above. That is to say, while the closed cells40L and the connectors70L of the low radial stiffness first region60are generally similar to the closed cells40E and the connectors70E of the elevated stiffness second region62, the reduced radial stiffness is achieved by altering (e.g., reducing) one or more of the strut lengths, widths, node height, node width, degree of taper, and/or connector dimensions. Further, the illustrated size and shape of the elevated stiffness strut72E, as well as the overall construction of the elevated radial stiffness cells40E is but one acceptable configuration encompassed by the pending disclosure. A plethora of different strut and/or closed cell shapes, sizes, and patterns are equally acceptable so long as at least one closed cell of the low radial stiffness region60incorporates a geometric reduction as compared to the closed cells of the elevated radial stiffness region62. With embodiments in which more than one band of the stent frame22incorporates the varying radial stiffness features (e.g., the first and second bands50,52ofFIG.2A), the low radial stiffness region60of longitudinally consecutive bands are aligned and in some embodiments can be similarly constructed. For example,FIG.2illustrates the first and second bands50,52as each having the low radial stiffness region60(i.e., the low radial stiffness region60of the stent frame22is optionally collectively defined by struts of two (or more) of the bands50,52). Returning toFIG.2A, the low radial stiffness region60can be located at any longitudinal point along the stent frame22. In general terms, the low radial stiffness region60is arranged at a location corresponding with expected cardiac conductive pathways of the native valve anatomy upon implant. For example, the stent frame22ofFIG.2Ais configured for implantation at the aortic valve. As described below, conductive pathways are likely to be found along the inflow end32. Thus, the low radial stiffness region60is provided at an anatomic location corresponding with the inflow end32. Alternatively, the low radial stiffness region60can be located anywhere along the stent frame22, for example at the outflow end36, or longitudinally between the inflow and outflow ends32,36. With embodiments in which the prosthetic heart valve20is intended to be implanted at the aortic valve, certain conductive pathways or fibers naturally occur at the aortic valve and surrounding anatomy. For example,FIG.5Aillustrates the anatomy of an aortic valve and surrounding structures100as found in the normal heart. Three valvular leaflets102L,102R,102N are attached across a ventriculoarterial junction104in a crown-like fashion running onto either a muscle of the ventricular septum106or the mitral valve108. A left bundle branch110emerges at a junction of a membranous septum112and right fibrous trigone114at the base of the interleaflet triangle between the right and noncoronary leaflets102R,102N. The left bundle branch110is separated from the aortic valve leaflets102L,102R,102N by the interleaflet triangle. A noncoronary sinus116, left coronary sinus118, right coronary sinus120, sinutubular junction122, and left fibrous trigone124are also identified. FIG.5Billustrates the stent frame22implanted to the aortic valve100. The stent frame22crosses the ventriculoarterial junction104and lies over a region of the left bundle branch110. In this regard, the low radial stiffness first region60is aligned with the left bundle branch110. As a result, the force exerted by the stent frame22on the left bundle branch110is reduced (as compared to a conventional configuration in which the band50would have a uniform, elevated radial stiffness along the entire circumference and thus apply a high force on to the left bundle branch110), and is thus less likely to negatively impact the conductive pathways of the heart. In more general terms, depending upon the native valve being repaired, the localized low radial stiffness region60is aligned with an expected location of native conduction fibers, several examples of which are identified in FIG. SC and include the left bundle branch110, SA node130, Bundle HIS132, right bundle branch134, AV node136, Purkingee fibers138, Moderator band140, and other locations on the conductive pathways of the heart while providing necessary radial resistive force and fatigue strength to maintain long term fixation across the valve being replaced. As a point of reference, the right atrium150, right ventricle152, left atrium154, and left ventricle156are also identified inFIG.5C. The stented transcatheter prosthetic heart valves of the present disclosure can be delivered to the targeted heart valve in a variety of manners using various transluminal delivery tools as known in the art. In general terms, and with reference toFIG.6, the prosthetic heart valve20is compressed and held within an outer delivery sheath or capsule200(referenced generally) and advanced in this compressed condition toward a target site202. Before deploying the prosthesis20(e.g., by retracting the capsule200from over the compressed prosthesis20), the prosthesis20is optionally spatially oriented to arrange or align the low radial stiffness region60(identified generally with stippling inFIG.6) with targeted tissue (i.e., where native conductive fibers are expected to reside). In this regard, the stented prosthetic heart valve20and/or the capsule200can include or carry markers204(e.g., radiopaque markers) that correspond with the commissure points38(FIG.1B) of the prosthesis20. The low radial stiffness region60has a known circumferential location relative to the commissure points38and thus relative to the markers204. With an aortic procedure, the markers204can then be aligned (e.g., fluoroscopic) with the native commissures between the native noncoronary and right coronary cusps; with this spatial arrangement, the deployed prosthesis20will naturally locate the low radial stiffness region60over the conductive fibers of the left bundle branch. A variety of other delivery and optional alignment techniques are also envisioned. Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure. | 24,778 |
11857414 | DETAILED DESCRIPTION Particular embodiments of the invention include endoluminal support structures (stents) and prosthetic valves. FIG.1is a perspective view of a particular endoluminal support structure. As shown, the support structure10is a medical stent that includes a plurality of longitudinal strut members11interconnected by a plurality of swivel joints15. In particular, the swivel joints15allow the interconnected strut members11to rotate relative to each other. As shown, there are eighteen struts11. The strut members11are fabricated from a rigid or semi-rigid biocompatible material, such as plastics or other polymers and metal alloys, including stainless steel, tantalum, titanium, nickel-titanium (e.g. Nitinol), and cobalt-chromium (e.g. ELGILOY). The dimensions of each strut can be chosen in accordance with its desired use. In a particular embodiment, each strut member is made from stainless steel, which is 0.005-0.020 inch thick. More particularly, each strut is 0.010 inch thick 300 series stainless steel. While all struts11are shown as being of uniform thickness, the thickness of a strut can vary across a strut, such as a gradual increase or decrease in thickness along the length of a strut. Furthermore, individual struts can differ in thickness from other individual struts in the same support structure. As shown, each strut member11is bar shaped and has a front surface l1fand a back surface11b. The strut members can however be of different geometries. For example, instead of a uniform width, the struts can vary in width along its length. Furthermore, an individual strut can have a different width than another strut in the same support structure. Similarly, the strut lengths can vary from strut to strut within the same support structure. The particular dimensions can be chosen based on the implant site. Furthermore, the struts can be non-flat structures. In particular, the struts can include a curvature, such as in a concave or convex manner in relationship to the inner diameter of the stent structure. The struts can also be twisted. The nonflatness or flatness of the struts can be a property of the material from which they are constructed. For example, the struts can exhibit shape-memory or heat-responsive changes in shape to the struts during various states. Such states can be defined by the stent in the compressed or expanded configuration. Furthermore, the strut members11can have a smooth or rough surface texture. In particular, a pitted surface can provide tensile strength to the struts. In addition, roughness or pitting can provide additional friction to help secure the support structure at the implant site and encourage irregular encapsulation of the support structure10by tissue growth to further stabilize the support structure10at the implant site over time. In certain instances, the stent could be comprised of struts that are multiple members stacked upon one another. Within the same stent, some struts could include elongated members stacked upon one another in a multi-ply configuration, and other struts could be one-ply, composed of single-thickness members. Within a single strut, there can be areas of one-ply and multi-ply layering of the members. Each strut member11also includes a plurality of orifices13spaced along the length of the strut member11. On the front surface l1f, the orifices are countersunk17to receive the head of a fastener. In a particular embodiment, there are thirteen equally spaced orifices13along the length of each strut member11, but more or less orifices can be used. The orifices13are shown as being of uniform diameter and uniform spacing along the strut member11, but neither is required. The strut members11are arranged as a chain of four-bar linkages. The strut members11are interconnected by swivelable pivot fasteners25, such as rivets, extending through aligned orifices13. It should be understood that other swivelable fasteners25can be employed such as screws, bolts, ball-in-socket structures, nails, or eyelets, and that the fasteners can be integrally formed in the struts11such as a peened semi-sphere interacting with an indentation or orifice, or a male-female coupling. In addition to receiving a fastener, the orifices13also provide an additional pathway for tissue growth-over to stabilize and encapsulate the support structure10over time. FIG.2is a perspective view of a four strut section of the stent ofFIG.1. As shown, two outer strut members11-1,11-3overlap two inner strut members11-2,11-4, with their back surfaces in communication with each other. In particular, the first strut member11-1is swivelably connected to the second strut member11-1by a middle swivel joint15-1using a rivet25-1, which utilizes orifices13that bisect the strut members11-1,11-2. Similarly, the third strut member11-3is swivelably connected to bisect the fourth strut member11-4by a middle swivel joint15-7using a rivet25-7. It should be understood that the middle swivel joints15-1,15-7function as a scissor joint in a scissor linkage or mechanism. As shown, the resulting scissor arms are of equal length. It should also be understood that the middle joint15-1,15-7need not bisect the joined strut members, but can instead utilize orifices13offset from the longitudinal centers of the strut members resulting in unequal scissor arm lengths. In addition to the middle scissor joint15-1, the first strut member11-1is swivelably connected to the third strut member11-3by a distal anchor swivel joint15-5, located near the distal ends of the strut members11-1,11-3. Similarly, the first strut member11-1is swivelably connected to the fourth strut member11-4by a proximal anchor swivel joint15-3, located near the proximal ends of the strut members11-1,11-4. To reduce stresses on the anchor rivets25-3,25-5, the distal and proximal ends of the struts11can be curved or twisted to provide a flush interface between the joined struts. As can be seen, the support structure10(FIG.1) is fabricated by linking together a serial chain of scissor mechanisms. The chain is then wrapped to join the last scissor mechanism with the first scissor mechanism in the chain. By actuating the linkage the links can be opened or closed, which results in expanding or compressing the stent10(FIG.1). Returning toFIG.1, by utilizing the swivel joints15, the diameter of the stent can be compressed for insertion through a biological lumen, such as an artery, to a selected position. The stent can then be expanded to secure the stent at the selected location within the lumen. Furthermore, after being expanded, the stent can be recompressed for removal from the body or for repositioning within the lumen. FIG.3is a perspective view of a compressed support structure ofFIG.1. When compressed, the stent10is at its maximum length and minimum diameter. The maximum length is limited by the length of the strut members, which in a particular embodiment is 15 mm. The minimum diameter is limited by the width of the strut members, which in a particular embodiment is 0.052 inch. FIG.4is a perspective view of the support structure ofFIG.1in a fully expanded state. As shown, the fully expanded support structure10forms a ring, which can be used as an annuloplasty ring. In particular, if one end of the stent circumference is attached to tissue, the compression of the stent will enable the tissue to cinch. Because the stent has the ability to have an incremental and reversible compression or expansion, the device could be used to provide an individualized cinching of the tissue to increase the competency of a heart valve. This could be a useful treatment for mitral valve diseases, such as mitral regurgitation or mitral valve prolapse. While the support structure10can be implanted in a patient during an open operative procedure, a closed procedure will often be more desirable. As such, the support structure10can include an actuation mechanism to allow a surgeon to expand or compress the support structure from a location remote from the implant site. Due to the properties of a scissor linkage wrapped into a cylinder (FIG.1), actuation mechanisms can exert work to expand the stent diameter by either increasing the distance between neighboring scissor joints, and decreasing the distance between the anchor joints. FIG.18shows a mechanism and elements to expand support structure86. In this case, an upper expansion element54is attached to one of the upper bar94of support structure86. A lower expansion element56is secured to the opposing lower bar94. In order to change the diameter of the device, upper expansion element54is displaced towards lower expansion element56, by pulling on wire60, which is attached to element54, causing a radial expansion of the device (large arrows). The catheter58attached to a lower bar94of the support structure86, provides a counterforce to pulling on wire60, effectively holding the support structure86in a fixed position during expansion of the support structure. The general principle of the mechanism is that applying an opposing axial load to any pair of opposing upper and lower ends of the bars94of the device, causes radial expansion of the device. The elements, such as54, could be simplified further by being replaced by a simple pull wire exerting the same forces on the structure. FIG.5is a perspective view of the support structure ofFIG.2having a particular actuator mechanism. As shown, the actuator mechanism30includes a dual-threaded rod32positioned on the inside of the support structure10(FIG.1). It should be understood, however, that the actuator mechanism30can instead be positioned on the outside of the support structure10. Whether positioned on the inside or outside, the actuator mechanism30operates in the same way. The rod includes right-hand threads34R on its proximal end and left-hand threads34L on its distal end. The rod32is mounted the anchor points15-3,15-5using a pair of threaded low-profile support mounts35-3,35-5. Each end of the rod32is terminated by a hex head37-3,37-5for receiving a hex driver (not shown). As should be understood, rotating the rod32in one direction will urge the anchor points25-3,25-5outwardly to compress the linkages while rotating the rod32in the opposite direction will urge the anchor points25-3,25-5inwardly to expand the linkages. FIG.6is a perspective view of the support structure ofFIG.2having another particular actuator mechanism. As shown, the actuator mechanism30′ includes a single-threaded rod32′ positioned on the inside of the support structure10(FIG.1). The rod32′ includes threads34′ on one of its ends. The rod32′ is mounted to lowprofile anchor points15-3,15-5using a pair of support mounts35′-3,35′-5, one of which is threaded to mate with the rod threads34′. The unthreaded end of the rod32′ includes a retaining stop39′ that bears against the support mount35′-5to compress the support structure. Each end of the rod32′ is terminated by a hex head37′-3,37′-5for receiving a hex driver (not shown). Again, rotating the rod32′ in one direction will urge the anchor points25-3,25-5outwardly to compress the linkages while rotating the rod32′ in the opposite direction will urge the anchor points25-3,25-5inwardly to expand the linkages. In addition, because the struts overlap, a ratcheting mechanism can be incorporated to be utilized during the sliding of one strut relative to the other. For example, the stent could lock at incremental diameters due to the interaction of features that are an integral part of each strut. An example of such features would be a male component (e.g. bumps) on one strut surface which mates with the female component (e.g. holes) on the surface of the neighboring strut surface, as the two struts slide pass one another. Such structures could be fabricated to have an orientation, such that they incrementally lock the stent in the expanded configuration as the stent is expanded. Such a stent could be expanded using a conventional balloon or other actuation mechanism described in this application. Because the support structure10ofFIGS.5and6are intended to be implanted during a closed surgical procedure, the actuator mechanism is controlled remotely by a surgeon. In a typical procedure, the support structure10is implanted through a body lumen, such as the femoral artery using a tethered endoluminal catheter. As such, the actuator mechanism30can be controlled via the catheter. FIG.7is a perspective view of a particular support structure and control catheter assembly usable with the actuator mechanisms ofFIGS.5and6. The control catheter40is dimensioned to be inserted with the support structure through a biological lumen, such as a human artery. As shown, the control catheter40includes a flexible drive cable42having a driver44on its distal end that removably mates with a hex head37,37′ of the actuator mechanism (FIGS.5and6). The proximal end of the cable42includes a hex head46. In operation, the proximal hex head46of the cable42is rotated by a surgeon, using a thumb wheel or other suitable manipulator (not shown). Rotation of the hex head46is transferred by the cable42to the driver head44to turn the actuator rod30,30′ (FIGS.5and6). The cable42is encased by a flexible outer sheath48. The distal end of the outer sheath48includes a lip or protuberance49shaped to interface with the support structure10. When the cable42is turned, the outer sheath lip49interacts with the support structure10to counteract the resulting torque. By employing threads, the rod is self-locking to maintain the support structure in the desired diameter. In a particular embodiment, the rod32,32′ has a diameter of 1.0 mm and a thread count of 240 turns/inch. While a threaded rod and drive mechanism are described, other techniques can be employed to actuate the linkages depending on the particular surgical application. For example, the actuator mechanism can be disposed within the thickness of the strut members, instead of inside or outside of the stent. For example, worm gears or a rack and pinion mechanism can be employed as known in the art. One of ordinary skill in the art should recognize other endoluminal actuation techniques. In other situations, the support structure can be implanted during an open procedure, which may not require an external actuation mechanism. Although there are other uses for the described support structure, such as drug delivery, a particular embodiment supports a prosthetic valve. In particular, the support structure is used in combination with a prosthetic valve, such as for an aortic valve replacement. FIG.19depicts the retrograde delivery of the device as an aortic valve replacement in a cross-sectional view of the heart. The valve88is compressed in the support structure86. A catheter58is used to pass the valve88and support structure86into the femoral artery at the groin. The catheter is advanced to the aortic valve site under fluoroscopic guidance. The support structure is deployed at the site by pulling on the expansion wire60as shown inFIG.18. Proper positioning of the valve88and support structure86at the implant site is confirmed by observing the valve function under fluoroscopy and the stabilization of hemodynamic parameters. After proper valve position is confirmed, the catheter58and all wires are detached from the device and removed from the body. The device could be delivered to the mitral position using the retrograde approach. FIG.20depicts a cross-sectional view of the heart showing the apical delivery of the device for aortic valve replacement. A small incision is made in the chest wall, and a cannula80is inserted in the left ventricle through the apex of the heart. Valve88and support structure86, on catheter92, is passed through cannula80. Following confirmation of correct valve position by fluoroscopy, a wire60is pulled to expand the device. The apical approach could be used for deployment of the valve into the mitral position. FIG.21depicts antegrade delivery of the device for aortic or mitral valve replacement using a close chest procedure. The valve88and support structure86mounted on a catheter56is inserted into femoral vein at the groin and advanced in the inferior vena cava and into right atrium. Under fluoroscopic guidance, the catheter is advanced across the septum and into the left atrium. The device is deployed at the implant site by pulling on wire60. FIG.8is a perspective view of a particular rotating prosthetic valve assembly. The prosthetic valve100comprises a three leaflet configuration shown in an open position. The leaflets are derived from a biocompatible material, such as animal pericardium (e.g. bovine, porcine, equine), human pericardium, chemically treated pericardium, gluteraldehyde-treated pericardium, tissue engineered materials, a scaffold for tissue engineered materials, autologous pericardium, cadaveric pericardium, Nitinol, polymers, plastics, PTFE, or any other material known in the art. The leaflets101a,101b,101care attached to a stationary cylindrical member105and a non-stationary cylindrical member107. One side of each leaflet101is attached to the non-stationary cylindrical member107. The opposing side of each leaflet101is attached to the stationary cylindrical member105. The attachment of each leaflet101is in a direction generally perpendicular to the longitudinal axis of the cylindrical members105,107. In this embodiment, each leaflet101is pliable, generally rectangular in shape, and has a 180 degree twist between its attachments to stationary member105and non-stationary member107. Each leaflet101has an inner edge102and an outer edge103, with the edges102c,103cof one leaflet101cbeing referenced in the figure. As known in the art, the leaflets can be fabricated from either biological or non-biological materials, or a combination of both. One way to actuate the valve to close is by utilizing the forces exerted by the normal blood flow or pressure changes of the cardiac cycle. More specifically, the heart ejects blood through the fully open valve in the direction of the arrow shown inFIG.8. Shortly thereafter, the distal or downstream blood pressure starts to rise relative to the proximal pressure across the valve, creating a backpressure on the valve. FIG.9is a perspective view of the valve assembly ofFIG.8while being closed. That backpressure along the direction of the arrow causes the axially displacement of the leaflets101and non-stationary member107towards the stationary cylindrical member105. As the leaflets101move from a vertical to horizontal plane relative to the longitudinal axis, a net counter-clockwise torque force is exerted on the non-stationary member107and leaflets101. The torque force exerts a centripetal force on the leaflets101. FIG.10is a perspective view of the valve assembly ofFIG.8once completely closed. Complete closure of the valve100occurs as the leaflets101displace to the center of the valve and the non-stationary cylindrical member107rests upon the stationary member105, as shown. The function of the valve100opening can be understood by observing the reverse of the steps of valve closing, namely following the sequence of drawings fromFIG.10toFIG.8. In considering the valve100as an aortic valve replacement, it would remain closed as shown inFIG.10, until the heart enters systole. During systole, as the myocardium forcefully contracts, the blood pressure exerted on the valve's proximal side (the side closest to the heart) is greater than the pressure on the distal side (downstream) of the closed valve. This pressure gradient causes the leaflets101and non-stationary cylindrical member107to displace away from the stationary member105along the axial plane. The valve100briefly assumes the half-closed transition state shown inFIG.9. As the leaflets101elongate from a horizontal to vertical orientation along the axial plane, a net torque force is exerted on the leaflets101and non-stationary cylindrical member107. Since the valve100is opening, as opposed to closing, the torque force exerted to open the valve is opposite to that exerted to close the vlave. Given the configuration of embodiment shown inFIG.9, the torque force that opens the valve would be in clockwise direction. The torque forces cause the leaflets101to rotate with the non-stationary member107around the longitudinal axis of the valve100. This, in turn, exerts a centrifugal force on each leaflet101. The leaflets101undergo radial displacement away from the center, effectively opening the valve and allowing blood to flow away from the heart, in the direction shown by the arrow inFIG.8. To summarize, the valve passively functions to provide unidirectional blood flow by linking three forces. Axial, torque, and radial forces are translated in a sequential and reversible manner, while encoding the directionality of prior motions. First, the axial force of blood flow and pressure causes the displacement of the leaflets101and non-stationary members107relative to the stationary member105along the axial plane. This is translated into a rotational force on the leaflets101and non-stationary member107. The torque force, in turn, displaces the leaflets101towards or away from the center of the valve, along the radial plane, which closes or opens the valve100. The valve100passively follows the pathway of opening or closing, depending on the direction of the axial force initially applied to the valve by the cardiac cycle. In the body, the stationary cylindrical member105can secured and fixed in position at the implant site, while the non-stationary member107and distal ends of leaflets101are free to displace along the axial plane. In using the prosthetic valve as an aortic valve replacement, the stationary member105would be secured in the aortic root. As the blood pressure or flow from the heart, increases, the valve100changes from its closed configuration to the open configuration, with blood ejecting through the valve100. Specific advantages of the rotating valve ofFIGS.8-10, along with further embodiments, are described in the above-incorporated parent provisional patent application. FIG.11is a perspective view of the valve ofFIGS.8-10in combination with the support structure ofFIG.1. As shown in the closed position, the valve's stationary member105is attached to the support structure10. The valve's nonstationary member107is not attached to the support structure10. This enables the non-stationary member107to displace along the axial plane along with the leaflets101during valve opening or closing. In this particular embodiment, the valve100occupies a position that is closer to one end of the support structure10, as shown. FIG.12is a perspective view of the valve ofFIG.11in the open position. As noted above, the non-stationary member107is not attached to support structure10, and is thus free to displace along the axial plane, along with the leaflets101. In this particular embodiment, during full opening, non-stationary member107and the leaflets101remain within the confines of the support structure10. The stented valve110can be implanted during a closed procedure as described above. However, because of the operation of the non-stationary member within the body of the stent, the actuator mechanism to compress and expand the stent would not be disposed within the stent. Further embodiments of the stented valve110, positioning of the valve in the body, and procedures for implantation are described in the above-incorporated parent provisional patent application. In addition, a tissue valve can be draped on the support structure. Additional embodiments should be apparent to those of ordinary skill in the art. FIG.13is a perspective view of a traditional tissue valve mounted to the support structure ofFIG.1. As shown, a stented valve120includes a prosthetic tissue valve121attached to a support structure10, such as that described above. The tissue valve121includes three pliable semi-circular leaflets121a,121b,121c, which can be derived from biocompatible materials as noted with reference toFIG.8. Adjacent leaflets are attached in pairs to commissures123x,123y,123zon the support structure10. In particular, the commissures123x,123y,123zcorrespond with spaced-apart distal anchor points13x,13y,13zon the support structure10. In an 18-strut stent, the commissures are attached the structure10via corresponding fasteners25at every third distal anchor point. From the commissures, the leaflet sides are connected to the adjacent diagonal struts. That is, the sides of the first leaflet121aare sutured to the struts11-Xa and11-Za, respectively; the sides of the second leaflet121bare sutured to the struts11-Xb and11-Yb, respectively; and the sides of the third leaflet121care sutured to the struts11-Yc and11-Zc, respectively. Those sutures end at the scissor pivot points on the diagonal struts. In the configuration shown, neighboring struts11are attached to one another in a manner that creates multiple arches128at the ends of the stent. Posts for leaflet attachment, or commissures, are formed by attaching neighboring leaflet to each of the struts that define a suitable arch128x,128y,128z. In the configuration shown, there are three leaflets121a,121b,121c, each of which is attached to a strut along two of its opposing borders. The commissures are formed by three equi-distance arches128x,128y,128zin the stent. The angled orientation of a strut in relationship to its neighboring strut enables the leaflets121a,121b,121cto be attached to the stent in an triangular configuration. This triangular configuration simulates the angled attachment of the native aortic leaflet. In the native valve this creates an anatomical structure between leaflets, known as the inter-leaflet trigone. Because the anatomical inter-leaflet trigone is believed to offer structural integrity and durability to the native aortic leaflets in humans, it is advantageous to simulate this structure in a prosthetic valve. One method of attachment of the leaflets to the struts is to sandwich the leaflet between a mutli-ply strut. The multiple layers are then held together by sutures. Sandwiching the leaflets between the struts helps to dissipate the forces on leaflets and prevent the tearing of sutures through the leaflets. The remaining side of each leaflet121a,121b,121cis sutured annularly across the intermediate strut members as shown by a leaflet seam. The remaining open spaces between the struts are draped by a biocompatible skirt125to help seal the valve against the implant site and thus limit paravalvular leakage. As shown, the skirt125is shaped to cover those portions of the stent below and between the valve leaflets. In more detail, the skirt125at the base of the valve is a thin layer of material that lines the stent wall. The skirt material can be pericardial tissue, polyester, PTFE, or other material or combinations of materials suitable for accepting tissue in growth, including chemically treated materials to promote tissue growth or inhibit infection. The skirt layer functions to reduce or eliminate leakage around the valve, or “paravalvular leak”. To that end, there are a number of ways to attach the skirt material layer to the stent, including:the skirt layer can be on the inside or the outside of the stent;the skirt layer can occupy the lower portion of the stent;the skirt layer can occupy the lower and upper portion of the stent;the skirt layer can occupy only the upper portion of the stent;the skirt layer can occupy the area between the struts that define the commissure posts;the skirt layer can be continuous with the leaflet material;the skirt layer can be sutured to the struts or a multitude of sites; orthe skirt layer can be secured to the lower portion of the stent, and pulled or pushed up to cover the outside of the stent during the deployment in the body. The above list is not necessarily limiting as those of ordinary skill in the art may recognize alternative draping techniques for specific applications. FIG.14is a perspective view of the valve structure ofFIG.13having a full inner skirt. A stented valve120′ includes a prosthetic tissue valve121′ having three leaflets121a′,121b′,121c′ attached to a support structure10. A skirt layer125′ covers the interior surface of the stent10. As such, the valve leaflets121a′,121b′,121c′ are sutured to the skirt layer125′. FIG.15is a perspective view of the valve structure ofFIG.13having a full outer skirt. A stented valve120″ includes a prosthetic tissue valve121″ having three leaflets121a″,121b″,121c″ attached to a support structure10, such as that described inFIG.13. A skirt layer125″ covers the exterior surface of the stent10. The tissue valve structures120,120′,120″ can also be implanted during a closed procedure as described above. However, the actuator mechanism to compress and expand the stent would be attached to avoid the commissure points and limit damage to the skirt layer125,125′,125″, such as by mounting the actuator mechanism on the outer surface of the stent10. While the above-described embodiments have featured a support structure having linear strut bars and equal length scissor arms, other geometries can be employed. The resulting shape will be other than cylindrical and can have better performance in certain applications. FIG.16is a perspective view of the arrangement of strut members in a conical-shaped support structure configuration. In the conical structure10′, the strut members11are arranged as shown inFIG.2, except that the middle scissor pivots do not bisect the struts. In particular, the middle scissor pivots (e.g.15′-1,15′-7) divide the joined strut members (e.g.11′-1,11′-2and11′-3,11′4) into unequal segments of 5/12 and 7/12 lengths. When fully assembled, the resulting support structure thus conforms to a conical shape when expanded. For illustration purposes, the stent10′ is shown with a single-threaded actuator rod32′ (FIG.6), but it is not a required element for this stent embodiment. The stent10′ can also assume a cone shape in its expanded configuration by imposing a convex or concave curvature to the individual strut members11that comprise the stent10′. This could be achieved by using a material with memory, such as shape-memory or temperature sensitive Nitinol. A valve can be orientated in the cone-shaped stent10′ such that the base of the valve was either in the narrower portion of the cone-shaped stent, with the nonbase portion of the valve in the wider portion of the cone. Alternatively, the base of the valve can be located in the widest portion of the stent with the non-base portion of the valve in the less-wide portion of the stent. The orientation of a cone-shaped stent10′ in the body can be either towards or away from the stream of blood flow. In other body lumens (e.g. respiratory tract or gastrointestinal tract), the stent could be orientated in either direction, in relationship to the axial plane. FIG.17is a perspective view of an hourglass-shaped support structure configuration. In this configuration, the circumference around the middle pivot points15″-1,15″-7,15″-9(the waist) is less than the circumference at either end of the stent10″. As shown, the hourglass shaped support structure10″ is achieved by reducing the number of strut members11″ to six and shortening the strut members11″ in comparison to prior embodiments. As a result of the shortening, there are fewer orifices13″ per strut member11″. Because of the strut number and geometry, each strut member11″ includes a twist at points19″ along there longitudinal planes. The twists provide a flush interface between joined strut15″-3. An hourglass stent configuration could also be achieved by imposing concave or convex curvatures in individual bars11″. The curvature could be a property of the materials (e.g. shape-memory or heat-sensitive Nitinol). The curvature could be absent in the compressed stent state and appear when the stent is in its expanded state. It should be noted that any of the above-described support structures can be extended beyond the anchor joints at either of both ends of the stent. By coupling a series of stents in an end-to-end chain fashion, additional stent lengths and geometries can be fabricated. In particular, an hourglass-shaped stent could be achieved by joining two cone-shaped stents at their narrow ends. The hourglass shape can also be modified by assembling the middle scissor pivots off center as shown inFIG.14. Particular embodiments of the invention offer distinct advantages over the prior art, including in their structure and applications. While certain advantages are summarized below, the summary is not necessarily a complete list as there may be additional advantages. The device allows the user to advert the serious complications that can occur during percutaneous heart valve implantation. Because the device is retrievable and re-positionable during implantation into the body, the surgeon can avoid serious complications due to valve mal-positioning or migration during implantation. Examples of these complications include occlusion of the coronary arteries, massive paravalvular leakage, or arrthymias. The device can also decrease vascular access complications because of the device's narrow insertion profile. The device's profile is low, in part, due to its unique geometry, which allows neighboring struts in the stent to overlap during stent compression. The device's low profile is further augmented by eliminating the necessity for a balloon or a sheath. The device's narrow profile offers the advantage of widening the vascular access route options in patients. For instance, the device can enable the delivery of the prosthetic valve through an artery in the leg in a patient whom would have previously been committed to a more invasive approach through the chest wall. The device therefore aims to decrease complications associated with the use of large profile devices in patients with poor vascular access. The tissue valve embodiments can offer improved durability by allowing for attachment of the leaflets to flexible commissural posts. The flexible posts allow dissipation of the stress and strain imposed on the leaflet by the cardiac cycle. The use of multi-ply struts enables the leaflets to be sandwiched in between the struts, which re-enforces the leaflet attachments and prevents tearing of sutures. The valve further assumes a desirable leaflet morphology, which further reduces the stress and strain on leaflets. Namely, the angled leaflet attachment to the stent is similar to the native human aortic valve's inter-leaflet trigone pattern. These properties significantly improve the longevity of percutaneous heart valve replacement therapies. The device could reduce or eliminate arrthymia complications due to the incremental expansion or compression of the stent. The stent can employ a screw mechanism for deployment, which enables the stent to self-lock or un-lock at all radii. This enables more controlled deployment and the potential for individualizing the expansion or compression of the device in each patient. Because the expansion or compression of the device is reversible at any stage during the procedure, the surgeon can easily reverse the expansion of the device to relieve an arrythmia. In addition, if an arrythmia is detected during implantation, the device can be repositioned to further eliminate the problem. The device can reduce or eliminate paravalvular leak due to the device's ability to be accurately positioned, and re-positioned, if necessary. That can considerably decrease the occurance and severity of paravalular leaks. The device eliminates balloon-related complications. The screw mechanism of deployment exploits the mechanical advantage of a screw. This provides for forceful dilation of the stent. The lever arms created by the pivoting of the struts in the scissor linkage of the stent, transmits a further expansion force to the stent. The stent is expanded without the need for a balloon. In addition, the ability of the device to be forcefully dilated reduces or eliminates the need for pre- or postballooning during the implantation procedure in patients. The device has more predictable and precise positioning in the body because the difference between the height of the stent in the compressed and expanded position is small. This “reduced foreshortening” helps the surgeon to position the device in the desirable location in the body. The ability to re-position the device in the body further confers the ability to precisely position the device in each individual. In addition to the mechanical advantages, the device enables a wider population of patients to be treated by a less invasive means for valve replacement. For example, the device enables patients with co-morbidites, whom are not candidates for open chest surgical valve replacement, to be offered a treatment option. The device's ability to assume a narrow profile also enables patients who were previously denied treatment due to poor vascular access (e.g. tortuous, calcified, or small arteries), to be offered a treatment option. The durability of the valve should expand the use of less-invasive procedures to the population of otherwise healthy patients, whom would otherwise be candidates for open chest surgical valve replacement. The device's ability to be forcefully expanded, or assume hourglass, or conical shapes, potentially expands the device application to the treatment of patients diagnosed with aortic insufficiency, as well as aortic stenosis. The device can also provide a less invasive treatment to patients with degenerative prosthesis from a prior implant, by providing for a “valve-in-valve” procedure. The device could be accurately positioned inside the failing valve, without removing the patient's degenerative prosthesis. It would help the patient by providing a functional valve replacement, without a “re-do” operation and its associated risks. While this invention has been particularly shown and described with references to particular embodiments, it will be understood by those skilled in the art that various changes in form and details may be made to the embodiments without departing from the scope of the invention encompassed by the appended claims. | 38,410 |
11857415 | DETAILED DESCRIPTION OF EMBODIMENTS Reference is now made toFIGS.1-2, which are schematic illustrations of a multi-component tubular system10providing one or more rotationally-controlled steering catheters configured for delivering an implant to a heart of a patient, in accordance with some applications of the present invention. System10provides an implant-delivery tool. Typically, system10comprises a first, outer catheter12comprising a sheath (i.e., a lateral wall that defines a lumen) configured for advancement through vasculature of a patient. For some applications of the present invention, outer catheter12comprises a sheath configured for advancement through a femoral artery toward an interatrial septum of a heart of a patient. A distal steerable end portion of outer catheter12is configured to pass through the septum and be oriented in a desired spatial orientation. System10comprises a second catheter, or guide catheter14, comprising a steerable distal end portion. Catheter14comprises a sheath (i.e., a lateral wall that defines a lumen), and is configured for advancement through the lumen of outer catheter12. Outer catheter12provides a first coupling152(e.g., a receptacle, such as an opening, such as a slit52) at a distal portion of the lateral wall thereof (e.g., a portion of catheter12that is proximal to the steerable distal end portion). Guide catheter14comprises a second coupling154(e.g., a protrusion, such as a depressible engager54) that is coupled to a displaceable tab56coupled to a base. As is described herein, depressible engager54(or the second coupling154) is configured so as to protrude within slit52(or the first coupling152). Thus, slit52defines a second-coupling-receiving element. First coupling152of catheter12defines a longer coupling, the second coupling154of catheter14defines a shorter coupling. The first and second couplings152and154of outer catheter12and guide catheter14, respectively, enable axial advancement and rotational motion of guide catheter14through the lumen of outer catheter12until engager54of catheter14is aligned with and engages slit52of catheter12, as will be described hereinbelow. As shown in cross-section A-A ofFIG.1, guide catheter14is configured to be concentrically disposed within a lumen of outer catheter12. It is to be noted that the scope of the present invention includes catheter12providing the shorter coupling, and catheter14providing the longer coupling. For example, catheter14may be shaped so as to provide slit52, and catheter12may comprise engager54, which is configured to engage slit52of catheter14. As shown in the exploded view of view B, first coupling152is shaped to define slit52. For some applications, slit52is provided by a metal frame50, as shown. Metal frame50has a length L22of between 7 and 15 mm, e.g., 13 mm. For such applications, a slit is created in material of catheter12(e.g., by creating a slit in the polymer material of catheter12during manufacturing of catheter12), and frame50is coupled to catheter12. Second coupling154comprises an engager54which comprises a protrusion disposed at a distal portion of displaceable tab56of a base of engager54. The base of engager54is shaped to define slits57which form tab56. Engager54is depressible when a force is applied thereto, and tab56facilitates movement of engager54in response to and in the absence of force applied to engager54. For some applications, during manufacture of catheter14, catheter14is manipulated in order to couple thereto engager54and tabs56, e.g., engager54and tabs56are embedded within the polymer of catheter14. It is to be noted that although slit52and depressible engager54are shown on outer catheter12and guide catheter14, respectively, at distal portions of catheters12and14, slit52and engager54may be provided along any suitable portion of catheters12and14, respectively (e.g., respective proximal portions of catheters12and14). FIG.2shows the concentric relationship between components of tubular system10(in an exploded view on the left side ofFIG.2). As described hereinabove, a distal end portion of outer catheter12is steerable. The distal end portion of outer catheter12comprises a pull ring11that is coupled to two or more pull wires29aand29b, that are disposed within respective secondary lumens within a wall of catheter12(as shown in section A-A). As shown in the exploded view, guide catheter14is configured to be concentrically disposed within the lumen of catheter12. As described hereinabove, the distal end portion of guide catheter14is steerable. The distal end portion of catheter14comprises a pull ring13that is coupled to two or more pull wires31aand31b, that are disposed within respective secondary lumens within a wall of catheter14(as shown in sections A-A and B-B). Guide catheter14is steerable to a desired spatial orientation in order to facilitate advancing and implantation of an implant in a body cavity of the patient. As shown, the implant comprises an annuloplasty ring structure222comprising a flexible sleeve26(shown in the exploded view ofFIG.2). Sleeve26typically comprises a braided fabric mesh, e.g., comprising DACRON™. Sleeve26is typically configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Alternatively, the ring structure is configured to be placed entirely around the valve annulus. In order to tighten the annulus, annuloplasty ring structure222comprises a flexible elongated contracting member226that extends along sleeve26. Elongated contracting member226comprises a wire, a ribbon, a rope, or a band, which typically comprises a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the wire comprises a radiopaque material. For some applications, contracting member226comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member226is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member226comprises a plurality of wires that are intertwined to form a rope structure. For applications in which system10is used to deliver an implant to the mitral valve of the patient, typically, outer catheter12is configured for initial advancement through vasculature of the patient until a distal end102of catheter12is positioned in the left atrium. The distal steerable end portion of catheter12is then steered such that distal end102of catheter12is positioned in a desired spatial orientation within the left atrium. The steering procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography. Following the steering of the distal end portion of catheter12, guide catheter14(which houses annuloplasty ring structure222) is advanced through catheter12in order to facilitate delivery and implantation of structure222along the annulus of the mitral valve. During the delivery, at least a portion of the steerable distal end portion of catheter14is exposed from distal end102of catheter12and is thus free for steering toward the annulus of the mitral valve, as is described hereinbelow. Annuloplasty ring structure222further comprises an adjusting mechanism40, which facilitates contracting and expanding of annuloplasty ring structure222so as to facilitate adjusting of a perimeter of the annulus and leaflets of the cardiac valve. Adjusting mechanism40is described in more detail hereinbelow. Adjusting mechanism40comprises a rotatable structure (e.g., a spool, as described hereinbelow) that is disposed within a housing44. As shown in the enlarged image ofFIG.1, adjusting mechanism40is surrounded by a braided mesh and is coupled (e.g., by being sutured or otherwise coupled) to the braided mesh of sleeve26. For some applications, adjusting mechanism40is coupled to an outer, lateral surface of sleeve26. During delivery of sleeve26to the annulus of the cardiac valve, sleeve26is disposed within a lumen of catheter14and sleeve26and mechanism40are aligned longitudinally with a longitudinal lumen of catheter14. Such coupling of mechanism40to sleeve26allows mechanism40to transition from a state in which it is in line with the longitudinal axis of catheter14(FIG.2) to a state in which it is disposed alongside sleeve26(FIG.1). The positioning of adjusting mechanism40alongside a portion of sleeve26exposes a driving interface of the rotational structure to be accessed by a rotational tool that is guided toward adjusting mechanism40via guide member86. A flexible, longitudinal guide member86(e.g., a wire) is coupled to a portion of adjusting mechanism40(e.g., a portion of the rotatable structure, as described hereinbelow). Guide member86is configured to facilitate guiding of a rotational tool via guide member86and toward the rotatable structure of adjusting mechanism40. Typically, the rotational tool is configured to engage the rotatable structure of adjusting mechanism40following implantation of sleeve26along the annulus of the cardiac valve. Guide member86passes from adjusting mechanism40, alongside a portion of the distal end portion of guide catheter14, and into a secondary lumen in the wall of guide catheter14, through an opening15in guide catheter14. Guide member86passes through the secondary lumen of guide catheter14(as shown in sections A-A and B-B inFIG.2) and has a proximal end that is accessible from outside the body of the patient. The secondary lumen in the wall of guide catheter14facilitates passage of guide member86through system10without interfering with the other concentrically-disposed elongate tubular members that pass concentrically through the lumen of guide catheter14. In addition, system10comprises a plurality of anchors32, typically between about 5 and about 20 anchors, such as about 10 or about 16 anchors. Each anchor32comprises a tissue coupling element60(e.g., a helical tissue coupling element), and a tool-engaging head62, fixed to one end of the tissue coupling element. Only one anchor32is shown inFIG.2as being reversibly coupled to a deployment element38of a rotating anchor driver36of an anchor deployment manipulator61. When sleeve26is disposed along the annulus of the cardiac valve, deployment manipulator61is configured to advance within a lumen of sleeve26and deploy each anchor32from within sleeve26through a wall of sleeve26and into cardiac tissue, thereby anchoring sleeve26around a portion of the valve annulus. The insertion of the anchors into the sleeve and deployment of the anchors into cardiac tissue is described in detail hereinbelow. Typically, but not necessarily, anchors32comprise a biocompatible material such as stainless steel 316 LVM. For some applications, anchors32comprise nitinol. For some applications, anchors32are coated with a non-conductive material. Deployment manipulator61comprises anchor driver36and deployment element38. As shown in the exploded view ofFIG.2, sleeve26is disposed within a lumen of guide catheter14. A force is applied to a proximal end of sleeve26is by a distal end of a reference-force tube19. As shown, an implant-decoupling channel18is advanceable within a lumen of reference-force tube19and through a lumen of sleeve26. Typically, decoupling channel18fits snugly within sleeve26. As shown in the enlarged image ofFIG.1, a distal end17of implant-decoupling channel18is disposed in contact with an inner wall of sleeve26at a distal end thereof. Additionally, a distal end portion of channel18comprises a radiopaque marker1018. As shown, tube19and sleeve26are longitudinally and coaxially disposed with respect to each other. Typically, manipulator61advances within channel18. For some applications, system10comprises a plurality of anchor drivers36of manipulator61, each driver36being coupled to a respective anchor32. Each driver36is advanced within channel18in order to advance and implant anchor32in tissue. Following implantation of anchor32, anchor32is decoupled from driver36, as described herein, and driver36is removed from within channel18. Subsequently, a new driver36coupled to another anchor32is then advanced within channel18. As will be described hereinbelow, a first anchor32is configured to be deployed through the wall of the sleeve into cardiac tissue, when sleeve26is positioned along the annulus of the valve. Following the deployment of the first anchor, a distal portion of sleeve26is slid distally off a portion of implant-decoupling channel18. In order to decouple sleeve26distally from a portion of outer surface of channel18, (1) a proximal force is applied to channel18, while (2) reference-force tube19is maintained in place in a manner in which a distal end of tube19provides a reference force to sleeve26in order to facilitate freeing of a successive portion of sleeve26from around channel18. Channel18is then positioned at a successive location within the lumen of sleeve26while either tube19and/or catheter14is steered toward a successive location along the annulus of the valve (as will be described hereinbelow). Consequently, the successive portion of sleeve26provides a free lumen for advancement of a successive anchor32and deployment of the anchor through the wall of the sleeve at the successive portion thereof. Such freeing of the successive portion of sleeve26creates a distance between successive anchors deployed from within the lumen of sleeve26. For some applications, sleeve26comprises a plurality of radiopaque markers25, which are positioned along the sleeve at respective longitudinal sites. The markers may provide an indication in a radiographic image (such as a fluoroscopy image) of how much of the sleeve has been deployed at any given point during an implantation procedure, in order to enable setting a desired distance between anchors32along the sleeve. For some applications, the markers comprise a radiopaque ink. Typically, at least a portion (e.g., at least three, such as all) of the longitudinal sites are longitudinally spaced at a constant interval. Typically, the longitudinal distance between the distal edges of adjacent markers, and/or the distance between the proximal edges of adjacent markers, is set equal to the desired distance between adjacent anchors. For example, the markers may comprise first, second, and third markers, which first and second markers are adjacent, and which second and third markers are adjacent, and the distance between the proximal and/or distal edges of the first and second markers equal the corresponding distance between the proximal and/or distal edges of the second and third markers. For example, the distance may be between 3 and 15 mm, such as 6 mm, and the longitudinal length of each marker may be between 0.1 and 14 mm, such as 2 mm. (If, for example, the distance were 6 mm and the length were 2 mm, the longitudinal gaps between adjacent markers would have lengths of 4 mm.) Each anchor32is coupled to deployment element38of anchor driver36. Anchor driver36comprises an elongate tube having at least a flexible distal end portion. The elongate tube of driver36extends within a lumen of channel18, through system10toward a proximal end of a proximal handle portion101of system10. Typically, the lumen of channel18has a transverse cross-sectional diameter of at least 2 mm, such as at least 2.5 mm. The tube of anchor driver36provides a lumen for slidable advancement therethrough of an elongate rod130. Rod130facilitates the locking and unlocking of anchor32to deployment element38, as is described hereinbelow. As shown in Section E-E ofFIG.2, a proximal end of rod130is coupled to a component of an anchor-release mechanism28at a proximal end of system10. Mechanism28comprises a housing135and a finger-engager131that is coupled to the proximal end of rod130. Finger-engager131is coupled to a housing135via a spring133(section E-E ofFIG.2). A proximal end of the tube of anchor driver36is coupled to housing135. As is described hereinbelow, the physician releases anchor32from deployment element38when finger-engager131is pulled proximally, thereby pulling rod130proximally. Proximal handle portion101is supported by a stand having support legs91and a handle-sliding track90. Handle portion101comprises an outer-catheter handle22, a guide-catheter handle24, an implant-manipulating handle126, and anchor-release mechanism28. Handle22is coupled to a proximal end of outer catheter12. Handle24is coupled to a proximal portion of guide catheter14. Handle126is coupled to a proximal portion of reference-force tube19. As described hereinabove, housing135of anchor-release mechanism28is coupled to a proximal portion of the tube of anchor driver36. The relative positioning of each of the concentrically-disposed components of system10is shown in the exploded view and sections A-A, B-B, C-C, and D-D ofFIG.2. The stand supporting proximal handle portion101may be moved distally and proximally to control a position of the entire multi-component system10, particularly so as to adjust a distance of distal end102of catheter12from the interatrial septum. Handle22comprises a steering knob210that is coupled to steering wires29aand29bdisposed within respective secondary lumens in the wall of outer catheter12. Rotation of knob210adjusts a degree of tension of wires29aand29bwhich, in turn, apply a force to pull ring11at the distal end portion of outer catheter12. Such force steers the distal end portion of catheter12within the atrium of the heart of the patient in a manner in which the distal end portion of catheter12is steered in a first plane that is typically parallel with the plane of the annulus of the valve (e.g., in a direction from the interatrial septum toward surrounding walls of the atrium). For some applications of the present invention, the distal end portion of catheter12may be pre-shaped so as to point downward toward the valve. For other applications, the distal end portion of catheter12may be pulled to assume an orientation in which the distal end portion points downward toward the valve. For yet other applications of the present invention, the distal end portion of catheter12is not made to point downward toward the valve. Handle24is coupled to track90via a first mount92. Mount92is slidable proximally and distally along track90in order to control an axial position of guide catheter14with respect to outer catheter12. Mount92is slidable via a control knob216. For example, control knob216of mount92controls the proximal and distal axial movement of the distal steerable portion of guide catheter14with respect to distal end102of outer catheter12. Handle24comprises a steering knob214that is coupled to steering wires31aand31bdisposed within respective secondary lumens in the wall of guide catheter14. Rotation of knob214adjusts a degree of tension of wires31aand31bwhich, in turn, apply a force to pull ring13at the distal end portion of guide catheter14. Such force steers the distal end portion of catheter14in a second plane within the atrium of the heart of the patient, typically downward and toward the annulus of the cardiac valve. Typically, as described hereinbelow, the second plane in which the distal end portion of catheter14is steered is substantially perpendicular to the first plane in which the distal end portion of outer catheter12is steered. The combined steering of the respective distal end portions of catheters12and14directs sleeve26down toward the annulus (e.g., via the steering of the distal end portion of catheter14) and along the perimeter of the annulus (e.g., from the posterior section of the valve to the anterior section of the valve, and vice versa, e.g., via the steering of the distal end portion of catheter12). For some applications, handle22may be tilted by the operating physician, in order to further adjust a position of the distal end of catheter12. As described herein, first and second couplings152and154of outer catheter12and guide catheter14, respectively (e.g., slit52and engager54, respectively), provide a controlled steerable system in which, during the steering and bending of the distal end portion of guide catheter14, the distal end portion of outer catheter12is maintained in its steered configuration, or in its spatial orientation, without substantially affecting the steering or the bending of the distal end portion of guide catheter14. Thus, first and second couplings152and154, respectively, minimize the effect of the distal end portion of outer catheter12on the steering and bending of catheter14. That is, first and second couplings152and154of outer catheter12and guide catheter14, respectively, collectively define a relative-spatial-orientation-controlling device which rotationally locks the relative spatial orientation of the steerable distal end portion and the bending section of outer catheter12with respect to the steerable distal end portion and the bending section of guide catheter14. Guide member86exits from the lumen in the wall of guide catheter14at a portion of handle portion101that is between handles22and24. Handle126is coupled to track90via a second mount93. Mount93is slidable proximally and distally along track90, in order to control an axial position of reference-force tube19and at least a proximal portion of sleeve26with respect to guide catheter14. Mount93is slidable via a control knob95. For example, control knob95of mount93controls the proximal and distal axial movement of the tube19and at least the proximal portion of sleeve26with respect to distal end104of guide catheter14. Taken together with the steering of the distal end portion of guide catheter14, such movement of tube19and at least the proximal portion sleeve26moves the proximal portion of sleeve26toward a desired portion of tissue of the annulus of the valve during deployment of anchors32from within the lumen of sleeve26, as is described hereinbelow. As is described hereinabove, in order to decouple sleeve26from a portion of an outer surface of channel18, (1) channel18is pulled proximally, while (2) reference-force tube19is maintained in place. A proximal end of channel18is coupled to a knob94, which adjusts an axial position of channel18proximally and distally with respect to reference-force tube19and sleeve26. Handle portion101(comprising handles22,24, and126and anchor-release mechanism28) has a length L1of between 65 and 85 cm, e.g., 76 cm. Typically, as shown, a majority of the body portion of outer-catheter handle22is disposed at a non-zero angle with respect to a longitudinal axis7of the multiple components of system10. The steering mechanism provided by handle22in order to steer the distal end portion of catheter12is disposed within the portion of handle22that is disposed at the non-zero angle with respect to axis7. Handle22comprises an in-line tubular portion21which is longitudinally disposed in-line along axis7and coaxially with respect to handles24and126and release mechanism28. Tubular portion21is shaped to define a lumen for inserting guide catheter14therethrough and subsequently into the lumen of outer catheter12(as is described hereinbelow with reference toFIG.3A). Tubular portion21has a length L24of between 7 and 11 cm, e.g., 7 cm. Such spatial orientation of the majority of handle22at an angle with respect to axis7reduces an overall functional length of handle portion101. Reference is now made toFIGS.3A-E, which are schematic illustrations of the functional relationship between first and second couplings152and154, respectively, and respective degrees of rotational freedom of guide catheter14with respect to outer catheter12, in accordance with some applications of the present invention. It is to be noted thatFIGS.3A-Eshow a functional relationship between catheters12and14, and, for clarity of illustration, does not show the concentric components disposed within a longitudinal lumen59of catheter14(i.e., reference-force tube19, channel18, anchor driver36, and rod130, as shown inFIGS.1and2).FIG.3Ashows catheters12and14in a state prior to advancing catheter14through a lumen58of catheter12. Sections A-A and B-B ofFIG.3Ashow slit52, or first coupling152, empty. Section C-C shows a portion of catheter14which provides engager54, or second coupling154. As described hereinabove with reference toFIG.1, engager54is coupled to a depressible tab56which facilitates depressible movement of engager54when a force is applied thereto (e.g., at a later stage by an inner wall51of catheter12that surrounds lumen58when catheter14is advanced through lumen58, as is described hereinbelow). As shown in section C-C ofFIG.3A, in the absence of a pushing force, tab56is disposed in parallel with longitudinal axis7, and engager54is in a resting state thereof in which engager54is not in a depressed state and protrudes from an external surface of catheter14. As shown in sections A-A and B-B ofFIGS.3A-B, first coupling152is provided in a manner in which lumen58of catheter12is free from any protrusions. Additionally, inner wall51of catheter12is not shaped to define any interrupted portions, such as recessed portions, along a proximal portion of catheter12and extending toward distal end102of catheter12, except for slit52at a distal portion thereof. Once catheter12is advanced through the vasculature of the patient, distal end104of catheter14is configured to enter a lumen provided by tubular portion21of handle22, and subsequently, catheter14passes through lumen58of catheter12. View E is a view of lumen58of catheter12from a proximal portion of tubular portion21of handle22. Since lumen58is free from any protrusions or recessed portions, as described hereinabove, and since engager54is depressible by tab56, catheter14is configured to enter lumen58of catheter12in any rotational configuration thereof. Catheter14is shown in section D-D in a manner in which engager is oriented at 12 o'clock, by way of illustration and not limitation. Catheter14may enter lumen58of catheter12in any rotational configuration thereof, therefore engager54is shown in phantom in a plurality of orientations in section D-D, since catheter14may enter lumen58of catheter12in a rotational orientation in which engager54may be oriented in any given orientation with respect to inner wall51of catheter12. Similarly, until couplings152and154are engaged (i.e., coupled to each other), catheter14may be freely rotated within catheter12. During the insertion of distal end104and the distal portion of catheter14, the physician pushes down on engager54such that engager54fits within the lumen of catheter12. In response to the pushing force on engager54, tab56is pushed downward as well. Typically, catheter12has an inner diameter (or the diameter of lumen58) of between 6.5 and 7.0 mm (e.g., 6.85 mm). Typically, catheter14has an inner diameter (or the diameter of lumen59) of between 4.7 and 5.3 mm (e.g., 5.1 mm). System10, by providing slit52and depressible engager54, provides a system in which the inner diameters of catheters12and14are maintained during given stages of the procedure. For example, engager54maintains the inner diameter of catheter12as catheter14is advanced within the lumen of catheter12, and slit52maintains the inner diameter of catheter14once engager54pops up and is disposed within slit52. That is, once catheters12and14are coupled via the engager and slit, the lumen of catheter14is typically constant along the length of the catheter (e.g., there are no protrusions into catheter14), thereby facilitating sliding through the lumen of large elements. FIG.3Bshows the axial advancement of a distal portion of catheter14through the lumen of catheter12in the direction as indicated by arrow1. Typically, the advancement of catheter14through catheter12is controlled by the physician who moves handle24axially closer to handle22. During the advancement of catheter14through catheter12, engager54is maintained in a pushed state (as shown in section A-A ofFIG.3B) by a pushing force applied thereto by inner wall51of catheter12. As shown in section B-B ofFIG.3B, inner wall51of outer catheter12pushes on engager54, in the direction as indicated by the radial arrow. In response to the force applied on engager54by inner wall51of catheter12, engager54is pushed and tab56is displaced at a non-zero angle with respect to axis7in order to allow for depression of engager54. During the depression of engager54, engager54is pushed slightly within lumen59of catheter14. As described hereinabove, inner wall51of catheter12is smooth and uninterrupted by recesses or slits (except for slit52at the distal end of catheter12). First coupling152(e.g., slit52thereof) is disposed at a given longitudinal site of catheter12, and slit52typically has a length L2(shown in view B ofFIG.1) of between 5 and 15 mm, e.g., 10 mm. A proximal-most end of slit52is disposed up to 100 mm (e.g., up to 60 mm) from distal end102of catheter12. Catheter12is typically between 80 and 100 cm long. Thus, inner wall51of the proximal portion of catheter12, until the proximal-most end of slit52, is smooth and uninterrupted by recesses or slits. Taken together, the depressibility of engager54and such a smooth configuration of inner wall51of catheter12enables rotation of catheter14by 360 degrees (i.e., as indicated by arrow2) within the lumen of catheter12. For some applications, it is hypothesized that the relatively short lengths of couplings152and154relative to the lengths of catheters12and14, and the absence of interruptions such as lateral openings (e.g., slits) and/or protrusions, other than those of the couplings, facilitates the use of catheters with lateral walls that are thinner than those of a catheter that, for example, comprises a coupling that has a longer relative length. FIG.3Cshows further axial advancement of catheter14within the lumen of catheter12. As described hereinabove, during the advancement, and prior to the engaging of engager54with slit52(as is described hereinbelow with reference toFIG.3D), inner wall51pushes on engager54such that catheter14can be rotated to any suitable rotational orientation within outer catheter12. For example, engager54is shown at 2 o'clock in section B-B ofFIG.3B, while engager54is shown at 11 o'clock in section B-B ofFIG.3C. That is, while second coupling154(e.g., engager54thereof) is disposed proximal to the longitudinal site at which first coupling152(e.g., slit52thereof) is disposed, catheter14is rotatable within the lumen of catheter12. Furthermore, prior to the engaging of engager54with slit52catheter14may be extracted from within the lumen of catheter12. FIG.3Cshows axial advancement of catheter14within catheter12in the distal direction, as indicated by arrow1, in a manner in which engager54is about to engage with slit52at a distal portion of catheter12.FIG.3Cshows a relative position of catheter14with respect to catheter12in a manner in which catheter14is not fully pushed within catheter12. Handle24of catheter14is still distanced from handle22of catheter12. However, catheter14is pushed distally sufficiently for distal end104and a portion of the distal end portion of catheter14to emerge from within catheter12and extend distally beyond distal end102of catheter12. Following further distal advancement of catheter14within catheter12, and slight rotation of catheter14within the lumen of catheter12, engager54of catheter14is aligned with slit52of catheter12, as shown inFIG.3D. In the absence of the pushing force of inner wall51of catheter12on engager54, engager54returns to its resting state and protrudes within slit52so as to engage slit52. That is, first coupling152is engaged with (i.e., coupled to) second coupling154. As engager54returns to its resting state, tab56returns to a position in which it is parallel with respect to longitudinal axis7. That is, in a given orientation of catheter14, when second coupling154(e.g., engager54thereof) becomes disposed at the longitudinal site at which first coupling152(e.g., slit52thereof) is disposed, the second coupling automatically couples to the first coupling. FIG.3Dshows engager54in a distal-most position within slit52, i.e., a fully-pushed state of catheter14. As such, handles24and22are disposed adjacently to each other. In this state, an exposed distal end portion114of catheter14extends beyond distal end102of catheter12. Typically, at least a portion of distal end portion114is steerable and bendable, as is described hereinbelow. Distal end portion114of catheter14has a length L3of between 25 and 35 mm, e.g., 30 mm. As described hereinabove, slit52has a length L2of between 5 and 15 mm, e.g., 10 mm. Reference is now made toFIGS.1and3D. As shown in view B ofFIG.1, engager54has a longitudinal length L26of between 2 and 3 mm, e.g., 2 mm. Length L26facilitates motion of engager54along length L2of slit52. A proximal-most end of engager54is disposed up to 120 mm (e.g., up to 80 mm) from distal end104of catheter14. As described hereinabove, a proximal-most end of slit52is disposed up to 100 mm (e.g., up to 60 mm) from distal end102of catheter12. Thus, since slit52has a length L2of between 5 and 15 mm, e.g., 10 mm, when engager54is disposed at a distal-most position within slit52, as shown inFIG.3D, exposed distal end portion114of catheter14has a length L3of between 20 and 35 mm, e.g., 30 mm. For some applications, the combined lengths of first and second couplings152and154, respectively, is less than 30 mm, e.g., less than 20 mm. For applications in which first coupling152(e.g., slit52) is between 5 and 15 mm, and second coupling154(e.g., engager54) is between 2 and 3 mm, the combined lengths of first and second couplings152and154, respectively, is less than 50 mm, e.g., less than 20 mm. Engager54has a longitudinal length L26that is less than 30% (e.g., less than 20%) of the longitudinal length of catheter14. Typically, however, as described hereinabove, engager54has a length L26of between 2 and 3 mm. That is, engager54has a longitudinal length that is less than 2% (e.g., less than 1%) of the longitudinal length of catheter14. Reference is now made toFIGS.3C-D. A portion of exposed distal end portion114extends beyond distal end102of catheter12prior to engager54engaging slit52. The length L2of slit52enables retraction of catheter14between 5 and 15 mm, proximally from the fully-pushed state of catheter14. As catheter14is retracted proximally, engager54moves proximally within slit52until a proximal-most end of engager54contacts a proximal-most end of slit52. When engager54is disposed at the proximal-most end of slit52, the distal end portion exposed from within catheter12is between 10 and 30 mm, e.g., 20 mm. When catheter14is pushed distally, engager54moves distally within slit52until a distal-most end of engager54contacts a distal-most end of slit52. Reference is again made toFIG.3D. In the state in which engager54is disposed within slit52, catheter14is restricted from rotating within the lumen of catheter12, and catheters12and14are thereby rotationally locked with respect to each other. FIG.3Eshows catheter12and14in a state in which catheter14has been pushed fully within catheter12(i.e., a state in which engager54is disposed at a distal-most end of slit52and handle24is disposed adjacently to handle22). As described hereinabove, during the fully-pushed state of catheter14, exposed distal portion114extends beyond distal end102of catheter12and has a length L3of between 25 and 35 mm, e.g., 30 mm. Additionally, as is described herein, at least a portion of distal end portion114is steerable and comprises an exposed bending section1403which is a portion of a collective distal bending section1405of catheter14(described hereinbelow with reference toFIGS.5and6). A distal end portion of catheter12comprises a bending section1203(described hereinbelow with reference toFIGS.4and6). A proximal portion of bending section1405of catheter14is bendable and disposed within the lumen of catheter12at bending section1203thereof. The distal end portion of catheter12is steerable in a first plane (e.g., a plane that is parallel with respect to the cardiac valve of the patient). Bending section1403of exposed distal portion114(and additional portions of collective bending section1405) is steerable in second plane that is substantially perpendicular to the first plane in which the distal end portion of catheter12is steerable (e.g., a plane that is perpendicular with respect to the valve of the patient). Typically, this configuration is achieved by couplings152and154locking the catheters such that a plane on which pull wires29aand29blie is generally orthogonal to a plane on which pull wires31aand31blie. As shown, bending section1203of the steerable distal end portion of outer catheter12is maintained in its steered configuration, or in its spatial orientation, without substantially affecting the steering of exposed distal end portion114of guide catheter14, nor of the bending of bending section1403, nor of the collective bending section1405(including the proximal portion of bending section1405of catheter14that is disposed within the lumen of catheter12at bending section1203thereof). That is, first and second couplings152and154, respectively, advantageously reduce the effect of the distal end portion of catheter12on the steering of section114and the bending of bending section1405. That is, first and second couplings152and154of outer catheter12and guide catheter14, respectively, collectively define a relative-spatial-orientation-controlling device which rotationally locks the relative spatial orientation of the steerable distal end portion and bending section1203of outer catheter12with respect to the steerable distal end portion and bending section1405of guide catheter14, specifically of exposed bending section1403. Thus, for applications in which system10is used to treat the mitral valve, bending section1203of catheter12bends the steerable distal end portion of catheter12within the atrium in the first plane that is parallel with respect to the mitral valve. First and second couplings152and154, respectively, enable (1) bending of bending section1405toward the valve in the second plane that is substantially perpendicular with respect to the first plane and to the plane of the mitral valve, while (2) restricting or minimizing the effect of the spatial orientation of bending section1203of catheter12on bending section1405of catheter14. Reference is now made toFIGS.3A-E. It is to be noted that for some applications, slit52has a longitudinal length L2of less than 20 cm, e.g., a length of less than 15 cm. That is, slit52has a longitudinal length L2that is less than 30% (e.g., less than 20%) of the longitudinal length of catheter12. Typically, however, as described hereinabove, slit52has a length L2of between 5 and 15 mm, e.g., 10 mm. That is, slit52has a longitudinal length that is less than 2% (e.g., less than 1%) of the longitudinal length of catheter12. For such applications, the proximal-most end of slit52is disposed up to 30 mm from distal end102of catheter12. It is to be noted that the scope of the present invention includes providing slit52and engager54at respective proximal portions of catheters12and14, respectively. For such applications, a distal-most end of slit52is disposed up to 100 mm (e.g., up to 60 mm) from the proximal end of catheter12and a distal-most end of engager54is disposed up to 120 mm (e.g., up to 80 mm) from the proximal end of catheter14. Reference is now made toFIGS.1,2, and3A-E. It is to be noted that first and second couplings152and154, respectively, may be provided on any standard catheter. That is, coupling152comprises frame50which can be coupled to an external surface of any standard catheter (in which case, a corresponding slit would be made in the standard catheter). Additionally coupling154may be coupled to any standard catheter by coupling the base portion of coupling154to any standard catheter. Suitable adjustments to the standard catheter would be made to accommodate the displacing of tab56and engager54in response to pushing forces applied to engager54. Reference is now made toFIG.4, which is a schematic illustration of catheter12comprising a multiple-durometer section1210at a distal steerable end portion of catheter12, in accordance with some applications of the present invention. Multiple-durometer section1210has a length L18of between 30 mm and 40 mm, e.g., 36 mm. Each section of multiple-durometer section1210has a respective durometer sections in Shore D, or scale D. Catheter12comprises a uniform durometer section1205that is disposed proximal to multiple-durometer bending section1210. Typically, multiple durometer section1210and uniform durometer section1205comprise an elastic tubular polymer1206(e.g., sequences of polyamide 12 segments (PA12) and polytetramethylene glycol segments (PTMG), polyether block amide, or PEBA) that defines the tubular structure of catheter12. Polymer1206has mechanical and dynamic properties which impart flexibility, impact resistance, energy return, and fatigue resistance to catheter12. As shown in the cross-sectional image, catheter12provides a wall which defines lumen58. The inner wall of catheter12(which defines lumen58) is coated with a friction-reducing liner comprising polytetrafluoroethylene (PTFE) so as to reduce friction during the sliding of catheter14through lumen58of catheter12. The wall of catheter12is shaped to define secondary lumens1211, which are typically spaced apart from each other by 180 degrees. A respective pull wire29aand29b(not shown inFIG.4for clarity of illustration, but are shown inFIGS.1and2) is advanced through each lumen1211. The inner walls of each secondary lumen1211is coated with a friction-reducing liner comprising polytetrafluoroethylene (PTFE) so as to reduce friction during the sliding of respective wires29aand29btherethrough. Typically, catheter12has an inner diameter D1(or the diameter of lumen58) of more than 6.5 mm and/or less than 7.0 mm (e.g., 6.85 mm) and an outer diameter D2of more than 7.0 mm and/or less than 9.0 mm (e.g., 8.3 mm). It is to be noted that even though catheter12has multiple durometer segments, inner and outer diameters D1and D2, respectively, remain constant along a longitudinal length L8of catheter12(with the exception of outer diameter D2being tapered at the distal end portion of section1201, as is described hereinbelow). Typically, catheter12has a longitudinal length L8of between 700 and 1200 mm, e.g., between 800 and 900 mm, e.g., between 853 and 867 mm, e.g., 860 mm. Uniform durometer section1205has a length L9that is between 770 and 860 mm, e.g., 824 mm. Tubular polymer1206extends an entire length L8of catheter12. Catheter12is surrounded by a braided mesh1207, which typically comprises a flexible metal (e.g., stainless steel 304 or nitinol). Typically, braided mesh1207extends along the length of catheter12until a proximal portion at which the pull wires29aand29b(not shown for clarity of illustration) are exposed from within lumens1211at a proximal section of catheter12, e.g., between 823 and 837 mm (e.g., 830 mm) from distal end102of catheter12. Section1210comprises a distal pull-ring section1201in which pull ring11is disposed. Typically, a distal-most portion of section1201is tapered so as to facilitate atraumatic advancement of catheter12through the vasculature of the patient. Section1201has a length of between 4 and 5 mm (e.g., 4.5 mm) and has a durometer of between 45D and 63D (e.g., 55D). Such a durometer of section1201imparts more hardness and rigidity to the distal portion of catheter12in which pull ring11is disposed, such that section1201supports ring11and protects the distal portion of catheter12from the impact of forces applied thereto during the pulling of pull ring11by the pull wires. Typically, pull ring11has a length of between 2.5 and 2.6 mm, e.g., 2.54 mm. A distal transition section1202is disposed proximal to section1201and has a length L5of between 1 and 2 mm (e.g., 1.5 mm) and has a durometer of between 63D and 72D (e.g., 72D). The relatively high durometer of section1202imparts hardness to section1202such that pull ring11is supported and maintained in place during the pulling of pull ring11by the pull wires. Thus, section1202helps overcome high tensile forces acting on the distal end of catheter12. Catheter12provides bending section1203proximally adjacent to section1202. As shown in the enlarged image, bending section1203comprises a coil1208which is embedded within the tubular polymer1206. Typically, coil1208comprises a flexible metal (e.g., stainless steel 304 or nitinol). Coil1208imparts efficient and durable bending (e.g., flexibility) to bending section1203. Additionally, polymer1206at bending section1203has a durometer of between 25D and 45D (e.g., 35D) which provides a degree of softness that facilitates bending of the distal steerable portion of catheter12at bending section1203. Bending section1203has a length L6of between 22 and 27 mm, e.g., 25 mm. Typically, bending section1203has a maximum bending angle between 120 and 140 degrees (e.g., 127 degrees). That is, bending section1203can bend between 0 and 140 degrees. For some applications, bending section1203has a pre-shaped angle of between 40 and 55 degrees (e.g., 45 degrees) so as to reduce force applied to bending section1203of catheter12by pull wires29aand29b. It is to be noted that only tubular polymer1206and braided mesh1207extend proximally and distally beyond bending section1203. Proximally adjacent to bending section1203is a transition section1204having a length L7of between 4 and 6 mm (e.g., 5 mm). Proximally adjacent to transition section1203is uniform durometer section1205. Uniform durometer section1205has a durometer of between 63D and 72D (e.g., 72D). Transition section1204has a durometer of between 35D and 55D (e.g., 45D) so as to provide a transition from the relatively low durometer of bending section1203to the relatively high durometer of uniform durometer section1205. FIG.4shows the relative position of slit52with respect to distal end102of catheter12. As described hereinabove, a proximal-most end of slit52is disposed up to 100 mm (e.g., up to 60 mm) from distal end102of catheter12. Typically, the spatial orientation of bending section1203is determined by pulling on pull wires29aand29bthat are disposed within lumens1211(wires29aand29bare not shown for clarity of illustration). Bending section1203, for some alternative applications of the present invention, may be pre-shaped (e.g., at 45 degrees with respect to a transverse plane provided by opposing pull wires29aand29b) to assume a given spatial orientation and the spatial orientation of section1203is additionally determined by pulling on pull wires29aand29b. Reference is now made toFIG.5, which is a schematic illustration of catheter14comprising a multiple-durometer section1410at a distal steerable end portion of catheter14, in accordance with some applications of the present invention. Multiple-durometer section1410has a length L19of between 70 mm and 80 mm, e.g., 74 mm. Each section of multiple-durometer section1410has a respective durometer sections in Shore D, or scale D. Catheter14comprises a uniform durometer section1407that is disposed proximal to multiple-durometer bending section1410. Typically, multiple durometer section1410and uniform durometer section1407comprise an elastic tubular polymer1416(e.g., sequences of polyamide 12 segments (PA12) and polytetramethylene glycol segments (PTMG), polyether block amide, or PEBA) that defines the tubular structure of catheter14. Polymer1416has mechanical and dynamic properties which impart flexibility, impact resistance, energy return, and fatigue resistance to catheter14. As shown in the cross-sectional image, catheter14provides a wall which defines lumen59. The inner wall of catheter14(which defines lumen59) is coated with a friction-reducing liner comprising polytetrafluoroethylene (PTFE) so as to reduce friction during the sliding of tube19(not shown for clarity of illustration, but shown inFIGS.1and2) through lumen59of catheter14. The wall of catheter14is shaped to define secondary lumens1421, which are typically spaced apart from each other by 180 degrees. A respective pull wire31aand31b(not shown inFIG.5for clarity of illustration, but are shown inFIGS.1and2) is advanced through each lumen1421. The inner walls of each secondary lumen1421is coated with a friction-reducing liner comprising polytetrafluoroethylene (PTFE) so as to reduce friction during the sliding of respective wires31aand31btherethrough. Additionally, the wall of catheter14is shaped to define a secondary lumen1422for passage therethrough of guide member86(not shown inFIG.5for clarity of illustration, but are shown inFIGS.1and2). The inner wall of secondary lumen1422is coated with a friction-reducing liner comprising polytetrafluoroethylene (PTFE) so as to reduce friction during the sliding of guide member86therethrough. Typically, catheter14has an inner diameter D3(or the diameter of lumen59) of between 4.7 and 5.3 mm (e.g., 5.1 mm) and outer diameter D4of between 6.3 and 6.9 mm (e.g., 6.5 mm or 6.7 mm). It is to be noted that even though catheter14has multiple durometer segments, inner and outer diameters D3and D4, respectively, remain constant along a longitudinal length L17of catheter14. Typically, catheter14has a length L17of between 1000 and 1500 mm, e.g., between 1190 and 1210 mm, e.g., 1200 mm. Uniform durometer section1407has a length L16that is between 900 and 1400 mm, e.g., between 1110 and 1130 mm, e.g., 1126 mm. Tubular polymer1416extends an entire length L17of catheter14. Catheter14is surrounded by a braided mesh1417, which typically comprises a flexible metal (e.g., stainless steel 304 or nitinol). Typically, braided mesh1417extends along the length of catheter14until a proximal portion at which the pull wires31aand31b(not shown for clarity of illustration) are exposed from within lumens1421at a proximal section of catheter14, e.g., between 993 and 1007 mm (e.g., 1000 mm) from distal end104of catheter14. Section1410comprises a distal pull-ring section1401in which pull ring13is disposed. Section1401has a length of between 3.5 and 4.5 mm (e.g., 4.04 mm) and has a durometer of between 45D and 63D (e.g., 55D). Such a durometer of section1401imparts more hardness and rigidity to the distal portion of catheter14in which pull ring13is disposed, such that section1401supports ring13and protects the distal portion of catheter14from the impact of forces applied thereto during the pulling of pull ring13by the pull wires. Typically, pull ring13has a length of between 2.5 and 2.6 mm, e.g., 2.54 mm. A distal transition section1402is disposed proximal to section1401and has a length L11of between 1 and 2 mm (e.g., 1.5 mm) and has a durometer of between 63D and 72D (e.g., 72D). The relatively high durometer of section1402imparts hardness to section1402such that pull ring13is supported and maintained in place during the pulling of pull ring13by the pull wires. Thus, section1402helps overcome high tensile forces acting on the distal end of catheter14. Catheter14provides collective bending section1405proximally adjacent to section1402. As shown in the enlarged image, bending section1405comprises a coil1418which is embedded within the tubular polymer1416. Typically, coil1418comprises a flexible metal (e.g., stainless steel 304 or nitinol). Coil1418imparts efficient and durable bending to bending section1405. Bending section1405has a length L14of between 60 and 70 mm, e.g., 62 mm. Collective bending section1405comprises exposed bending section1403and a proximal bending section1404. Reference is now made toFIG.6, which is a schematic illustration of a relative spatial orientation of the steerable distal end portions of catheters12and14, respectively. Typically, in a fully-pushed state of catheter14within catheter12, as described hereinabove, catheter14provides exposed distal end portion114that extends beyond distal end102of catheter12. Distal end portion114comprises exposed bending section1403. In the fully-pushed state of catheter14, exposed bending section1403is configured to be exposed from and extend beyond distal end102of catheter12, while at least a distal portion of proximal bending section1404is configured to remain concentrically disposed within the lumen of catheter12in general alignment with bending section1203of catheter12, as indicated by the broken line inFIG.6. Reference is now made toFIGS.5and6. Polymer1416at exposed bending section1403(inFIG.5) has a durometer of between 20D and 35D (e.g., 25D) which provides a degree of softness at exposed bending section1403that facilitates bending of section1403. Additionally, proximal bending section1404has a durometer of between 25D and 45D (e.g., 35D) which provides a degree of softness at exposed bending section1404that facilitates bending of section1404. It is to be noted that the durometer of proximal bending section1404is higher than the durometer of exposed bending section1403. Since the durometer of proximal bending section1404of catheter14is generally similar to the durometer of bending section1203of catheter12, the steering of the distal end portion of catheter14(and of exposed distal portion114) and the bending of bending section1405of catheter14(especially the bending of exposed bending section1403) does not substantially influence the bending and spatial orientation of bending section1203at the distal end portion of catheter12when catheter14is disposed within catheter12. Typically, bending section1405has a maximum bending angle between 100 and 140 degrees (e.g., 117 degrees). That is, bending section1405can bend between 0 and 140 degrees. For some applications, at least a portion of bending section1405has a pre-shaped angle of between 40 and 55 degrees (e.g., 45 degrees) so as to reduce force applied to bending section1405of catheter14by pull wires31aand31b. Reference is again made toFIG.5. It is to be noted that only tubular polymer1416and braided mesh1417extend proximally and distally beyond bending section1405. Proximally adjacent to bending section1405is a transition section1406having a length L15of between 4 and 6 mm (e.g., 5 mm). Proximally adjacent to transition section1406is uniform durometer section1407. Uniform durometer section1407has a durometer of between 63D and 72D (e.g., 72D). Transition section1406has a durometer of between 35D and 55D (e.g., 45D) so as to provide a transition from the relatively low durometer of proximal bending section1404of bending section1405to the relatively high durometer of uniform durometer section1407.FIG.5shows the relative position of slit engager54with respect to distal end104of catheter14. As described hereinabove, a proximal-most end of engager54is disposed up to 120 mm (e.g., up to 80 mm) from distal end104of catheter14. Typically, the spatial orientation of bending section1405is determined by pulling on pull wires31aand31bthat are disposed within lumens1421(wires31aand31bare not shown for clarity of illustration). Bending section1405, for some alternative applications of the present invention, may be pre-shaped to assume a given spatial orientation and the spatial orientation of section1405is additionally determined by pulling on pull wires31aand31b. Reference is now made toFIG.7A, which is a schematic illustration of a catheter1012as described hereinabove with regard to catheter12with reference toFIG.4, with the exception that catheter1012comprises a tubular portion1250that is shaped to define slit52described herein, in accordance with some applications of the present invention. Tubular portion1250comprises a flexible or rigid metal segment that is shaped to provide first coupling152. For some applications, slit52is created in tubular portion1250. For other applications, frame50(described hereinabove with reference toFIG.1) is coupled to tubular portion1250in alignment with a slit generated therein. During manufacture of catheter1012, tubular portion1250is positioned longitudinally and coaxially between segments of section1205of catheter1012. That is, a portion of section1205is cut in order to generate intermediate free ends, and tubular portion1250is attached at respective free ends thereof to the intermediate free ends of section1205. For some applications, catheter1012is not cut, but rather catheter1012is comprised of two separate parts, each having free ends which are each coupled to portion1250. For some applications, the intermediate free ends are coupled to respective metal segments, and tubular portion1250is coupled to the metal segments at the intermediate free ends of catheter12by being welded to the metal segments. Typically, but not necessarily, the metal of portion1250is covered by plastic or the polymer of catheter12, described hereinabove with reference toFIG.4. Typically, the pull wires of catheter12described hereinabove with reference toFIG.2, run through secondary lumens in the wall of tubular portion1250, or adjacently to the wall of portion1250. It is to be noted that tubular portion1250may be coupled to any suitable catheter known in the art. Reference is now made toFIG.7B, which is a schematic illustration of a catheter1014as described hereinabove with regard to catheter14with reference toFIG.5, with the exception that catheter1014comprises a tubular portion1450that is shaped to define engager54and tab56described herein, in accordance with some applications of the present invention. Tubular portion1450comprises a flexible or rigid metal segment that is shaped to provide second coupling154. That is, tubular portion1450provides slits57(as shown inFIG.1) which define tab56and engager54. Thus, for some applications, tubular portion1450and tab56are constructed from a single unit by creating slits in tubular portion1450, and the protrusion of engager54is welded or otherwise coupled to a distal end of tab56. For other applications, coupling154comprises a base which defines tab56and provides engager54, and the base is coupled to tubular portion1450. During manufacture of catheter1014, tubular portion1450is positioned longitudinally and coaxially between segments of section1407of catheter1014. That is, a portion of section1407is cut in order to generate intermediate free ends, and tubular portion1450is attached at respective free ends thereof to the intermediate free ends of section1407. For some applications, catheter1014is not cut, but rather catheter1012is comprised of two separate parts, each having free ends which are each coupled to portion1250. For some applications, the intermediate free ends are coupled to respective metal segments, and tubular portion1450is coupled to the metal segments at the intermediate free ends of catheter14by being welded to the metal segments. Typically, but not necessarily, the metal of portion1450is covered by plastic or the polymer of catheter14, described hereinabove with reference toFIG.5. Typically, the pull wires of catheter14described hereinabove with reference toFIG.2, run through secondary lumens in the wall of tubular portion1450, or adjacently to the wall of portion1450. It is to be noted that tubular portion1450may be coupled to any suitable catheter known in the art. Reference is now made toFIG.8, which is a schematic illustration of a system300comprising a generally-rigid segment302positioned between catheters12and14described herein, in accordance with some applications of the present invention. Typically, generally-rigid segment302is disposed at an outer surface of catheter14and is configured to extend between 20 and 40 degrees circumferentially around the outer surface of catheter14. For some applications, segment302comprises a metal. Segment302is configured to restrict bending of catheter14in a given plane so as to minimize interference of the bending and steering of catheter14on catheter12. Additionally, segment302is configured to minimize the effect of the spatial orientation of catheter12on the steering and bending of catheter14. Thus, segment302provides a relative-spatial-orientation-controlling device to control the relative spatial orientations of the respective steerable distal end portions of catheters12and14. Generally-rigid segment302may be used with catheters12and14independently of or in combination with first and second couplings152and154, as described hereinabove with reference toFIGS.1,2, and3A-E. Reference is now made toFIG.9, which is a schematic illustration of a system320comprising a friction-enhancing element322positioned between catheters12and14described herein, in accordance with some applications of the present invention. Typically, friction-enhancing element322is disposed at an outer surface of catheter14and is configured to extend between 20 and 40 degrees circumferentially around the outer surface of catheter14. For some applications, friction-enhancing element322comprises a metal or a plastic. Friction-enhancing element322is configured to restrict bending of catheter14in a given plane so as to minimize interference of the bending and steering of catheter14on catheter12. Additionally, friction-enhancing element322is configured to minimize the effect of the spatial orientation of catheter12on the steering and bending of catheter14. Thus, friction-enhancing element322provides a relative-spatial-orientation-controlling device to control the relative spatial orientations of the respective steerable distal end portions of catheters12and14. Friction-enhancing element322may be used with catheters12and14independently of or in combination with first and second couplings152and154, as described hereinabove with reference toFIGS.1,2, and3A-E. Reference is now made toFIGS.10A-C, which are schematic illustrations of a system330comprising a hypertube section332disposed at a distal end of catheter12and14described herein, in accordance with some applications of the present invention. Typically, hypertube section332provides a lumen for passage therethrough of a distal portion of catheter14. Hypertube section332is configured to facilitate bending of the distal portion of catheter12in the first plane, as shown inFIGS.10B-C(e.g., the plane parallel with respect to the valve of the patient), while restricting bending of catheter12the second plane that is perpendicular with respect to the first plane. As such, during the bending and steering of the distal end portion of catheter14in the second plane, catheter12is restricted from being bent in the second plane, by hypertube section332. Thus hypertube section332minimizes interference of the bending and steering of catheter14on catheter12. Additionally, hypertube section332is configured to minimize the effect of the spatial orientation of catheter12on the steering and bending of catheter14. Thus, hypertube section332provides a relative-spatial-orientation-controlling device to control the relative spatial orientations of the respective steerable distal end portions of catheters12and14. Hypertube section332may be used with catheters12and14independently of or in combination with first and second couplings152and154, as described hereinabove with reference toFIGS.1,2, and3A-E. Reference is now made toFIGS.11A-B, which are schematic illustrations of a catheter340having multiple steering segments (e.g., first and second steering segments346and348, respectively), in accordance with some applications of the present invention. First steering segment346comprises a first pull ring345that is coupled to respective distal ends of first and second first-segment steering wires344aand344b. Steering wires344aand344bextend from the distal end of catheter340toward a proximal portion of catheter340. Second steering segment348comprises a second pull ring343that is coupled to respective distal ends of first and second first-segment steering wires342aand342b. Steering wires342aand342bextend from pull ring343toward a proximal portion of catheter340. Segment346is configured to be coupled to only steering wires344aand344b. Steering wires344aand344bpass through respective channels provided by pull ring343. In response to the pulling of wires342aand342bsteering segments348is steering in a first plane, and in response to the pulling of wires344aand344bsteering segments346is steering in a second plane. For applications in which catheter340is used to deliver the annuloplasty structure222and anchor driver36described herein to a cardiac valve, segment348is configured to be steered in the plane that is parallel with respect to the valve, and segment346is configured to be steered toward the valve in a second plane that is perpendicular with respect to the plane of the valve. For some applications catheter340may be introduced within multi-component tubular system10, described hereinabove with reference toFIGS.1and2, in place of catheters12and14. That is reference force tube19, implant222, channel18, and deployment manipulator61may be advanced within a lumen of catheter340. Reference is made toFIGS.12A-B, which are schematic illustrations of rotating deployment element38, as described hereinabove with reference toFIG.2, in radially-expanded and radially-compressed states, respectively, in accordance with some applications of the present invention. For some applications, rotating deployment element38is shaped to define at least two prongs124A and124B that extend in a distal direction from a proximal base122of the deployment element. Engagement elements120A and120B extend in a distal direction from prongs124A and124B, respectively. The engagement elements are typically male, and, for example, may together have a cross-sectional shape that is rectangular, e.g., square. Optionally, rotating deployment element38comprises more than two prongs and two engagement elements, e.g., three or four of each. Rotating deployment element38is typically configured to assume a radially-expanded state as its resting state, as shown inFIG.12A. In this expanded state, engagement elements120A and120B, as well as prongs124A and124B, are positioned apart from one another. In this state, the engagement elements are shaped and sized to engage tool-engaging head62of anchor32, as shown, for example, inFIG.2. As shown inFIG.12B, the rotating deployment element38assumes a radially-compressed state, when the engagement elements and prongs are squeezed together, such as by passing through the engaging opening of tool-engaging head62of anchor32. Reference is now made toFIGS.13A-B, which are schematic illustrations of rotating deployment element38engaging tool-engaging head62of anchor32, with the element38in locked and unlocked states, respectively, in accordance with an application of the present invention. In accordance with this application, rotating deployment element38comprises a locking mechanism128, which is configured to selectively assume locked and unlocked states. When locking mechanism128assumes the locked state (FIG.13A), the locking mechanism prevents disengagement of rotating deployment element38from the anchor which rotating deployment element38currently engages. This locking allows deployment element38to proximally withdraw anchor32if necessary, without coming disengaged therefrom. Disengagement is thus prevented even upon withdrawal of the rotating deployment element in the proximal direction. When the locking mechanism assumes the unlocked state (FIG.13B), the locking mechanism does not prevent disengagement of the rotating deployment element from the anchor upon withdrawal of rotating deployment element38in the proximal direction. The rotating deployment element thus can be disengaged and withdrawn from the anchor in a proximal direction. It is noted that even when the locking mechanism assumes the unlocked state, the rotating deployment element generally does not disengage from the anchor unless the rotating deployment element is withdrawn in the proximal direction. As mentioned above with reference toFIG.12A, rotating deployment element38is typically configured to assume a radially-expanded state as its resting state. In this radially-expanded state, engagement elements120A and120B are positioned apart from each other, and engage tool-engaging head62of anchor32. Thereby, even in the unlocked state shown inFIG.13B, engagement elements120A and120B typically remain positioned apart from each other. For some applications, locking mechanism128comprises elongate rod130. In order to cause the locking mechanism to assume the locked position, rod130is advanced distally between engagement elements120A and120B. The rod holds the engagement elements in their radially-expanded state, as described hereinabove with reference toFIG.12A, thereby preventing the engagement elements from assuming the radially-compressed state shown inFIG.12Band disengaging from the anchor. In the radially-expanded state, the engagement elements engage a proximal engaging surface66of tool-engaging head62of anchor32. In order to cause locking mechanism128to assume the unlocked state, rod130is withdrawn proximally from between engagement elements120A and120B. As a result, as deployment element38is subsequently pulled in the proximal direction, the engagement elements are pushed together by tool-engaging head62(e.g., proximal engaging surface66thereof), so as to assume the radially-compressed state shown inFIG.12B. In the radially-compressed state, the engagement elements do not engage the tool-engaging head of the anchor, and deployment element38is thereby decouplable from anchor32. Movement of rod130proximally and distally is described hereinabove with reference toFIG.2. As shown in Section E-E ofFIG.2, a proximal end of rod130is coupled to a component of an anchor-release mechanism28at a proximal end of system10. Mechanism28comprises a housing135and a finger-engager131that is coupled to the proximal end of rod130. Finger-engager131is coupled to a housing135via a spring133(section E-E ofFIG.2). A proximal end of the tube of anchor driver36is coupled to housing135. As is described hereinbelow, the physician releases anchor32from deployment element38when finger-engager131is pulled proximally, thereby pulling rod130proximally. When rod130is moved proximally, the distal portion of rod130is removed from between engagement elements120A and120B, and elements120A and120B assume the unlocked state described hereinabove. Providing this selective, actively-controllable engagement and release of the anchor allows rotating deployment element38to be used to unscrew an already-deployed anchor from the tissue, and/or to proximally withdraw an anchor, without deployment element38unintentionally disengaging from the anchor head. Such unscrewing or proximal withdrawal may allow an anchor to be repositioned if it is initially coupled to the tissue in an incorrect location. Rotating deployment element38is capable of performing this redeployment for both (a) the anchor that has been most recently deployed into the tissue, and to which the deployment element38is still coupled, and (b) an anchor that was previously deployed, and from which deployment element38has already been decoupled (and, optionally, even after another anchor has subsequently been deployed). In the latter case, deployment element38re-engages the anchor that is to be redeployed. For some applications, such re-engaging occurs when deployment element38, in its compressed state, reenters the opening of tool-engaging head62and coupling elements120A and120B are allowed to assume their radially-expanded states (e.g., such as by advancing rod130therebetween). Reference is now made toFIGS.14A-I, which are schematic illustrations of a procedure for implanting an annuloplasty ring structure222to repair a mitral valve230, in accordance with an application of the present invention. This procedure is one exemplary procedure that can be performed using system10. Annuloplasty ring structure222is used to repair a dilated valve annulus of an atrioventricular valve, such as mitral valve230. For some applications, the annuloplasty ring is configured to be placed only partially around the valve annulus (e.g., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. The annuloplasty ring comprises flexible sleeve26and a plurality of anchors32. Anchor deployment manipulator61is advanced into a lumen of sleeve26, and, from within the lumen, deploys the anchors through a wall of the sleeve and into cardiac tissue, thereby anchoring the sleeve around a portion of the valve annulus. For some application, annuloplasty ring structure222is implemented using techniques described in U.S. application Ser. No. 12/437,103, filed May 7, 2009 which published as US 2010/0286767 (now U.S. Pat. No. 8,715,342), and/or U.S. application Ser. No. 12/689,635, filed Jan. 19, 2010 which published as US 2010/0280604 (now U.S. Pat. No. 8,545,553), both of which are assigned to the assignee of the present application and are incorporated herein by reference. As described hereinabove, annuloplasty ring structure222comprises adjusting mechanism40. The adjusting mechanism comprises a rotatable structure, such as a spool, arranged such that rotation of the rotatable structure contracts the implant structure. The implant further comprises a longitudinal member, such as a wire, which is coupled to the adjusting mechanism. A rotation tool is provided for rotating the rotatable structure. The tool is configured to be guided along (e.g., over, alongside, or through) the longitudinal member, to engage the rotatable structure, and to rotate the rotatable structure in response to a rotational force applied to the tool. As shown inFIG.14A, the procedure typically begins by advancing a semi-rigid guidewire202into a right atrium220of the patient. The procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography. As show inFIG.14B, guidewire202provides a guide for the subsequent advancement of outer catheter12therealong and into the right atrium. Once a distal portion of catheter12has entered the right atrium, guidewire202is retracted from the patient's body. Catheter12typically comprises a 14-24 F sheath, although the size may be selected as appropriate for a given patient. Catheter12is advanced through vasculature into the right atrium using a suitable point of origin typically determined for a given patient. For example:catheter12may be introduced into the femoral vein of the patient, through an inferior vena cava223, into right atrium220, and into a left atrium224transseptally, typically through the fossa ovalis;catheter12may be introduced into the basilic vein, through the subclavian vein to the superior vena cava, into right atrium220, and into left atrium224transseptally, typically through the fossa ovalis; orcatheter12may be introduced into the external jugular vein, through the subclavian vein to the superior vena cava, into right atrium220, and into left atrium224transseptally, typically through the fossa ovalis. For some applications of the present invention, catheter12is advanced through inferior vena cava223of the patient (as shown) and into right atrium220using a suitable point of origin typically determined for a given patient. Catheter12is advanced distally until the sheath reaches the interatrial septum, and guidewire202is withdrawn, as shown inFIG.14C. As shown inFIG.14D, a resilient needle206and a dilator (not shown) are advanced through catheter12and into the heart. In order to advance catheter12transseptally into left atrium224, the dilator is advanced to the septum, and needle206is pushed from within the dilator and is allowed to puncture the septum to create an opening that facilitates passage of the dilator and subsequently catheter12therethrough and into left atrium224. The dilator is passed through the hole in the septum created by the needle. Typically, the dilator is shaped to define a hollow shaft for passage along needle206, and the hollow shaft is shaped to define a tapered distal end. This tapered distal end is first advanced through the hole created by needle206. The hole is enlarged when the gradually increasing diameter of the distal end of the dilator is pushed through the hole in the septum. As shown inFIG.4, for example, a distal-most end102of catheter12is tapered so as to facilitate passage of the distal portion of catheter12through the opening in the septum. The advancement of catheter12through the septum and into the left atrium is followed by the extraction of the dilator and needle206from within catheter12, as shown inFIG.14E. Once the distal portion of catheter12is disposed within atrium224, the steerable distal end portion of catheter12(which includes at least a portion of bending section1203, as described hereinabove with reference toFIGS.4and6) is steered in a first plane that is parallel to a plane of the annulus of mitral valve230. Such steering moves the distal end portion of catheter12in a direction from the interatrial septum toward surrounding walls of the atrium, as indicated by the arrow in atrium224. As described hereinabove, steering of the distal portion of catheter12is performed via steering knob210of handle22in handle portion101(inFIGS.1and2). As shown inFIG.14F, annuloplasty ring structure222(not shown for clarity of illustration, with anchor deployment manipulator61therein) is advanced through guide catheter14, which is in turn, advanced through catheter12into left atrium224. As shown inFIG.14F, exposed distal end portion114of catheter14extends beyond distal end102of catheter12. Exposed distal end portion114is then (1) steered toward the annulus of valve230along a plane that is perpendicular with respect to the steering plane of catheter12and that is perpendicular with respect to valve230, and is (2) bent, via bending section1403(as described hereinabove with reference toFIGS.5and6) toward valve230. As described hereinabove, steering of the distal portion of catheter14is performed via steering knob214of handle24in handle portion101(inFIGS.1and2). As shown inFIG.14G, a distal end251of sleeve26is positioned in a vicinity of a left fibrous trigone242of an annulus240of mitral valve230. (It is noted that for clarity of illustration, distal end251of sleeve26is shown schematically in the cross-sectional view of the heart, although left trigone242is in reality not located in the shown cross-sectional plane, but rather out of the page closer to the viewer.) Alternatively, the distal end of sleeve26is positioned in a vicinity of a right fibrous trigone244of the mitral valve (configuration not shown). Further alternatively, the distal end of the sleeve is not positioned in the vicinity of either of the trigones, but is instead positioned elsewhere in a vicinity of the mitral valve, such as in a vicinity of the anterior or posterior commissure. Once positioned at the desired site near the selected trigone, deployment manipulator61deploys a first anchor32through the wall of sleeve26(by penetrating the wall of the sleeve in a direction in a direction parallel to a central longitudinal of deployment manipulator61, or anchor driver36, through the distal end of channel18, and/or parallel to central longitudinal axis of tissue coupling element60of anchor32) into cardiac tissue near the trigone, using the techniques described hereinabove with reference toFIGS.12A-Band13A-B. Following the deployment of anchor32in the cardiac tissue, deployment element38is decoupled from anchor32by moving rod130proximally, as described hereinabove with reference toFIGS.2,12A-B, and13A-B. Anchors32are typically deployed from a distal end of manipulator61while the distal end is positioned such that a central longitudinal axis through the distal end of manipulator61forms an angle with a surface of the cardiac tissue of between about 20 and 90 degrees, e.g., between 45 and 90 degrees, such as between about 75 and 90 degrees, such as about 90 degrees. Typically, anchors32are deployed from the distal end of manipulator61into the cardiac tissue in a direction parallel to the central longitudinal axis through the distal end of manipulator61. Such an angle is typically provided and/or maintained by channel18being more rigid than sleeve26. Distal end17(shown inFIG.2) of channel18is typically brought close to the surface of the cardiac tissue (and the wall of sleeve26that is disposed against the surface of the cardiac tissue), such that little of each anchor32is exposed from channel18before penetrating the sleeve and the tissue. For example, distal end17of channel18may be placed (e.g., pushed) against the wall of the sleeve, sandwiching the sleeve against the cardiac tissue. For some applications, this placement of distal end17of channel18against the cardiac tissue (via the wall of the sleeve), stabilizes the distal end during deployment and anchoring of each anchor32, and thereby facilitates anchoring. For some applications, pushing of distal end17against the cardiac tissue (via the wall of the sleeve) temporarily deforms the cardiac tissue at the site of contact. This deformation may facilitate identification of the site of contact using imaging techniques (e.g., by identifying a deformation in the border between cardiac tissue and blood), and thereby may facilitate correct positioning of the anchor. For some applications of the present invention, anchors32may be deployed from a lateral portion of manipulator61. Reference is now made toFIGS.14G and2. Following the deployment of the first anchor, a distal portion of sleeve26is decoupled from a portion of implant-decoupling channel18. In order to decouple the portion of sleeve26from outer surface of channel18, (1) channel18is pulled proximally, while (2) reference-force tube19is maintained in place in a manner in which a distal end of tube19provides a reference force to sleeve26in order to facilitate retraction freeing of a successive portion of sleeve26from around channel18. In order to decouple sleeve26from the outer surface of channel18, (1) channel18is pulled proximally, while (2) reference-force tube19is maintained in place. An indicator2120(shown herein with reference toFIGS.30A-B) on handle126provides an indication of how much channel18is withdrawn from within sleeve26(i.e., how much the delivery tool is decoupled from sleeve26, and how much sleeve has advanced off channel18and against tissue). A proximal end of channel18is coupled to a knob94(FIG.2) which adjusts an axial position of channel18proximally and distally with respect to reference-force tube19and sleeve26. As shown inFIG.14H, deployment manipulator61is repositioned along annulus240to another site selected for deployment of a second anchor32. Reference is now made toFIGS.1and14H. Such repositioning of manipulator61is accomplished by:(1) the steering of the distal end portion of catheter12(e.g., by steering knob210of handle22) in the first plane that is parallel with respect to annulus240of valve230to a desired spatial orientation and in a manner which bends bending section1203of catheter12,(2) the steering of the distal end portion of portion of catheter14(e.g., by steering knob214of handle24) in the second plane that is perpendicular with respect to annulus240of valve230to a desired spatial orientation, and in a manner which bends bending section1405of catheter14(specifically bending section1403),(3) by axially moving catheter14with respect to catheter12via knob216,(4) by axially moving the stand supporting handles22and24to move both catheters12and14,(5) by moving tube19and sleeve26axially by sliding mount93along track90via knob95, and/or(6) by moving channel18relative to tube19by actuating knob94. Typically, the first anchor is deployed most distally in the sleeve (generally at or within a few millimeters of the distal tip of the sleeve), and each subsequent anchor is deployed more proximally, such that the sleeve is gradually decoupled from channel18of deployment manipulator61in a distal direction during the anchoring procedure (i.e., channel18is withdrawn from within sleeve26, and handle126is moved distally so as to retract the tool to make the successive proximal portion sleeve26ready for implantation of a subsequent anchor). The already-deployed first anchor32holds the anchored end of sleeve26in place, so that the sleeve is drawn from the site of the first anchor towards the site of the second anchor. Typically, as sleeve26is decoupled from channel18, deployment manipulator61is moved generally laterally along the cardiac tissue, as shown inFIG.14H. Deployment manipulator61deploys the second anchor through the wall of sleeve26into cardiac tissue at the second site. Depending on the tension applied between the first and second anchor sites, the portion of sleeve26therebetween may remain tubular in shape, or may become flattened, which may help reduce any interference of the ring with blood flow. As shown inFIG.14I, deployment manipulator61is repositioned along the annulus to additional sites, at which respective anchors are deployed, until the last anchor is deployed in a vicinity of right fibrous trigone244(or left fibrous trigone242if the anchoring began at the right trigone). Alternatively, the last anchor is not deployed in the vicinity of a trigone, but is instead deployed elsewhere in a vicinity of the mitral valve, such as in a vicinity of the anterior or posterior commissure. Then, system10is removed, leaving behind guide member86. A rotation tool (not shown) is then threaded over and advanced along guide member86toward adjusting mechanism40and is used to rotate the spool of adjusting mechanism40, in order to tighten structure222by adjusting a degree of tension of contracting member226, as is described hereinbelow with reference toFIG.17. Once the desired level of adjustment of structure222is achieved (e.g., by monitoring the extent of regurgitation of the valve under echocardiographic and/or fluoroscopic guidance), the rotation tool and guide member86are removed from the heart. For some applications, a distal portion of guide member86may be left within the heart of the patient and the proximal end may be accessible outside the body, e.g., using a port. For such applications, adjusting mechanism40may be accessed at a later stage following initial implantation and adjustment of ring structure222. As shown, sleeve26of ring structure222comprises a plurality of radiopaque markers25, which are positioned along the sleeve at respective longitudinal sites to indicate anchor-designated target areas. The markers may provide an indication in a radiographic image (such as a fluoroscopy image) of how much of sleeve26has been deployed at any given point during an implantation procedure, in order to enable setting a desired distance between anchors32along the sleeve26. Alternatively, annuloplasty ring structure222is implanted by right or left thoracotomy, mutatis mutandis. For some applications of the present invention, following implantation of sleeve26along the annulus, an excess portion of sleeve26may be present at the proximal portion of sleeve. In such applications, following removal of manipulator61, a cutting tool (not shown) may be advanced within channel18and into the lumen of the excess portions of sleeve26(e.g., from within sleeve26) in order to cut the sleeve proximal to the proximal-most-deployed anchor32. Reference is made toFIG.15. For some applications of the present invention, annuloplasty ring structure222is used to treat an atrioventricular valve other than the mitral valve, i.e., tricuspid valve231, using system10in a similar method as described hereinabove with reference toFIGS.14A-I, in accordance with some applications of the present invention. For these applications, ring structure222and other components of system10described hereinabove as being placed in the left atrium are instead placed in the right atrium220.FIG.15shows accessing right atrium220through superior vena cava225by way of illustration and not limitation. Components of system10may be advanced into the right atrium through inferior vena cava223. Although annuloplasty ring structure222is described hereinabove as being placed in an atrium, for some application the ring is instead placed in either the left or right ventricle. Accordingly, it is noted that, annuloplasty ring structure222and other components of system10described hereinabove and methods shown in the application can be used on any cardiac valve (e.g., the mitral, tricuspid, aortic, and/or pulmonary). Reference is made toFIGS.16A-B, which are schematic illustrations of a multiple-anchor deployment system110which is configured to be used in combination with anchor driver36, as described hereinabove with reference toFIGS.1and2, in accordance with an application of the present invention. In this configuration, an anchor restraining mechanism70typically comprises one or more distal tabs72for temporarily restraining the distal-most anchor32currently stored in an anchor storage area76from advancing in the distal direction. The distal tabs may be cut out of a flexible outer tube34, as shown, or they may be provided as separate elements coupled to the outer tube. The distal tabs apply a force in a radially-inward direction against a distal portion of anchor32, gently squeezing against the distal portion. The force is sufficient to prevent distal motion of distal-most anchor32and the other anchors currently stored in anchor storage area76, which otherwise would be advanced distally by passive force applied thereto by other anchors in storage area76. However, the radially-inward force is insufficient to prevent distal advancement of distal-most anchor32when the anchor is engaged and advanced distally by rotating deployment element38, as described herein. For some applications, anchor restraining mechanism70comprises two distal tabs72, typically on opposite sides of the outer tube (typically axially aligned with each other), as shown, while for other applications, the anchor restraining mechanism comprises exactly one distal tab, or three or more distal tabs, e.g., three or four distal tabs (typically axially aligned with one another). Typically, for applications in which system10comprises multiple-anchor deployment system110, outer tube34is disposed between anchor driver36and channel18(shown inFIGS.1-2). Typically, a distal anchor manipulation area75is provided, which is typically flexible and steerable. Typically, only one anchor at a time is deployed through anchor manipulation area75and into the tissue of the patient, such that no more than exactly one anchor is within anchor manipulation area75at any given time. As a result, anchor manipulation area75retains its flexibility. Because the anchors are typically rigid, when more than one of the anchors are longitudinally contiguously positioned within storage area76, the area of the tool in which the anchors are positioned becomes fairly stiff, substantially losing the flexibility it would otherwise have. Thus, while anchor storage area76is fairly rigid, anchor manipulation area75remains flexible because it only contains exactly one anchor at a given time. The stiffness of the area of the tool in which the anchors are positioned also may enable the user to better control the exact location of distal-most anchor32currently stored in anchor storage area76. Anchor restraining mechanism70comprises a plurality of sets73of proximal tabs74, labeled73A,73B,73C,73D, and73E inFIGS.16A-B. Each set of proximal tabs74engages exactly one anchor32. For example, the distal ends of proximal tabs74of set73A engage the proximal end of the tool-engaging head of distal-most anchor32, and the distal ends of proximal tabs74of set73B engage the proximal end of the tool-engaging head of second-to-distal-most anchor32. Sets73thus provide respective anchor storage locations. Therefore, the anchor restraining mechanism comprises a number of sets73greater than or equal to the number of anchors32initially stored in anchor storage area76. For some applications, anchor restraining mechanism70comprises between 6 and 20 sets73, such as between 8 and 16 sets73. For some applications, each of sets73comprises two proximal tabs74, typically on opposite sides of the outer tube (typically axially aligned with each other), as shown, while for other applications, each of the sets comprises exactly one proximal tab, or three or more proximal tabs, e.g., three or four proximal tabs (typically axially aligned with one another). For some applications, each of sets73(except the proximal-most set73) additionally functions as a distal tab72for the anchor proximally adjacent to the set. For example, set73A, in addition to engaging distal-most anchor32A, also prevents distal motion of second-to-distal-most anchor32. Each of anchors32remains in place in its initial, respective anchor storage location in anchor storage area76, until the anchor is individually advanced out of anchor storage area76during deployment by deployment manipulator61. The anchor to be deployed is the distal-most one of the anchors stored in anchor storage area76, and is initially restrained in the anchor storage area by anchor restraining mechanism70. Anchor driver36is advanced in a distal direction until rotating deployment element38directly engages tool-engaging head62of the anchor (by “directly engages,” it is meant that rotating deployment element38comes in direct contact with the anchor, rather than indirect contact via one or more of the other anchors). Rotating deployment element38assumes its radially-expanded state, as described hereinbelow with reference toFIGS.12A and13A, to enable this engagement. In order to deploy anchors32, anchor driver36is advanced in the distal direction, until rotating deployment element38brings the anchor into contact with the tissue of the patient at a first site. For example, the tissue may be cardiac tissue. Typically, deployment manipulator61is configured such that, as rotating deployment element38advances each of the anchors in the distal direction, only the single anchor32currently being advanced is within distal anchor manipulation area75. Rotating deployment element38is rotated, in order to screw helical tissue coupling element60of the anchor into the tissue. For some applications, rotating deployment element38is rotated by rotating anchor driver36. For other applications, rotating deployment element38is rotated by rotating an additional rotation shaft provided within anchor driver36, which additional shaft is coupled to rotating deployment element38. Rotation of rotating deployment element38typically rotates only the anchor currently engaged by the deployment element, while the other anchors still stored in the storage area typically are not rotated. For applications in which system10comprises multiple-anchor deployment system110, deployment manipulator61comprises anchor driver36, deployment element38, and outer tube34. Typically, anchor32is deployed from the distal end of outer tube34of tool30into cardiac tissue in a direction parallel to a central longitudinal axis of outer tube34through the distal end of tube34, and/or parallel to central longitudinal axis of tissue coupling element60of anchor32, as described herein. The evacuation of the distal-most anchor from anchor restraining mechanism70frees up the anchor restraining mechanism for the next distal-most anchor remaining in anchor storage area76. After the distal-most anchor has been coupled to the tissue, rotating deployment element38is disengaged from the anchor by withdrawing the rotating deployment element in a proximal direction. As the rotating deployment element passes through the next anchor in the proximal direction (i.e., the anchor positioned at set73A), the rotating deployment element is squeezed by the engaging opening of tool-engaging head62of the next anchor, causing the rotating deployment element to assume its radially-compressed state, as described hereinbelow with reference toFIGS.12B and13B. Deployment element38is repositioned to deploy a second anchor32at a second site of the tissue, different from the first site. Such repositioning is typically accomplished using the steering functionality of catheters12and14, as described hereinabove. The steps of the deployment method are repeated, until as many anchors32as desired have been deployed, at respective sites, e.g., a first site, a second site, a third site, a fourth site, etc. Reference is now made toFIG.17, which is a schematic illustration showing a relationship among individual components of adjusting mechanism40, in accordance with some applications of the present invention. Adjusting mechanism40is shown as comprising spool housing44which defines an upper surface160and a lower surface176defining a recessed portion (as described with regard to recess142with reference toFIG.3). A spool246is configured to be disposed within housing44and defines an upper surface178, a lower surface180, and a cylindrical body portion disposed vertically between surfaces178and180. The cylindrical body portion of spool246is shaped to define a channel which extends from a first opening at upper surface178to a second opening at lower surface180. Typically, spool246is configured to adjust a perimeter of annuloplasty ring structure222by adjusting a degree of tension of contracting member226that is coupled at a first portion of member226to spool246. As described hereinabove, contracting member226extends along sleeve26and a second portion of contracting member226(i.e., a free end portion) is coupled to a portion of sleeve26such that upon rotation of the spool in a first rotational direction, the portion of sleeve26is pulled toward adjusting mechanism40in order to contract annuloplasty ring structure222. It is to be noted that the contraction of structure222is reversible. That is, rotating spool246in a second rotational direction that opposes the first rotational direction used to contract the annuloplasty structure, unwinds a portion of contracting member226from around spool246. Unwinding the portion of contracting member226from around spool246thus feeds the portion of contracting member226back into a lumen of sleeve26of structure222, thereby slackening the remaining portion of contracting member226that is disposed within the lumen sleeve26. Responsively, the annuloplasty structure gradually relaxes and expands (i.e., with respect to its contracted state prior to the unwinding). Lower surface180of spool246is shaped to define one or more (e.g., a plurality, as shown) of recesses182which define structural barrier portions188of lower surface180. It is to be noted that any suitable number of recesses182may be provided, e.g., between 1 and 10 recesses. For some applications, but not necessarily, recesses182are provided circumferentially with respect to lower surface180of spool246. Typically, spool246comprises a locking mechanism145. For some applications, locking mechanism145is coupled, e.g., welded, at least in part to a lower surface of spool housing44. Typically, locking mechanism145defines a mechanical element having a planar surface that defines slits1158. The surface of locking mechanism145may also be curved, and not planar. Locking mechanism145is shaped to provide a protrusion156which projects out of a plane defined by the planar surface of the mechanical element. The slits define a depressible portion1128of locking mechanism145that is disposed in communication with and extends toward protrusion156. In a resting state of locking mechanism145(i.e., a locked state of spool246), protrusion156is disposed within a recess182of spool246. Additionally, in the locked state of spool246, protrusion156is disposed within the recess of housing44. Depressible portion1128is aligned with the opening at lower surface180of spool246and is moveable in response to a force applied thereto by a distal force applicator88that extends in a distal direction from a distal portion of longitudinal guide member86. That is, distal force applicator88is configured to be disposed within the channel of spool246. A distal end of applicator88is configured to push on depressible portion1128in order to move depressible portion1128downward so as to disengage protrusion156from within a recess182of spool and to unlock spool246from locking mechanism145. It is to be noted that the planar, mechanical element of locking mechanism145is shown by way of illustration and not limitation and that any suitable mechanical element having or lacking a planar surface but shaped to define at least one protrusion may be used together with locking mechanism145. A cap1044is provided that is shaped to define a planar surface and an annular wall having an upper surface244that is coupled to, e.g., welded to, lower surface176of spool housing44. The annular wall of cap1044is shaped to define a recessed portion1144of cap1044that is in alignment with the recessed portion of spool housing44. Locking mechanism145is disposed between lower surface180of spool246and the planar surface of cap1044. In an unlocked state of adjusting mechanism40, protrusion156of locking mechanism145is disposed within recessed portion1144of cap1044. In the unlocked state, force applicator88extends through spool246and pushes against depressible portion1128of locking mechanism145. The depressible portion is thus pressed downward, freeing protrusion156from within a recess182defined by structural barrier portions188of the lower portion of spool246. Additionally, protrusion156is freed from within the recessed portion of spool housing44. As a result, adjusting mechanism40is unlocked, and spool246may be rotated with respect to spool housing44. Cap1044functions to restrict distal pushing of depressible portion1128beyond a desired distance so as to inhibit deformation of locking mechanism145. For applications in which adjusting mechanism40is implanted in heart tissue, cap1044also provides an interface between adjusting mechanism40and the heart tissue. This prevents interference of heart tissue on adjusting mechanism40during the locking and unlocking thereof. Additionally, cap1044prevents damage to heart tissue by depressible portion1128as it is pushed downward. Spool246is shaped to define a rotation-facilitating head170, or a driving interface. A rotation tool (not shown) is configured to slide distally along guide member86to engage head170of spool246. The rotation tool is configured to rotate spool246by applying rotational force to head170. A friction-reducing ring172is disposed between upper surface178of spool246and the inner surface of upper surface160of spool housing44. For some applications, as described herein, guide member86is not coupled to spool246. For such applications the rotation tool used to rotate spool246may be shaped to provide a distal force applicator (similar to distal force applicator88) configured to unlock spool246from locking mechanism145. During the unlocked state, spool246may be bidirectionally rotated. Following rotation of spool246such that contracting member226is pulled sufficiently to adjust the degree of tension of contracting member226so as treat tissue of the ventricle as described herein, spool246is then locked in place so as to restrict rotation of spool246. Force applicator88is removed from within the channel of spool246, and thereby, depressible portion1128returns to its resting state. As depressible portion1128returns to its resting state, protrusion156is introduced within one of the plurality of recesses182of lower surface180of spool246and within the recess of housing44, and thereby restricts rotation of spool246. Spool246is shaped so as to provide a hole242or other coupling mechanism for coupling a first portion of contracting member226to spool246, and thereby to adjusting mechanism40. Reference is now made toFIGS.18A-D, which are schematic illustrations of an indicator and locking system1700comprising (1) a protrusion1724coupled to guide-catheter handle24, and (2) a housing1702, or cradle, shaped to define a groove1704configured to receive protrusion1724, in accordance with some applications of the present invention. System1700is configured to provide an indication (i.e., to act as an indicator), at a proximal location outside the body of the patient, of the coupling of first and second couplings152and154of outer catheter12and guide catheter14, respectively (i.e., when engager54is received within slit52at the distal end portions of catheters14and12, respectively). Additionally, system1700is configured to rotationally lock catheter12to catheter14, as is described hereinbelow. Housing1702comprises a handle portion that is coupled to a proximal end of catheter12. As shown, groove1704is shaped to define a curved groove along a lateral portion of housing1702. Groove1704extends between 45 and 135 rotational degrees, e.g., 90 degrees, as shown. As described hereinabove with reference toFIGS.1-2, proximal handle portion101is supported by a stand having support legs91(i.e., first leg91aand second leg91b, as shown inFIGS.18A-D). As shown inFIGS.18A-D, first leg91a(which is configured to receive guide-catheter handle24) provides housing1702. As described hereinabove, guide catheter14is first advanced within the lumen of outer catheter12when the physician places the distal end of catheter14within the lumen of catheter12(via outer-catheter handle22) and advances handle24(coupled to the proximal end of catheter14) toward handle22, as indicated by the arrow inFIG.18A. As described hereinabove with reference toFIGS.3A-B, since the lumen of catheter12is free from any protrusions or recessed portions, and since engager54is depressible by tab56, catheter14is configured to enter the lumen of catheter12in any rotational configuration thereof. As handle24is advanced toward handle22, protrusion1724of handle24advances toward groove1704. Groove1704is shaped to provide a protrusion-access location1706and a protrusion-locking location1708, which locations are typically but not necessarily spaced 90 degrees apart. Protrusion-locking location1708is shaped to provide a depressible locking element1710which comprises a depressible pin to lock protrusion1724in place, as is described hereinbelow. As shown inFIG.18B, when handle24has been pushed distally toward handle22, protrusion1724advances toward groove1704in order to engage protrusion-access location1706thereof. Depending on the rotational orientation of handle24with respect to handle22, the physician may need to rotate handle24to bring protrusion1724in alignment with protrusion-access location1706of groove1704. Once protrusion1724is in alignment with protrusion-access location1706, handle24is further pushed distally in order to engage protrusion1724with protrusion-access location1706of groove1704. Once protrusion1724is located within protrusion-access location1706of groove1704, engager54is disposed in proximity with slit52(e.g., at the longitudinal site at which coupling152is disposed). As shown in the enlarged image at the distal end portion of system10and in section A-A, when protrusion1724is located within protrusion-access location1706of groove1704, engager54of catheter14is rotationally offset with respect to slit52of catheter12by generally the same rotational degree by which protrusion-access location1706and protrusion-locking location1708are rotationally spaced (e.g., 90 degrees). FIG.18Cshows rotation of catheter14with respect to catheter12, in response to rotation of handle24with respect to handle22, in the direction indicated by the arrow. As handle24is rotated, protrusion1724slides within groove1704toward protrusion-locking location1708, as shown in the enlarged image of a portion of handle24. As shown in the enlarged section of the distal end portion of system10and in section A-A, as protrusion1724is being advanced toward protrusion-locking location1708, engager54is brought closer to slit52, so as to be rotationally offset with respect to slit52by fewer degrees than when protrusion1724is located at protrusion-access location1706. FIG.18Dshows system1700following the rotation of handle24so as to position protrusion1724within protrusion-locking location1708, in order to rotationally lock catheter12to catheter14. As protrusion1724advances toward location1708, protrusion1724pushes locking element1710. For some applications, locking element1710is spring-loaded, and is configured to return to a resting state (as shown inFIG.18D) in the absence of force applied thereto. Thus, once protrusion1724has advanced beyond locking element1710into protrusion-locking location1708, element1710returns to its resting state, and inhibits protrusion from returning toward protrusion-access location1706. That is, locking element1710is only depressible when protrusion1724advanced from protrusion-access location1706toward protrusion-locking location1708. Thereby, in the state shown inFIG.18D, catheters12and14are rotationally locked (1) by insertion of engager54within slit52, as shown in the enlarged section of the distal end portion of system10and in section A-A, and (2) by insertion of protrusion1724within protrusion-locking location1708, as shown in the enlarged section of the proximal portion of system10. In such a manner, groove1704, protrusion1724, and locking element1710of system1700rotationally lock catheters12and14and also prevents accidental movement of handle24with respect to handle22. System1700(e.g., groove1704and protrusion1724thereof) typically further facilitates rotational locking of catheters12and14, by acting as an indicator that provides the physician with an extracorporeal indication of the intracorporeal juxtaposition of couplings152and154(e.g., an indication of the state of locking of the couplings). For some applications of the invention, housing1702, groove1704, and protrusion1724are used in the absence of couplings152and154. Reference is now made toFIGS.19A-B, which are schematic illustrations of system10and a sleeve-deployment indicator2120, in accordance with some applications of the present invention. As described hereinabove, in order to release sleeve26from channel18, knob94is rotated while handle126is kept stationary. Such rotation keeps reference-force tube19stationary while adjusting a proximal and distal position of channel18with respect to tube19. As knob94is rotated in a first rotational direction, channel18is withdrawn proximally. Additionally, handle126is moved distally such that reference-force tube19is advanced distally to expose sleeve26from within catheter14such that it reaches the annulus and/or push a portion of sleeve26off of channel18, as channel18is withdrawn proximally. Responsively, sleeve26is advanced off of channel18and along the annulus of the valve in order to implant a subsequent anchor. In the state shown inFIG.19A, sleeve26remains within catheter14at the distal end of system10(only adjusting mechanism40is exposed), and therefore indicator2120is exposed only slightly proximally. As shown inFIG.19B, sleeve26is entirely exposed from within catheter14and has been fully advanced off of channel18(at the distal end of system10), and therefore, indicator2120is fully exposed at the proximal end of system10, indicating that sleeve26has been released and advanced entirely off of channel18(i.e., channel18has been withdrawn fully from within sleeve26). Indicator2120thereby acts as an indicator that provides the physician with an extracorporeal indication of the intracorporeal juxtaposition of channel18, tube19, and sleeve26(e.g., extracorporeal indication of the state of deployment of tube26). For some applications, indicator2120is coupled to reference-force tube19. It is to be noted that the numeric gradation shown on indicator2120inFIGS.19A-Bis purely an example, and that indicator2120may alternatively or additionally comprise other indicators including, but not limited to, numeric, non-numeric gradated, and color indicators. Reference is made toFIG.20, which is a schematic illustration of a system2600for coupling pull ring11of catheter12to pull wires29aand29b, in accordance with some applications of the invention. View A shows system2600with catheters12and14themselves removed (e.g., to illustrate the relative positioning of the pull ring and pull wires), and view B shows an exploded view of system2600. As described hereinabove (e.g., with reference toFIGS.1-2), pull ring11and pull wires29aand29bare disposed within catheter12, and configured such that adjusting a degree of tension of the pull wires (e.g., by rotating knob210) applies a force to the pull ring, which thereby steers the catheter (i.e., the distal end thereof). For example, increasing tension on pull wire29asteers the catheter toward the side on which pull wire29ais disposed. Typically, the pull wires are coupled to the pull ring by welding. For some applications, the pull ring defines two or more recesses2604in which a respective pull wire (e.g., a distal end thereof) is disposed, so as to increase the surface area of contact between the pull ring and the pull wire, and thereby to facilitate the coupling therebetween. For some applications, and as shown inFIG.20, the coupling of each pull wire to the pull ring is further facilitated (e.g., reinforced) by a respective cap2602(e.g., a cap2602aand a cap2602b). Cap2602bridges at least part of recess2604, and thereby further holds the respective pull wire within the recess. Cap2602is typically welded to the pull ring, and further typically also to the pull wire. It is hypothesized that system2600provides a strong coupling between the pull wires and the pull ring, and thereby advantageously facilitates the application of strong tensile forces by the pull wires on the pull ring, and/or a large angle of steering of the catheter. It is to be noted that system2600may be used to couple other pull wires to other pull rings, such as to couple pull wires31aand31bto pull ring13, mutatis mutandis. It is to be further noted that, althoughFIG.20shows the coupling wires being coupled to a recess in the outer surface of the pull ring, for some applications, the coupling wires are coupled to a recess in the inner surface of the pull ring. Reference is again made toFIGS.1-20. It is to be noted that following implantation of the annuloplasty structures described herein, the dimensions of the annuloplasty structures may be adjusted remotely and while the patient is not on a cardio-pulmonary bypass pump (i.e., with a beating heart), under fluoroscopy and/or echo guidance. It is to be further noted that systems10,300,320,330,110,1700and2600, and catheters12,14,340,1012and1014may be advanced using a (1) trans-septal procedure in which the system is advanced through vasculature of the patient at any suitable access location (e.g., femoral vein), (2) a minimally-invasive transapical approach (as shown inFIG.31), (3) a minimally-invasive transatrial approach (e.g., an intercostal approach), or (4) a surgical, open-heart approach. Furthermore, for some applications, the systems described herein are not steerable and may comprise straight elements (e.g., in a surgical, open-heart procedure). It is to be further noted that systems10,300,320,330,110,1700and2600, and catheters12,14,340,1012and1014for repairing a dilated annulus of the patient may be used to treat any cardiac valve of the patient, e.g., the aortic valve, the pulmonary valve, the mitral valve, and the tricuspid valve. It is to be still further noted that systems described herein for treatment of valves may be used to treat other annular muscles within the body of the patient. For example, the systems described herein may be used in order to treat a sphincter muscle within a stomach of the patient. It is further noted that the scope of the present invention includes the use systems10,300,320,330,110,1700and2600, and catheters12,14,340,1012and1014(or subcomponents thereof) and methods described hereinabove on any suitable tissue of the patient (e.g., stomach tissue, urinary tract, and prostate tissue). Additionally, the scope of the present invention includes applications described in one or more of the following:U.S. patent application Ser. No. 12/435,291 to Maisano et al., entitled, “Adjustable repair chords and spool mechanism therefor,” filed on May 4, 2009, which published as US Patent Application Publication 2010/0161041 (now U.S. Pat. No. 8,147,542);U.S. patent application Ser. No. 12/437,103 to Zipory et al., entitled, “Annuloplasty ring with intra-ring anchoring,” filed on May 7, 2009, which published as US Patent Application Publication 2010/0286767 (now U.S. Pat. No. 8,715,342);U.S. patent application Ser. No. 12/548,991 to Maisano et al., entitled, “Implantation of repair chords in the heart,” filed on Aug. 27, 2009, which published as US Patent Application Publication 2010/0161042 (now U.S. Pat. No. 8,808,368);PCT Patent Application PCT/IL2009/001209 to Cabiri et al., entitled, “Adjustable annuloplasty devices and mechanisms therefor,” filed on Dec. 22, 2009, which published as PCT Publication WO 10/073246;PCT Patent Application PCT/IL2010/000357 to Maisano et al., entitled, “Implantation of repair chords in the heart,” filed on May 4, 2010, which published as WO 10/128502; and/orPCT Patent Application PCT/IL2010/000358 to Zipory et al., entitled, “Deployment techniques for annuloplasty ring and over-wire rotation tool,” filed on May 4, 2010, which published as WO 10/128503. All of these applications are incorporated herein by reference. Techniques described herein can be practiced in combination with techniques described in one or more of these applications. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description. | 118,552 |
11857416 | While the present disclosure is subject to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. The invention should be understood to not be limited to the particular forms disclosed, but to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION The following description and accompanying figures, which describe and show certain embodiments, are made to demonstrate, in a non-limiting manner, several possible configurations of systems, platforms, devices, methods, etc. that may be used for various aspects and features of the present disclosure. In some embodiments, a delivery apparatus that can be used to deliver a medical device, tools, agents, or other therapy to a location within the body of a subject can include one or more steerable catheters and/or sheaths. Examples of procedures in which steerable catheters and sheaths are useful include cardiovascular, neurological, urological, gynecological, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and/or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like. In some embodiments, the delivery apparatus can include a steerable shaft such as a guide sheath having one or more delivery catheters coaxially disposed within the guide sheath. The delivery apparatus can comprise one or more eccentrically positioned pull wires configured to cause the steerable shaft to curve in a given direction, or to straighten. In some embodiments, the delivery apparatus can be used to deliver a medical device through the vasculature, such as to a heart of the subject. In certain configurations, a balloon-inflatable or self-expandable prosthetic heart valve can be mounted on a distal portion of the delivery apparatus. Exemplary configurations of the prosthetic heart valve and implant catheter are further disclosed in U.S. Patent Application Publication Nos. 2013/0030519, 2012/0123529, 2010/0036484, 2010/0049313, 2010/0239142, 2009/0281619, 2008/0065011, and 2007/0005131, each of which is incorporated by reference herein. In addition, it should be understood that the delivery apparatus can be used to deliver any of various other implantable devices, such as docking devices, leaflet clips, annuloplasty devices, etc. As an exemplary embodiment,FIG.1shows a catheter assembly10that includes a prosthetic heart valve80mounted on a delivery apparatus12.FIG.2shows a distal portion of the delivery apparatus12, according to one exemplary embodiment. As shown, the delivery apparatus12can include a first shaft14, a connector assembly20that is coupled to a distal end portion of the first shaft14, an outer sheath16sized to extend over the first shaft14and the connector assembly20, a second shaft18(which can also be referred to as an “inner shaft” in the illustrated embodiment) extending through the first shaft14and the connector assembly20, and a nose cone22connected to a distal end18dof the inner shaft18. A guide wire76can extend through the central lumen of the inner shaft18and the inner lumen of the nose cone22, so that the delivery apparatus12can be advanced over the guide wire76inside the patient's vasculature. The connector assembly20in the illustrated embodiment includes a first connector portion26and a second connector portion28, wherein the first connector portion26is positioned proximally relative to the second connector portion28. The first connector portion26(which can be referred to as a “proximal connector portion” in the illustrated embodiment) can be fixedly coupled to the distal end14dof the first shaft14, and the first connector portion26can be generally coaxial with the first shaft14. The second connector portion28(which can be referred to as a “distal connector portion” in the illustrated embodiment) can be coupled to the first connector portion26so as to permit limited movement of the second connector portion relative to the first connector portion. As indicated inFIG.2and described more fully below, the second connector portion28can be configured to have one or multiple degrees of freedom to move relative to the first connector portion26. For example, with respect to the first connector portion26, the second connector portion28can translate axially (in the directions indicated by double-headed arrow A) along the longitudinal axis24of the first shaft14, rotate in a plane that is transverse to the longitudinal axis24(in the directions indicated by double-headed arrow R), and/or axially tilt with respect to the longitudinal axis24(in the directions indicated by arrow T). Various combinations of degrees of these and/or other freedom of movement are possible. The delivery apparatus12can have a device retaining portion78located between the connector assembly20and the nose cone22. The device retaining portion78can be configured to accommodate an implantable medical device, such as a prosthetic heart valve80(see e.g.,FIG.1), in a radially compressed state within the outer sheath16. As described herein, the prosthetic heart valve80can be balloon inflatable, self-expandable, mechanically-expandable, and/or one or more combinations of these. As described more fully below, the outer sheath16can be configured to move axially (or longitudinally) relative to the first shaft14and the second shaft18between a first, distal position extending over the device retaining portion78and the implantable medical device for delivery through the vasculature of a patient (as shown inFIG.1) and a second, proximal position in which the distal end of the outer sheath is proximal to the device retaining portion78(as shown inFIG.2) to allow the implantable medical device to be expanded at the desired implantation site, as further described below. For example, as shown inFIGS.1and3and described more fully below, the prosthetic heart valve80can have one or more retaining arms84that engage respective attachment features of the connector assembly20. When the prosthetic heart valve80is deployed from the sheath (e.g., by sliding the outer sheath16proximally or sliding the inner shaft18distally), the retaining arms84can disengage from respective attachment features. Accordingly, the prosthetic heart valve80can be released from the device retaining portion78, and expanded to its functional size (see e.g.,FIG.3) for deployment at the target site. In some embodiments, the prosthetic heart valve80can be self-expandable such that the prosthetic heart valve80automatically expands from the radially compressed state to a radially expanded state once it is deployed from the outer sheath16. In other embodiments, the prosthetic heart valve80can be configured to be expanded by an expansion device (e.g., an inflatable balloon) or combination of expansion devices. As shown inFIG.1, the delivery apparatus12can include a handle68at a proximal end thereof. During delivery of the implantable medical device (e.g., the prosthetic heart valve80), the handle68can be maneuvered by a surgeon to advance and retract the delivery apparatus12through the patient's vasculature. In one exemplary, non-limiting embodiment illustrated inFIG.1, the handle68can include a knob or a plurality of knobs (e.g., 1, 2, 3, 4, or more knobs) for controlling different components or aspects of the delivery apparatus12. For example, in one embodiment, the proximal end16pof the outer sheath16can be operatively coupled to a first knob70, the proximal end14pof the first shaft14can be operatively coupled to a second knob72, and the proximal end18pof the inner shaft18can be operatively coupled to a knob74. The handle68can additionally or alternatively include a button or a plurality of buttons (e.g., 1, 2, 3, 4, or more buttons) for controlling different components or aspects of the delivery apparatus12. In some embodiments, operation (e.g., rotational or axial movement) of a knob or button (e.g., the first knob70) can cause the outer sheath16to slide over and retain the implantable medical device (e.g., the prosthetic heart valve80) or withdraw proximally so as to expose and release the implantable medical device. In some embodiments, operation of the first knob70can cause rotational twisting of the outer sheath16relative to the first shaft14and the inner shaft18. In some embodiments, operation (e.g., rotational or axial movement) of a knob or button (e.g., the second knob72) can cause the first shaft14to rotate about and/or slide along its longitudinal axis24. Because the distal end14dof the first shaft14is fixedly coupled to the first connector portion26, operation of the second knob72can produce limited movement (e.g., rotational and/or axial movement) of the first connector portion26relative to the second connector portion28. In some embodiments, operation (e.g., rotational or axial movement) of a knob or button (e.g., the third knob74) can cause the inner shaft18(and the nose cone) to slide longitudinally relative to the first shaft14and the outer sheath16. For example, in certain embodiments, the inner shaft18can be moved distally to move the nose cone22distally relative to the sheath16so that the implantable medical device can then be deployed from the sheath. Further details of the construction of the handle with knobs and the means for operating the handle and knobs are described in U.S. Patent Application Publication Nos. 2013/0030519, 2009/0281619, 2008/0065011, and 2007/0005131, each of which is incorporated by reference herein. Optionally, different components of the delivery apparatus12can be controlled by other actuation mechanisms (e.g., other knobs, buttons, joysticks, voice-controlled actuators, touch pads, touch screens, etc.) FIG.4shows an exemplary connector assembly20in isolation without displaying other parts of the delivery apparatus12. As shown, the connector assembly20can include the first connector portion26and the second connector portion28that is distal to the first connector portion26. The first and second connector portions26,28can be generally cylindrical in shape, or can be one or more other shapes. The first and second connector portions26,28can be rotatably coupled to each other by at least one radially extending pin30retained within at least one slot40formed in the second connector portion28. FIGS.5-6show one exemplary, non-limiting embodiment of the detailed structure of the connector assembly20. As shown, the first connector portion26can include a proximal end portion42and a distal end portion44connected by an intermediate portion46. The proximal end portion42can be fixedly coupled to the distal end portion14dof the shaft14. While various shapes are possible, in one embodiment, each portion42,44,46has a cylindrical or generally cylindrical shape but can vary in cross-sectional area (e.g., the cross-section of the intermediate portion can have a smaller area, diameter, and/or thickness than the proximal and distal end portions). In some embodiments, each portion42,44,46can have a non-cylindrical shape (e.g., the cross-sectional shape of the portion can be square, oval, hexagonal, etc.). The first connector portion26can comprise a sidewall48defining a proximal lumen50along the proximal end portion42and a distal lumen52extending through the intermediate and distal end portions44,46. The proximal lumen50can have a larger interior dimension (e.g., diameter) than the distal lumen52. To affix the shaft14to the first connector portion26, the distal end portion14dof the shaft14can extend into the proximal lumen50and can be secured in place, such as with an interference fit and/or a suitable adhesive. The second connector portion28can include a distal end portion54and a proximal end portion56. Each portion54,56can have a generally cylindrical shape. In some embodiments, each portion54,56can have a non-cylindrical shape (e.g., the cross-sectional shape of the portion can be square, oval, hexagonal, etc.). The outer surface of the distal end portion54can define a plurality of recesses32and optional bosses34extended therefrom, which form attachment features for forming a releasable connection with each of the retaining arms84of the prosthetic valve, as further described below. The second connector portion28can comprise a sidewall58defining a proximal lumen62along the proximal end portion56and a distal lumen60along the distal end portion54, wherein the proximal lumen62can have a larger interior dimension (e.g., diameter) than the distal lumen60. In the exemplary embodiment depicted inFIGS.5-6, the outer dimension of the distal end portion44of the first connector portion26is smaller than the interior dimension of the proximal lumen62of the second connector portion28such that there is a radial gap between the outer surface of the distal end portion44and the inner surface of the proximal lumen62. Accordingly, the distal end portion44of the first connector portion26can be inserted into the proximal lumen62(which can also be referred to as an “axial bore”) of the second connector portion28. The respective lumens50,52,62, and60of the first and second connector portions26,28can collectively define a central passage for the inner shaft18to extend through. In the exemplary embodiment depicted inFIG.6, two pins30′,30″ extend radially outward from the distal end portion44of the first connector portion26respectively into two slots40′,40″ formed in the proximal end portion56of the second connector portion28. In some embodiments, the pins30′,30″ can be embedded in and extend radially outward from respective recesses64′,64″ located at the distal end portion44of the first connector portion26. The recesses64′,64″, which can be formed in the sidewall48at diametrically opposed locations. The radial inner end portions of the pins30,30″ can be secured in the recesses64′,64″, such as with an adhesive and/or a frictional fit. Alternatively, the sidewall48can be without recesses64′,64″ and the pins30′,30″ can be secured to the outer surface of the sidewall48. Optionally, the pins30′,30″ can be formed as integral parts of the first connector portion26(i.e., they form a unitary piece) such that they protrude outwardly from the outer surface of the wall48without any recesses64′,64″. In the depicted embodiment, both slots40′,40″ extend through the sidewall58of the second connector portion28, and they are arranged on opposite sides of the sidewall58with respect to the longitudinal axis24. Each of the slots40′,40″ can have an arc length of less than 180 degrees. Although the exemplary embodiment described herein have two pins30in two slots40, it should be understood that any number of pins30and slots40(e.g., 1, 2, 3, 4, or more, etc.) can be used. Further, the slots40are not necessarily equally spaced circumferentially. In the embodiments shown inFIGS.4-6, the pins30′,30″ have a generally cylinder shape with a cross-sectional diameter D1. In some embodiments, the pins30′,30″ can have one or more other cross-sectional shapes (e.g., square, oval, hexagonal, etc.) with a maximum cross-sectional dimension D1. Each of the slots40′,40″, which defines an opening in the sidewall58of the second connector portion28, has a circumferential dimension (or length) L measured circumferentially and an axial dimension (or width) W measured longitudinally over the outer surface of the second connector portion28. In some embodiments, the slot40can have an oversized circumferential dimension L (i.e., L>D1) or arc length (measured in degrees) that allows limited rotation (e.g., clockwise or counter-clockwise) of the second connector portion28relative to the first connector portion26about the longitudinal axis24of the shaft14(see e.g.,FIGS.2and9). The degree of rotational movement of the second connector portion28relative to the first connector portion26can be limited by the length (L) of the slot40. In addition, the slot40can have an oversized width W (i.e., W>D1) in a direction along the longitudinal axis24that allows limited axial movement (e.g., distally or proximally) of the second connector portion28relative to the first connector portion26. The degree of axial movement of the second connector portion28relative to the first connector portion26can be limited by the width (W) of the slot40. The second connector portion28can also be configured to tilt relative to the first connector portion26about a tilt axis82(FIG.4) defined by the pins30,30″ by virtue of the arrangement of the distal end portion44of the first connector portion26with respect to the axial bore62. For example, as noted above, the axial bore62of the second connector portion28can be oversized (e.g., in cross-sectional dimension) relative to the distal end portion44of the first connector portion26(e.g., D3>D2as illustrated inFIG.6) such that there is an annular or radial gap between the adjacent surfaces of the first and second connector portions. This allows the second connector portion28to tilt about the tilt axis82(in the directions indicated by double-headed arrow T inFIG.2) wherein the tilt axis82extends through the pins30′,30″ perpendicular to the longitudinal axis24. In this manner, the pins30′,30″ function as a fulcrum, allowing the second connector portion28to tilt relative to the first connector portion26about the tilt axis82. In addition, since the width W of the slots40′,40″ is greater than the dimension D1of the pins30′,30″, the tilting motion of the second connector portion28relative to the first connector portion26is not necessarily limited to tilting motion about tilt axis82extending through the pins30′,30″. Explaining further, due to the width W being oversized relative to the dimension D1and the diameter D3being oversized relative to the diameter D2, the second connector portion28can “float” relative to the first connector portion26in three-dimensional space with movement of the second connector portion28being constrained by contact between the pins30,30″ with the sides of the slots40′,40″. As such, the second connector portion28can shift and/or tilt relative to the first connector portion such that the central axis88of the second connector portion28(FIG.8) deviates from the longitudinal axis24(i.e., movement of the second connector portion28causes the central axis88to become non-collinear with the longitudinal axis24). Accordingly, in some embodiments, the second connector portion28can tilt and/or shift in any direction relative to the first connector portion26, with movement of the second connector portion limited by the spacing or gap between the axial bore62and the distal end portion44of the first connector portion26and the spacing or gap between the pins30,30″ and the sides of the slots40′,40″. In some embodiments, as noted above, the second connector portion28can include one or more attachment features configured to form a releasable attachment with corresponding retaining arms of an implantable medical device, such as a prosthetic heart valve80, retained in the device retaining portion78(see, e.g.,FIGS.1and3). One exemplary, non-limiting embodiment of attachment features are shown inFIGS.1-6. As depicted, the second connector portion28can have a plurality of circumferentially spaced recesses32formed in the outer surface of the distal end portion54and sized to receive respective retaining arms84of the prosthetic heart valve80. Optional radially-extending bosses or pins34can be disposed within the plurality of recesses32. Each boss34can be so complimentarily shaped and sized to engage with a corresponding aperture86in a retaining arm84of the prosthetic heart valve80. Thus, by extending through the corresponding apertures86, the bosses can serve as anchors to help secure the retaining arms84within the recesses. The distal end of the second connector portion can be formed with a flange36that has a slightly larger outer diameter than the section in which the recesses32are formed. The flange36can have one or more notches38along its circumferential edge. The notches38can be in communication with the recesses32such that the retaining arms84can extend through the notches. When the prosthetic heart valve80is in a radially compressed state and attached to the delivery apparatus for delivery into a patient's body, the prosthetic heart valve80is positioned distal to the flange36within the retaining portion78. The retaining arms84extend through the notches32in the flange36so as to position the end portions of the retaining arms84within respective recesses32. The sheath16is extended over the prosthetic heart valve80to retain the retaining arms84within recesses32and to retain the prosthetic heart valve80in the radially compressed state. AlthoughFIG.4shows three recesses32(and three corresponding bosses34and notches38) that are equally spaced circumferentially around the outer surface of the second connector portion28, it should be understood that any number of recesses32(and corresponding bosses34and notches38) can be included so long as they collectively engage with the respective retaining arms84of the prosthetic heart valve80. Further, it should be understood that the attachment features can take any other forms so long as to enable releasable attachment with the implantable medical device. For example, in some embodiments, the attachment features can include a suture retention member and a slidable release member, as disclosed in US 2014/0343670, which is incorporated by reference herein. After attaching the prosthetic heart valve80to the delivery apparatus12as described above, the delivery apparatus can be inserted in the vasculature of a patient (e.g., a femoral artery and the aorta when delivering a prosthetic aortic valve in a retrograde delivery approach). Because the implantable medical device can be releasably attached to the second connector portion28, the connector assembly20in the illustrated embodiment supports limited, multiple degrees of movement of the implantable medical device retained within the outer sheath16at the device retaining portion78. As a result, the connector assembly20can function as a flexible self-tracking joint, such that when pushing the delivery apparatus12through a patient's vasculature, the distal portion of the delivery apparatus12(and the implantable medical device retained therein) can more easily track or follow the contour of the vasculature by passive deflections, for example, in one embodiment, in at least three independent degrees of freedom (by limited tilting, rotation, and/or translation) against resistance from the vascular wall. Such self-tracking capability is advantageous because it allows the physician to more easily navigate the delivery apparatus12through a challenging vascular path, and in some embodiments reducing or even eliminating the need to operate control mechanisms for steering the delivery apparatus12(e.g., actively bending the distal portion through pull wires to achieve a desired curvature). FIG.7Ashows an enlarged view of the connector assembly20and its coupling with the shaft14of the delivery apparatus12depicted inFIG.2. FIG.7Bshows an exemplary connector assembly100incorporated in the delivery apparatus12b, which can be used in place of and/or similarly to connector assembly20. The connector assembly100comprises the first and second connector portions102,104, respectively (which can be the similar to portions26,28and/or can include similar features, components, etc.). The first connector portion102is fixedly coupled to the shaft14, and the inner shaft18extends through the shaft14and the connector assembly100. In the illustrated embodiment, the second connector portion104has a proximal end portion106which has an outer diameter that is smaller than the interior diameter of a distal lumen108of the first connector portion102. Accordingly, the proximal end portion106of the second connector portion104can extend into the distal lumen108of the first connector portion102. In addition, the first and second connector portions102,104can be rotatably coupled to each other by one or more pins30extending radially outwardly from the second connector portion104and retained within respective slots40on the first connector portion102. Similarly, a distal lumen108of the first connector portion102can be oversized relative to a proximal end portion106of the second connector portion28b, and the slots40can be oversized in length and width relative to the cross-sectional dimensions of the pins30so that the second connector portion104can have a limited degree of freedom to rotate around the longitudinal axis24, and/or translate along the longitudinal axis24, and/or tilt in any direction relative to the first connector portion102. FIG.7Cshows an exemplary connector assembly200incorporated in a delivery apparatus12c, which can be used in place of and/or similarly to connector assembly20or100. The connector assembly200comprises a first connector portion206and a second connector portion208(which can be the similar to portions26,28or portions102,106, and/or can include similar features, components, etc.). The first connector portion can be fixedly coupled to a first shaft segment202, and the second connector portion can be fixedly coupled to a second shaft segment204. Similar to the connector assembly20, the first and second connector portions206,208can be rotatably coupled to each other by one or more pins30extending from the first connector portion206and retained within respective slots40on the second connector portion208. The connector assembly200can have the same configuration as the connector assembly20previously described and include similar features, except that the second connector portion208is not formed with any retaining features for retaining an implantable medical device. Instead, the connector assembly200is used as a linkage between adjacent ends of two shaft segments of a catheter assembly. Similar to the connector assembly20, a proximal lumen of the second connector portion208can be oversized relative to a distal end portion of the first connector portion206, and the slots40can be oversized in length and width relative to the cross-sectional dimensions of the pins30so that the second connector portion208can have limited rotational, axial, and/or tilting movement relative to the first connector portion206. Because the second shaft segment204is fixedly coupled to the second connector portion208, any rotational, axial, and/or tilting movement of the second connector portion208can also cause corresponding rotational, axial, and/or tilting movement of the second shaft segment204relative to the first shaft segment. In this manner, the connector assembly200increases the flexibility of the shaft assembly along its length. Although only two shaft segments are generally shown in the various embodiment of the figures, it should be understood that a shaft assembly can comprise any number of shaft segments coupled to end-to-end with respective connector assemblies (e.g., 1, 2, 3, 4, 5, 6, or more connector assemblies20,100,200connected to multiple shaft segments) to enhance the flexibility of the shaft assembly along its length. A variety of different types of connector assemblies (e.g., assemblies20,100,200) can be used in different locations along a shaft assembly as well. Each shaft segment of the multi-segment hinged shaft assembly can have a limited degree of rotational, axial, and/or tilting movement relative to an attached connector assembly and an adjacent shaft segment. In one implementation, connector assemblies can be used to interconnect relatively short, non-flexible shaft segments, such as metal shaft segments, to form a shaft assembly with a high degree of flexibility. InFIGS.7A-7C, the pins extend radially outwardly and are retained in respective outer slots. For example, inFIG.7A(and similarly inFIG.7C), because the distal end portion44of the first connector portion26is inserted into the proximal lumen62of the second connector portion28, the slots40retaining the pins30are positioned exterior to the distal end portion44from which the pins30extend radially outward. InFIG.7B, because the proximal end portion106of the second connector portion104is inserted into the distal lumen108of the first connector portion102, the slots40retaining the pins30are also positioned exterior to the proximal end portion106from which the pins30extend radially outward. Although not shown, it should be understood that the pin-in-slot configuration can be structured differently such that the pins can extend inwardly and are retained in respective inner slots. For example, the connector assembly can have an inner portion inserted into the central lumen of an outer portion, and the pins can extend radially inward from the outer portion and be retained within corresponding inner slots located on the inner portion. The inner portion can be part of the first connector portion and the outer portion can be part of the second connector portion. Optionally, the inner portion can be part of the second connector portion and the outer portion can be part of the first connector portion. Similarly, the inner slots can be oversized relative to the inwardly extending pins so that the second connector portion can have limited rotational, axial, and/or tilting movement relative to the first connector portion. General Considerations The disclosed embodiments can be adapted to deliver and implant prosthetic devices in any of the native annuluses/valves of the heart (e.g., the pulmonary, mitral, and tricuspid annuluses/valves), and can be used with any of various delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, transvascular, etc.) or other organs. For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosed technology. Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art. As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “connected” generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. Directions and other relative references (e.g., inner, outer, upward, downward, interior, exterior, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inside,” “outside,”, “top,” “down,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same. As used herein, “and/or” means “and” or “or”, as well as “and” and “or”. In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims and encompasses all that falls within the scope of these claims. | 34,072 |
11857417 | DETAILED DESCRIPTION OF EMBODIMENTS Reference is made toFIGS.1A-C, which are schematic illustrations showing perspective views of a leaflet support20, in accordance with some applications of the invention. As shown, leaflet support20comprises a ring-shaped frame30that defines an array of adjoining cells32. The ring formed by frame30extends radially outward from an aperture34that is defined by an inner ring-perimeter26, to an outer ring-perimeter28. For some applications, aperture34is central with respect to leaflet support20(e.g., with respect to outer ring-perimeter28of frame30). That is, for such applications, a central axis d18of leaflet support20passes through aperture34(e.g., through a center point d35of the aperture). For some applications, an annulus-fitting zone33of leaflet support20is concavely shaped. For example, and as shown inFIG.1C, annulus-fitting zone33may be shaped as a spherical segment. Alternatively or in addition, annulus-fitting zone33may be frustoconical. Typically, each cell32, and therefore frame30as a whole, is configured to facilitate passage of blood therethrough, such that when leaflet support20is implanted within a heart90of a subject, blood may flow between an upstream side22and a downstream side24of the frame. For some applications, and as shown, each cell32is defined by frame30, without other elements within the cell. It is hypothesized by the inventors that cells32being defined solely by the frame: (i) facilitates passage of blood through the cells, and (ii) reduces the amount of material required to define the cells. For some applications, and as shown, adjoining cells32form a series of geometric patterns. For some such applications, and as shown, the series of geometric patterns is repeated circumferentially about frame30. It is hypothesized by the inventors that cells32forming a repeating series of geometric patterns: (i) facilitates distribution of external forces applied to frame30, among the cells, and (ii) increases likelihood that different portions of frame30will react similarly to the application of external forces. Leaflet support20further comprises a barrier36that is impermeable to blood flow. For some applications, and as shown, barrier36is a flexible sheet. For example, barrier36may comprise a sheet (e.g., a fabric and/or a polymer, such as a polymer fabric). Alternatively, barrier36may comprise an ex-vivo-derived or in-vitro-derived tissue, such as pericardium. Barrier36is coupled (e.g., fixedly coupled, such as by stitching or by gluing) to frame30such that the barrier obstructs blood flow through aperture34. For some applications, barrier36is planar (e.g., disc-shaped). For example, and as shown inFIGS.1A-1B, barrier36may be shaped as a circular disc. Alternatively, barrier36may be shaped as an oval disc. Alternatively still, barrier36may be shaped as a “D”-shaped disc. For some applications, and as shown, barrier36is centrally located with respect to leaflet support20. That is, central axis d18of the support passes through barrier36. For some such applications, and as shown, central axis d18passes through a center point d37of barrier36. For some applications, and as shown, aperture34is centrally located with respect to leaflet support20. That is, central axis d18of the support passes through aperture34. For some such applications, and as shown, central axis d18passes through a center point d35of aperture34. For example, central axis d18may pass through both center point d35of aperture34, as well as center point d37of barrier36. Typically, barrier36and aperture34at least partially overlap, e.g., such that barrier36covers at least 10 percent (e.g., at least 20 percent, e.g., at least 30 percent, e.g., at least 40 percent, e.g., at least 50 percent, e.g., at least 60 percent, e.g., at least 70 percent, e.g., at least 80 percent, e.g., at least 90 percent) and/or up to 100 percent (e.g., up to 90 percent, e.g., up to 80 percent, e.g., up to 70 percent, e.g., up to 60 percent, e.g., up to 50 percent, e.g., up to 40 percent, e.g., up to 30 percent, e.g., up to 20 percent) of the cross-sectional area of the aperture. For example, barrier36may cover the aperture entirely. For some applications, barrier36covers an area greater than aperture area. For example, barrier36may be larger than the aperture, and/or may extend radially outward further than an inner ring-perimeter26, e.g., such that the barrier covers at least some of frame30(e.g., covering at least a portion of at least one of the cells defined by the frame). For some applications, and as shown, barrier36does not cover cells32of frame30, e.g., such that barrier36is disposed only radially inward from inner ring-perimeter26. For example, and as shown in the inset ofFIG.1B, barrier36may be coupled to frame30via fasteners38. Leaflet support20further comprises a plurality of ventricular legs40(e.g., three legs, as shown). For some applications, each ventricular leg40is coupled to frame30(e.g., at inner ring-perimeter26). For some such applications, ventricular legs40and barrier36are each coupled to the frame at a shared site of frame30. For some applications and as shown, legs40are connected to frame30via a connecting portion44disposed downstream of aperture34. Typically for such applications, connecting portion44also connects each leg40to the other legs. For some applications, and as shown inFIG.1B, connecting portion44and barrier36are each coupled to frame30at a shared site of the frame (e.g., at inner ring-perimeter26). For some applications, and as shown, legs40are spaced evenly from central axis d18. That is, legs40are positioned to be radially equidistant from central axis d18. For some applications, and as shown, legs40are arranged evenly about central axis d18. For some applications, radial arrangement of legs40around central axis d18is determined responsively to anatomy of a given native valve (e.g., a tricuspid valve60or a mitral valve74) at which support20is to be implanted. For some such applications, two legs40may be disposed radially closer to each other than they are to a third leg. For example, legs40may be arranged such that two legs may be positioned under a posterior leaflet63of mitral valve74, and the third leg may be positioned under an anterior leaflet61of the mitral valve. Alternatively, legs40may be arranged such that each respective leg may be positioned under an anterior leaflet, posterior leaflet or a septal leaflet of tricuspid valve60. Typically, each leg40extends (e.g., from connecting portion44) both radially outward, and upstream toward frame30. For some applications, and as shown, end-portions41of legs40do not reach frame30. Typically for such applications, each respective end-portion41faces frame30(e.g., from a position that is (i) radially outward of barrier36and/or inner ring-perimeter26; and (ii) downstream of frame30. Reference is made toFIG.2, which includes schematic illustrations showing leaflet support20in an expanded state, and in a compressed state suitable for transluminal delivery, in accordance with some applications of the invention. For some applications, leaflet support20(e.g., frame30and/or legs40thereof) comprises an elastic shape-memory material (e.g., Nitinol), such that upon removal of external constraining forces, leaflet support20automatically expands into the expanded state. As shown in upper frame ofFIG.2, while support20is in the expanded state, the ring formed by frame30typically extends radially outward (e.g., from connecting portion44). For some applications, and as shown, while leaflet support20is in the compressed state (lower frame ofFIG.2), ventricular legs40extend downstream from connecting portion44, and/or frame30assumes a tubular shape extending upstream from the connecting portion. For example, cells32may become narrower as frame30assumes the tubular shape. For some such applications, boundaries of at least some of cells32may come into contact with each other as frame30assumes the tubular shape. For some applications in which frame30assumes a tubular shape while leaflet support20is compressed into the compressed state, frame30assumes the tubular shape around barrier36, such that the barrier is disposed within a lumen defined by the tubular shape. Reference is made toFIG.3, which is a schematic illustration showing system10comprising leaflet support20and delivery tool80, in accordance with some applications of the invention. As shown,FIG.3shows leaflet support20, in the compressed state, disposed within delivery tool80for transluminal (e.g., transfemoral) delivery to heart90. Reference is made toFIGS.4A-F, which are schematic illustrations showing leaflet support20being implanted at tricuspid valve60of heart90, in accordance with some applications of the invention. Particularly, leaflet support20is shown expanding into the expanded state as it is exposed from delivery tool80. Illustrating implantation of leaflet support20at tricuspid valve60is not meant to exclude implantation of leaflet support20at other native valves (e.g., a mitral valve74) of heart90, mutatismutandis. FIG.4Ashows delivery tool80having been advanced via inferior vena cava66, through right atrium70to right ventricle68. As shown inFIG.4B, delivery tool80has begun to be retracted over leaflet support20such that end-portions41of ventricular legs40are exposed from the tool.FIG.4Cshows delivery tool80having been further retracted over leaflet support20, such that ventricular legs40are further exposed from the tool. As described hereinabove, shape-memory of ventricular legs40causes the legs to extend radially outward. Accordingly,FIG.4Dshows ventricular legs40having extended further radially outward, as delivery tool80is further retracted, exposing connecting portion44. Since a frame30is still disposed within tool80, connecting portion44typically remains at least compressed, as the frame is exposed from the tool (FIG.4E). As shown inFIG.4F, leaflet support20is deployed such that frame30is disposed upstream of annulus48of tricuspid valve60. As shown, frame30(e.g., annulus-fitting zone33thereof) is placed against annulus48such that tissue of the annulus supports leaflet support20. For some applications, and as shown, while frame30is supported by tissue of annulus48, ventricular legs40contact valvular tissue on the ventricular side of tricuspid valve60. Reference is made toFIG.5, which includes schematic illustrations showing leaflet support20implanted at tricuspid valve60, in accordance with some applications of the invention. The left pane ofFIG.5shows tricuspid valve60during ventricular systole, and the right pane ofFIG.5shows the tricuspid valve during ventricular diastole. As shown, leaflet support20is typically sized such that frame30fits annulus48of tricuspid valve60(e.g., such that frame30(e.g., annulus-fitting zone33thereof) can be placed against the annulus). For example, a greatest width (e.g., a greatest diameter) of the ring formed by frame30(measured transverse to a central axis d18of support20) may be greater than 20 mm (e.g., greater than 30 mm, e.g., greater than 40 mm, e.g., greater than 50 mm, e.g., greater than 60 mm, e.g., greater than 70 mm, e.g., greater than 80 mm, e.g., greater than 90 mm) and/or less than 100 mm (e.g., less than 90 mm, e.g., less than 80 mm, e.g., less than 70 mm, e.g., less than 60 mm, e.g., less than 50 mm, e.g., less than 40 mm, e.g., less than 30 mm). Further, a greatest width of support20as a whole (measured transverse to axis d18) may be greater than 20 mm (e.g., greater than 30 mm, e.g., greater than 40 mm, e.g., greater than 50 mm, e.g., greater than 60 mm, e.g., greater than 70 mm, e.g., greater than 80 mm, e.g., greater than 90 mm) and/or less than 100 mm (e.g., less than 90 mm, e.g., less than 80 mm, e.g., less than 70 mm, e.g., less than 60 mm, e.g., less than 50 mm, e.g., less than 40 mm, e.g., less than 30 mm). It is hypothesized by the inventors that implantation of leaflet support20at tricuspid valve60may facilitate treatment of different pathological processes effecting heart90. For example, in some cases, one or more of the native leaflets may translate or “flail” from right ventricle68into right atrium70(e.g., during ventricular systole). It is hypothesized by the inventors that upon implantation of leaflet support20at the native valve, barrier36and/or frame30may be disposed such that they obstruct flailing of the native leaflets. In some cases, the subject may experience retrograde blood flow, or “regurgitation” from a ventricle to an atrium of the heart (e.g., during ventricular systole). It is therefore further hypothesized by the inventors that upon implantation of leaflet support20at the native valve, barrier36obstruct regurgitation. The right pane ofFIG.5shows the native leaflets having deflected downstream as heart90cycles from ventricular systole to ventricular diastole. As shown, leaflet support20typically affords the native leaflets a range of motion in which to deflect during the cardiac cycle. Arrows indicate antegrade blood flow from right atrium70on upstream side22of support20to right ventricle68on downstream side24of the ring. Since barrier36typically obstructs blood flow through aperture34, arrows indicate flow of blood via cells32, radially outward of the barrier. Reference is made toFIGS.6A-B, which are schematic illustrations showing a leaflet support20′, in accordance with some applications of the invention. As shown, leaflet support20′ is generally similar to leaflet support20. Accordingly, components bearing identical reference numerals are typically interchangeable between leaflet support20′ and leaflet support20. Leaflet support20′ comprises a ring-shaped frame30′ that defines an array of adjoining cells32′. Frame30′ is typically similar to frame30, except where noted. Leaflet support20′ further comprises a barrier36′ that is impermeable to blood flow. Barrier36′ is typically similar to barrier36, except where noted. One difference between leaflet support20′ and leaflet support20lies in that barrier36′ is offset with respect to frame30′ (e.g., with respect to an outer ring-perimeter28′ of the frame). That is, a central axis d18′ of support20′ does not pass through a center point d37′ of barrier36′. For some applications, and as shown inFIG.6A, central axis d18′ nonetheless passes through barrier36′. For some applications, and as shown, barrier36covers a portion of frame30(e.g., at least a portion of at least one cell32′), such that the barrier obstructs blood flow through the portion of the frame. For some such applications, and as shown, barrier36′ is coupled to frame30′ via a plurality of ring struts31′ that extend from at least some of cells32′. In this way, barrier36′ is disposed off-center with respect to frame30′. Alternatively or in addition, the shape or number of cells32′ defining frame30′ may be altered, relative to frame30, thereby facilitating coupling barrier36′ off of center with respect to frame30′. It is hypothesized by the inventors that the offset barrier36′ of leaflet support20′ may advantageously fit certain native valves (e.g., mitral valve74, as shown). That is, in some cases, a site of leaflet flailing and/or regurgitation may be offset with respect to annulus48of the native valve. Therefore, in some such cases, offset leaflet support20′ may be advantageously implanted at the native valve, such that barrier36′ will be favorably positioned to block the flailing and/or regurgitation. For example, it may be desirable for two legs40′ to be disposed radially closer to each other than they are to a third leg, as described hereinabove in reference toFIGS.1A-C, in order to facilitate positioning barrier36favorably for blocking the flailing and/or regurgitation. FIG.6showing support20′ implanted at mitral valve74is not intended to exclude cases in which non-offset leaflet support20may be advantageously implanted at mitral valve74, or wherein offset leaflet support20′ may be advantageously implanted at tricuspid valve60. Reference is made toFIGS.7A-F, which are schematic illustrations showing use of a system110comprising a barrier-delivery tool150and a leaflet support120, in accordance with some applications of the invention. As shown, leaflet support120is generally similar to leaflet support20′. Accordingly, components bearing identical reference numerals are typically interchangeable between leaflet support120and leaflet support20′. For some applications, and as shown, a barrier-delivery tool150may be used to couple a barrier136to frame130of support120. For some such applications, and as shown inFIG.7A, delivery tool150is also used to deploy frame130of support120at the native valve. For example, and as shown, delivery tool150may reversibly connect to a portion of frame130. It is hypothesized by the inventors that delivery tool150being reversibly connected to frame130facilitates use of the delivery tool to couple barrier136to the frame, as described hereinbelow. A difference between supports120and20′ is that while support20′ is typically provided with barrier36′ already coupled to frame30′, for some applications and as shown inFIG.7A, frame130is deployed at the heart prior to coupling barrier136to the frame. Typically for such applications, barrier136is transluminally advanced to the heart before the barrier is coupled to frame130. That is, barrier136may be coupled to frame130during deployment of the leaflet support120. For some applications, and as shown, barrier136is transluminally coupled to frame130after the frame is implanted at the native valve (e.g., while the frame remains disposed at the native valve). FIG.7Bshows barrier136being deployed from a barrier-delivery capsule154of barrier-delivery tool150. For some applications, and as shown in the inset ofFIG.7C, barrier136comprises a flexible sheet (e.g., a fabric sheet)138that is coupled to a barrier-frame135. For example, and as shown, barrier-frame135may be ring-shaped. Alternatively or in addition, barrier-frame135may be shaped to define cells, and/or radially-aligned elements. For some such applications, barrier-frame135comprises a shape-memory material. For some such applications, barrier136is constrained within barrier-delivery capsule154to a compressed width (e.g., a compressed diameter), and exposure of the barrier from capsule154causes the barrier to expand to an expanded width (e.g., an expanded diameter). In this way, expansion of the barrier to the expanded width typically causes sheet138to cover barrier-frame135such that the sheet obstructs blood flow through the barrier-frame. FIG.7Cshows barrier136having been deployed from barrier-delivery capsule154, at an intermediate step in which barrier136is still engaged by delivery tool150. During this intermediate step, extracorporeal control of delivery tool150regulates both: (i) longitudinal movement of barrier136along a central axis d116of barrier-delivery tool150, and (ii) rotation of the barrier about the central axis. In this way, delivery tool150facilitates alignment of barrier136to a desired portion of frame130. FIG.7Dshows barrier136having been rotated about central axis d116of delivery tool150. For some applications, and as shown, barrier136is offset with respect to tool150. That is, central axis d116of tool150does not pass through a center-point d137of barrier136. For some applications, and as shown, barrier136comprises a frame-fitting portion152that is dimensioned to fit (e.g., to snugly engage) a portion of frame130. For some applications, barrier136is offset with respect to frame-fitting portion152thereof. That is, frame-fitting portion152is defined at a portion of barrier136that is radially outward of center-point d137. In this way, and as shown, rotation of barrier136about frame-fitting portion152positions a greater portion of the barrier on a particular side of the frame-fitting portion. For some applications, and as shown, central axis d116and a central axis d118of support120are coaxial, such that rotation of barrier136using delivery tool150also rotates the barrier with respect to frame130. In this way, rotation of barrier136may be used to align the barrier with a desired portion of frame130, prior to coupling the barrier to the frame, which is hypothesized by the inventors to facilitate alignment of the barrier with a desired anatomical location (a location identified with leaflet flailing and/or regurgitation) of the native valve. As shown inFIGS.7D-E, barrier136is typically coupled to frame130, after the barrier is radially aligned to the desired portion of the barrier, e.g., by fitting frame-fitting portion152to frame130. For some applications, and similarly to barrier36′, barrier136is offset with respect to frame130. Typically, and as shown inFIG.7F, after barrier136is coupled to frame130, the barrier is decoupled from delivery tool150. Delivery tool150is removed from the subject, such that fully assembled support120remains at the native valve. Reference is made toFIGS.8A-C, which are schematic illustrations showing a system210comprising a leaflet support220and an adjustment tool250, in accordance with some applications of the invention. As shown, leaflet support220is generally similar to leaflet support20. Accordingly, components bearing identical reference numerals are typically interchangeable between leaflet support220and leaflet support20. Leaflet support220comprises a ring-shaped frame230that defines an array of adjoining cells232, and that is typically similar to frame30, except where noted. Leaflet support220further comprises a barrier236(e.g., comprising a flexible sheet) that is impermeable to blood flow. A difference between supports20and220is that whereas barrier36is typically fixedly coupled to frame30, barrier236is adjustably coupled to frame230(e.g., to one or more sizing struts231thereof). Typically, and as shown, barrier236is transluminally adjustable in a manner that adjusts a portion of an area of aperture234(an “aperture area”) that is covered by the barrier. For example, the portion of the aperture area covered by barrier236may be repositioned and/or resized. For some applications, and as shown, an adjustment tool250may be used to transluminally adjust the portion of the aperture area covered by barrier236. For some such applications, adjustment tool250also facilitates implantation of support220at the native valve (e.g., may be a component of a delivery tool). For some applications, barrier236comprises one or more adjustment locks264configured to facilitate engagement of the barrier by tool250.FIG.8Ashows support220having been implanted at the native valve, and adjustment tool250engaging adjustment locks264of barrier236. For some applications, and as shown, each end-portion262of a respective arm260of adjustment tool250, engages an adjustment lock264of barrier236. For some applications, adjustment tool250is extracorporeally controlled to transfer a force to barrier236(e.g., to adjustment locks264thereof) in order to change the portion of the aperture area covered by the barrier. As shown inFIG.8B, the force has caused adjustment lock264to move along sizing strut231, radially away from center-point d237of barrier236and toward outer ring-perimeter228. In response to radial movement of adjustment lock264, barrier236may stretch and/or move, thereby adjusting the portion of the aperture area covered by the barrier. For some applications, barrier236comprises an elastic material. Therefore, for some such applications, radial movement of adjustment lock264stretches barrier236such that a greater portion of the aperture area becomes covered by the barrier. Alternatively, barrier236may comprise a nonelastic material that is incapable of stretching in response to radial movement of adjustment lock264. Therefore, for some such applications, radial movement of one of the adjustment locks264causes movement of barrier236(e.g., such that the entire barrier moves radially). Alternatively still, barrier236may comprise a slightly elastic material, such that radial movement of adjustment lock264both stretches and causes movement of the barrier. It is generally desirable that the change in the portion of the aperture area covered by barrier236remain in effect, after adjustment tool250has been disengaged and removed. Therefore, support220typically comprises a locking mechanism to retain barrier236in its adjusted configuration. For example, and as shown, frame230may comprise sizing struts231(inset ofFIG.8A). For some such applications, sizing struts231are shaped to define angled protrusions235along a length of the sizing struts. For example, the protrusions may be shaped such that a greater force is required to move adjustment lock264radially outward along sizing strut231, than is required to move the lock radially inward along the sizing strut. In this way, adjustment lock264may be anticipated to remain in the radial position to which the lock was advanced by adjustment tool250, also after disengagement of the tool from the lock. As such, the portion of the aperture area covered by barrier236while tool250engages the barrier may be anticipated to be maintained, after disengagement of the tool from the barrier. FIG.8Cshows adjustment tool250having been transluminally withdrawn, such that the position of adjustment lock264, as well as the portion of the aperture area covered by barrier236, remains generally similar to that shown inFIG.8B. InFIGS.8A-C, barrier236is shown as being generally triangular in shape (e.g., a circular triangle, such as a Reuleaux triangle or a deltoid curve). While it is hypothesized by the inventors that such a triangular shape may facilitate stretching barrier236towards one or more corners of the barrier (e.g., for use with an adjustment tool250that comprises three arms260), other shapes of the barrier, and corresponding configurations of adjustment tool250, mutatismutandis, are contemplated. Reference is made toFIG.9, which is a schematic illustration showing a leaflet support320, in accordance with some applications of the invention. As shown, leaflet support320is generally similar to leaflet support20. Accordingly, components bearing identical reference numerals are typically interchangeable between leaflet support320and leaflet support20. Leaflet support320comprises a ring-shaped frame330that defines an array of adjoining cells332. Similarly to frame30, frame330extends radially outward from an aperture334that is defined by an inner ring-perimeter326, to an outer ring-perimeter328. Further similarly to leaflet support20, support320comprises a blood flow-impermeable barrier336that is coupled to frame330such that the barrier obstructs blood flow through aperture334. However, a difference between supports20and320is that support320comprises a plurality of barriers336(e.g., two barriers, such as336aand336bshown inFIG.9, or more). For some applications, each of barriers336obstructs blood flow not only through aperture334, but also through a portion of frame330. However, barriers336are typically spaced apart from each other to allow blood flow between the respective barriers and through frame330. For some applications, barriers336are offset with respect to frame330. That is, a central axis d318does not pass through respective center-points d337aor d337bof barriers336a,336b. For some such applications, and as shown, central axis d318does not pass through any portion of barriers336a,336b. For some applications, support320is provided with barriers336fixedly coupled to frame330—i.e., the position of the barriers is predetermined. Alternatively, the position of one or more of barriers336may be adjusted (e.g., relative to aperture334and frame330), e.g., according to the judgement of a clinician. For example, the respective positions of barriers336may be adjusted prior to delivery of support320to the heart, and/or after fastening frame330to the native valve (e.g., transluminally, as described hereinabove in reference toFIGS.8A-B). Reference is made toFIGS.10A-C, which are schematic illustrations showing perspective views of a leaflet support420, a leaflet support520and a leaflet support620, in accordance with some applications of the invention. Certain aspects of leaflet supports420,520,620are shared with previously described leaflet support20. Thus, components that are identically named between supports420,520,620and support20share similar features and serve similar functions as each other. Similarly to support20, supports420,520,620comprise a frame430,530,630that defines an aperture434,534,634, as well as ventricular legs440,540,640and a barrier436,536,636. Similarly to frame30of leaflet support20described hereinabove, frame430,530,630defines an array of adjoining cells432,532,632that form a ring that extends radially outward from an inner ring-perimeter426,526,626to an outer ring-perimeter428,528,628. Further similarly to frame30of support20, frame430,530,630is configured to facilitate blood flow between an upstream side422,522,622and a downstream side424,524,624of respective rings formed by each support420,520,620. Further similarly to barrier36of leaflet support20, barrier436,536,636of support420,520,620obstructs blood flow through aperture434,534,634. However, in contrast to leaflet support20, leaflet support420,520,620comprises a tubular portion442,542,642that supports the barrier. As shown, tubular portion442,542,642comprises a circumferential wall446,546,646that extends between an upstream end445and a downstream end447of the tubular portion. For some applications, a circumferential space448,548,648(e.g., that circumscribes circumferential wall446,546,646) is defined between tubular portion442,542,642and legs440,540,640. Typically for such applications, circumferential space448,548,648is both: (i) radially inward from legs440,540,640, and (ii) downstream of a downstream side424,524,624of frame430,530,630. In this way, circumferential space448,548,648is typically free of elements that would obstruct movement of leaflets of the native valve. It is hypothesized by the inventors that circumferential space448,548,648facilitates functioning of the native valve while leaflet support420,520,620is implanted at that valve, by allowing leaflets of the native valve to deflect as heart90cycles between ventricular systole and ventricular diastole. Typically for applications in which the leaflet support comprises a tubular portion, the tubular portion is positioned and sized to facilitate obstruction of blood flow through aperture, as described hereinbelow. For some applications, and as shown, tubular portion442,542,642is coupled to frame430,530,630downstream of aperture434,534,634(e.g., the tubular portion is connected to inner ring-perimeter426,526,626). For some applications, tubular portion442,542,642and aperture434,534,634are of similar width (e.g., such that a tubular area is no less than 80 percent of an aperture area, and up to 120 percent of the aperture area). For some such applications, the tubular area is equal to the aperture area. For some applications, and as shown inFIG.10A, tubular portion442,542,642is radially centered with respect to frame430,530,630. That is, circumferential wall446,546,646circumscribes central axis d418, d518, d618of leaflet support20. For some applications, leaflet support420,520,620is configured to obstruct blood flow not just through aperture434,534,634but also through tubular portion442,542,642. For some such applications, and as shown, a circumferential sleeve449,549,649is coupled to (e.g., covers) circumferential wall446,546,646. Circumferential sleeve449,549,649is typically impermeable to blood flow (e.g., the sleeve may comprise the same material as the barrier). It is hypothesized by the inventors that implanting support420,520,620at the native valve may advantageously mitigate regurgitation by circumferential sleeve449acting as a spacer against which the native leaflets may coapt against during ventricular systole. For some such applications, and as shown regarding support420, barrier436(e.g., barrier436aand barrier436b) covers both upstream end445(FIG.10B) and downstream end447(FIG.10C) of tubular portion442. Reference is made toFIGS.11-12, which are schematic illustrations showing perspective views of leaflet supports520,620, in accordance with some applications of the invention. As shown, and in contrast to support420, supports520and620each have an open end, not covered by respective barrier536,636. That is, tubular portion542of support520has an open upstream end (FIG.11), while barrier536covers downstream end547(FIG.10C). Complementarily, tubular portion642of support620has an open downstream end (FIG.12), while barrier636covers upstream end645(FIG.10B). When considering supports420,520,620in relation to support20, tubular portion442,542,642may be considered to serve as a connecting portion (e.g., similar to connecting portion44, mutatismutandis). That is, tubular portion442,542,642couples ventricular legs440,540,640to frame430,530,630, while also coupling the legs to each other. Therefore, another difference between supports420,520,620and support20lies in the respective point from which each leg440,540,640extends radially outward and upstream, toward frame430,530,630. That is, for some applications, each leg440,540,640extends outward and upstream from tubular portion442,542,642. For some such applications, each leg440,540,640extends further outward than barrier436,536,636and/or inner ring-perimeter426,526,626. In other respects, supports420,520,620are similar to support20described hereinabove. For some applications, and similarly to central axis d48of support20, central axis d418, d518, d618passes through barrier436,536,636(e.g., such that the central axis passes through a center point of the barrier). Alternatively or in addition, central axis d418, d518, d618may pass through aperture434,534,634(e.g., such that central axis d418passes through a center point of the aperture). Supports420,520,620are typically sized to fit annulus48of the native valve. For example, a greatest width (e.g., a greatest diameter) of the ring formed by frame430,530,630(measured transverse to a central axis d418, d518, d618of support420,520,620) may be greater than 20 mm (e.g., greater than 30 mm, e.g., greater than 40 mm, e.g., greater than 50 mm, e.g., greater than 60 mm, e.g., greater than 70 mm, e.g., greater than 80 mm, e.g., greater than 90 mm) and/or less than 100 mm (e.g., less than 90 mm, e.g., less than 80 mm, e.g., less than 70 mm, e.g., less than 60 mm, e.g., less than 50 mm, e.g., less than 40 mm, e.g., less than 30 mm). Further, a greatest width of support420,520,620as a whole (measured transverse to axis d418, d518, d618) may be greater than 20 mm (e.g., greater than 30 mm, e.g., greater than 40 mm, e.g., greater than 50 mm, e.g., greater than 60 mm, e.g., greater than 70 mm, e.g., greater than 80 mm, e.g., greater than 90 mm) and/or less than 100 mm (e.g., less than 90 mm, e.g., less than 80 mm, e.g., less than 70 mm, e.g., less than 60 mm, e.g., less than 50 mm, e.g., less than 40 mm, e.g., less than 30 mm). For some applications, and similarly to annulus-fitting zone33, an annulus-fitting zone433,533,633of leaflet support20is concavely shaped (e.g., frustoconical shaped or shaped as a spherical segment). Reference is made toFIGS.13-14, which are schematic illustrations showing leaflet support420,520,620implanted at tricuspid valve60, in accordance with some applications of the invention. As shown inFIG.13, support420,520,620is deployed such that frame430,530,630is disposed upstream of annulus48of tricuspid valve60. As shown, frame430,530,630(e.g., annulus-fitting zone433,533,633thereof) is placed against annulus48such that tissue of the annulus supports leaflet support420,520,620. For some applications, and as shown, while frame430,530,630is supported by tissue of annulus48, ventricular legs440,540,640contact valvular tissue on the ventricular side of tricuspid valve60. The left pane ofFIG.14shows tricuspid valve60during ventricular systole, and the right pane ofFIG.14shows the tricuspid valve during ventricular diastole. It is hypothesized by the inventors that implantation of leaflet support20at tricuspid valve60may facilitate treatment of different pathological processes effecting heart90. For example, in some cases, one or more of the native leaflets may flail or blood may regurgitate from right ventricle68into right atrium70(e.g., during ventricular systole). It is hypothesized by the inventors that upon implantation of support420,520,620at the native valve, barrier436,536,636and/or frame430,530,630may obstruct flailing and/or regurgitation. The right pane ofFIG.14shows the native leaflets having deflected downstream as heart90cycles from ventricular systole to ventricular diastole. As shown, support420,520,620typically affords the native leaflets a range of motion in which to deflect during the cardiac cycle. Arrows indicate antegrade blood flow from right atrium70on upstream side422,522,622of the ring, via cells432,532,632. Reference is made toFIGS.15A-C, which are schematic illustrations showing different perspective views of a leaflet support720, in accordance with some applications of the invention. As shown, leaflet support720is in many ways similar to leaflet support20. Accordingly, components that are identically named between leaflet support720and previously described leaflet support20typically share similar features and serve similar functions as each other. That is, leaflet support720comprises a blood-impermeable barrier736that is coupled to a frame730in a manner that obstructs blood flow through an aperture734, between an upstream side722and a downstream side724of the frame. Further similarly to as described hereinabove with reference toFIG.16regarding connecting portion44of support20, connecting portion744of leaflet support720connects each of a plurality of ventricular legs740to frame730, such that each leg extends radially outward from the connecting portion, and upstream toward the frame. However, legs740of support720may extend further upstream than do legs40of support20. For example, shape-memory of legs740of support720may be such that each leg end-portion741reaches (e.g., presses against) frame730and/or barrier736. For some applications, leg end-portion741extends upstream of at least a portion of frame730, e.g., pressing against barrier736such that the barrier bulges away from upstream side722. Another difference between leaflet support720and leaflet support20lies in the radial position of leg end-portions41,741with respect to barrier36,736. As shown inFIGS.1A-B, leg end-portions41typically extend radially outward of barrier36. However, for some applications, and as shown, barrier736and legs740extend outward to approximately the same extent (e.g., to exactly the same extent). For some such applications, barrier736extends further outward than do legs740. For some such applications, legs740extend further outward than does barrier736. Reference is made toFIGS.16-17, which are schematic illustrations showing leaflet support720implanted at tricuspid valve60, in accordance with some applications of the invention. As shown inFIG.16, support720is deployed such that frame730is disposed upstream of annulus48of tricuspid valve60. Similarly to frame30of support20described hereinabove, frame730is placed against tissue of right atrium70of heart90. However, in contrast to frame30, frame730does not comprise an annulus-fitting zone. In further contrast to frame30, frame730is typically sized to not reach annulus48when implanted at the native valve. For such applications, a greatest width (e.g., a greatest diameter) of the ring formed by frame730(measured transverse to a central axis d718of support720) is less than the greatest width of frames30,30′,130,230,330,430,530,630. For example, the greatest width of the ring may be greater than 10 mm (e.g., greater than 20 mm, e.g., greater than 30 mm, e.g., greater than 40 mm, e.g., greater than 50 mm) and/or less than 60 mm (e.g., less than 50 mm, e.g., less than 40 mm, e.g., less than 30 mm, e.g., less than 20 mm). Further, a greatest width of support720as a whole (measured transverse to axis d718) may be greater than 10 mm (e.g., greater than 20 mm, e.g., greater than 30 mm, e.g., greater than 40 mm, e.g., greater than 50 mm, e.g., greater than 60 mm, e.g., greater than 70 mm, e.g., greater than 80 mm, e.g., greater than 90 mm) and/or less than 100 mm (e.g., less than 90 mm, e.g., less than 80 mm, e.g., less than 70 mm, e.g., less than 60 mm, e.g., less than 50 mm, e.g., less than 40 mm, e.g., less than 30 mm, e.g., less than 20 mm). In further contrast to support20, support720is shown such that cusps of native leaflets61,63are captured between frame730and legs740. That is, leg end-portions741abut leaflets61,63at a greater distance from frame730than were they disposed prior to implantation (FIGS.15A-C). In this way, shape-memory of legs740may cause tissue of the native valve (e.g., cusps of native leaflets61,63) to be squeezed between the legs and frame730. It is hypothesized by the inventors that squeezing tissue of the native valve between legs740and frame730facilitates fastening support720to the native valve. Support720being fastened to the native valve by squeezing tissue between legs740and frame730stands in contrast to the manner in which supports20,420,520,620are fastened to the native valve. That is, instead of squeezing tissue of the native valve, supports20,420,520,620are typically implanted such that frame30,430,530,630abuts annulus48. Since frame30,430,530,630(e.g., annulus-fitting zone33,433,533,633thereof) is typically sized to fit annulus48of the native valve, it is hypothesized by the inventors that abutment of the frame to the annulus may be sufficient to inhibit downstream migration of supports20,420,520,620. Similarly, legs40,440,540,640of supports20,420,520,620have a span that is sufficient to inhibit upstream migration of the supports. Supports20,420,520,620therefore typically do not require immobilization or gripping of leaflets, and are therefore typically not configured to do so. The left pane ofFIG.17shows tricuspid valve60during ventricular systole, and the right pane ofFIG.17shows the tricuspid valve during ventricular diastole. It is hypothesized by the inventors that implantation of leaflet support720at tricuspid valve60may facilitate treatment of different pathological processes effecting heart90. For example, in some cases, one or more of the native leaflets may flail or blood may regurgitate from right ventricle68into right atrium70(e.g., during ventricular systole). Similarly to support20, it is hypothesized by the inventors that upon implantation of support720at the native valve, barrier736and/or frame730may obstruct flailing and/or regurgitation. Supports20,420,520, and620are hypothesized by the inventors to reduce valve regurgitation by inhibiting the native leaflets from flailing into the atrium during ventricular systole, while allowing the leaflets to deflect into the ventricle during ventricular diastole, e.g., as they would in the absence of the support. In contrast, support720is hypothesized by the inventors to reduce valve regurgitation by restraining the edges of the leaflets close to each other, so as to configure the leaflets into a multi-orifice arrangement. Therefore, support720is configured to squeeze the native leaflets between legs740and frame730of support720in order to grip the leaflets, while supports20,420,520, and620are typically not configured in this manner. The right-side frame ofFIG.17shows a portion of the native leaflets having deflected downstream during ventricular diastole, to a lesser degree than as shown in the right pane ofFIG.5. As described hereinabove, support720is configured to configure the leaflets into a multi-orifice arrangement. That is, a secondary aperture765(e.g., three secondary apertures765a,765b,765cfor a trileaflet valve such as the tricuspid valve, or two secondary apertures for a bileaflet valve, such as the mitral valve) typically open between the native leaflets, radially outward from frame730, as heart90cycles from ventricular systole to ventricular diastole. Arrows indicate antegrade blood flow from right atrium70to right ventricle68, through secondary apertures765a,765b,765c. It is hypothesized by the inventors that, for some applications, the smaller size of frame730compared with that of frames30,430,530,630may further facilitate antegrade blood flow through secondary apertures765. Reference is made toFIGS.18A-Cand20A-C, which are schematic illustrations showing perspective views of respective leaflet supports820,920, in accordance with some applications of the invention. As shown, leaflet supports820,920are each in certain ways similar to leaflet support20described hereinabove. Components that are identically named between the leaflet supports typically share similar features and serve similar functions as each other. As such, leaflet supports820and920will first be jointly described in relation to leaflet support20, after which differences between leaflet supports820and920will be described. Similarly to leaflet support20, each of leaflet supports820,920comprises a frame830,930that defines an array of adjoining cells832,932and an aperture834,934between an upstream side822,922and a downstream side824,924of the frame. Similarly to frame30, which extends radially inward from an outer ring-perimeter28, frames830,930extend radially inward from outer frame-perimeter828,928(FIGS.18A,20A). However, in contrast to frame30of leaflet support20, frames830,930are not necessarily ring-shaped. Therefore, whereas frame30extends radially outward from inner ring-perimeter26that defines aperture34, frames830,930each comprise a plurality of aperture-surrounding struts844,944that extend radially inwardly and in a downstream direction from outer frame-perimeter828(FIGS.18B-Cand20B-C). For some applications, and as shown inFIGS.18B and20B, two aperture-surrounding struts (e.g.,844aand844b,944aand944b) surround each aperture834,934. For some such applications, frame830,930defines a plurality of apertures (834i,834ii,834iii, or934i,934ii,934iii), such that each aperture is surrounded by at least two aperture-surrounding struts (FIGS.18A,20A). Further similarly to leaflet support20, leaflet supports820and920comprise ventricular legs840,940that extend radially outward and upstream, towards frame830,930(FIGS.18C and20C). Ventricular legs840,940typically afford the native leaflets a range of motion in which to deflect during the cardiac cycle, as described hereinbelow with reference toFIGS.19and21. Similarly to the application described hereinabove with reference toFIGS.1A-5, in which legs40are connected to frame30via connecting portion44, legs840,940are typically connected to frame830,930via aperture-surrounding struts844,944. For some applications, and as shown, each ventricular leg840,940extends radially outward, and toward frame830,930from a downstream end845,945of aperture-surrounding strut844,944. For example, each leg840,940may extend radially outward from a pair of the aperture-surrounding struts844,944(e.g., such that the pair of aperture-surrounding struts meet at downstream end845,945). For some such applications, each of the pair of aperture-surrounding struts partially surrounds a different aperture834,934(FIGS.18B-Cand20B-C). Further similarly to leaflet support20, leaflet supports820and920respectively comprise a barrier836,936that is impermeable to blood flow. Barrier836,936is coupled to frame830,930in a manner that obstructs blood flow through aperture834,934(e.g., by at least partially covering at least one of apertures834i,834ii,834iiior934i,934ii,934iii). For example, and as shown inFIGS.18A and20A, barrier836,936is coupled to frame830,930in a manner that partially covers more than one of apertures834,934. For some applications, and further similarly to leaflet support20, barrier836,936is coupled to frame830,930in a manner that also at least partially covers the array of cells832,932(not shown). For example, and as shown, barrier836,936may be coupled to frame830,930in a manner that at least partially covers a plurality of cells832,932(e.g., each cell of frame830,930). A feature that distinguishes between leaflet supports820and920lies in the shape of respective barriers836,936. Barrier836of leaflet support820is in many ways similar to barrier36of leaflet support20. For example, barrier836may define a barrier-fitting portion as described hereinabove with reference to barrier36of leaflet support20, mutatis mutandis. In contrast to barrier836, barrier936defines a radial strip938that extends between central axis d918and outer frame-perimeter928. That is, radial strip938may not reach central axis d918and/or outer frame-perimeter928, yet the radial strip extends between the central axis and the outer frame-perimeter. In this way, radial strip938extends radially inwardly toward central axis d918and radially outwardly toward the outer frame-perimeter. For some applications, radial strip938may be sized to correspond to dimensions of the native heart valve. For example, radial strip938may extend at least two thirds of a radial distance from central axis d918to outer frame-perimeter928. For some applications, barrier936defines more than one radial strip938(e.g., corresponding to a number of commissures of a native heart valve). For some such applications, each radial strip938is positioned to align with a respective commissure of the native heart valve. For example, and as shown, a leaflet support that is configured to be implanted at tricuspid valve60may have exactly three radial strips938. Reference is made toFIGS.19and21, which include schematic illustrations showing leaflet supports820,920respectively implanted at tricuspid valve60, in accordance with some applications of the invention. The left panes ofFIGS.19and21show tricuspid valve60during ventricular systole, and the right panes ofFIGS.19and21show the tricuspid valve during ventricular diastole. Similarly to as described hereinabove with reference to leaflet support20, each cell832,932and therefore frame830,930as a whole, is configured to facilitate passage of blood therethrough. Therefore, when leaflet support820,920is implanted at tricuspid valve60, blood may flow between upstream side822,922and downstream side824,924of the frame (e.g., during ventricular diastole). Further similarly to leaflet support20, leaflet supports820and920are typically sized such that frame830,930fits annulus48of tricuspid valve60(e.g., such that frame830,930(e.g., an annulus-fitting zone833,933thereof) can be placed against the annulus). A greatest width (measured transverse to axis d818, d918) of frame830,930is also typically similar to the greatest width of frame30. For some applications, the greatest width of frame830,930is between 10 mm and 100 mm. For some such applications, the greatest width of frame830,930is less than 60 mm. Alternatively or additionally, the greatest width of frame830,930may be greater than 40 mm. Further similarly to leaflet support20, upon implantation of leaflet support820,920at the native valve, barrier836,936and/or frame830,930are typically disposed such that they reduce flailing of native leaflets of the heart into an atrium of the heart, and barrier836,936may obstruct regurgitation of blood (e.g., during ventricular systole). Thus, leaflet support820,920may be desirably implanted in the heart of a subject experiencing leaflet flailing and/or regurgitation at a portion of a native heart valve that is covered by barrier836,936when the leaflet support is implanted at the native valve. Furthermore, barrier836,936is typically sized and positioned to facilitate antegrade blood flow during ventricular diastole. Arrows in the right panes ofFIGS.19and21indicate antegrade blood flow from the right atrium on upstream side22of support820,920to the right ventricle on downstream side824,924of frame830,930. For some applications, and as shown inFIG.19, barrier836of leaflet support820only partially covers apertures834. As such, blood may flow antegrade through apertures834and/or cells832of leaflet support820, during ventricular diastole. In contrast to barrier836, radial strips938of leaflet support920extend radially outwardly toward outer frame-perimeter928. Thus, leaflet support920may be desirably implanted in the heart of a subject experiencing leaflet flailing and/or regurgitation at a portion of a native heart valve that is covered by radial strips938when leaflet support920is implanted at the native valve. It is nonetheless desirable that radial strips938do not unduly obstruct antegrade blood flow during ventricular diastole. Radial strips938are therefore typically sized and positioned so as to allow for blood to flow between the radial strips (right pane ofFIG.21). It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description. | 53,656 |
11857418 | While the disclosure of the methods implementable using the alignment and engagement systems disclosed herein is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be further described in detail below. It should be understood, however, that the intention is not to limit the disclosure to the particular exemplary implementations described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives. DETAILED DESCRIPTION Provided herein are exemplary implementations of methods, systems, subsystems and kits for aligning an annuloplasty ring or its first toroidal portion to at least one natural fiducial of an annular target and engage a portion of the annular target aligned with the at least one natural fiducial. The annular target can be, for example: a pulmonary valve, a mitral valve, a tricuspid valve, and an aortic valve. Furthermore, and as is typically the case, the three dimensional profile of the annulus in some of these valves is dynamic during the cardiac cycle absent implantation of the annuloplasty ring or its toroidal portion, making proper alignment using the methods and systems disclosed beneficial for proper operation of the valves. Furthermore, in the context of the disclosure, the term annuloplasty ring, or its toroidal portion does not necessarily mean a ring defining a single plane, but rather encompasses other planes, for example, a saddle-shaped ring. Likewise, the term “its (first, second) toroidal portion” means, in the context of the disclosure, any part of the ring operable to be adjoined to form the full annuloplasty ring. For example, in certain implementations, the toroidal portion can be less than half the full ring, or less than a quarter of the full ring and be operable to adjoin other components and form the full annuloplasty ring. Definitions The term “coupled,” including its various forms such as “operably coupling,” “coupling” or “couplable,” refers to and comprises any direct or indirect structural coupling, connection or attachment, or adaptation or capability for such a direct or indirect structural or operational coupling, connection or attachment, including integrally formed components and components which are coupled via or through another component or by the forming process. Indirect coupling may involve coupling through an intermediary member or adhesive, or abutting and otherwise resting against, whether frictionally or by separate means without any physical connection. In addition, for the purposes of the present disclosure, directional or positional terms such as “top,” “bottom,” “upper,” “lower,” “side,” “front,” “frontal,” “forward,” “rear,” “rearward,” “back,” “trailing,” “above,” “below,” “left,” “right,” “radial,” “vertical,” “upward,” “downward,” “outer,” “inner,” “exterior,” “interior,” “intermediate,” “apical,” “basal,” etc., are merely used for convenience in describing the various exemplary implementations of the present disclosure. Likewise, the term “engage” and various forms thereof, when used with reference to an engaging element, for example in the engagement of washer302in docking member301between the pair release cords103, refers in an exemplary implementation to the application of any forces that tend to hold docking member301and a pair of release cords103together against inadvertent or undesired separating forces (e.g., such as may be introduced during alignment/engagement and manipulation of the annuloplasty ring or its toroidal portion). It is to be understood, however, that engagement does not in all cases require an interlocking connection that is maintained against every conceivable type or magnitude of separating force. Further, the term “engaging element” refers in another exemplary implementation to one or a plurality of coupled components, at least one of which is configured for releasably engaging another element. Thus, this term encompasses both single part engaging elements and multi-part assemblies, for example, coupling assembly303as a whole. The terms “first,” “second,” and the like herein do not denote any order, quantity, or importance, but rather are used to denote one element from another. The terms “a,” “an” and “the” herein do not denote a limitation of quantity, and are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The suffix “(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including one or more of that term (e.g., lance-member(s)2014jincludes one or more lance members). Reference throughout the specification to “one exemplary implementation,” “another exemplary implementation,” “an exemplary implementation,” and so forth, means that a particular element (e.g., step, feature, structure, and/or characteristic) described in connection with the exemplary implementation is included in at least one exemplary implementation described herein, and may or may not be present in other exemplary implementations. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various exemplary implementations. In the context of the disclosure, the term “operable” means the system and/or the device, or a certain element or step is fully functional, sized, adapted and calibrated, comprises elements for, and meets applicable operability requirements to perform a recited function when activated, coupled, implemented, actuated, effected, or realized. In relation to systems, the term “operable” means the system is fully functional and calibrated, having the necessary elements, as well as the mechanisms for, and meets applicable operability requirements to perform a recited function when executed by a user. The term “abut” refers in the context of the disclosure, to items that are in direct physical contact with each other, although the items may not be attached, secured, fused, glued, sewn, or welded together. In the context of the disclosure, the term “natural fiducial” is used to describe an identifiably distinctive anatomical feature including, without limitation, the right fibrous trigon, left fibrous trigon, interleaflet triangle, tricuspid posterior-anterior hinge, or a combination comprising one or more of the foregoing. In the context of the disclosure, the term “aligned” is a broad term and is generally meant to include, without limitation, having a fixed angular relationship between about 0 degrees and about 180 degrees between at least one alignment and engagement construction, the delivery catheter, or a marker on the annuloplasty ring or its toroidal portion, and at least one natural fiducial. In the context of the disclosure, the term “saddle-shaped” is used herein to mean an annuloplasty ring generally made of two arcuate members, for example, two toroidal portions with each toroidal portion having an apex and two ends connecting the toroidal portions. The apex of the toroidal portion in one member can be in the same or opposite direction of the other member. The formed ring can be generally D-shaped. A more complete understanding of the methods, systems, subsystems and kits for aligning an annuloplasty ring or its first toroidal portion to at least one natural fiducial of an annular target and engaging the portion of the annular target aligned with the at least one natural fiducial can be obtained by reference to the accompanying drawings. These figures (also referred to herein as “FIGS.”) are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to indicate relative size, scale and dimensions of the devices or components thereof, and/or to define or limit the scope of the exemplary implementations. Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the exemplary implementations selected for illustration in the drawings, and are not intended to define or limit the scope of the disclosure. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like function. FIGS.1-3illustrate an exemplary implementation of the alignment and engagement device. As illustrated, device10is operable to align to at least one natural fiducial (see, e.g.,511,512,FIG.11) of an annular target and engage a location of the portion of the annular target aligned with the at least one natural fiducial (see, e.g.,1000,FIG.10A), device10comprising: an annuloplasty ring100or a first toroidal portion thereof, each having an outer hollow tube101with a plurality of slotted backbone104(see, e.g.,FIG.3) therein, annuloplasty ring100or its toroidal portion (not shown), with a plurality of segments formed by slotted ribbon104(see, e.g., commonly assigned U.S. application Ser. No. 16/702,338, filed Mar. 12, 2019 and titled “STABILIZING AND ADJUSTING TOOL FOR CONTROLLING A MINIMALLY INVASIVE MITRAL/TRICUSPID VALVE REPAIR SYSTEM,” which is incorporated herein in its entirety), are each operable to change from an insertion configuration to an operable configuration; alignment and engagement construction comprising at least one cannula105,105′, each cannula105,105′ having sleeve106,106′ coupled to distal end of cannula105,105′, each sleeve being releasably coupled to outer hollow tube101, or, in other exemplary implementations, to wrapper102via coupling sub-assembly107,107′, the construction operable to align the at least one natural fiducial and engage the location of the portion of the annular target aligned with the at least one natural fiducial; and delivery catheter108having proximal end1080and distal end1081, adapted, sized and configured to accommodate: the alignment and engagement construction, coupling sub-assembly107,107′ and annuloplasty ring100or the first toroidal portion thereof in its insertion configuration, and wherein delivery catheter108is operable, once annuloplasty ring100or its first toroidal portion is inserted, to alter annuloplasty ring100or its first toroidal portion from the insertion configuration to the operable configuration. Also illustrated inFIGS.1-3are release cords103and anchors150i, forming a portion of the one or more zones such as, for example, a posterior zone (as illustrated by element150iinFIG.1,1501iinFIG.10F, and1502iinFIG.10H), each zone comprising a plurality of internal anchor members1501i,1502′ located at least partially within outer hollow tube101, the zones of the annuloplasty ring, or the second toroidal portion thereof disposed opposite (e.g.,1502′ location) the alignment and engagement construction, each it h anchor150ioperable to selectably extend radially from outer hollow tube101and engage portion1000,1001(see, e.g.,FIG.10A) of the annular target. FIG.4illustrates each cannula105,105′ as comprising harpoon200operable to engage the portion of the annular target, at a location aligned with the at least one natural fiducial (see, e.g.,511,512,FIG.11, andFIG.10D). As illustrated, in an exemplary implementation, harpoon200comprises: self-penetrating tip201; foreshaft202distally coupled to self-penetrating tip201; foreshaft202defining radial (XR) aperture2020disposed along the foreshaft202longitudinal axis XL; pushrod203, having a proximal end defining axial socket2030sized to accommodate a (distal) portion of foreshaft202, releasably coupled to the distal end2021(see, e.g.,FIG.5A) of foreshaft202; optionally, tether204looped through radial aperture2020; and optionally, at least one spur205, operably coupled to the self-penetrating tip, configured to transition from a first insertion position (see, e.g.,FIG.4) to a second anchoring position (see, e.g.,FIGS.5A,10D). In certain exemplary embodiments, pushrod203is a hollow tube, operable to both accommodate optional tether204, or additionally, or alternatively, deliver other structural members, compositions and the like, to the engagement site, as well as remove portions of the engagement site. In certain exemplary implementations, each sleeve106,106′ used in the devices disclosed for implementing the methods provided, is sized and configured to accommodate self-penetrating tip201, foreshaft202, and optionally, at least one spur205. Under certain circumstances, and as illustrated inFIGS.5B-7B, self-penetrating tip201, foreshaft202and at least one spur205are all integrated to single penetrating head2000, wherein single penetrating head2000is operable to transition between an insertion configuration as illustrated inFIGS.5B,5Cand an anchoring configuration as illustrated inFIGS.6A-7B. As illustrated inFIGS.5B-7B, single penetrating head2000comprised of a plurality of lancing members (in other words, a multi-lance split tip), configured to have a cross section2124p,2014joperable to form filled cylinder single penetrating head2000in the insertion configuration, the filled cylinder having a conical tip2121p,2011j(see, e.g.,FIGS.6A,7A,7B). Additionally, or alternatively, in certain exemplary implementations, one or both harpoons200can be configured to comprise single penetrating head2000(multi-lance split tip) having a plurality of lancing members2125p, configured to form, in the insertion configuration as illustrated inFIG.6B, with a cross section2124p, operable to form a hollow cylinder having a frusto-conical conical tip2122p. As illustrated inFIGS.6A-8, upon actuation, each of the lancing members is configured to curve whereby tip2011j,2121p,2131qof each lancing head is directed, in other words pointing to the distal end of a single penetrating head2000. As further illustrated inFIGS.5B,7B and8, showing exemplary implementation of a single penetrating head2000comprised of a plurality of lancing members2010j(in other words, a multi-lance split tip), configured to have a cross section2124p,2014joperable to form filled cylinder single penetrating head2000in the insertion configuration, the filled cylinder having a conical tip2121p. When curved back, lancing members2010jhaving a length of between about 0.01 mm and about 5.00 mm, are each configured to form angle a, defined between the tangent of each curved lancing member2010j, and longitudinal axis XL of single penetrating head2000. FIGS.9A-9Cillustrate the components of the alignment and engagement constructions, withFIG.9A, illustrating sleeve106,106′,FIG.9Billustrating docking member301, andFIG.9Cillustrating the releasable coupling sub-assembly107,107′ of sleeve106,106′ to docking member301in the presence of release cords103. Accordingly, and as illustrated inFIG.9A, each sleeve106,106′ further comprises dorsal peg1063extending radially from each sleeve106,106′, whereby each sleeve106,106′ having open proximal end1060, and open distal end1062. Furthermore, each coupling sub-assembly107,107′ comprises docking member301coupled to outer hollow tube101, or wrapper102, operable to releasably engage sleeve106,106′. As further illustrated inFIG.9C, each coupling sub-assembly107,107′ further comprises: washer302, operably coupled to peg1063, forming a flanged peg; and pair of release cords103, wherein docking member301having arcuate apical surface3010with a diameter configured to abut the curvature of outer hollow tube101of annuloplasty ring100, or its toroidal portion, docking member301further defines opening3025having a cylindrical internal surface with diameter D301of between about 2.0 mm and about 5.0 mm, configured to accommodate the flanged peg, with two pairs3022,3022′ and3023,3023′ of diametrically aligned openings defined in docking member301, the distance (W301) between each pair3022,3022′ and3023,3023′ sized and configured to be wider than the (dorsal) peg1063and narrower than the flange defined by washer302diameter, such that each pair of release cords103is threaded through the diametrically opposed openings3022,3022′ and3023,3023′ between the flange and sleeve106,106′ (see, e.g.,FIG.9C). In certain exemplary implementations, and as illustrated schematically inFIG.11, the at least one natural fiducial is the right fibrous trigon512, the left fibrous trigon511, the interleaflet triangle (not shown), and the tricuspid posterior-anterior hinge5031, and wherein the annular target is at least one of: mitral valve502, tricuspid valve503, aortic valve501, and pulmonary valve504. For example, in an exemplary implementation, the annular target is mitral valve (MV)502, the natural fiducials are right fibrous trigon512and left fibrous trigon511and wherein sleeves106,106′ are radially spaced apart to align with right fibrous trigon512and left fibrous trigon511, sequentially or simultaneously and engage anterior portion5022of mitral valve annulus5020at the location, or point of contact with anterior portion5022that is aligned with right fibrous trigon512and left fibrous trigon511, see, e.g.,FIG.10D. In an exemplary implementation, the methods disclosed herein are implemented using the devices and systems disclosed herein. Accordingly, provided herein is a method for aligning an annuloplasty ring, or its first toroidal portion to at least one natural fiducial of an annular target and engage a portion of the annular target aligned with the at least one natural fiducial, implementable in a system comprising an annuloplasty ring100, or a first toroidal portion thereof, each having an outer hollow tube101with a plurality of slotted backbone104therein, the annuloplasty ring100or its toroidal portion are each operable to change from an insertion configuration to an operable configuration; an alignment and engagement construction comprising at least one cannula105,105, ′ the cannula having a sleeve106,106′ coupled to a distal end1050(see, e.g.,FIG.2) of the cannula105,105′, the sleeve106,106′ being releasably coupled to the outer hollow tube101via a coupling sub-assembly107,107′, the construction operable to align the at least one natural fiducial (see, e.g.,511,512,FIG.11) and engage a portion of the annular target aligned with the at least one natural fiducial; and a delivery catheter108having a proximal end1080and a distal end1081, adapted, sized and configured to accommodate: the alignment and engagement construction, the coupling sub-assembly107,107′ and the annuloplasty ring100or the first toroidal portion thereof in its insertion configuration, and wherein the delivery catheter108is operable, once the annuloplasty ring100or its first toroidal portion is inserted, to alter the annuloplasty ring100or its first toroidal portion from the insertion configuration to the operable configuration, the method comprising: using the delivery catheter108, introducing the annuloplasty ring100or the first toroidal portion thereof to the annular target site (see, e.g.,601,FIG.10A); using the delivery catheter, altering the insertion configuration of the annuloplasty ring100or the first toroidal portion thereof to the operable configuration; using the alignment and engagement construction, aligning (see, e.g.,602,FIG.10B) the at least one sleeve106,106′ with the at least one natural fiducial (see, e.g.,511,512,FIG.11); engaging the annular target (see, e.g.,603,FIG.10C) at the location aligned with the at least one natural fiducial (see, e.g.,511,512,FIG.11); and releasing the sleeve106,106′ from the outer hollow tube101. Furthermore, the step of engaging the annular target at the location aligned with the at least one natural fiducial comprises: using the pushrod203, penetrating the location aligned with the at least one natural fiducial with the self-penetrating tip201, wherein at least a portion of the foreshaft202remains external to the location aligned with the at least one natural fiducial; and optionally transitioning the at least one spur205to the anchoring position (see, e.g.,FIGS.5A,10D). Likewise, the step of releasing the sleeve106,106′ from the outer hollow tube101comprises: pulling the release cords103; and using the delivery catheter108, releasing the sleeve106,106′ from the outer hollow tube (see, e.g.,610-612,FIGS.10J-10L). In certain exemplary implementations, the method for aligning an annuloplasty ring or its first toroidal portion to at least one natural fiducial of an annular target and engage a portion of the annular target aligned with the at least one natural fiducial further comprises comprising: either simultaneously or sequentially, with releasing the pushrod from the foreshaft, using the delivery catheter108, maneuvering (605,FIG.10E) the one or more zones1051i, each comprising the plurality of internal anchor heads150iof the annuloplasty ring100or the second toroidal portion thereof to the posterior rim5021(see, e.g.,FIG.11) of the mitral valve502; deploying (606,FIG.10F) the anchors1052ithereby engaging the posterior rim5021of the mitral valve502; using tethers204, pulling (607,FIG.10G) the posterior rim5021of the mitral valve502toward the anterior rim5022, aligned with natural fiducials512,511. Thereafter, deploying (608,FIG.10H) the anchors1052iconfigured to engage the anterior rim5022of the mitral valve502; anchoring the anterior rim5022of the mitral valve502to the annuloplasty ring100or the first toroidal portion thereof; pulling (610,FIG.10J) the release cords103, thereby releasing the sleeve106,106′ from the annuloplasty ring100or the first toroidal portion thereof; using the delivery catheter108, retracting (611,FIG.10K) each cannula105,105′ and sleeve106,106′; and releasing (612,FIG.10L) the annuloplasty ring100or the first toroidal portion thereof from the delivery catheter108. While in the foregoing specification the methods, systems, subsystems and kits for aligning an annuloplasty ring or a toroidal portion thereof with at least one natural fiducial in an annular target and engage a portion of the annular target at a location aligned with the at least one natural fiducials described herein have been described in relation to certain exemplary implementations, and many details are set forth for purposes of illustration, it will be apparent to those skilled in the art that the disclosure of the alignment methods, implementable using the systems disclosed herein, are susceptible to additional implementations and that certain of the details described in this specification and as are more fully delineated in the following claims can be varied considerably without departing from the basic principles disclosed herein. | 22,632 |
11857419 | DETAILED DESCRIPTION OF EMBODIMENTS With reference to the drawings wherein like numerals indicate like elements there is shown inFIG.1Aa perspective view of an implant system100, including a graft collar120engaged with a fastener140in accordance with one or more embodiments herein.FIG.1Bis a longitudinal sectional view of the implant system100ofFIG.1A. The details of the fastener140, shown inFIGS.1A and1B, exemplify a bone screw and are provided by way of example only, it being understood that the faster140may be of many other configurations, such as a bone nail. In the example shown, the fastener140includes a head142and an elongate body144, extending along a longitudinal axis101. The elongate body144includes threads148to facilitate threaded engagement into a biological structure of the patient, such as one or more bones of the skeletal structure. The head142includes a head upper surface145and a head lower surface146, defining a peripheral edge of diameter D1. The head142also includes a driver receiver147for engagement with a corresponding rotational driver element of an insertion tool. In the example shown, the head lower surface146of the fastener140is convex and extends from the peripheral edge of the head142downward to a shank of the elongate body144. In this embodiment, the shank of the elongate body144is a non-threaded portion extending longitudinally between the lower surface146of the head142to the beginning of the threads148. The details of the graft collar120, shown inFIGS.1A and1B, are provided by way of example only, it being understood that the graft collar120may be of many other configurations. In the example shown, the graft collar120is of an annular (cylindrical) shape122, including an upper surface124and a spaced apart lower surface126, defining an outer wall/surface therebetween of diameter D2. The upper surface124is characterized by a concavity128defining a chamfer or seat extending inwardly into the body of the graft collar120. The graft collar120also includes a longitudinally (axially) extending through hole or bore125extending between the upper surface124and the lower surface126. The specific material from which the graft collar120is made will vary based on the surgical procedure and fixation device employed. These materials may include varying degrees of soft and hard cadaveric allografts or synthetic bone void fillers in a variety of formulations to create different levels of shape retention, physical shape change, structural integrity, porosity, and biomaterials with different levels of mineralization to match surgeon preference. Graft collars for spine fusion surgery can be made of human or non-human tissue. When engaged, the shank of the elongate body144of the fastener140is located coaxially within the longitudinally (axially) extending through hole or bore125of the graft collar120, such that the graft collar120is in alignment with the longitudinal axis101. By way of example, a diameter of the shank of the elongate body144of the fastener140is greater than a diameter of the through hole or bore125. To ensure engagement, however, a diameter between peaks of the threads148is larger than the diameter of the through hole or bore125of the graft collar120. As will be discussed in more detail below, the size, shape, and position of the concavity128of the graft collar120are complementary to the convex characteristics of the head lower surface146of the fastener140, which promotes engagement therebetween. Further characteristics of the implant system100will be discussed with reference toFIGS.2,3A,3B,3C. As illustrated inFIG.2, the longitudinal axis101of the implant system100is aligned with an axis of an instrument guide150. The instrument guide150may be used to extend through an incision through the skin, fat and muscle of the patient to a site where the thread148of the elongate body144of the fastener140is to engage the biological structure, e.g., the bone110, of the patient. The instrument guide150includes a hollow and elongate body152extending from a first (proximal) end154to a second (distal) end156. The hollow elongate body152defines an internal passage158of diameter D3therethrough. An insertion tool includes a driver160having a longitudinally extending shaft162, terminating at a drive tip164. The drive tip is of a complementary size and shape as the driver receiver147of the head142of the fastener140. With the drive tip164of the insertion tool received within, and engaging, the driver receiver147of the head142, the insertion tool may advance the implant system100through the internal passage158of the elongate body152of the instrument guide150. Preferably, the diameter D3is large enough to accommodate the diameters D1of the head142of the fastener140and D2of the graft collar120. It is noted that the diameter D2of a graft collar for use in minimally invasive surgery (MIS) of a spine fusion surgery procedure may be smaller than the diameter D1of the fastener140to ensure easy passage down the internal passage158of the instrument guide150. (It is noted that the relatively small diameter D2of the graft collar120may also assists in reducing drag in a tubeless MIS procedure.) As shown inFIG.3A, once a tip of the elongate body144of the fastener140is proximate to a hole112in the biological structure, e.g., the bone110, of the patient, the driver160, shaft162, and drive tip164of the insertion tool may impart a rotational force to the head142of the fastener140and set the threads148into advancing engagement into the bone110. As also shown inFIG.3A, prior to the graft collar120engaging the bone110, the graft collar120is characterized by a first shape114′, which includes size, shape, etc. of all aspects thereof. Said another way, the first shape114′ of the graft collar120is exhibited at rest, without any eternal forces imparting any elastic deformation thereof. As shown inFIG.3B, when the insertion tool has advanced the fastener140a sufficient amount into the bone110, the head lower surface146of the fastener140will engage and press against the concavity128of the upper surface124of the graft collar120from one direction, while the bone110will contact the lower surface126of the graft collar120from another opposite direction. At this point, the graft collar120exhibits a diameter Ø D2. As shown inFIG.3C, when the insertion tool has advanced the fastener140even further into the bone110, the head lower surface146of the fastener140and the bone110elastically deform the graft collar120into second shape114″, which includes an increased diameter Ø D4as compared to diameter Ø D2. It is noted that the body of the graft collar120may deform, in response to force from the head lower surface146of the fastener140during implantation between the condition shown inFIG.3Band the condition shown inFIG.3C, such that a change from the first shape114′ to an intermediate shape (not shown) is achieved, which includes an increased diameter of the body as compared to diameter Ø D2. In one or more embodiments, the material of the graft collar120may include characteristics that cause the achieved final, second shape114″ (FIG.3C) to remain in a relatively solid state, maintaining the achieved compression (elastic deformation) while healing is progressing. Alternatively and/or additionally, material of the graft collar120may include characteristics that permit for wicking of liquid biologics and/or absorption of the patient's blood and cells after the implant system100has been deployed (FIG.3C). The degree of wicking of liquid biologics and/or absorption of the patient's blood and cells may be varied based on a designed porosity and/or relative hydration level of the graft material of the graft collar120, such as by designing with varying degrees of open areas to retain fluids within the graft material. In the process of wicking, the graft material of the graft collar120may expand or shrink, or become independent of the delivery mechanism, depending on desired surgical result. Alternatively and/or additionally, material of the graft collar120may include characteristics that permit a timed phase change or melting to occur, which results in the graft material of the graft collar120to flow to a lower fusion site around the fixation device. The specific timing of the phase change from a solid to a gel/liquid during melting may be controlled through graft material design, which ensures the collar graft120remains in the first shape114during the surgical insertion process (FIGS.2and3A). FIGS.4A,4B, and4Care perspective, exploded, and longitudinal sectional views, of an implant system200in accordance with one or more further embodiments. The implant system200is similar to the implant system100, and therefore includes the characteristics, functions, etc., discussed above; however, the implant system200also includes one or more variations, which will be discussed below. The implant system200includes a graft collar220engaged with a fastener240. In the example shown, the fastener240includes a head242and an elongate body244, extending along a longitudinal axis201,421. The elongate body244includes threads248to facilitate threaded engagement into a biological structure of the patient, such as one or more bones110of the skeletal structure. The head242includes a head upper surface245, a head lower surface246, and a driver receiver247. In the example shown, the head lower surface246of the fastener240is convex and extends from the peripheral edge of the head242downward to a shank of the elongate body244. In this embodiment, the shank of the elongate body244is a non-threaded portion extending longitudinally between the lower surface246of the head242to the beginning of the threads248. In the example shown, the graft collar220is of an annular (cylindrical) shape222, including an upper surface224and a spaced apart lower surface226, defining an outer wall/surface therebetween. The upper surface224is characterized by a concavity228defining a chamfer or seat extending inwardly into the body of the graft collar220. The graft collar220also includes a longitudinally (axially) extending through hole or bore225extending between the upper surface224and the lower surface226. As best seen inFIG.4C, the shank of the elongate body244of the fastener240is tapered, having a larger diameter at the head lower surface246as compared to a diameter of the shank just before the threads248. In a cooperative manner, the longitudinally (axially) extending through hole or bore225of the graft collar220is also tapered. In accordance with design consideration, the graft collar220may be sized with only one taper or multiple tapers to permit retention on shafts diameters ranging from about 3.00 mm to about 10 mm. Mating tapers may also expand the graft collar220(i.e., deform same) into a second shape as compared with a first shape at rest, shown inFIG.4C. FIGS.5A and5Bare perspective and longitudinal sectional views, of an implant system300in accordance with one or more further embodiments. The implant system300is similar to the implant system100, and therefore includes the characteristics, functions, etc., discussed above; however, the implant system300also includes one or more variations, which will be discussed below. The implant system300includes a graft collar320engaged with a fastener340. In the example shown, the fastener340includes a head342and an elongate body344, extending along a longitudinal axis301. The elongate body344includes threads348to facilitate threaded engagement into a biological structure of the patient, such as one or more bones110of the skeletal structure. The head342includes a head upper surface345, a head lower surface346, and a driver receiver347. The graft collar320is of an annular (cylindrical) shape322, including an upper surface324and a spaced apart lower surface326, defining an outer wall/surface therebetween. As best seen inFIG.5B, the head lower surface346of the fastener340is flat (not convex as in previous embodiments) as it extends from the peripheral edge of the head342radially inwardly to a shank of the elongate body344. As in previous embodiments, the shank of the elongate body344is a non-threaded portion extending longitudinally between the lower surface346of the head342to the beginning of the threads348. The upper surface324of the graft collar320may be characterized by a flat surface (not concave as in previous embodiments). The graft collar320also includes a longitudinally (axially) extending through hole or bore325extending between the upper surface324and the lower surface326. It is noted that in alternative embodiments, the upper surface324of the graft collar320may alternatively be characterized by a concavity as in the previous embodiments. Additionally and/or alternatively, the shank of the elongate body344of the fastener340may be tapered (or alternatively straight), with or without a corresponding tapered longitudinally (axially) extending through hole or bore325of the graft collar320. Reference is now made toFIG.6, which is a perspective view of a graft collar420in accordance with one or more further embodiments herein. In the example shown, the graft collar420is of an annular (cylindrical) shape422, including an upper surface424and a spaced apart lower surface426, defining an outer wall/surface therebetween. The graft collar420also includes a longitudinally (axially) extending through hole or bore425, extending along an axis401, between the upper surface424and the lower surface426. At rest, the graft collar420exhibits a shape432′ (without elastic deformation). The graft collar420also includes a split or gap427, which permits some additional functionality when engaging the graft collar420with a fastener (e.g., any of the fasteners disclosed herein). The split or gap427may serve to accommodate a taper on the fastener, provide material memory (to return to a particular diameter after stretching to go over a larger diameter area such as one of the aforementioned threads148,248,348or smooth shafts), and/or to create better retention based on the elasticity or flex inherent in the grafting material. The C-shape of the graft collar420, permits placement and engagement to the fastener from the side of the fastener and/or to add the graft material into an area where a void remains after implantation. Reference is now made toFIGS.7A and7B, which are a perspective, and a longitudinal sectional view, of a graft collar520in accordance with one or more further embodiments herein. In the example shown, the graft collar520is of an annular (cylindrical) shape522, including an upper surface524and a spaced apart lower surface526, defining an outer wall/surface therebetween. The graft collar520also includes a longitudinally (axially) extending through hole or bore525, extending along an axis501, between the upper surface524and the lower surface526. At rest, the graft collar520exhibits a shape532′ (without elastic deformation). As best seen inFIG.7B, the upper surface524is not parallel to the lower surface526, but rather exhibits a particular angle A. The particular angle A may be established to accommodate different boney voids or gaps expected and/or present in the patient's biological structure or provide a desired orientation of a fastener. Reference is now made toFIGS.8A and8B, which are a perspective, and a longitudinal sectional view, of a graft collar620in accordance with one or more further embodiments herein. In the example shown, the graft collar620is of an non-annular, asymmetrical shape622, including an upper surface624and a spaced apart lower surface626, defining an outer wall/surface therebetween. The graft collar620also includes a longitudinally (axially) extending through hole or bore625, extending along an axis601, between the upper surface624and the lower surface626. As best seen inFIG.8B, the axis601is asymmetrically disposed through the graft collar620, which non-annular, asymmetrical shape622allows for a biased placement of the graft material away from the sacrum and/or an adjacent non-fused level of a spinal fusion application. Reference is now made toFIGS.9A and9B, which are a perspective, and a longitudinal sectional view, of a graft collar720in accordance with one or more further embodiments herein. In the example shown, the graft collar720is of an annular (cylindrical) shape722, including an upper surface724and a spaced apart lower surface726, defining an outer wall/surface therebetween. The graft collar720also includes a longitudinally (axially) extending through hole or bore725, extending along an axis701, between the upper surface724and the lower surface726. At rest, the graft collar720exhibits a shape732′ (without elastic deformation). As best seen inFIG.9B, the semi-longitudinally (axially) extending through hole or bore725is disposed such that the axis701is not perpendicular to the upper surface724and the lower surface726, but rather transverse with respect to perpendicular, see angle B. The angle of the semi-longitudinally (axially) extending through hole or bore725may be specifically, directionally oriented in to avoid migration of the graft material to the sacrum and/or an adjacent non-fused level of a spinal fusion application or provide a desired orientation of a fastener. Reference is now made toFIGS.10A and10B, which are a perspective, and a longitudinal sectional view, of a graft collar820in accordance with one or more further embodiments herein. In the example shown, the graft collar820is of an annular (cylindrical) shape822, including an upper surface824and a spaced apart lower surface826, defining an outer wall/surface therebetween. The graft collar820also includes a longitudinally (axially) extending through hole or bore825, extending along an axis801, between the upper surface824and the lower surface826. As best seen inFIG.10B, the longitudinally (axially) extending through hole or bore825includes threads821, which may engage the threads148,248,348of the fasteners disclosed herein. This permits an alternative approach to securely engaging the graft collar820to the fastener. Reference is now made toFIGS.11A and11B, which are a perspective, and a longitudinal sectional view, of a graft collar920in accordance with one or more further embodiments herein. In the example shown, the graft collar920is of an non-annular, asymmetrical shape922, including an upper surface924and a spaced apart lower surface926, defining an outer wall/surface therebetween. The graft collar920also includes a semi-longitudinally (axially) extending through hole or bore925, extending along an axis901, between the upper surface924and the lower surface926. As best seen inFIG.1B, the upper surface924is not parallel to the lower surface926, but rather exhibits a particular angle D. The particular angle D may be established to accommodate different boney voids or gaps expected and/or present in the patient's biological structures. In addition, the axis901is asymmetrically disposed through the graft collar920, which itself is of a non-annular, asymmetrical shape922, which allows for a biased placement of the graft material away from the sacrum and/or an adjacent non-fused level of a spinal fusion application. In addition, the semi-longitudinally (axially) extending through hole or bore925is disposed such that the axis901is not perpendicular to the upper surface924and the lower surface926, but rather transverse with respect to perpendicular, see angle C. The angle of the semi-longitudinally (axially) extending through hole or bore925may be specifically, directionally oriented in to avoid migration of the graft material to the sacrum and/or an adjacent non-fused level of a spinal fusion application or provide a desired orientation of the fastener in bone110. Reference is now made toFIG.12, which is a perspective view of a graft collar system1100in accordance with one or more further embodiments herein. In the illustrated example, the graft collar system1100includes a first graft collar1120and a second graft collar1220, which are specifically sized and shaped to nest with one another. In the example shown, the first graft collar1120is of an annular (cylindrical) shape1122, including an upper surface1124and a spaced apart lower surface1126, defining an outer wall/surface therebetween. The first graft collar1120also includes a longitudinally (axially) extending through hole or bore1125, extending along a first axis, between the upper surface1124and the lower surface1126. In the example shown, the second graft collar1220is of an non-annular, asymmetrical shape1222, including an upper surface1224and a spaced apart lower surface1226, defining an outer wall/surface therebetween. The second graft collar1220also includes a longitudinally (axially) extending through hole or bore1225, extending along a second axis, between the upper surface1224and the lower surface1226. Notably, the second axis is asymmetrically disposed through the graft collar1220. As previously mentioned the first graft collar1120and the second graft collar1220are specifically sized and shaped to nest with one another, such that they do not overlap one another, yet there shapes enable desired placements of the graft material, including desired distances between the first and second axes of the respective longitudinally (axially) extending through holes or bores1125,1225. In particular, the second graft collar1220includes a concavity1237in the outer wall, which is of a size and shape that corresponds and complements a portion1139of the outer wall of the first graft collar1120, permitting the first and second graft collars1120,1220to nest. Reference is now made toFIG.13, which is a perspective view of a system employing a pair of implant systems suitable for use in intervertebral stabilization and/or fusion. Each of the implant systems is similar to one or more of the previously discussed implant systems100,200,300and therefore includes the characteristics, functions, etc., discussed above. Each of the implant systems includes a graft collar1320engaged with a fastener1340. The specific design of the graft collar1320may be in accordance with any of the aforementioned graft collars (and/or combinations of features thereof). In the example shown, the fastener1340of each implant system includes a head1342and an elongate body1344, extending along a respective longitudinal axis. The elongate body1344includes threads1348to facilitate threaded engagement into a biological structure of the patient, such as one or more bones110of the skeletal structure. The head1342includes a tulip structure1349that engages a set screw1343. In the illustrated example, the graft collar1320of each implant system is of an annular (cylindrical) shape1322, including an upper surface and a spaced apart lower surface, defining an outer wall/surface therebetween. A rod1370extends between the respective tulips of the implant systems, and is retained by the respective set screws1343. When the respective fasteners1340of each implant system are driven into the bone110of the patient, the graft collars1320of each implant system are properly located, elastically deformed, and/or exhibit the various characteristics previously discussed in connection with other embodiments. Reference is now made toFIGS.14A,14B, and14C, which are a perspective view, a disengaged (exploded) view, and a longitudinal sectional view, respectively of a graft collar1420formed in a mold1480before or during a surgical procedure in accordance with one or more further embodiments herein. Indeed, some surgeons may desire to form the graft collar1420in time proximity to the actual surgical procedure, such as after evaluating the particular characteristics of the injury and/or the patient's physiological characteristics, thereby achieving a particular collar geometry. The surgeon may also control the particular mixture of grafting materials, pre-op or during the surgical procedure. The mold1480includes a base outer mold portion1482defining an inner cavity1484of particular geometrical characteristics to a void. An inner mold portion (or pin)1486fits within the inner cavity1484to define additional geometrical characteristics to the void. The specific sub-materials and proportions thereof to produce the grafting material are mixed and then poured into the void of the mold1480. After a curing period, the graft collar1420having the desired material and geometrical properties is achieved. A skilled artisan will appreciate that a set of outer mold portion(s)1482defining and/or inner mold portion(s)1486may be made available to achieve any of the geometrical characteristics of the aforementioned graft collar embodiments. The mold1480may be modular to allow the graft collar to be retained around different major/minor diameter screws with varying degree of taper, by inserting a corresponding pin1486, from among a set of such pins, into a standard (or one of a series of) outer mold portion(s)1482. The components of the mold(s)1480may be formed from a flexible material to allow for easy changes of the shape by pressing to bend in or out different sections of the mold or adding solid materials to block flow of moldable materials. Reference is now made toFIGS.15A and15B, which are a perspective view and a disengaged (exploded) view, respectively of an implant system1500in accordance with one or more further embodiments. The implant system1500includes a bone plate1570having an upper surface1572, a spaced apart lower surface1574, a plurality of apertures1576, and a centrally disposed aperture1578. A plurality of fasteners1540are used through the plurality of apertures1576to engage the bone plate1570to one or more bones of a patient's skeletal system (such as to stabilize and/or fuse across an injury, such as an intervertebral injury). The implant system1500also includes a graft collar1520. In the example shown, the graft collar1520is of an annular (cylindrical) shape1522, including an upper surface and a spaced apart lower surface, defining an outer wall/surface therebetween. The graft collar1520also includes a longitudinally (axially) extending through hole or bore1525, extending along an axis, between the upper surface and the lower surface. The graft collar1520includes an annular engagement protrusion1530extending from the upper surface. The engagement protrusion1530includes slots1532, which provide some elastic deformation of the engagement protrusion1530when inserting same into the centrally disposed aperture1578of the bone plate1570. Alternatively and/or additionally, one or more of the aforementioned graft collars120,220,320,420,520,620,720,820,920, etc. may be employed on one or more of the fasteners1540prior to engagement within one of the apertures1576. When used with the plate1570the graft collars may work internal to the plate slots, ridges or rails with a partial split design incorporating, slight compressibility to allow the grafts to be held in place in open areas around the screws. Reference is now made toFIGS.16A and16B, which are a perspective view and a disengaged (exploded) view, respectively of an implant system1600in accordance with one or more further embodiments. The implant system1600includes a bone plate1670having an upper surface1672, a spaced apart lower surface1674, a plurality of apertures1676, and a centrally disposed, elongate aperture1678. The implant system1600also includes a graft plate1620. In the example shown, the graft plate1620is of a shape that complements the shape of the bone plate1670, including an upper surface1624, a spaced apart lower surface1626, and a plurality of apertures1634. The graft plate1620also includes an annular engagement protrusion1630extending from the upper surface1624. The engagement protrusion1630includes an elongate head on a shank, where the shank extends from the upper surface1624. In order to engage the graft plate1620to the bone plate1670, a rotation is established therebetween by some angle (e.g., 90 degrees) so that the elongate head of the engagement protrusion1630may enter the centrally disposed, elongate aperture1678of the bone plate1670from below. Then, a counter-rotation is established therebetween so that the respective pluralities of apertures1634,1676of the graft plate1620and the bone plate1670are in registration with one another. A plurality of fasteners1640are used through the plurality of apertures1676,1634to engage the bone plate1670and the graft plate1620to one or more bones of a patient's skeletal system (such as to stabilize and/or fuse across an injury, such as an intervertebral injury). Alternatively and/or additionally, one or more of the aforementioned graft collars120,220,320,420,520,620,720,820,920, etc. may be employed on one or more of the fasteners1640prior to engagement within the apertures1676,1634. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. | 29,385 |
11857420 | DETAILED DESCRIPTION The present disclosure relates in general to SI joint fusions and, more particularly, to implants and methods for posterior SI joint fusion. The embodiments described herein provide methods of performing SI joint fusions via posterior approaches (i.e., posterior SI joint fusions). The embodiments described herein also provide reaming guides utilizable in posterior SI joint fusions for defining the tool path and limiting the depth of cut as needed for a particular physiology. In some embodiments, the reaming guides are boxes oriented parallel to the SI joint. Other embodiments described herein provide a fusion plate utilizable in a posterior SI joint fusion and having a window for holding graft material that helps bone grow across the porous fusion plate through the window. In some embodiments, the fusion plate is made from a porous material that helps bone grow into and across the fusion plate, which thereby facilitates bone growth through the plate and bone fusion within the SI Joint. FIG.2is a posterior view of the SI joint100. Thus,FIG.2illustrates the SI joint100when accessed posteriorly (i.e., with a posterior approach). Physicians performing spinal fusions in the lumbar region, for example, to correct scoliosis, will utilize the posterior approach and may be provided access to the SI joint100as depicted inFIG.2. In addition,FIG.2illustrates the ala202of the sacrum102and the iliac crest204of the ilium106, and further depicts how the SI joint100generally extends along an axis X. The SI joint100ofFIG.2is shown prior to any bone removal as described below. Thus,FIG.2shows the cortical bone of the sacrum102and the ilium106. When performing posterior SI joint fusions, an implant (seeFIG.5) may be placed in the SI joint100. As described below, such implants may facilitate fusion of the SI joint100by providing a scaffold for a graft material that will generate bone across the SI joint100and, after fully healing, strengthen the fusion across the SI joint100. Before placing the implant within the SI joint100, however, the SI joint100may be prepared such that there is sufficient space to receive the implant. FIG.3illustrates the SI joint100ofFIG.2after being prepared, according to one or more embodiments of the present disclosure. As illustrated, a space300was formed at the SI joint100for receiving the implant. The space300has a length dimension L, a width dimension W, and a depth dimension (not illustrated) that is normal to the length and width dimensions W, L. Here, the space300is formed generally parallel the SI joint100, meaning that the length dimension L of the space300is parallel to the axis X of the SI joint100. Also, the dimensions of the space300may vary depending on the size of the implant. For example, the width dimension W of the space300may be sized to correspond with a width of the implant such that the implant may be inserted into the space300. A variety of methods and tools may be utilized to form the space300in the SI joint100. In the illustrated examples, the SI joint100was prepared via a reaming procedure. In the reaming procedure, a rotational cutting tool (e.g., a reamer) is utilized to cut portions of the sacrum102and the ilium106on either side of the SI joint100, and thereby define the space300into which the implant may be inserted. During the reaming procedure, the cortical bone layers of the sacrum102and the ilium106are removed to expose the underlying cancellous bone, which more readily fuses across the SI joint100as compared to the cortical bone. Thus, the width dimension W of the space300is mostly defined by the distance between exposed cancellous bone of the sacrum102and the ilium106. A guiding tool may be utilized in the reaming procedure to control the dimensions of the space300. The guiding tool may provide an envelope or template that guides and limits movement of the rotary cutting tool as it cuts the space300. For example, the guiding tool may be utilized to form the space300according to specific length and width dimensions L, W, and may also limit the rotary cutting tool's depth of cut to control the depth dimension of the space300. The guiding tool may be made from various materials, including without limitation, stainless steel alloys, commercially pure titanium, titanium alloys, etc. FIG.4Aillustrates an exemplary guiding tool400, according to one or more embodiments of the present disclosure. Here, the guiding tool400includes a body402having a proximal side404and a distal side406. Here, the body402is configured as a box shaped member with an opening408extending through the body402from the proximal side404to the distal side406. The body402includes a rim410extending around the opening408at the proximal side404. The guiding tool400also includes at least one mounting feature for securing the guiding tool400to bone relative to the SI joint100. Here, the guiding tool400includes a pair of mounting posts412that may be driven into the bone of the pelvis108with a mallet to anchor the guiding tool400relative to the SI joint100; however, the mounting feature may be differently configured. For example, the mounting features may include one or more phalanges, screws, etc. or combinations of the same. In the illustrated example, the mounting posts412include flat surfaces that are oriented with the SI joint100, generally parallel to the axis X of the SI joint100, such that they may more easily slide into the SI joint100. Here, the mounting posts412are positioned centered on a sidewall of the body402, but they may be positioned differently along the sidewall (or another sidewall) of the body402. Thus, the guide400may be configured to slide into the SI joint100, with the mounting posts412sliding therein between the cortical surfaces of the SI joint100to keep the guiding tool400oriented so that there is an even cut from both the iliac crest surface and the sacral surface. However, the mounting posts412may have various other configurations relative to the axis X of the SI joint100, which may help secure the guiding tool400within the SI joint100. During the reaming procedure, the distal side406of the guiding tool400is secured over the SI joint100and a rotary cutting tool420may be inserted through the opening408such that the rotary cutting tool420may access the SI joint100positioned beneath the guiding tool400. As illustrated, the rotary cutting tool420includes a cutting edge422positioned at a distal end thereof, a shaft portion424extending proximally from the cutting edge422, and a shank426extending proximally from the shaft portion424for mounting the rotary cutting tool420within a driver or other equipment. The rotary cutting tool420also includes a stopper428positioned on the shaft portion424and is configured to limit the depth that the cutting edge422may extend distally beneath the guide tool400. In the illustrated example, the stopper428is a flange member that, during the reaming procedure, abuts and contacts the rim410of the body402, thereby inhibiting further distal translation of the cutting edge422and limiting the depth at which it extends into the SI joint100. The size of the space300formed in the SI joint100during the reaming procedure is controlled by the guiding tool400. More particularly, the rotary cutting tool420cuts the space300with length and width dimensions L, W corresponding to a width W′ and length L′ of the opening408in the box shaped body402of the guiding member400. In addition, the depth dimension of the space300formed in SI joint100is controlled by a vertical dimension Z′ of the guiding tool400, which may be influenced by various parameters of the rotary cutting tool420, such as the distance at which the cutting edge422extends distally from the stopper428, etc. As illustrated inFIG.4B, the guiding tool400is positioned parallel to the SI joint100. Thus, the length L′ of the opening408is aligned with the axis X of the SI joint100such that the guiding tool400and the SI joint100are parallel. Various techniques and/or equipment may be utilized to position the guiding tool400before anchoring it to the SI joint100. In one example, a stereotactic computer aided guidance system (not illustrated) is utilized. Here, the guiding tool400may include one or more sensors that communicate with the stereotactic computer aided guidance system to allow placement of the guiding tool400in a desired position and orientation relative to the SI joint100. After the SI joint100has been prepared by cutting the space300therein, the implant may be placed therein to facilitate fusing the SI joint100.FIG.5Aillustrates an exemplary implant500that may be fused in the SI joint100, according to one or more embodiments of the present disclosure. Here, the implant500is a plate502with first face504, a second face (obscured from view) opposite from the first face504, and a graft window506extending there through between the first face504and the second face. The plate502may be made from a porous material.FIG.5Billustrates the implant500ofFIG.5Ahaving been inserted into the space ofFIG.3via a posterior approach.FIG.5Cillustrates the implant500ofFIG.5Ahaving been inserted through the guiding tool400ofFIG.4Aand into the space ofFIG.3via a posterior approach. The implant500may have various geometries and shapes. For example, the first face504and/or the second face may be concave or convex. In one example, the first face504and the second face are both flat, but in other examples, they are biconvex and, in some of these latter examples, the implant500is pointed in the direction of insertion and opens up posteriorly like a cup. In some examples, the first face504and/or the second face include both concave and convex portions that correspond with the particular geometry of the portion of the SI joint100that they are configured to abut when compressed therein. For example, a particular patient's SI joint100may be scanned and modeled in a CAD software, and then the implant500may be designed to best correspond and fit that particular patient's SI joint100geometry and then printed and surgically installed in the patient's SI joint100. Thus, the implant500may have a customized geometry and size corresponding with the actual geometry of a patient's SI joint100and the first face504and/or the second face may be contoured to correspond with contours of the particular patient's SI joint100. However, the implant500also be provided in standard sizes and geometries. The implant500may also have various shapes. Here, the plate502is square shaped with approximately ninety degree (90°) corners, but the corners may have various other geometries. For example, one or more of the corners may be rounded, chamfered, etc. Also, the plate502may have various other non-square or non-rectangular shapes, such as circular, oval, etc., however, the implant500may be custom 3D printed such that the plate502may conform or fit anatomic variants or joints that had previous surgeries. Thus, the implant500and the plate502thereof may be customized to the particular patient and may thus have any number of shapes or geometries. In some examples, the plate502is shaped to fit a particular patient's SI joint100. Here, the implant500includes various dimensions, including a width dimension W″, a length dimension L″, and a vertical dimension Z″. The implant500may be provided with various sizes depending on the particular size of the space300into which the implant500is to be placed. However, the thickness of the plate502should be sufficient to cross the SI joint100and enter the cancellous bone exposed after the reaming procedure cut away the layer of cortical bone. For example, the thickness of the plate502may vary to allow maximum bony surface contact between the implant500and the SI joint100. Also, where the guide tool400is utilized to form the space300in the SI joint100, the implant500may be inserted into the space300in the SI joint100through the opening408in the box shaped body402(FIG.5C). Thus, in such embodiments, the implant500may be sized to fit within the guiding tool400and may even be provided together as a kit for SI joint fusions. Alternatively, the implant500may be inserted directly into the SI joint100(FIG.5B) and, in such examples, the guiding tool400would be removed from the SI joint100or not utilized at all to form the space300therein. The plate502may be formed of a porous material selected to promote bone growth. In one embodiment, the plate502is formed of porous titanium with a modulus similar to natural bone. In other embodiments, selected portions of the plate502are formed of porous material while other portions are formed of non-porous materials. In some embodiments, the plate502is formed by an additive manufacturing process, such as 3D printing. In some embodiments, the porous material forms a lattice having pores of approximately 0.75 millimeter in diameter. The graft window506is configured to receive a graft material. For examples, the graft window506may be filled with either autologous or allograft. The graft window506allows for the fusion to grow through the implant500and the porous material from which the body502is manufactured allows fusion to grow into and through the plate502. The implant500may include various features for strengthening the plate and/or helping secure the plate within the SI joint100. For example, the implant500may have various features and/or designs that prevent micro-motion and allow maximum contact with the bone of the SI joint100. In the illustrated examples, the implant500includes a plurality of rails or ridges508oriented in the direction at which the implant500is to be inserted into the space300of the SI joint100. The rails or ridges508may be made of the same porous material as the remainder of the implant500to allow in growth into and through the ridges508. Thus, the ridges508extend from a top edge510to a bottom edge of the plate502. The ridges508may help secure the implant500within the SI joint100by providing a friction fit and inhibit it from sliding such that the ridges508remove at least one degree of freedom of movement of the implant500when installed in a patient's SI joint100. In addition, the ridges508may help the implant500slide down, with the top edge510or the bottom edge510leading, into the SI joint100. In some examples, the ridges508may include serrations or other features that allow the implant500to slide into the SI joint100but inhibit the implant500from backing out after being inserted into the SI joint100. For example, the ridges508may include triangular serrations with a flat side posterior and pointed anterior to ease insertion into the SI joint100. Here, four (4) ridges508extend from the first face504of the plate502and four (4) ridges508extend from the second face of the plate502. As illustrated, the ridges508provide the implant500with an “I-beam” configuration, and are positioned proximate to the lateral edges of the plate502and proximate to the lateral edges of the graft window506. However, more or less of the ridges508may be utilized. For example, just the lateral edge ridges508or the ridges508sandwiching the graft window506may be included, or the implant may include ridges508on only one side (e.g., the first side504) of the plate502. Also, the ridges508may have one or more different geometries than the generally straight rail members illustrated in the figures. Moreover, the plate502may have various textures, such as asperities or other features that help create friction. For example, the first face504and/or second face may include asperities. The implant500may include various features for helping secure the graft material within the graft window506. Where utilized, the ridges508disposed proximate the graft window506may also help maintain the graft material within the graft window506. In addition, the plate502may include a lip portion (not illustrated) extending around at least a portion of the graft window506to help maintain the graft material within the graft window506, and such lip portion may be included with or without the one or more ridges and/or other features. In some examples, one or more sutures (not illustrated) may be wrapped around the plate502to help retain the graft material within the graft window506. For example, a first suture may be wrapped around the plate502in the length dimension L″ and a second suture may be wrapped around the plate502in the vertical dimension Z″ such that the first and second sutures cross each other at the graft window506. More or less sutures may be utilized, however, and they may be wrapped differently around the plate502without departing from the present disclosure. Also, in some examples, one or more structures (not illustrated) connected to the plate502may be arranged across the graft window506. Where utilized, such structures may have various orientations (e.g., arranged along the length, vertical, and/or width dimensions L″, Z″, W″), and such structures may support various sub-structures suspended within the graft window506, any of which may be provided to facilitate bone growth and fusion. When the implant500is installed in a patient, the plate502contacts the sacrum102and the ilium106under pressure. By applying pressure at the points of contact, the implant500achieves compression that promotes bone growth in a manner not previously possible with posterolateral vertebrae fusion devices. In this manner, the presently disclosed implant500may achieve an improved rate of fusion. Thus, after the SI joint100has been prepared and the implant500has been placed within the space300cut into the SI joint100, the SI joint100will be compressed. Compression will facilitate SI joint fusion because, pursuant to Wolf's law, compression across a fusion device yields the greatest fusion. Various fasteners may be utilized to compress the implant500within the space300of the SI joint100. For example, pedicle screws may be installed within the surgical site of the patient and connected with rods that are compressed with compression devices to squeeze the SI joint100and sandwich the implant500therein. The various pedicle screws may be placed at various times during the SI joint fusion. For example, they may be placed at the beginning of the procedure, at various times before preparing the joint, at various times after preparing the joint but before inserting the implant500therein, or after inserting the implant500within the space300previously formed in the SI joint100, etc. FIG.6Aillustrates exemplary screw placement about the SI joint100, according to one or more embodiments. In particular,FIG.6Aillustrates placement of an iliac screw602in the iliac crest204, as well as an S-1 screw604and an S-2 alar screw606placed in the sacrum102. As described below, a rod may be placed to bridge the SI joint100and interconnect either the iliac screw602and the S-1 screw604or the iliac screw602and the S-2 alar screw606. Thus, both the S-1 screw604and the S-2 alar screw606need not be placed during the same SI joint fusion operation to apply compression to the implant500placed in the space300of the SI joint100, and either the S-1 screw604or the S-2 alar screw606may be utilized depending on which may provide best compression in a particular fusion operation. For example, either the S-1 screw604or the S-2 alar screw606may be utilized depending on which will orient the rod more perpendicular to the structure of a patient's SI joint100when connected to the iliac screw602. However, in some long segment operations, such as a scoliosis operation, a first rod may be placed between the S-1 screw604and the S-2 alar screw606and then a lateral rod may attach to a mid-point of the first rod and connect to the iliac screw602and thereby bridge the SI joint100as described below with reference toFIG.6C. FIG.6Billustrates an exemplary lateral rod608placement, according to one or more embodiments. Here, the lateral rod608has been placed in the screw heads of the iliac screw602and the S-1 screw604. However, as mentioned above, the lateral rod608may instead be installed in the head of the S-2 alar screw606and bridge the SI joint100to interconnect to the head of the iliac screw602, or the lateral rod608may be a lateral connecting rod spanning between the head of the iliac screw602and another rod (i.e., a long segment rod) installed between S-1 screw604and the S-2 alar screw606. Once the one or more rods have been placed in the screw heads, a compression device (not illustrated) may be utilized to compress the SI joint100via the pedicle screws and rods and thereby squeeze the implant500within the space300of the SI joint100. FIG.6Cillustrates an exemplary placement of a long segment rod610and a lateral rod612in a long segment operation, according to one or more embodiments. As illustrated, the long segment rod610is placed between the S-1 screw604and the S-2 alar screw606, and the lateral rod612is secured within the head of the iliac screw602and spans the SI joint100by connecting to a portion of the long segment rod610between the S-1 screw604and the S-2 alar screw606. While not illustrated, in these long segment operations, additional rods similar to the long segment rod610may extend superiorly and/or inferiorly, from either or both the S-1 screw604and the S-2 alar screw606, to other pedicle screws secured along other portions of the spine. Once the lateral rod612has been placed in the screw head of the iliac screw602and connected to the long segment rod610, a compression device (not illustrated) may be utilized to compress the SI joint100and thereby squeeze the implant500within the space300prepared therein. Also disclosed herein is a method for performing an SI joint fusion. The method of fusing the SI joint, sometimes referred to as the SI joint fusion method, includes a first step of preparing the joint, a second step of placing an implant within the SI joint, and a third step of compressing the SI joint. The SI joint fusion method, however, may include one or more additional steps performed before or after the SI joint fusion method, or performed in between any of the foregoing steps. For example, the SI joint fusion method may include an additional step of placing pedicle screws about the SI joint, and such additional step of placing the pedicle screws may be performed at any time before the step of compressing the SI joint or it may be included as part of the step of compressing the SI joint. The first step of preparing the joint is performed to ensure that there is adequate space within the SI joint to receive the implant. As previously described, a reaming procedure may be utilized to cut the space300within the SI joint100. Also as previously described, the guiding tool400may be utilized to control the dimensions of the space300cut into the SI joint100during the reaming procedure. Thus, the first step of preparing the joint may include placing and installing the guiding tool400relative to the SI joint100. In addition, the pedicle screws may be placed about the SI joint100during this step, or at other times during the SI joint fusion method. The second step of placing an implant within the SI joint is performed to place an implant within the SI joint that permits a bone graft to grow across the SI joint100, thereby improving and strengthening the fusion after healing. Various types of implants may be utilized, such as the implant500described above. Also, in examples where the guiding tool400is utilized, the implant500may be inserted into the SI joint100through the opening408in the guiding tool400. Thus, the second step of placing an implant within the SI joint may include inserting the implant500through the guiding tool400and into the space300prepared in the SI joint100and/or positioning the implant500within the space300prepared in the SI joint100via the guiding tool400, etc. In addition, the pedicle screws may be placed about the SI joint100during this step, or at other times during the SI joint fusion method. The third step of compressing the SI joint is performed to compress the implant across the SI joint100because, according to Wolf's law, such compression will provide the greatest fusion. This step may include placing the pedicle screws about the SI joint100; however, such pedicle screws may be placed during any of the preceding steps, or before the SI joint fusion method altogether, for example, during a long segment operation to correct scoliosis, which may be conducted immediately prior to the SI joint fusion method. This step may include bridging the SI joint100by placing a lateral rod (e.g., the lateral rod608or the lateral rod612) across the SI joint100, as previously described, and then using a compression device to compress the SI joint100and the implant500previously inserted therein. As described above, the lateral rod608may be placed within the heads of the iliac screw602and the S-1 screw604(FIG.6B) or within the heads of the the iliac screw602and the S-2 alar screw606. Alternatively, the lateral rod612may be placed in the head of the iliac screw602and connect to the long segment rod610spanning between the S-1 screw604and the S-2 alar screw606(FIG.6C). Thus, this step may also include placing the long segment rod610before bridging the SI joint100with the lateral rod612, as previously described; however, placing the long segment rod610may be performed during any of the preceding steps or before the SI joint fusion method altogether. Also disclosed herein is a sacroiliac joint implant system. The sacroiliac joint implant system may include a pair of fasteners configured to be fixed to opposite sides of the SI joint100and a lateral rod securable within the pair of fasteners. For example, a first fastener may be anchored to the sacrum and a second fastener may be anchored to the ilium and, in some examples, the first fastener is either an S-1 screw or an S-2 alar screw and the second fastener is an iliac screw. In some examples, the sacroiliac joint implant system includes three or more fasteners. For example, the sacroiliac joint implant system may include an S-1 screw, an S-2 alar screw, and an iliac screw; and, in such embodiments, the sacroiliac joint implant system may also include one or more long segment rods and/or a lateral rod configured to attach to a long segment rod, as described above. The sacroiliac joint implant system may also include one or more implants, any of which may be configured as described with reference to the implant500. Thus, the implant of the sacroiliac joint implant system may have a porous body that is placed within the SI joint and configured to promote bone growth. The porous body of the implant includes a first face configured to contact a sacrum of the sacroiliac joint when the implant is compressed within the sacroiliac joint, a second face configured to contact an ilium of the sacroiliac joint when the implant is compressed within the sacroiliac joint, and a graft window extending between the first and second faces and configured to hold a graft material. The sacroiliac joint implant system, or portions thereof may be provided as a “kit.” For example, a kit of implants may also be provided that includes a selection of implants of different sizes. In some examples, the kit includes digital instructions or schematics for a 3D printer, or the like, which a user may utilize to print (or create) the implant. The kit may also include one or more guiding tools having corresponding sizes to receive the implant(s), and may also include a rotary cutting tool configured to operate within the envelope defined by the guiding tool. In some examples, the kit includes digital instructions or schematics for a 3D printer, or the like, which a user may utilize to print (or create) the guiding tool. In addition, the kit may include various pedicle screws and various types of connecting rods for applying compression to the SI joint. A surgeon may select the implant, guiding tool and rotary cutting tool, screws, connecting rods best suited to the particular size and geometry of the patient's SI joint. In this manner, the presently disclosed implant may be used in treatment of a wide variety of applications. The presently disclosed implant may provide numerous advantages for SI joint fusion. An implant formed of porous titanium manufactured with an additive manufacturing process may allow bone growth into it and participate in the fusion. The implant has a pore structure that allows bone growth. Local bone may be trapped within the implant creating a compressed area that would further augment the fusion. The components of the implant500and/or the guiding tool400may be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of the implant500and/or the guiding tool400, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, super elastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®. manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO.sub.4 polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate such as hydroxyapatite (HA), corraline HA, biphasic calcium phosphate, tricalcium phosphate, or fluorapatite, tri-calcium phosphate (TCP), HA-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations, biocompatible ceramics, mineralized collagen, bioactive glasses, porous metals, bone particles, bone fibers, morselized bone chips, bone morphogenetic proteins (BMP), such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized bone matrix (DBM), transforming growth factors (TGF, e.g., TGF-(3), osteoblast cells, growth and differentiation factor (GDF), insulin-like growth factor 1, platelet-derived growth factor, fibroblast growth factor, or any combination thereof. Various components of the implant500and/or the guiding tool400may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of the implant500and/or the guiding tool400, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of the implant500and/or the guiding tool400may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. In one embodiment, the implant500, as described herein, may be formed substantially of a biocompatible metal, such as titanium and selectively coated with a bone-growth promoting material, such as HA. In one embodiment, the implant500, as described herein, may be formed substantially of a biocompatible polymer, such as PEEK, and selectively coated with a biocompatible metal, such as titanium, or a bone-growth promoting material, such as HA. In some embodiments, titanium may be plasma sprayed onto surfaces of the spinal implant to modify a radiographic signature of the implant and/or improve bony on growth to the spinal implant by application of a porous or semi-porous coating of titanium. Aspects of the presently disclosed implant and methods of SI joint fusion are further illustrated in the images and figures attached as an appendix, which is incorporated herein. While principles and modes of operation have been explained and illustrated with regard to particular embodiments, it must be understood, however, that this may be practiced otherwise than as specifically explained and illustrated without departing from its spirit or scope. | 33,097 |
11857422 | DETAILED DESCRIPTION The following description and examples illustrate some exemplary implementations, embodiments, and arrangements of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present invention. Implementations of the technology described herein are directed generally to an acetabular cup assembly comprising a cup and a liner. General Interpretive Principles for the Present Disclosure Various aspects of the novel systems, apparatuses, and methods are described more fully hereinafter with reference to the accompanying drawings. The teachings disclosure may, however, be embodied in many different forms and should not be construed as limited to any specific structure or function presented throughout this disclosure. Rather, these aspects are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Based on the teachings herein one skilled in the art should appreciate that the scope of the disclosure is intended to cover any aspect of the novel systems, apparatuses, and methods disclosed herein, whether implemented independently of or combined with any other aspect of the disclosure. For example, a system or an apparatus may be implemented, or a method may be practiced using any one or more of the aspects set forth herein. In addition, the scope of the disclosure is intended to cover such a system, apparatus or method which is practiced using other structure, functionality, or structure and functionality in addition to or other than the various aspects of the disclosure set forth herein. It should be understood that any aspect disclosed herein may be set forth in one or more elements of a claim. Although some benefits and advantages of the preferred aspects are mentioned, the scope of the disclosure is not intended to be limited to particular benefits, uses, or objectives. The detailed description and drawings are merely illustrative of the disclosure rather than limiting, the scope of the disclosure being defined by the appended claims and equivalents thereof. With respect to the use of plural vs. singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. When describing an absolute value of a characteristic or property of a thing or act described herein, the terms “substantial,” “substantially,” “essentially,” “approximately,” and/or other terms or phrases of degree may be used without the specific recitation of a numerical range. When applied to a characteristic or property of a thing or act described herein, these terms refer to a range of the characteristic or property that is consistent with providing a desired function associated with that characteristic or property. In those cases where a single numerical value is given for a characteristic or property, it is intended to be interpreted as at least covering deviations of that value within one significant digit of the numerical value given. If a numerical value or range of numerical values is provided to define a characteristic or property of a thing or act described herein, whether or not the value or range is qualified with a term of degree, a specific method of measuring the characteristic or property may be defined herein as well. In the event no specific method of measuring the characteristic or property is defined herein, and there are different generally accepted methods of measurement for the characteristic or property, then the measurement method should be interpreted as the method of measurement that would most likely be adopted by one of ordinary skill in the art given the description and context of the characteristic or property. In the further event there is more than one method of measurement that is equally likely to be adopted by one of ordinary skill in the art to measure the characteristic or property, the value or range of values should be interpreted as being met regardless of which method of measurement is chosen. It will be understood by those within the art that terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are intended as “open” terms unless specifically indicated otherwise (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). In those instances where a convention analogous to “at least one of A, B, and C” is used, such a construction would include systems that have A alone, B alone, C alone, A and B together without C, A and C together without B, B and C together without A, as well as A, B, and C together. It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include A without B, B without A, as well as A and B together.” Various modifications to the implementations described in this disclosure can be readily apparent to those skilled in the art, and generic principles defined herein can be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word “exemplary” is used exclusively herein to mean “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other implementations. Certain features that are described in this specification in the context of separate implementations also can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination can be directed to a sub-combination or variation of a sub-combination. Any methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and/or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims. Disclosure of Several Example Embodiments Turning now to the figures,FIG.1illustrates an acetabular cup assembly10. The assembly10includes an acetabular cup20and an acetabular liner50. The cup20is adapted for use with the liner50as will be described in greater detail below with reference at least toFIGS.2-13. As best seen inFIG.3, the cup20comprises an inner surface14and an outer surface16. The outer surface16is generally hemispherical in shape and is configured to create a press fit with prepared acetabulum bone of a pelvis. The outer surface16can include a porous coating configured to provide an improved matrix for mineralization and promote bone in-growth into the cup20. The porous coating may cover all or only a portion of the outer surface16of the cup20. The cup20can be constructed of a biocompatible metal or other suitable material such as a ceramic material. Suitable metals include, without limitation, stainless steel, titanium, titanium alloy, cobalt chromium molybdenum, cobalt chromium, or other biocompatible material. In some embodiments, the cup20comprises one or more fixation holes40configured to receive a fixation device such as a screw or peg to attach the cup20to prepared acetabulum (see, e.g.,FIG.3). The fixation hole(s)40can generally be used for passing a screw or other fixation member into the acetabular portion during implantation and fixation of the acetabular cup20. It will be appreciated that a plurality of fixation holes can be provided at various positions on the cup20and a clinician or practitioner can selectively pass screws for fixing the cup20to the acetabulum of the patient. Additional fixation means can be employed to fix the cup20to the pelvis, including, without limitation, modular pegs, projections, spikes, or porous coating of the outer surface of the cup20as described anywhere in this disclosure. In some embodiments, cup20further comprises an aperture or hole38configured, in some embodiments, to receive a mating peg70of a liner50(see, e.g.,FIGS.10and12). As illustrated at least inFIG.1, the aperture38may be threaded to receive and engage with such a mating peg70of liner50. In one embodiment, the aperture38is located at an apex (e.g., a polar base) of the cup20as is illustrated in at leastFIGS.1and3. However, it will be appreciated that the cup20can optionally include additional apertures at other locations for the purpose of inserting the cup20into a prepared acetabulum, receiving an insertion tool, and/or receiving and/or securing the liner50within the cup20. As best seen inFIGS.1-3, the inner surface14of the cup20comprises a generally concave shape. Nevertheless, it will be appreciated that other shapes may be employed. The inner surface14is designed to accept and lock a liner50(also called a bearing herein). In some embodiments, liner50can comprise polyethylene (e.g., a “poly”) liner or bearing, in some embodiments, having a liner locking feature and, in some embodiments, for use in a standard mobility articulation, as will be described in greater detail below with reference to at leastFIGS.6-9. In some embodiments, the liner50can comprise a metal and/or metal alloy liner or bearing for a dual mobility articulation, as will be described in greater detail below with reference to at leastFIGS.10-12. The cup20comprises an annular cylindrical band26formed at an upper end of the cup20. The annular cylindrical band26has a flat top face18. An inner surface of the annular cylindrical band26may be inset or recessed (e.g., radially inset and/or recessed) from an adjacent lower portion of the inner surface14, thereby allowing for engagement of the liner50. A plurality of inward-facing recessed scallops22are disposed on the inner surface of the annular cylindrical band26and adjacent the top face18. The inward-facing recessed scallops22are configured to receive and accept mating outward-protruding scallops58on the liner50and, thereby, achieve and/or provide anti-rotational stability between the liner50and the cup20. In some embodiments, the plurality of inward-facing recessed scallops22can be evenly spaced and/or distributed around annular cylindrical band26. In some embodiments, the cup20includes at least 12 inward-facing recessed scallops22. However, the present disclosure is not so limited and any number of inward-facing recessed scallops22are contemplated. Advantageously, in some embodiments, the cup20includes the same number of inward-facing recessed scallops22as there are corresponding outward-protruding scallops58on the liner50. In some other embodiments, the cup20includes a greater number of inward-facing recessed scallops22(e.g., 12 inward-facing recessed scallops) than the liner50has outward-protruding scallops58(e.g.,6outward-protruding scallops). In some embodiments, a number of evenly spaced inward-facing recessed scallops22of the cup20is an integer multiple of a number of evenly outward-protruding scallops58on the liner50to ensure multiple compatible rotational orientations between the cup20and the liner50. A combination of the cylindrical band26and the plurality of inward-facing recessed scallops22also affords advantages with respect to manufacture. More particularly, because the plurality of inward facing scallops22in the cup20project from the substantially vertically-oriented cylindrical band26, instead of a tapered or substantially hemispherical surface, the mating outward-protruding scallops58on the liner50can be machined on a corresponding cylindrical band easily using standard lathe equipment. In some embodiments, a lower portion of the annular cylindrical band26comprises an inward-facing recess or groove24(see, e.g.,FIGS.3and5). This recess or groove24may be configured for use with surgical instruments, such as trial liners or the like, but is not intended to affect or interact with the liner50. The cup20further includes an upper partially-tapered surface28extending immediately below cylindrical band26and towards a bottom of the cup20. In some such embodiments, the taper of upper tapered wall portion28has a substantially semi-conical shape, rather than a substantially semi-hemispherical shape such that, for example, a cross-section of an inward-facing surface of upper tapered wall portion28(see, e.g.,FIG.3) follows a substantially straight line, rather than a curved or semi-circular line. In some embodiments, the tapered wall portion28creates an interference fit with the liner50. In some embodiments, the upper tapered wall portion28can have a taper of between about 2 degrees and about 40 degrees from a vertical orientation when cup20is oriented as shown inFIG.3. In some embodiment, the upper tapered wall portion28has a taper of between about 9 degrees and about 20 degrees. In some embodiments, the upper tapered wall portion28has taper of between about 10 degrees and about 15 degrees. In another aspect, the upper tapered wall portion28has taper of about 12 degrees. In some embodiments, the design of the acetabular cup20provides clearance for a poly liner with respect to the tapered wall portion28. Adjacent the base or bottom edge of the tapered wall portion28, the cup20comprises an inner spherical surface32. In some embodiments, an annular groove34is formed in the inner surface14of the cup20and intersects or interrupts the inner spherical surface32such that a top portion30of the inner spherical surface32is disposed above the annular groove34and the remainder of the inner spherical surface32is disposed below the annular groove34. In some such embodiments, groove34extends peripherally or circumferentially about the inner spherical surface32of the cup20and defines a bottom edge of the top portion30of the inner spherical surface32. In some embodiments, groove34has a substantially cylindrical shape, e.g., a sidewall of annular groove34has a substantially vertical orientation when the cup20is in the orientation shown in, e.g.,FIGS.3and4. In some embodiments, the groove34extends fully about the interior of the cup20. In some other embodiments, the groove34may be discontinuously spaced within the interior of the cup20, may have a “C” shape, a hemispherical shape, or some other suitable shape. The sections of the inner spherical surface32above (30) and below (32) the groove34have a uniform radius of curvature. Accordingly, the groove34does not protrude beyond a base of the tapered wall portion28as can be seen at least inFIG.4, which illustrates an enlarged cross-sectional view of the locking groove34as an interruption of the spherical inner surface32of the cup20. In some, but not all embodiments, the groove34acts as a locking feature for a liner50. In some such embodiments, the groove34is configured to capture a locking feature62of the liner50as will be discussed with reference to at leastFIGS.6-8Dbelow. Certain aspects of a liner50will now be described in connection with at leastFIGS.6-11and in connection with at leastFIGS.10and11. As used herein, the terms “liner” and “bearing” are used interchangeably to refer to a body comprising a bearing material and that fits within the acetabular cup20. In some embodiments, the liner50comprises polyethylene, e.g., a high molecular weight and/or cross-linked polyethylene. Alternatively, the liner50may be a metal bearing constructed from, e.g., stainless steel, titanium, titanium alloy, cobalt chromium molybdenum, cobalt chromium, a shape memory alloy such as nitinol, tantalum or other composites or biocompatible material(s). In yet another aspect, the liner50can be a ceramic liner made from, e.g., aluminum oxide, zirconium oxide, tetragonal zirconia polycrystal, alumina-zirconia composites, and/or non-oxide ceramics such as silicon carbide and silicon nitride. In some embodiments, the liner50can be pre-assembled to the cup20prior to insertion into a patient. In some other embodiments, the cup20can be positioned in a patient first and then the liner50can be introduced and positioned within the cup20. Thus, the acetabular system described herein contemplates at least a two-piece component design, which can be assembled prior to or during surgery. Turning toFIG.6, in some embodiments, the liner50is symmetric about at least one plane coincident with central axis60. However, once installed, rotation of the liner50within the cup20is prevented and micromotion therebetween is reduced at least partly as a result of interlocking of a plurality of outward-protruding scallops58on the liner50with the inward-facing protrusions22of the cup20. In some embodiments, the plurality of outward-protruding scallops58are evenly spaced and/or distributed around liner50. As described above, in some embodiments, the liner50includes the same number of outward-protruding scallops58as the cup has inward-facing recessed scallops22. In some other embodiments, the liner50includes a lesser number of outward-protruding scallops58(e.g.,6outward-protruding scallops) than the cup50has inward-facing recessed scallops22(e.g., 12 inward-facing recessed scallops). And in some embodiments, a number of evenly spaced inward-facing recessed scallops22of the cup20is an integer multiple of a number of evenly outward-protruding scallops58on the liner50to ensure multiple compatible rotational orientations between the cup20and the liner50. In some embodiments, e.g., where the liner50is a poly liner, the liner50can have at least a portion with an increased thickness compared to conventional poly liners. A thicker poly liner rim offers numerous benefits. For example, a thicker poly liner reduces the likelihood of impingement damage failure, which, in turn, lessens the incidence of hip dislocation, which is a serious complication in total hip replacement. Thinner poly liners can lead to cracking at the rim or locking mechanism on the acetabular cup. The liner50is designed to mate with the cup20. Accordingly, similar to the cup20, the liner50is substantially hemispherical in shape and has a liner outer surface52, which is substantially convex (as viewed from the outside) and a liner inner surface54, which is substantially concave (as viewed from the inside). The liner50comprises a liner rim56disposed at the top of the liner outer surface52. The liner50has a thickness t, measured between the liner outer surface52and the liner inner surface54. In some embodiments, the thickness t of the liner50is substantially uniform. In some other embodiments, the thickness t of the liner50varies between the liner rim56and the liner apex (where axis60crosses the liner50cross-section at the bottom ofFIG.6). The liner50comprises a plurality of outward-protruding scallops58which extend from the outer surface52of the liner50at the rim56. As described above, these outward-protruding scallops58are configured to facilitate the alignment and fixation of the liner50with respect to the cup20by engaging the inward-facing recessed scallops22of the cup20and substantially rotationally fixing the liner50with respect to the cup20. In one embodiment, the number of outward-protruding scallops58is equal to the number of inward-facing recessed scallops22of the cup20. In another embodiment, the number of outward-protruding scallops58is less than the number of inward-facing scallops22of the cup20. For example, in some embodiments, the number of outward-protruding scallops58may be half the number (e.g., 6) of inward-facing recessed scallops22of the cup20(e.g., 12). In some embodiments, the liner outer surface52can also include a locking feature62, for example as illustrated inFIGS.6-9. The locking feature62can be formed by conventional molding and forming techniques and is configured to engage with the groove34within the inner spherical surface32of the cup20during implantation, positioning, and fixing of the liner50within the cup20. The locking feature62is preferably integral with the liner50. The locking feature62snaps into groove34to thereby secure the liner50in position relative to the cup20. In some embodiments, the locking feature62is formed as a continuous overhang around the exterior of the liner50. In some other embodiments, the locking feature62alternatively comprises a plurality of segmented projections having discreet projection regions around the exterior of the liner50. In some embodiments, the locking feature62has a substantially angular (i.e. substantially non-rounded) geometry. In one embodiment, the locking feature62is substantially triangular in shape as best illustrated in the enlarged partial view ofFIG.7. It will be appreciated, however, that various geometries can be employed for the locking feature62such that the locking feature62is sufficiently captured as it engages with the groove34. Notably, the locking feature62includes an angled portion64and an extension lip66. In some embodiments, the angled portion64diverges from the hemispherical shape of the outer surface52of the liner50such that angled portion64has a substantially vertical orientation (e.g., substantially cylindrical face) when the liner50is oriented as shown inFIG.6. The extension lip66extends from the angled portion64. Preferably, the extension lip66extends from the angled portion64at an angle of, for example, 90 degrees such that a top surface of the extension lip66has a substantially horizontal orientation when the liner50is oriented as shown inFIG.6(i.e., perpendicular to angled portion64). Such a horizontal orientation of the top surface of the extension lip66may be substantially parallel to an orientation of an upper surface of the inside of the groove34when the liner50is properly seated within the cup20. However, the present disclosure is not so limited and the angled portion64and/or the extension lip66can have any orientations with respect to one another and/or with respect to the outer surface52of the liner50suitable for ensuring the extension lip66properly snaps into the groove34and secures the liner50into the cup20. The locking feature62can be disposed at any position below the outward-protruding scallops58. In some aspects, the locking feature62is positioned just below (e.g., substantially immediately below and adjacent to) the outward-protruding scallops58. Accordingly, the locking feature62is positioned along the exterior of the liner50such that, when it engages with the cup20, the locking feature62is positioned at or below the cylindrical band26of the cup20. In another aspect, the locking feature62is located at or around a mid-way point as measured from the liner rim56and the liner apex at the distal end of central axis60. Turning toFIGS.8A-8D, which illustrate partial sectional side views of a cup20having a poly liner locking feature62of the liner50engaged with groove34of the cup20. The cup assembly10is dimensioned to optimize the amount of capture between the locking feature62and groove34to ensure proper position, fit, and/or fixation of the liner50relative to the cup20. By optimizing the interference between the liner50and cup20through tolerances and dimensions of at least the locking feature62and the groove34, the acetabular cup assembly10disclosed herein has enhanced characteristics for assembly and resistance to dissociation. As seen inFIG.8A, the engagement of the locking feature62and cup20should have sufficient capture such that the hold is sufficiently strong with the least amount of interference (i.e., relatively low push-in force) and can be assembled with most interference (i.e., removal of the device should require relatively and/or comparatively high push-out force). In some embodiments, as the liner50is introduced into the cup20, locking feature62engages the inner surface of the cup20and is urged into groove34. As seen inFIG.8B, the outside diameter (Dl) of the locking feature62and inside diameter (Dg) of the cup groove34are sized to squeeze or very slightly deform the locking feature62to optimize liner alignment and stability leading to increased push-out strength. For example, in some embodiments, outside diameter (Dl) of the locking feature62can be up to about 0.03 inches larger than the inside diameter (Dg) of the cup groove34. In some embodiments, outside diameter (Dl) of the locking feature62can be up to about 0.008 inches larger than the inside diameter (Dg) of the cup groove34. In some embodiments, outside diameter (Dl) of the locking feature62can be up to about 0.002 inches smaller than the inside diameter (Dg) of the cup groove34. Accordingly, in some embodiments where Dlis smaller than Dg, the squeeze and/or very slight deformation of the locking feature62may no longer occur once locking feature62has settled into the cup groove24. In some such embodiments, when the liner20is seated in position, the locking feature62secures the liner to the cup20. InFIG.8C, the locking feature62is configured to optimize clearance between the top of the locking feature62and the top of the groove34to ensure that the locking feature62has sufficient distance (DS) to spring back into the groove34and thereby be fully captured. For example, in some embodiments, distance (DS) is approximately equal to, or slightly greater than, a distance from the angled portion64of the locking feature62to the outermost tip of the extension lip66of the locking feature62. InFIG.8D, the locking feature62is dimensioned with a shear thickness (T) sufficient to ensure sufficient strength at the thinnest condition. Advantageously, in some embodiments, the shear thickness (T) is 0.02 inches or less. In some embodiments, the shear thickness (T) is greater than or equal to 0.016 inches. However, the present disclosure is not so limited and the shear thickness (T) can have any suitable value. The thickness of the locking feature62is selected to ensure adequate strength so that the liner50does not push out with too little force to snap into place within the groove34while also avoiding being too thick such that full and secure assembly is prevented. Turning toFIGS.10and11, additional embodiments of a liner50are illustrated. In some embodiments, the liner50is cylindrically symmetric about the central axis60. However, once installed, rotation of the liner50within the cup20is prevented and micromotion therebetween is reduced at least partly as a result of interlocking of a plurality of outward-protruding scallops58on the liner50with the inward-facing protrusions22of the cup20. The liner50is designed to mate with the cup20. Accordingly, similar to the cup20, the liner50is substantially hemispherical in shape and has a liner outer surface52, which is substantially convex (as viewed from the outside) and a liner inner surface54, which is substantially concave (as viewed from the inside). The liner50comprises a liner rim56disposed at the top of the liner outer surface52and a plurality of outward-protruding scallops58which extend from the outer surface52of the liner50at the rim56. In one embodiment, the number of outward-protruding scallops58is equal to a number of inward-facing recessed scallops22of the cup20. In another embodiment, the number of outward-protruding scallops58will be less than the number of inward-facing scallops22of the cup20. For example, in some embodiments, the number of outward-protruding scallops58may be half the number (e.g., 6) of inward-facing recessed scallops22of the cup20(e.g., 12). And in some embodiments, a number of evenly spaced inward-facing recessed scallops22of the cup20is an integer multiple of a number of evenly outward-protruding scallops58on the liner50to ensure multiple compatible rotational orientations between the cup20and the liner50. As described above, these outward-protruding scallops58are configured to facilitate the alignment and fixation of the liner50with respect to the cup20by engaging the inward-facing recessed scallops22of the cup20and substantially rotationally fixing the liner50with respect to the cup20. In some embodiments, the plurality of outward-protruding scallops58have a thickness t2that is as thin as practical such that liner50rests as close as practical to an “engaged” position above the cup20when the liner50is disposed on a top of the cup20but oriented with sufficient axial rotation, relative to an “aligned” position with the cup20, to initially prevent the plurality of outward-protruding scallops58of the liner50from interlocking with the plurality of inward-facing scallops22of the cup20and to initially prevent the liner50from entirely seating in the cup20. This initial orientation between the cup20and the liner50ensures the liner50is properly aligned with the cup20in a “pre-installed” position. Deliberately providing the plurality of outward-protruding scallops58with a thickness t2that is as thin as practical provides several benefits over systems having a greater thickness. For example, such a minimal thickness t2ensures the liner50only has to descend a minimal distance from the above-described “pre-installed” position to the “aligned” and “engaged” position, which significantly reduces the probability of liner50becoming misaligned when secured to the cup20. In some embodiments, at least an upper portion68of the outer surface52of the liner50can be tapered (e.g., an upper portion configured to mate against the upper tapered wall portion28of the cup20). Advantageously, in some such embodiments, the degree of such a taper mirrors the taper of the upper tapered wall portion28of cup20and, therefore, can have a degree of taper of any angle or range of angles as described above with respect to the upper tapered wall portion28of cup20. In some such embodiments, the tapered upper portion68of the outer surface52of the liner50provides an interference and/or friction fit with the upper tapered wall portion28of cup20. In some such embodiments, liner50may not be configured to extend into any annular groove34formed in the inner surface14of the cup20. Accordingly, in some such embodiments, liner50does not include the locking feature62as previously described in connection withFIGS.6-9. Furthermore, in some but not all such embodiments, the cup20can also omit the annular groove34. In some embodiments, the liner50comprises a peg70extending from a bottom of the outer surface52of the liner50. The peg70is configured to engage with the aperture38of the cup20when the liner50is properly seated within the cup20. In some embodiments, the peg70is threaded and configured to engage with mating threads within the aperture38of the cup20, thereby securing the liner50within the cup20. In some embodiments, the peg70is configured to rest just above the mating aperture38of the cup20when the liner50is resting on the cup20in the above-described “pre-installed” position. When the liner50is rotated sufficiently to align the outward-protruding scallops58of the liner50with the plurality of inward-facing scallops22of the cup20, the liner50drops the deliberately-shortened distance to the “aligned” and “engaged” position, defined by the deliberately-decreased thickness t2of the outward-protruding scallops58of the liner50, and the peg70of the liner50engages with the aperture38of the cup20, thereby preventing misalignment between the liner50and the cup20. It should be appreciated that the peg70disposed at the bottom of the liner50and the deliberately-decreased thickness of the outward-protruding scallops58of the liner50and/or of the inward-facing scallops22of the cup20function together to properly and accurately “pre-align” the liner50with the cup20and then maintain alignment as the liner50is seated into its final position within the cup20. By contrast, systems not utilizing such a peg in connection with such a deliberately-decreased thickness of outward-protruding scallops of a liner and/or of inward-facing scallops of a cup risk an increased probability of misalignment between cups and liners in vivo due at least in part to an increased drop distance and increased off-alignment mobility between such a “pre-aligned” position and such an “aligned” and “engaged” position. Such misalignment and canted liners in vivo have been found to significantly increase the risk of corrosion of the implanted parts. Accordingly, systems, liners and/or cups as disclosed herein provide novel and non-obvious improvements over previous systems, liners and/or cups. Turning toFIG.12, in some embodiments, upon securing the liner50in the cup20, liner50can be configured to receive a femoral assembly300therein. In some embodiments, such a femoral assembly300can comprise an outer head330disposed over and/or around an inner head320and a stem trunnion330coupled to the inner head320. The stem trunnion330is configured to be secured within a femur of a patient and configured to secure the inner head320to the femur of the patient. The inner head320is configured to function as a replacement for the natural proximal head of the femur of the patient. The inner head320can comprise any suitable material, e.g., metal, metal alloy, etc. In some embodiments, the outer head330functions as a sleeve that provides a low-friction interface with the inner surface of the liner50. The outer head330can comprise any suitable material, e.g., polyethylene, metal, metal alloy, etc. Discussion now turns to an example method of using an acetabular cup assembly, such as that described in connection with any ofFIGS.1-12.FIG.13illustrates a flowchart1300corresponding to such a method of use, in accordance with some embodiments. While flowchart1300illustrates one or more actions and/or steps, it should be understood that one or more described actions can be omitted, one or more additional or alternative actions can be added, and/or one or more actions can be performed in another order than that specifically described without departing from the spirit or scope of the present disclosure. Block1302includes preparing a bone of a patient for receiving a cup of the acetabular cup system. For example, as previously described in connection with at least one figure, a surgeon can prepare the bone by reaming the acetabular socket to create a surface for accepting the cup20. Block1304includes securing the cup to the prepared bone of the patient. For example, as previously described in connection with at least one figure, the cup20may be held in place by bone cement, an interference or press fit, or one or more bone screws for example, through one or more hole(s)40(see, e.g.,FIG.3). As previously described, the cup20comprises an outer surface16configured to engage an anatomy, a top face18at an upper end of the cup20, and a generally concave inner surface14. The generally concave inner surface14comprises a cylindrical band26having disposed therein a plurality of inward-facing recessed scallops22adjacent to the top face18, a tapered wall28disposed adjacent to the cylindrical band26, and an inner spherical surface30,32adjacent to the tapered wall28. The inner spherical surface14has a substantially uniform radius of curvature and a single groove34interrupting the spherical surface14. In some embodiments, the plurality of inward-facing recessed scallops22of the cylindrical band26comprises at least twelve inward-facing recessed scallops22. In some embodiments, the outer surface16of the cup20comprises a porous coating configured to aid bone in-growth between the prepared bone of the patient and the outer surface16of the cup20. Block1306includes aligning a liner over the cup. For example, as previously described in connection with at least one figure the surgeon can align the liner50over the cup20. As previously described, the liner50can comprise a substantially convex outer surface52configured to be received within the concave inner surface14of the cup20, a rim56and a plurality of outward-projecting scallops58adjacent to the rim56. In some embodiments, the liner50comprises a metallic material. In some embodiments, the metallic material is selected from the group consisting of stainless steel, cobalt-based alloys, a shape memory alloy, tantalum, metal composites, and combinations thereof. In some embodiments, the plurality of outward-protruding scallops58comprises at least six outward-protruding scallops58. In some embodiments, aligning the liner over the cup (e.g., block1306) can include aligning a bottom of the peg70a predetermined distance t2above the aperture38of the cup50when the plurality of outward-protruding scallops58of the liner50are disposed on the top face18of the cup20and oriented with sufficient axial rotation relative to the cup20to prevent the plurality of outward-protruding scallops58of the liner50from interlocking with the plurality of inward-facing scallops22of the cup50. Block1308includes securing the liner within the cup such that each of the outward-projecting scallops of the liner engage with a respective one of the inward-facing recessed scallops of the cup. For example, as previously described in connection with at least one figure, in some embodiments (see, e.g.,FIGS.10ands11), the outer surface52of the liner50comprises a tapered portion68and securing the liner50within the cup20comprises engaging the tapered portion68of the liner50with the tapered wall28of the cup20in a substantially interference fit. In some embodiments (see, e.g.,FIGS.10and11) the cup20further comprises an aperture38and the liner50further comprises a peg70. In some such embodiments, securing the liner50within the cup20comprises receiving the peg70into the aperture38. In some embodiments, securing the liner50within the cup20comprises axially rotating the liner50until the plurality of outward-protruding scallops58of the50liner interlock with the plurality of inward-facing scallops22of the cup20and the peg70closes the predetermined distance t2and properly seats within the aperture38of the cup50. In some embodiments (see, e.g.,FIGS.6-9), the liner50comprises polyethylene or another suitable plastic material. In some such embodiments, the liner50comprises a locking feature62and securing the liner50within the cup20comprises securing the locking feature62within the single groove34disposed in the inner spherical surface14of the cup20. In some embodiments, the locking feature62has a substantially triangular shape. In some embodiments, the locking feature62extends continuously around the outer surface52of the liner50. In some embodiments, the locking feature62comprises a plurality of discrete projections disposed discontinuously around the outer surface of the liner50. In some embodiments, the locking feature62comprises an angled portion64that has a substantially vertical orientation so as to diverge from the convex outer surface52of the liner50, and an extension lip66extending substantially perpendicularly from the angled portion34and configured to engage the single groove34of the cup20. In some embodiments, an upper surface of the extension lip66has a substantially horizontal orientation that is substantially parallel to an orientation of an upper inside surface of the single groove34when the liner50is seated within the cup20. In some embodiments, an outer diameter Dl of the extension lip66is greater than an inner diameter Dgof the single groove34such that the single groove34exerts a deforming force on the extension lip66while securing the liner50within the cup20. In some embodiments, a first distance Ds between an upper inside surface of the single groove34of the cup20and an upper surface of the extension lip66of the locking feature62is greater than or equal to a second distance from the angled portion64to the outermost tip of the extension lip66of the locking feature62. Reference throughout this disclosure to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this disclosure are not necessarily all referring to the same embodiment. Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim in this or any application claiming priority to this application require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the disclosure is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present disclosure disclosed herein without departing from the spirit and scope of the disclosure. | 44,315 |
11857423 | DETAILED DESCRIPTION Disclosed herein are liners (e.g., metal liners, such as made of titanium, plastic liners, such as made of Polyethylene, ceramic liners) for use in a hip joint surgical procedure, such as hip joint revision surgery, where an acetabular cup is implanted in the acetabulum of the pelvis bone. The acetabular cup can at least partially receive the liner, which can at least partially receive a ball of a femoral stem implant, or can receive a second liner (e.g., made of plastic, such as Polyethylene) that can then receive the ball of the femoral stem implant. The liners disclosed below advantageously provide structural support to the ball of the femoral stem while inhibiting (e.g., preventing) loss of material as occurs with plastic liners. Additionally, the liners disclosed herein allow a smaller femoral stem head to be used with a same sized acetabular cup, with the head laterally displaced farther away from the bottom of the acetabular cup, which advantageously provides improved stability of the hip joint. FIG.1shows a perspective view of an acetabular cup100having an outer convex surface10, an outer rim20and an inner convex surface or bearing surface30that defines a cavity that receives a liner, such as the liners disclosed herein. FIG.2Ashows a liner200coupled to the acetabular cup100andFIG.2Bshows a top view of the liner200and an impactor300that can be used to impact the liner200into place in the acetabular cup100. The liner200can sit flush with the acetabular cup100and have a proximal portion220that protrudes relative to the outer rim20of the acetabular cup100. The liner200can also have a bearing surface210and an outer rim230that circumscribes the bearing surface210. The outer rim230can extend a long a plane (e.g., be planar). The liner200can have one or more visual indications240,250identifying the location of the impaction force for the liner200to be impacted square relative to the acetabular cup100. The visual indicators can include an indicator240(e.g., cross-hairs, dot, sticker or removable layer) on the bearing surface210. The visual indicators can also include one or more indicators250(e.g., etched lines, markings) on the outer rim230or bearing surface210that align with the indicator240. The visual indicators can be in separate components (e.g., stickers), which can be removed after the impaction force is applied. In another implementation, the visual indicators can be made (e.g., etchings, grooves) in the material of the liner200. In still another implementation, the visual indicators can be virtual (e.g., applied to or projected onto the liner200by a robotic system, such as by an imaging system of a robotic surgical system). The impactor300has a shaft S and an impaction surface310corresponding to the liner200. In the illustrated implementation, the impaction surface310is planar and corresponds to the planar outer rim230of the liner200, so that the impactor300can apply a force square relative to the liner200to seat the liner200in the acetabular cup100(e.g., so the center of the impaction force that is applied is located at the location of the visual indicator240). In one implementation, an outer diameter or dimension of the impaction surface310corresponds with an outer diameter of the outer rim230of the liner200. FIG.3Ashows a liner200A coupled to the acetabular cup100andFIG.3Bshows a top view of the liner200A and the impactor300, which can be used to impact the liner200A into place in the acetabular cup100. Some of the features of the liner200A are similar to features of the liner200inFIGS.2A-2B. Thus, reference numerals used to designate the various components of the liner200A are identical to those used for identifying the corresponding components of the liner200inFIGS.2A-2B, except that an “A” has been added to the numerical identifier. Therefore, the structure and description for the various features of the liner200inFIGS.2A-2Bare understood to also apply to the corresponding features of the liner200A inFIGS.3A-3B, except as described below. The liner200A differs from the liner200in that it's outer rim230A is laterally spaced from the outer rim20by a larger amount than the liner200. Similarly, the bearing surface210A can be laterally spaced from a distal end of the acetabular cup100by a larger amount than the bearing surface210of the liner200, allowing the head of the femoral stem implant to be further laterally spaced apart (as compared with the liner200and acetabular cup100). The outer rim230A of the liner200A can be planar (e.g., extend along or be defined by a plane) so the same impactor300used for the liner200can be used for the liner200A to apply an impaction force on the liner200A square with the acetabular cup100(e.g., so the center of the impaction force that is applied is located at the location of the visual indicator240). FIG.4Ashows a liner200B coupled to the acetabular cup100andFIG.4Bshows a top view of the liner200B and an impactor300B, which can be used to impact the liner200B into place in the acetabular cup100. Some of the features of the liner200B and impactor300B are similar to features of the liner200and impactor300inFIGS.2A-2B. Thus, reference numerals used to designate the various components of the liner200B and impactor300B are identical to those used for identifying the corresponding components of the liner200and impactor300inFIGS.2A-2B, except that a “B” has been added to the numerical identifier. Therefore, the structure and description for the various features of the liner200and impactor300inFIGS.2A-2Bare understood to also apply to the corresponding features of the liner200B and impactor300B inFIGS.4A-4B, except as described below. The liner200B differs from the liner200in that the outer rim230B (and therefore the face) of the liner200B extends at an angle f relative to the outer rim20of the acetabular cup100. The bearing surface210B has visual indicators240B,250B for applying an impaction force on the liner200B square with the acetabular cup100using an impactor300B. The bearing surface210B of the liner200B can also have a visual indicator260B indicating the offset location of the center of the bearing surface resulting from the angled outer rim230B. The impactor300B has an impactor surface310B corresponding to the outer rim230B of the liner200B. The impactor surface310B can be angled at the same angle ϕ relative to the shaft S as the outer rim230B is to the outer rim20of the acetabular cup100. This advantageously allows the impactor300B to apply an impaction force square on the outer rim230B of the liner200relative to the acetabular cup100(e.g., so the center of the impaction force that is applied is located substantially at the location of the visual indicator240B). FIG.5Ashows the liner200attached to the acetabular cup100andFIG.5Bshows an impactor300C that can be used to impact the liner200into place in the acetabular cup100. The impactor300C can have a curved (e.g., convex, spherical) impactor surface310C. The impactor300C can be used instead of the impactor300to apply an impaction force on the liner200to seat the liner200in the acetabular cup. Unlike the impactor300, which applies the impaction force on the outer rim230of the liner200, the impactor300C can be used to apply the impaction force on or proximate the visual indicator240so that the impactor300C impacts the liner200square relative to the acetabular cup100. FIG.6shows a perspective view of a liner200D attached to the acetabular cup100.FIG.7Ashows a cross-sectional side view of the liner200D coupled to the acetabular cup100andFIG.7Bshows a top view of the liner200D and an impactor300D, which can be used to impact the liner200D into place in the acetabular cup100. Some of the features of the liner200D are similar to features of the liner200inFIGS.2A-2B. Thus, reference numerals used to designate the various components of the liner200D are identical to those used for identifying the corresponding components of the liner200inFIGS.2A-2B, except that a “D” has been added to the numerical identifier. Therefore, the structure and description for the various features of the liner200inFIGS.2A-2Bare understood to also apply to the corresponding features of the liner200D inFIGS.6-7B, except as described below.FIGS.6-7Bare not to scale and are exaggerated to show that the center of the bearing surface of the liner200D, and therefore the head of the femoral stem implant received therein, would be offset or off-center relative to the center of the acetabular cup100. The liner200D differs from the liner200in that bearing surface210D (e.g., concave) of the liner200D is offset from a centerline of the acetabular cup100so that the bearing surface210D is not coaxial with the bearing surface30of the acetabular cup100, and so that a center of the head of the femoral stem implant that is received by the bearing surface210D would be offset or off-center relative to the axis or center of the acetabular cup100. As shown inFIG.7A, the axis of the bearing surface210D can be offset by a distance X from a centerline or axis of the acetabular cup100. The distance X can be between a few millimeters and a few centimeters, such as between about 2 mm and about 2-3 cm. The distance X can in one implementation be no more than 3 cm, such as no more than about 2.5 cm. Therefore, the proximal surface230D of the liner200D is planar except for the opening above the bearing surface210D. The location of the bearing surface210D relative to the central axis of the acetabular cup100(e.g., phase change of the bearing surface210D) can be adjusted by the surgeon before or after seating the liner200D in the acetabular cup100. The impactor300D has an impactor surface310D corresponding to the planar proximal surface230D of the liner200D and has a curved (e.g., convex, spherical) impactor surface320D corresponding to (e.g., having the same radius of curvature as) the bearing surface210D of the liner200D. This advantageously allows the impactor300D to apply an impaction force square on the liner200D relative to the acetabular cup100(e.g., so the center of the impaction force that is applied by the impactor300D is located at the location of the visual indicator240D). FIG.8Ashows a cross-sectional side view of the liner200E coupled to the acetabular cup100andFIG.8Bshows a top view of the liner200E and an impactor300E, which can be used to impact the liner200E into place in the acetabular cup100. Some of the features of the liner200E are similar to features of the liner200D inFIGS.6-7B. Thus, reference numerals used to designate the various components of the liner200E are identical to those used for identifying the corresponding components of the liner200D inFIGS.6-7B, except that an “E” instead of a “D” has been added to the numerical identifier. Therefore, the structure and description for the various features of the liner200D inFIGS.6-2B, which are based on the structure and description of the features of the liner200inFIGS.2A-2B, are understood to also apply to the corresponding features of the liner200E inFIGS.8A-8B, except as described below.FIGS.8A-7Bare not to scale and are exaggerated to show that the center of the bearing surface of the liner200E, and therefore the head of the femoral stem implant received therein, would be offset or off-center relative to the center of the acetabular cup100in two planes. The liner200E differs from the liner200D in that the proximal surface230E has an inclined portion235E across the bearing surface210E relative to the remainder of the proximal surface230E. The bearing surface210E (e.g., concave) of the liner200E is offset from a centerline of the acetabular cup100so that the bearing surface210E is not coaxial with the bearing surface30of the acetabular cup100, and so that a center of the head of the femoral stem implant that is received by the bearing surface210E would be offset or off-center (in two planes) relative to the axis or center of the acetabular cup100. As shown inFIG.8A, the axis of the bearing surface210E can be offset by a distance X′ from a centerline or axis of the acetabular cup100. The distance X′ can be between a few millimeters and a few centimeters, such as between about 2 mm and about 2-3 cm. The distance X′ can in one implementation be no more than 3 cm, such as no more than about 2.5 cm. Therefore, the proximal surface230E of the liner200E has a first planar portion, an inclined portion235E that extends at an angle from the planar portion, and an opening defined in the inclined portion235E above the bearing surface210E. The location of the bearing surface210E relative to the central axis of the acetabular cup100(e.g., phase change of the bearing surface210E) can be adjusted by the surgeon before or after seating the liner200D in the acetabular cup100. The inclined portion235E allows the head of the femoral stem (not shown) to be further laterally offset from the acetabulum. The impactor300E has an impactor surface310E corresponding to the planar proximal surface230E of the liner200E, a curved (e.g., convex, spherical) impactor surface320E corresponding to (e.g., having the same radius of curvature as) the bearing surface210E of the liner200E, and an inclined surface330E corresponding to the inclined portion235E of the liner200E. This advantageously allows the impactor300E to apply an impaction force square on the liner200E relative to the acetabular cup100(e.g., so the center of the impaction force that is applied by the impactor300E is located at the location of the visual indicator240E). FIG.9shows a side view of a liner200F attached to the acetabular cup100and an impactor300F, which can be used to impact the liner200F into place in the acetabular cup100. Some of the features of the liner200F are similar to features of the liner200inFIGS.2A-2B. Thus, reference numerals used to designate the various components of the liner200F are identical to those used for identifying the corresponding components of the liner200inFIGS.2A-2B, except that an “F” has been added to the numerical identifier. Therefore, the structure and description for the various features of the liner200inFIGS.2A-2Bare understood to also apply to the corresponding features of the liner200F inFIG.9, except as described below. The liner200F differs from the liner200in that the proximal surface230F (e.g., outer rim) has an inclined portion235F relative to the remainder of the proximal surface230F. The proximal surface230F of the liner200F has a planar portion (e.g., portion of the outer rim defined by a plane perpendicular to an axis of the liner200F) and an inclined portion235F that extends at an angle from the planar portion. The impactor300F has an impactor surface310F corresponding to the planar portion of the proximal surface230F of the liner200E and an inclined surface320F corresponding to the inclined portion235F of the liner200F. This advantageously allows the impactor300F to apply an impaction force square on the liner200F relative to the acetabular cup100(e.g., so the center of the impaction force that is applied by the impactor300F is located at the location of the visual indicator240F). FIG.10shows a side view of the liner200B ofFIGS.4A-4Battached to the acetabular cup100. Instead of using the impactor300B to impact the liner200B to seat the liner200B in the acetabular cup100, the impactor300C can be used. The impactor300C can be operated by a surgeon to apply an impaction force with the impaction surface310C on the liner200B on the visual indicator240B. This advantageously allows the impactor300C to apply an impaction force square on the liner200B relative to the acetabular cup100(e.g., so the center of the impaction force that is applied by the impactor300C is located at the location of the visual indicator240B). FIG.11shows a liner kit400for use with an acetabular cup100in hip joint replacement or revision surgery. The kit400can include one or more of each of the liners200,200A,200B,200D,200E,200F disclosed herein. In one implementation, the kit400can also include one or more of the impactors300,300B,300C,300D,300E,300F disclosed herein. In one implementation, the kit400can also include one or more of the acetabular cups100sized to receive the liner200,200A,200B,200D,200E,200F. Advantageously, the bearing surface30of the acetabular cup100and outer surface of the liners200,200A,200B,200D,200E,200F allow for each of the liners200,200A,200B,200D,200E,200F to seat in the acetabular cup100. In one implementation, the kit400has liners200,200A,200B,200D,200E,200F sized to correspond to a particular size acetabular cup100. Therefore, each acetabular cup100of a different size can have a separate kit400of associated liners200,200A,200B,200D,200E,200F that can be used with that size acetabular cup100. The kit400provides the surgeon with different liner options for use with a particular size acetabular cup100, depending on the anatomy of the patient to provide the desired relationship between the femur and acetabulum with the hip joint replacement prosthesis. FIG.12shows a flow chart of a process or method500for using a liner, such as the liners200,200A,200B,200D,200E,200F disclosed herein, in hip joint replacement or revision surgery. The method500includes the step510of evaluating the size of the acetabular hole in the pelvis bone and identifying the size of acetabular cup needed for the acetabular hole. The method500also includes the step520of preparing the acetabular hole (e.g., reaming the acetabulum to create a base of vascular cancellous bone to facilitate bone growth) for receiving the acetabular cup, such as the acetabular cup100. The method500also includes the step530of identifying the liner (such as one of the liners200,200A,200B,200D,200E,200F) for use with the acetabular cup (such as the acetabular cup100). The method500also includes the step540of inserting and attaching the acetabular cup in the acetabular hole, and the step550of inserting the liner (such as the liner200,200A,200B,200D,200E,200F) in the acetabular cup. The method500also includes the step560of impacting the liner (such as the liner200,200A,200B,200D,200E,200F) into place (e.g., seating) within the acetabular cup with an impactor (such as the impactor300,300B,300C,300D,300E,300F), such that the impactor applies an impaction force on the liner square with the acetabular cup. ADDITIONAL EMBODIMENTS In embodiments of the present disclosure, a liner for an acetabular cup, liner and impactor system and method for implanting a liner may be in accordance with any of the following clauses: Clause 1. A liner for an acetabular cup, comprising:a proximal surface;an outer convex surface configured to at least partially extend into an acetabular cup when the liner is seated in the acetabular cup;a concave bearing surface recessed relative to the proximal surface and configured to receive a head of a femoral stem; andone or more visual indicators on the liner configured to identify a location for applying an impaction force on the liner so that the liner is impacted square relative to the acetabular cup. Clause 2. The liner of clause 1, wherein the one or more visual indicators are markings on the proximal surface or concave bearing surface. Clause 3. The liner of clause 2, wherein the markings include one of cross hairs, dots and dashed lines. Clause 4. The liner of any preceding clause, wherein the visual indicators are virtual indicators applied or projected onto the proximal surface or concave bearing surface. Clause 5. The liner of any preceding clause, wherein the concave bearing surface extends about an axis that is offset from an axis of the acetabular cup when the liner is seated in the acetabular cup. Clause 6. The liner of any preceding clause, wherein at least a portion of the proximal surface extends along a plane perpendicular to an axis of the acetabular cup when the liner is seated in the acetabular cup. Clause 7. The liner of any preceding clause, wherein at least a second portion of the proximal surface extends along a second plane at an angle relative to the plane, the second portion defining an opening above the concave bearing surface. Clause 8. The liner of any preceding clause, wherein at least a portion of the proximal surface extends along a plane perpendicular to an axis of the acetabular cup when the liner is seated in the acetabular cup. Clause 9. The liner of any preceding clause, wherein at least a second portion of the proximal surface extends along a second plane at an angle relative to the plane, the second portion defining an opening above the concave bearing surface. Clause 10. A liner and impactor system for an acetabular cup, comprising:a liner comprisinga proximal surface;an outer convex surface configured to at least partially extend into an acetabular cup when the liner is seated in the acetabular cup;a concave bearing surface recessed relative to the proximal surface and configured to receive a head of a femoral stem; andone or more visual indicators on the liner configured to identify a location for applying an impaction force on the liner; andan impactor having an impaction surface corresponding to one or both of the proximal surface and the concave bearing surface of the liner, the impactor configured to apply an impaction force on the liner so that the liner is impacted square relative to the acetabular cup. Clause 11. The system of clause 10, wherein the one or more visual indicators include markings on the proximal surface or concave bearing surface. Clause 12. The system of clause 11, wherein the markings include one of cross hairs, dots and dashed lines. Clause 13. The system of any of clauses 10-12, wherein the visual indicators are virtual indicators applied or projected onto the proximal surface or concave bearing surface. Clause 14. The system any of clauses 10-13, wherein the concave bearing surface extends about an axis that is offset from an axis of the acetabular cup when the liner is seated in the acetabular cup. Clause 15. The system of any of clauses 10-14, wherein at least a portion of the proximal surface extends along a plane perpendicular to an axis of the acetabular cup when the liner is seated in the acetabular cup. Clause 16. The system of any of clauses 10-15, wherein at least a second portion of the proximal surface extends along a second plane at an angle relative to the plane, the second portion defining an opening above the concave bearing surface. Clause 17. The system of any of clauses 10-16, wherein at least a portion of the proximal surface extends along a plane perpendicular to an axis of the acetabular cup when the liner is seated in the acetabular cup. Clause 18. The system of any of clauses 10-17, wherein at least a second portion of the proximal surface extends along a second plane at an angle relative to the plane, the second portion defining an opening above the concave bearing surface. Clause 19. A method for implanting a liner in an acetabular cup, comprising:evaluating a size of an acetabular hole;identifying a size of an acetabular cup for the acetabular hole;preparing the acetabular hole to receive the acetabular cup;identifying a liner for use with the acetabular cup;inserting the acetabular cup in the acetabular hole;inserting the liner in the acetabular cup; andimpacting the liner into place in the acetabular cup with an impactor square with the acetabular cup to seat the liner in the acetabular cup. Clause 20. The method of clause 19, wherein impacting the liner with the impactor includes applying an impaction force on the liner so that the applied force is centered on a visual indicator on the liner. While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the systems and methods described herein may be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure. Accordingly, the scope of the present inventions is defined only by reference to the appended claims. Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination. Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z. Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree. The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Of course, the foregoing description is that of certain features, aspects and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Moreover, the devices described herein need not feature all of the objects, advantages, features and aspects discussed above. Thus, for example, those of skill in the art will recognize that the invention can be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or subcombinations of these specific features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed devices. | 31,799 |
11857424 | DETAILED DESCRIPTION OF THE DISCLOSURE Referring toFIGS.4and5, an illustrated embodiment of a hinged articulating spacer system for revision knee arthroplasty constructed according to the teachings of the present disclosure is generally indicated at reference numeral100. The hinged articulating spacer system100generally comprises a hinged rod assembly, generally indicated at102, and an articulating component assembly, generally indicated at104. InFIGS.4and5, the hinged articulating spacer system100is assembled. As explained in more detail below, the hinged articulating spacer system100is suitable for use in two-stage revision TKA. More specifically, the spacer system100is implanted after removing the infected knee prosthesis to allow for antibiotic treatment of the infected jointed space (e.g., 6 to 12 weeks) before performing the revision TKA. The spacer system100allows range of motion of the knee, unlike the static spacer, such as shown inFIG.2. Further, the spacer system100inhibits dislocation of the knee joint, unlike a conventional articulating spacer, such as shown inFIG.3. It is believed the implantation of the spacer system100allows for better weight bearing than the articulating spacer, such that motion, pain control and subsequent surgical exposure may be better than the conventional articulating spacer. Referring toFIGS.4-8, the hinged rod assembly102generally comprises a femur rod108, and a tibia rod110hingedly coupled to the femur rod at a hinged joint to allow rotational or pivoting motion of the tibia rod relative to the femur rod about a transverse rotational axis A (FIG.4). As seen best inFIG.8, the distal end of the femur rod108has a first coupler (e.g., a fork coupler) hingedly couplable with a second coupler (e.g., a male coupler) at a proximal end of the tibia rod110. In the illustrated embodiment, the first and second couplers define aligned transverse openings112,113, respectively, through which a hinge pin, generally indicated at114inFIG.7, is inserted to allow rotational movement of the tibia rod110relative to the femur rod108about the transverse rotational axis A. In one or more embodiments, the femur rod108and the tibia rod110may be formed from, for example, one or more of metal, PMMA (Poly(methyl methacrylate)) (e.g., coated with PMMA), polyethylene, other suitable materials, and combinations thereof. The hinge pin114may be of suitable design and construction. In one or more embodiments, such as shown inFIG.7, the hinge pin114comprises a cylindrical bearing114ahaving a first end shoulder or stop, and a retainer114bhaving a second end shoulder or stop. The cylindrical bearing114ais internally threaded to threadably mate with external threading on a shaft of the retainer114bto form the hinge pin114. The end shoulders retain the hinge pin within the couplers of the femur and tibia rod108,110. In one or more embodiments, such as shown inFIGS.9A and9B, a hinge pin114′ may include a cylindrical bearing114a′ having an end shoulder or stop, and a snap-fit retainer114b′ including cantilevered snap-fit arms and an end shoulder or stop. The snap-fit arms are slidably insertable into the cylindrical bearing114a′ and secured therein by snap-fit connection, as shown inFIG.9B, to form the hinge pin114′. The end shoulders retain the hinge pin114′ within the couplers of the femur and tibia rods108,110. In one or more embodiments, the hinge pin may be a hinge pin secured in the aligned openings of the femur and tibia rods108,110by a cotter pin or retaining ring, as is generally known. The femur and tibia rods108,110may be hingedly couplable to one another in other ways. For example, inFIG.10another hinged rod assembly102′ comprises a femur rod108′, and a tibia rod110′ hingedly coupled to the femur rod at a hinged joint to allow rotational or pivoting motion of the tibia rod relative to the femur rod about a transverse rotational axis A′. The hinged rod assembly102′ is similar to the hinged rod assembly102and functions, in operation, in essentially the same way. The distal end of the femur rod108′ has a first coupler (e.g., a fork coupler) hingedly couplable with a second coupler (e.g., a male coupler) at a proximal end of the tibia rod110′. In the illustrated embodiment, the first and second couplers define aligned transverse openings through which a hinge pin, generally indicated at114′, is inserted to allow rotational movement of the tibia rod110′ relative to the femur rod108′ about the transverse rotational axis A′. Compared to the hinged rod assembly102, the fork coupler of the femur rod108′ of the present hinged rod assembly102′ has struts or tines that have a greater thickness than struts or tines of the other hinged rod assembly102. Moreover, the hinge pin114′ in this embodiment may comprise a single component having a snap-fit connector that “snaps” directly onto the distal end of the femur rod108′, rather than a two-piece component as shown inFIGS.9A and9B, for example. Referring toFIGS.13-15, the femur rod108is configured to be inserted into the medullary canal of the femur. The tibia rod110is configured to be inserted into the medullary canal of the tibia. As explained in more detail below, when the femur and tibia rods108,110are inserted into the respective medullary canals of the femur and tibia, the axis of the hinged joint is located generally at the rotational axis of the knee to allow at least limited extension and flexion of the knee. Moreover, the hinged rod assembly102(e.g., the hinge joint) may bear at least some of the load at the knee joint. The femur and tibia rods108,110may be constructed of suitable biocompatible material that is generally rigid. For example, the rods108,110may be formed from stainless steel, titanium, or other materials. In one or more embodiments, the body or shaft of the femur rod108may have a diameter from about 10 mm to about 16 mm, or other suitable diameters or cross-sectional dimensions. In one or more embodiments, the femur rod108may have a length from about 150 mm to about 200 mm, or other suitable lengths. In one or more examples, the body or shaft of the tibia rod110may have a diameter from about 10 mm to about 14 mm, or other suitable diameters or cross-sectional dimensions. In one or more embodiments, the tibia rod110may have a length of about 150 mm, or other suitable lengths. Referring toFIGS.4,5and11A-12C, the articulating component assembly104generally comprises a femoral spacer component120and a tibial spacer component122. The femoral spacer component120is configured to be secured to the distal end of the femur, such as by bone cement (e.g., PMMA (Poly(methyl methacrylate))), which may be pre-loaded with antibiotics. The femoral spacer component120may be pre-formed (i.e., pre-manufactured) from bone cement (e.g., PMMA) and impregnated with antibiotics (e.g., gentamicin), similar to conventional articulating spacers. The femoral spacer component120may have a shape similar to conventional femoral articulating spacers and/or TKA femoral spacer components or may have other suitable shapes. The tibial spacer component122is configured to be secured to the proximal end of the tibia, such as by bone cement (e.g., PMMA), which may be pre-loaded with antibiotics. The tibial spacer component122may be pre-formed (i.e., pre-manufactured) from bone cement (e.g., PMMA) and impregnated with antibiotics (e.g., gentamicin), similar to conventional tibial articulating spacers. The tibial spacer component122may have a shape similar to conventional tibial articulating spacers and/or TKA tibial spacer components or may have other suitable shapes. When implanted, respective articular surfaces of the femoral and tibial spacer components120,122engage one another through range of motion of the knee while bearing at least some load. As shown inFIG.11A-12C, unlike conventional articulating spacers, the femoral and tibial spacer components120,122define openings120a,122a, e.g., through openings, recesses, or clearances, in or through which the hinged rod assembly102is received. In the illustrated embodiment, only the tibia rod110extends through the openings120a,122asuch that the hinged joint of the hinged rod assembly102is superior to the openings. In one or more other embodiments, the hinged joint of the hinged rod assembly102may be received in the openings120a,122asuch that the openings provide clearance for the hinged joint through range of motion of the knee. It is understood that the hinged joint of the hinged rod assembly102may be disposed at any location relative to the openings120a,122aof the femoral and tibial spacer components120,122that is suitable for allowing at least some range of motion of the hinged rod assembly102and the knee joint. Another embodiment of a femoral spacer component is generally indicated at reference numeral120′. In this embodiment, the femoral spacer component120′ defines a notch120a′ or recess extending from a posterior end of the component. This is slightly different than the through opening120aof the femoral spacer component120. Other configurations of the opening120a,120a′ are possible. Referring toFIGS.16A-16C, in one or more embodiments, the hinged articulating spacer system100is utilized in a two-stage revision TKA. As shown inFIG.16A, in a first step, the femoral and tibial TKA components are removed from the patient. As is known, in general the joint space is cleaned, and remaining bone cement and necrotic debris and bone tissue is removed, leaving a large joint space between the femur and tibia. Next, one or both of the femur rod108and the tibial rod110are individually inserted into the respective medullary canals of the femur and tibia. That is, the femoral and tibial rods may be unattached when inserted into the respective bones. Bone cement may be used to secure the femoral and tibial rods108,110to the respective femur and tibia. Other ways of fixing the rods to the respective bones may be used. For example, the rods may include friction-enhancing structures, such as teeth or ribs or knurls, for increasing friction and inhibiting axial movement of the hinged rod assembly102within the medullary canals. The femoral and tibial spacer components120,122are inserted into the joint space and after insertion of the femur and tibia rods108,110, respectively. For example, as shown inFIG.16B, the femoral spacer component120may be placed on the distal end of the femur such that the femur rod108is received in the opening120aof the femoral spacer component120, and the tibial spacer component122may be placed on the proximal end of the tibia such that the tibia rod110is received in the opening122aof the tibial spacer component. Bone cement may be applied to the respective ends of the femur and the tibia and/or of the respective surfaces of the femoral and tibial rods to facilitate coupling of the components to the respective bones. In another example, the tibia rod110may be inserted through the openings120a,122aof both the tibial and femur components122,120, such as in an embodiment where the femur component is not inserted into the opening of the femur, such as shown inFIGS.4and5. With the rods108,110in place and the femoral and tibial spacer components120,122in the joint space, the femur and tibia rods are then hingedly coupled to one another, such as by bringing the respective couplers together and inserting the hinge pin114through aligned transverse openings112,113in the couplers. At this time, the articular surfaces of the femoral and tibial spacer components120,122may contact and engage one another. Bone cement130may be applied to bone defects in the femur and tibia. Moreover, additional bone cement may be applied to facilitate proper seating and securement of the femoral and tibial spacer components120,122on the respective bones. In the second stage of the revision TKA, the hinged articulating spacer system100is removed, typically 6 to 12 weeks after implantation. The revision TKA system is then implanted. Thus, the hinged articulating spacer system100is only temporary and used to facilitate eradication of the infection. It is believed that the teachings set forth in the present disclosure provide a hinged articulating spacer system that allows for range of motion of the knee joint while inhibiting dislocation of the joint during the infection-treatment time of a two-stage revision TKA. Thus, it is believed the patient is more mobile and ambulatory, with reduced pain and risks of dislocation of knee joint, compared to both the static spacer and the articulating spacer. This further leads to a better quality of life for the patient and increases success of the second stage of the revision TKA. Modifications and variations of the disclosed embodiments are possible without departing from the scope of the invention defined in the appended claims. When introducing elements of the present invention or the embodiment(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. As various changes could be made in the above constructions, products, and methods without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. | 13,531 |
11857425 | DETAILED DESCRIPTION In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The following describes preferred embodiments of the present invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiments described herein. The system and method of making a personalized implant will be described herein with respect to making of a knee meniscus implant. Although the instant implant is described in relation to making of a knee meniscus implant, the teachings of the instant disclosure may also be applied to making implants for replacing other tissues similar in nature and function to the meniscus, such as intervertebral discs, temporomandibular discs, wrist menisci, and the like. These tissues are similar to the knee meniscus in that they are composed of fibrocartilage and function as load transmitters and distributors to prevent high-stress cartilage-on-cartilage or bone-on-bone contact that is detrimental to the joint. It will also be understood that the instant teachings may be applied to make implants for both human and animal patients. Exemplary implants will be described with reference toFIGS.1-4C. Referring toFIG.1, there is shown an implant100comprising a scaffold102and reinforcing matrix120embedded in or coupled to the scaffold102. The scaffold102generally comprises a material that has been engineered to cause desirable cellular interactions to contribute to the formation of new functional tissues for medical purposes and/or the replacement of portions of or whole biological tissues. The reinforcing matrix120is an engineered structure generally configured to strengthen and/or support the scaffold. As such, the reinforcing matrix120may also have the same general shape and geometry as the scaffold102, but with a greater density of material (e.g., fiber) as compared to that of the scaffold102. The material can include, but is not limited to, natural materials, synthetic materials, biodegradable materials and permanent materials. The increased density causes the reinforcing matrix120to be stiffer than the scaffold102such that the reinforcing matrix120provides structure support to the scaffold102. The structural support can include, but is not limited to, tensile support and/or compressive support. In some scenarios, the porosity of the implant100is designed in accordance with a particular application. For example, the implant100is designed to have a relatively high porosity to ensure adequate tissue and cell infiltration therethrough. Any level of porosity can be used herein without limitation provided that is sufficient for facilitating adequate cell seeding, fluid flow and structural integrity. In some scenarios, the implant100is used as a fibrocartilage implant (e.g., a knee meniscus, intervertebral disc and/or TMJ joint implant), a tendon implant, a ligament implant and/or cartilage implant. The shape and geometry of the scaffold102(and consequently the implant) is based on the shape and geometry of the soft tissue in need of replacement. Thus, in the case of a meniscus implant, the scaffold102may be constructed as a c-shaped disc with a wedge-like cross-section (similarly to a knee meniscus). Furthermore, the scaffold102may be shaped concave on the top (which would come in contact with a femur) and flat on the bottom (which would rest on the tibial plateau). The scaffold102includes an anterior end110, a posterior end112and a middle section114defining a path between the anterior end110and the posterior end112. In a meniscus replacement scenario, the middle section114is essentially arc-shaped and defines a curved path between the anterior and posterior ends110,112. Referring toFIGS.1-2, for the purposes of the instant disclosure, the circumferential direction of the scaffold102is indicated by arrow A and generally extends along the middle section114of the scaffold102. Referring back toFIG.1, the reinforcing matrix120may be formed by at least one fiber122extending between the anterior end110and posterior end112of the scaffold102and exiting each end to form an anterior attachment point124and a posterior attachment point126. As used herein, the term “fiber” refers to any generally elongated member consisting of a single component (e.g., monofilament suture) or multiple components (e.g., multifilament suture). The physical property of the fiber122(such as tensile strength, cross-sectional area, diameter, flexibility, etc.) may vary over the length of the fiber122. In some scenarios, multiple fibers may be used to form the reinforcing matrix120. The fibers may be made of the same or different materials and may follow the same or different paths. Preferably, at least a portion of the fiber122forming the reinforcing matrix120is positioned substantially in circumferential direction104. In some scenarios, the fiber122forming the reinforcing matrix120may be arranged in two (2) different arrangements: the circumferential arrangement104; and an orthogonal arrangement106. As used herein, the terms “orthogonal arrangement” and “arranged orthogonally” mean an arrangement of fibers extending in directions substantially parallel to arrows B inFIG.2at various angles in relation to the scaffold102. In reference toFIG.3, the reinforcing matrix120comprises one or more circumferential fibers104a,104b(collectively referred to as “104”) and one or more orthogonal fibers106. The term “circumferential fiber” refers to a fiber that extends between the anterior end110and posterior end112of the scaffold102along the middle section114of the scaffold102and is positioned at least in part substantially parallel to the circumferential axis. The term “orthogonal fibers” refers to fibers that cross the circumferential fibers at various angles to keep them from separating. Keeping the circumferential fibers from separating increases the durability and longevity of the implant. For convenience, terms “circumferential fiber network” and “orthogonal fiber network” may be used herein to refer to multiple circumferential fibers or multiple orthogonal fibers, respectively. In operation, the compressive force on the implant1in the axial direction is translated into tensile hoop stresses in the circumferential direction. The hoop stresses propagate along the circumferential fibers104. In vivo, as meniscal tissue grows into the implant1and cells attach to the fiber networks, cells on or about the circumferential fibers104experience the same mechanical environment as in a normal meniscus, resulting in the formation of tissue with the essentially the same organization and directionality of collagen fibers as the original meniscus. The reinforcing matrix120may be formed with one single continuous fiber arranged both circumferentially and orthogonally. Alternatively, the reinforcing matrix120may be formed using multiple fibers. In such scenarios, the circumferential fibers104as well as orthogonal fibers106may be formed by the same or different strands of fiber or a combination thereof. As noted above, the implant1includes an anterior attachment point124and a posterior attachment point126for attaching the implant to tissue adjacent to the implantation site. These attachment points are formed by fiber exiting from the anterior and posterior ends124,122of the scaffold102, respectively. Moreover, in some scenarios, the implant100may comprise one or more additional attachment points300formed in the middle section114of the scaffold102. For example, the additional attachment points300are formed on the exterior periphery of the middle section114. Such attachment points300are referred to as peripheral attachment points. In some scenarios, the peripheral attachment points coincide with points at which orthogonal fibers cross circumferential fibers. As noted above, intervertebral discs or temporomandibular joint discs function as load transmitters and distributors to prevent high-stress bone-on-bone contact. For example, an intervertebral disc comprises the annulus fibrosus and the nucleus pulposus. The nucleus pulposus is the inner gelatinous material surrounded by the annulus fibrosus. The nucleus pulposus distributes mechanical loads placed upon the disc, while the annulus fibrosus provides structural integrity and constrains the nucleus pulposus to a specific spinal region. The annulus fibrosus has an internal structure which is very similar to the internal structure of meniscal tissue. Accordingly, torroidal concepts herein described may be utilized to construct implants for full or partial replacement of annulus fibrosus. Referring toFIG.4A, an implant400may comprise a torroidal-shaped scaffold402and a reinforcing matrix404. The reinforcing matrix404may be constructed as is described above in reference to meniscus implants. In some scenarios, the reinforcing matrix404comprises circumferential fibers406and orthogonal fibers408. The orthogonal fibers408cross the circumferential fibers406to prevent separation of the circumferential fibers406. However, in contrast to other scenarios (such as those described above), the fibers forming the reinforcing matrix404do not exit the scaffold402and the implant400may be secured by attaching the implant400to the healthy tissues at peripheral attachment points410. The implant400in the process of being wound is depicted inFIGS.4B and4C. The implant400may be fabricated in the shape of a vertebral disc, wherein the torroidal-shaped scaffold402defines an interior cavity filled with a biocompatible material with physical properties equivalent to the properties of the nucleus pulposus of a patient's vertebral disc. Alternatively, the implant400is configured to replace only the annulus fibrosus or a part of the annulus fibrosus. For both the arcuate and torroidal implant constructs, both the scaffold and the reinforcing circumferential and orthogonal matrix fibers may be constructed of naturally-occurring or synthetic biocompatible materials or a combination thereof so to enable infiltration, attachment and proliferation of cells from surrounding tissues once the implant is in place. The naturally-occurring or synthetic biocompatible materials may also be bioresorbable. The scaffold and the reinforcing matrix fibers may be constructed from the same material or different materials and may be fully or partially biodegradable and may have the same or different rate of degradation. As used herein, the term “synthetic polymer” refers to polymers that are not found in nature, even if the polymers are made from naturally occurring biomaterials. The term “natural polymer”, as used herein, refers to polymers that are naturally occurring. The term “biocompatible”, as used herein, refers to materials that, in the amounts employed, do not elicit a detrimental response in the host. The term “biocompatible”, as used herein, is intended to include materials that may cause some inflammation, tissue necrosis or other immune responses when introduced into the host, provided that these effects do not rise to the level of pathogenesis. The term “bioresorbable”, as used herein, refers to those materials that when placed in a living body at standard physiological conditions are degraded through either enzymatic, hydrolytic or other chemical reactions or cellular processes into by-products that are either integrated into or expelled from the body. It is recognized that in the literature, the terms “bioresorbable,” “resorbable”, “absorbable”, “bioabsorbable” and “biodegradable” are frequently used interchangeably and such interchangeable meaning is intended for the present application. In some scenarios, the implant100,400is formed from biodegradable material or materials. The polymers for the instant implant100,400are selected so the implant possesses mechanical properties which are the same or substantially similar to the mechanical properties of the native tissue being replaced. Examples of suitable natural polymers include, but are not limited to, collagen, hyaluronic acid, fibrin glue, bone marrow, chitosan, alginates, celluloses, starches, silk, elastin, and other animal- or plant-derived proteins or polysaccharides. Suitable synthetic polymers include, but are not limited to, poly(alpha-hydroxy acids), poly(lactide-co-glycolide) (PLGA), poly(L-lactides) (PLLA), polylactides (PLA), polyglycolides (PGA); polyethylene, polypropylene, polyvinyl alcohol (PVA), polyethylene oxide (PEO); poly-p-dioxanone (PDO); polyarylates, polyacrylates, polycarbonates, polyesters, polycaprolactone (PCL) and combinations thereof. Suitable polyarylates and polycarbonates include, but are not limited to the tyrosine-derived polyarylates and polycarbonates disclosed by U.S. Pat. Nos. 5,099,060, 5,198,507, 5,216,115, 5,587,507, 5,658,995 and 6,048,521 (the disclosures of all of which are incorporated herein by reference). In some scenarios, the scaffold402is an amorphous structure composed primarily of Type I collagen. In addition to collagen, other types of materials may be added to alter the scaffold's properties as necessary or desired. For example, other proteins or proteoglycans may be used, including, but not limited to, glycosaminoglycans such as chondroitin sulfate, keratan sulfate, dermatan sulfate, heparin, heparin sulfate and hyaluronic acid. The percentage of these materials in the scaffold may range between zero (0) and about twenty percent (20%) of the dry weight of the scaffold. The fiber for the reinforcing matrix may preferably be made from a bioresorbable synthetic polymer (such as a polyarylate) or a non-synthetic material (such as collagen). The physical characteristics of the implant may be modified by using different materials for the scaffold and/or forming the reinforcing matrix from fibers of different diameter, mechanical strength, stiffness, or durability. Moreover, the physical characteristics of the implant may be modified by cross-linking the scaffold, the reinforcing matrix or both. Cross-linking may be achieved by employing a variety of known methods including, but not limited to: chemical reaction with a carbodiimide, glutaraldehyde or formaldehyde among others; the application of energy such as radiant energy, which includes irradiation by UV light or microwave energy; dehydrothermal treatment in which water is slowly removed while the bone tissue is subjected to a vacuum; and enzymatic treatment. A system and method for forming an implant with a reinforcing matrix will now be described with respect toFIGS.5-9. Notably, the system and method are described herein in relation to the implant100ofFIGS.1-3. This discussion is sufficient for understanding the system and method for forming an implant400ofFIGS.4A-4C. Referring toFIG.5, an exemplary system500is shown. The system500generally comprises a fabrication path-planning tool502and a weaving machine520. The fabrication path-planning tool502includes a computing device. Computing devices are well known in the art, and therefore will not be described in detail herein. Still, an exemplary computing device1000is shown inFIG.10. Computing device1000is described below. As shown inFIG.5, the fabrication path-planning tool502comprises at least a processor504configured to receive implant data from an input device510. The input device510may be in the form of an image scanning device (e.g., a magnetic resonance imaging instrument (MRI), a nuclear imaging instrument, an ultrasound instrument or other imagining technology) configured to provide three-dimensional (3D) image data of the target tissue. In the event of input from an image scanning device, software506is provided for execution by processor504. The software506includes instructions for causing processor504to reconstruct a 3D model of the native tissue (i.e., the meniscus from the non-injured knee) from the image data received from the image scanning device and then extract the articulating surface geometry of the tissue. Once the 3D model is created, the software506causes the processor504to derive the configuration of the intended reinforcing matrix120. The determination may be made by doing a geometrical analysis of the 3D model relative to a large-scale knee MRI database. Alternative methods may also be utilized. Alternatively, the input device510may be a manual input device (e.g., a keyboard), which allows the user to enter specific data associated with the target implant (e.g., left or right side of body, ML compartment width, AP compartment length, and whether there is a shift in symmetry to one side or the other). As a further alternative, the input device510may include both an image scanning device and a manual input. Once the configuration of the intended implant is known (either via an image scanning device, manual input or a combination thereof), the software506causes the processor504to determine a “weaving path” of the weaving machine520to achieve the determined configuration of the reinforcing matrix120. The weaving path will consist of a series of distinct weaving patterns at different height levels. With reference to an exemplary planning of a weaving path for a meniscus implant, the software506(based on the determined or manually input implant data) causes the processor504to set the side of the body to a value of left or right, set the ML, set the AP, and set a pause time between each weaving step. Thereafter, the software506may cause the processor504to determine (either based on database lookup or manual input) the number of pins to be used in the weaving pattern, the symmetrical weight to be applied, and the number of inner and outer rounds within a weaving step.FIGS.6A and6Billustrate the distinct, asymmetrical weaving patterns of a left knee meniscus (FIG.6A) versus a right knee meniscus (FIG.6B). From this information, the software506may cause the processor504to set the X radius to half of AP and the Y radius to half of the ML. With the input information, the software506causes the processor504to determine the arc length of outer pins and to adjust such based on the symmetrical weighting. With the arc length and number of pins known, the radial positions of the pins may be determined as an X and Y position of each pin in a 2D scenario (or additional a Z position in a 3D scenario). Additionally, in part based on whether the implant100is to be used on the left side or right side, the software506may cause the processor504to set the length (and thereby the X and Y position) for the anterior tail and posterior tail pins. With the pins located, the software506causes the processor504to determine the specific weaving pattern for each layer or weaving step. Optionally, after the planned path is determined, the software506causes the processor504to conduct a simulation to verify that the weaving path can generate the intended articulating surface. As illustrated inFIG.7, the simulated weaving pattern may be superimposed onto an image of the meniscus to verify the proper reinforcing matrix120is achieved. The software506may be further configured to cause the processor504to adjust the weaving pattern to achieve a proper reinforcing matrix120(e.g., by making the posterior region further thicker than the anterior region). Once the planned weaving path has been determined, the data represented thereby may be provided from the processor504to the weaving machine520. The weaving machine520may take various formats (e.g., a power loom or an additive manufacturing machine). In the scenario illustrated inFIG.5, the weaving machine520applies the fiber122onto a base surface524about the pins to form the reinforcing matrix120. As another alternative, a weaving machine may not be utilized and instead the reinforcing matrix may be woven by a user (e.g., by hand). In such case, the processor504may provide the planned weaving path to the user via another output device (e.g., a display or printer). Referring toFIGS.8-9, an exemplary forming process about pins (or pegs)806positioned on the base surface524will be described. The number of pins806is based on the determined planned path for the fiber122. In the illustrated scenario, the base surface524includes twenty-four (24) holes802as shown inFIG.8A. Twenty-two (22) holes802are at equal intervals forming a semi-circle with the remaining two (2) holes802opposite the center of the semi-circle. Pins806are positioned in the holes802forming the pattern shown inFIG.8B. For purposes of explanation, each hole802of the base surface524is assigned a number from 1, 3-24 or 26. Holes3through24define the actual dimensions of the meniscus scaffold, while holes1and26define the anchor points for the scaffold. Referring toFIGS.9(a)-9(g), a continuous length of fiber122is dispensed from the weaving machine520and wrapped around the pins806in a quasi-circumferential pattern. Starting from point1, fibers were wrapped and pivoted at one of six different off-tangent angles from the pins: (a) 11.25°, (b) 28.125°, (c) 39.375°, (d) 50.625°, (e) 61.875°, and (f) 73.125°. This continued until point26, at which time the fiber was wrapped in reverse. For pins3-6and21-24, fibers23were wrapped back to point1or26for formation of anchor bundles. This process was repeated for each angle to produce a complete pattern shown inFIG.9(g). In accordance with the determined planned path, the pattern may be repeated several times. The pin pattern allows for a semi-lunar shape to be formed along with two (2) bundles of fibers at each horn for formation of the anchor plugs to form a meniscus implant. As explained above, implants with other shapes and configurations may also be formed. After wrapping has been completed, the fibers may be teased up (e.g., to form a wedge shaped cross-section) or otherwise treated. To complete the implant100, the reinforcing matrix120is inserted into a mold assembly (not shown) or a mold assembly is formed around the reinforcing matrix120. The mold preferably has the same shape as the soft tissue in need of replacement. In some scenarios, the ends of the fiber forming the reinforcing matrix extend outside each end of the mold assembly to form the attachment points. The polymer or other material from which the scaffold102is to be manufactured is injected into the mold assembly to form the scaffold body102, which is then solidified. The process for solidifying the scaffold depends on the polymer used to form the scaffold. For example, if collagen is used, the implant assembly may be lyophilized. In some scenarios, the implant100may be cross-linked to alter its physical characteristics. Moreover, additives (such as proteins, glycosaminoglycans, cells, growth factors, medical agents, and/or labels, etc.) may be added to the implant100at any point during the fabrication thereof according to standard techniques known and used in the field. As noted above, in some scenarios, both the fiber network matrix and the scaffold have same the shape and geometry as the soft tissue they are made to replace. For example, in implementations for the knee, the reinforcing matrix and the mold assembly may be constructed as a c-shaped disc with a wedge-like cross-section, similar to a knee meniscus. Referring now toFIG.10, there is provided a schematic illustration an exemplary computing device1000. The computing device can include, but is not limited to, a personal computer, a laptop computer, a desktop computer and/or a server. The computing device1000is generally configured to perform operations for facilitating the generation of an implant (e.g., implant100ofFIG.1or implant400ofFIGS.4A-4C). As such, the computing system1000comprises a plurality of components1002-1012. The computing system1000can include more or less components than those shown inFIG.10. However, the components shown are sufficient to disclose an illustrative embodiment implementing the present solution. Notably, the hardware shown inFIG.10can include physical hardware and/or virtual hardware. The hardware architecture ofFIG.10represents one (1) embodiment of a representative computing device configured to facilitate the generation of an implant (e.g., implant100ofFIG.1or implant400ofFIGS.4A-4C). As such, the computing system1000implements methods of the present solution. As shown inFIG.10, the computing system1000includes a system interface1012, a user interface1002(e.g., a keyboard for data input and a display for data output), a Central Processing Unit (“CPU”)1004, a system bus1006, a memory1008connected to and accessible by other portions of the computing system1000through system bus1006, and hardware entities1010connected to system bus1006. System bus1006is also used to communicate one or more mission plans to and from the computing system1000. At least some of the hardware entities1010perform actions involving access to and use of memory1008, which can be a Random Access Memory (“RAM”), a disk driver and/or a Compact Disc Read Only Memory (“CD-ROM”). System interface1012allows the computing system1000to communicate directly or indirectly with external devices (e.g., sensors, servers and client computers). Hardware entities1010can include microprocessors, Application Specific Integrated Circuits (“ASICs”) and other hardware. Hardware entities1010can include a microprocessor programmed to facilitate the generation of an implant (e.g., implant100ofFIG.1or implant400ofFIGS.4A-4C). As shown inFIG.10, the hardware entities1010can include a disk drive unit1016comprising a computer-readable storage medium1018on which is stored one or more sets of instructions (or programming instructions)1014(e.g., software code) configured to implement one or more of the methodologies, procedures, or functions described herein. The instructions1014can also reside, completely or at least partially, within the memory1008and/or the CPU1004during execution thereof by the computing device1000. The components1008and1004also can constitute machine-readable media. The term “machine-readable media”, as used here, refers to a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions1014. The term “machine-readable media”, as used here, also refers to any medium that is capable of storing, encoding or carrying a set of instructions1014for execution by the computing device1000and that cause the computing device1000to perform any one or more of the methodologies of the present disclosure. Notably, the present solution can be implemented in a single computing device as shown inFIG.10. The present solution is not limited in this regard. Alternatively, the present solution can be implemented in a distributed network system. For example, the present solution can take advantage of multiple CPU cores over a distributed network of computing devices in a cloud or cloud-like environment. The distributed network architecture ensures that the computing time of the statistics and enhanced functionality is reduced to a minimum, allowing end-users to perform more queries and to receive reports at a faster rate. The distributed network architecture also ensures that the implementing software is ready for being deployed on an organization's internal servers or on cloud services in order to take advantage of its scaling abilities (e.g., request more or less CPU cores dynamically as a function of the quantity of data to process or the number of parameters to evaluate). The following EXAMPLE is provided in order to further illustrate the present solution. The scope of the present solution, however, is not to be considered limited in any way thereby. EXAMPLE Initial Symmetric Weaving In one case, a computing device was configured to determine pin placement and pattern weaving. In this regard, the computing device first took two (2) primary dimensions: an Anterior-to-Posterior (AP) length; and a Medial-to-Lateral (ML) width. Based on these dimensions (obtained from X-ray, MRI, CT or predictive modeling), an ellipse was constructed with n nodes equally spaced around the circumference from +225 degrees (left) to −45 degrees (right). As shown inFIG.11(a), twenty-five (25) nodes were used which have a spacing of 11.25 degrees. This approach is adapted from initial ovine studies (AP: 26 mm, ML: 20 mm) and scaled up (AP: 45 mm, ML: 32 mm). During fabrication of an implant, a platform with holes at the specified locations was constructed. Pins were placed through the holes. A scaffold was fabricated using an 86-pattern weave as shown inFIG.11(b). The dimensions of the resulting implant were slightly greater (<5%) than the original ellipse due to wound fiber around the outside of pins, but still within an acceptable tolerance. Root Location Nodes In order to achieve a more anatomically accurate implant, the end node locations (i.e., Node 1 and Node 25 with 25 nodes) were more accurately defined based on MRI measurements or average historical data. Thus, for n nodes, theta varies according to the following Mathematical Equation (1). Θ(x)=Θ(x-1)+Θ(n)-Θ(1)n-1(1) where θ(x) represents an xthangle, θ(x−1) represents a previous adjacent angle, θ(n)−θ(1) represents a total angular distance from a first node to a last node, and n−1 represents a number of gaps (one less than the number of nodes n). In this EXAMPLE, images were taken of human cadaveric medial menisci. Based on these images, roots were placed at 220 degrees and −60 degrees. As shown inFIG.12, an ellipse (created using AP and ML dimensions of cadaveric meniscus) accurately recreated the outer meniscal rim and meniscal root placements (anterior on left, posterior on right). Asymmetry Pin Arrangements In order to also account for differences in anterior, body, and posterior widths, the spacing between nodes was varied. This spacing variation was achieved by rewriting Mathematical Equation (1) as Mathematical Equation (2) including a third term. The third term ensures that the spacing between nodes (or pins) n can be changed using a weighting factor W. Θ(x)=Θ(x-1)+Θ(n)-Θ(1)n-1-W*(n2-x+1)(2) The weighting factor W ranges from zero (0) to one (1), with zero (0) being symmetrical and one (1) being very asymmetrical. Using the base pattern of a meniscus scaffold design, it becomes evident how varying the weighting factor W can greatly change the asymmetry of the scaffold and close in on a more anatomically accurate design. FromFIG.13, it appears that a weighting factor W=0.25 approximates a given image of a cadaveric medial meniscus. Weighting Factor Optimization Furthermore, if specific anterior, body, and posterior dimensions are given for a desired meniscus based on MM or historical data, the weighting factor W for each implant can be optimized. Average anterior (“ANT”), body (“BOD”) and posterior (“POS”) widths from literature were typically 8.68, 9.14 and 14.26, respectively. The weighting factor W that minimizes the root-mean-square error between desired implant widths and actual implant widths in the three (3) regions was found and can be found if a patient's anterior, body, and posterior widths are available. The root-mean-square computations can be defined by the following the Mathematical Equation (3). RMSError=(ANTdes-ANTact)2+(BODdes-BODact)2+(POSdes-POSact)2(3) where RMSError represents a root-mean-square error, ANTdesrepresents a desired anterior width, ANTactrepresents an actual anterior width, BODdesrepresents a desired body width, BODactrepresents an actual body width, POSdesrepresents a desired posterior width, and POSactrepresents an actual posterior width. With an average AP of 41.38 mm, an average ML of 30.63 mm, and the above listed typical anterior, body and posterior widths, a weighting factor W of 0.228 was found to minimize the overall error between the three (3) regions. This weighting factor W of 0.228 can then used to fabricate patient specific menisci, as shown inFIG.14. Based on Mill- or historical data-derived dimensions of AP, ML, Ant, BOD, POS, the node placement and weighting factor W can be optimized to minimize error in the final dimensions. Node/Pattern Variations The above simulations were performed using twenty-five (25) nodes and a base pattern that skipped ten (10) nodes per weave (Pattern 10). However, varying the number of nodes and pattern number (nodes skipped) can provide other options to minimize the root-mean-square error. Thus, twenty-three (23) to thirty (30) nodes were attempted, varying the pattern number from eight (8) to fourteen (14). For each combination, following weighting factor optimization, the root-mean-square error was recorded. The resulting errors are shown inFIG.15. The following were the best node-pattern combinations.23-Node, Pattern 925-Node, Pattern 1027-Node, Pattern 1129-Node, Pattern 12 These combinations can be attempted by the code for each specific patient's dimensions, and thus would change based upon the required scaffold design. Patient/Donor-Specific Menisci Based on statistical approaches, a person's height, weight, and gender can be used to accurately predict their menisci's AP and ML dimensions. Thus, three (3) cadaveric knee specimens and the donor information were obtained from the Robert Wood Johnson Medical School Anatomical Association. Based on the information, AP and ML dimensions were calculated, allowing for node placement with a weighting factor W of 0.228. Platforms with these nodes were constructed, and donor-specific implants were fabricated as shown in the left image ofFIG.16. The scaffolds were fabricated with an anterior tail of 30 mm and posterior tail of 50 mm to aid in our approach to surgical fixation. These tail lengths could be easily altered for the desired fixation technique. Following fabrication, dimensions were comparable to those obtained with the computer program. In addition, all five (5) dimensions (AP, ML, anterior, body, posterior widths) were within ten percent (10%) of the native meniscus values. Additionally, devices were implanted into cadaveric knees (as shown inFIG.16—middle image) and the load-distributing properties were characterized with a Tekscan strip (as shown inFIG.16—right image). The implanted devices improved load-distributing properties over meniscectomy with some similarities to native, and no issues with implant sizing were noted. Referring now toFIG.17, there is provided a flow diagram of an exemplary method1700for fabricating a soft tissue (e.g., a fibrocartilage tissue) implant (e.g., implant100ofFIG.1or400ofFIG.4). Method1700can be implemented by system500ofFIG.5and/or computing device1000ofFIG.10. Method1700begins with1702and continues with1704where a processor (e.g., processor504ofFIG.5and/or CPU1004ofFIG.10) receives first data specifying at least an AP compartment length, an ML compartment width, and a weighting factor W. Next in1706, the processor uses the first data to generate second data defining a target soft tissue implant. The target soft tissue implant comprises a scaffold (e.g., scaffold102ofFIG.1or scaffold402ofFIG.4) designed to replace a biological soft tissue in a subject and a reinforcing matrix (e.g., reinforcing matrix120ofFIG.1or matrix404ofFIG.4) designed to provide structural support to the scaffold. The processor then uses the plurality of node locations in1708to determine a planned weaving path for forming an interlaced fibrous structure having a shape based on a shape of the target soft tissue implant. Information defining the planned weaving path is communicated from the processor to an external output device (e.g., weaving machine520ofFIG.5) for facilitating performance of the subsequent weaving operations resulting in the fabrication of the soft tissue implant. In some scenarios, the external output device is a weaving machine which forms the interlaced fibrous structure in accordance with the planned weaving path. Alternatively or additionally, the external output device is a display or printer (as shown in box1002ofFIG.10). Upon completing1708, optional operation1710is performed for optimizing the weighting factor W based on an actual anterior width, an actual posterior width, and an actual body width. The weighting factor W is optimized using a root-mean-square error algorithm to identify a value that minimized an error between desired implant widths and actual implant widths in an anterior region, a posterior region and a body region. The root-mean-square error algorithm is defined by the above specified Mathematical Equation (3). Method1700may also optionally involve: simulating the subsequent weaving operations using the planned weaving path to generate a simulated articulating surface (as shown by1712); superimposing the simulated articulated surface into an image of soft tissue to be replaced by the soft tissue implant (as shown by1714); and adjusting the planned weaving path based on an analysis of results of said superimposing (as shown by1716). Subsequently,1718is performed where method1700ends or other processing is performed. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention which is defined by the following claims. | 37,697 |
11857426 | DETAILED DESCRIPTION When referring to specific directions in the following discussion of certain implantable joint replacement devices, it should be understood that such directions are described with regard to the orientation and position of the implantable joint replacement devices during exemplary application to the human body. Thus, as used herein, the term “proximal” means situated nearer to the center of the body or the point of attachment and the term “distal” means more situated away from the center of the body or from the point of attachment. The term “anterior” means towards the front part of the body or the face and the term “posterior” means towards the back of the body. The term “medial” means toward the midline of the body and the term “lateral” means away from the midline of the body. Further, as used herein, the terms “about,” “generally,” and “substantially” are intended to mean deviations from absolute are included within the scope of the term so modified. FIGS.1-4depict a joint replacement assembly100comprising a joint replacement prosthesis102and a filamentary fixation device120. The joint replacement prosthesis102is a tibial component of a total knee arthroplasty system and is made from biologically suitable material for implantation, such as titanium, stainless steel, cobalt chromium, niobium, and the like. In addition, joint replacement prosthesis102may have porous outer surfaces to facilitate bone ingrowth therein. Joint replacement prosthesis102comprises a tibial baseplate106, a stem boss104, and a keel112. Tibial baseplate106comprises an insert mating portion108and a planar lower surface110disposed opposite insert mating portion108. Planar lower surface110is configured to engage a proximal sub-condylar area of a tibia, which is formed by resecting a proximal tibia transverse to an axis thereof. Moreover, planar lower surface110may further comprise engagement features (not shown), such as a porous or corrugated surface, or a rim depending downwardly therefrom about a perimeter thereof for engaging the proximal sub-condylar area of the tibia. However, surface110is generally understood to be planar. Stem boss104and keel112extend from planar lower surface110. Keel112, which appears as a wing or blade, is configured to prevent rotation of tibial baseplate106and is positioned adjacent stem boss104. In this regard, keel112has a length that extends in a lateral-medial direction, but may also include a component of its travel in an anteroposterior direction. In the particular configuration depicted, prosthesis102includes two keels112a-b, which are integral with baseplate106and stem boss104. However, in some embodiments, only one keel112may be provided. Also, keels112a-bmay be modular such that they are not rigidly fixed to either lower surface110or stem104. In still further embodiments, keels112a-bmay be connected to lower surface110, but not stem boss104. Regardless, in each of these embodiments, keels112a-bextends from lower surface110and are positioned adjacent stem104. Stem boss104is cylindrical or frustoconical in shape to substantially match a cavity of a bone, such as an intramedullary canal of the tibia. In addition, stem boss104is configured to connect to a stem extension (not shown), such as via an opening114in stem boss104. As best shown inFIG.2, insert mating portion108of tibial baseplate106is defined by a shoulder portion107(e.g., a rim) extending about a periphery of baseplate106. Such shoulder portion107forms a dish or tray configured to receive a tibial bearing component (not shown) where such bearing component includes an articular surface that is configured to articulate with a femoral component, as is understood in the art. Filamentary receiving component, filamentary fixation device, or filamentary sleeve120, as best shown inFIGS.3and4, includes a first portion128and a second portion122extending from an anterior end of first portion128. First portion128has a planar upper surface125that corresponds to planar lower surface110of tibial baseplate106. First portion128further comprises an opening129that extends through first portion128. A central axis (dotted line inFIG.3) extends perpendicular to planar upper surface125of first portion128. Opening129extends along the central axis and is symmetrical about an anterior-posterior plane in which the central axis lies. A thickness between planar upper surface125and a lower surface124of first portion128is smaller than a distance from a perimeter of first portion128and opening129of first portion128. Opening129comprises a main region121having a cylindrical shape and lobe portions or offset regions123a-bextending outwardly from main region121. Main region121is sized and shaped to receive stem boss104, and lobe portions123a-bare sized and shaped to receive keels112. In this regard, lobe portions123a-beach extend radially outward from main region121both laterally-medially and anteriorly-posteriorly at an angle towards a posterior side of first portion128just as keels112a-bextend from stem boss104. However, in some embodiments, first lobe123aand second lobe123bmay extend away from main region121in only a mediolateral direction depending on the configuration of keels112a-b. A shape of first lobe123aand second lobe123bis not limited to the depicted and described shape as additional shapes are contemplated. However, the shape of lobes123a-bgenerally correspond to a geometry of keels112a-bso as to conform thereto. As mentioned above, second portion122extends from an anterior side of first portion128. As shown, second portion122also extends in a direction transverse to planar upper surface125and away from planar upper surface125. Also, as shown, second portion122has a smaller lateral-medial width than that of first portion128. In this regard, second portion122includes a transition region127(seeFIG.4) in which second portion122tapers to its more narrow width from first portion128. Second portion122is also generally rectangular in a lateral medial plane and has a larger dimension in a lateral-medial direction than an anteroposterior direction. Filamentary receiving component120is made from a filamentary material that may be a knitted or woven material, a non-woven material, or a combination thereof. Such filamentary material may comprise one or more of: a synthetic polymer, a bioresorbable fiber, a ceramic/a glass, a biological material, and a pharmacological agent, among others. The synthetic polymer comprises one or more materials, such as: an ultra-high molecular weight polyethylene (UHMWPE), a polyether-ether-ketone (PEEK), a carbon reinforced PEEK, a polyether-ketone (PEK), a texturized polyethylene terephthalate (PET), an open-weave PET, and a polytetrafluorethylene (PTFE), among others. The bioresorbable fiber comprises one or more materials, such as: a polylacatic acid (PLA), a polyglycolide (PGA), and a poly-L-lactic acid (PLLA), among others. The ceramic/the glass comprises one or more of: an alumina, a zirconia, and a pyrolytic carbon, among others. The biological material comprises one or more materials, such as: a collagen, a silk, and a chitosan, among others. According to some embodiments, the filamentary material of filamentary receiving component120comprises a knitted or woven mesh material, such as a monofilament mesh material. It should be appreciated that the listed materials are non-exhaustive and other materials are contemplated herein. However, it should be understood that it is preferable that filamentary receiving component120be made from a material that encourages soft tissue growth therein. Thus, a knitted or woven material that has a weave that encourages tissue growth into its porous structure is preferable. An exemplary weave is shown inFIG.13. As assembled, filamentary receiving component120receives tibial component102to form joint replacement prosthesis100. In this regard, main portion121of opening129receives stem104of tibial baseplate102, first lobe123areceives a first keel112a, and second lobe123breceives a second keel112b. Moreover, planar lower surface of baseplate106sits generally flush against upper planar surface125of first portion128. The shape of first portion128corresponds to the shape of baseplate106so that first portion128does not extend beyond its perimeter with the exception of near the anterior side thereof where first portion128meets second portion102. In addition, first portion122extends upwardly toward mating portion108of baseplate106, as best shown inFIG.2. First portion122extends along the anterior surface of baseplate portion and beyond baseplate106. In a method for attaching the soft tissue to the joint replacement prosthesis102, a previously implanted joint prosthesis may be removed from a proximal tibia. After the proximal tibia is prepared, such as by resecting the proximal tibia, joint replacement assembly100is assembled and connected to the tibia. In this regard, filamentary receiving component120is engaged to joint prosthesis102by inserting stem boss104through main portion121of opening129and keels122a-bthrough respective lobe portions123a-bof opening129so that planar lower surface110of baseplate106is brought into communication with planar upper surface125of filamentary receiving component120. Thereafter, bone cement, such as polymethyl methacrylate (PMMA), is placed on a proximal surface of the tibia and/or on lower surface124of first portion128of filamentary receiving component128. In some embodiments, bone cement may even be placed between first portion of filamentary component and baseplate. As shown inFIG.1, a portion of lower surface110of baseplate106is not covered by first portion128. This portion of baseplate106also receives bone cement. Once the bone cement is applied, stem boss104, along with any stem extension attached thereto, is inserted into the intramedullary canal of the tibia and keels112a-bare driven into the proximal end of the bone until baseplate106and filamentary component120engage the proximal end of the tibia. Once baseplate106is fully seated, first portion122of filamentary component120is trapped or sandwiched between baseplate106and the proximal tibia. Moreover, second portion122extends from between the proximal tibia and baseplate106and extends superiorly away from the tibia. In this configuration, second portion122is well secured by first portion's arrangement between bone and baseplate106and also around stem boss104and keels112a-b. Once assembly100is mounted to the tibia, soft tissue is secured to joint replacement prosthesis102via filamentary device120. In this regard, an intact patellar tendon can be attached to filamentary device120, such as in a revision procedure, to reinforce the tendon from subsequent damage as patellar tendon tears regularly occur postoperatively. Alternatively, a patellar tendon may have been detached from the tibia for any number of reasons. In order to re-secure the intact or detached patellar tendon, the patellar tendon is sewn to a posterior side of second portion122. Moreover, a muscle, such as the medial gastrocnemius may be sewn to an anterior side of second portion122of filamentary component120via suture or wire. The arrangement of the patellar tendon and muscle is partially illustrated inFIG.8. This configuration allows the soft tissue to grow into filamentary component120thereby providing a strong long term connection. Thus, filamentary component120provides a soft tissue ingrowth structure to prosthesis102. FIGS.5-7depict a joint replacement assembly200according to another embodiment of the present disclosure. Joint replacement assembly200includes joint replacement prosthesis201and filamentary receiving component or filamentary fixation device220. Joint replacement prosthesis201is a tibial prosthesis. However, unlike prosthesis102which is a revision tibial prosthesis, prosthesis201is configured for use in limb salvage procedures, such as for oncology applications. In this regard, prosthesis201comprises a baseplate component202that includes a tibial baseplate212and a stem204extending from tibial baseplate212. Prosthesis201also includes a separately formed body member or metaphyseal member240which is connectable to baseplate component202. Tibial baseplate212comprises an insert mating portion206and a planar lower surface214disposed opposite insert mating portion206. Insert mating portion206is configured to articulate with a femoral articulating surface on a distal end of a femur. In this regard, insert mating portion206may be configured to receive a bearing insert (not shown) similar to baseplate106, described above. Planar lower surface214includes projections or posts216extending from a lateral and medial side thereof. Such posts are configured to be received in apertures246of body member240, as discussed below. Stem204extends from planar lower surface214of tibial baseplate212and includes a connection feature205at a distal end thereof for connecting to a resected tibial shaft. In this regard, stem204acts as a diaphyseal portion of prosthesis201for replacing a portion of a diaphysis of a tibia. Body member240is a metaphyseal portion for replacing a metaphysis of a tibia and includes a proximal end, a distal end, and an opening247that extends therethrough for receipt of stem204. The proximal end of body240includes a planar surface248and apertures246extending therein for receipt of posts216, as best shown inFIG.6. Such apertures246and posts214may be correspondingly tapered, such as to form Morse taper locks. An outer surface of body member240is tapered so that body240expands outwardly in a distal to proximal direction. Additionally, one or more attachment holes242and an attachment region244are located on the anterior side of body member240and are configured for securing a soft tissue to joint replacement assembly200. In this regard, attachment holes242extend in a generally lateral-medial direction through body member240so that such attachment holes242can receive suture, wire, and the like. Attachment region244may also include a patch of filamentary material embedded in the solid structure of body member244, which can allow soft tissue to be sutured and/or can facilitate tissue growth therein. Filamentary receiving component220is similar to filamentary receiving component120. In this regard, filamentary receiving component220includes a first portion229and a second portion222extending from first portion229. First portion229includes upper and lower planar surfaces225,224and an opening extending therethrough. The opening includes a main region221and adjacent lobe regions223similar to those of component120. However, adjacent lobe regions223are configured to receive projections rather than keels112. Thus, while lobes223are shown as communicating with main region221, such as with component120, it is contemplated that lobes223may not be in communication with main region221and, instead, may be positioned remote from main region221in respective locations to receive projections216. As assembled, stem204extends through main region221of the opening extending through first portion229and through the opening247in body member240, as best illustrated inFIGS.6and7. In addition, projections216extend through corresponding lobes223and into corresponding apertures246in body member240, which secures body member240to baseplate212. In this configuration, first portion229of filamentary receiving component220is trapped between planar surface248of body member240and baseplate212. This is similar to the finally implanted assembly100in which first portion229is trapped or sandwiched between baseplate106and a proximal tibia. However, in this configuration, first portion229is trapped or sandwiched between baseplate212and body member240, rather than between bone and a prosthetic component. In addition, second portion222extends from between baseplate212and body member240and superiorly beyond baseplate212. In a method for attaching the soft tissue to joint replacement prosthesis201, a patellar tendon is detached from the tibial tubercle and a proximal section of the tibia is resected at a location along the tibial shaft so that the removed bone includes the tibial tubercle. Thereafter, filamentary receiving component220is engaged to joint prosthesis201by inserting stem204through opening main region221of the opening in first portion229and projections216extend through lobes223into corresponding apertures246so that first portion229is trapped between surface248of body240and surface214of baseplate212. Implant201is then connected to the bone via connection portion205. Once assembly200is mounted to the tibia, soft tissue, such as a patellar tendon, is secured to joint replacement assembly by suturing the soft tissue to second portion222of filamentary receiving component220as described above with respect to assembly100. The soft tissue may also be secured to joint replacement prosthesis201directly by threading wire, such as cerclage wiring, or suture through the soft tissue and through one or more suture holes242on joint replacement assembly200. FIGS.8-10Bdepict a joint replacement assembly300according to an even further embodiment of the disclosure. Joint replacement assembly300, as best shown inFIG.9, comprises a joint prosthesis302and a filamentary receiving component or filamentary fixation device340. Joint prosthesis302is a tibial component of a hinge knee system that may be used in limb salvage procedures, such as for oncology applications. In this regard, prosthesis includes a body330, a bearing portion320, and a hinge portion310that bears on bearing portion320. Body330has a diaphyseal portion336and a metaphyseal portion334for replacement of the same of a tibia. At a distal end of diaphyseal portion336is a connection feature338that allows prosthesis302to be connected to a resected portion of a tibial shaft. Metaphyseal portion334includes one or more suture holes or openings332located on a medial side and/or a lateral side of an anterior face thereof and extending entirely therethrough. According to some embodiments, a region between suture holes332may comprise a material integrated into the structure of body330so that body330has a patch of filamentary material embedded therein to assist in securing the soft tissue to joint replacement assembly300and/or one or more porous surfaces to support tissue ingrowth. Metaphyseal portion334is connected to a proximal end of diaphyseal portion336so that body330tapers outwardly in a distal to proximal direction. Filamentary receiving component340, as shown inFIGS.10A and10B, is similar to filamentary receiving component120and220in that it is made from filamentary material and includes a first portion344and second portion342. Moreover, first portion344has an opening346extending therethrough and second portion342extends from an anterior side of first portion344. However, unlike filamentary receiving components120and220, filamentary component340has an annular opening346that flares or tapers outwardly in an inferior to superior direction so as to form an annulus with a sidewall that is thinner than the proximal-distal length of second portion. This allows filamentary component340to correspondingly engage a prosthesis, such as prosthesis302, which also tapers along its length. Thus, in the assembly, as shown inFIG.8, diaphyseal portion336extends through opening346in first portion344of filamentary component340. The inner surface of first portion346bears on body330along the tapered outer surface thereof such that the taper of body330prohibits second portion344from moving proximally beyond a predesignated location on body330. In a method for attaching the soft tissue to joint replacement prosthesis302, a patellar tendon902is detached from the tibial tubercle and a proximal section of the tibia is resected at a location along the tibial shaft so that the removed bone includes the tibial tubercle. In addition, prosthesis302is assembled by connecting body330, bearing320, and hinge component310. Thereafter, filamentary receiving component340is engaged to joint prosthesis302by inserting diaphyseal portion336through opening346so that the inner surface of first portion344is brought into communication with a correspondingly tapered outer surface of prosthesis302. Implant302is then connected to the bone via connection portion338. Once assembly300is mounted to the tibia, soft tissue is secured to joint replacement prosthesis302via filamentary device340. In order to re-secure the detached patellar tendon902, the patellar tendon902is sewn to a posterior side of second portion342, as depicted inFIG.8. Moreover, a muscle904, such as the medial gastrocnemius may be sewn to an anterior side of second portion342of filamentary component340via suture or wire. In addition, a suture906may be threaded through openings332and passed through tendon902, first portion342of filamentary component340, and muscle904. Thus, this configuration allows for a traditional connection to implant302via openings332and also allows for the soft tissue902,904to grow into filamentary component340thereby providing a strong long term connection. Thus, filamentary component340provides a soft tissue ingrowth structure to prosthesis302. FIG.11depicts a joint replacement assembly400according to yet another embodiment of the present disclosure. Joint replacement assembly400generally includes a joint replacement prosthesis402and a filamentary receiving component or filamentary fixation device440. Joint replacement prosthesis402is a humeral joint prosthesis. Thus, as should be understood, the concepts described above with regard to the tibial prostheses embodiments may also be applied to other long bones and joints, such as the humerus and shoulder joint in this embodiment. It should also be understood that the same concepts could also apply to a joint prosthesis for proximal femur and hip joint, for example. Such a hip joint prosthesis would be similarly configured to prosthesis402in that it would include an intramedullary stem and a ball joint portion at an end thereof. Prosthesis402comprises a proximal end remote from a distal end. The proximal end includes a head portion412that includes a bearing surface that articulates with a glenoid component (not shown) when used in a total should replacement system. Head412is connected to a body element418which connects to a stem portion404. Stem portion404comprises a tip portion403that is adapted to be inserted into an intramedullary canal of a proximal humerus such that stem portion404is located within the intramedullary canal thereof. Body element418is preferably conically tapered so as to correspond to a taper of an opening of filamentary component440, as described below. Filamentary receiving component440is the same as filamentary receiving component340and may be used similarly. In this regard, stem404is inserted through an opening in a first portion444of filamentary component440so that filamentary component440bears on body418and is retained by corresponding tapers. Additionally, a first portion442extends superiorly beyond head element412. Moreover, a tendon, such as one or all of the tendons of the rotator cuff, may be connected to first portion of filamentary device440via suture or wire. In this regard, tissue may grow into first portion442to provide long term fixation thereof to prosthesis402. FIG.12depicts a front perspective view of an alternative filamentary fixation device500configured for use with a joint replacement prosthesis or a joint replacement assembly, according to at least some embodiments disclosed herein. Filamentary device500comprises a hoop structure503and an opening501located within hoop structure503. Hoop structure503is defined by arm members504aand504b. Such arm members504a-b, as shown, are connected together to form hoop structure503. However, arm members504a-bare preferably provided disconnected so that they may be tied together or otherwise connected during a procedure, such as about a stem boss104and keels112or about stem336or403, for example. Moreover, arm members504a-bmay be each comprised of single or double strands of filament such that they have an appearance of shoelaces. This differs from first portion of filamentary device120in that when device500is connected to prosthesis102, its footprint relative to baseplate106is much smaller than that of filamentary device120. This allows hoop structure to be trapped between bone and a prosthesis or between components of a prosthesis, as described above, while having a low profile so as to not interfere with direct contact between the bone and prosthesis or prosthesis and prosthesis. FIGS.14A-14Edepict a joint replacement assembly600according to yet another embodiment of the disclosure. Joint replacement assembly600is similar to joint replacement assembly300in that it includes a joint prosthesis602similar to joint prosthesis302. In this regard, joint prosthesis602includes a diaphyseal portion605with a connection feature604configured to connect to a resected portion of a tibial shaft and a metaphyseal portion634configured to interface/articulate with another joint prosthesis, such as a femoral prosthesis (not shown). In the particular embodiment depicted, metaphyseal portion is particularly configured to form a hinged connection with a femoral component. In this regard, metaphyseal portion includes a tray region642for a tibial insert (not shown) and an elongate opening641extending therein for a stem of an axle assembly (not shown). Exemplary components that can be used in conjunction with assembly600, and other tibial assemblies described herein, can be found in U.S. Pub. No. 2017/0035572, the disclosure of which is hereby incorporated by reference herein in its entirety. However, assembly600differs in that it also includes a filamentary fixation device640and a connectable sleeve662. Moreover, joint prosthesis602is configured to receive filamentary fixation device640and connectable sleeve662. In this regard, metaphyseal portion634includes openings or elongate slots658which extend through metaphyseal portion634in an anteroposterior direction and are positioned at opposite lateral and medial sides of a longitudinal axis of prosthesis602. Such elongate slots658have their longitudinal length extending in a generally superior-inferior direction. This elongate configuration corresponds to a flat geometry of filamentary fixation device640, as described below. Metaphyseal portion634also includes one or more openings632located at an anterior side634bof prosthesis602and extends entirely through prosthesis602in a lateral-medial direction. Another opening660similarly extends through prosthesis602in a lateral-medial direction. In addition, opening660intersects elongate slots658so as to be in communication therewith, as best shown inFIG.14A. The intersection of opening660with elongate slots658allows for a suture or the like to be threaded through filamentary fixation device640while disposed in slots658and through opening660in order to help retain device640in a connected state with prosthesis602. As mentioned above, prosthesis602is also configured to receive sleeve662. In this regard, diaphyseal portion605is conically tapered so as to accommodate sleeve662in a taper lock configuration. In addition, metaphyseal portion634includes an anterior recess669that extends into the anterior face of metaphyseal portion634. Anterior recess669intersects or communicates with openings632and660to form longitudinal grooves667and668that are located within the perimeter of recess669. Sleeve662, as best shown inFIG.14A, includes a ring or cylindrical portion661and a tab portion or ingrowth portion663extending superiorly therefrom. Ring portion661has an opening666extending therethrough and is correspondingly tapered relative to portion605, as indicated above. Also, as mentioned above, tab portion663includes projections664which extend posteriorly for communication with grooves667and/or668. In this regard, projections664may have a concave surface (not shown) that extends laterally-medially to form a groove that corresponds to that of grooves667and668. Thus, when tab portion663is positioned within anterior recess669, projections664mate with grooves667/668so that the concave surfaces of projections664and grooves667/668together form cylindrical channels extending through prosthesis602. Preferably when tab portion663is received within recess669, an outer surface thereof is flush with an outer surface of prosthesis602. Preferably, tab portion663of sleeve662is made of a porous material, such as titanium foam, to support tissue ingrowth. For example, an exterior surface opposite projections664may be porous while projections664may be made from a solid metal material. Such configuration may be made via an additive manufacturing process so as to form a unitary structure. In addition, ring portion661may also be made of the same porous material or conversely a solid structure. Although the embodiment depicted includes a taper-lock mechanism to connect sleeve662to prosthesis602, other locking mechanisms are contemplated. For example, one or more threaded fasteners may connect ring portion661to diaphyseal portion605. Filamentary fixation device640is similar to filamentary fixation device120in that it is made from a filamentary material that may be a knitted or woven material, a non-woven material, or a combination thereof. However, filamentary fixation device640is an elongate flat strip of filamentary material that, when initially connected to prosthesis602, is folded over so that it resembles “U” shape with an inner surface640aand an outer surface640b. Thus, as assembled, terminal ends643of filamentary fixation device640are threaded through elongate slots658in a posterior to an anterior direction (seeFIGS.14D and14E) so that inner surface640bof the U-shaped construct engages a posterior side634aof metaphyseal portion634. The flat profile of filamentary fixation device640helps it conform to prosthesis602to provide a low profile. Thus, filamentary fixation device640has free ends643that can wrap around the anterior outer surface634aof metaphyseal portion634with the ends643of filamentary fixation device640going through respective openings658. A suture (not shown) may be passed through suture opening660and fixation device640at both the lateral and medial sides of prosthesis602to further secure filamentary fixation device640and to prosthesis602and to prevent device640from backing out of openings. Also, as assembled, ring portion661of sleeve662receives diaphyseal portion605so that tab portion663extends superiorly and so that an outer surface of portion605interferes with an inner surface of ring portion661to form a taper lock. Projections664of tab portion663are positioned in communication with grooves667/668of prosthesis602so as to partially define openings632and660. This allows sutures to be threaded through openings632and660, as desired, to secure soft tissue and filamentary fixation device640to prosthesis602. Furthermore, filamentary fixation device640may arrive to the operating theater pre-loaded to prosthesis602so that its free ends643extend in a posterior to anterior direction through openings658. The operator may optionally thread a suture through device640and through opening660in order to further secure device640to prosthesis. Alternatively, such suture may be pre-threaded to device640and prosthesis602before arriving to the operating theater. In a method for attaching the soft tissue to joint replacement prosthesis602, a similar method as shown inFIG.8is used with the joint replacement assembly600depicted inFIGS.14A-14E. In this regard, a patellar tendon902is detached from the tibial tubercle and a proximal section of the tibia is resected at a location along the tibial shaft so that the removed bone includes the tibial tubercle. In addition, prosthesis602is assembled by connecting sleeve662thereto. However, sleeve662may be pre-assembled prior to delivery to the operating theater. Thereafter, filamentary fixation device640is engaged to joint prosthesis602by inserting ends643of filamentary fixation device640into openings658so that inner surface640bis brought into communication with a posterior surface634aof metaphyseal portion634. Prosthesis602is then connected to the bone via a connection portion604and/or intramedullary stem (not shown) at the distal end of diaphyseal portion604. Once assembly600is mounted to the tibia, soft tissue is secured to joint replacement prosthesis602via filamentary device640. In order to re-secure the detached patellar tendon902, the patellar tendon902is positioned adjacent tab portion663of sleeve662so that tendon902contacts the porous structure thereof. Free ends643of filamentary device640are then wrapped tightly about the tendon902(see e.g.,FIG.8) and sewn thereto such that tendon902is sandwiched between porous sleeve662and filamentary fixation device640. This allows tissue to grow from tendon902into the porous sleeve662and the porous, mesh-like structure of filamentary device640. Moreover, a muscle, such as muscle904inFIG.8may be sewn to the fixation device640at an anterior side of prosthesis602. In addition, a suture or cerclage wire may be threaded through openings632and/or660and passed through tendon902and/or muscle904. Thus, this configuration allows for a traditional connection to implant602via openings632and660and also allows for the soft tissue902,904to grow into filamentary component640thereby providing a strong initial and long-term connection. Thus, filamentary component640provides a soft tissue ingrowth structure to prosthesis602. Joint replacement assembly700, as shown inFIGS.15A-15C, is yet another embodiment of the disclosure and generally includes a joint prosthesis702, cannulated screws,760and a connection plate or ingrowth plate750. Joint prosthesis702is similar to prosthesis302in that it includes a metaphyseal portion734configured for connection to another joint prosthesis, such as a femoral component, and a diaphyseal portion705with a connection feature704that allows prosthesis702to be connected to a resected portion of a tibial shaft. Metaphyseal portion734is connected to a proximal end of diaphyseal portion705so that prosthesis702tapers outwardly in a distal to proximal direction. Metaphyseal portion734includes one or more openings754that extend entirely through prosthesis702in an anteroposterior direction and that are each configured to receive a cannulated screw760. Metaphyseal portion734also includes a recessed portion731that matches the shape and size of plate750, as described in more detail below. Cannulated screws760have a shaft761, a head763, and a through-opening762extending through the length of screw760. The shaft761is generally cylindrical and comprises the majority of the screw760. The distal end of screw760includes a threaded portion765. Screw760is cannulated so that sutures706can be threaded through the length of screw760. This allows screws760to be inserted into openings754so that through-opening762of each screw760provides a passage for a suture through prosthesis702. The threaded portion765of screw760is configured to threadedly engage threaded openings752in plate so as to secure plate750to prosthesis702, as described below. In the embodiment shown, plate750has a “T” like shape, in which plate750has a body751and two projections or wings755extending from body751in a lateral-medial direction. Plate750further includes threaded openings752that extend through the thickness of plate750and correspond to the location of openings754in prosthesis702such that when plate750is inserted into recess731, openings752and754align. Openings752are threaded to so that screws760can secure plate750to prosthesis702. Plate750is preferably composed of a porous material, such as titanium foam, that supports tissue in-growth. However, openings752may have a solid metallic structure to provide sufficient strength for a threaded connection with screws760. As mentioned previously, plate750has openings752with threads to receive screw760. As seen inFIG.17, openings752appear to be where the body751of plate750meets projections755. However, openings752can be located anywhere on plate750so long as openings754on body730correspond. However, it is preferable that openings754and openings752are located at respective lateral and medial sides of a longitudinal axis of prosthesis702so that a suture or the like can be passed from one side of axis to another to secure soft tissue to prosthesis702. Moreover, plate750does not have to be limited to a “T” shape. For example, plate could just be rectangular and not include projections755. However, in such embodiment, plate750would have a larger lateral-medial width than the plate depicted. Other exemplary configurations of plates are describe in more detail below. In a method of using assembly700to connect a patellar tendon thereto, plate750may be connected to prosthesis702via cannulated screws760. This may be done in the operating theater or prior to delivery to the operating theater. Prosthesis702may then be connected to a proximal end of a resected tibia and the patellar tendon positioned adjacent porous plate750. Suture or wire may then be threaded through cannulated screws760about metaphyseal portion734and through and/or about the patellar tendon so as to secure the patellar tendon against porous plate750so that tissue from the tendon can grow into its porous structure. Thus, while assembly700may not include a filamentary fixation device that would allow for tissue growth therein like that of assembly600, assembly700still allows for tissue in-growth into the porous plate750at the anterior face of prosthesis702. Thus, a filamentary device, such as strand of suture or wire, positioned through cannulated screws760can help provide immediate fixation, while porous plate750facilitates long-term fixation. However, it is contemplated that assembly700can also include a filamentary fixation device to further enhance long term fixation. For example, filamentary fixation device340may be slid over diaphyseal portion705so that portion705is received within opening346. The patellar tendon may sutured to second portion342as described above with respect toFIG.8. In this regard, the patella902may be sandwiched between porous plate750and second portion342of device340so that the soft tissue may grow into bone plate750and second portion342. Joint replacement assembly800, as shown inFIG.16, depicts a further joint replacement assembly embodiment of the present disclosure. Joint replacement assembly800is similar to assemblies600and700. In this regard, assembly800includes a joint prosthesis802, cannulated screws862, and a connection plate or ingrowth plate850that is of a porous material or has a porous exterior surface connectable to the joint prosthesis802similar to that of assembly700. However, unlike assembly700, four cannulated screws860are used to connect plate850to prosthesis802. Thus, it should be understood that two or more cannulated screws860may be used to connect a porous plate to an underlying prosthesis. Also, unlike in assembly700but similar to assembly600, prosthesis802includes longitudinal slots similar to that of slots658. This allows filamentary fixation device640to be used in assembly800to help secure soft tissue thereto as described above. Also, as shown, plate850has a rough hour-glass shape which helps occupy as much space as possible between longitudinal slots or through-slots858to help ensure contact with soft tissue for growth therein. Soft tissue is connected to prosthesis802similar to that of prosthesis602and702. In this regard, a patellar tendon that has been disconnected from a tibia is positioned against porous plate850. Filamentary fixation device640is threaded through slots858and free ends643thereof are placed over the tendon and sewn together via suture or wire, as described with respect to assembly600. In addition, the tendon may be further secured via sutures or wire through cannulated screws860, as described with respect to assembly700. Thus, this configuration allows for a connection to implant802via the cannulation in screws860to provide for a strong immediate connection and also allows for the soft tissue, such as tissue902,904ofFIG.8, to grow into filamentary fixation device640and porous plate850thereby providing a strong long-term connection. FIG.17depicts another joint replacement assembly900similar to that of800and is accorded like reference numerals, but within the900series of numbers. However, the difference between assembly800and900is that assembly900includes a connection plate or ingrowth plate950that is of a porous material or has a porous exterior surface with a depression952on its anterior or outer surface. This depression952allows a portion of bone, such as a resected tibial tubercle with attached tendon, to be received therein and so that such bone can grow into the porous structure of plate950. Depression952provides a relief for the resected bone with tendon attached thereto to seat at a natural anatomic height relative to the anterior face of prosthesis902. Thus, the method is identical to that of assembly800with the difference being that bone underlying the patella is excised and connected to plate within its anterior depression952. FIGS.18A-18Edepict another joint replacement assembly1000similar to that of assemblies800and900. In this regard, assembly1000includes a joint prosthesis1002that includes a metaphyseal portion1034and a diaphyseal portion1005and is generally constructed as a tibial prosthesis. Moreover, metaphyseal portion1034includes a tray region1042for a tibial insert, a plurality of through-holes1054,1056configured to each receive a cannulated screw, such as screws860and960, an anterior recessed portion1031for receipt of an ingrowth plate, such as plates850and950, and through-slots1058for receipt of a filamentary fixation device, such as filamentary device640. However, through-slots1058are differently configured than slots858and958. In this regard, slots1058each extend through posterior and anterior sides of prosthesis1002such that each slot1058defines an anterior or first aperture1057aand posterior or second aperture1057b. The posterior aperture1057b, as best shown inFIG.18C, is pill-shaped such that it defines a longitudinal axis1058bthat is parallel to a central axis of prosthesis1002. The anterior aperture1057a, as best shown inFIG.18A, is triangular, as illustrated by the superimposed right triangle1058a. However, the apices of the triangle formed by anterior aperture1057aare rounded rather than pointed. In addition, each slot1058is defined along its anteroposterior traversal by first and second opposing sidewalls1051a-b. The first sidewall1051ahas a constant superior-inferior height along the traversal of each slot1058from posterior aperture1057bto anterior aperture1057a. However, the second sidewall1051bgradually shortens in height along the traversal of each slot1058from posterior aperture1057bto anterior aperture1057b. In addition, first wall1051ais generally parallel to a central axis1004of prosthesis at both the anterior and posterior aperture1057a-band also therebetween. However, second wall1051b, while being substantially parallel to central axis1004at the posterior aperture1057b, gradually tilts away from central axis1004as second wall1051bextends posterior to anterior so that second wall1051badjacent the anterior aperture1057ais canted away from axis1004and forms the hypotenuse of the triangular-shaped anterior aperture1057a. Thus, a plane tangent to second sidewall1051bintersects central axis1004. Moreover, in the particular embodiment depicted, second sidewall1051balso curves inwardly about central axis1004in a posterior to anterior direction, as illustrated by the arc line overlay1053inFIG.18B. In other words, second sidewall1051bfollows a curved path so that second sidewall1051bitself defines a curved surface. However, it is contemplated that second sidewall1051bmay be planar while having other characteristics described above, such as being canted away from central axis1004. It is also contemplated that both first and second apertures1057a-bmay be triangular. The depicted embodiment allows filamentary fixation device640to be threaded through slots1058similar to that described above with respect to assemblies800and900so that a segment641of device640that spans between slots1058conforms to the posterior side of prosthesis1002and is pressed flat against the posterior side of prosthesis1002, as best shown inFIG.18D. In this regard, the flat configuration of filamentary device640and the orientation of slots1058so that they form a posterior aperture1057bthat is substantially parallel to the central axis1004helps provide a low profile of device640at the posterior side of prosthesis1002so as to minimize soft tissue irritation while also distributing loads over a broad surface area for durability. In addition, each free end643of device640, as they follow second wall1051bof their respective apertures1058, turns so that their axes are no longer horizontal, but instead are angled superiorly so that free ends643cross in an X-shaped arrangement, as best shown inFIG.18E. This arrangement helps redirect free ends643so that they do not interfere with each other as they extend over the anterior side of prosthesis1002and also help distribute loads applied to filamentary fixation640device to walls1051b. In other words, a patella sewn to filamentary fixation device640will have a tendency to be pulled superiorly by the extensor mechanism during normal movement of the knee joint. Thus, loads applied to device640via the patella will tend to pull on free ends640superiorly. With assembly1000, when such loads are applied to device640, free ends640will be further compressed to surfaces1051swhich further helps distribute the loads over a broad area to maximize durability of device640. In addition, the curvature of second surfaces1051aand their angled orientation helps prevent filamentary device640from being bunched up at a superior end of each slot1058. Several filamentary fixation devices, such as filamentary fixation devices120,220,340,500, and640, are described herein. Such fixation devices may be made by folding over and or tubularizing sheets of synthetic mesh, such as Marlex mesh manufactured by CR Bard, Inc., and then shaping such mesh into the desired form. However, folding over or rolling sheets of mesh material can result in a stiff, bulky structure. In addition, sutures threaded through such structures cut through or rip through edges of the mesh material as the only structure preventing this are the woven fibers of the filamentary material which typically loosely engage the suture. In order to address some of the existing problems with surgical mesh in extensor mechanism repair, filamentary fixation devices120,220,340,500, and640described herein and other filamentary fixation devices not described herein can be made by layering individual sheets of synthetic mesh/filamentary material and heat sealing/bonding the sheets of material together to form an integrated structure. An embodiment of such integrated filamentary fixation structure1100′ is depicted inFIG.19C-19E. Filamentary fixation device1100′ is similar to filamentary device640and, therefore, can be used in the same manner described above. Filamentary fixation device1100′ begins as a plurality of layers1102of mesh material that are stacked onto one another to form a construct1100having a desired width “W”, length “L”, and thickness “T”, as shown inFIGS.19A and19B. In this regard, the construct1100can have any number of layers of material, such as 2 to 20, but preferably 8 to 12 layers. The construct1100is then heat sealed through its full thickness so that each layer1102is connected to an adjacent layer in order to form device1100′. In some embodiments, large sheets of material may be layered, heat sealed, and then cut to the desired dimensions to form device1100′. In addition, it is contemplated that other means of connection between layers1102is contemplated, such as sonic welding, adhesives, and the like. As shown inFIG.19C-19E, filamentary fixation device1100′ includes a plurality of seams1104that are formed so that they each extend continuously along the entire length thereof and through the entire thickness thereof. In this regard, the length of each seam1104is in a direction of the expected load. Thus, in some circumstances, where the expected load may be multi-directional, it is contemplated that there may be overlapping seams that extend in different directions, such as along both the length and width of device1100′. In the embodiment depicted, a first and second seam1104a-bare formed at the side edges of device1100′ and a third seam1104cis formed down a centerline of device1100′. In this regard, each layer1102is free to move relative to adjacent layers between the seams1104a-c, as depicted in the cross-sections ofFIGS.19D and19E. Some embodiments may have more than three continuous seams1104, such as 4 to 8 seams. Moreover, seams1104may be positioned relative to each other at consistent intervals or at differing intervals such that the distance between each seam1104differs from one seam to the next. FIG.19Eillustrates various suture pathways that may be used to connect soft tissue to device1100′. As shown, a suture may be threaded through each layer of device1100′ between adjacent seams. In this regard, seams act as a structural barrier that helps prevent sutures from cutting entirely through device and helps maintain the sutures in their respective lanes between seams. FIG.19Fdepicts an alternative fixation device1100″. Fixation device1100″ has a plurality of interrupted or discontinuous seams1104′, whereas device1100′ has a plurality of continuous seams1104. Thus, while each seam1104′ similarly extends along the length of device1100″ and through its full thickness, each seam1104′ is interrupted at predetermined intervals along its length by free segments1106which lie along the axis of the seam1104′. The layers1102at the free segments1106are not bonded together and, therefore, are free to move relative to each other. Such an interrupted configuration can provide further flexibility over that of device1100′. It is also contemplated that other devices not shown can have a combination of continuous and interrupted seams. For example, side edges of a filamentary fixation device can be sealed with continuous seams, such as seams1104a-b, while one or more seams between such side edges are sealed with interrupted seams, such as seams1104′. Layered mesh with continuous or interrupted seams1104,1104′ are advantageous because they allow the overall construction of a filamentary fixation device to have a thinner profile than a typical folded or rolled construction. Moreover, such layered construction provides enhanced flexibility as the overall construct is less bulky. In addition, the interrupted seam1104′ may provide even further flexibility due to free segments1106, as mentioned above. Even further, layering mesh filamentary material and connecting them via a heat fusion or the like allows the layered construction to be cut and shaped much like a textile material so that the layered construct can take on any of the forms of the herein described filamentary fixation devices. FIGS.20A-20Fdepict further joint replacement assembly1200similar to that of assembly1000. In this regard, assembly1200includes a joint prosthesis1210that includes a metaphyseal portion1234and a diaphyseal portion1205and is generally constructed as a tibial prosthesis. Moreover, metaphyseal portion1234includes a tray region1242for a tibial insert, a plurality of screw openings1254,1256configured to each receive a screw1260, an anterior recessed portion similar to recessed portion1031, a connection plate or ingrowth plate1290received within such recessed portion, and through-slots or through-openings1258for receipt of a filamentary fixation device, such as filamentary devices640,1100,1100′, and1100″, for example. Assembly1200also includes through-holes1232configured to receive sutures or wires, such as cerclage wires, for example. However, through-slots1258are differently configured than slots1058. In this regard, slots1258each extend through posterior and anterior sides of prosthesis1210such that each slot1258defines an anterior or first aperture1257aand posterior or second aperture1257b. The posterior and anterior apertures1257a-b, as best shown inFIGS.20A and20B, are both elliptical in shape such that their respective major axes (i.e., an ellipses major axis) extend in a generally mediolateral direction. In addition, each slot1258is defined along its anteroposterior traversal by first and second opposing sidewalls1251a-b. First sidewall1251a, which is closer to a midline longitudinal axis of prosthesis1210, is convexly curved generally about such midline axis. Conversely, the second sidewall1251bis concavely curved but also generally about the midline axis of prosthesis1210. In addition, as best shown inFIG.20E, opening1258has a narrower opening in a proximal-distal direction near the center of opening1258while being wider nearer the anterior and posterior apertures1257a-b. In other words, opening1258gradually narrows from posterior aperture1257bto a center of opening1258and then gradually widens from the center of opening1258to anterior aperture1251a. The depicted embodiment allows filamentary fixation device640(or also1100,1100′,1100″) to be threaded through slots1258similar to that described above with respect to assembly1000. However, the narrowing and widening of openings1258in addition to their elliptical shape causes a flat filamentary fixation device to slightly fold over itself as it extends from posterior aperture1257bto anterior aperture1257band vice versa. This allows filamentary fixation device640to conform to convex inner surface1251awhile being manipulable at the anterior side of prosthesis1210so that free ends640a-bof fixation device640can be oriented at any desired angle without awkward crimping or bunching thereof. In this regard, prosthesis1210allows fixation device640to achieve any of the orientations previously described and more such that an extensor mechanism can be connected thereto in the manner previously described. Connection plate or ingrowth plate1290, as shown inFIGS.20C and20D, include a plate body1291that has a thickness extending between an anterior face1292and a posterior face1295thereof. Anterior face1292(seeFIG.20D) preferably includes a porous material extending over at least a portion of its area in order to promote tissue ingrowth therein. Plate1290includes a proximal portion1270, a distal portion1280, and an intermediate member1294extending therebetween. Distal portion1280includes a first and second boss1281a-bextending posteriorly from the posterior face1295. A first and second through-opening1286a-brespectively extend through bosses1281a-bfrom the anterior side to the posterior side of plate body1291. Distal portion1280also includes a first and second counterbore1288a-beach of which are respectively coaxial with first and second through-openings1278a-b. Such configuration forms a circular rim1282between each counterbore and through-opening pairing. First and second openings1286a-bare each configured to receive a threaded shaft1262of screw1260. However, openings1286a-beach have a cross-sectional dimension smaller than that of a head1264of screw1260such that head1264is prevented from passing therethrough, but is capable of being disposed within each of counterbores1288a-bas best shown inFIGS.20E and20F. In this regard, screw1260is engaged to distal portion1280via the anterior side of plate body1281such that threaded shaft1262is passed through one of counterbores1288a-band then through respective through-opening1286a-bso that head1264rests against rim1282from within counter bore1288aor1288b. Proximal portion1270also includes a first and second boss1271a-bextending posteriorly from posterior face1295. However, proximal portion1270does not include counterbores. In addition, bosses1271a-beach include a respective side-slot1276a-bthat defines a U-shaped rim1272. A groove1274extends along posterior face1295in a mediolateral direction and communicates with side-slots1276a-b. A first and second through-opening1278a-bextend through the anterior face1292and posterior face1295and each intersect a respective side-slot1276a-b. First and second through-openings1278a-beach have a cross-sectional dimension smaller than that of screw head1264. Unlike distal portion, a screw1260is engaged to proximal portion1270via the posterior side of plate body1291such that head1264is inserted into groove1274and slide along posterior surface1295and into one of side slots1276a-b. Once disposed within one of side-slots1276a-b, head1264rests on rim1272and is positioned between rim1272and a respective through-opening1278a-b. In this regard, through-opening1278aor1278baligns with a tool opening within head1264of screw so that a tool/driver can engage screw1260which is rotatably positioned within one of side-slots1276a-bdespite being positioned on the posterior side of plate body1291, as best shown inFIG.20D. However, threaded shaft1262extends posteriorly from side-slot1276a-bfor engagement with one of threaded openings1254of prosthesis1210. This configuration reduces the overall footprint of through-openings1278a-brelative to anterior surface1292of plate body1291as compared to that of counterbores1288a-b. As such, more surface area of plate body1291can be dedicated to a porous surface for ingrowth particularly in the proximal portion1270of plate1290which is more likely to be in direct contact with soft tissue than distal portion1280. However, it should be understood that proximal portion1270can be configured the same as distal portion1280such that proximal portion1270includes counterbores, such as counterbores1288a-b, for screw loading via the anterior side of plate body1291. Alternatively, distal portion1280may be configured the same as proximal portion1270such that distal portion1280includes side-slots, such as side-slots1276a-b, so that screw1260can be loaded from the posterior side of plate1290. Also, it should be understood that in some embodiments, plate1290may not include bosses1271a-bor1281a-b, and may instead just have extra plate thickness. Moreover, in some embodiments, plate1290may not include groove1274. However, groove1274is helpful to make space for head1264of screw1260. Proximal portion1270and distal portion1280are connected via intermediate member1294such that plate body1291has an hour-glass shape. In other words, proximal portion1270and distal portion1290are wider than at intermediate portion1294. This configuration creates indentations at the sides of plate body1291to make space for openings1258ofFIGS.20A and20B.FIGS.20E and20Fillustrate the connection between plate1290and prosthesis1210. In this regard, plate1290is disposed in an anterior recess of prosthesis1210with conforms to the shape of plate body1290. Porous anterior face1292is positioned outward at the anterior side of prosthesis1210so as to engage tissue when implanted, as described above with respect to other embodiments of the present disclosure. Screws1260pass through distal portion1280such that threaded shafts1262engage threaded openings1256and heads1264engage circular rim1282from within counterbores1288a-b. Additional screws1260are positioned at posterior side of plate1290within side-slots1276a-bsuch that threaded shafts1262extend from plate body1291and into threaded openings1254. In this regard, each head1264is sandwiched between rim1272and at least a portion of the thickness of plate body1291. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. For example, although embodiments of the invention have generally been described in reference to an orthopedic assembly in a tibia, the principles described herein are equally applicable to bones of other joints. | 60,727 |
11857427 | DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION Generally stated, disclosed herein are shoulder prostheses with stemless humeral components and stemmed humeral components. Further, surgical methods for using the shoulder prostheses are discussed. In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, “proximal” means the portion of a device or implant nearest the torso, while “distal” indicates the portion of the device or implant farthest from the torso. As for directional terms, “anterior” is a direction towards the front side of the body, “posterior” means a direction towards the back side of the body, “medial” means towards the midline of the body, “lateral” is a direction towards the sides or away from the midline of the body, “superior” means a direction above and “inferior” means a direction below another object or structure. As used herein, the word “exemplary” or “illustrative” means “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “illustrative” is not necessarily to be construed as preferred or advantageous over other implementations. Moreover, in the present description, the terms “upper”, “lower”, “left”, “rear”, “right”, “front”, “vertical”, “horizontal”, and derivatives thereof shall relate to the invention as oriented in the first figure of each embodiment. Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current implants, devices, systems and methods are described herein with reference to use with the bones of the shoulder, the bones of the shoulder and upper arm may be used to describe the surfaces, positions, directions or orientations of the implants, devices, systems and methods. Further, the implants, devices, systems and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the implants, devices, systems and methods, and the aspects, components, features and the like thereof, described and/or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the invention. For example, the implants, devices, systems and methods, and the aspects, components, features and the like thereof, described herein with respect to the right shoulder may be mirrored so that they likewise function with the left shoulder and vice versa. Further, the implants, devices, systems and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the shoulder for brevity purposes, but it should be understood that the implants, devices, systems and methods may be used with other bones of the body having similar structures, for example the lower extremity, and more specifically, with the bones of the ankle, foot, and leg. Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference toFIGS.1-8, there is illustrated a stemless humeral component or anchor110of a stemless implant system100. The stemless implant system100includes a stemless humeral component or anchor110, an articulating portion150, and a coupling member170. The humeral component110has a first end112and a second end114. The first end112of the humeral component110has a first width and the second end of the humeral component110has a second width. The first width may be for example larger than the second width. The humeral component may include a base116. The base116may include a recess or circumferential groove118extending into the base116from the first end112towards the second end114. The groove118may be, for example, tapered as the groove118extends from a first end112into the base116of the anchor member110, as shown inFIGS.7,8,20and24. The recess118may form an interior lip120of the base116. The base116may also be configured to mate out at the periphery when inserted into a patient. With continued reference toFIGS.1-16, the humeral component110may also include a central number122positioned within the base116. The central member122may include a through hole124extending through the humeral component110from the first end112to the second end114. The through hole124may include a first portion126, a threaded portion128, and a second portion130. The first portion126may extend from the first end112toward the second end114. The second portion130may extend from the second end114toward the first end112. The threaded portion128may be positioned between the first portion126and the second portion130. The first portion126may have, for example, a larger diameter than the second portion130. The threaded portion128may have, for example, a diameter larger than the diameter of the second portion130and smaller than the diameter of the first portion126. The humeral component110may also include arms or support members132extending between an exterior surface of the central number122and an interior surface of the lips120of the base116, as shown inFIGS.1-8and14. The base116of the humeral component110may also include windows or openings134extending through the base portion116from the first end112of the humeral component110toward the second end114. The openings134may be, for example, positioned between each of the arms132. As shown inFIGS.1,5, and14, the humeral component110may include, for example, four arms. The base116may also include a plurality of fastener openings142extending through the base116from the first end112toward the second end114. The plurality of openings142may be positioned between an exterior surface of the base116and the recess118. The plurality of fastener openings142may be, for example, configured or sized and shaped to receive fasteners, such as, sutures and the like. In addition, the humeral component110may include legs or extension members136extending away from a bottom surface of the base116toward the second end114of the humeral component110. A first end of each leg136is coupled to the base116and the second end of each leg136is coupled to the exterior surface of the central member122at a distal end. The legs136may be, for example, curved or arced as they extend from a bottom surface of the base116to the second end114of the humeral component110. Each leg136may be coupled to the base116and an arm132by a base member138. The base members138may each have a width larger than the width of the coupled leg136. The legs136may be, for example, equally spaced apart from each other circumferentially around the base116of the humeral component110. A cutout140may extend through each leg136below or distal to a corresponding arm132. The cutouts140may be, for example, position perpendicular to the openings134. Referring now toFIGS.9-16, the orthopedic implant assembly or stemless implant system100is shown. As shown inFIGS.12-16, the articulating portion150includes an articulating surface152and a coupling surface or bottom surface154positioned opposite the articulating surface152. The articulating surface152is a convex articulating surface. The coupling surface154may include, for example, a recessed region156extending into the bottom surface154toward the articulating surface152. The inset recessed region156forms an outer edge158surrounding the recessed region156. The recessed region156may be, for example, sized and shaped to receive the base116of the stemless humeral component110. The articulating portion150may also include an opening160extending into the articulating portion150from the bottom surface154. A lip162may surround the opening160, as shown inFIG.13. The lip162may include at least one slot or anti-rotation slot164inset into the lip162. The at least one slot164may be, for example, four slots164. With continued reference toFIGS.9-16, the coupling member170may include a first end172and a second end174positioned opposite the first end172. Coupling member170may include a first portion or base member176coupled to a second portion or extension number182. The second portion182extends away from a bottom surface178of the base member176. The first portion176may have a first diameter larger than a second diameter of the second portion182. The coupling member170may also include, for example, an anti-rotation protrusion or protrusion180extending away from an exterior surface of the base member176. The coupling member170may also include a through hole or threaded opening184extending through the coupling member170from the first end172to the second end174. Referring now toFIG.12, a cross-section of an assembled stemless implant system100is shown. The first end172of the coupling member170is inserted into the opening160of the articulating portion150. The alignment protrusion180may be, for example, aligned with at least one slot164and inserted into a slot164of the at least one slot164to prevent rotation of the articulating portion150with respect to the coupling member170. The coupling member170may be coupled to the articulating portion150, for example, with a fastener (not shown), a friction fit, such as, a taper fit, and alternative known methods for coupling articulating portion152and anchor110. The base116of the humeral component110may be, for example, received within the recessed region156of the articulating portion150, as shown isFIG.12. Referring now toFIGS.17-24and with continued reference toFIGS.1-8, a reverse orthopedic implant assembly or a reverse stemless implant system200is shown. The reverse implant system200may have a first end202at a second end204. The reverse implant system200may include, for example, a stemless humeral component or anchor110, a spacer or coupling member210, and a socket number240. The humeral component110is as described with reference toFIGS.1-8and will not be described again here for brevity's sake. As shown inFIGS.20-24, the coupling member210includes a first end or upper surface212and a second end or lower surface214. The coupling member210includes a base member216, an extension number224, and a protrusion or extension number232. The extension member224extends away from a bottom surface of the base number216and the protrusion232extends away from the extension number224. The base member216includes a recessed region218inset into the coupling member210from the first end212and forming an interior side wall surrounding the recessed region218. The interior side wall may include, for example, a circumferential groove220extending from the recessed region218toward an exterior surface of the base member216. The circumferential groove220may receive, for example, a coupling element260, such as, an O-ring, as shown inFIG.20. At least a portion of the recessed region218may be, for example, a flat surface222as best seen inFIGS.20and24. The flat surface222may extend from the interior side wall toward a center of the base member216. Referring now toFIGS.20and22-24, the extension number224includes a rim226extending away from a bottom surface of the base member216. The rim226surrounds a bottom surface228of the extension member224. The bottom surface228may be, for example, a flat surface for receiving the first end112of the humeral component110. The top surface230of the extension member224may coupled to and extend from the flat surface222of the base number216. The top surface230may be, for example, arced or curved as shown inFIGS.20and24. The extension member224may also be, for example, tapered as the extension member224extends away from the bottom surface of the base member216, as shown inFIGS.20and24. The extension member224may be used, for example, to secure the spacer210to the anchor member110in the reverse implant system200. The protrusion or extension member232extends away from the bottom surface228to the second end214, as shown inFIGS.20and22-24. The protrusion232may include a through hole or threaded opening234extending through the protrusion232from the second end214to the top surface230, as best seen inFIG.24. With continued reference toFIGS.20-24, the socket member240includes a first end or upper surface242and a second end or lower surface244. The first end242includes an articulating surface246recessed into the socket member240. The first end242also includes a tapered edge248extending circumferentially around the socket member240, as shown inFIGS.19,20,23and24. The socket member240also includes an engagement protrusion250extending away from the tapered edge248. The engagement protrusion250may be, for example, inset from the outermost portion of the tapered edge248. The engagement protrusion250may include a circumferential groove252. The circumferential groove252of the socket member240may align with the circumferential groove220of the coupling member210when the socket member240is inserted into the coupling member210. The circumferential groove252of the socket member240may be configured to receive a coupling member260, such as, an O-ring. The socket member240may also include a bottom surface254. The bottom surface254may include a flat portion and an arced or curved portion256. The socket member240may also include a protrusion or stem258extending away from the bottom surface254. The curved portion256may extend between the flat portion of the bottom surface254and the protrusion258. The protrusion258may be, for example, configured or sized and shaped to engage the through hole234of the coupling member210. As shown inFIGS.17-20, the implant system200may be assembled by inserting the protrusion232of the coupling member210into the through hole124of the humeral component110and the extension number224of the coupling member210into the interior of the base116. In addition, the protrusion258of the socket member240may be inserted into the through hole234of the coupling member210and the engagement protrusion250may engage the recessed region218of the coupling member210. An O-ring260or like coupling member may be positioned within the circumferential groove220of the coupling member210and the 42 circumferential groove252of the socket member242secure the socket member242the coupling member210. Finally, a fastener (not shown) may be inserted into the through hole124of the humeral component110and engage the threaded opening234of the coupling member210to secure the humeral component110to the coupling member210. Referring first collectively toFIGS.25-37, another orthopedic implant assembly or stemless implant system300is shown.FIGS.25-30show multiple views of an anchor or humeral component310for use in the orthopedic implant assembly300. The anchor310is adapted to be inserted into a humeral bone, as shown inFIG.37. The anchor300generally includes a base312, a first or central keel320, a second or rear keel324, a third or medial keel328, and a fourth or lateral keel332. The base312may be disposed at a constant angle, for example, ranging from 125 degrees to 155 degrees and more preferably about 135 degrees, relative to each keel320,324,328,332. Each keel320,324,328,332may be, for example, co-planar with the axis of insertion. The axis of insertion may be, for example, approximately 45 degrees from the top surface of the base116and may be in-line with the canal. With continued reference toFIGS.25-30, the base312of the anchor310has the shape of a low-profile cylinder with an open center338and a pair of flattened forward panels340, as best shown inFIG.27. As further illustrated inFIGS.25-30, the base312has a proximal upper surface342and an opposing distal bone contacting surface344. As also shown inFIGS.25-30, the anchor310further includes central keel320. The central keel320extends across the diameter of the open center338of base312. The central keel320further extends from the bone contacting surface344of the base312in a direction opposite the proximal surface342such that the central keel320has a first length. Importantly, the central keel320has a first length such that when implanted into a humeral bone the central keel320does not, for example, extend into the diaphysis of the bone. However, the central keel320and the base312are designed to engage the bone to achieve sufficient short and long term fixation. The central keel320has a first length of not more than 45 millimeters and preferably not more than 40 millimeters. In the most preferred embodiment, the central keel320has a length of not more than 35 millimeters. In addition, the central keel320may have a length of not more than 30 millimeters. The rear keel324, the medial keel328, and the lateral keel332have lengths no greater than the length of central keel320. Moreover, in the preferred embodiment, each keel324,328,332has a constant cross-sectional shape and volume between an initial bone insertion taper at a distal end316and the bone contacting surface344at a proximal end314. Referring still toFIGS.25-30, the central keel320further includes a plurality of bone rasping fins322that extend from the central keel320. The fins322are preferably disposed vertically along the exterior length of the central keel320. The fins322may extend directly or at an angle from the central keel320. Each fin322may be of any desired shape useful in being inserted into the bone. Returning toFIGS.25-30, the rear keel324extends from the bone contacting surface344of the base312in a direction opposite the proximal surface342of the base312and generally parallel to the central keel320. The rear keel324includes a plurality of bone engaging fins326that extend from the rear keel324. The fins326are preferably disposed horizontally, perpendicular to the exterior length of the central keel320. The fins326may extend directly or at an angle from the central rear keel320. Each fin326may be of any desired shape useful in being retained in a bone. With continued reference toFIGS.25-30, the anchor310further includes the medial keel328. The medial keel328extends from the bone contacting surface344of the base312in a direction opposite the proximal surface342of the base312and generally parallel to the central keel320. The medial keel328also includes a plurality of bone engaging fins330that extend from the medial keel328. The fins330are preferably disposed horizontally, perpendicular to the exterior length of the medial keel328. The fins330may extend directly or at an angle from the medial keel328. Each fin330may be of any desired shape useful in being retained in a bone. Referring again toFIGS.25-30, the lateral keel332extends from the bone contacting surface344of the base312in a direction opposite the proximal surface342of the base312and generally parallel to the central keel320. The lateral keel332includes a plurality of bone engaging fins334that extend from the lateral keel332. The fins334are preferably disposed horizontally, perpendicular to the exterior length of the lateral keel332. Fins334may extend directly or at an angle from lateral keel332. Each fin334may be of any desired shape useful in being retained in a bone. Referring now toFIGS.38-44and with continued reference toFIGS.25-30, there is shown several views of a shoulder implant assembly300including anchor310attached to a humeral head350. The humeral head350is a common component of its type having a convex outer articular surface352and an anchor engaging surface354. The humeral head350is attached to the anchor310by common mechanical means, for example, a coupling member.FIG.44shows the implant300inserted in a humeral bone. Referring now toFIGS.38-44, there is shown several views of a reverse shoulder implant assembly400including the anchor310attached to the articular component410. The articular component410is a common component of its type having a concave outer articular surface412and an anchor engaging surface354. The articular component410is attached to the anchor310by common mechanical means, for example, a coupling member.FIG.44shows the implant400inserted in a humeral bone. Advantageously, the finned shape and short keel length allow the anchor310, the implant300, or the implant400to be inserted vertically into a resected humeral bone without significant preparation. Indeed, only a punch is needed prior to inserting the anchor310into the bone. While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims. Referring now toFIGS.55-67, an orthopedic implant system or stemmed implant system500is shown. This stemmed implant system500may include a stem component510, an articulating portion150and a coupling member170. The articulating portion150and the coupling member170are as described above with reference to implant system100and will not be described again here for brevity's sake. As shown inFIGS.45-54, the stem component510may include a first end512and a second end514. The stem component510may include a plate or base516and a stem542. The base516may have a large ring or surface area to assist with fixation, for example, the base516may contact cancellous bone to provide better support for the implant500. The base516may include a recess or circumferential groove518extending into the base516from the first end512. The groove518may be, for example, tapered as the groove518extends from a first end512into the base516of the anchor member510, as shown inFIGS.63and76. The circumferential groove518forms an interior lip520positioned within the base516. The base516may also include a central member522with an opening524extending into the central member522, as shown inFIG.53. The opening524may include a first portion or first wall portion526and a threaded portion528. The first portion526may extend from the first end512of the stem component510toward the second end514. The threaded portion528may be positioned at a bottom of the opening524. The diameter of the threaded portion528may be, for example, smaller than the diameter of the first portion526. With continued reference toFIGS.45-54, the stem component510may also include arms530extending between the interior lip520and the central member522. The arms530may include, for example, at least one tapered edge532, as shown inFIG.51. As shown, the stem component510may include two arms530which may be positioned on opposite sides of the central member522. The stem component510may also include a first support member534and a second support member536. The first support member534may be positioned between the two arms530. Likewise, the second support member536may be positioned between the 2 arms530and the second support member536may be positioned opposite the first support member534. The first support member534may extend between the first end512of the stem component510and the stem542on a first side. The second support member536may extend between the first end512and the stem542on a second side. The base516may also include windows or openings538positioned between the arms530and support members534,536. The openings538may extend entirely through the base516. The base516may also include a plurality of fastener openings540. The plurality of fastener openings540may be, for example, configured or sized and shaped to receive fasteners, such as, sutures and the like. The plurality of fastener opening540may extend through the base516from the first end512toward the second end514. In addition, the plurality of fastener openings540may include openings extending through the second support member536from an interior surface to an exterior surface. As also shown inFIGS.45-54, the stem542may include a proximal end544coupled to the second support member536of the base516and a distal end or tip546positioned at the second end514of the stem component510. The stem542extends away from a bottom surface of the base516to the second end514. The stem542may extend away from the base516at an angle, as shown inFIGS.48,50and53. The stem542may include an exterior surface548and at least one interior surface552,554. The stem542may also include a fin, legs, or protrusion550extending away from the at least one interior surface552,554. The fin550may be positioned, for example, at a midpoint or midline of the stem542. The fin550may divide the interior surface552,554into a first interior surface552and a second interior surface554. Each interior surface552,554may be, for example, curved or arced from the medial or lateral exterior surface to the fin550. As shown in at leastFIGS.46and54, the stem542may have, for example, a “T” shape as the stem542extends away from the distal end of the base516. The exterior surface548and at least one interior surface552,554make up the horizontal portion of the “T” shape and the fin550makes up the vertical portion of the “T” shape. The stem542may be, for example, tapered as it extends away from the proximal end544. Referring now toFIGS.55-67, the assembled stemmed implant system500is shown. Specifically,FIG.63shows a cross-section of an assembled stemmed implant system500. The first end172of the coupling member170is inserted into the opening160of the articulating portion150. The alignment protrusion180may be, for example, aligned with at least one slot164and inserted into a slot164of the at least one slot164to prevent rotation of the articulating portion150with respect to the coupling member170. The coupling member170may be coupled to the articulating portion150, for example, with a fastener (not shown), a friction fit, such as, a taper fit, and alternative known methods for coupling articulating portion152and stem component510. The base516of the humeral component510may be, for example, received within the recessed region156of the articulating portion150, as shown isFIG.63. Referring now toFIGS.68-80and with continued reference toFIGS.45-54, a reversed stemmed implant system600is shown. The implant system600includes a stem component510, a coupling member or spacer210, and a socket member240. The stem component510is as described with reference to implant system500and which will not be described again here for brevity's sake. The coupling member210and the socket member240are as described above with reference to implant system200, which will not be described again here for brevity's sake. As shown inFIGS.68-80, the implant system600may be assembled by inserting the protrusion232of the coupling member210into the opening524of the stem component510and the extension number224of the coupling member210into the interior of the base516. Specifically, extension member224may be inserted into the recessed region518to secure the spacer210to the base516of the stem component510in the reverse implant system600. In addition, the protrusion258of the socket member240may be inserted into the through hole234of the coupling member210and the engagement protrusion250may engage the recessed region218of the coupling member210. An O-ring260or like coupling member may be positioned within the circumferential groove220of the coupling member210and the circumferential groove252of the socket member242secure the socket member242the coupling member210. Finally, a fastener (not shown) may engage the threads528of the stem component510and the threaded opening234of the coupling member210to secure the stem component510to the coupling member210. Referring now toFIGS.81-91, there are shown several views of stem component710in accordance with the present invention. The stem component710includes a base712, a stem726, and a plate730. Referring again toFIGS.81-91, the base712has a proximal surface714, an opposing distal bone contacting surface716, and an open center or opening718. The base712also includes a flat anterior segment720, a flat anterior lateral segment722, and a flat anterior medial segment724. Referring still toFIGS.81-91, the elongate stem726extends across the diameter of the open center of the base712such that stem726bisects the open center718of the base712and connects to anterior segment720. The stem726further extends from the base712in a direction opposite the proximal surface714of the base712. With continued reference toFIGS.81-91, the tapered elongated posterior plate730extends medially and laterally from the stem726. The plate730further extends from bone contacting surface716of the base712in a direction opposite the proximal surface714of the base712. As further illustrated inFIGS.81-91, the plate730is disposed perpendicularly to the stem726. Moreover, the plate730has an anterior face732connected to the posterior face734of the stem726. Referring now toFIGS.92-102, there are shown several views of a shoulder implant assembly800in accordance with the present invention. As illustrated inFIGS.92-102, the implant assembly800generally includes humeral component710attached via traditional means known in the art to articular liner810. Referring now toFIGS.98-102, there are shown several views of a shoulder implant assembly800. As illustrated inFIGS.98-102, implant assembly800includes humeral component or stem component710attached via traditional means known in the art to an articular liner810. It is within the scope of the present invention to provide a system of implants comprising a plurality of stem components, humeral heads, and liners of various sizes. For illustrative purposes, several views of should implant assembly800implanted into a humerus are shown inFIGS.98-102. A surgical method for implanting the implant systems100,200,300,400,500,600,700,800may include preparing the patient's joint using cut guides. Next, punches may be used to prepare the interior surfaces of the bone for receiving a stemless component110,310or a stemmed component510,710. Using the punches for insertion of the implant systems100,200,300,400,500,600,700,800maximizes bone preservation, especially since additional bone does not need to be removed after the punches are used in order to implant the stemless components110,310or the stemmed components510,710. Once the bones are prepared, the implant systems100,200,300,400,500,600,700,800may be inserted or coupled to the bones. Since the instruments and preparation technique are the same to this point for both the stemless and stemmed implants, either a stemless implant100,200,300,400or stemmed implant500,600,700,800may now be inserted into the prepared bone. The stemless implants100,200may be inserted at an insertion angle which is, for example, in a generally perpendicular orientation. As shown inFIGS.37and44, the stemless implants300,400may be inserted at an insertion angle which is, for example, in a vertical orientation with respect to the axis of the canal of the humerus. As shown inFIGS.98-102, the stemmed implants500,600,700,800may be inserted at an insertion angle which is, for example, in a generally vertical orientation. When inserted into a patient's bone, the base116,516each include a large ring extending away from the groove118,518and the large ring should be placed into contact with cancellous bone to provide better support for the implant100,200,300,400,500,600,700,800. Once placed in the desired position, the anchor members110,510of the implants100,200,300,400,500,600,700,800may be, for example, sutured in place. Next, for an anatomic implant100,300,500,800the coupling member170with the tapered second portion182engaging the tapered through hole124in the anchor member110,510may be used to secure the anchor member110,510to the articulating portion150. Alternatively, for a reverse implant200,400,600,800the coupling member210with the tapered extension member224engaging the tapered groove118of the anchor member110,510may be used to secure the anchor member110,510to the socket member240. Finally, the patient's incision may be closed. As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present disclosure without departing from the scope of the disclosure. The components of the implants, devices, and/or systems as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the implants, devices, and/or systems may include more or fewer components or features than the embodiments as described and illustrated herein. For example, the components and features of implants100,200,300,400,500,600,700,800may be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Further, the steps of the surgical methods associated with the implants100,200,300,400,500,600,700,800may be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Accordingly, this detailed description of the currently-preferred embodiments is to be taken in an illustrative, as opposed to limiting of the disclosure. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. The invention has been described with reference to the preferred embodiments. It will be understood that the operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations. | 35,851 |
11857428 | The modular humeral prosthesis for an inverted shoulder prosthesis shown inFIG.1comprises an anatomical rod1, a separable epiphyseal head2which is positioned at the upper end (or proximal extremity) of the anatomical rod1, and a screw3for connecting the epiphyseal head2to the rod1. The anatomical rod of which the shape is known per se comprises a generally cylindrical stem4which is extended in its upper portion by a metaphyseal portion5which flares upwardly so as to have a shape which is adapted to the form of the epiphyseal joint of a humerus with the metaphysis of this humerus. This head5constitutes the proximal extremity of the anatomical rod, the lateral wall of the head5of the anatomical rod comprises ribs6for blocking in position relative to a humerus in which the rod is implanted. The proximal extremity of the anatomical rod1is limited by a planar surface7which corresponds to a section perpendicular to the longitudinal axis of the anatomical rod. A hole8extending within the anatomical rod and parallel to the axis of this rod is drilled perpendicularly to the surface7delimiting the proximal extremity. The hole8comprises a first bore9followed by a screw-threaded hole of smaller diameter10. Preferably, the hole8and the stem4of the anatomical rod are coaxial. The surface7further comprises a lug11which projects longitudinally relative to the metaphyseal rod. The epiphyseal head2is a portion of a sphere delimited by an equatorial plane21and a plane forming an acute angle with an equatorial plane. Below the equatorial plane21, the epiphyseal head2comprises a bowl21A intended to receive a polyethylene or ceramic cup. This cup is the part which is intended to cooperate with the mating portion of the prosthesis which will be fixed to the scapula. The plane forming an acute angle with the equatorial plane defines a polar surface22intended to come into contact with the end surface7of the anatomical metaphyseal rod1. The polar surface22comprises a cylindrical lug23which projects from the polar surface22and is perpendicular thereto. The size of this cylindrical lug23is adapted so that it can cooperate with the greater diameter bore9of the axial hole8in the anatomical rod and thus locate the epiphyseal head relative to the anatomical rod. An axial hole24for receiving a screw3extends through the cylindrical lug23, the screw3extending both in the hole24in the epiphyseal head and in the hole8in the anatomical rod so that it will be screwed into the screw-threaded portion10of the hole8. The hole24comprises a first portion25of greater diameter intended to receive the head31of the screw and a portion of smaller diameter26intended to receive the body32of the screw3. The cylindrical lug23and the hole8constitute means for locating and guiding in rotation the epiphyseal head relative to the anatomical rod. The portion of smaller diameter26comprises a first portion26A of short length having a diameter and a screw thread identical to the diameter and screw thread of the screw-threaded portion10of the axial hole8, the metaphyseal rod and a second portion26B of greater length extending to the point where the hole emerges at the end of the cylindrical lug23and of which the diameter is greater than or equal to the external diameter of the screw-threaded portion of the screw3. The body32of the screw3comprises, at its extremity, a screw-threaded end32A which is capable of cooperating with the screw thread of the screw-threaded portion10of the axial hole8in the metaphyseal rod, and a stem32B connecting the head31of the screw3to the screw-threaded end, and having a diameter smaller than the internal diameter of the first screw-threaded portion26A of the portion of smaller diameter26of the hole24in the epiphyseal head. With this arrangement, the epiphyseal head is completely separated from the anatomical rod by unscrewing the screw. In order to put the screw in position, it first has to be screwed into the screw-threaded portion26A of the hole in the epiphyseal head. This has the advantage of making the screw integral with this epiphyseal head while leaving it free in rotation and in translation over a specific length and thus facilitates manipulation by the surgeon who is putting the prosthesis in position. The polar surface22comprises a plurality of notches28disposed radially relative to the axis of the cylindrical lug23and at a distance from this lug such that, when the cylindrical lug23is disposed inside the hole8of the anatomical rod1, the lug11situated on the surface7of the proximal extremity of the anatomical rod1can cooperate with a notch28. These notches are arranged at 10° from one another in a fan and are complemented by markings which allow the position of the epiphyseal head2relative to the anatomical rod1to be determined when the epiphyseal head is disposed on the anatomical rod and the lug11is within a notch28. In addition, the plane defining the polar surface22is selected so that the diameter of this polar surface is sufficient for the polar surface22to extend laterally beyond the surface7of the proximal extremity of the anatomical rod, whatever the orientation of the epiphyseal head relative to the anatomical rod. As a result, when the prosthesis is in position in a humerus, the re-growing bone does not form bands which extend beyond the proximal extremity of the anatomical rod and therefore does not prevent extraction of the prosthesis. Referring toFIG.4, the epiphyseal head2is able to rotate about the longitudinal axis XX of the anatomical rod. The axis YY of the epiphyseal head perpendicular to the equatorial plane21intersects the longitudinal axis XX of the anatomical rod1at a point A preferably located on a surface defined by the contact between the proximal face7of the anatomical rod1and the polar face22of the epiphyseal head2. Finally,FIG.3shows that the length of the anatomical rod and the dimensions of the epiphyseal head are selected so that, when the prosthesis is in position, the epiphyseal head is completely included in the epiphysis of the humerus. In order to put a prosthesis of this type in position, the surgeon begins by preparing the humerus by producing, in a known manner, an axial hole adapted to receive an anatomical humeral rod and an epiphyseal head. Then, using an appropriate gauge, he determines the retroversion which the epiphyseal head will have to perform relative to the anatomical humeral rod. The surgeon then puts in position the anatomical rod then the epiphyseal head while orientating it at a predetermined angle and immobilises it in rotation by causing the lug11of the proximal extremity of the anatomical rod to cooperate with the appropriate groove28in the polar surface22of the epiphyseal head. He finally tightens the screw3to lock the assembly. | 6,806 |
11857429 | DETAILED DESCRIPTION The Intervertebral Cage As shown inFIGS.1A and1Band inFIGS.2A and2B, an intervertebral implant, preferably an intervertebral cage100is provided. Although some details of the intervertebral cage100and methods of use are provided herein, further details can be found in U.S. Publication No. 2012/0083887 published on Apr. 5, 2012, entitled “Intervertebral Device and Methods of Use,” and in U.S. Publication No. 2012/0083889 published on Apr. 5, 2012, entitled “Intervertebral Device and Methods of Use,” both of which are incorporated herein in their entirety by reference. Both of these publications are further found attached in Appendix A, which material constitutes part of the present application. The intervertebral cage100can be configured for positioning between two vertebrae and specifically for positioning between the end plates of two vertebrae. The intervertebral cage100can be positioned in an undeployed configuration as depicted inFIGS.1A and1Band can be positioned in a deployed configuration as depicted inFIGS.2A and2B. In some embodiments, and as depicted inFIGS.1A-Band2A-B, the change of the intervertebral cage100from an undeployed configuration to a deployed configuration can result in a change of the dimensions and shape of the intervertebral cage100. The intervertebral cage100can comprise a body102. The body102can be configured to contact the two vertebrae between which the intervertebral cage100is positioned and/or to transfer force from one of the vertebrae between which the intervertebral cage100is positioned to the other of the vertebrae between which the intervertebral cage is positioned. The body102can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, for example, the body102can comprise a circuitous body defining a perimeter and an internal volume. In some embodiments, the body102can be sized and shaped for positioning between two vertebrae, and thus, can comprise dimensions and shapes that approximate the dimensions and shape of the space between the two vertebrae. In some embodiments, the body102can comprise a biocompatible material including, for example, a natural biocompatible material, a synthetic biocompatible material, a metallic biocompatible material, and/or any other desired biocompatible material. In some specific embodiments, the body102can be made of polyetherketone (PEK), polyetherimide (PEI), such as Ultem, ultrahigh molecular weight polyethylene (UHMPE), polyphenylene, polyether-ether-ketone (PEEK), or any other desired biocompatible material. In some embodiments, the body102can comprise a memory material. In some specific embodiments, the body102can comprise a memory PEEK material such as, for example, PEEK Altera™. In one such embodiment in which a memory material is used for the body102, the body102can be configured such that the deployed configuration is the first position to which the body102returns when the memory material is triggered and that the undeployed configuration is the second position. In such an embodiment, the body102of the intervertebral cage100can be positioned within an intervertebral space when the body102is in the undeployed, second position. After the body102has been properly positioned within the intervertebral space, the memory material can be triggered and the body can return to the deployed, first position. The body102can have a proximal end110and a distal end112. In some embodiments, the proximal end110and/or the distal end112can be an integral part of the body102and can partially define the internal volume of the body102. In some embodiments, the proximal end110of the body102can be configured for interaction with an insertion tool to allow insertion of the intervertebral cage100and for the deployment of the intervertebral cage100. In some embodiments, and as seen inFIG.2A, the proximal end110of the body102can comprise a proximal aperture124. In some embodiments, for example, the proximal aperture124can extend through the proximal end110of the body102and into the internal volume126of the body102. Advantageously, in embodiments in which the proximal aperture124extends through the proximal end110of the body102and into the internal volume126of the body102, the proximal aperture124can provide access to the internal volume126and/or components or features of an intervertebral cage apparatus located within the internal volume126. The proximal end110can comprise a variety of shapes and sizes. Similarly, the proximal aperture124can comprise a variety of shapes and sizes. The distal end112of the body102can be configured to facilitate insertion of the intervertebral cage100between the vertebrae. In some embodiments, for example, the distal end112of the body102can comprise a tapered and/or pointed shape to facilitate insertion of the body102into the space between the vertebrae. Advantageously, such a tapered and/or pointed shape to the distal end of the body102can facilitate in achieving adequate separation between the vertebrae and/or can minimize the insertion force required to insert the body102of the intervertebral cage100into the space between the vertebrae. As seen inFIG.1A, a longitudinal axis104of the body102can extend between the proximal end110and the distal end112of the body. As further seen inFIG.1A, the body102can comprise a top120and a bottom122. In some embodiments, the top120and the bottom122can each be configured for interaction with one of the vertebrae between which the intervertebral cage100is positioned, and specifically for interaction with one of the end plates of one of the vertebrae between which the intervertebral cage100is positioned. As also seen inFIG.1A, the body102can define a vertical axis108extending perpendicular to the longitudinal axis104and between the top120and the bottom122of the body102. As further seen inFIG.1A, the body102can define a lateral axis106extending perpendicular to both the longitudinal axis104and the vertical axis108. As seen inFIGS.1A-Band inFIGS.2A-B, some embodiments of the body102can comprise segments116connected to each other by flexible connectors118, which can comprise any bendable connector, including, for example, one or several living hinges. In some embodiments, for example, the segments116can comprise elongate members which are bounded by the flexible connectors118. The flexible connectors118can, in some embodiments, be located on an interior surface of the body102proximate to the internal volume126, and in some embodiments, the flexible connectors118can be located on an exterior surface of the body102. In some embodiments, the flexible connectors118can comprise portions of the body102that are configured to bend. In some embodiments, the flexible connectors102can be discrete elements in that the bending may be localized in one or several positions on the body102, and in some embodiments, the flexible connectors102may be non-discrete elements in that the bending may not be localized, but rather occur over all or large portions of the body102. In some embodiments in which the flexible connectors118comprise discrete elements, the flexible connector can comprise a shape, a feature, a material characteristic, or any other aspect that concentrates stresses and/or deformation. As specifically depicted inFIGS.1A-Band2A-B, in some embodiments, the flexible connectors118can comprise narrowed portions of the body102and/or cutouts into the body102to allow localized deformations of the body102when the body102is moved from an undeployed configuration to a deployed configuration. The segments116and the flexible connectors118can comprise a variety of shapes and sizes. In some embodiments, for example, the shapes and sizes of the segments116and/or the flexible connectors118can be determined by the desired size of the intervertebral cage100, the desired deployment force, the desired deployed resulting shape, the desired undeployed shape, and/or a number of other considerations. As seen inFIGS.1A-Band2A-B, the combination of the segments116and the flexible connectors118allow deployment of the body102of the intervertebral cage100, which deployment decreases the distance between the proximal end110and the distal end112and increases the width of the body102as measured along the lateral axis106. In some embodiments, an intervertebral cage100can be configured such that dimensions of the intervertebral cage100vary along one, two, or three of the above discussed axes104,106,108when the intervertebral cage100is moved from an undeployed configuration to a deployed configuration.FIG.3depicts such an embodiment of an intervertebral cage300configured for dimensional change along three of its axes104,106,108. The intervertebral cage300depicted inFIG.3comprises a body102having a proximal end110and a distal end112. The body102defines a longitudinal axis104extending down the center of the body102and between the proximal end110and the distal end112. The body102of the intervertebral cage300depicted inFIG.3further comprises a top120and a bottom122and defines a vertical axis108extending between the top120and the bottom122and perpendicular to the longitudinal axis104. The body102of the intervertebral cage300further defines a lateral axis106which extends perpendicular to both the longitudinal axis104and the vertical axis108. The body102of the intervertebral cage300depicted inFIG.3further comprises a plurality of segments116joined by flexible connectors118. The segments116and flexible connectors118of the body102define an internal volume126of the body102. As also seen inFIG.3, the body102of the intervertebral cage300comprises a lateral split302. The lateral split302can be configured to allow the expansion of the body102of the intervertebral cage300. In some embodiments, for example, the lateral split302can be configured to allow the expansion of all or a portion of the body102of the intervertebral cage300in a direction perpendicular to the lateral split302. The lateral split302can comprise a variety of sizes and shapes. In some embodiments, for example, the lateral split302can extend from one end of the body102towards another end of the body102. As specifically depicted inFIG.3, the lateral split302extends from the distal end112of the body102towards the proximal end110of the body102. The length of the lateral split302can vary based on the desired amount of expansion allowed by the lateral split302. In some embodiments, for example, the lateral split302can extend for 5% of the length of the body, 10% of the length of the body, 25% of the length of the body, 50% of the length of the body, 75% of the length of the body, 90% of the length of the body, or any other intermediate or other desired percent of the length of the body as measured along one of the axes104,106,108of the body102. As further seen inFIG.3, the lateral split302comprises a first end304and a second end306. As specifically depicted inFIG.3, the first end304of the lateral split302is located proximate to the distal end112of the body102and the second end306of the lateral split302is located approximately in the middle of the body102. As also seen inFIG.3, the lateral split302divides the body102at least partially into a top portion308and a bottom portion310. As seen inFIG.3, the top portion308is located between the top120of the body102of the intervertebral cage300and the lateral split302and the bottom portion310is located between the bottom122of the body102of the intervertebral cage300and the lateral split302. Advantageously, the division of the body102into a top portion308and into a bottom portion310by a lateral split302allows the expansion of the body102of the intervertebral cage300. In some embodiments, for example, this expansion of the body102of the intervertebral cage300can be perpendicular to the lateral split302, and in some embodiments, this expansion of the body102can be nonperpendicular to the lateral split302. As specifically depicted inFIG.3, the top portion308and the bottom portion310of the body102allow the expansion of the body102in a direction parallel to the lateral axis106by the expansion of the lateral split302. The Variable Volume Pouch Some embodiments of an intervertebral cage apparatus can include a variable volume pouch.FIG.4Adepicts a perspective view of one embodiment of a variable volume pouch400in an unexpanded state andFIG.4Bdepicts one embodiment of a variable volume pouch400in an expanded state. The variable volume pouch400can be configured for expansion in response to receiving material in an internal portion of the variable volume pouch400. In some embodiments, the variable volume pouch400can be configured to resist compressive forces when the variable volume pouch400is filled with material. One example of a variable volume pouch is the OptiMesh® Deployable Grafting System available from Spineology, Inc. Although some details of the variable volume pouch400and methods of use are provided herein, further details can be found in U.S. Pat. No. 5,549,679 published on Mar. 1, 1995, entitled “Expandable Fabric Implant For Stabilizing the Spinal Motion Segment,” and in U.S. Pat. No. 5,571,189 published on Nov. 5, 1996, entitled “Expandable Fabric Implant For Stabilizing the Spinal Motion Segment,” both of which are incorporated herein in their entirety by reference. Both of these patents are further found attached in Appendix A, which material constitutes part of the present application. The variable volume pouch can comprise a variety of shapes and sizes. In some embodiments, for example, the variable volume pouch400can be shaped to allow uniform expansion of the variable volume pouch400when material is added into the internal portion of the variable volume pouch400. In some embodiments, for example, the variable volume pouch can be approximately spherical, ovular, elongate, cylindrical, rectangular, or have any other desired shape. In the embodiment depicted inFIGS.4A and4B, the variable volume pouch400is approximately balloon shaped. As also seen inFIGS.4A and4B, the variable volume pouch400comprises a first end402and a second end404positioned opposite the first end402. As seen inFIGS.4A and4B, the variable volume pouch400further comprises a single opening406located at the first end402. In some embodiments, the variable volume pouch400can include features configured to allow the selectable sealing and/or closing of the opening406. These features can include, for example, one or several tics, one or several drawstrings, one or several plugs, or any other mechanical or other feature configured to allow the sealing and/or closing of the opening406. The variable volume pouch400can comprise a variety of materials. In some embodiments, the variable volume pouch can comprise a natural material, a synthetic material, a man-made material, a polymer, composite material, an elastic material, an inelastic material and/or any other desired material. In some embodiments, and as depicted inFIGS.4A and4B, the variable volume pouch400can comprise a woven material. Advantageously, a woven material can allow expansion of the variable volume pouch400to a desired maximum size. The variable volume pouch400can comprise a variety of sizes. In some embodiments, the variable volume pouch400can be sized to allow placement between two vertebrae. Specifically, in some embodiments, the variable volume pouch400can be sized to fit between two vertebrae and specifically between the end plates of two vertebrae. The Intervertebral Cage Apparatus Some embodiments relate to an intervertebral cage apparatus.FIG.5Adepicts a perspective view of one embodiment of the intervertebral cage apparatus500. The intervertebral cage apparatus500comprises the intervertebral cage100. The intervertebral cage100depicted inFIG.5Acomprises the features of the intervertebral cage100depicted inFIG.1A, including a body102having a proximal end110and a distal end112. The body102defines a longitudinal axis104extending down the center of the body102and between the proximal end110and the distal end112. The body102of the intervertebral cage100depicted inFIG.5Afurther comprises a top120and a bottom122and defines a vertical axis108extending between the top120and the bottom122and perpendicular to the longitudinal axis104. The body102of the intervertebral cage300further defines a lateral axis106which extends perpendicular to both the longitudinal axis104and the vertical axis108. The body102of the intervertebral cage100depicted inFIG.5Afurther comprises a plurality of segments116joined by flexible connectors118. The segments116and flexible connectors118of the body102define an internal volume126of the body102. As seen inFIG.5A, the intervertebral cage apparatus500further includes the variable volume pouch400located within the internal volume126of the intervertebral cage100. In some embodiments, the variable volume pouch400can be affixed to all or portions of the intervertebral cage100. In some embodiments, for example, the variable volume pouch400can be inserted into the internal volume126of the intervertebral cage100such that the second end404of the variable volume pouch400is proximate to the distal end112of the intervertebral cage100and the first end402is proximate to the proximal end110of the intervertebral cage100. In some advantageous embodiments, in which the first end402is proximate to the proximal end110of the intervertebral cage100, the opening406of the variable volume pouch400is located proximate to the proximate aperture124of the body102of the intervertebral cage100. Thus, in some embodiments, the variable volume pouch400can be inserted into the internal volume126of the body102of the intervertebral cage100through the proximal aperture124. In such an embodiment, after the variable volume pouch400is inserted into the internal volume126of the body102via the proximal aperture124, the variable volume pouch400can be partially or completely affixed to the body102of the intervertebral cage100. In some embodiments, the variable volume pouch400can be affixed to the body102of the intervertebral cage100such that the expansion of the variable volume pouch400can result in the deployment of the body102of the intervertebral cage100and in some embodiments, the affixation of the variable volume pouch400to the body102of the intervertebral cage100can result in the expansion of the variable volume pouch400when the body102of the intervertebral cage100is deployed. In some embodiments, the intervertebral cage apparatus500can further comprise a plug502. The plug502can be configured to sealingly fit within the proximal aperture124to seal the proximal aperture, to secure the first end402of the variable volume pouch400to the proximal end110of the intervertebral cage100, and to seal the opening406of the variable volume pouch. In some embodiments, the plug502can be further configured to facilitate in the deployment of the intervertebral cage100. The plug502can comprise a variety of shapes and sizes, and can be made from a variety of materials, including, for example, all of the materials from which the intervertebral cage100can be made. In some embodiments, the plug502can comprise a proximal shaft504and a distal head506. The proximal shaft504can comprise a variety of shapes and sizes. In some embodiments, the proximal shaft504can be sized and shaped to seal the proximal aperture124, and specifically can be sized and shaped with larger dimensions than the proximal aperture124. In some embodiments, the configuration of the proximal shaft504with dimensions larger than the dimensions of the proximal aperture124can facilitate the retention of the plug502in the proximal aperture124. In some embodiments, the distal head506can comprise a variety of shapes and sizes. In some embodiments, the distal head506can be conical shaped, having a distal base508, and extending towards the apex in the direction of the proximal shaft504. The distal head506can be shaped, in some embodiments, to facilitate in deploying the intervertebral cage100. FIG.6Adepicts one embodiment of the intervertebral cage apparatus500in a deployed configuration in which the body102of the intervertebral cage100is deployed and in which the variable volume pouch400is in its expanded configuration. As seen inFIG.6A, the variable volume pouch400in its expanded configuration fills and/or substantially fills the internal volume126of the intervertebral cage100. FIG.6Bis a cutaway top-view of the intervertebral cage apparatus500in a deployed configuration. As seen inFIG.6B, the proximal shaft504of the plug502is located in the proximal aperture124of the body102of the intervertebral cage100. As also seen inFIG.6B, the proximal shaft504of the plug has expanded the diameter of the proximal aperture124, and is thereby secured within the proximal aperture124. As also seen inFIG.6B, the plug502is positioned within the proximal aperture124such that a portion of the first end402of the variable volume pouch400is between the proximal shaft504and the wall of the proximal aperture, thereby securing the variable volume pouch400. FIG.6Bfurther depicts the distal head506of the plug502extending into the internal volume126of the intervertebral cage100. As seen inFIG.6B, the distal head506is engaging portion of the body102, to thereby bias the body102of the intervertebral cage100towards a deployed configuration. In some embodiments, in which the plug502is used in connection with the intervertebral cage apparatus500, the variable volume pouch400can be inserted into the intervertebral cage100through the proximal aperture124and positioned such that the first end402of the variable volume pouch400and the opening406are proximate to the proximal aperture124. In some embodiments, the variable volume pouch400can be at least partially affixed to the intervertebral cage100. After the variable volume pouch400is inserted into the intervertebral cage100, positioned, and if desired, at least partially affixed to the intervertebral cage100, the variable volume pouch can be filled and/or the intervertebral cage100can be deployed. In some embodiments, the plug502can be inserted into the intervertebral cage100, and partially into the internal volume126of the intervertebral cage, by inserting the plug502into and through the proximal aperture124from the proximal end110of the intervertebral cage100towards the distal end112of the intervertebral cage100. Advantageously, the insertion of the plug502can affix the variable volume pouch400to the proximal end110of the intervertebral cage, can seal the opening406of the variable volume pouch400, and can assist in the deployment of the intervertebral cage100. In some embodiments, in which the plug502, and specifically in which the distal head506and the proximal shaft504have a larger diameter than the proximal aperture124, the insertion of the plug into and through the proximal aperture124from the proximal end110of the intervertebral cage100towards the distal end112of the intervertebral cage100can result in the deformation of the proximal aperture124. In some embodiments, all or portions of the proximal aperture124may partially or completely elastically rebound after the insertion of the plug502, and in some embodiments, all or portions of the proximal aperture124may not elastically rebound after the insertion of the plug502. FIG.7depicts an alternative embodiment of the intervertebral cage apparatus500. Specifically,FIG.7depicts an embodiment of the intervertebral cage apparatus500comprising a variable volume pouch400shown in this figure in its expanded state, and the intervertebral cage300comprising a lateral split302shown in its fully deployed configuration. As seen inFIG.7, the intervertebral cage300is deployed in both the lateral direction106as measured along the lateral axis106and deployed in the vertical direction as measured along the vertical axis108. As seen inFIG.7, the variable volume pouch400substantially fills and/or fills the internal volume126of the intervertebral cage300. The Deployment System Some embodiments relate to systems and devices for the insertion and deployment of an intervertebral cage apparatus500and/or of the intervertebral cage100,300.FIG.8depicts one embodiment of insertion deployment system800. As seen inFIG.8, the deployment system800can include a deployment tool802. The deployment tool802can be configured to facilitate in the insertion of the intervertebral cage apparatus500and/or the intervertebral cage100,300and to control the deployment of the intervertebral cage apparatus500and/or the intervertebral cage100,300. The deployment tool802can comprise a variety of shapes and sizes and can comprise a variety of features. In some embodiments, for example, the deployment tool802can be a mechanical device, an electromechanical device and/or an electrical device. In some embodiments, for example, the deployment tool802can be manually operated, can be electrically controlled, and/or can be controlled using any other desired control technique. As depicted inFIG.8, the deployment tool802comprises a control interface804. The control interface804can be configured to allow a user to control the deployment tool802and the insertion and/or deployment of the intervertebral cage apparatus500and/or the intervertebral cage100,300. In some embodiments, for example, the control interface can comprise any feature, system, and/or module configured to receive user input and use that input to effect the deployment of the intervertebral cage apparatus500and/or the intervertebral cage100,300. As depicted inFIG.8, the control interface804can comprise a simple manual control configured to apply a force to one end of a deployment cable806. In some embodiments in which the deployment tool802can be used in connection with other features to insert the intervertebral cage100,300. In such embodiments, the deployment tool802can be used with a rigid shaft. In one embodiment, the rigid shaft can comprise a proximal end that is affixed to the deployment tool802and a distal end configured to engage with the intervertebral cage100,300. In some embodiments, these features configured to engage with the intervertebral cage100,300and located at the distal end of the rigid shaft can comprise one or several prongs (not shown) configured to engage portions of the intervertebral cage100,300. In some embodiments, the features configured to selectively affix the intervertebral cage100,300to the deployment tool802, can allow the manipulation and movement of the intervertebral cage100,300along and/or about any of the axes104,106,108of the intervertebral cage100,300. In some embodiments, the rigid shaft can be configured to allow the passage of the deployment cable806from the deployment tool802to the intervertebral cage100,300. In some embodiments, the deployment cable806can pass along the rigid shaft and/or through the rigid shaft from the deployment tool802to the intervertebral cage100,300. The passing of the deployment cable806from the deployment tool802to the intervertebral cage100,300can be facilitated by one or several channels located within the rigid shaft. In some embodiments, these rigid channels can be located on an exterior surface of the rigid shaft, and or located within the rigid shaft. In some embodiments, the channels can extend the entire length of the rigid shaft, and/or along portions of the rigid shaft. In some embodiments in which the deployment tool802is only used for deployment of the intervertebral cage100,300a separate insertion tool and/or tools can be used in the insertion of the intervertebral cage100,300. Some embodiments of such an insertion tool and/or implantation tool can be found in U.S. Publication No. 2012/0083887 published on Apr. 5, 2012 which is incorporated herein in its entirety by reference. This publication is attached in Appendix A, and constitutes part of the present application. The deployment cable806can be configured to transfer a force from the deployment tool802to the intervertebral cage apparatus500and/or the intervertebral cage100,300. In some embodiments, the deployment cable806can be configured to facilitate the deployment of the intervertebral cage apparatus500and/or the intervertebral cage100,300and/or to facilitate in maintaining the intervertebral cage apparatus500and/or the intervertebral cage100,300in a deployed configuration. In some embodiments, the deployment cable806can be configured for use as a marker, and specifically, can be used as a marker to indicate the position of the intervertebral cage100,300and/or to determine whether and to what extent the intervertebral cage100,300has been deployed. In some embodiments, for example, the deployment cable806can include regularly spaced features that can allow determination of whether and/or to what extent the intervertebral cage100,300is deployed by allowing the determination of the length of the deployment cable806within the intervertebral cage100,300As the deployment of the intervertebral cage100,300may, in some embodiments, change a dimension of the intervertebral cage100,300the determination of the length of the portion of the deployment cable806located within the intervertebral cage can facilitate in determining whether and/or to what extent the intervertebral cage100,300is deployed. The deployment cable806can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the deployment cable806can comprise any shape and size and can be made from any material capable of applying and withstanding the forces necessary to deploy the intervertebral cage apparatus500and/or the intervertebral cage100,300. As depicted inFIG.8, the deployment cable806comprises a first end808and a second end810. In some embodiments, the first end808can comprise an attachment feature812. The attachment feature812can be any feature configured to allow the attachment of the deployment cable806to a portion of the intervertebral cage100,300and/or to prevent the movement of the deployment cable806in one or several specified directions relative to the intervertebral cage100,300. The attachment feature812can comprise a variety of shapes and sizes and can be made from a variety of materials. In one embodiment, for example, the attachment feature812can comprise a shape and/or size that allows the attachment feature812to engage a portion of the intervertebral cage100,300and thereby restrict the movement of the deployment cable806relative to the intervertebral cage100,300. As specifically seen inFIG.8, in some embodiments, the attachment feature can comprise a spherical feature located at the first end808of the deployment cable806. In some embodiments, the deployment cable806can comprise a breakage point (not shown). In some embodiments, the breakage point can be a portion of the deployment cable806that is configured to sever, break, and/or separate when a force threshold is exceeded. In some embodiments, the force threshold for the breakage point can be below the force threshold that would cause other portions and/or features such as, for example, the attachment feature812and/or the locking feature814of the deployment cable806to break or fail. In some embodiments, the breakage point can be positioned between, for example, between the locking feature814and the second end810of the deployment cable806. Advantageously, as the application of a force above the force threshold results in the breakage of the deployment cable806at the breakage point, such positioning of the breakage point can eliminate the need to cut the deployment cable806after the intervertebral cage100,300has been deployed. As also seen inFIG.8, the second end810of the deployment cable806can be connected to a portion of the deployment tool802. As further seen inFIG.8, in some embodiments, the deployment cable806further comprises a locking feature814that can be, for example, located at any position along the deployment cable, and in some embodiments, located between the attachment feature812and the second end810of the deployment cable806. The locking feature814can be configured to allow a user to lock and/or secure the intervertebral cage100,300in a deployed configuration. In some embodiments, the locking feature814can comprise the size and/or shape configured to interact with a portion of the intervertebral cage100,300and thereby prevent the intervertebral cage100,300from returning to an undeployed configuration after the intervertebral cage100,300has been deployed. In some embodiments, for example, the distance between the attachment feature812and the locking feature814can vary. Specifically, for example, the distance between the attachment feature812and the locking feature814can vary based on the size of the intervertebral cage100,300, the distance that the deployment cable806must be moved before the intervertebral cage100,300deploys, and/or any other desired parameters. FIGS.9and10depict perspective views of one embodiment of an intervertebral cage apparatus900. Specifically,FIG.9depicts one embodiment of the intervertebral cage apparatus900in an undeployed configuration andFIG.10depicts a perspective view of one embodiment of an intervertebral cage apparatus900in a deployed configuration. As seen inFIGS.9and10, the intervertebral cage100can be configured for use with a deployment cable806. In some embodiments, for example, the intervertebral cage100can comprises one or several opening and/or one or several channels configured to receive, direct, and/or hold a portion of the deployment cable. These openings can comprise a variety of shapes and sizes, and can be located on any desired portion of the intervertebral cage. In some embodiments, the size and shape of the openings can be determined by the size and shape of features accommodated by the openings, such as, for example, the deployment cable806, the attachment feature812, and/or the locking feature814. Specifically, for example, the intervertebral cage100can comprise one or several distal openings902located proximate to the distal end112of the body102of the intervertebral cage100and a first and/or second proximal opening906,908located proximate to the proximal end110of the intervertebral cage100. The distal opening(s)902, the first proximal opening906, and the second proximal opening908can be configured to receive a portion of the deployment cable806. In some embodiments, for example, all or some of the distal opening(s)902, the first proximal opening906and/or the second proximal opening908can guide the deployment cable806into and out of a portion of the intervertebral cage100. In some embodiments, these openings902,906,908can be connected to one or several channels that pass through all or portions of the intervertebral cage100. Thus, in some embodiments, the deployment cable may enter into the intervertebral cage100through the first proximal opening906, and after passing through all or a portion of the intervertebral cage100, the deployment cable806may then exit the channel inside the intervertebral cage100via another opening such as, for example, the distal opening902and/or the second proximal opening908. As further seen inFIG.9, in some embodiments, the deployment cable806can pass through the internal volume126of the body102of the intervertebral cage100. Specifically, in some embodiments, all or portions of the deployment cable806can extend from a first proximal opening906to a distal opening902and/or from a distal opening902to a second proximal opening908alongside an inner surface of the cage100. In some embodiments, a plurality of deployment cables806can be used in connection with a single intervertebral cage100,300. In some embodiments, the number of deployment cables806can be determined by the desired type of deployment. Thus, in some embodiments, the more deployment cables806may be used to achieve a more complex deployment motion. FIG.11depicts one embodiment using a plurality of deployment cables. Specifically,FIG.11depicts a further embodiment of the intervertebral cage apparatus1100. As seen inFIG.11, the intervertebral cage apparatus1100comprises the intervertebral cage300comprising a lateral split302. As further seen inFIG.11, the intervertebral cage300further comprises a lower first proximal opening1102, a lower second proximal opening1104, an upper first proximal opening1106, an upper second proximal opening1108, a lower distal opening1110, and an upper distal opening1112. As also seen inFIG.11, the intervertebral cage apparatus1100comprises two deployment cables806. One of the deployment cables806depicted inFIG.11inserts through the lower first proximal opening1102and then passes through the variable volume pouch400where it exits through one of at least one lower distal opening1110before again passing through the variable volume pouch and to the lower second proximal opening1104. This path of the deployment cable806secures a portion of the variable volume pouch400to the intervertebral cage300and specifically to the bottom portion310of the intervertebral cage300. As also seen inFIG.11, the other deployment cable806passes through the upper first proximal opening1106and then through the variable volume pouch to at least one of the upper distal openings1112before again passing through the variable volume pouch and to the upper second proximal opening1108. Similar to the deployment cable806passing through the lower openings1102,1104,1110, the deployment cable806passing through the upper openings1106,1108,1112, secures a portion of the variable volume pouch400to the intervertebral cage300and specifically to the top portion308of the intervertebral cage300. Advantageously, the securement of the variable volume pouch400to the top portion308and the bottom portion310allows use of a variable volume pouch400to at least partially vertically deploy the intervertebral cage300with respect to the vertical axis108by filling the internal portion of the variable volume pouch400. WhileFIG.11depicts an embodiment in which two deployment cables806are used and showing specific positions for the openings1102,1104,1106,1108,1110,1112, a person of skill in the art will recognize that any number of deployment cables806can be used in connection with the intervertebral cage300and that a wide variety of positions for the openings can be used. Methods of Using an Intervertebral Cage Apparatus FIG.12is a flowchart illustrating one embodiment of process1200for using the intervertebral cage100,300and/or the intervertebral cage apparatus500,1100. The process begins at block1210wherein the intervertebral disc space is prepared, for example, by removing a portion of the annulus, evacuating the nucleus, and then removing the cartilaginous endplates. After the intervertebral disc space is prepared, the process1200proceeds to block1212wherein the intervertebral cage100,300is placed into the intervertebral disc space. In one embodiment, the intervertebral cage100,300is rotated about its longitudinal axis104and placed in the intervertebral disc space such that the vertical axis108of the body102of the intervertebral cage100,300is parallel to the vertebral endplates. The process1200proceeds to block1214wherein the intervertebral cage100,300is rotated 90 degrees about its longitudinal axis104. After the rotation of the intervertebral cage100,300, the top120and the bottom122contact the vertebral endplates. In some embodiments, in which the distance between the top120and the bottom122of the body102of the intervertebral cage100,300is larger than the width of the body102of the intervertebral cage100,300as measured parallel to the lateral axis106, the 90 degree rotation of the body102along its longitudinal axis104increases the height of the intervertebral disc space. After the intervertebral cage100,300is rotated 90 degrees about its longitudinal axis104, the process1200proceeds to block1216wherein the intervertebral cage100,300is expanded to increase the internal volume126defined by the body102, and in some embodiments, defined by the segments116and flexible connectors118forming the body102. In some embodiments, the expansion of the intervertebral cage100,300can proceed as outlined in step1406as depicted inFIG.14. In some embodiments, the body102is expanded until the body102attains a deployed configuration. In some embodiments, for example, in which a the intervertebral cage100,300is used in connection with a deployment tool802, the actuation of the deployment tool802can cause the deployment of the intervertebral cage100,300and thereby the expansion of the intervertebral cage100,300and the expansion of the internal volume126of the intervertebral cage100,300. In some embodiments in which the intervertebral cage100,300comprises a body102made of a memory material such as, for example, PEEK Altera™, the intervertebral cage100,300can be deployed by triggering the memory material such that the intervertebral cage100,300transforms from the undeployed, second position to the deployed, first position. In some embodiments, triggering can be temperature induced, stress induced, electrically and/or mechanically induced, chemically induced, and/or through any other triggering mechanism. In some specific embodiments, the triggering can be induced when a threshold temperature of the intervertebral cage100,300is exceeded, or when a stress threshold for the intervertebral cage100,300is surpassed. After the intervertebral device is expanded to increase the internal volume126defined by the body102, the process1200can, in some embodiments, proceed to block1218wherein the intervertebral device is locked in a deployed configuration with a locking mechanism such as, for example, a deployment cable806. Although the process1200can, in some embodiments, include block1218, the steps of this block can be omitted and the process1200can proceed to block1220. The process1200can then proceed to block1220, wherein the internal volume126of the body102of the intervertebral cage100,300is filled with bone graft material to permit bone fusion between adjacent vertebrae. In some embodiments, the internal volume126of the body102of the intervertebral cage100,300can be filled via the proximal aperture124located in the proximal end110of the body102of the intervertebral cage100,300. A person of skill in the art will recognize that the steps of the aforementioned process can be performed in the same order, or in a different order. A person of skill in the art will further recognize that the process1200can include more or fewer steps than those outlined above. FIG.13is a flow chart illustrating one embodiment of the process1300for using an intervertebral cage apparatus500. In some embodiments, parts of the process1300can be performed before insertion of the intervertebral cage apparatus500into an intervertebral space, and in some embodiments, parts of the process1300can be performed after insertion of the intervertebral cage apparatus into an intervertebral space. The process1300begins at block1302wherein the variable volume pouch400is inserted into the intervertebral cage100,300. In some embodiments, for example, the insertion of the variable volume pouch400into the intervertebral cage100,300can be performed using a variety of tools and techniques. In some embodiments, for example, the variable volume pouch can be inserted into the intervertebral cage100,300via the proximal aperture124in the proximal end110of the body102of the intervertebral cage100,300. In some embodiments, the variable volume pouch400can be inserted into the internal volume126of the intervertebral cage100,300via the proximal aperture124located in the proximal end110of the intervertebral cage100,300. In some embodiments, the variable volume pouch400can be pre-inserted into the intervertebral cage100,300, and the process1300can begin at a block other than block1302. After the variable volume pouch400has been inserted into the intervertebral cage100,300, the process1300then proceeds to block1304wherein the opening406of the variable volume pouch400is positioned proximate to the proximal aperture124of the intervertebral cage100,300. In some embodiments, the positioning of the opening406of the variable volume pouch400proximate to the proximal aperture124of the intervertebral cage100,300can be achieved, for example, by inserting the second end404of the variable volume pouch400through the proximal aperture124before inserting the first end402of the variable volume pouch400through the proximal aperture124. By following this insertion procedure, and thereby inserting the second end404of the variable volume pouch400through the proximal aperture124first, the opening406of the variable volume pouch400which is located at the first end402of the variable volume pouch400can be easily positioned proximate to the proximal aperture124of the intervertebral cage100,300. In some embodiments in which the variable volume pouch400is pre-inserted into the intervertebral cage100,300, the process1300can begin at block1304. In some embodiments, the opening406of the variable volume pouch400can be pre-positioned proximate to the proximal aperture124of the intervertebral cage100,300, and the process1300can begin at a block other than block1304. After the opening406of the variable volume pouch400has been positioned proximate to the proximal aperture124of the intervertebral cage100,300, the process1300proceeds to block1306wherein the variable volume pouch400is affixed to the intervertebral cage100,300. In some embodiments, for example, the variable volume pouch400can be affixed to all or portions of the intervertebral cage100,300and specifically to all or portions of the body102of the intervertebral cage100,300. In some embodiments, for example, the variable volume pouch400can be affixed to the body102of the intervertebral cage100,300along the portions of the body102defining the internal volume126. Specifically, portions of the variable volume pouch400can be affixed to the segments116and flexible connectors118that constitute the body102. In some embodiments, the variable volume pouch400can be affixed to the body102of the intervertebral cage100,300with features located on the body102of the intervertebral cage100,300such as, for example, one or several fasteners, one or several hooks, one or several snaps, one or several adhesive regions, and/or any other desired feature located on either or both of the variable volume pouch400and the body102of the intervertebral cage100,300. In some embodiments, for example, the variable volume pouch400can be affixed to the intervertebral cage100,300through additional features that are not an integral part of either the variable volume pouch400or the body102of the intervertebral cage100,300. In some embodiments, these features can include, for example, one or several deployment cables806. In some embodiments, for example, the deployment cable806can be fused to affix the variable volume pouch400to the intervertebral cage100,300. In some specific embodiments, the deployment cable806can be inserted through a portion of the intervertebral cage100,300such as, for example, the body102, be threaded through a portion of the variable volume pouch400, and then again be inserted through a portion of the intervertebral cage100,300. In some embodiments, the passing of the deployment cable806through portions of the intervertebral cage100,300and through portions of the variable volume pouch400can secure the variable volume pouch400to the intervertebral cage100,300. In some embodiments, the variable volume pouch400can be connected to the intervertebral cage100,300along the entire perimeter of the internal volume126, and in some embodiments, the variable volume pouch400can be connected to the intervertebral cage100,300at discrete points. In some embodiments, the variable volume pouch400can be connected to the intervertebral cage100at one point, two points, three points, four points, five points, six points, eight points, 10 points, 20 points, 50 points, or at any other or intermediate number of points. In some embodiments in which the variable volume pouch400is pre-inserted into the intervertebral cage100,300and in which the opening406of the variable volume pouch400has been pre-positioned proximate to the proximal aperture124of the intervertebral cage100,300, the process1300can begin a block1306. In some embodiments, the variable volume pouch400can be pre-affixed to the intervertebral cage100,300, and the process1300can begin at a block other than block1306. In some embodiments in which the assembly of the intervertebral cage apparatus500is temporally separated from the use of the intervertebral cage apparatus500, the process1300can terminate with block1306. In some embodiments of the process1300in which the assembly of the intervertebral cage apparatus500is temporally proximate to the use of the intervertebral cage apparatus500, after the variable volume pouch400is affixed to the intervertebral cage100,300, the process1300can proceed to block1308wherein the intervertebral cage100,300is deployed. In some embodiments, block1308can be preceded by processes for preparing the intervertebral space and for inserting the intervertebral cage apparatus500. In some embodiments, these processes can include, for example, some or all of the steps of the process1200depicted inFIG.12. In some embodiments, the intervertebral cage100,300can be deployed using any desired deployment technique and/or deployment device. In some specific embodiments, for example, the intervertebral cage can be deployed using a deployment system800comprising a deployment tool802and a deployment cable806. In some embodiments, deployment of the intervertebral cage100,300can result in a change in the dimensions of the intervertebral cage100,300as measured along one or more of the longitudinal axis104, the lateral axis106, and/or the vertical axis108. After the intervertebral cage100,300is deployed, the process1300proceeds to block1310wherein the variable volume pouch400is filled. In some embodiments, for example, the variable volume pouch400can be filled via the opening406at a variable volume pouch400. In some embodiments, the variable volume pouch400can be filled via the opening406of the variable volume pouch and the proximal aperture126located in the proximal end110of the intervertebral cage100,300. In some embodiments, the variable volume pouch can be filled with, for example, a gaseous material, a liquid material, and/or a solid material. In some embodiments, the variable volume pouch400can be filled with a graph material which can comprise, for example, a solid material and specifically, a plurality of pieces of solid material. In some embodiments, these materials can comprise bone fragments and/or pieces of hones, and/or any biocompatible material. In some embodiments, the variable volume pouch400can be filled with a desired amount of film material. In some embodiments, the desired amount of film material can be based on the desired size of the variable volume pouch400in its expanded state. Thus, in some embodiments, the desired size of the expanded state of the variable volume pouch400can determine the amount of film material. After the variable volume pouch400has been filled, steps can be taken to maintain the fill material within the variable volume pouch400. In some embodiments, these steps can include, for example, scaling the opening406, closing the opening406, plugging the opening406, or any other action that would prevent the film material from emptying out of the variable volume pouch400. FIG.14is a flowchart illustrating one embodiment of the process1400for preparing and/or using the intervertebral cage apparatus900,1100, which may or may not have a variable volume pouch400. In some embodiments, the process1400can be performed before insertion of the intervertebral cage apparatus900,1100into an intervertebral space, and in some embodiments, the process1400can be performed after insertion of the intervertebral cage apparatus into an intervertebral space. The process1400begins at block1402wherein the deployment cable806is inserted through the proximal end110of the intervertebral cage100,300. In some embodiments, for example, the deployment cable806is inserted through the proximal end110of the intervertebral cage100,300by inserting the deployment cable806through a first proximal opening906,1104,1108. In some embodiments, the deployment cable806that is inserted through the first proximal opening906,1104,1108passes through the proximal end110of the intervertebral cage100,300and into the internal volume126of the intervertebral cage100,300. In some embodiments, the deployment cable806that is inserted into the first proximal opening906,1104,1108passes into a channel and passes through all or portions of the intervertebral cage100,300. In some embodiments, the deployment cable806can be pre-inserted through the proximal end110of the intervertebral cage100,300, and the process1400can begin at a block other than block1402. In some embodiments, the deployment cable806need not be inserted through the proximal end110of the intervertebral cage100,300, hut is rather simply attached or affixed at or near the proximal end110of the intervertebral cage100,300. After the deployment cable806is inserted through or affixed to the proximal end110of the intervertebral cage100,300, the process1300moves to block1304and the deployment cable806is inserted through the distal end112of the intervertebral cage100,300. In some embodiments, the deployment cable806can be inserted into the distal end112of the intervertebral cage100,300by inserting the deployment cable806into and/or through a distal opening902,1110,1112. In some embodiments, in which the deployment cable806passed through the proximal end1110of the intervertebral cage100,300and into the internal volume126, the deployment cable806can be inserted into the distal end112via the distal opening902,1110,1112from the internal volume126. In some embodiments, in which the deployment cable806passes through a channel from the first proximal opening906,1104,1108, the deployment cable806may be inserted through the distal end1112of the intervertebral cage100,300by passing through a channel that travels through the distal end of the intervertebral cage. In some embodiments in which the deployment cable806has been pre-inserted through the proximal end110of the intervertebral cage100,300, the process1400can begin at block1404. In some embodiments, the deployment cable806can be pre-inserted through the distal end112of the intervertebral cage100,300, and the process1400can begin at a block other than block1404. In some embodiments in which the assembly of the intervertebral cage apparatus900,1100is temporally separated from the use of the intervertebral cage apparatus900,1100, the process1400can terminate with block1404. In some embodiments, after the deployment cable806is inserted through the distal end112of the intervertebral cage100,300the deployment cable806can be returned to the proximal end110of the intervertebral cage100,300. In some embodiments, the deployment cable806can return to the proximal end110of the intervertebral cage100,300by inserting the deployment cable806into and/or through a second distal opening902,1110,1112. After the deployment cable806has been inserted into and/or through the second distal opening902,1110,1112, the deployment cable806passes through the distal end112of the intervertebral cage100,300and into the internal volume126of the intervertebral cage100,300. In some embodiments, the deployment cable806that is inserted into the distal opening902,1110,1112passes into a channel and passes through all or portions of the intervertebral cage100,300. After the deployment cable806returns to the proximal end110of the intervertebral cage100,300, the deployment cable806can be inserted through the proximal end110of the intervertebral cage100,300by inserting the deployment cable806through a second proximal opening908,1102,1106. In some embodiments, the deployment cable806that is inserted through the second proximal opening908,1102,1106passes from the internal volume126of the intervertebral cage100,300and through the proximal end110of the intervertebral cage100,300. In some embodiments, the deployment cable806can be pre-inserted through the proximal end110of the intervertebral cage100,300. In some embodiments, the deployment cable806need not be inserted through the proximal end110of the intervertebral cage100,300, but can rather be simply attached or affixed at or near the proximal end110of the intervertebral cage100,300. After the deployment cable806is inserted through or affixed to the proximal end110of the intervertebral cage100,300, the deployment cable806can be connected to the deployment tool802, which can then be used to deploy the intervertebral cage100,300. In some embodiments of the process1400in which the assembly of the intervertebral cage apparatus900,1100is temporally proximate to the use of the intervertebral cage apparatus900,1100, the process1400proceeds to block1406wherein the intervertebral cage100,300is deployed by applying a force to the intervertebral cage100,300via the deployment cable806. The force that is applied to the intervertebral cage100,300via the deployment cable806can be generated using a variety of tools and/or techniques. In some embodiments, for example, in which the deployment cable806is part of an insertion system800including a deployment tool802, the force can be applied to the intervertebral cage100,300via the deployment cable806by using the control interface804to tension the deployment cable806. In some embodiments, and as the force is applied to the intervertebral cage100,300via the deployment cable806, the user is provided feedback via the deployment tool802to allow the user to understand the status of the deployment. Specifically, in some embodiments, the deployment tool802can be configured to provide user feedback indicating that the further application of force to the intervertebral cage100,300will result in the locking of the intervertebral cage100,300in a deployed configuration. In some embodiments, for example, this feedback can comprise an audible, visual, and/or tactile signal that indicates that the intervertebral cage100,300is nearing the locked and/or deployed configuration. In some embodiments, block1406can be preceded by processes for preparing the intervertebral space and for inserting the intervertebral cage apparatus900,1100. In some embodiments, these processes can include, for example, some or all of the steps of the process1200depicted inFIG.12. After the intervertebral cage100,300is deployed by applying a force to the intervertebral cage100,300via the deployment cable806, the process1400proceeds to block1408wherein the intervertebral cage100,300is locked in the deployed configuration. In some embodiments, in which the deployment cable806includes a locking feature814, the intervertebral cage100,300can be locked into the deployed configuration through the use of the locking feature814on the deployment cable806. In one specific embodiment of how the locking feature814could be used in connection with the intervertebral cage100,300to lock the intervertebral cage100,300into a deployed configuration, the locking feature can comprise a member having a dimension and/or diameter larger than the diameter of the deployment cable806. As the deployment cable806is retracted from the second proximal opening908,1104,1108to deploy the intervertebral cage100,300the locking feature814can be moved through the proximal end110of the intervertebral cage100,300and out the second proximal opening908,1104,1108. In some embodiments, in which a locking feature814is used to secure the intervertebral cage100,300in a deployed and/or locked configuration, the second proximal opening908,1104,1108can be configured to allow the locking feature814to pass through the proximal end110of the intervertebral cage100,300and out the second proximal opening908,1104,1108but to prevent the locking feature814from retracting through the second proximal opening908,1104,1108and back into the proximal end110of the intervertebral cage100,300. Thus, in some embodiments, once the locking feature has been withdrawn from the proximal end110of the intervertebral cage100,300, via the second proximal opening908,1104,1108, the locking feature can engage with portions of the second proximal opening908,1104,1108to secure the intervertebral cage100,300in a locked and/or deployed configuration. In some embodiments, after the intervertebral cage100,300has been locked in the deployed configuration, the force threshold can be exceeded, and the deployment cable806can break at the breakage point. In some embodiments, after the intervertebral cage100,300is in the locked and/or deployed configuration, fill and/or graft material can be inserted into the internal volume126of the body102of the intervertebral cage100,300via the proximal aperture124. A person of skill in the art will recognize that the process1300and1400can include more or fewer steps than those outlined above. A person of skill in the art will further recognize that the above outlined steps of processes1300and1400can be performed in any desired order, and can include substeps or subprocesses. A person of skill in the art will further recognize that the specific methods of locking the intervertebral cage100,300into a deployed configuration are not limited to the specific embodiments enumerated herein, but that a wide variety of techniques and devices can be used to lock the intervertebral cage100,300in a deployed and/or locked configuration. A person of skill in the art will further recognize that the processes depicted inFIGS.12,13, and14can be combined, and that thus an intervertebral cage100,300can be used with both the variable volume pouch400and the deployment cable806. FIGS.15A-15Care illustrations of an embodiment of an intervertebral cage apparatus1500which has a distal aperture1502located at a distal end of the body102. With reference toFIG.15Awhich is a perspective view of the intervertebral cage apparatus1500, the distal aperture1502is centered on the longitudinal axis104although in alternative embodiments the aperture1502may be offset from the axis104. In the illustrated embodiment, the distal aperture1502has a diameter less than that of the proximal aperture124and incorporates a coupling mechanism along its inner surface. In certain embodiments, the coupling mechanism takes the form of a bayonet mount. As shown inFIG.15Bwhich is a cross-sectional view of the intervertebral cage apparatus1500along Section A-A (shown inFIG.15A), the distal aperture may have two or more slots1504configured to receive two or more pins1618on a distal end of an implantation tool1600(described further with respect toFIGS.16A-16C). In the illustrated embodiment, the slots1504are “L-shaped” slots formed along the inner surface of the distal aperture such that a first portion of the slot extends from a proximal end of the distal aperture1502distally to a location between the proximal end and distal end of the aperture1502. As shown more clearly inFIG.15Cwhich is a cross-sectional view of the intervertebral cage apparatus1500along Section B-B (shown inFIG.15B), a second portion of the slot1504then extends radially along the inner circumference of the inner surface of the distal aperture. The radial extension can be about 45 degrees to about 135 degrees about the longitudinal axis104. In the illustrated embodiment, the circumferential extension is about 90 degrees. In some embodiments, fewer or greater slots1504may be used. Additionally, in some embodiments, the slots1504may be placed such that the first portion of the slot1504is centered on a plane formed by axes104and108. This could advantageously allow larger pins1618to be used (described further with respect toFIGS.16A-16C) thereby reducing localized stresses and strains when deploying the device. In other embodiments, slots1504of the distal aperture1502have no second portion such that the first portion runs entirely from a proximal end of the aperture1502to a distal end of the aperture1502allowing for the pins1618to wholly pass therethrough. In such embodiments, the pins1618of the implantation tool can instead be used to engage and abut a distal face1505of the intervertebral cage apparatus1500. In yet other embodiments, the distal aperture1502has a diameter which is equal to, or greater than, the diameter of the proximal aperture124. Furthermore, it is contemplated that in other embodiments, other types of coupling mechanisms may be used to couple the implantation device with the body102, such as, but not limited to, a press fit, an interference fit, a friction fit, threads, and other coupling mechanisms known in the art. With reference toFIG.15B, the proximal end110of the body102has cutouts1506configured to receive mating portions1608of an implantation tool1600shown inFIGS.16A-16C. In the illustrated embodiment, two cutouts1506are located along the outer perimeter of the proximal end110. In other embodiments, a different number of cutouts1506can be used and is not limited to placement along the outer perimeter of the proximal end110of the body102. FIGS.16A-16Care illustrations of an embodiment of an implantation tool1600which can be used to convert the intervertebral cage apparatus1500or other cage apparatuses described herein from an undeployed position to a deployed position. With reference toFIG.16Awhich is a partial cross-section of an embodiment of an implantation tool1600, the implantation tool1600has an outer cannula1602extending between a proximal end and a distal end of the tool1600and centered on luminary axis1604. At the distal end of outer cannula1602is a connector1606configured to contact the proximal end110of body102. As shown more clearly inFIG.16C, which is a view of the distal end of the implantation tool1600, in one embodiment the connector1606has dimensions which are equal to, or greater than, the dimensions of the proximal end110of body102such that the connector1606advantageously distributes any contact pressure over the entire surface area of the proximal end110. In some embodiments, connector1606has two mating portions1608such as teeth protruding distally from the connector1606which are configured to be inserted into and engage cutouts1506on the proximal end110of the body102. In other embodiments, connector1606may have fewer or greater mating portions1608depending on the amount of cutouts1506on the proximal end110of the body102. Once engaged, the mating portions1608are configured to directly link the rotation of the body102with the rotation of the outer cannula1602thereby providing a user of the implantation tool1600direct control of the rotation of the body102during an implantation procedure. At the proximal end of the outer cannula1602is a handle1610configured to be held by a user of the implantation tool1600. The handle1610is directly attached to the outer cannula1602such that rotation of the handle1610also causes rotation of the outer cannula1602. As such, a user of the implantation tool1600can advantageously control the rotation of the body102through the handle1610. Implantation tool1600also has an internal shaft1612centered about the luminal axis1604which is both slidably translatable and slidably rotatable within the outer cannula1602. In the illustrated embodiment, the internal shaft1612is directly attached to control member1614such that rotation and translation of control member1614rotates and translates the internal shaft1612. In this embodiment, the control member1614is wholly received within an aperture1616in the handle. In other embodiments, the aperture is sized only to receive the internal shaft1612such that the control member1614remains outside of the handle. Control member1614may have raised ridges, protrusions, texturing, grips, or other mechanisms to assist a user of the device to rotate and translate the control member1614. In some embodiments, at the distal end of shaft are pins1618which correspond to the coupling mechanism in the form of slots1504located on the distal aperture1502of the intervertebral cage apparatus1500. Since shaft1612is slidably translatable and slidably rotatable within the outer cannula1602, the shaft1612can be both be translated and rotated to engage the “L-shaped” slot1504of the distal aperture1502while a counter-force is applied to the body102via the outer cannula1602due to the engagement of the mating portions1608with the cutouts1506. FIG.17illustrates one method by which the implantation tool1600can be used to convert the intervertebral cage apparatus1500and any other such apparatus described herein from an undeployed position to a deployed position. In the illustrated embodiment, a shaft1612with pins1618and an intervertebral cage apparatus1500with a distal aperture1502containing slots1504is used. During a first step, the implantation tool1600is advanced towards the proximal end110of the intervertebral cage apparatus1500in the undeployed configuration such that the connector1606is placed adjacent to and in contact with the proximal end110of the body102. During this advancement process, mating portions1608are simultaneously inserted into and engage the cutouts1506thereby linking the rotation of the body102with the rotation of the outer cannula1602. During a second step, the shaft1612is then slidingly advanced distally through the outer cannula1602and into the intervertebral cage apparatus1500. The shaft advances first through the proximal aperture124, then through the internal volume126, and finally placed adjacent to and in contact with the trailing edge of the distal aperture1502. In this embodiment, since the distal aperture1502has slots1504which correspond to the pins1618at the distal end of the shaft1612, the shaft1612can be further advanced into the distal aperture1502by following the profile of the slot1504. The shaft1612can then be rotated such that the shaft1612is engaged with the distal aperture1502. In this engaged position, the shaft1612and body102are linked such that translation of the shaft1612results in translation of the body1502. Note that the labeling of the above steps as “first” and “second” is used solely to describe one method of deploying the intervertebral cage apparatus1500and other cage apparatuses described herein. In other embodiments, this sequence can be reversed such that the second step is completed before the first step. In embodiments of the intervertebral cage apparatus1500having slots1504which extend throughout the length of the distal aperture1502, the shaft is advanced wholly through the distal aperture1502. Upon the pins1618being distal the distal face1505of the body102, the shaft1612is rotated and retracted such that the pins1618are abutting a distal face1505. Additionally, the above described steps can either be performed prior to or after insertion of the intervertebral cage apparatus1500into the intervertebral space. In embodiments where the above-described steps are performed prior to insertion into the intervertebral space, the implantation tool1600is used to deliver the device into the space. In embodiments where the above-described steps are performed after insertion into the intervertebral space, a separate tool may be used to deliver the device into the space. During the third step, after the shaft1612has been engaged with the distal aperture1502, a force is applied, in the distal direction, to the proximal end110of the body102while the shaft1612is held in place. The force applied to the proximal end110causes the body102to convert from the undeployed position to the deployed position due to deformation along flexible connectors118. In an alternative embodiment, a force is applied, in the proximal direction, to the distal end of the body102at the distal aperture1502while the outer cannula1602is held in place to convert the body102from an undeployed position to a deployed position. During the final step, the shaft1612is rotated to disengage pins1618from the “L-shaped” slot of the distal aperture1502. The shaft1612is then slidingly retracted from the intervertebral cage apparatus1500such that the shaft1612is removed from the body102. The connector1606may then be retracted such that the mating portions1608are removed from cutouts1506. The tool may then be removed from the intervertebral space and the body of the patient. Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the principles and features disclosed herein. | 73,182 |
11857430 | DETAILED DESCRIPTION When referring to specific directions in the following discussion of certain implantable devices, it should be understood that such directions are described with regard to the implantable device's orientation and position during exemplary application to the human body. The term “inferior” means toward the feet and the term “superior” means toward the head. Also, as used herein, the terms “about,” “generally” and “substantially” are intended to mean that slight deviations from absolute are included within the scope of the term so modified. To aid the Patent Office and any readers of any patent issued on this application in interpreting the claims appended hereto, Applicant notes that it does not intend any of the appended claims or claim elements to invoke 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim. Bones are highly adaptive and change in response to external stimuli, such as stress. Bones typically include dense cortical bone and spongy cancellous bone. Cancellous bone has a porous structure that includes blood vessels, bone marrow, and stem cells which repair damaged or broken bone. Orthopedic implants often have porous structures which are intended to contact cancellous bone and encourage bone tissue growth therein. FIGS.1A and1Bdepict a porous structure for use in an orthopedic implant according to an embodiment of the disclosure. The porous structure is comprised of adjoined cells which together form a porous material volume.FIG.1Adepicts a cell100of the porous structure. Such cell100includes a plurality of intersecting members or struts102a-d. As shown inFIG.1B, a plurality interconnected cells100form a lattice structure. In this regard, struts102a-dof cell100aare connected to struts of adjacent cells100b-dso as to form the lattice/porous structure of cells100. The struts102of the adjoining cells100a-ddefine pores or empty spaces104of the porous structure. The totality of these empty spaces104can be expressed as the porous structure's porosity. Porosity is generally a measure of a structure's empty space relative to the total space occupied by the structure (i.e., the volume occupied by both the struts102and empty space therebetween). More specifically porosity is characterized by the equation Ψ=VV/VTwhere Ψ is the porosity, VVis the volume of empty space or void-space, and VTis the total volume including the volume of materials defining the void-space and the void-space itself. Studies suggest that strain is important for stimulating bone growth via a strain induced cellular response. In this regard, the strain exhibited by a porous material of a prosthetic implant under normal operating loads can encourage bone growth into the porous structure. Thus, when bone cells are in contact with a porous material, strain is an important factor in stimulating new bone growth. The inventors have found that the cells of a porous structure can be optimized by adjusting one or more geometric parameters of the cell so that the struts or members that comprise the cell exhibit a strain under operating loads that is within a target range of about 1000 to 1800 micro strain, which has been determined to be optimal for promoting bone growth without sacrificing needed strength. These parameters include the length and cross-sectional area of each individual strut that make up a cell. Indeed, struts can be tapered so that the cross-sectional dimension of a particular strut varies along its length. In addition, the overall shape or geometry of the cell, the total number of struts in a particular cell, the cross-sectional shape of the struts, the angulation of intersecting struts, the location of connection between two or more struts (i.e., the location along the length of any given strut the intersection of another strut occurs), and the like can also be adjusted to achieve an operating strain within the desired range. Cell100is illustrative of such strain optimization. More particularly, as best shown inFIG.1A, the cross-sectional dimensions of cell100decrease in order from first strut102ato fourth strut102d. The differences of the cross-sectional dimensions can be used to achieve the desired strain in each strut102a-dbased on the expected loads imposed on each strut102a-d. In this regard, first strut102ahas the largest cross-sectional dimension as it is oriented in a direction of the largest load. Thus, it is contemplated that in some embodiments, depending on the expected load, some struts102may have the same cross-sectional dimensions and same lengths. Also, as shown, second, third, and fourth struts102b-deach intersect first strut102asuch that their respective axes are obliquely angled relative to each other. In porous structure150, struts102a-dof cell100aare connected to similarly sized struts102of adjacent cells100b-d. However, it should be understood that depending on the loads imposed on porous structure150, like struts102can vary in size and length over porous structure150to ensure the resulting strain is within the target strain range. Thus, corresponding struts102of cell100e, which is remote from cell100a, may have different lengths and/or cross-sectional dimensions. Also, the lengths of each strut102a-din cell100may be increased or decreased to achieve the desired porosity while the cross-sectional dimension thereof can be increased or decreased to ensure struts102a-dstay within the desired strain range criteria. In the embodiment depicted inFIG.1B, the porosity of the porous structure150may be about 10% to 90% with an average pore size of between 20-1000 microns. However, porous structure150preferably includes a pore size of between 100 and 700 microns with a mean pore size of 400 to 500 microns and a mean porosity of 55% to 65%. As mentioned above, other parameters can be adjusted to optimize mechanical strain, such as the number of struts and their angles of intersection, Thus while the cell100discussed above has four intersecting struts102a-d, it should be understood that the above principles can be applied to the struts of cell structures having more or less struts and having differing geometric orientations of such struts. Examples of such cells are described in U.S. Pat. No. 9,456,901 (“the '901 patent”) and U.S. Pat. No. 9,135,374, which are incorporated by reference herein in their entirety. In this regard, the struts of such disclosed cells may be varied in length and cross-sectional dimension to achieve the desired strain under normal operating conditions. Moreover, the cells and porous structures described above can be made through an additive manufacturing process as detailed in the '901 patent and as described further below. As indicated above, the length of struts102of each cell100within porous structure150may be increased or decreased to achieve the desired porosity. This allows the porosity of the porous structure to be varied throughout the porous material of an implant. Thus, a porous structure may have regions of high porosity where strut length of the porous structure's cells are longer than in regions of relatively low porosity. This also allows the porosity of the structure to gradually decrease/increase between regions of minimum and maximum porosities. Pore size can also be controlled by varying cell geometry. This may provide a discontinuous porosity change where abrupt changes in porosity may be desired. Thus, a porous structure may have cells of the geometry of cell100and other cells of a different geometry. Some of the different cell geometries that can be combined with each other and cell ofFIG.1Ato vary porosity and to optimize strain include diamond cubic, single cubic, body-centered cubic, face centered cubic, tetrahedron, dodecahedron, and octahedron, to name a few. Some of these cell geometries and methods of manufacturing the same are described in the heretofore referenced '901 patent. Varying porosities are exemplified in several of the following implant embodiments, discussed below. All of the geometric parameters mentioned herein, including others not specifically mentions, that effect strain can be further optimized to achieve strain targets using computer aided design and topology optimization tools. However, until now, such optimization tools have never allowed for a strain range between a non-zero minimum and non-zero maximum to dictate the geometry of a cell and lattice structure. A case study, depicted inFIGS.2A and2B, demonstrates strain optimization using structural analysis tools. In this regard, a sample IBD220was constrained at an inferior side thereof and fixed in all planes to replicate the constraint of such IBD in an intervertebral space. A sample load of 360 N was applied to a superior side of IBD220to replicate normal operating loads within the intervertebral space. The target strain range for the struts of the porous structure was set to be between 1000 and 1500 micro strains, and the target strut size was set to be between 0.4 mm and 0.8 mm. The resulting porous structure is depicted inFIG.2B, which includes a variable size struts throughout the IBD220, which each have a strain within the predetermined range under the sample load. FIG.2Cdepicts a strain map where a porous structure200is optimized to have a uniform strain within a target range throughout the entire volume, whileFIG.2Ddepicts a strain map in which a porous structure200′ is not optimized for strain. Such porous structure200′ has a non-uniform strain throughout the entire volume and has regions of very high and very low strain. Additionally, it should be pointed out that, while the porous structure200′ ofFIG.2Dhas a randomized pattern of cells, such randomization would not preclude strain optimization. Indeed, the struts of porous structure200′ can be adjusted in length and cross-sectional dimension so that even structure200′ could exhibit a uniform strain throughout. Thus, as discussed above, an IBD, or some other prosthetic implant with a porous structure, may manufactured by designating a bone growth region or regions of the implant. A target/predetermined strain range between a minimum non-zero strain and a maximum non-zero strain determined to be conducive to a strain induced cellular response may then be selected. The geometry, such as length and cross-sectional dimension, of the struts of each cell in the designated bone growth region of the implant's porous structure can then be adjusted so that each of such struts has a strain within the target range under a predetermined operating load. The resultant structure can then be formed using additive manufacturing or the like. FIGS.3B and3Cdepict an IBD300according to an embodiment of the disclosure. IBD300is particularly suitable for insertion into an intervertebral space, such as a cervical disc space, via an anterior approach. IBD300generally includes a solid frame or outer wall310and a porous core320that includes a porous structure with a varying porosity. As shown, outer wall310extends about porous body or core320and forms a perimeter thereof. Outer wall310includes teeth or spikes312at superior and inferior sides302,304thereof. Such spikes312generally extend above and below porous core320so that such spikes312can engage vertebral bodies that are disposed above and below IBD300to help prevent movement of IBD300while bone grows into porous core320. Outer wall310also includes an engagement opening314at a trailing end301of IBD300. Such engagement opening314is configured to connect to a corresponding inserter instrument (not shown). Such connection may be a threaded connection, collet connection, or the like. The solid structure of outer wall310facilitates such a connection. Porous core320is disposed within the perimeter formed by outer wall310and is connected to outer wall310such that solid outer wall310and porous core320form a unitary or monolithic device. This is preferably achieved through additive manufacturing (discussed below) in which porous core320and outer wall310are formed together layer by layer so that porous core320and outer wall310form a seamless structure. As shown, porous core320includes a first section or ring322, a second section or ring324, and a third section or ring326. In this regard, first section322surrounds second and third sections324,326, while second section324surrounds third section326. Sections322,324, and326may be concentric. In addition, third section326may be concentric with a geometric center of outer wall310. However, it should be understood that the depicted porosity gradients need not be concentric. For example, in some embodiments third section326may be biased toward leading end303such that third section is positioned much closer to leading end303than trailing end301. Sections322,324, and326are distinguished by their relative porosities. As discussed above, porosity is generally a measure of a material's empty space relative to the total space occupied by the material. In contrast, solid outer wall310does not have a porosity or has a porosity of substantially zero. In this regard, while outer wall310is considered a solid structure, it is recognized that structures that are seemingly non-porous, at least to the naked eye, may have a porosity on a very small scale. Indeed, structures that are manufactured using the additive manufacturing technique of selective laser sintering (discussed below) often have an inherent porosity to the material. Thus, as used herein, the terms non-porous and solid mean a porosity so small or so close to zero as to prohibit bone growth therein. As mentioned, first, second, and third portions322,324, and326of porous core320are distinguished by their relative porosities. In this regard, sections322,324, and326have differing porosities. As described above, this can be achieved by varying dimensions of cells that make up the porous structure or by varying the geometric shape of the porous structure's cells. In the particular embodiment depicted, the porosities vary so that porosity increases toward the center of core320. As such, third section326has a greater porosity than first and second sections322,324, and second section324has a greater porosity than first section322. In one particular example, third section326may have a porosity of 80%, second section324may have a porosity of 60%, and third section326may have a porosity of 40%. However, in other embodiments the first, second, and third sections322,324, and326may have a respective porosity within the range of about 10% to 90% with an average pore width/diameter between 20-1000 microns. The above described arrangement of increasing porosity toward the center of IBD100mimics the bone density of a natural vertebral body, as illustrated by the bone density map ofFIG.3A. As shown, the lowest density of bone is located in the center of the vertebral body with an increasing density towards the outer wall of the vertebral body. This correspondence to the natural bone density helps facilitate bone growth in that the porosity of implant300closely aligns with the natural porosity of the vertebral body. In addition, mimicking the natural bone densities of vertebrae positioned above and below IBD300, particularly where IBD is strain optimized as discussed above, reduces the overall stiffness of IBD as compared to an IBD that does not have varying porosities so as to reduce the likelihood of stress shielding. It should be understood that, while three sections of porous core320are shown, porous core320can include more or less porous sections. For example, if more fidelity or precision is desired to match a particular patient's bone density, as may be determined through imaging the particular patient's bone or through matching the patient to a corresponding population within a bone database, porous core320can have more than three sections. For example, porous core can have 4 to 10 sections of differing porosities. Moreover, as discussed above, a gradual increase in porosity may be achieved by increasing the lengths of the struts forming the cells of the porous core so that there is almost an indiscernible number of sections of the porous core. Conversely, abrupt changes between each section can be achieved by having differing cell geometries for each section. For example, first section may be comprised of diamond cubic cells, second section may be comprised of single cubic cells, and third section may be comprised of body-centered cubic cells. FIGS.4A and4Bdepict another embodiment IBD400. For ease of review, like elements are accorded like reference numerals to that of IBD300, but within the 400-series of numbers. For instance, IBD400includes solid outer wall410and porous body or core420. Moreover, porous core420of IBD400also includes a first section or ring422, second section or ring424, and third section or ring426. The porosities of sections422,424, and426mirror that of sections322,324, and326of IBD300. Thus, the porosity of porous core420increases toward the center thereof such that the respective porosities of sections422,424, and426are within the range of about 30 to 80%. However, IBD400also differs from IBD300in a number of ways. First, IBD400is particularly suited for implantation into a lumbar disc space via an anterior approach. In this regard, IBD400has superior and inferior sides402,404that converge toward each other from a trailing end401to a leading end403of IBD400so as to provide a preferred lordotic angle. Moreover, superior and inferior sides402,404may have a slight convexity to conform to concavities in adjacent vertebral bodies. Further, IBD400includes lateral windows418, which may help reduce the stiffness of outer wall410. Also, unlike IBD300, which has spikes312extending from outer wall310, IBD400includes spikes412extending from both superior and inferior sides402,404of porous core420. Such spikes412are generally non-porous and are embedded in porous core420so that spikes412extend from upper and lower surfaces thereof. Spikes412may extend partially into the respective surfaces of porous core420. However, spikes412may also be constructed as columns that extend full thickness through porous core420. Thus, as described above, both IBD300and IBD400include porous cores320,420that vary in porosity in a radial direction such that when these respective IBD's are implanted, each porous section of a different porosity directly contacts bone to encourage bone to grow therein. In contrast,FIGS.5A-5Cdepict a further IBD embodiment500. IBD500is similar to IBD400in that it is particularly configured for implantation into a lumbar disc space via an anterior approach and has a lordotic taper, as best seen inFIG.3C. In addition, IBD500includes a solid outer wall510, porous body or core520, and spikes512embedded in inferior and superior sides502,504of porous core520. However, unlike porous core420, porous core520includes a first section or outer layer522that entirely surrounds a second section or inner layer524so that when IBD500is implanted, only outer layer522of porous core520is exposed to adjacent vertebrae. Inner and outer layers522,524are distinguishable based on their relative porosities where inner layer524preferably has a higher porosity than outer layer522. For example, in one embodiment inner layer524may have a porosity of 60%, and outer layer522may have a porosity of 40%. However, the respective porosities of inner and outer layers524,522can be within the range of about 30 to 80% with an average pore width/diameter between 20-1000 microns. Thus, for example, outer layer522may have a porosity of 10% and inner layer524may have a porosity of 90%. The lower porosity outer layer522helps provide strength to IBD and a strong initial fusion with bone to help resist movement of IBD500within the disc space in response to flexion, extension, torsion, and bending range of motions. However, higher porosity inner layer524facilitates strong long term bone ingrowth by providing more volume for bone proliferation than outer layer522. Thus, inner layer524, while potentially taking longer to facilitate bone growth, provides a stronger long term connection than outer layer522. Moreover, while only an inner and outer layer524,522are depicted, in some embodiments of IBD500, further layers can be provided so that the transition to the greatest porosity inner layer is more gradual. For example, IBD500may have three or four layers where each successive layer toward the center of IBD500has a larger porosity. FIGS.6A-6Cdepict another embodiment IBD600, which is similar to IBD500. For ease of review, like elements are accorded like reference numerals to that of IBD500, but within the 600-series of numbers. For instance, IBD600includes solid outer wall610and porous body or core620where porous core620includes an inner layer with a larger porosity than an outer layer. However, IBD400differs from IBD600in that outer layer, in addition to having a porous structure comprised of a plurality of adjoined cells, includes through-holes618of a much larger size than the porous structure that makes up outer layer622. In this regard, outer layer622forms a grid-like pattern in which outer layer622comprises intersecting beams616of porous material and in which spikes412project from outer layer622at the intersections of such beams616. This configuration, just as in IBD300, allows for a strong initial ingrowth connection between outer layer622and bone. However, through-holes618facilitate enhanced blood flow to inner layer624over that of IBD500. Moreover, through-holes617facilitate accelerated contact between bone cells and inner layer624by providing a path of reduced resistance for the movement of such cells. Again, it is contemplated that further layers may be included in IBD600. In addition, it is contemplated that outer layer622may not have a porous structure separate and apart from the through-openings618and instead may be a solid grid that is an extension of solid outer wall610. However, in such an embodiment, portions of inner layer624may extend up into through-openings618so as to be disposed close to the bone when implanted. FIGS.7A-7Edepict a further embodiment IBD700. While IBD700is similar to the IBD's described above in that IBD700does not include a graft window, IBD700differs in that it does not include any exterior solid portions. Instead IBD700includes an entirely porous body700and a plurality of layers of solid reinforcing members710embedded in the porous body or core720. Porous body720can be formed into any shape to suit the particular application, such as for fusion of vertebrae in the cervical or lumbar spine. The embodiment depicted is particular suited for application to a lumbar spine. Moreover, the porosity of porous body720may be uniform throughout or may vary as described above with respect to IBD500and600. In the embodiment depicted, the solid reinforcing members710a-bare gridded structures that each include a plurality of perpendicularly intersecting beams718that form through-openings717that extend in a superior-inferior direction. Reinforcing members710a-bare embedded within porous body720at predetermined intervals such that they each extend in respective planes that are transverse to a spinal axis when IBD700is implanted. In this regard, beams718of reinforcing members710a-bextend in directions which are generally perpendicular to the compressive loads normally imposed on IBD700within a disc space. Porous body720completely encompasses reinforcing members710a-bsuch that porous body720extends through through-openings717of reinforcing members710a-b, as best shown inFIG.7D. While two reinforcing members710a-bare depicted, the number of reinforcing members710and the spacing therebetween can increase or decrease as needed to provide optimal support. IBD700is a composite-like structure in which the tensile strength of solid reinforcing members710a-bincreases the shear strength of porous body710, which tends to have more strength in compression than in tension. Thus, when IBD700is axially loaded, the gridded beams718of reinforcing members710a-bact in multiple directions to help alleviate stress in the areas under tension. In this regard, reinforcing members710a-bcan have different configurations depending on the directions of highest tensile stress. For example, reinforcing members710a-bcan be oriented vertically or obliquely within IBD, rather than horizontally as shown. In another example, reinforcing members710a-bmay comprise concentric rings of solid material with elongate beams extending radially from a center of the rings. Moreover, the internal reinforcement provided by reinforcement members710a-bhelp assess fusion via radiographic imagery as new bone growth is not obscured by outer solid structures and new bone growth can be measured relative to the known depth of reinforcement members710a-bwithin porous body720. While various windowless IBD's are described above as having differing porous and solid structural configurations, other windowless IBD's may be modified to have similar configurations. Some of such windowless IBD's are described in U.S. Application No. 62/560,910, which is hereby incorporated by reference herein in its entirety. Moreover, while certain solid and porous configurations are described above in association with certain types of IBD's, such as certain cervical and lumbar IBD configurations, it should be understood that the above described solid and porous configurations can be implemented in any type of spinal implant including those that can be implanted in a cervical or lumbar spine via anterior, posterior, lateral, and posterolateral approaches, for example. Also, such configurations may be implemented in other types of orthopedic devices, such as tibial and femoral components of a knee prosthesis, femoral and acetabular components of a hip prosthesis, and humeral and glenoid components of a shoulder prosthesis, to name a few. In this regard, such implants often have porous bone interfacing surfaces which, as described above, can have varying porosities to match the bone density of associated bones, or varying porosities in which an outer layer has a lower porosity to establish a strong initial connection and a higher porosity inner layer to facilitate a stronger long term connection. FIG.8depicts a cross-section of another one of such windowless IBD's. IBD800is similar to IBD500and600in that it includes multiple layers of a porous body or core820where each successive layer has a different porosity. In addition, while not shown, IBD800may include a solid outer wall and may also include solid projections or other bone engaging projections embedded in its porous structure, such as at superior and inferior sides802,804of IBD800. However, unlike IBD's500and600, the porosity of IBD800increases toward the inner layer822dof porous structure820. Thus, in the embodiment depicted, first layer822ahas the highest porosity while fourth layer822dhas the lowest porosity. Also, second layer822bhas a higher porosity than third layer822c. For example, first layer822amay have a porosity of 70%-80%, second layer822bmay have a porosity of 60%-70%, third layer822cmay have a porosity of 50%-60%, and fourth layer822dmay have a porosity of 30%-50%. As discussed in more detail above, this change of porosity between each layer822a-dcan be achieved by changing the length of the struts of the cells comprising each layer822, and/or by changing the geometric shape of the cells that make up the layers822a-d. Thus, for the embodiment depicted, the first layer822amay have cells with longer struts than second, third and fourth layers822b-d. Alternatively, first layer822amay comprise diamond cubic cells, second layer822bmay comprise simple cubic cells, third layer822cmay comprise body-centered cubic cells, and forth layer822dmay comprise face centered cubic cells, for example. The configuration of IBD800in which porosity decreases toward the center of IBD800allows a bioactive material, such as sol-gel bioactive glass (e.g., silicate, borate, and borosilicate bioglasses) or sol-gel derived bone graft, to be dispersed into the porous structure820of IBD800to enhance bone growth within the porous structure820. Such bioactive material is generally provided in the form of particles or beads that have a known size distribution. The pore size of each layer of IBD800may be tuned so that the chosen particle size of the bioactive material can penetrate the desired volume of IBD800. For example, in one embodiment first and second layers822a-bmay have an average pore size greater than the particle size of a bioactive material, while third and fourth layers822c-dmay have an average pore size less than the particle size of the bioactive material. In such embodiment, the bioactive material can only be dispersed into the first and second layers822a-b. In another embodiment, the pore size of the layers822a-dcan be tuned so that the bioactive material can only penetrate first layer822a, while in other embodiments the pore size of the layers822a-dcan be tuned such that the bioactive material can be dispersed through all the layers822a-d. In addition to allowing bioactive materials to be dispersed through one or more layers of IBD800, the configuration of decreasing porosity toward the center of IBD800allows initial blood flow to penetrate into the deeper layers of IBD800. Such blood flow can accelerate time to fusion while the internal strength of the lowest porosity layers of IBD can help resist subsidence. FIG.9Adepicts another embodiment IBD900according to the present disclosure. Unlike the previously described IBD's, IBD900includes a graft window960. In addition, IBD900includes a porous body or wall920or boundary surrounding graft window960. Thus, graft window960is in communication with the pores of porous wall920. While not shown, IBD900may further include a solid outer wall surrounding porous wall920and bone engaging projections, like those of IBD's400and500, embedded in porous wall920. FIGS.9B to9Ddepict various configurations of IBD900in conjunction with a bioactive material, such as the bioactive materials mentioned above with respect to IBD800. In particular,FIG.9Bdepicts a portion of porous outer wall920and graft window960. In this configuration, the bioactive material905is selected such that the size of the beads or particles907are larger than the pore size of porous wall. For example, in one embodiment, the particle size of bioactive material905may be at least 500 microns. In this regard, the size of pores922may be less than 500 microns, but preferably 20 to 450 microns. As such, bioactive material905may only be deposited into the graft window as the relatively large particles907are prohibited from being received by pores922. Moreover, pores922of porous wall920directly communicate with graft window960so that bone can proliferate from graft window960into the adjacent porous structure. In the configuration shown inFIG.9C, bioactive material905′ is selected to have a particle size smaller than pores922of the porous structure920. Preferably the pore size of porous structure920is 100 microns greater than the published range of the bioactive material's particle size, or 500 microns greater than its published mean particle size. For example, in one embodiment particles907′ may have a particle size of 100 microns or less. In this regard, the pore size of the porous structure920of implant900may be greater than 100 microns, but preferably between 200 to 1000 microns. Thus, in this configuration, bioactive particles907′ penetrate the porous structure920so as to be dispersed therein. In addition, as shown, the bioactive material905′ fills graft window960. It is also contemplated, that IBD900may not include a graft window and instead may include the porous material in its place. In such embodiment, the bioactive material905′ may be dispersed throughout such a porous structure. The configuration depicted inFIG.9Dis similar to that ofFIG.9Cin that the particle size of the bioactive material is selected to be less than the pore size of the implant's porous structure920. However, in this configuration, graft window960is plugged while IBD900is impregnated with the bioactive material, and then later unplugged so that graft window960does not include the bioactive material. In this regard, the bioactive material only populates porous structure920of IBD900. Bone graft material, such as demineralized bone matrix or bone morphogenetic protein, can then be packed into graft window960, if desired. In a method of manufacture, the IBD's described above can be impregnated with bioactive materials by loading the IBD into a mold, jig, or housing that substantially conforms to the IBD, such as the mold950depicted inFIG.9G. The bioactive particles, preferably in a sol-gel state, are then injected into the mold, jig, or housing under greater than ambient pressure so as to force the bioactive material into the appropriately sized pores of the porous structure and/or the graft window of the implant. The solution (i.e., sol-gel) is then allowed to solidify. Thereafter, the implant is demolded or otherwise removed from the jig or housing. The impregnated IBD may then be post processed to remove an outer layer of the bioactive material so that the porous structure is exposed at the bone interfacing sides of the IBD. Alternatively, the injection molded surface of bioactive material, which may coat the outer surfaces of the porous structure, may not be removed so as to provide a smoother surface for implantation of the IBD. For this method of high pressure injection, it is preferable to select a bioactive material that can be put into a polymer carrier for the injection molding process. Moreover, this process is not limited to IBD's as it can be used on any device that has a porous structure that mates with bone. FIG.9Edepicts an IBD1600according to a further embodiment of the present disclosure. IBD1600is similar to IBD800in that it is windowless and includes differing layers of porosity. Moreover, outer layer1620has a higher porosity than inner layers1621and1622. However, IBD1600differs in that inner core has the same porosity as outer layer. Moreover, porous channels or pathways1612extend from outer layer1620to inner core1610such that they are in communication. In this regard, inner layers1621and1622form discrete segments of relatively lower porosity embedded in a higher porosity substrate. In addition, as described above, IBD1600may be impregnated with a bioactive material such that the bioactive material is distributed through outer layer1620and inner core1610and, in some embodiments, inner layers1621and1622. However, inner layers1621and1622may have a porosity that prevents the bioactive material from being distributed therein. This configuration helps control the regions in which the bioactive material can be distributed. In addition, IBD1600helps enable quick bone growth for initial fixation and long-term ingrowth. FIG.9Fdepicts another alternative embodiment IBD1600″, which is similar to IBD1600′. As shown inFIG.9E, IBD1600′ depicts pathways1612extending superiorly-inferiorly through bone contacting surfaces thereof, but also side-to-side, such as through anterior and posterior ends and/or lateral sides of IBD1600′. However, unlike IBD1600′, IBD1600″ does not include pathways extending side-to-side and instead includes a single large pathway1612′ that extends superiorly-inferiorly. Such pathway1612′ extends from one bone contacting surface to another and may have the same porosity as outer layer1620. However, it may also have an even larger porosity than that of layer1620so that core1610′ also has a larger porosity than outer layer1620. Additional features may be incorporated into orthopedic implants to further enhance bone growth.FIGS.10A-10Ddepict a further embodiment IBD1000of the present disclosure that includes one such additional feature. IBD1000is similar to the windowless IBD's above in that IBD1000does not have a graft window and includes a solid outer wall1010and porous body or core1020. However, IBD1000includes a plurality of tissue through-channels1024that extend longitudinally through a superior side1002of IBD1000to an inferior side1004of IBD1000, as best shown inFIG.6C. Through-channels1024provide an avenue of least resistance for blood and bone cells to travel through porous structure1022between bones or bone fragments. As such, through-channels1024are preferably deployed in implants that fuse two or more bones or bone fragments together. In addition, since through-channels1024are formed in porous structure1022, such porous structure1022defines through-channels1024. Thus, blood and bone cells travelling through or residing within through-channels1024can access the porous structure1022from therein, which further promotes ingrowth. In this regard, through-channels1024are oriented in a direction of desired bone growth. Through-channels1024are elongate in that they are significantly longer than they are wide. Through-channels1024are distinguishable from the porous structure1022surrounding such through-channels1024in that through-channels1024extend axially along their entire lengths and extend entirely through IBD1000. In addition, each of through-channels1024have a significantly larger cross-sectional dimension than the individual pores of porous structure1022, as best shown inFIG.10D. For example, porous structure1022of porous core1020preferably has a pore size within a range of 100 to 700 microns with a mean pore size range of about 400 to 500 microns and a mean porosity of about 55% to 65%. However, the diameter or cross-sectional dimension of any one of through-channels1024is 0.2 to 1 mm. Also, in the embodiment depicted, solid elongate struts or axial members1026extend along the length of each through-channel1024and are positioned at a periphery thereof, as best shown inFIG.10D. For example, five axial members1026are positioned about a central axis of each through-channel1024. However, more or less axial members1026are contemplated. Such members1026provide connection points for the porous structure1022surrounding through-channels1024which helps support the interface between the porous structure1022and channels1024, and also provides a surface for initial cell attachment for growth into porous structure1022. However, as shown, members1026do not obscure communication between channels1024and the adjacent porous structure1022. In this regard, longitudinal spaces are defined between adjacent axial members1026, as best shown inFIG.10D, so that porous structure1022of core1020can communicate directly with channels1024. FIGS.11A and11Bdepict an even further embodiment IBD1100, which is particularly suited for implantation into a lumbar disc space via a posterior approach. IBD1100generally includes a solid outer wall1110and a porous body or core1120. Outer wall1110surrounds porous core and forms a nose at a leading end1103. Outer wall1110helps provide strength to device1100particular for insertion. However, to reduce the stiffness of IBD1100, a lateral window1132extends laterally through IBD1100including through outer wall1110and porous core1120. Also, a threaded opening1114extends into a trailing end1101of IBD1100for connection to an inserter instrument (not shown). Moreover, unlike IBD1000, IBD1100includes a graft window1130extending from a superior side to an inferior side thereof and intersects lateral graft window1132. Serrations or teeth1112extend inwardly from solid outer wall1110and are embedded in porous structure1120, such that teeth1112sit proud of porous core1120for direct engagement with bone. Porous core11120includes a porous structure similar to that of IBD1000in that porous core1120, in addition to having a plurality of pores defined by cells thereof, includes tissue through-channels1124extending from a superior side to an inferior side thereof. Also, tissue-channels1124optionally include elongate struts1126lining each of through-channels1124for support of the porous structure1122adjacent channels1124. As shown inFIG.11A, at least one through-channel1124is situated between each serration. Also, through-channels1124are interrupted by lateral window1132, and are substantially smaller in cross-sectional dimension than graft window1130. This is at least because graft window1130is intended to be packed with a bone graft material, while through-channels1124may either remain empty to facilitate tissue cell transfer or may be filled with a bioactive material. However, it is preferable that through-channels1124remain free from obstruction. Thus, in embodiments where porous core1120is impregnated with a bioactive material, as discussed above, through channels1124may be plugged during an injection molding process and later unplugged so that, while the porous structure1122of porous core1124may have bioactive material dispersed therein, tissue-channels1124remain clear of the same. FIGS.12-15depict additional IBD embodiments that can deploy one or more of the optimization features described herein. Such IBD's include IBD1300which is particular configured for implantation into a disc space via a posterior approach, IBD1400which is particularly configured for a posterolateral approach, IBD's1500and1600which are particularly configured for an anterior approach, and IBD1700which is particularly configured for a lateral approach. More particularly, IBD's1200,1300,1400, and1500similarly include solid reinforcing structures1210,1310,1410, and1510, porous structures1220,1320,1420, and1520, and graft windows1230,1330,1430, and1530such that they can be modified to include any one or more of the optimization features described herein. These IBD's and additional IBD's that can be modified to incorporate any of the previously described features is discussed in more detail in U.S. Pub. No. 2016/0199193, which is hereby incorporated by reference in its entirety herein. In this regard, each of these IBD's can have one or more of a strain optimized porous structure, a porous structure with varying porosities, a porous structure and/or graft window impregnated with a bioactive material, and tissue-through channels extending from one bone interface to another bone interface, for example. Moreover, any one of IBD's1200,1300,1400, and1500, while depicting graft windows, may be windowless and instead include porous material located in the spaces of windows1230,1330,1430, and1530so that such porous material can have varying porosities for facilitating bone ingrowth, as described herein. Also, any of the IBD's disclosed herein, such as IBD's300,400,500,600,700,800,900,1000, and1100can include one or more of the optimization features described herein. For example, all of these IBD's have porous structures which can be manufactured to have varying porosities to achieve desired objectives, such as mimicking bone densities, encouraging both initial and long term connection strength, and resisting subsidence. Also, the porous structures of these IBD's may be impregnated with a bioactive material and/or may be strain optimized to have strains during operation that fall within a predetermined strain range conducive to bone growth. In addition, IBD's300,400,500,600,700,800, and900may further include tissue through-channels. In this regard, such through-channels may extend between every other bone engaging projection of IBD's400and500, and may align with the through-channels of outer layer of IBD600, for example. Moreover, with regard to IBD700, tissue through-channels may extend from superior to inferior surfaces thereof so that such channels extend through more than one, but less than all, of the openings defined in gridded reinforcement members. Also, while the above described implant modifications are exemplified by spinal implants, such implant optimization modifications can be used in any orthopedic application, particularly those where bone ingrowth is desirable. One such orthopedic application includes filling bone voids in knee revision procedures using bone void filling prostheses, such as those described in U.S. Pat. No. 9,668,758, which is hereby incorporated by reference herein in its entirety. Such void filling prostheses have a porous structure that can include some or all of the optimization features disclosed herein. For instance, the porous structure of a void filling prosthesis may have a varying porosity such that successive layers thereof have differing porosities, be impregnated with bioactive glass, and/or be strain optimized, as described above. In another example, hip or knee implants and the like may include any one of the above described features. More particularly, an intramedullary stem of an endoprosthesis may have any one of or all of a varying porosity, tissue through-channels, a porous structure impregnated with a bioactive material, and a strain optimized porous structure. Even further, the porous interfaces between a tibial baseplate and resected tibia, femoral component and resected distal femur, acetabular cup and resected acetabulum, and the like may include any one of the above described features to help promote bone ingrowth and minimize stress shielding. The exemplary implants described herein and the features thereof may be formed layer-by-layer using an additive layer manufacturing (ALM), i.e., 3D printing, process so no separate connection mechanism is necessary to bring together any of the components of such implants. In some examples, ALM processes are powder-bed based and involve one or more of selective laser sintering (SLS), selective laser melting (SLM), and electron beam melting (EBM), as disclosed in the heretofore referenced '901 patent as well as U.S. Pat. Nos. 7,537,664; 8,728,387; 9,180,010 and U.S. Patent Publication No. 2006/0147332, each of which is hereby incorporated by reference in their entireties herein. Other methods of ALM, which can be used to form the herein described implants, include stereolithography (SLA), fused deposition modeling (FDM), and continuous liquid interface production (CLIP). When employing powder-bed based technologies, articles are produced in layer-wise fashion according to a predetermined digital model of such articles by heating, e.g., using a laser or an electron beam, multiple layers of powder, which preferably may be a metallic powder, that are dispensed one layer at a time. The powder is sintered in the case of SLS technology and melted in the case of SLM technology, by the application of laser energy that is directed in raster-scan fashion to portions of the powder layer corresponding to a cross section of the article. After the sintering or melting of the powder on one particular layer, an additional layer of powder is dispensed, and the process repeated, with sintering or melting taking place between the current layer and the previously laid layers until the article is complete. The powder layers similarly may be heated with EBM technology. Additive manufacturing techniques such as the ALM processes described above may be employed to form the solid and porous layers and any other components, as applicable. In some instances, materials for one layer may be different than the materials for successive layers. This process allows for porous portions to extend full thickness through a particular structure, such as the porous cores of the IBD's described above. It also allows porous portions to be formed in locations impossible to reach by other methods, such as adjacent through-channels1022and1122and in connection with struts1026and1126of implants1000and1100, respectively. Moreover, it allows intricate structures to be formed, such as cell100and lattice structure150formed thereof, where traditional forms of subtractive manufacturing fall short. Each of solid and porous layers of the above described implants may be constructed from biocompatible metals, such as but not limited to any one of or any combination of titanium and its alloys, stainless steel and its alloys, magnesium and its alloys, cobalt and its alloys including a cobalt chrome alloy, nickel and its alloys, silver, tantalum, and niobium, or biocompatible polymers, such as but not limited to any one of or any combination of polyethylene (PE) and variations thereof, polyetheretherketone (PEEK), polyetherketone (PEK), acrylonitrile butadiene styrene (ABS), silicone, and cross-linked polymers. In some arrangements, the implants described herein may be made of certain other materials such as but not limited to bioabsorbable glass, ceramics, and biological active materials including collagen/cell matrices. In some arrangements, the implant may be made of a combination of any of these metals, polymers, and other materials. All constituent porous and solid portions of the above described implants may be a common material, such as one of those listed above, or different materials can be employed for each part. Particular combinations of materials and their use for specific parts of herein described implants are a matter of design choice and may include the combination of different metals, different polymers, or metals combined with polymers. For example, the solid portions of the herein described implants can be made from a metal while the porous portions may be made from a polymer. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. | 49,979 |
11857431 | DETAILED DESCRIPTION OF THE INVENTION As discussed above, a procedure described as a transcorporeal procedure in the cervical spine, also known as an intravertebral corpectomy, has a specific definition. While the definition does not change, some people use the additional terms: single-level partial vertebral body replacement, and/or partial replacement of a vertebral body, and/or partial vertebrectomy. By any of these names, this is a procedure wherein a portion of a vertebra, referred to herein as a portion of the vertebral corpus or vertebral body, is removed and/or drilled through. In order to be referred to as an intravertebral corpectomy or a transcorporeal procedure, the process of removing a portion of the vertebral body begins anteriorly or anterolaterally upon the front half on a vertebral body and proceeds posteriorly or posterolaterally through the back half of the vertebral body creating an exit opening through the back wall of the vertebral body, thus creating a working channel to provide surgical access to the area behind the vertebral body. In the present disclosure, the terms “anterior” and “posterior” with regard to the anatomy of a vertebral body in the cervical spine, can be used to refer to the anterior half of the vertebral body or the posterior half of the vertebral body. The working channel includes an entry point on the anterior half of the vertebral body and an exit point on the posterior half of the vertebral body creating a functional pathway through the vertebral body passing from the front of the vertebral body through the back of the vertebral body. The purpose of the transcorporeal procedure is to provide surgical access to the pathology that lies upon, in proximity to, or behind the vertebral body portion of a vertebra. Using the transcorporeal approach to gain access to the area behind the vertebral body, the surgeon creates a working channel. The area behind the vertebral body is sometimes referred to as the greater epidural space. This working channel represents a functional pathway from the front of the vertebra, through the vertebral body, which includes passing through a back wall of the vertebral body in order to gain functional surgical access to pathologies that lie behind the vertebral body or in the greater epidural space. After the performance of a transcorporeal procedure, including the treatment of the pathology that the surgeon treated behind the vertebral body, the transcorporeal void which is the working channel, must either be left void or repaired with an implantable device. This application discloses repairing the void created in the process of performing the transcorporeal procedure by the method of placing a Vertebral Body Replacement device into the void made during the creation of the working channel. The Vertebral Body Replacement device of this application is also useful in other vertebral body replacement procedures as the device can be used to preserve motion with placement into a vertebral body of a single vertebra or it can be used to eliminate motion by placing the device between two vertebrae into the space of a removed intervertebral disc. Therefore, the implant of this disclosure can preserve motion by placement into a transcorporeal void or eliminate motion by placement between two vertebrae in the cervical spine. FIG.1illustrates a void created within a single vertebra for acceptance of a VBR implant therein. FIGS.2A-2Cillustrate the single vertebra after the insertion of the VBR implant between two endplates.FIGS.2A,2B, and2C, each show a VBR device or implant inserted within a transcorporeal void of a single vertebra, where each VBR device is of a different size and/or dimension. FIGS.3A-3Cillustrate alternate versions of the VBR implant showing a space therein for receiving bone graft. The figures show an implant that represents the method of the placing of a Vertebral Body Replacement device into a void created in a vertebral body within a single vertebra of the cervical spine. The actual features of the Vertebral Body Replacement device will vary based upon anatomical needs and requirements of surgeons, patients, and regulatory bodies. Referring toFIGS.1and2A-2C, disclosed herein is a method of performing a transcorporeal procedure including placement of a Vertebral Body Replacement (“VBR”) device10into a transcorporeal void12within a cervical spine (not shown), the method includes creating a working channel through a vertebral body14of a vertebra15, beginning anteriorly and extending inwardly toward the epidural space. Herein, the “corpus portion of the vertebra15” may also be referred to as the vertebral body14. A working channel through which surgery can be performed is formed when the transcorporeal void12is completed. The working channel extends from an anterior wall through a posterior wall. The Vertebral Body Replacement device10is placed within the working channel, the placement of the Vertebral Body Replacement device10leaving the superior endplate18and inferior endplate20to perform their function and leaving at least a portion of the intervertebral disc22functional thereby avoiding an intervertebral fusion to an adjacent vertebra16. In the present disclosure, the terms “void” or “defect,” with regard to transcorporeal surgery, can be used to refer to the surgically created space within or through a vertebral body14. It is possible that a surgeon will perform a transcorporeal procedure upon more than one vertebra15, but in such a case, each vertebra15would receive a VBR device10to repair the surgically created transcorporeal void12. This is unlike traditional use of a VBR device10in which a VBR device10is used to span across multiple vertebrae. In one embodiment, a method of placing an implant into a surgically created void in the spine is disclosed, the method including creating a void12in a vertebral body14of a cervical vertebra15, the void12beginning anteriorly and directed posteriorly, creating an exit at the back of the vertebral body14, and placing the implant into the void12between a superior endplate18and an inferior endplate20of the vertebra15, the implant being a Vertebral Body Replacement device10. In another embodiment, a method of placing an implant into a surgically created void12in the spine is disclosed, the method including creating a void12in a vertebral body14of a cervical vertebra15, the void12beginning anteriorly and directed posteriorly creating an exit at the back of the vertebral body14, and placing the implant into the void12below the superior endplate18and above the inferior endplate20of the vertebra15, the implant being a Vertebral Body Replacement device10. The afore-mentioned greater epidural space includes the spinal canal and its contents, the neural foramen, and all the ligamentous and neural tissues such as the spinal cord, nerve roots, and intervertebral discs, among other tissues. The goal of the transcorporeal procedure is to surgically treat a spinal problem that is causing the patient to suffer and at the same time preserve the motion segment. In the spine, a motion segment, which includes an intervertebral disc22allows the movement that takes place between two adjacent vertebrae, i.e.,15and16. The disc22sits between the two adjacent vertebrae15and16, separating the bodies and allowing for movement. The goal of the transcorporeal procedure is to address the pathology by going through the vertebral body14, between the superior endplate18and inferior endplate20of a single vertebral body14without eliminating the movement of the vertebra15by preserving the intervertebral disc22and the movement in allows. If a surgeon does not want to try to preserve the motion of the two vertebrae15and16, the surgeon will not perform a transcorporeal procedure; the surgeon can simply remove the disc22that separates the two vertebrae15and16and access the pathology by going between the two vertebrae15and16through the now open space where the disc22was removed. In this case, the surgeon would now fuse the two vertebrae15and16together by using an implant, often a Vertebral Body Replacement device10, placed between the endplates of two vertebrae15and16thus eliminating the motion segment. While the transcorporeal procedure has been thoroughly documented to be successful and beneficial to the patient, the procedure has failed to get widespread acceptance. One of the reasons for this lack of acceptance is due to a lack of implants available to repair the working channel or void created in the process of gaining access to the greater epidural space by working through a vertebral body. Disclosed herein is an inventive method of using a specific class of implant called a Vertebral Body Replacement (or “VBR”) device10as the implant to be placed into a transcorporeal void12, which is also referred to herein, when completed, as a working channel. The VBR devices10are from a category of implants that are associated with intervertebral use. This is what one would intuitively consider to be the opposite of a transcorporeal procedure. Intervertebral use means the devices are placed between at least two vertebrae15and16. VBR devices10are implants that are typically associated with the fusion of two or more vertebrae15and16after removing an intervertebral disc22and some of the bone of at least one or more vertebrae15and16. What is common among VBR devices10is that this group of implants is typically associated with a fusion procedure which eliminates the motion between at least two vertebrae15and16. This is the opposite of the goal of performing a transcorporeal procedure. As stated earlier, the intent of a transcorporeal procedure is to avoid performing an intervertebral fusion so it is counterintuitive to look to the VBR intervertebral fusion device to perform a motion-preserving surgical procedure. Disclosed herein is an inventive method of using a specific type of implant, a VBR device10that has not, heretofore, been used in conjunction with transcorporeal surgery or for use within a single vertebra15. In accordance with the methods disclosed herein, the implant10may be placed for the filling, the repair, and or the support and healing of the transcorporeal void12, i.e. working channel. This specific use of VBR10, placed within a transcorporeal void12within a single vertebra15, has not been done before because the use of such a VBR implant10is counterintuitive as explained herein. VBR devices10are typically used as intervertebral implants, meaning they are implants that are engineered to succeed after being placed into an environment which carries significant compressive loads. These types of implants are typically placed between two vertebrae15and16, or what remains of two vertebrae in the cervical spine after the removal of part of or all of an intervertebral disc22as well as a portion of, or all of, one, or both of the vertebrae15and16adjacent to the disc space. After placement between two vertebrae15and16, all of the weight of the body above the implant10is compressing down upon the implant10. VBR devices, including the VBR device10disclosed herein, may include “teeth”26(shown inFIGS.3A-3C) or significant features of engagement to keep them from sliding or moving forward or backward. This compressive force allows the teeth of the implant10to press into the vertebra15above and the vertebra16below the implant10to provide engagement. During surgery, the surgeon distracts or holds the vertebrae15and16apart from one another. Distracting or holding the vertebrae15and16apart accomplishes two primary functions. The first is it enlarges the space between the vertebrae15and16providing greater access to the greater epidural space. Secondly, the enlarged space also importantly allows for the placement of the VBR device10. A VBR device10is engineered not to slide or otherwise move within bone. During the traditional use of a VBR device10, once the device10is placed into the open space between two vertebrae15and16, the surgeon will release the distraction and allow the two or more vertebrae to compress down on the VBR device10creating engagement with the teeth pressing into the bone. This compression only increases as the patient stands up post operatively and gravity and the weight of the patient further compress the implant10between the vertebrae15and16. This compression creates engagement that holds the implant10in place and facilitates healing through bone growth. The teeth also prevent the implant10from being easily slid into a fixed, non-distracted void such as a transcorporeal void12that cannot be distracted apart. As a transcorporeal void12is created in a single vertebra15, i.e., a single bone, the space cannot be distracted apart to make room for the VBR device10having a significant number (or size) of teeth to be slid into position when implanted. The size and design of the teeth, which provide features engineered to grasp and hold position to bone and not slide, have to be taken into consideration for use in a transcorporeal application. As described, a transcorporeal procedure requires the placement of the VBR device10within a void12made in the body of a single vertebra15. This disclosure of the method of placing a VBR device10into a transcorporeal void12is as mentioned counterintuitive for a number of reasons. One reason is the relationship between the implant10and the stability of the spinal segment. Currently, VBR devices10have been placed into unstable spinal segments of the cervical spine where a discectomy and partial or complete vertebrectomies have been performed. In these cases, the VBR device10is placed into an unstable spinal segment. The disclosed inventive method provides for a VBR device10to be placed into the transcorporeal void12in the vertebral body14portion of an individual vertebra15of the cervical spine. In such a case, the VBR device10performs in a spinal segment that does not have a lack of stability; the VBR device10must perform in a stable environment. Further, using a VBR device10in the manner described herein is counterintuitive because VBR devices10are designed to take advantage of a characteristic of bone and bone growth referred to as Wolff's Law. Wolff's Law teaches that bone density changes in response to changes in the functional forces on the. bone. In other words, Wolff's Law teaches that bone grows when stress or pressure in applied to it. For example, this is the reason why regular exercise is vital to maintaining bone mass and strength throughout life and it is also for example, a challenge to astronauts who spend significant time in low gravity environments. Without loads, bone begins to weaken, while with loads bone begins to strengthen and grow. This is one of several reasons why the placement of a VBR device10into the vertebral body14of a single vertebra15has not been attempted. Traditional analysis teaches that a VBR device10placed into a transcorporeal void12will not have an adjacent vertebra16to press into in order to be fully and formally loaded to function as intended. VBR devices10are designed to carry and function and heal growing bone under a load and this load is an important part of the healing process as it stimulates new bone growth. This intervertebral load is not available to a VBR device10placed into a transcorporeal void12. Therefore bone growth has to be achieved via other assisting mechanisms. Placement of a VBR device10into a single vertebra15instead of between two vertebrae15and16under load is, with initial analysis, in contrast to Wolff s Law of bone growth and other principles that relate to bone growth and Vertebral Body Replacement devices10. The implant of the present disclosure is a VBR device10that is placed between the internal aspects of the endplates of a single vertebra15, i.e., into the body or created defect in a vertebra15, below the superior endplate18and above the inferior endplate20of one vertebra15. This is different than intervertebral surgeries. Phrased differently, the method of the present disclosure includes placing a VBR device10into the vertebral body14of one vertebra15to fill a transcorporeal defect or hole. By contrast, prior to this disclosure, a VBR device10was placed only between two vertebrae15and16replacing a removed intervertebral disc22. When an intervertebral disc22is removed and replaced by an implant for fusion, the vertebral endplates in contact with the implant are no longer functionally intact. This means the endplates are no longer interfacing with an intervertebral disc22but are interfacing with a fusion implant. Thus, bone is growing into the fusion implant eliminating the motion and the traditionally healthy function of a vertebral endplate. Disclosed herein is the method comprising creating a void12in a vertebral body14of a cervical vertebra15, the void beginning anteriorly and directed posteriorly, creating an exit at a posterior aspect of the vertebral body14and placing an implant into the void12between a superior endplate18and an inferior endplate20of the vertebra15, the implant being a Vertebral Body Replacement device10, leaving both endplates functionally intact. The method of placing a VBR device10into a transcorporeal void12will necessarily require the VBR device10to function and promote bone growth and healing without the benefit of intervertebral compression. This disclosure discloses a VBR device10to be used to repair and help heal a transcorporeal void12using the methods disclosed herein. An exemplary method is placing an implant into a transcorporeal void12created in at least one vertebra15of the cervical spine, the method including creating a void12in a vertebral body14of a vertebra15, the void12beginning anteriorly and directed posteriorly creating an exit at the back of the vertebral body14; and placing the implant into the void12between a superior endplate18and an inferior endplate20of the vertebra15, the implant being a Vertebral Body Replacement device10. The aforementioned methods described herein will allow the superior endplate18and the inferior endplate20of the vertebra15to remain functionally intact. FIGS.3A-3Cillustrate alternate versions of the VBR implant10of the present disclosure. In each figure, space24is shown. Space24is configured to receive bone graft therein. Further, each figure illustrates a series of teeth26on both the top and bottom of implant10. It should be noted that the placement, size, number, and dimension of teeth26shown in the figures is exemplary only, and the present disclosure is not limited to the placement, size, number, and dimension of teeth26shown in these figures. As shown in the figures, one of a plurality of VBR devices10can be selected for placement into the cervical spine. In one or more embodiments, at least one of the plurality of VBR devices10has dimensions different from other VBR devices10. The shape, size and dimensions of the VBR devices10shown in the figures are not meant to be limiting in any way and the method disclosed herein can use VBR devices10of shapes, sizes, and dimensions not necessarily depicted in the drawing figures. | 19,182 |
11857432 | Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the disclosure, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the principles of the present disclosure. The exemplifications set out herein illustrate several embodiments, but the exemplifications are not to be construed as limiting the scope of the disclosure in any manner. DETAILED DESCRIPTION Before turning to the figures, which illustrate certain exemplary embodiments in detail, it should be understood that the present disclosure is not limited to the details or methodology set forth in the description or illustrated in the figures. It should also be understood that the terminology used herein is for the purpose of description only and should not be regarded as limiting. The present disclosure relates to expandable and/or dynamic implants. In an example embodiment, the implant may be an interbody (between adjacent vertebrae), intravertebral-body (inside the vertebrae) and/or spinal stabilization device that may or may not be used as an interbody fusion cage or device, interbody/intravertebral body stabilization device and/or the like (e.g., spinal device(s)) for providing support, stabilization and/or promoting bone growth between or inside vertebrae or other portions of bone that have been destabilized or otherwise due to injury, illness and/or the like. Particularly, the present disclosure provides various versions of dynamic (expandable and/or expandable and retractable) interbody/intravertebral body devices that are usable in a spinal column or other areas of a human. Various embodiments disclosed herein are directed to expandable implants that are implantable between adjacent bodies of bone. For example, the implant may be implanted or inserted into a human spine adjacent upper and lower vertebrae of the spine. According to various exemplary embodiments, the components of the implants disclosed herein may be made of any suitable material(s), including a variety of metals, plastics, composites, or other suitable bio-compatible materials. In some embodiments, one or more components of the implants disclosed herein may be made of the same material, while in other embodiments, different materials may be used for different components of the various implants. Referring now toFIGS.1-10, an expandable implant10is shown according to an exemplary embodiment. The implant10is usable, for example, between and/or within vertebral bodies of the spine. It should be understood that the implant10may in some embodiments be usable in other portions of the body in addition to the spine, and all such applications are to be understood to be within the scope of the present disclosure. According to an exemplary embodiment, the implant10includes a first, or front component12(e.g., a first wedge member), a second, or rear component14(e.g., a second wedge member), and a third, intermediate, or control member16, which collectively form a control assembly that extends along a longitudinal axis of the implant10. A first, or upper support18(e.g., an upper plate, support member, assembly, etc.) and a second, or lower support20(e.g., a lower plate, support member, assembly), are coupled to the body assembly and extend generally between the front component12and rear component14. In certain embodiments, the upper support18may be identical to the lower support20, which may reduce manufacturing costs of the implant10. According to an exemplary embodiment, the upper and lower supports18,20define a height of the implant10(e.g., a support height defined by the upper and lower grooved/toothed surfaces of the implant), wherein the height of the implant10is the vertical distance between an outer or top surface48of upper support18and outer or lower surface76of lower support20. In some embodiments, the top surface48of the upper support18is substantially parallel to the lower surface76of the lower support20. In these embodiments, the height of the implant10is substantially constant throughout the implant10. However, in other embodiments, the top surface48of the upper support18and the lower surface76of the lower support20are not parallel. For example, the top surface48of the upper support18and the lower surface76of the lower support20may form an angle, such that the height of the implant10is not consistent throughout, as will be discussed further herein. In some embodiments, such as the embodiments shown inFIGS.13and14, the front component12includes a front portion122, a rear portion123opposite the front portion122, a first side portion124, and a second side portion125opposite the first side portion124. The front component12also includes a first ramped surface26and a second ramped surface27proximate the first side portion124. The front component12also includes a third ramped surface28and fourth ramped surface29proximate the second side portion125. Further, the front component12includes a first projection30proximate the first ramped surface26, a second projection31proximate the second ramped surface27, a third projection32proximate the third ramped surface28, and a fourth projection33proximate the fourth ramped surface29. In certain embodiments, the front portion122of the front component12may have an angular profile as shown inFIG.2. For example, the height of the front portion122(i.e., the distance between surface of the front portion122that engages the upper support18and the surface of the front portion122that engages the lower support20) may be greater proximate the second side portion125(seeFIG.14) than the height of the front portion122proximate the first side portion124(seeFIG.13). In some embodiments, the first ramped surface26and the third ramped surface28are angled in an upwards direction towards the top surface48of the upper support18. Conversely, the second ramped surface27and fourth ramped surface29are angled in a downwards direction towards the lower surface76of the lower support20. The ramped surfaces26,27,28,29and the projections30,31,32,33facilitate controlled sliding movement of the upper support18and the lower support20, as will be discussed further herein. In some embodiments, the front component12may include a control bore34configured to receive the control member16, such that the control bore34extends from the front portion122through the rear portion123. In some embodiments, the control bore34may be threaded. In other embodiments, such as the embodiment shown inFIGS.13and14, the control bore34may be unthreaded. Further, the front component12may include a first installation tool interface35proximate the first side portion124and a second installation tool interface37proximate the second side portion125. The first and second tool interface35,37may be utilized with an installation tool to assist a medical practitioner or other user in inserting the implant10into a patient, as will be discussed further herein. Further, the front component12may include a wedge slot126on the first side portion124and a wedge slot126on the second side portion125. As shown inFIGS.12and13, the wedge slots126may span from the first side portion124into the control bore34or from the second side portion125into the control bore34. The wedge slot126is configured to receive a portion of a retention wedge127(seeFIG.11). In some embodiments, such as the embodiment shown inFIG.3, the rear component14includes a rear nose142, a threaded bore145positioned opposite the rear nose142, a first side portion143, and a second side portion144opposite the first side portion143. The rear nose142also includes an upper ramp149and a lower ramp150. Further, in some embodiments, the rear component14includes a first guide groove146proximate the first side portion143and a second guide groove147proximate the second side portion144. In some embodiments, as viewed from the front, the first guide groove146is generally angled downwards towards the lower surface76of the lower support20, and the second guide groove147is generally angled upwards towards the top surface48of the upper support18. The first guide groove146and the second guide groove147may facilitate controlled sliding movement of the upper support18and the lower support20, as will be discussed further herein. In some embodiments, the rear nose142of the rear component14may be generally wedge-shaped. In further embodiments, the rear nose142may also include a nose at either the first side portion143or second side portion144. For example, as shown inFIG.16, the generally wedge-shaped rear nose142of the rear component14also includes a nose proximate the first side portion143of the rear component14. In some embodiments, having a nose, such as the nose on the first proximate side143of the rear component14, may facilitate inserting the implant10into a patient, as will be discussed further herein. Further, in some embodiments, the rear component14may have a through whole148extending from the first side portion143to the second side portion144. Referring now toFIG.18, the control member16includes a tip161at a first end and a head164at a second end, opposite the first end. In some embodiments, the tip161may be flat. In some embodiments, the control member16also includes a threaded shaft162extending from the tip161to a shoulder167. In other embodiments, the control member16may include a plurality of teeth or strips or other securing mechanisms that may be received by the rear component14, as will be discussed further herein. The control member16also may include a through hole168that may facilitate implanting bone graft growth within the implant10. Through hole168may be in communication with a tool port166to enable insertion of bone graft or other material into the interior of implant10via tool port166. In some embodiments through hole168defines openings on opposing portions of control member16. The control member16may also include a groove169near the head164. The groove169may be configured to receive a portion of a retention wedge127in order to prevent back out of the control member16. In some embodiments, the tool port166is configured to receive a tool that may be used to manipulate the control member16. For example, the tool port166may be configured to receive a hex head driver. While this example embodiment shows the tool port166as being a hex head socket, it should be appreciated that the tool port166can be designed to receive several different types of hand tools, including a slotted screwdriver, a Phillips-head screwdriver, an Allen wrench screwdriver, a hexagonal drive, a torx drive, a Robertson drive, a tri-wing screwdriver, an Allen security driver, a torx security driver, a Pozidriv, a clutch drive, a spanner, a Schrader drive, a nut driver, a hex wrench, a node security driver, any combination of the listed driver interfaces, and any other type of driver interface. Referring toFIGS.19and20, the upper support18is shown according to an example embodiment. In this example embodiment, the upper support18includes a top surface48, a front portion49, a rear portion51opposite the front portion49, a first side50, and a second side52opposite the first side50. In this example embodiment, the upper support18further includes a plurality of ridges54on the top surface48. The series of ridges54may create a surface roughness that provides additional stability of the implant10once installed. The upper support18further includes a first ramp55, a second ramp56, a third ramp57, and a fourth ramp58. The first ramp55and the second ramp56are proximate the front portion49, and are configured to engage the first ramped surface26and the third ramped surface28of the front component12. In some example embodiments, the first ramp55will slide along the first ramped surface26of the front component12and the second ramp56will slide along the third ramped surface28of the front component12as the implant10expands from a first position to a second position. The upper support18further includes a third ramp57and a fourth ramp58proximate the rear portion51of the upper support18. The third ramp57and the forth ramp58are configured to engage the upper ramp149of the rear component14. In some example embodiments, the third ramp57and the fourth ramp58will slide along the upper ramp149of the rear component14as the implant10expands from a first position to a second position. The upper support18may further includes a guide rail59proximate the rear portion51. The guide rail59is configured to be received by the second guide groove147of the rear component14. In some embodiments, the guide rail59will translate within the second guide groove147of the rear component as the implant10expands from a first position to a second position, as will be discussed further herein. In some embodiments, the guide rail59and the guide groove147may be dovetail shaped, as shown inFIG.3. The dovetail shape may help keep the various components of the implant from undesirably shifting relative to one another. Further, the upper support18may include a first side projection61, a first side slot64, and a second side slot65proximate the first side50. The upper support18may also include a second side projection62, a third side projection63, and a third side slot66proximate the second side52. Additionally, the upper support18may include a pin aperture68proximate the second side52. The pin aperture68may be configured to receive a pin67, as will be discussed further herein. In some embodiments, the upper support18further includes an upper mounting plate300proximate the front portion49. In this example embodiment, the upper mounting plate300is integrated into the upper support18, such that the upper support18and upper mounting plate300are manufactured as one piece. For example, the upper support18and upper mounting plate300may be 3D printed as a single piece. The upper mounting plate300may include an unthreaded bore302configured to receive a first portion of an anchoring member, such as a bone screw22(seeFIG.23), as will be discussed further herein. Additionally, the upper mounting plate300may include a threaded bore304configured to receive a retention member24(seeFIG.23), as will be discussed further herein. Referring now toFIGS.21and22, the lower support20is shown according to an example embodiment. In this example embodiment, the lower support20includes a lower surface76, a front portion79, a rear portion81opposite the front portion79, a first side80, and a second side82opposite the first side80. In this example embodiment, the lower support20further includes a plurality of ridges84on the lower surface76. The series of ridges84may create a surface roughness that provides additional stability of the implant10once installed. The lower support20further includes a first ramp85, a second ramp86, a third ramp87, and a fourth ramp88. The first ramp85and the second ramp86are proximate the front portion79, and are configured to engage the second ramped surface27and the fourth ramped surface29of the front component12. In some example embodiments, the first ramp85will slide along the second ramped surface27and the second ramp86will slide along the fourth ramped surface29as the implant10expands from a first position to a second position, as will be discussed further herein. The lower support20further includes a third ramp87and a fourth ramp88proximate the rear portion81of the lower support20. The third ramp87and the forth ramp88are configured to engage the lower ramp150of the rear component14. In some example embodiments, the third ramp87and the fourth ramp88will slide along the lower ramp150of the rear component14as the implant10expands from a first position to a second position, as will be discussed further herein. The lower support20may further includes a guide rail89proximate the rear portion51. The guide rail89is configured to be received by the first guide groove146of the rear component14. In some embodiments, the guide rail89will translate within the first guide groove146of the rear component14as the implant10expands from a first position to a second position, as will be discussed further herein. Further, the lower support20may include a first side projection90, a second side projection91, and a first side slot93proximate the first side80. Further, the lower support20may include a third side projection92, a second side slot94, and a third side slot95proximate the second side82. Additionally, the lower support20may include a pin aperture97configured to receive a pin67, as will be discussed further herein. In some embodiments, the lower support20further includes a lower mounting plate400proximate the front portion79. In this example embodiment, the lower mounting plate400is integrated into the lower support20, such that the lower support20and lower mounting plate400are manufactured as one piece. For example, the lower support20and lower mounting plate400may be 3D printed as a single piece. The lower mounting plate400may include an unthreaded bore402configured to receive an anchoring member, such as a bone screw22(seeFIG.23), as will be discussed further herein. Additionally, the upper mounting plate300may include a threaded bore304configured to receive a retention member24(seeFIG.23), as will be discussed further herein. Referring now toFIGS.23and24, the implant10is shown with a plurality of anchoring members. According to some example embodiments, the implant10may contain at least one anchoring member used to secure the implant10inside a patient. For example, the anchoring member may be a bone screw22. The example embodiment shown inFIG.23shows an implant10with two bone screws22used as anchoring members. According to this example embodiment, each bone screw22includes a linear, externally threaded shaft222, a head224at a first end, and a tip226at a second end opposite the first end. In some embodiments, the tip226is pointed. In some embodiments, the diameter of the bone screw22remains constant from the head224to the tip226. The head224further includes a socket228that is configured to receive an installation tool. While this example embodiment has a torx drive socket228, it should be appreciated that the socket158can be designed to receive several different types of hand tools, including a slotted screwdriver, a Phillips-head screwdriver, an Allen wrench screwdriver, a hexagonal drive, a torx drive, a Robertson drive, a tri-wing screwdriver, an Allen security driver, a torx security driver, a Pozidriv, a clutch drive, a spanner, a Schrader drive, a nut driver, a hex wrench, a node security driver, any combination of the listed driver interfaces, and any other type of driver interface. Once the bone screw22is inserted into a bone, as will be discussed further herein, a retention screw24may be used to prevent a back out of the bone screw22. In an example embodiment, such as the embodiment shown inFIG.24, the retention screw24may include a head244, a tool port248, and a threaded shaft242(see.FIG.11). The threaded shaft242may be screwed into either the threaded bore304of the upper mounting plate300and/or the threaded bore404of the lower mounting plate400, as shown inFIG.24. The head244further includes a flat portion240and a rounded shoulder portion249. In some embodiments, when the flat portion240is proximate the head244of the bone screw22, the retention screw24is not in contact with the bone screw22. However, the retention screw24may be tightened into the threaded bore304of the upper mounting plate300and/or the threaded bore404of the lower mounting plate400, such that the rounded shoulder portion249is proximate to the bone screw22. In some embodiments, when the retention screw24is tightened into the threaded bore304of the upper mounting plate300or the threaded bore404of the lower mounting plate400, the underside of the rounded shoulder portion249is in contact with the head224of the bone screw22. In doing so, the retention screw24may be used to prevent back out of the bone screw22. In the example embodiment shown inFIG.24, the retention screw24includes a tool port248configured to receive a hex head driver. It should be appreciated that the tool port248can be designed to receive several different types of hand tools, including a slotted screwdriver, a Phillips-head screwdriver, an Allen wrench screwdriver, a hexagonal drive, a torx drive, a Robertson drive, a tri-wing screwdriver, an Allen security driver, a torx security driver, a Pozidriv, a clutch drive, a spanner, a Schrader drive, a nut driver, a hex wrench, a node security driver, any combination of the listed driver interfaces, and any other type of driver interface. Referring now toFIGS.25and26, an implant500is shown according to an example embodiment. The implant500is usable, for example, between and/or within vertebral bodies of the spine. It should be understood that the implant500may, in some embodiments, be usable in other portions of the body in addition to the spine, and all such applications are to be understood to be within the scope of the present disclosure. According to an exemplary embodiment, the implant500includes a first, or front component530(e.g., a first wedge member), a second, or rear component540(e.g., a second wedge member), and a third, intermediate, or control member550, which collectively form a control assembly that extends along a longitudinal axis582of the implant500. A first, or upper support510(e.g., an upper plate, support member, assembly, etc.) and a second, or lower support520(e.g., a lower plate, support member, assembly), are coupled to the control assembly and extend generally between the front component530and rear component540. In certain embodiments, the upper support510may be identical to the lower support520, which may reduce manufacturing costs of the implant500. The control assembly can be used to expand the implant500between at least a first, collapsed position and a second, expanded position, as shown inFIG.25. The control assembly, including the front component530, the rear component540, and the control member540, can be used to control the implant height (e.g., a support height defined by the upper and lower grooved/toothed surfaces of the implant), wherein the height of the implant500is the vertical distance between an outer or top surface of upper support510and outer or lower surface of lower support520. The control assembly is configured to interface with the upper support510and the lower support520to control the height of the implant500in a similar manner as described above with respect to the implant10shown inFIGS.1-10. The upper support includes a first side projection511and a second side projection512on a first lateral side518of the upper support510. The upper support510further includes a third side projection513, a fourth side projection514, and a fifth side projection515on a second lateral side519of the upper support510. The lower support520includes a first side projection521, a second side projection522, and a third side projection523on a first lateral side528of the lower support520. The lower support520further includes a fourth side projection524and a fifth side projection525on a second lateral side529of the lower support. As the implant500expands from the first, collapsed position to the second, expanded position, the plurality of side projections511,512of the upper support510slidably interface with the plurality of side projection521,522,523of the lower support520. Additionally, as the implant500expands from the first, collapsed position to the second, expanded position, the plurality of side projections513,514,515of the upper support510slidably interface with the plurality of side projection524,525of the lower support520. The plurality of side projections511,512,513,514,515of the upper support510and the plurality of side projections521,522,523,524,525of the lower support520may provide the implant500with additional mechanical stability by preventing the various components from shifting, including preventing lateral movement of the upper support510relative to the lower support520. The upper support510may further include a mounting plate516configured to receive a retention member24and an anchoring member560, such as a bone screw. The lower support520may also included a mounting plate526configured to receive a retention member24and an anchoring member560, such as a bone screw. In some embodiments, such as the embodiment shown inFIGS.25and26, the mounting plate516of the upper support510and the mounting plate526of the lower support520may be angled, such that when the anchoring member560is inserted into the mounting plate516,526, a center-line trajectory584of the anchoring member560is not parallel with the longitudinal axis582of the implant500. For example, as shown inFIG.26, the center-line trajectory584and the longitudinal axis582form a plate angle580. In certain embodiments, such as the implant10shown inFIGS.1-10, the plate angle580may be 0 degrees. However, in other embodiments, such as the implant500shown inFIGS.25and26, the plate angle580may be around 20 to 30 degrees. The plate angle580may be vary from 0 degrees to 90 degrees, depending on the application of implant500. The plate angle580may vary based on the location an implant is being inserted into, and also based upon the insertion angle into the patient. For example, the implant500may be used in an Anterior to Psoas (ATP) Fusion surgery. Referring now toFIG.27, a method of installing an implant1000is shown according to an example embodiment. If should be appreciated that the method shown is exemplary in nature, and should not be construed as limiting. Additional steps may be included in the method, and steps shown may be omitted and/or performed in any suitable order. While reference is made to specific implants, it should be appreciated that this method may apply to any suitable implant. Step1100involves inserting an implant into a desired location. For example, step1100may involve inserting the implant10shown inFIG.1into a patient. In some embodiments, step1100involves inserting the implant10between two adjacent vertebrae in a patient's spinal column. In certain embodiments, the implant10is inserted into a patient's spinal column through the lateral side of a patient. In some embodiments, the implant10may be used in a lateral lumbar interbody fusion (LLIF) surgery. For example, an incision in the lateral side of a patient may be made, and the implant10may be inserted into the patient's spine. In this example embodiment, the rear nose142of the rear component14may be inserted between two adjacent vertebrae in the patient's spinal column. In some embodiments, a surgeon or other user may use an installation tool to grip the installation tool interfaces35,37of the implant10, and the installation tool may then be used to insert the implant10into a desired location. In some embodiments, when the implant10is inserted, the implant10is in a first, collapsed position, as shown inFIGS.1-4. According to some embodiments, when the implant10is in the first, collapsed position, the control member16is received by the control bore34of the front component12. The control member16may be received by the control bore34prior to the implant10being inserted. The control member16extends into a central cavity of the implant10, and the threaded shaft162of the control member16is received by the threaded bore145of the rear component14, as shown inFIG.4. In this example embodiment, the threaded shaft162of the control member16, and the threaded bore145of the rear component14are threaded such that turning the control member16in a clockwise direction will cause the head164of the control member16to move in a direction towards the rear nose142of the rear component14. However, in other embodiments, the threaded shaft162and threaded bore145may be threaded such that turning the control member16in a counter-clockwise direction will cause the head164of the control member16to move in a direction towards the rear nose142of the rear component14. In further embodiments, the rear component14and the control member16may mechanically engage using other mechanisms, such as a zipper mechanism, a plurality of teeth on the shaft162and the bore145, etc. to allow an operator to manipulate the position of shaft162within the bore145. In an example embodiment, the control member16and the rear component14engage the upper support18and the lower support20in the first, collapsed position. For example, the guide rail59of the upper support18may be received by the second guide groove147of the rear component14. Further, the guide rail89of the lower support20may be received by the first guide groove146of the rear component14. In some embodiments, the guide grooves146,147may prevent the upper support18from expanding away from the lower support20when the implant10is in the first, collapsed position. Further, the first ramped surface26and the first projection30of the front component12may engage the first ramp55of the upper support18in the first, collapsed position. Similarly, the third ramped surface28and the third projection32of the front component12may engage the second ramp56of the upper support18in the first, collapsed position. Additionally, the second ramped surface27and the second projection31of the front component12may engage the first ramp85of the lower support20when the implant10is in the first, collapsed position. Similarly, the fourth ramped surface29and the fourth projection33may engage the second ramp86of the lower support20when the implant10is in the first, collapsed position. These ramps and projections may prevent the upper support18and the lower support20from undesirably shifting laterally or expanding away from one another when the implant10is in the first, collapsed position. In certain embodiments, such as the embodiments shown inFIGS.13and14, the projections30,31,32,33may be dovetail shaped. The dovetail shape may help keep the various components of the implant from undesirably shifting relative to one another. Further, in some embodiments, when the implant10is in the first, collapsed position, the upper support18interfaces with the lower support20as shown inFIGS.1and4. In this example embodiment, the second side projection62of the upper support18is positioned between the first side projection90and the second side projection91of the lower support20. Further, the third side projection92of the lower support20is positioned between the second side projection62and third side projection63of the upper support18in the first, collapsed position. Step1200involves expanding an implant to a desired height. For example, after the implant is inserted between two adjacent vertebrae, the implant may be expanded. In some embodiments, the implant10may be expanded to a second, expanded position as shown inFIGS.5-9. In this example embodiment, a person may expand the implant10from a first, collapsed position to a second, expanded position using the control member16. For example, the person may use an expansion tool that engages with the tool port166of the control member16. For example, the expansion tool may be a hex head screw driver. The person may then use the installation tool to turn the control member16, for example, in a clock-wise direction. In this example embodiment, the threaded shaft162of the control member16, and the threaded bore145of the rear component14are threaded such that turning the control member16in a clockwise direction will cause the head164of the control member16to move in a direction towards the rear nose142of the rear component14. As the control member16is turned, the threaded shaft162will screw into the threaded bore145, until the threaded shaft162is completely within rear component14, as shown inFIG.10. It should be appreciated that, while the Figures generally show control member116threadingly engaging the rear component14, in other embodiments, other adjustment mechanisms may be used (e.g., ratchet mechanisms, indents/detents, etc.). In these embodiments, the control member16may be manipulated (e.g., urged, turned, pushed, rotated, etc.) to control relative movement between the upper support18and the lower support20. As the head164of the control member16moves towards the rear nose142of the rear component14, the guide rail59of the upper support18will slide within the second guide groove147of the rear component14. Further, the guide rail89of the lower support20will slide within the first guide groove146of the rear component14. Further, the first ramp55of the upper support18will slide along the first ramped surface26of the front component12, and the second ramp56will slide along the third ramped surface28of the front component12. Additionally, the first ramp85of the lower support20will slide along the second ramped surface27of the front component12, and the second ramp86of the lower support20will slide along the fourth ramped surface29of the front component12. Thus, as the control member16is screwed into the threaded bore145of the rear component14, the upper support18and the lower support20will expand away from each other at least in part due to the ramped surfaces26,27,28,29on the front component12, the rear component14, the upper support18, and the lower support20. Further, it should be appreciated that the expansion profile of an implant may be customized in part by changing the angles of the various ramped surfaces. Using the implant in various locations may require a custom expansion profile. For example, if the implant is inserted into a patient's spine, the implant expansion profile may be customized to match the curvature of the patient's spine at the desired location that the implant is to be implanted into. In some example embodiments, the ramped surfaces26,27,28,29of the front component12may have a much higher angle (i.e., the angle that upward angled surface and the downward angle surface form) than the ramped surfaces26,27,28,29of the rear component14. In this example embodiment, turning the control member16will cause the implant10to expand more near the front component12than near the rear component14. In this example embodiment, the implant10height will be larger near the front component12than near the rear component14. It should be appreciated that further customization of the expansion profile of an implant10may be accomplished by adjusting the angle of ramped surfaces26,27,28,29on the front component12, the rear component14, the upper support18, and the lower support20. Step1300involves securing the implant in a desired location within a patient. For example, step1300may involve securing the implant to the two adjacent vertebrae that the implant was inserted between. In an example embodiment, the implant10, as shown inFIG.23, may be secured to adjacent vertebrae using bone screws22. For example, the implant10may be inserted between two vertebrae, and expanded to a desired height. In this example embodiment, the top surface48of the upper support18may engage the upper vertebrae and the lower surface76of the lower support20may engage the lower vertebrae. A first bone screw22may be driven through the unthreaded bore302of the upper mounting plate300and into an adjacent vertebrae. A second bone screw22may then be driven through the unthreaded bore402of the lower mounting plate400and into another adjacent vertebrae. It should be appreciated that the bone screws22may inserted into the unthreaded bore402of the lower mounting plate400, securing the implant10to the lower vertebrae before the first bone screw22is through the unthreaded bore302and into the upper vertebrae. It should be appreciated that step1300may occur before, after, or in conjunction with step1200. For example, in one embodiment, the implant10may be secured to two adjacent vertebrae while in a first, collapsed position, and then expanded to a desired height. Alternatively, the implant10may be secured to one vertebrae while in a first, collapsed position, then expanded to a desired height, and then secured to a second vertebrae. Additionally, the implant10may be used without any anchoring members. Step1400involves locking the implant components into a desired position. In some embodiments, for example, a plurality of retention wedges127and pins67(seeFIG.11) may be used to secure components in place. For example, once the implant10is set to a desired height, a first retention wedge127and a second retention wedge127may be driven (e.g., pressure fit) into a first wedge slot126and a second wedge slot126on the front component12. In this example embodiment, the retention wedges127are driven through the wedge slots126and into the groove169of the control member16. In doing so, the control member16will be prevented from backing out. Therefore, the retention wedges127will prevent the implant10from further expanding or collapsing. Further, the implant10may be locked into a desired position using retention pins67. For example, once the implant10is in a desired position, a first retention pin67may be driven (e.g., press fit) into the pin aperture68on the upper support18and a second retention pin67may be driven (e.g., press fit) into the pin aperture96of the lower support20. In doing so, the retention pins67may extend into the center cavity of the implant10, thereby preventing the front component12from moving closer to the rear component14, thereby preventing over expansion of the implant10. Additionally, the retention pins67may prevent the implant10from collapsing by preventing the lower support20and the upper support18from returning to the first, collapsed position. Step1400may further include locking anchoring members into place. For example, the bone screws22of the implant10shown inFIG.24, may be locked into place using the retention members24. For example, before the implant10is installed, a first retention member24may be partially screwed into the threaded bore304of the upper mounting plate300and a second retention member24may be threaded into the threaded bore404of the lower mounting plate400. In this example embodiment, the first retention member24may be screwed into the threaded bore304such that the flat portion240of the retention member24is proximate the unthreaded bore302. Additionally, the second retention member24may be screwed into the threaded bore404such that the flat portion240of the retention member24is proximate the unthreaded bore402. Once the implant10is in place, the bone screws22may be inserted into the unthreaded bores302,402and driven into the adjacent vertebrae. Since the flat portion240of the retention members24is proximate the unthreaded bores302,402, the retention members24will not interfere with the bone screws22as the bone screws22are driven into the adjacent vertebrae. Once the bones screws22are secured, the retention members24may be turned using a tool. For example, in the embodiment shown inFIG.24, the retention members24may be turned using a hex head screw driver. The retention members24may be turned such that the rounded should portion249is proximate the head224of the bone screw22. In doing so, the underside of the head244of the retention member24may be pressed up against the head224of the bone screw22, thereby preventing the bone screw22from backing out. Referring now to the Figures generally, the various embodiments disclosed herein provide expandable implants including a lower support and an upper support adjustably coupled to the lower support and movable between a first, collapsed position, and a second, expanded position. Further, a rear component and a control shaft rotatably received by the rear component is disclosed, where rotation of the control shaft causes relative movement of a front component relative to the rear component. In some embodiments, the upper support moves in a linear fashion relative to the lower support. In other embodiments, the upper support may move in a non-linear fashion relative to the lower support. In some embodiments, a single control member and control shaft are utilized. In other embodiments, multiple (e.g., 2) control members and control shafts are utilized. In some embodiments, the multiple control channels are parallel and straight. In other embodiments, the control channels are non-parallel and straight (e.g., angled toward each other). In further embodiments, the control channels are non-parallel and non-straight such that the adjustable member moves in a non-linear fashion relative to the base member. In some embodiments, the control shaft includes a control thread corresponding to each control member. As such, while in some embodiments the control shaft includes a single control thread, in other embodiments the control shaft includes multiple (e.g., first and second) control threads. In some embodiments, the control threads are like-threaded. In other embodiments, the control threads have different threads. For example, in some embodiments, a first control thread is opposite-handed from a second control thread. In further embodiments, a first control thread has a different pitch from a second control thread. In yet further embodiments, a first control thread is different handed and has a different pitch from a second control thread. In some embodiments, one or both of the lower support and the upper support include projections/grooves to provide a gripping surface intended to facilitate gripping adjacent portions of bone. In further embodiments, one or both of the lower support and the upper support include one or more apertures and/or cavities configured to promote bone growth in and around the lower support and the upper support. In some embodiments, the apertures extend from a top, bottom, and/or side surface of the lower support and the upper support and to a central cavity of the implant. According to any of the embodiments disclosed herein, one or more bone screws may be included and positioned to extend through one or both of the lower support and the upper support and into adjacent portions of bone. In some embodiments, multiple bone screws are used. A first bone screw may extend through the adjustable member and into a first portion of bone, and a second bone screw may extend through the base member and into a second portion of bone. In further embodiments, multiple bone screws are accessible and manipulatable by way of the front face of the implant defined by one or both of the adjustable member and the base member. A head and tool port of the control shaft may further be accessible by way of the front face of the implant. In various embodiments, any suitable configuration of the control shaft/control member(s)/control channel(s) may be utilized. In some embodiments, an at least partially spherical control member threadingly engages a threaded control shaft and translates both along the control shaft and within the control channel. In other embodiments, the control member is non-spherical and is received at least partially on or in a control rail or control channel provided by the adjustable member, such that the control member translates along both the control shaft and the control channel or control rail. As utilized herein, the terms “approximately,” “about,” “substantially”, and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of some features described and claimed without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and claimed are considered to be within the scope of the application as recited in the appended claims. It should be noted that the term “exemplary” as used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representations, and/or illustrations of possible embodiments (and such term is not intended to connote that such embodiments are necessarily extraordinary or superlative examples). The terms “coupled,” “connected,” and the like as used herein mean the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another. References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below,” etc.) are merely used to describe the orientation of various elements in the FIGURES. It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure. Although the figures and description may illustrate a specific order of method steps, the order of such steps may differ from what is depicted and described, unless specified differently above. Also, two or more steps may be performed concurrently or with partial concurrence, unless specified differently above. Such variation may depend, for example, on hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. It is important to note that the construction and arrangement of the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter described herein. For example, elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes and omissions may also be made in the design, operating conditions and arrangement of the various exemplary embodiments without departing from the scope of the present application. It should be appreciated that dimensions of the components, structures, and/or features of the present implants and installation instruments may be altered as desired within the scope of the present disclosure. | 47,205 |
11857433 | DETAILED DESCRIPTION OF THE INVENTION In the description which follows, any reference to direction or orientation is intended primarily and solely for purposes of illustration and is not intended in any way as a limitation to the scope of the present invention. Also, the particular embodiments described herein are not to be considered as limiting of the present invention. Referring now to the figures, in which like reference numerals refer to like elements,FIGS.1and2illustrate an implant100in accordance with the invention, including a flexible core200, a first support component300, operative to contact a first engaging surface204of core200, and a second support component400, operative to contact an opposing second engaging surface208of core200. With reference toFIG.3, implant100is operative, when positioned between adjacent bones of a joint, such as for example vertebrae10,12, to stabilize a joint formed by adjacent vertebrae. Implant100further enables natural kinematic movement of the joint while limiting movement beyond a therapeutic range of motion. In one embodiment, this range of motion reflects the complete natural kinematic signature for the patient. Referring again toFIGS.1and2, flexible core200includes a first engaging surface204disposed upon a first segment202, and a second engaging surface208, disposed upon a second segment206. In the embodiment shown inFIGS.1and2, flexible core200is provided with an inflection region210of greater flexibility, which enables a displacement or changed orientation of engaging surface204with respect to engaging surface208. In particular, first segment202tapers at one end to form inflection region210, which may deform or buckle to enable a relative angular displacement of engaging surfaces204,208. In addition, core200may compress to reduce a distance between portions of first and second engaging surfaces204,208. Compression may include an expansion of material outwards relative to an interior214of core200, resulting in an increase in a diameter of core200, or material of core200may collapse into an interior of core200, thereby partially or completely maintaining an exterior dimension of core200. Alternatively, spaces within the material of core200may be reduced in size, for example spaces formed by a cellular or porous matrix of the material of core200may compress, whereby expansion of an exterior dimension of core200may be maintained or limited. First support component300includes an engagement plate302having a core engaging surface304, and a bone engaging surface306. A keel or other projection308extends from bone engaging surface306, and is operative to engage a bony surface, for example, an interior portion of vertebra10or12. Projection308includes bone ingrowth spaces310, operative to provide an area for bone ingrowth, to further secure plate302into engagement with the bone to which plate302is attached. Second support component400includes an engagement plate402having a core engaging surface404, and a bone engaging surface406. A keel, extension, or projection408extends from bone engaging surface406, and is operative to engage a bony surface, for example, an interior portion of vertebra10or12. Projection408includes bone ingrowth spaces410, operative to provide an area for bone ingrowth, to further secure plate402into engagement with the bone to which plate402is attached. Bone ingrowth spaces310,410may each advantageously be formed at an angle with respect to a direction of projection308,408insertion, thereby potentially reducing an incidence of separation of implant100from the bone, after bone ingrowth has taken place. Core engaging surfaces304,404of first and second support component300,400are advantageously formed with a lubricious material relative to a surface material of engaging surface204,208of core200, if sliding or rotating relative to core200is intended. FIG.2additionally illustrates a tether, or lanyard218, operative to limit a maximum displacement of core200and one or both of first and second support components300,400. Lanyard218is affixed to two of either core200and one of support components300,400, or both support components300,400. Lanyard218is formed of a flexible material which does not prevent movement within an intended range of motion of implant100, as described herein, and may advantageously be formed of a resilient material, to avoid an abrupt relative cessation of movement, at a limit of travel, of elements to which it is affixed. In the embodiment ofFIGS.1-4, inflection region210is most flexible at a point proximate engaging surface204. A hollow interior212may be included, operative to provide a space into which material forming region210may deflect during displacement of engaging surface204relative to engaging surface208. A tether218may be provided, operative to limit a maximum extent of motion of first and second support components300,400. In this embodiment, core engaging surface404is provided with a smooth surface, upon which a second engaging surface of flexible core200may slide. Core engaging surface404is illustrated as substantially planar inFIG.4, although a projection and recess, as described forFIGS.1and2, may alternatively be provided. A lip or raised portion extending from core engaging surface404, not shown, may further, or in alternative to lanyard218, operate to limit an extent of movement of engaging surface208upon core engaging surface404. With reference toFIGS.3and4, relative motion of bones10and12result from movement of a patient into which implant100is implanted. As first and second support components300,400are attached to bones10,12, respectively, a corresponding motion is induced in components300,400. It should be understood that, in accordance with the invention, component400may be connected to bone10, and component300may be connected to bone12; that is, either component300or400may be positioned superiorly with respect to the other. In the natural body of the patient, bones10and12move in accordance with six degrees of motion. Each of these degrees of motion is enabled with an implanted implant100, as diagrammed inFIG.4. Specifically: (1) translation in the direction indicated by line “X”, corresponding to core200sliding along engaging surface404; (2) translation in the direction indicated by line “Y”, corresponding to axial compression of core200; (3) translation in the direction indicated by line “Z”, corresponding to core200sliding along engaging surface404; (4) rotation about an axis indicated by line “X”, corresponding to compression of one side of core200; (5) rotation about an axis indicated by line “Y”, corresponding to core200rotating upon engaging surface404; and (6) rotation about an axis indicated by line “Z”, corresponding to compression of one side of core200. Alternatively stated, if an axis of the implant is defined as extending through an implant of the invention from a first adjacent bone to a second adjacent bone, the implant would enable relative motion of the first and second adjacent bones with respect to:(a) opposite rotation about the axis;(b) axially bending;(c) axially compressing; and(d) radial sliding with respect to the axis.In an alternative embodiment, shown inFIGS.5and6, core200A includes first and second segments202A,206A, separated by an inflection region210A that is substantially narrower than flanking segments202A,206A, and thus bends to enable an angular displacement of segments202A,206A, and accordingly enables an angular relative displacement of engaging surfaces204A,208A. FIG.6illustrates a cross-section of the implant100ofFIG.5, taken through projections308and408. At least a portion of core engaging surface404A is configured as a curved smooth surface upon which a mating region of curved smooth surface of second engaging surface208A of flexible core200A may slide. In the illustration, a curved slidable portion of core engaging surface404A is recessed within second support component400A, and a mating slidable portion of engaging surface208A projects from core200A; however, it should be understood that engaging surface404A may be projected, and engaging surface208A may be recessed. Similarly, a portion of first engaging surface204A is a curved smooth surface upon which a mating curved smooth surface of core engaging surface306A may slide. In the embodiment shown inFIGS.5-6, core200A forms two convex surfaces204A,208A, to foster a desired kinematic movement, and to maintain a desired ligament tension throughout the expected range of motion, and to promote a natural resting position of the bones. It should be understood, however, that in accordance with the invention, either surface204A or208A may be either convex or concave, as the therapeutic needs of the patient dictate. Alternatively, either surface may be flat, as illustrated inFIGS.1-4, discussed above, orFIGS.7-8, discussed below. In one embodiment, a projection312extends from first engaging surface306A into core aperture or hollow interior212A, and is operative to limit an extent of movement of first support component300with respect to core200. A similar configuration could be provided for slidably mating engaging surfaces404A and208A. Embodiments of the invention may be provided with one or more apertures316,416through which fasteners may be installed, to further secure implant100within a patient. For example, a bone screw may be passed through aperture316in first support component300and into bone10, and another bone screw may be passed through aperture416in second support component400, and into bone12. A bone growth agent may alternatively or additionally be provided within aperture316or416, or upon bone engaging surface306and or406, to promote bone growth thereinto. Bone growth surfaces may be provided with openings or texture into which tissue may grow and adhere. In use, the embodiment ofFIGS.5-6enables all six degrees of movement as described above, however, due to the mating curved slidable engaging surfaces208A and404A, additional directional stability is provided, whereby sliding is inhibited to an extent in the absence of flexion or extension of the joint. This inhibition arises from a natural gravitational resting state of the mating curved engaging surfaces208A and404A. Referring now to the embodiment illustrated inFIGS.7-8, in which core200B is provided with a flat surface at second engaging surface208B, matably connectable to flat core engaging surface404B of second support component400. In this embodiment, core200B is configured to affix core200B with respect to rotation upon second engaging surface404B, by one or more pins414, which pass through one or more pin bores or apertures216,416, provided in core200B and second support component400B, respectively. While pins are illustrated, it should be understood that other fastener configuration are possible, including screws, adhesive, set screws, interference fit, press fit, or other methods as would be understood by one skilled in the art. Pins414may be threaded or press fit into apertures216or416, or secured using adhesive, and may be secured to either or both of core200B or second support component400B. While pins414may be utilized to prevent rotation as well as to maintain core200B in a position upon engagement surface404B, an axial position of core200B against engagement surface404B may alternatively or additionally be maintained by a snap fit engagement between recessed portion220and projected portion420of core200B and core engaging surface404B, respectively. Alternatively, core200B may be provided with a projecting portion, and core engaging surface404B may be provided with a mating recess. In any of the embodiments of the invention, should it be desired to maintain a position of either or both core engagement surfaces304,304A,304B and404,404A,404B relative to core200,200A,200B, pins, a snap fit, or other fasteners may be used, as described above. With further reference toFIG.8, it can be seen that core engaging surface304B has a curved portion having a radius which is larger than a curved portion of first engaging surface204B. As such, core engaging surface304B and first engaging surface204B may readily slide, to a limited extent, relative to each other, as influenced by the difference between their respective curvatures. Core200B may also be rotated, and compressed evenly or laterally, as detailed elsewhere herein with respect to other embodiments of the invention. It should be understood that superior and inferior positions of components, as illustrated, are for the convenience of the reader in understanding the invention, and that implant100may be implanted in a reverse orientation than is shown, as benefits the patient. In use, the embodiment ofFIGS.7-8enables all six degrees of movement as described above, however, due to the mating curved slidable engaging surfaces204B and304B, additional directional stability is provided, whereby sliding is inhibited to an extent in the absence of flexion or extension of the joint. This inhibition arises from a natural gravitational resting state of the mating curved engaging surfaces204B and304B. Rotation, or spinning, of bone10with respect to bone12, is translated only through an interface between first engaging surface204B and core engaging surface304B, as second engaging surface208B is affixed with respect to core engaging surface404B. Similarly, sliding is carried out solely through this interface, for the same reasons. Surfaces208B and404B may alternatively slide with respect to each other, as detailed herein with respect to other embodiments. Mating surfaces204,204A,204B and304,304A,304B; or208,208A,208B and404,404A,404B, may, for example, be concave, convex, semi-spherical, elliptical, complex, or barrel shaped, whereby a resistance to sliding, spinning, rotating, rocking, or other relative movement may be uniform in all directions, or different in specific directions. FIG.8further illustrates insertion tool channels, bores, openings, or apertures218,418, in first and second support components300B,400B. As implant100is inserted between joint surfaces maintained in spaced relation by ligaments, it may be necessary to mechanically compress implant100prior to insertion within the joint. A tool, not shown, such as is known in the art, may be provided with tines which engage tool apertures218,418, whereupon first and second support components300B,400B may be moved together, or apart, as determined by the practitioner, during implantation. Further, implant100may be implanted through an anterior, anterolateral, or lateral approach, and accordingly, tool apertures218,418provide a means for mechanically grasping and manipulating implant100during implantation. The invention provides a joint replacement implant, for example for replacement or stabilization of a cervical disc replacement, although other joints may be partially or completely replaced by implant100, for example one or more joints of the fingers, hand, wrist, elbow, shoulder, other areas of the spine, hip, knee, ankle, foot, or toes. Implant100is operative to restore the natural kinematic signature and natural joint properties, particularly for spinal discs, but for all joints which exhibit movement in all six degrees of motion, as detailed above. All elements of implant100may be made from a flexible material, although core200, in particular, flexes in order to accommodate an angular displacement of first and second support components300,400. As the joint is flexed or extended, the flexible and or resilient material of core200may bulge or stretch to enable an angular displacement of first and second engaging surfaces204,208. Additionally, or alternatively, inflection region210provides a relatively weaker region of core200which is adapted through thickness and or shape to facilitate bending of core200. Implant100may be fabricated using any biocompatible materials known to one skilled in the art, having sufficient strength, flexibility, resiliency, and durability for the patient, and for the term during which the device is to be implanted. Examples include but are not limited to metal, such as, for example titanium and chromium alloys; polymers, including for example, PEEK or high molecular weight polyethylene (HMWPE); and ceramics. Portions or all of the implant may be radiopaque or radiolucent, or materials having such properties may be added or incorporated into the implant to improve imaging of the device during and after implantation. Opposing mating surfaces which rotate, spin, or slide, including core engaging surfaces304,304A,304B,404,404A,404B, and first and second engaging surfaces204,204A,204B and208,208A,208B, may be made of the same or different materials, which combination produces a therapeutic fluidity of motion, or desired drag. Surfaces of implant100may be plasma sprayed, for example by titanium plasma spray, and may be bead blasted or electropolished. More particularly, the support components may be manufactured from cobalt-chrome-molybdenum alloy, Co—Cr—Mo, as specified in ASTM F1537 (and ISO 5832-12). The smooth surfaces may be plasma sprayed with commercially pure titanium, as specified in ASTM F1580, F1978, F1147 and C-633 (and ISO 5832-2). The core may be manufactured from ultra-high molecular weight polyethylene, UHMWPE, as specified in ASTM F648 (and ISO 5834-2). Core200,200A,200B, may alternatively, in one embodiment, be fabricated using polycarbonate urethane (PCU), or a thermoplastic polycarbonate urethane (TPU) such as Bionate, a registered trademark of DSM IP Assets B.V. Corporation, of Heerlen Netherlands, for a thermoplastic elastomer formed as the reaction product of a hydroxyl terminated polycarbonate, an aromatic diisocyanate, and a low molecular weight glycol used as a chain extender. Other polymeric materials with suitable flexibility, durability, and biocompatibility may also be used, as understood by one skilled in the art. In accordance with the invention, implants of various sizes may be provided to best fit the anatomy of the patient. Support components and a core of matching or divergent sizes may be assembled during the implantation procedure by a medical practitioner as best meets the therapeutic needs of the patient, the assembly inserted within the body using an insertion tool. Implants of the invention may also be provided with an overall angular geometry, for example angular mating dispositions of support components and core, to provide for a natural lordosis, or a corrective lordosis, for example of from 0° to 6° for a cervical application, although much different values may be advantageous for other joints. Implant heights, for use in the cervical vertebrae for example, may typically range from 7 mm to 12 mm, although the size is dependent on the patient, and the joint into which an implant of the invention is to be implanted. In accordance with the invention, a single implant100may be used, to provide stabilization for a weakened joint or joint portion. Alternatively, two, three, or more implants100may be used, at a single joint level, or in multiple joints. Moreover, implants100may be combined with other stabilizing means. Additionally, implant100may be fabricated using material that biodegrades in the body during a therapeutically advantageous time interval. Further, implant100is advantageously provided with smooth and or rounded exterior surfaces, which reduce a potential for deleterious mechanical effects on neighboring tissues. Any surface or component of the invention may be coated with or impregnated with therapeutic agents, including bone growth, healing, antimicrobial, or drug materials, which may be released at a therapeutic rate, using methods known to those skilled in the art. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention. All references cited herein are expressly incorporated by reference in their entirety. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. There are many different features to the present invention and it is contemplated that these features may be used together or separately. Thus, the invention should not be limited to any particular combination of features or to a particular application of the invention. Further, it should be understood that variations and modifications within the spirit and scope of the invention might occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention. | 21,189 |
11857434 | DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring now toFIGS.1-12, an implant and an implant assembly10are shown. The implant assembly10comprises a first implant member12and a second implant member14. The implant assembly10is adapted to be received in an implant assembly receiving area15(FIG.4) between bones, such as between a first vertebra or bone17and a second vertebra or bone19. The second implant member14has an open-end configuration as illustrated inFIG.3. Further details of the second implant member14will be described later herein. Although not shown, it should be understood that the first implant member12could have an open-end configuration with U-shaped channel (not shown) and the second implant member14could have a mating U-shaped projection (not shown) for receipt in the U-shaped channel. The first implant member12comprises a first wall16having a generally U-shaped projection18. As best illustrated inFIG.3, note that the second implant member14comprises a generally U-shaped wall20having a first wall portion20a, a second wall portion20band a third wall portion20cjoining the first and second wall portions20a,20bto define a generally U-shaped channel22. In the illustration being described, the generally U-shaped channel22is adapted to provide a guide channel for receiving and guiding the generally U-shaped projection18, as best illustrated inFIGS.1and3, into a mating or assembled configuration. The generally U-shaped projection18is adapted and configured so that it complements the shape of the generally U-shaped channel22and fits snugly therein. As best illustrated inFIG.3, note that the first wall portion20acomprises through-holes or bores28and30defined by generally cylindrical walls26aand26b, respectively. Likewise, the second wall portion20bcomprises through-holes or bores34and36that are defined by generally cylindrical walls32aand32b, respectively. Note that the through-holes and bores34and36are generally aligned with the through-holes or bores28and30, respectively, as shown. The generally U-shaped projection18likewise comprises a pair of generally cylindrical walls38aand38bthat define through-holes or bores40and42, respectively. It should be understood that after the first implant member12is mounted in the second implant member14, the through-holes or bores30,42and36become generally aligned to provide a first lock aperture and through-holes or bores28,40and34being generally aligned to provide a second lock aperture. The first and second lock apertures are adapted to receive pins44and46, respectively, in order to lock the first and second implant members12and14together. Thus, the implant assembly10provides means and apparatus for locking the first and second implant members12and14together as shown inFIGS.8-10. Referring now toFIGS.3and7-10, details of a screw locking system49(FIG.1) will now be described. The screw locking system49is adapted to retain at least one or a plurality of screws, such as screws50and52(FIG.1), in the implant assembly10and prevent them from withdrawing therefrom after the implant assembly10is assembled together and implanted in the implant assembly receiving area15and the at least one or a plurality of screws50and52are screwed into the first and second vertebrae or bones17and19, respectively. The first implant member12comprises a first wall12a, which is anterior or downward of a rear wall14aof the second implant member14after the implant assembly10is assembled and implanted. It should be understood that when the implant assembly10is inserted into the implant assembly receiving area15between the first vertebra or bone17and the second vertebra or bone19(FIG.4), the first wall12abecomes associated with an anterior opening or area21into the implant receiving area15. A second wall or rear wall14bof the second implant member14becomes associated with a posterior area (not shown) of the implant assembly receiving area15. In general, the first wall12ais adapted and configured to receive the at least one or a plurality of screws50and52and the screw locking system49secures them in a locked position so that after the at least one or a plurality of screws50and52are screwed into bone, they will become locked in the implant assembly10and not withdraw therefrom. The screw locking system49, in turn, facilitates preventing the screws50and52from unscrewing from the bones into which they are screwed. The first wall12acomprises at least one or a plurality of apertures or bores, such as bore or aperture60(FIG.3) having a first aperture or bore axis A1and a second aperture62having a second aperture or bore axis A2, respectively. The cylindrical bores or apertures60and62are defined by generally cylindrical walls64and66, respectively. Note that the bores or apertures60and62and their respective bore axes A1and A2, respectively, are angled in different directions (i.e., one upward and one downward in the illustration shown inFIG.3) so that the screws50and52may engage and be screwed into different bones, such as the first vertebra or bone17and the second vertebra or bone19. In the illustration being described, the first wall12acomprises a first side wall surface12a1and a second side wall surface12a2that is generally opposed to the first side wall surface12a1. Note that the first side wall surface12a1is posterior relative to the second side wall surface12a2when viewed from a front of the implant assembly10after the implant assembly10is implanted into the implant receiving area15. In one embodiment, each of the plurality of bores or apertures60and62comprises at least one or a plurality of arms, fingers or latches. For example, the first bore or aperture60and the second bore or aperture62comprise a first arm70and a second arm72, respectively. For ease of illustration, the at least one or a plurality of arms will be illustrated here as comprising the first arm70and the second arm72associated with the first bore or aperture60and the second bore or aperture62, respectively, but it should be understood that more or fewer apertures could be provided and more or fewer arms could be used or provided in the apertures60and62. The first and second arms70and72are operatively associated with and located in the first and second bores or apertures60and62, respectively. In the illustration, each of the first and second arms70and72are flexible, elastic and/or resilient so that they can be actuated from a normally closed position (illustrated inFIGS.1-4) to an actuated open position (illustrated inFIG.5relative to the first arm70). Each of the first and second arms70and72comprises elongated portions70aand72a, free ends or detent ends70band72band fixed ends or coupling ends70cand72c. The first and second arms70and72have an associated arm axis AA1(FIGS.3,9and10) and AA2, respectively, in the illustration being described. In this example, the arm axis, such as arm axis AA1, is not parallel or generally not parallel with respect to an imaginary plane IP (FIG.10) in which the implant assembly10lies and is also generally not parallel to a coronal plane CP (illustrated inFIG.9). For ease of understanding, the imaginary plane IP (FIG.10) lies generally midway between a first bone-engaging surface37and a generally opposed second bone-engaging surface39, which is adapted and configured to engage or become associated with the first and second vertebrae or bones17and19, respectively, after the implant assembly10is received in the implant receiving area15. The first and second arms70and72are not generally parallel to the imaginary plane IP or coronal plane CP as mentioned, and it is important to note that they lie at different angles with respect to each other and with respect to the imaginary plane IP and coronal plane CP, as illustrated by the angles Θ and X (FIG.9) and angles (D and Y (FIG.10). In the illustration being described, the first implant member12is machined to define the apertures60and62and their associated first and second arms70and72, respectively. In the illustration being described, the first and second arms70and72are defined by at least one or a plurality of cut-out areas84,85,86,87and88(with only areas84and86labeled inFIG.7with respect to first arm70for ease of illustration) in a coupling or intermediate portion90of the first wall12a. In the illustration being described, the second arm72comprises the elongated portion72athat joins the free end or detent end72band the coupling or fixed end72cwhich couples or joins the second arm72to the coupling or intermediate portion90. For example, the first implant member12was machined and cut-out areas84,85,86,87and88were machined or cut out to define the second aperture62and its associated second arm72, as best illustrated inFIG.7. The first arm70extends from a first side wall surface12a1toward the generally opposing second side wall surface12a2as best illustrated inFIGS.7-10. Likewise, the second arm72is configured similarly except that it extends upward and toward the reader (as viewed inFIG.7) from the first side wall surface12a1toward an opening62aof the aperture62as illustrated. Notice that the second arm72has the coupling or fixed end72cthat is coupled to or integrally formed in the coupling or intermediate portion90and angles upward in the aperture62(as viewed inFIGS.5,7and8) toward the second side wall surface12a2. In contrast, note that the first arm70has its fixed end70ccoupled to or integral with the coupling or intermediate portion90and extends or projects in the aperture60and angles downward (as viewed inFIGS.5,7and8) from the first side wall surface12a1toward the second side wall surface12a2. Thus, it should be appreciated that in this embodiment, the first and second arms70and72diverge as they extend or project away from the coupling or intermediate portion90associated with the first side wall surface12a1. Advantageously, each of the first and second arms70and72, therefore, extend from the posterior first side wall surface12a1toward the anterior second side wall surface12a2. Thus, as the first and second arms70and72extend or project from the coupling or intermediate portion90, they not only generally diverge from each other, but they also generally diverge, project or extend away from both the imaginary plane IP and the coronal plane CP, as illustrated inFIGS.9and10. It is important to note, however, that their axes, namely axes AA1and AA2, are generally parallel to their respective bore or aperture axes A1and A2, respectively. This is best shown inFIG.3. As illustrated in the Figures, after the implant assembly10is implanted, for example, between the first and second vertebrae or bones17and19(FIG.4) in the implant receiving area15, the first side wall surface12a1becomes situated posterior relative to the second side wall surface12a2. Each of the first and second arms70and72are located in the apertures60and62and extend or project in the apertures60and62toward the second side wall surface12a2as mentioned, and their respective free ends or detent ends70b,72bbecome operatively positioned and associated with openings60aand62ainto the apertures60and62, respectively. Thus, it should be appreciated that the fixed ends70cand72cof the first and second arms70and72are integral with or coupled to the coupling or intermediate portion90and extend interiorly in the at least one or a plurality of apertures60and62, respectively, as shown. In the illustration being described, this configuration causes the free end or detent end70b,72bof the first and second arms70and72, respectively, to be operatively positioned relative to the entry opening, such as openings60aand62a, into the at least one or plurality of apertures60and62. It should be understood that this design is advantageous because it maximizes use of available space by placing the first and second arms70and72inside the apertures60and62, respectively, as opposed to outside the aperture (such as on the second side wall surface12a2). As best illustrated inFIGS.4-6, after the implant assembly10is implanted in the implant receiving area15, a screw, such as screw50or screw52, can be inserted or received in the apertures60,62, respectively, and ultimately screwed into the bones17and19, respectively. Note that the free ends or detent ends70band72bare engaged by the screw heads50aand52a, respectively, and are actuated or driven away from their respective axes A1and A2. For example, when screw head50aengages the free end or detent end70b, it is driven or moves in the direction of arrow A inFIG.5in response to the axial movement of the screw50as it is screwed into the first vertebra or bone17(FIGS.4and5). Each free end or detent end70band72bcomprises a generally U-shaped detent70b1(FIGS.4,6A and11) and72b1, respectively. Although the generally U-shaped detent70b1and72b1are shown situated at the free ends or detent ends70band72b, it should be understood that they could be positioned at other positions or locations on the first and second arms70and72, respectively. The detents70b1and72b1define receiving areas or locking channels70b1iand72b1i, respectively, and each comprise or define a pawl or latch70d,72das best illustrated inFIG.7. As the screws50and52are driven axially into the apertures60and62, respectively, when the screws50and52are screwed into the first vertebra or bone17(FIG.4) and the second vertebra or bone19, the first and second arms70and72move or deflect until latches70dand72dclear top edges50a1iand52a1iof the generally circular wall portions50a1and52a1(FIG.1) of the screws50and52, respectively, whereupon the resilient first and second arms70and72cause the detents70b1and72b1move back toward their home position toward the axes A1and A2of the apertures60and62, respectively. For example, the detent70b1moves in the direction of arrow B inFIG.6toward the axis A1. This causes the latches70dand72dto become operatively positioned so that the receiving areas or locking channels70b1iand72b1i, respectively, become generally aligned with, and adapted to receive, the generally circular wall portions50a1and52a1, respectively, as shown inFIGS.1and2. After the detents70b1and72b1“clear” the wall portions50a1and52a1, the screws50and52may be backed out or unscrewed slightly until the top surfaces50a1iand52a1iengage the surface70d1(FIG.4) and72dl, respectively, thereby causing the wall portions50a1and52a1to be captured in the channels70b1iand72b1i, respectively. Note that the wall portions50a1and52a1comprise a thickness that is slightly smaller than a width W (FIG.6A) of the channels70b1iand72b1i. The screws50and52become locked or retained in the implant assembly10so that they cannot withdraw therefrom or from the first and second vertebrae or bones17and19, thereby locking the screws50and52in the implant assembly10. If it is desired to remove the screws50and52, the first and second arms70and72can be manually deflected to the open position (e.g., first arm70can be actuated in the direction of arrow A inFIG.5) and the screws50and52unscrewed from the first and second vertebrae or bones17and19, respectively. Although not shown, a generally L-shaped detent may be used with the free ends if, for example, the screws50and52did not have the wall portions50a1and52a1. Advantageously, the generally U-shaped capturing detents70b1and72b1are adapted to prevent the screws50and52from withdrawing from the implant assembly10. This design also facilitates preventing the first and second arms70and72from splaying or moving away from their respective axes AA1and AA2, respectively. Notice inFIG.4that overhang wall portions70b3and72b3of detents70b1and72b1, respectively, are generally arcuate or curved and generally complement or match a shape of an inner curved surface50cand52cof the screws50and52, as shown inFIGS.1,2and4-6. In the illustration being described, the detent70b1is defined by and located on the free end or detent end70band detent72b1is defined by and located on the free end or detent end72b. As described, the detents70b1and72b1are generally U-shaped as shown inFIG.6A, but it should be understood that they could assume other shapes or configurations. As mentioned earlier, each of the first and second arms70,72are defined by machining the first wall12aof the first implant member12as mentioned. The free ends or detent ends70b,72band their respective detents70b1and72b1are also defined by machining. The detents70b1and72b1comprise beveled surfaces70b2(FIGS.1,2and4) and72b2, respectively, that are generally coplanar with the second side wall surface12a2. The free ends or detent ends70band72balso comprise generally curved or arcuate camming surfaces70b3and72b3(FIGS.1,2and7) which engage the screw heads50aand52a, respectively, when the screws50and52are driven axially into the apertures60and62as described earlier. The screws50and52cam against the surfaces70b3and72b4, respectively, which causes the free ends or detent ends70band72bto deflect away from the axes A1and A2, respectively. Again, it should be noted that the resilient first and second arms70,72are urged away from their respective bores or apertures60and62and away from the axes A1and A2in response to the axial movement of the screws50and52in the bores or apertures60and62. It should be understood that the elongated portion, such as the elongated portion70aof first arm70and elongated portion72aof second arm72, are in communication with at least one of the plurality of apertures60,62, respectively, and notice that they facilitate defining at least a portion of the boundary of the bores or apertures60,62, respectively. For example, note relative to the first arm70inFIG.7, the surface71facilitates defining a portion or boundary of the bore or aperture60. As shown inFIG.7, walls64and66comprise seats64aand66a, respectively. The seats64aand66aare adapted to receive and support the heads50aand52aof the screws50and52, respectively, after the screws50and52are screwed into bone. Although the embodiment being described shows a pair of apertures, namely apertures60and62, it should be appreciated that more or fewer apertures could be used. Also, it should be understood that the locking system49of the embodiments shown and described could be used with other types of implants, such as plates, cages, spinal implants, bone implants, fusion devices and the like. Referring back toFIG.7, note that the coupling or intermediate portion90is an integral construction in the first wall12aand it integrally joins and couples the fixed ends or coupling ends70cand72cas shown. The coupling or intermediate portion90is situated between the first and second arms70and72and facilitates and enables the first and second arms70and72to extend from the first side wall surface12a1toward the second side wall surface12a2so that the first and second arms70and72can extend or project into the apertures60and62, respectively. This configuration also enables the free ends or detent ends70band72bto become operatively associated with openings60aand62a, respectively, into the apertures60and62as mentioned earlier. Advantageously, the coupling or intermediate portion90is generally situated or located between the pair of apertures60and62as shown. As illustrated inFIGS.9and10, the first and second side wall surfaces12a1and12a2are generally perpendicular to the imaginary plane IP and generally parallel to the coronal plane CP. As mentioned earlier herein, the axes AA1and AA2of the first and second arms70and72diverge (as illustrated inFIGS.7,9and10), and they are generally not parallel to either the imaginary plane IP or the coronal plane CP. Indeed and as mentioned earlier herein, the axes AA1and AA2of the first and second arms70and72form acute angles Θ, Φ and X, Y, respectively, of generally less than about 45 degrees with respect to the imaginary plane IP and coronal plane CP. In a preferred embodiment the angles Θ and Φ are between about 20-70 degrees and angles X and Y are between about 20-70 degrees. For example, note that the angles Θ and X inFIG.9, which shows the angles between the imaginary plane IP and the coronal plane CP and the longitudinal axis AA1of the first arm70, is less than about 45 and 70 degrees, respectively. Again, and as mentioned earlier herein, this axis AA1and the imaginary plane IP and the coronal plane CP are generally not parallel, but axis AA1and axis A1of the aperture60are generally parallel. Likewise, and as shown inFIG.10, the axis AA2is not generally parallel to the imaginary plane IP and the coronal plane CP, but it is generally parallel to the axis A2, which is the axis of the aperture62. The free ends or detent ends70band72bextend between the first and second side wall surfaces12a1and12a2as shown. Indeed, a majority, if not all, of the first and second arms70and72, including their respective elongated portions70aand72a, are in communication with and lie in and project or extend a substantial or majority of a length of the apertures60and62. After the screws50and52are received in the apertures60and62, note that their axes become generally co-axial with the axes A1and A2, respectively, of apertures60and62. The axes of the screws50and52also become generally parallel to the axes AA1and AA2, respectively, of the first and second arms70and72. Advantageously, the configuration of the screw locking system49described herein associates the fixed end or coupling end70cand72cwith exit areas60band62b, respectively, of the apertures60and62and the free ends or detent ends70band72bwith the openings60aand62ainto the apertures60and62. During use, the first and second implant members12and14are assembled by sliding the projection18into the channel22. The generally U-shaped projection18is guided into the channel22until the holes or bores40and42become generally aligned with the holes or bores28,34and30,36, respectively. Once they become aligned, the pins44and46, can be inserted as illustrated inFIGS.7-10, and the first implant member12and second implant member14become locked together to provide the implant assembly10. The generally U-shaped projection18cooperates with the first wall12ato define a fusion material receiving area73(FIG.3). This fusion material receiving area73is filled with a fusion or graft material by the user. The implant assembly10is situated between the first and second vertebrae or bones17and19in the implant receiving area15as generally illustrated inFIG.4. In this assembled position, the surface18aof the projection18becomes generally coplanar with the generally U-shaped third wall portion20cas shown inFIG.7. After the implant assembly10is positioned in the implant receiving area15, the screws50and52are guided into the apertures60,62, respectively, and screwed into the first and second vertebrae or bones17and19until the channels70b1iand72b1ibecome operatively associated with and positioned generally opposed to the wall portions50a1and52a1, respectively, as described earlier herein. As mentioned earlier, after the screws50and52“clear” their respective detents70b,72b, the first and second arms70,72urge the detents70b,72bto their home position, whereupon the channels70b1iand72b1ibecome operatively associated or positioned in opposed relationship to the wall portions50a1and52a1, respectively. The user may optionally unscrew or back out the screws50and52enough to cause the wall portions50a1and52a1to be captured in their respective generally U-shaped channel70b1ior72b1i. The implant assembly10becomes screwed and locked in the implant receiving area15, thereby preventing the first implant member12separating from the second implant member14, facilitating preventing the screws50and52from unscrewing, and also preventing the implant assembly10from expulsion or withdrawing from the implant receiving area15once the screws50and52are locked in the apertures60and62by the detents70b1and72b1, respectively. If the screws50and52expel or unscrew, the wall portions50a1and52a1will be captured in the channels70b1iand72b1i, respectively. Advantageously, the implant assembly10comprises the screw locking system49which facilitates preventing at least one or a plurality of screws, such as screws50and52, from withdrawing from the implant assembly10. Although the apertures60and62and their associated first and second arms70and72, respectively, are shown as extending in diverging directions as described earlier, it should be understood that the apertures60,62and the first and second arms70,72could be arranged differently. For example, they could be arranged so that the axes AA1and AA2are generally parallel, extend in the same direction but diverge or converge in a common horizontal or vertical plane, extend in different directions and diverge, as illustrated inFIGS.1-10, but with angles Θ, X (FIG.9) and Φ, Y (FIG.10) that are different, or the like. An important feature, however, is that the at least one or a plurality of the apertures have the screw locking system49in the form of at least one or a plurality of arms, such as one or more of the first and second arms70,72, respectively, and the arm axes, such as the axes AA1and AA2of the first and second arms70and72, respectively, are generally parallel with the aperture axes, such as the axes A1and A2of the apertures60and62. Note that a majority of the first and second arms70and72, including the elongated portions70a,72a, are situated in the apertures60and62, respectively. Another feature is that the first and second arms70,72are situated in the apertures which is advantageous because of space and size constraints associated with the second side wall surface12a2. Situating a majority or all of the first and second arms70,72in the apertures60,62, respectively, enables the use of the first and second arms70and72. In one embodiment, the first and second implant members12and14are made of different materials, such as PEEK and titanium, with the second implant member14having a modulus of elasticity similar to bone. FIG.12shows another embodiment wherein the implant assembly10″ is an integral, one-piece body17″ construction, rather than the two-piece construction shown inFIG.1. In this embodiment, like parts are identified with the same part numbers, except that a double prime mark (“″”) has been added to the part numbers. In one embodiment, the implant assembly10″ is a monolithic construction machined from titanium. Notice it has the locking system49″ the same or similar to the embodiment ofFIGS.1-11. While the system, apparatus and method herein described constitute preferred embodiments of this invention, it is to be understood that the invention is not limited to this precise system, apparatus and method, and that changes may be made therein without departing from the scope of the invention which is defined in the appended claims. | 26,788 |
11857435 | DETAILED DESCRIPTION OF THE INVENTION Hereinafter, the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art to which the present invention pertains can easily implement the present invention. However, the present invention may be implemented in various ways and is not limited to the embodiments described herein. In order to clearly describe the present invention, parts irrelevant to the description are omitted. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. In addition, the terms or words used in the specification and claims should not be construed as being limited to conventional or dictionary meanings, but should be interpreted as having meanings and concepts consistent with the technical spirit of the present invention based on the principle that the inventor may appropriately define concepts of the terms in order to describe his or her invention in the best mode. FIGS.1A-1Bare views showing the overall appearance of an angle-expandable spinal cage according to an embodiment of the present invention, andFIG.2is a view showing the exploded state of each component of the angle-expandable spinal cage according to the embodiment of the present invention. FIG.1Ais a view showing the state before the angle of the angle-expandable spinal cage according to the embodiment of the present invention is increased, andFIG.1Bis a view showing the state after the angle of the angle-expandable spinal cage according to the embodiment of the present invention is increased. As shown inFIGS.1A-1B, the angle-expandable spinal cage according to the present invention includes an upper plate100, a lower plate200, a frame300, a block400, and a driving bolt500. The upper plate100is disposed at the upper portion of the frame300, and the lower plate200is disposed at the lower portion of the frame300. A plurality of teeth are formed on the upper surface of the upper plate100and the lower surface of the lower plate200. Here, the plurality of teeth dig into an upper vertebral body and a lower vertebral body so that the spinal cage has a constant fixing force between the vertebral bodies. The plurality of teeth allow the spinal cage to stably maintain the position thereof at the initial stage of spinal fusion procedures. Each of the upper plate100and the lower plate200has a hollow formed therein. The hollow is filled with an autograft, allograft, or synthetic bone to accelerate bone growth. In the embodiment, the upper plate100, the lower plate200, and the frame300are together formed in a long bullet shape in the forward-and-rearward direction, but are not limited thereto. The same may be formed in various shapes such as a flat shape, a curved shape, or a disk shape. The frame300is disposed between the upper plate100and the lower plate200. Specifically, the frame300includes a front part310having a front hole311formed therein, a connection part320extending in the longitudinal direction from the rear end of the front part310, and a rear part330coupled to the rear end of the connection part320. A pair of connection parts320is provided, and an internal space321is defined between the pair of connection parts320in the longitudinal direction. The block400is disposed between the upper plate100and the lower plate200, and is disposed in front of the frame300. The driving bolt500has the rear end thereof connected to the frame300and the front end thereof connected to the block400. The distance between the block400and the frame300may be increased or decreased by rotating the driving bolt500. The driving bolt500is formed of a bolt body510, having male threads511formed on the outer circumferential surface thereof, and a bolt head520formed at the end of the bolt body510, the bolt head520having a diameter larger than that of the bolt body510. The front end of the bolt body510is rotatably inserted into a block hole411in the block400to be movable forwards and rearwards, and the bolt head520is accommodated in the front hole311in the frame300to pull the frame300forwards and rearwards. Normally, when the driving bolt500moves rearwards, the frame300also moves rearwards, and the upper plate100and the lower plate200maintain a minimum angle therebetween, as shown inFIG.1A. After the angle-expandable spinal cage is implanted into an affected area and the driving bolt500is moved forwards, the frame300also moves forwards, thereby moving the upper plate100and the lower plate200forwards. Accordingly, as shown inFIG.1B, the angle of each of the upper plate100and the lower plate200with respect to the frame300is increased, thereby making it possible to increase the angle between the vertebral bodies. As described above, according to the present invention, the angle-expandable spinal cage may be implanted into the affected area while occupying the minimum angle thereof and may then be expanded between the vertebral bodies, thereby having an effect of being usefully used for minimally invasive surgery. FIG.3is a view showing the block according to the embodiment of the present invention, seen from the front,FIG.4is a view showing the block according to the embodiment of the present invention, seen from the rear,FIGS.5A-5Bare views showing a portion at which the upper plate and the block according to the embodiment of the present invention are in contact with each other, andFIGS.6A-6Bare views showing a portion at which the lower plate and the block according to the embodiment of the present invention are in contact with each other. As shown in the drawing, the block400includes a block body410having the block hole411formed in the center thereof, a first inclined part420coupled to one side of the block body410, the first inclined part420having a first inclined surface421inclined at a predetermined inclination angle, a second inclined part440coupled to the other side of the block body410, the second inclined part440having a second inclined surface441inclined at a predetermined inclination angle, a first inclined accommodation groove430formed between the block body410and the first inclined part420, the first inclined accommodation groove430inclined at a predetermined inclination angle, and a second inclined accommodation groove450formed between the block body410and the second inclined part440, the second inclined accommodation groove450inclined at a predetermined inclination angle. The block body410is formed in a hexahedral shape overall, and the block hole411is formed through the center of the block body410in the forward-and-rearward direction. The bolt body510of the driving bolt500is accommodated in the block hole411. A front inclined surface412oriented at a predetermined angle relative to the center of the block body410is formed on the front surface of the block body410. The first inclined part420is coupled to the left side of the block body410and the second inclined part440is coupled to the right side of the block body410. The first inclined part420is formed in an inverted triangle shape so that the first inclined surface421is inclined downwards and forwards at a predetermined inclination angle, and the second inclined part440is formed in a triangular shape so that the second inclined surface441is inclined upwards and forwards at a predetermined inclination angle. The first inclined accommodation groove430is formed between the block body410and the first inclined part420, and the second inclined accommodation groove450is formed between the block body410and the second inclined part440. The first inclined accommodation groove430is formed to be inclined upwards and forwards at a predetermined inclination angle, and the second inclined accommodation groove450is formed to be inclined downwards and forwards at a predetermined inclination angle. That is, the first inclined surface421and the second inclined surface441are formed to have inclination angles in opposite directions to each other, and the first inclined accommodation groove430and the second inclined accommodation groove450are formed to have inclination angles in opposite directions to each other. In this case, it is preferable that the first inclined surface421of the first inclined part420and the second inclined accommodation groove450be disposed parallel to each other, and that the second inclined surface441of the second inclined part440and the first inclined accommodation groove430be disposed parallel to each other. The first inclined part420or the second inclined part440has a restraint hole422or442formed therein. As shown inFIGS.1A-1B, a restraint pin460may be inserted into the restraint hole422or442, and the restraint pin460may be oriented in the transverse direction between the first inclined part420or the second inclined part440and the block body410. A long hole120or220, which is elongated in the vertical direction, is formed in a side portion of the upper plate100or the lower plate200so as to be aligned with the position of the restraint pin460. The restraint pin460is slidably inserted into and accommodated in the long hole120or220. Accordingly, the vertical angle that the upper plate100or the lower plate200is capable of forming may be limited. When the restraint pin460is located at the lowermost end of the long hole120in the upper plate100, the upper plate100has the maximum angle; that is, the upper plate100is raised as far as possible. FIG.5Ais a view showing a portion at which the upper plate and the block according to the embodiment of the present invention are in contact with each other, seen from the left side,FIG.5Bis a view showing a portion at which the upper plate and the block according to the embodiment of the present invention are in contact with each other, seen from the right side,FIG.6Ais a view showing a portion at which the lower plate and the block according to the embodiment of the present invention are in contact with each other, seen from the right side, andFIG.6Bis a view showing a portion at which the lower plate and the block according to the embodiment of the present invention are in contact with each other, seen from the left side. As shown inFIGS.5A-5B, the upper plate100has a first upper protrusion110coupled thereto on the left side thereof, the first upper protrusion110being accommodated in the first inclined accommodation groove430. Further, the upper plate100has a second upper protrusion130coupled thereto on the right side thereof, the second upper protrusion130being in contact with the second inclined surface441of the second inclined part440. As described above, each of the first inclined accommodation groove430and the second inclined surface441is inclined upwards and forwards at a predetermined inclination angle. Accordingly, when the frame300moves forwards and the distance between the block400and the frame300is decreased, the front end of the upper plate100moves forwards and upwards, and the angle of the upper plate100with respect to the frame300is increased. As shown inFIGS.6A-6B, the lower plate200has a second lower protrusion230coupled thereto on the right side thereof, the second lower protrusion230being accommodated in the second inclined accommodation groove450. Further, the lower plate200has a first lower protrusion210coupled thereto on the left side thereof, the first lower protrusion210being in contact with the first inclined surface421of the first inclined part420. As described above, each of the second inclined accommodation groove450and the first inclined surface421is inclined downwards and forwards at a predetermined inclination angle. Accordingly, when the frame300moves forwards and the distance between the block400and the frame300is decreased, the front end of the lower plate200moves forwards and downwards, and the angle of the lower plate200with respect to the frame300is increased. FIG.7is a view showing the frame according to the embodiment of the present invention,FIGS.8A-8Bare views showing the state in which the rear ends of the upper plate and the lower plate according to the embodiment of the present invention are disassembled from the frame,FIG.9is an enlarged view showing an upper hinge part of the upper plate and an upper hinge groove of the frame according to the embodiment of the present invention,FIG.10is a view showing a process in which the upper hinge part according to the embodiment of the present invention is coupled into the upper hinge groove, andFIG.11is a view showing the state in which the upper hinge part according to the embodiment of the present invention is completely coupled into the upper hinge groove. FIG.8Ais a view showing the state in which the upper hinge part of the upper plate according to the embodiment of the present invention is disassembled from the upper hinge groove of the frame, andFIG.8Bis a view showing the state in which a lower hinge part of the lower plate according to the embodiment of the present invention is disassembled from a lower hinge groove of the frame. As shown in the drawings, the frame300includes the front part310, the connection part320, and the rear part330. The front hole311is formed in the center of the front part310in the longitudinal direction (the forward-and-rearward direction), and bolt head520of the driving bolt500is rotatably inserted into the front hole311. A fusion passage312is formed in the upper surface of the front part310, the lower surface thereof, or both the upper and lower surfaces thereof. The fusion passage312provides a passage to allow autogenous bone, allograft bone, or synthetic bone to pass therethrough. The connection part320extends rearwards from the rear end of the front part310. In the embodiment, a pair of connection parts320is provided, but the number thereof is not limited thereto. The internal space321is defined between the pair of connection parts320. The rear part330is coupled to the rear end of the connection part320. A frame penetration hole331is formed in the center of the rear part330in the longitudinal direction (the forward-and-rearward direction), and the frame penetration hole331is connected to the internal space32. A mechanism-coupling groove332is formed to be recessed into a side portion of the rear part330. The mechanism-coupling groove332allows the frame300to be coupled to a predetermined mechanism. In the embodiment, each of the mechanism-coupling grooves332is formed in a corresponding one of opposite sides of the rear part330, but the present invention is not limited thereto. As shown inFIGS.8A-8B, at least one upper hinge groove340and at least one lower hinge groove350are formed to be recessed into the side portion of the rear part330. The upper plate100has an upper hinge part140at the rear end thereof. Here, the upper hinge part140is formed to protrude so as to be inserted into and accommodated in the upper hinge groove340. Further, the lower plate200has a lower hinge part240at the rear end thereof. Here, the lower hinge part240is formed to protrude so as to be inserted into and accommodated in the lower hinge groove350. The upper plate100and the lower plate200are rotatable with respect to the upper hinge part140and the lower hinge part240, respectively. Specifically, as shown inFIG.9, the upper hinge groove340includes an upper curved surface part341having a curved inner surface, and an upper coupling passage part342connected to the upper portion of the upper curved surface part341. In the embodiment, only the upper hinge groove340is shown for convenience of description, but the lower hinge groove350may also include a lower curved surface part (not shown) and a lower coupling passage part (not shown) in a similar manner. Meanwhile, the upper hinge part140has an upper hinge curved surface141formed at the rear end thereof, the upper hinge curved surface141having a curved surface to correspond to the upper curved surface part341of the upper hinge groove340. In the embodiment, only the upper hinge curved surface141is shown for convenience of description, but a lower hinge curved surface (not shown) may also be formed in the lower hinge part240in a similar manner. The upper hinge curved surface141may be in contact with the upper curved surface part341of the upper hinge groove340(refer toFIG.11). Accordingly, the upper plate100may rotate with respect to the frame300along the trajectory of the upper curved surface part341. The upper hinge part140has an upper entrance part142formed on the upper surface of the rear end thereof so as to enter the upper coupling passage part342. The upper entrance part142has a flat surface. Accordingly, the rear end of the upper hinge part140including the upper hinge curved surface141and the upper entrance part142has a circular cross-section, one side of which is partially cut off. In the embodiment, only the upper entrance part142is shown for convenience of description, but a lower entrance part (not shown) may also be formed in the lower hinge part240in a similar manner. As shown inFIG.10, the width A of the upper entrance part142is formed to be equal to or smaller than the width B of the upper coupling passage part342, and the width B of the upper coupling passage part342is formed to be smaller than the maximum width C of the upper curved surface part341. Since the width B of the upper coupling passage part342is formed to be smaller than the maximum width C of the upper curved surface part341, the upper hinge part140may enter the upper coupling passage part342only in the direction of the upper entrance part142, and may not enter the same in another direction. That is, the upper hinge part140may enter the inside of the upper coupling passage part342only when the upper plate100is disposed at an angle of approximately 90 degrees with respect to the frame300, in which state the upper entrance part142is in contact with the upper coupling passage part342. As shown inFIG.11, after the upper entrance part142passes through the upper coupling passage part342and is disposed inside the upper curved surface part341, the upper plate100is disposed substantially parallel to the frame300, and the upper hinge curved surface141is in contact with the upper curved surface part341. In this case, as described above, the maximum width C of the upper curved surface part341is formed to be larger than the width B of the upper coupling passage part342. Accordingly, unless the upper plate100is disposed at the angle of approximately 90 degrees with respect to the frame300, the upper hinge part140may not pass through the upper coupling passage part342and may not be separated therefrom. That is, the upper hinge part140remains held in the upper curved surface part341. FIG.12is a view showing a driving bolt according to the embodiment of the present invention,FIG.13is a partial cross-sectional view showing the state in which the driving bolt according to the embodiment of the present invention is inserted into the block,FIG.14is a view showing a fixing ring according to the embodiment of the present invention,FIG.15is a view showing the state in which the fixing ring is coupled to the driving bolt according to the embodiment of the present invention,FIG.16is a view showing a fixing cap according to the embodiment of the present invention,FIGS.17A-17Bare partial cross-sectional views showing the state in which the fixing cap according to the embodiment of the present invention is inserted into the frame,FIG.18is a partial cross-sectional view showing the state in which the fixing end of the fixing cap according to the embodiment of the present invention is in contact with and supported by the front end,FIG.19is a cross-sectional view showing the state in which the angle of each of the upper plate and the lower plate according to the embodiment of the present invention with respect to the frame is increased, andFIG.20is a cross-sectional view showing the state in which the angle of each of the upper plate and the lower plate according to the embodiment of the present invention with respect to the frame is decreased. As shown in the drawings, the driving bolt500includes the bolt body510, the bolt head520, and a fixing groove530. The bolt body510is formed in a cylindrical shape, and has the male threads511formed on the outer circumferential surface thereof. The bolt head520is coupled to the rear end of the bolt body510, and has a diameter larger than that of the bolt body510. The fixing groove530is formed between the bolt body510and the bolt head520, and has a diameter smaller than that of the bolt body510. As shown inFIG.13, the block400has the block hole411formed in the center thereof in the longitudinal direction (the forward-and-rearward direction), and the block hole411has female threads411aformed on the inner surface thereof so as to be engaged with the male threads511of the driving bolt500. When the driving bolt500is rotated, the male threads511of the driving bolt500are engaged with the female threads411aof the block hole411. Accordingly, the driving bolt500and the frame300connected thereto may move forwards or rearwards in the direction of the block400. As shown inFIGS.14and15, a fixing ring540is coupled to the fixing groove530. The fixing ring540is formed in a ‘C’ shape with one side thereof open, and may be inserted into and accommodated in the fixing groove530, or may be separated from the fixing groove530. When the fixing ring540is coupled to the fixing groove530, the rear surface of the fixing ring540is in contact with the front surface of the frame300. The bolt head520, having a diameter larger than that of the bolt body510, is accommodated in the frame300, and the fixing ring540is in contact with the front surface of the frame300. Accordingly, the driving bolt500is rotatably coupled to the frame300to pull the frame300. As shown inFIGS.16and17, a fixing cap550to come into contact with the rear end of the bolt head520may be further accommodated in the front hole311in the front part310in the frame300so as to be rotatable therein. FIG.17Ais a partial cross-sectional view showing the state in which the fixing cap according to the embodiment of the present invention is in contact with the rear end of the bolt head, andFIG.17Bis a partial cross-sectional view showing the state in which the fixing cap according to the embodiment of the present invention rotates to come into close contact with the rear end of the bolt head. A bolt inclined surface521inclined at a predetermined inclination angle is formed at the rear end of the bolt head520. A fixing inclined surface551is formed at the front end of the fixing cap550to come into contact with the rear end of the bolt head520, the fixing inclined surface551being formed so as to correspond to the shape of the bolt inclined surface521. When the angle of each of the upper plate100and the lower plate200with respect to the frame300is set by operating the driving bolt500as shown inFIG.17A, the fixing inclined surface551presses the bolt inclined surface521by rotating the fixing cap550inserted into the front hole311, and the fixing inclined surface551and the bolt inclined surface521are kept in close contact with each other, as shown inFIG.17B. Accordingly, the driving bolt500is firmly fixed without loosening. In this case, the fixing cap550includes a fixing hole552opening in the longitudinal direction (the forward-and-rearward direction) of the frame300, and a plurality of fixing rotation grooves553are recessed into a side portion of the fixing cap550so as to hold and rotate the fixing cap550. In the embodiment, the number of fixing rotation grooves553is four, but the number thereof is not limited thereto. A fixing end554is formed to protrude in the shape of a ring from the side portion of the fixing cap550. As shown inFIG.18, the fixing end554is in contact with and supported by a front end311aformed to protrude from the inside of the front hole311. Accordingly, the fixing cap550is prevented from becoming separated from the front hole311. The operation process of the angle-expandable spinal cage according to the present invention will be described. As shown inFIG.19, when the driving bolt500is moved forwards by rotating the driving bolt500, the frame300coupled to the driving bolt500also moves forwards. When the frame300moves forwards, the upper plate100and the lower plate200also move forwards. When the upper plate100and the lower plate200move forwards, the first upper protrusion110and the second upper protrusion130of the upper plate100move forwards and upwards in the state of remaining in contact with the first inclined accommodation groove430and the second inclined surface441, respectively, and the first lower protrusion210and the second lower protrusion230of the lower plate200move forwards and downwards in the state of remaining in contact with the first inclined surface421and the second inclined accommodation groove450, respectively. Accordingly, the angle of each of the upper plate100and the lower plate200with respect to the frame300is increased. On the other hand, as shown inFIG.20, when the driving bolt500is moved rearwards by rotating the driving bolt500, the frame300coupled to the driving bolt500also moves rearwards. When the frame300moves rearwards, the upper plate100and the lower plate200also move rearwards. When the upper plate100and the lower plate200move rearwards, the first upper protrusion110and the second upper protrusion130of the upper plate100move rearwards and downwards in the state of remaining in contact with the first inclined accommodation groove430and the second inclined surface441, respectively, and the first lower protrusion210and the second lower protrusion230of the lower plate200move rearwards and upwards in the state of remaining in contact with the first inclined surface421and the second inclined accommodation groove450, respectively. Accordingly, the angle of each of the upper plate100and the lower plate200with respect to the frame300is decreased. As is apparent from the above description, an angle-expandable spinal cage of the present invention having the above-described configuration has an effect of making it possible to increase or decrease the angle of each of an upper plate and a lower plate with respect to a frame by adjusting the distance between a block and the frame. In other words, according to the present invention, the angle-expandable spinal cage may be implanted into an affected area of a patient suffering from a spinal injury in the state in which the angle of each of the upper plate and the lower plate with respect to the frame is reduced to the minimum angle, and the angle of the angle-expandable spinal cage may be expanded in the affected area, thereby having an effect of being usefully used for minimally invasive surgery. Although preferred embodiments of the present invention have been disclosed for illustrative purposes, those skilled in the art will appreciate that various modifications, additions and substitutions are possible, without departing from the scope and spirit of the invention as disclosed in the accompanying claims. | 27,203 |
11857436 | DETAILED DESCRIPTION OF THE INVENTION The implants in one embodiment of this invention are designed for spinal fusion procedures. Surgical spacers exist in the art. U.S. Pat. No. 5,702,449, which is hereby incorporated by reference in its entirety, teaches an implant with a body and a sleeve where the sleeve is composed of material that is stronger under compressive loads than the body. U.S. Pat. Appl. Publ. No. 2009/0012620 A1, which is hereby incorporated by reference in its entirety, teaches an implantable intervertebral device made of bone with a cavity extending throughout the body that is filled with osteoconductive or osteoinductive graft material. U.S. Pat. Appl. Publ. No. 2014/0142708A, which is hereby incorporated by reference in its entirety, teaches a surgical implant designed to conform to the adjacent endplates such that cutting and manipulation of bone is minimized. Several methods to promote bone growth have also been tried. U.S. Pat. No. 9,987,051 B2, which is hereby incorporated by reference in its entirety, teaches a surgical implant with a cavity that increases in width at a medial position and includes a plurality of orifices. U.S. Pat. Nos. 6,123,705 and 6,447,547, each of which are hereby incorporated by reference, teach perforated implants. Although these patents describe implants and methods for promoting bone growth and healing, it remains a slow process which does not always end up in the successful securing of one bone surface to another. In one embodiment of the invention, there is provided as shown inFIG.1Aa surgical implant110comprising a body105having a peripheral section102and at least one central opening101extending into the body105, and at least one porous insert120inserted into the central opening(s)101, with the porous insert120having its own vertical (or axially extending) opening(s)121. Threaded opening127extends through the front face of the peripheral section102and allow the attachment of an insertion device. The peripheral section102can serve as the primary load bearing member. In one embodiment of the invention, the body105has at least one interior surface106, and the porous insert120is comprised of a porous material, and has therein an axially-extending hole121. The porous insert120is attached to the body105along the at least one interior surface106such that the porous material extends across a height of the body, and preferably does not extend beyond an uppermost surface of body105. In one embodiment of the invention, the porous insert120has a locking mechanism formed therein or extending therefrom which is configured to prevent the porous insert120from moving within the body. In one embodiment of the invention, the porous insert120has a plurality of interconnected holes extending throughout a section of the porous insert. The interconnected holes are of a predefined size. In one embodiment of the invention, the interconnected holes extend linearly across a section of the porous insert. In one embodiment of the invention, the interconnected holes extend linearly and diagonally across a section of the porous insert. In one embodiment of the invention, the interconnected holes are of a predefined size. For example, the interconnected holes can have a width or diameter between 100 to 1000 microns, 200 to 800 microns, 250 to 700 microns, and/or 300 to 600 microns (or any intervening ranges or values in between). These sizes of the interconnected holes may (after insertion into a patient and if conditions are favorable) promote bone growth in the porous insert120. As used herein, predefined means that the holes are created or the porous implant is selected such that the holes are of a standard or nominal (average) size typically, but not necessarily, formed by an engineering process making the holes by lithography, etching, machining, or printing (three-dimensional printing) determined by the characteristics of the engineering process. The porosity of the porous insert120ranges from 20 to 70%, or from 30 to 50%, or from 40 to 45%, and includes intermediate and overlapping ranges of these porosities. Body105may be formed of various metals such as for example cobalt chrome, stainless steel or titanium including its alloys, various plastics including those which are bio-absorbable, and various ceramics or combinations of these materials. In one embodiment, body portion105is made of medical grade PEEK (Polyetheretherketone may comprise 5% to 75% carbon fibers by weight percent. In one embodiment the insert120has locking mechanisms123and125, at least one of which has shown is formed in the insert120. In this embodiment, recess123formed in the insert120is configured to receive locking pin125which extends through hoke129in body portion105, as shown in the sectional and perspective view ofFIGS.1B and1C. This locking mechanism prevents insert120from moving once it is disposed in the body105. Insert120, as would be understood by one with skill in the art, is not limited by shape. Insert120could have any regular geometrical shape (square, rectangular, circular) or any irregular shape without leaving the contemplated nature of the invention. In an embodiment the body105is tapered such that the body105has a distal end with a smaller height than a proximal end. In an embodiment the body105is composed of peak or modified peak. The peak composing body105may comprise 5% to 75% carbon fibers by weight percent. Body105may have at least one rounded edge. This rounded edge may extend laterally along either the posterior or anterior side of body105. Body105may or may not be grooved as shown inFIG.1A. In an embodiment insert120is composed of porous titanium. Although described with here with respect to pure titanium, titanium alloys such as titanium-6 aluminium-4 vanadium or other metals such as zirconium may be used. In another embodiment, insert120is composed of porous titanium but with an outer layer of titanium dioxide. The outer layer of titanium dioxide could be formed by exposing insert120to air or artificially produced by exposing insert body120to high temperatures, an oxidizing gas, strong oxidants in a wet chemical environment, or through an electrochemical process such as anodic oxidation. In another embodiment, insert120is 3-D printed through laser sintering or any process known in the art.FIG.1Dis a photographic depiction of a porous surface120aof a three-dimensionally printed porous insert120. In this example, an edge section120bof the porous insert120forming a part of a frame120con the perimeter can have a different porosity that an interior section120cof porous insert120. In this example, an edge section120bof the porous insert120has a lower porosity than the interior section102c. and may be a solid material. As depicted, insert102may have a tapered section120dmade of a solid material, with the tapering facilitating insertion between vertebrae. Accordingly, in one embodiment, the implants110of the present invention can be composed entirely of metal with for example a solid metal frame (acting as peripheral section102for supporting the weight of the spinal column) and one or more porous sections for promotion of bone growth once the insert is implanted. Meanwhile, in one embodiment, the three dimensionally printed inserts120may be a part of implant110shown inFIG.1A, with the implant110having a body105and a peripheral section102forming a place where the porous insert120can be disposed. As examples of suitable ways to make porous insert120or other porous bodies of the invention, the techniques described in US 20190054536 (the entire contents of which are hereby incorporated in its entirety) can be used to make the porous bodies of this invention. Alternatively, the techniques described in US 20180296343 (the entire contents of which are hereby incorporated in its entirety) can be used to make the porous bodies of this invention. Insert120could also be formed through gel or other foaming techniques, molding, use of the Hunter or Kroll process, or any other method known in the art as described in US 2012/0310357 (the entire contents of which are hereby incorporated in its entirety). In one embodiment, insert120has pore sizes on the exposed surfaces on the order of approximately 400-600 μm. In other embodiments, the pore size may be between 100 to 1000 microns, 200 to 800 microns, 250 to 700 microns, 300 to 600 microns, about 0.1 mm to about 5 mm, about 0.5 mm to about 3 mm, or about 1 mm to about 2 mm (or any intervening ranges or values in between). Insert120could contain continuous pores, non-continuous pores, or a mixture of both. FIG.2Ashows a perspective view of one embodiment of the device10. In this embodiment, aperture101extends through a body105which may comprise a rounded edge201and teeth203along a surface of body105. InFIG.2A, aperture101has a first perimeter sidewall205and a second perimeter sidewall207of smaller diameter than and positioned underneath the first perimeter sidewall205. This embodiment may also include an upper insert209and lower insert211composed of a different or similar material than body105. Inserts209and211may each have a through hole221aligned with the aperture of the body105. At least one of the inserts209and211may have a flange225(i.e., an extrusion) which contacts a lateral surface adjoining the first perimeter sidewall to the second perimeter sidewall. The size of the flange225of the porous body may be slightly oversized with respect to the interior size formed first perimeter sidewall205. Similarly, the size of the vertical extrusion227of the porous body may be slightly oversized with respect to the interior size formed by second perimeter sidewall207. By having any of these extrusions oversized, the porous body once inserted is fixed inside the implant. Inserts209and211may or may not contact each other at the center of body105. Insert209may be disposed downward in the aperture and insert211may be disposed upward. FIG.2Bis a perspective view of porous insert211of the implant device ofFIG.2A. In this embodiment, vertical extrusion227of the porous insert211is made with one section231having a thinner wall than an adjacent section232.FIG.2Cis a sectional view of both halves of the porous insert of the implant device ofFIG.2A. (The upper insert209similarly has one section233having a thinner wall than an adjacent section234.) Once the inserts209and211are in place as shown inFIG.2C, a tool (not shown) can be used push the thinner wall sections231into recesses240in the body105, and thereby providing a locking mechanism for this embodiment. While as shown, the thinner wall sections231,233are themselves of the same porous material as the respective inserts209or211, the thinner wall sections231can be made of a different porous material or a non-porous material. For example, inserts209and211may be comprised of porous titanium or any of the same materials as insert body120. Like insert body120, inserts209and211could be 3-D printed, formed through gel or other foaming techniques, molding use of the Hunter or Kroll process, or any other method known in the art as described in US/2012/0310357 previously incorporated by reference. Inserts209and211can have the pore sizes noted above pores, and could contain continuous, non-continuous or a mixture of continuous and non-continuous pores. Threaded opening127extends through the front face of the peripheral section102and permits the attachment of an insertion device (not shown here). As shown inFIG.3A, body105may be composed of two complementary sections301and303. In this embodiment, insert120may engage both complementary sections301and303. Complementary sections301and303may be comprised maybe formed of the same materials as described above for body105. The embodiment shown inFIG.3Acould be assembled as where insert body120may slide longitudinally305or vertically307into place between the two complementary sections301and303. The complimentary sections can have a number of interlocking components (as described below) which form another locking mechanism of the present invention. Rods or pins309may also connect insert120to complementary sections301and303. Through holes122in the porous insert120in one embodiment form another locking mechanism of the present invention. Alternatively, complementary sections301and302may horizontally sandwich311insert120and connect using a hook and eye system. FIG.3Bshows a method of assembling the embodiment shown inFIG.3A. As shown inFIG.3B, locking extrusions310can slide around protrusions on the body portions301,303, as for example dovetail-type connectors. Also, locking extrusions310can fit into slots in the body portions301,303. Locking extrusions310in one embodiment form another locking mechanism of the present invention. Complementary sections301and303may not connect to each other as shown inFIG.4AandFIG.4B. In this embodiment complementary sections301and303connect only to insert120. Furthermore, side cut outs in complementary sections301and303may lead to the creation of cross shape401. Complementary sections301and303in the form of the cross shape40in one embodiment form another locking mechanism of the present invention. FIG.5Ashows a perspective schematic of one embodiment of the device10related to the texture of body105discussed above. As shown inFIG.5, the central opening101is surrounded by peripheral section102. A plurality of holes3are formed on exterior surfaces of the implant, for example on the top, bottom, and sides of the peripheral section102. A threaded opening127, which extends through the front face of the peripheral section102, allows the attachment of an insertion device. One threaded opening127is shown here, but the implant could be modified to work with multiple threaded openings or other types of insertion devices. FIG.5Bis an enlarged view of a peripheral section102of the implant device depicted inFIG.5Ashowing first and second rows3a,3bof holes having respective sidewalls through which interconnected openings3cextend between holes on different rows (in this embodiment). The invention is not so limited, and the interconnected openings3ccan extend between holes on the same row and/or extend to holes separated from each other over multiple rows, as illustrated inFIG.5A.FIG.5Balso shows that the holes3are blind holes formed in body5.FIG.5Balso shows all the holes3having the same diameter, but the invention is not so limited and different diameter holes can be used on different rows or along the same raw.FIG.5Balso shows all the where interconnected openings3chaving the same width and depth, but the invention is not so limited and different diameter widths and depths can be used for the interconnected openings3c. In one embodiment of the invention, holes3are formed with their central axis extending perpendicular to or within +/−10 degrees or within +/−20 degrees of or within +/−40 degrees of normal to the top or bottom surfaces of peripheral section102. Similarly, in one embodiment, the sidewalls are formed with their vertical traces extending perpendicular to or within +/−10 degrees of or within +/−20 degrees of or within +/−40 degrees of normal to the top or bottom surfaces of peripheral section102. Similarly, in one embodiment, the interconnected openings3care formed with their vertical traces extending perpendicular to or within +/−10 degrees of or within +/−20 degrees of or within +/−40 degrees of normal to the top or bottom surfaces of peripheral section2. In one embodiment of the invention, the sidewalls extend vertically downward from a top surface of the peripheral section102or extend vertically upward from a bottom surface of the peripheral section102along a constant pitch angle. In one embodiment of the invention, the sidewalls extend vertically downward from a top surface of the peripheral section102or extend vertically upward from a bottom surface of the peripheral section102along two or more constant pitch angles. In one embodiment of the invention, the sidewalls can have contoured shapes with distinct interconnecting channels extending through the body material to connect one or more the holes together. Accordingly, in one aspect of the present invention, the holes and/or the sidewalls have regular, machine-type formed surfaces with well defined angles and intersections between the surfaces of the peripheral section102with the holes. This aspect would contrast to that pores or holes etched in to the surface forming dimples on the surfaces of the peripheral section102. In one embodiment of the invention, the interconnected openings3chave a width between 100 to 1000 microns, 200 to 700 microns, 250 to 500 microns, and/or 300 to 400 microns (or any intervening ranges or values in between) for promoting bone growth in the interconnected openings3cand in the holes3. In one embodiment of the invention, the holes3have a diameter from 100 to 10,000 microns, 500 to 7000 microns, 1000 to 5000 microns, or 2000 to 3000 microns (or any intervening ranges or values in between). In one embodiment of the invention, the holes3have a depth from 100 to 1000 microns, 200 to 700 microns, 250 to 500 microns, and/or 300 to 400 microns (or any intervening ranges or values in between). Accordingly, in one embodiment of the invention, the implant comprises a body105with a peripheral section102and a central opening101that extends through the peripheral section102. First and second rows3a,3bof holes3are formed in an exterior surface of the peripheral section102. As shown inFIG.5B, the first hole has a first sidewall and defines a first cavity in the body portion while the second hole has a second sidewall and defines a second cavity in the body portion. The rows3a,3bof holes are arranged such that the first and second cavities are interconnected by interconnected openings3c. The holes3and the interconnected openings3con external surface of the implant promote bone regrowth, especially when a bone graft material is included in the holes and the interconnected openings. FIG.6is a top view of another embodiment of the device110. As shown inFIG.6, the top, sides, and bottom of the peripheral section102have a plurality of holes3, which in this embodiment are overlapping holes with the region of overlap forming interconnected opening3cas shown inFIG.5b. As shown inFIG.6, the holes have different diameters on different rows. The invention is not so limited, and the holes on different rows may have the same diameter. As shown inFIG.6, a relief4aextends into the central opening101. Also shown, recesses20and21are provided which can accommodate metal beads herein, permitting the implant to be located during a radiographic scan. FIG.7is a side view of the device shown inFIG.6. In this embodiment, the height of the distal end30is smaller than the height of the proximal end31. Similar toFIG.5andFIG.6, the bottom top and sides of the peripheral portion102of the device inFIG.7can have a plurality of interconnected holes3which are (in one embodiment) all blind holes.FIG.8shows an expanded view of the implant device ofFIG.6. Arranged in rows, the interconnected blind holes define a cross-shaped region50in this example defined by four larger blind holes51that interconnect with smaller blind holes52or53. The cross-shaped region50can be achieved by displacing the smaller blind holes52from each other by a distance greater than twice the diameter of the larger blind holes51. The cross shaped solid section55is also present in this embodiment. In this embodiment, the holes connect due to overlap of their radii. In one embodiment, this pattern of connection extends throughout the entire peripheral portion. In one embodiment, some of the holes need not overlap, but rather could be interconnected as inFIG.5Bby a separate channel formed in the body of the implant to interconnect the holes. The row arrangement and interconnecting openings (channels)61are illustrated inFIG.9A. Here, smaller blind holes separate larger blind holes with the interconnecting openings61formed as a result of the overlap of one hole with the other. Although the channels61can be on the same plane (i.e., have the same depth) as the blind holes3, the channels61can also be on a higher or lower plane (i.e., have a different depth than the blind holes3). Though not shown, in one embodiment of the invention, the insert120inFIG.1is inserted into a body105having the plurality of holes and interconnecting channels shown inFIGS.5through9A. FIG.9Bis an illustration of another implant device according to another embodiment. In this embodiment, the channels61are formed in intersection directions. The boundary region70of the implant device does not have any holes while the interior region72(between the boundary region70and the central opening74) has through holes3aextending across a depth of the implant device. The right side view shown inFIG.9Bshows that, in one embodiment, the implant device is tapered with the widest section being on a side where an insertion device would connect to holes80on the side wall of the implant device. FIG.9Cis a top view of the implant device ofFIG.9Bshowing more clearly the intersecting channels61and the through holes3a.FIG.9Dis a cross sectional view of the implant device ofFIG.9Bshowing the through holes3aextending across a depth of the implant device. FIG.9Eis an enlarged view of the implant device ofFIG.9B. Here, one aspect of the invention is the construction formed where the channels61intersect the through holes3a. This construction forms surface wall which has a vertical edge61awith two opposing surfaces, one planar along the cut forming the channel61and one curved surface along the hole3a. This aspect in one embodiment of the invention is advantageous for bone in-growth. In general, the vertical edge61amay have two opposing surfaces, one planar surface along the interconnected opening and one curved surface along the first cavity, as shown inFIG.9E. However, the present invention is not so limited, and a vertical edge can be formed by overlapping of the holes3awithout there being a channel61. In this case, a vertical edge61bis formed from two opposing curved surfaces (see edge61binFIG.8). Similarly, vertical edges can be formed in the body portion of the implant device by the intersection of the channels61. In this case, the vertical edge (see edge61cinFIG.9E) is formed from two plane opposing surfaces. FIG.9Fis a scaled drawing of the implant device ofFIG.9Bwith the dimensions shown in millimeters. The view inFIG.9Fis that of a vertical cut through the right-had side view shown inFIG.9B. In one embodiment of the invention, the channels61have a width between 100 to 1000 microns, 200 to 700 microns, 250 to 500 microns, and/or 300 to 400 microns (or any intervening ranges or values in between) for promoting bone growth in the channels61and in the holes3a. In one embodiment of the invention, the body portion comprises a cross shaped solid section66(as shown inFIGS.9C and9E) extending in a region of the body portion and bounded by four holes in the body portion. In one embodiment of the invention, intersecting channels68(as shown inFIGS.9C and9E) are formed in the body portion where one of the intersecting channels comprises the interconnected opening. In one embodiment of the invention, the intersecting channels68connect between four holes in the body portion. In one embodiment of the invention, the body portion comprises a set of regularly spaced six holes with an “X” pattern of interconnection channels between first set of the six holes and with a cross shaped body portion between a second set of the six holes, the set repeating as a unit across the body portion In one embodiment of the invention, there are corrugations76(as shown inFIG.9B) formed on an outermost region of the body implant not having any holes therein. In one embodiment of the invention, the corrugations comprise teeth on the body portion with diagonal cuts78(as shown inFIG.9B) formed therethrough the teeth by the intersecting channels, and optionally the teeth extend above a surface of the body portion containing the first hole and the second hole. While not being constrained by theory, the porous bodies of this invention are believed to increase the speed of bone ingrowth and vertebra fusion by stimulating bone to grow into the holes or porous titanium as well as the channels in-between. By stimulating bone growth into connecting channels, the implant increases the speed of bone growth into adjacent holes. The strength of the vertebra fusion is also increased as bone is likely to continue growing through the channel or porous titanium and connect the implant and the bone together. The implant can be composed of any applicable biocompatible material either currently known or unknown. It can also be constructed by any means known in the art such as but not limited to machining, injection molding, or lithographic etching. The implant can also be constructed by pressing indentations into a green or partially green body portion mold and then curing the mold. The implant can be of any size. An embodiment can be 5-12 mm high and have a lordotic angle of 0 or 5-10 degrees. Some embodiments could have footprints of 12 mm×14 mm, 13 mm×15 mm, or 14 mm×16 mm. Some embodiments will have degrees of 6 or 10. An embodiment of the implant could be packaged in a kit including an insertion device. Such an example with implant81and an insertion device82is shown inFIG.10. Though not shown it is entirely possible to combine the insert120inFIG.1,2,3, or4with the first and second rows of holes3a3bshown inFIG.5, the plurality of holes6shown inFIG.6, the taper shown inFIG.7, the cross shaped region inFIG.8or the row and interconnecting openings inFIG.9A. FIG.11is a flow diagram explaining a method of the present invention. In one embodiment, a method of use for example secures two bones surfaces together. At81, an implant (such as any of the implants described above) is provided between two bone surfaces. The implant has at least one porous surface. At83, a bone graft material is supplied into the porous surface. At85, the porous surface with the implant is secured in place between two bone surfaces. A method of use is also outlined inFIG.12. At91, the involved disc level is identified through radiologic control. At93, anterior cervical approaches are used for intervertebral disc exposure. At94, after anterior cervical discectomy, a fusion procedure is performed, a curette or rasp is used to prepare the implant bed and graft surfaces. At95, the correct implant size is selected by inserting trials into the intervertebral space. At96, once the proper size implant is selected, it is attached to an inserter instrument such as insertion tool82. In some embodiments of the invention, the implant is then filled with an autograft material. At97, the implant is inserted under fluoroscopy into the disc space once mounted on the insertion tool. In some embodiments of the invention, a tamp is used to secure the device in its final position. At98, the final position of the implant is verified visually and/or alternatively using x-ray techniques. A supplemental fixation system may then be applied. The implant may be later removed. This can be accomplished by attaching the inserter to the implant anteriorly and removing the implant from the disc space. A cobb elevator or an osteotome can be used to loosen the implant from the bone if needed. This invention is not limited to a specific type of bone graft or autograft material. In general, a variety of bone graft materials are known and suitable for this invention. These typically comprise calcium phosphate-based or gel-based materials. Polymer-based bone graft substitutes containing (or not containing) collagen can be used. Ceramic bone graft substitutes can be used. In one embodiment, the implantable bone graft material comprises a composite of a ceramic and a polymer. The ceramic and the polymer can be present at a weight ratio ranging from about 10:1 ceramic to polymer to about 2:1 ceramic to polymer. Alternatively, the weight ratio of the ceramic to the polymer can range from about 2:1 (about 66% ceramic to about 33% polymer), from about 3:1 (about 75% ceramic to about 25% polymer), from about 4:1 (about 80% ceramic to about 20% polymer), from about 9:1 (about 90% ceramic to about 10% polymer), from about 10:1 (about 99% ceramic to about 1% polymer). Other bone graft materials besides those specifically listed above can be used. This invention is also not limited to the type of material that the implant is made of. The implants of this invention can be made of any material appropriate for human implantation and having the mechanical properties sufficient to be utilized for the intended purpose of spinal fusion, including various metals such as cobalt chrome, stainless steel or titanium including its alloys, various plastics including those which are bio-absorbable, and various ceramics or combination sufficient for the intended purpose. In one embodiment, the implant is made of medical grade PEEK (Polyetheretherketone). Further, the implants of this invention may be made of a solid material, a mesh-like material, a porous material and may comprise, wholly or in part, materials capable of directly participating in the spinal fusion process, or be loaded with, composed of, treated of coated with chemical substances such as bone, morphogenic proteins, hydroxyapatite in any of its forms, and osteogenic proteins, to make them bioactive for the purpose of stimulating spinal fusion. The implants of this invention may be wholly or in part bioabsorbable. Other materials for the implant device besides those specifically listed above can be used. This invention is also not limited to the methods by which the implants are made. The individual components can be machined from solid stock pieces. Molding can be used to make the individual components. In this case, machining to final dimensions may or may not be in order. The surfaces once properly dimensioned can be coated with a variety of biocompatible coatings and/or surface treatments. Various coatings include for example calcium phosphate ceramics, such as tricalcium phosphate (TCP) and hydroxyapatite (HA), and hydroxyapatite (a naturally occurring material in bone). Moreover, If the implant is not made of bone, surfaces of the implant that contact bone may be treated to promote fusion of the implant to the bone. Treatment may include, but is not limited to, applying a hydroxyapatite coating on contact surfaces, spraying a titanium plasma on contact surfaces, and/or texturing the contact surfaces by scoring, peening, implanting particles in the surfaces, or otherwise roughening the surfaces of the implant. In one embodiment of the invention, the holes and interconnecting openings described above can be machined into the body portion. In one embodiment of the invention, the holes and interconnecting openings described above can be pressed into or formed with an uncured mold of the body portion after which the uncured mold is cured. In one embodiment of the invention, the holes and interconnecting openings described above can be lithographically formed by etching the body portion. In some embodiments, any of the implants and instruments described above (such as the insertion tool) can be used with additional implants and instruments. In some embodiments, the implants and instruments can be used with stabilization members, such as plates, screws, and rods. In addition, a multi-level construct can be formed, wherein any one or more of the implants20described above can be used on one level, while a similar or different implant (e.g., fusion or prosthetic) can be used on a different level. This invention is also not limited to the shapes and designs noted above. Generalized Statements of the Invention: The following numbered statements describe generalized aspects or embodiments of the invention and are provided for illustrative purposes. Statement 1. A surgical implant comprising: a body having at least one interior surface, the body forming a peripheral support for the implant; a porous insert comprised of a porous material, having an axially-extending hole, and attached to the body (e.g., along the at least one interior surface such that the porous material extends across a height of the body); and the porous insert comprising a locking mechanism formed in the porous insert or extending from the porous insert, the locking mechanism minimizing movement of the porous insert within the body. In one aspect of the invention, the porous insert preferably does not extend beyond an uppermost surface of the body and is not a substantial load bearing member. In one aspect of the invention, the body is preferably, but not necessarily, non-porous and made of material different than the porous insert. Indeed, in one aspect of the invention, the body can be made of the same material as the porous insert. In one aspect of the invention, the body is preferably, but not necessarily, a separate piece from the porous insert. Indeed, in one aspect of the invention, the body and the porous insert could be made at the same time by a three-dimensional printing process making the body and the porous insert a singular piece in which the locking mechanisms may or may not be also formed at the same time. For example, the body and the porous insert could be made at the same time by a three-dimensional printing process by which respective holes are formed in the body and the porous insert for acceptance of pin125. For example, the body and the porous insert could be made at the same time by a three-dimensional printing process by which the thin-walled sections231and233in an interlocked state engaging and contacting recesses240would be formed. Statement 2. The implant of statement 1, wherein the porous body comprises a plurality of interconnected holes extending throughout a section of the porous insert. Statement 3. The implant of statement 2, wherein the interconnected holes are of a predefined size. Statement 4. The implant of statement 2, wherein the interconnected holes extend linearly across the section of the porous insert. Statement 5. The implant of statement 2, wherein the interconnected holes extend linearly and diagonally across the section of the porous insert. Statement 6. The implant of any of the statements above (or a combination thereof), wherein the porous insert is three-dimensionally printed. Statement 7. The implant of any of the statements above (or a combination thereof), wherein the porous insert is enclosed by the peripheral support of the body. Statement 8. The implant of any of the statements above (or a combination thereof), wherein the porous insert is partially enclosed by the peripheral support of the body. Statement 9. The implant of any of the statements above (or a combination thereof), wherein the body comprises two sections, and the porous insert contacts the two sections of the body. Statement 10. The implant of any of the statements above (or a combination thereof), wherein the porous insert comprises an upper insert and a lower insert. Statement 11. The implant of statement 10, wherein at least one of the upper insert and the lower insert have a flange which contacts a laterally-extending interior surface of the body. Statement 12. The implant of any of the statements above (or a combination thereof), wherein the locking mechanism comprises a projection from the porous insert which engages in a recess in the body. Statement 13. The implant of any of the statements above (or a combination thereof), wherein the locking mechanism comprises a cross-channel in the porous insert accepting a flange extending from the body toward the porous insert. Statement 14. The implant of any of the statements above (or a combination thereof), wherein the cross-channel traverses the porous insert laterally. Statement 15. The implant of any of the statements above (or a combination thereof), wherein the cross-channel traverses the porous insert axially. Statement 16. The implant of any of the statements above (or a combination thereof), wherein the locking mechanism comprises a pair of projections of the porous material from the porous insert engaging around a flange of the body. Statement 17. The implant of any of the statements above (or a combination thereof), wherein the locking mechanism comprises a through-channel in the porous insert accepting a flange extending from the body toward the porous insert. Statement 18. The implant of any of the statements above (or a combination thereof), wherein the locking mechanism comprises a hole in the porous insert configured for accepting a pin connecting the body to the porous insert. Statement 19. The implant of any of the statements above (or a combination thereof), wherein the porous insert slides longitudinally into place between two complementary sections of the body. Statement 20. The implant of any of the statements above (or a combination thereof), wherein the porous insert slides vertically into place between the two complementary sections. Statement 21. The implant of any of the statements above (or a combination thereof), wherein the body comprises polyetheretherketone (PEEK). Statement 22. The implant of statement 21, wherein the PEEK comprises carbon fibers present in a weight percentage of the component of about 5 to 75%. Statement 23. The implant of any of the statements above (or a combination thereof), wherein the porous insert comprises a plurality of interconnected holes extending throughout a section of the porous insert. Statement 24. The implant of any of the statements above (or a combination thereof), wherein the porous material comprises porous titanium. Statement 25. The implant of statement 24, wherein the porous titanium is formed by a three-dimensional printing process. Statement 26. The implant of statement 25, wherein the porous titanium has a plurality of interconnected holes extending throughout a section of the porous insert. Statement 27. The implant of statement 26, wherein the interconnected holes extend linearly across the section of the porous insert. Statement 28. The implant of statement 26, wherein the interconnected holes extend linearly and diagonally across the section of the porous insert. Statement 29. The implant of any of the statements above (or a combination thereof), wherein the body is tapered with a smaller height toward a posterior side and a greater height toward an anterior side. Statement 30. The implant of statement 29, wherein a lateral extending edge on at least one of the posterior side or the anterior side comprises a rounded edge. Statement 31. The implant of any of the statements above (or a combination thereof), further comprising teeth present on a surface of the body as corrugations. Statement 32. A kit comprising: the surgical implant of any of statements 1-31 (or combinations thereof); and an intervertebral insertion device. Statement 33. A method for securing two bones surfaces together, comprising: providing between two bone surfaces the surgical implant of any of statements 1-31 (or combinations thereof) including the porous insert; supplying bone graft material into the surface of the porous implant; and securing the porous surface with the bone graft material in place between the two bone surfaces. Statement 34. The method of statement 33, wherein providing comprises locking an extrusion of the porous insert into the body to prevent the porous insert from moving within the body. Statement 35. A surgical implant comprising:a body portion comprising a first hole formed in the exterior surface thereof, a second hole adjacent the first hole, and a central opening extending through the body portion,whereinthe first hole has a first sidewall and a first cavity in the body portion,the second hole has a second sidewall and a second cavity in the body portion, andthe first cavity and the second cavity have an interconnected opening there between. Statement 36. The surgical implant of statement 35, wherein the interconnected opening comprises a surface channel formed in the surface of the body portion for interconnecting the first cavity and the second cavity together. Statement 37. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the interconnected opening is formed by an overlap of the first hole with the second hole. Statement 38. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the interconnected opening comprises a vertically-extending slot in at least one of the first sidewall and the second sidewall. Statement 39. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein at least one of the first hole and the second hole comprises a blind hole or a through hole. Statement 40. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the first hole comprises a first plurality of first blind holes, and the second hole comprises a second plurality of second blind holes, or wherein the first hole comprises a first plurality of first through holes, and the second hole comprises a second plurality of second through holes. Statement 41. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion comprises a biocompatible material for permitting tissue in-growth in the first cavity, the second cavity, and the interconnected opening. Statement 42. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion is tapered such that a first height of the body portion at a distal end is smaller than a second height at a proximal end. Statement 43. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the first hole comprises a first row of first holes, and the second hole comprises a second row of second holes. Statement 44. The surgical implant of statement 43, wherein the first holes have a larger diameter than the second holes Statement 45. The implant of statement 43, wherein, in the second row, one of the second holes is disposed offset and centered with respect to one of the first holes in the first row. Statement 46. The surgical implant of statement 43, wherein, in the second row, one of the second holes is displaced from one of the first holes a distance greater than two diameters of the first holes. Statement 47. The surgical implant of statement 43, wherein the interconnected opening is formed by an overlap of one of the second holes with one of the first holes. Statement 48. The surgical implant of statement 43, wherein the body portion comprises a cross-shaped solid section extending between the plural second holes in different rows. Statement 49. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion comprises a cross shaped solid section extending in a region of the body portion having no holes. Statement 50. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the first hole and the second hole comprise holes machined into the body portion. Statement 51. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the first hole and the second hole comprise holes pressed into or formed with an uncured mold of the body portion after which the uncured mold is cured. Statement 52. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the first hole and the second hole comprise holes lithographically formed by etching the body portion. Statement 53. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion is configured to fit between two vertebrae. Statement 54. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion comprises a sidewall having one or more apertures for holding the body portion to an intervertebral insertion device for insertion of the implant between two vertebrae. Statement 55. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion comprises a biocompatible material that permits tissue growth therewith. Statement 56. The surgical implant of any of the statements above below statement 35 (or a combination thereof), further comprising: a bone graft material for application to at least one of the first hole, the second hole, and the interconnected opening. Statement 57. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the first cavity and the interconnected opening form at an intersection thereof a vertical edge. Statement 58. The surgical implant of statement 57, wherein the vertical edge has two opposing surfaces, one planar surface along the interconnected opening and one curved surface along the first cavity. Statement 59. The surgical implant of statement 57, wherein the vertical edge is formed from two opposing curved surfaces. Statement 60. The surgical implant of statement 57, wherein the vertical edge is formed from two plane opposing surfaces. Statement 61. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion comprises a cross-shaped solid section extending in a region of the body portion and bounded by four holes in the body portion. Statement 62. The surgical implant of any of the statements above below statement 35 (or a combination thereof), further comprising intersecting channels formed in the body portion where one of the intersecting channels comprises the interconnected opening. Statement 63. The surgical implant of statement 62, wherein the intersecting channels connect between four holes in the body portion. Statement 64. The surgical implant of any of the statements above below statement 35 (or a combination thereof), wherein the body portion comprises a set of regularly spaced six holes with an “X” pattern of interconnection channels between first set of the six holes and with a cross shaped body portion between a second set of the six holes, the set repeating as a unit across the body portion Statement 65. The surgical implant of any of the statements above below statement 35 (or a combination thereof), further comprising corrugations formed on an outermost region of the body implant not having any holes therein. Statement 66. The surgical implant of statement 65, wherein the corrugations comprise teeth on the body portion with diagonal cuts formed therethrough the teeth by the intersecting channels, and optionally the teeth extend above a surface of the body portion containing the first hole and the second hole. Statement 67. A surgical implant comprising:a body portion comprising a peripheral section and a central opening extending through the peripheral section;a plate attached to the peripheral section; andthe plate comprising a first hole formed in an external surface thereof, a second hole adjacent the first hole,whereinthe first hole has a first sidewall and a first cavity in the body portion,the second hole has a second sidewall and a second cavity in the body portion, andthe first cavity and the second cavity have an interconnected opening there between. Statement 68. A kit comprising:the surgical implant of statement 35 or statement 58; andan intervertebral insertion device. Statement 69. A method for securing two bones surfaces together, comprising:providing between two bone surfaces a porous surface implant having first and second holes with an interconnection there between;supplying bone graft material into the first and second holes and the interconnection; andsecuring the porous surface implant with the bone graft material in place between the two bone surfaces. Numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein. | 48,704 |
11857437 | DETAILED DESCRIPTION The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. A spinal fusion is typically employed to eliminate pain caused by the motion of degenerated disk material. Upon successful fusion, a fusion device becomes permanently fixed within the intervertebral disc space. Looking atFIG.1, an exemplary embodiment of an expandable fusion device10is shown between adjacent vertebral bodies2and3. The fusion device10engages the endplates4and5of the adjacent vertebral bodies2and3and, in the installed position, maintains normal intervertebral disc spacing and restores spinal stability, thereby facilitating an intervertebral fusion. The expandable fusion device10can be manufactured from a number of materials including titanium, stainless steel, titanium alloys, non-titanium metallic alloys, polymeric materials, plastics, plastic composites, PEEK, ceramic, and elastic materials. In an embodiment, the expandable fusion device10can be configured to be placed down an endoscopic tube and into the disc space between the adjacent vertebral bodies2and3. In an exemplary embodiment, bone graft or similar bone growth inducing material can be introduced around and within the fusion device10to further promote and facilitate the intervertebral fusion. The fusion device10, in one embodiment, is preferably packed with bone graft or similar bone growth inducing material to promote the growth of bone through and around the fusion device. Such bone graft may be packed between the endplates of the adjacent vertebral bodies prior to, subsequent to, or during implantation of the fusion device. With reference toFIGS.2-7, an embodiment of the fusion device10is shown. In an exemplary embodiment, the fusion device10includes a first endplate14, a second endplate16, a central ramp18, and a driving ramp260. In an embodiment, the expandable fusion device10can be configured to be placed down an endoscopic tube and into the disc space between the adjacent vertebral bodies2and3. One or more components of the fusion device10may contain features, such as through bores, that facilitate placement down an endoscopic tube. In an embodiment, components of the fusion device10are placed down the endoscopic tube with assembly of the fusion device10in the disc space. Although the following discussion relates to the second endplate16, it should be understood that it also equally applies to the first endplate14as the second endplate16is substantially identical to the first endplate14in embodiments of the present invention. Turning now toFIGS.2-7and10, in an exemplary embodiment, the second endplate16has a first end39and a second end41. In the illustrated embodiment, the second endplate16further comprise an upper surface40connecting the first end39and the second end41, and a lower surface42connecting the first end39and the second end41. In an embodiment, the second endplate16further comprises a through opening44, as seen onFIG.11. The through opening44, in an exemplary embodiment, is sized to receive bone graft or similar bone growth inducing material and further allow the bone graft or similar bone growth inducing material to be packed in the central opening in the central ramp18. As best seen inFIGS.7and10, the lower surface42includes at least one extension46extending along at least a portion of the lower surface42, in an embodiment. In an exemplary embodiment, the extension46can extend along a substantial portion of the lower surface42, including, along the center of the lower surface42. In the illustrated embodiment, the extension46includes a generally concave surface47. The concave surface47can form a through bore with the corresponding concave surface47(not illustrated) of the first endplate14, for example, when the device10is in an unexpanded configuration. In another exemplary embodiment, the extension46includes at least one ramped surface48. In another exemplary embodiment, there are two ramped surfaces48,50with the first ramped surface48facing the first end39and the second ramped surface facing the second end41. In an embodiment, the first ramped surface48can be proximate the first end39, and the second ramped surface50can be proximate the second end41. It is contemplated that the slope of the ramped surfaces48,50can be equal or can differ from each other. The effect of varying the slopes of the ramped surfaces48,50is discussed below. In one embodiment, the extension46can include features for securing the endplate16when the expandable fusion device10is in an expanded position. In an embodiment, the extension46includes one or more protuberances49extending from the lateral sides51of the extension. In the illustrated embodiment, there are two protuberances49extending from each of the lateral sides51with each of the sides53having one of the protuberances49extending from a lower portion of either end. As will be discussed in more detail below, the protuberances49can be figured to engage the central ramp18preventing and/or restricting longitudinal movement of the endplate16when the device10is in an expanded position. As illustrated inFIGS.2-5, in one embodiment, the upper surface40of the second endplate16is flat and generally planar to allow the upper surface40of the endplate16to engage with the adjacent vertebral body2. Alternatively, as shown inFIG.15, the upper surface40can be curved convexly or concavely to allow for a greater or lesser degree of engagement with the adjacent vertebral body2. It is also contemplated that the upper surface40can be generally planar but includes a generally straight ramped surface or a curved ramped surface. The ramped surface allows for engagement with the adjacent vertebral body2in a lordotic fashion. While not illustrated, in an exemplary embodiment, the upper surface40includes texturing to aid in gripping the adjacent vertebral bodies. Although not limited to the following, the texturing can include teeth, ridges, friction increasing elements, keels, or gripping or purchasing projections. Referring now toFIGS.2-8, in an exemplary embodiment, the central ramp18has a first end20, a second end22, a first side portion24connecting the first end20and the second end22, and a second side portion26(best seen onFIG.5) on the opposing side of the central ramp12connecting the first end20and the second end22. The first side portion24and the second side portion26may be curved, in an exemplary embodiment. The central ramp18further includes a lower end28, which is sized to receive at least a portion of the first endplate14, and an upper end30, which is sized to receive at least a portion of the second endplate16. The first end20of the central ramp18, in an exemplary embodiment, includes an opening32. The opening32can be configured to receive an endoscopic tube in accordance with one or more embodiments. The first end20of the central ramp18, in an exemplary embodiment, includes at least one angled surface33, but can include multiple angled surfaces. The angled surface33can serve to distract the adjacent vertebral bodies when the fusion device10is inserted into an intervertebral space. The second end22of the central ramp18, in an exemplary embodiment, includes an opening36. The opening36extends from the second end22of the central ramp18into a central guide37in the central ramp18. In an embodiment, the central ramp18further includes one or more ramped surfaces33. As best seen inFIG.8, the one or more ramped surfaces33positioned between the first side portion24and the second side portion26and between the central guide37and the second end22. In an embodiment, the one or more ramped surfaces33face the second end22of the central ramp18. In one embodiment, the central ramp18includes two ramped surfaces33with one of the ramped surfaces33being sloped upwardly and the other of the ramped surfaces33being sloped downwardly. The ramped surfaces33of the central ramp can be configured and dimensioned to engage the ramped surface48in each of the first and second endplates14,16. Although the following discussion relates to the second side portion26of the central ramp18, it should be understood that it also equally applies to the first side portion24in embodiments of the present invention. In the illustrated embodiment, the second side portion26includes an inner surface27. In an embodiment, the second side portion26further includes a lower guide35, a central guide37, and an upper guide38. In the illustrated embodiment, the lower guide35, central guide37, and the upper guide38extend out from the inner surface27from the second end22to the one or more ramped surfaces31. In the illustrated embodiment, the second end22of the central ramp18further includes one or more guides38. The guides38can serve to guide the translational movement of the first and second endplates14,16with respect to the central ramp18. For example, protuberances49on the second endplate16may be sized to be received between the central guide37and the upper guide38. Protuberances49of the first endplate16may be sized to be received between the central guide37and the lower guide35. A first slot29may be formed proximate the middle of the upper guide38. A second slot31may be formed between end of the upper guide38and the one or more ramped surfaces33. The protuberances49may be sized to be received within the first slot29and/or the second slot31when the device10is in the expanded position. Referring now toFIGS.4-7and9, the driving ramp260has a through bore262. In an embodiment, the driving ramp260is generally wedge-shaped. As illustrated, the driving ramp260may comprise a wide end56, a narrow end58, a first side portion60connecting the wide end56and the narrow end58, and a second side portion62connecting the wide end56and the narrow end58. The driving ramp260further may comprise ramped surfaces, including an upper ramped surface64and an opposing lower ramped surface66. The upper ramped surface64and the lower ramped surface66may be configured and dimensioned to engage the ramped surface50proximate the second end41in of the first and the second endplates14,16. The first and second side portions60,62may each include grooves68that extend, for example, in a direction parallel to the longitudinal axis of the through bore262. The grooves68may be sized to receive the central guide37on the interior surface27of each of the side portions24,26of the central ramp18. In this manner, the grooves68together with the central guide37can surface to guide the translational movement of the driving ramp260in the central ramp18. A method of installing the expandable fusion device10ofFIG.1is now discussed in accordance with one embodiment of the present invention. Prior to insertion of the fusion device10, the intervertebral space is prepared. In one method of installation, a discectomy is performed where the intervertebral disc, in its entirety, is removed. Alternatively, only a portion of the intervertebral disc can be removed. The endplates of the adjacent vertebral bodies2,3are then scraped to create an exposed end surface for facilitating bone growth across the intervertebral space. One or more endoscopic tubes can then be inserted into the disc space. The expandable fusion device10can then be introduced into the intervertebral space down an endoscopic tube and seated in an appropriate position in the intervertebral disc space. After the fusion device10has been inserted into the appropriate position in the intervertebral disc space, the fusion device10can then be expanded into the expanded position. To expand the fusion device10, the driving ramp260may be moved in a first direction with respect to the central ramp18. Translational movement of the driving ramp260through the central ramp18may be guided by the central guide37on each of the first and second side portions24,26of the central ramp18. As the driving ramp260moves, the upper ramped surface64pushes against the ramped surface50proximate the second end41of the second endplate16, and the lower ramped surface66pushes against the ramped surface50proximate the second end41of the first endplate14. In addition, the ramped surfaces33in the central ramp18push against the ramped surface48proximate the first end41of the first and second endplates14,16. In this manner, the first and second endplates14,16are pushed outwardly into an expanded configuration. As discussed above, the central ramp16includes locking features for securing the endplates14,16. It should also be noted that the expansion of the endplates14,16can be varied based on the differences in the dimensions of the ramped surfaces48,50and the angled surfaces62,64. As best seen inFIG.16, the endplates14,16can be expanded in any of the following ways: straight rise expansion, straight rise expansion followed by a toggle into a lordotic expanded configuration, or a phase off straight rise into a lordotic expanded configuration. Turning back toFIGS.2-7, in the event the fusion device10needs to be repositioned or revised after being installed and expanded, the fusion device10can be contracted back to the unexpanded configuration, repositioned, and expanded again once the desired positioning is achieved. To contract the fusion device10, the central ramp18is moved with respect to the central ramp260away from the central ramp260. As the central ramp18moves, the ramped surfaces33in the central ramp18ride along the ramped surfaces48of the first and second endplates14,16with the endplates14,16moving inwardly into the unexpanded position. With reference now toFIG.17, fusion device10is shown with an exemplary embodiment of artificial endplates100. Artificial endplates100allows the introduction of lordosis even when the endplates14and16of the fusion device10are generally planar. In one embodiment, the artificial endplates100have an upper surface102and a lower surface104. The upper surfaces102of the artificial endplates100have at least one spike106to engage the adjacent vertebral bodies. The lower surfaces104have complementary texturing or engagement features on their surfaces to engage with the texturing or engagement features on the upper endplate14and the lower endplate16of the fusion device10. In an exemplary embodiment, the upper surface102of the artificial endplates100have a generally convex profile and the lower surfaces104have a generally parallel profile to achieve lordosis. In another exemplary embodiment, fusion device10can be used with only one artificial endplate100to introduce lordosis even when the endplates14and16of the fusion device10are generally planar. The artificial endplate100can either engage endplate14or engage endplate16and function in the same manner as described above with respect to two artificial endplates100. With reference toFIGS.11-14, an embodiment for placing an expandable fusion device10into an intervertebral disc space is illustrated. The expandable fusion device10can be introduced into the intervertebral space down an endoscopic tube utilizing a tool70that is attached to endplate16, with the second endplate16being first placed down the tube with tool70and into the disc space, as seen inFIG.11. After insertion of the second endplate16, the first endplate14can be placed down the same endoscopic tube with tool72and into the disc space, as shown onFIG.12. Following the first endplate14, the central ramp12can be placed down the same endoscopic tube and into the disc space guided by tools70and72, as shown onFIGS.13and14. Referring now toFIGS.18-23, an alternative embodiment of the expandable fusion device10is shown. In an exemplary embodiment, the fusion device10includes a first endplate14, a second endplate16, a central ramp18, and an actuator assembly200. As will be discussed in more detail below, the actuator assembly200drives the central ramp18which forces apart the first and second endplates14,16to place the expandable fusion device in an expanded position. One or more components of the fusion device10may contain features, such as through bores, that facilitate placement down an endoscopic tube. In an embodiment, components of the fusion device10are placed down the endoscopic tube with assembly of the fusion device10in the disc space. Although the following discussion relates to the second endplate16, it should be understood that it also equally applies to the first endplate14as the second endplate16is substantially identical to the first endplate14in embodiments of the present invention. With additional reference toFIG.24, in an exemplary embodiment, the second endplate16has a first end39and a second end41. In the illustrated embodiment, the second endplate16further comprise an upper surface40connecting the first end39and the second end41, and a lower surface42connecting the first end39and the second end41. While not illustrated, in an embodiment, the second endplate16further comprises a through opening. The through opening, in an exemplary embodiment, is sized to receive bone graft or similar bone growth inducing material. In one embodiment, the upper surface40of the second endplate16is flat and generally planar to allow the upper surface40of the endplate16to engage with the adjacent vertebral body2. Alternatively, as shown inFIG.15, the upper surface40can be curved convexly or concavely to allow for a greater or lesser degree of engagement with the adjacent vertebral body2. It is also contemplated that the upper surface40can be generally planar but includes a generally straight ramped surface or a curved ramped surface. The ramped surface allows for engagement with the adjacent vertebral body2in a lordotic fashion. While not illustrated, in an exemplary embodiment, the upper surface40includes texturing to aid in gripping the adjacent vertebral bodies. Although not limited to the following, the texturing can include teeth, ridges, friction increasing elements, keels, or gripping or purchasing projections. In one embodiment, the second endplate16further comprises a first side portion202connecting the first end39and the second end41, and a second side portion204connecting the first end39and the second end41. In the illustrated embodiment, the first and second side portions202,204are extensions from the lower surface42. In an exemplary embodiment, the first and second side portions202,204each include ramped surfaces206,208. In the illustrated embodiment, the ramped surfaces206,208extend from the first end39of the second endplate16to bottom surfaces210,212of each of the side portions202,204. In one embodiment, the ramped surfaces206,208are forward facing in that the ramped surfaces206,208face the first end39of the second endplate. As previously discussed, the slope of the ramped surfaces206,208may be varied as desired for a particular application. In an embodiment, the first and second side portions202,204each comprise at least one protuberance214. In an exemplary embodiment, the first and second side portions202,204each comprise a first protuberance214, a second protuberance216, and a third protuberance218. In one embodiment, the protuberances214,216,218extend from the interior surface220of the first and second side portions202,204. In an exemplary embodiment, the protuberances214,216,218extend at the lower side of the interior surface220. As best seen inFIG.24, the first and the second protuberances214,216form a first slot222, and the second and third protuberances216,218form a second slot224. As best seen inFIG.24, the lower surface42of the second endplate16, in an embodiment, includes a central extension224extending along at least a portion of the lower surface. In the illustrated embodiment, the central extension224extends between the first and second side portions202and204. In an exemplary embodiment, the central extension224can extend from the second end41of the endplate16to the central portion of the endplate. In one embodiment, the central extension224includes a generally concave surface226configured and dimensioned to form a through bore with the corresponding concave surface226(not illustrated) of the first endplate14. The central extension224can further include, in an exemplary embodiment, a ramped surface228. In the illustrated embodiment, the ramped surface228faces the first end39of the endplate16. The ramped surface228can be at one end of the central extension224. In an embodiment, the other end of the central extension224forms a stop230. In the illustrated embodiment, the stop230is recessed from the second end41of the second endplate16. Referring toFIGS.25-27, in an exemplary embodiment, the central ramp18includes a body portion232having a first end234and a second end236. In an embodiment, the body portion232includes at least a first expansion portion238. In an exemplary embodiment, the body portion232includes a first expansion portion238and a second expansion portion240extending from opposing sides of the body portion with each of the first and second expansion portions238,240having a generally triangular cross-section. In one embodiment, the expansion portions238,240each have angled surfaces242,244configured and dimensioned to engage the ramped surfaces206,208of the first and second endplates14,16and force apart the first and second endplates14,16. In an embodiment, the engagement between the angled surfaces242,244of the expansion portions238,240with the ramped surfaces206,208of the first and second endplates14,16may be described as a dovetail connection. The second end236of the central ramp18, in an exemplary embodiment, includes opposing angled surfaces246. The angled surfaces246can be configured and dimensioned to engage the ramped surface228in the central extension224in each of the first and second endplates14,16. In other words, one of the angled surfaces246can be upwardly facing and configured, in one embodiment, to engage the ramped surface228in the central extension224in the second endplate16. In an embodiment, the engagement between the angled surfaces246of the second end236of the central ramp18with the ramped surface228in the first and second endplates14,16may be described as a dovetail connection. The second end236, in an exemplary embodiment, can further include an extension252. In the illustrated embodiment, the extension252is generally cylindrical in shape with a through bore254extending longitudinally therethrough. In one embodiment, the extension252can include a beveled end256. While not illustrated, at least a portion of the extension252can be threaded. Referring still toFIGS.25-27, the central ramp18can further include features for securing the first and second endplates14,16when the expandable fusion device10is in an expanded position. In an embodiment, the body portion232of the central ramp18includes one or more protuberances248,250extending from opposing sides of the body portion232. As illustrated, the protuberances248,250, in one embodiment, can be spaced along the body portion232. In an exemplary embodiment, the protuberances248,250can be configured and dimensioned for insertion into the corresponding slots222,224in the first and second endplates14,16when the device10is in an expanded position, as best seen inFIGS.19and21. The protuberances248,250can engage the endplates14,16preventing and/or restricting movement of the endplates14,16with respect to the central ramp18after expansion of the device10. With reference toFIGS.20-23, in an exemplary embodiment, the actuator assembly200has a flanged end253configured and dimensioned to engage the stop232in the central extension224of the first and the second endplates14,16. In an embodiment, the actuator assembly200further includes an extension254that extends from the flanged end253. In a further embodiment, the actuator assembly200includes a threaded hole256that extends through the actuator assembly200. It should be understood that, while the threaded hole256in the actuator assembly200is referred to as threaded, the threaded hole256may only be partially threaded in accordance with one embodiment. In an exemplary embodiment, the threaded hole256is configured and dimensioned to threadingly receive the extension252of the central ramp18. With additional reference toFIGS.28-32, a method of installing the expandable fusion device10ofFIGS.18-27is now discussed in accordance with one embodiment of the present invention. Prior to insertion of the fusion device, the disc space may be prepared as described above and then one or more endoscopic tubes may then inserted into the disc space. The expandable fusion device10can then be inserted into and seated in the appropriate position in the intervertebral disc space, as best seen inFIGS.28-32. The expandable fusion device10can be introduced into the intervertebral space down an endoscopic tube (not illustrated), with the central ramp18being first placed down the tube and into the disc space, as seen inFIG.28. After insertion of the central ramp, the first endplate14can be placed down an endoscopic tube, as shown onFIG.29, followed by insertion of the second endplate16, as shown onFIG.30. After the second endplate16, the actuator assembly200can then be inserted to complete assembly of the device10, as best seen inFIG.31. After the fusion device10has been inserted into and assembled in the appropriate position in the intervertebral disc space, the fusion device10can then be expanded into the expanded position. To expand the fusion device10, the actuator assembly200can be rotated. As discussed above, the actuator assembly200is in threaded engagement with the extension250of the central ramp18. Thus, as the actuator assembly200is rotated in a first direction, the central ramp18moves toward the flanged end253of the actuator assembly200. In another exemplary embodiment, the actuator assembly200can be moved in a linear direction with the ratchet teeth as means for controlling the movement of the central ramp18. As the central ramp18moves, the angled surfaces242,244in the expansion portions238,240of the central ramp18push against the ramped surfaces206,208in the first and second side portions202,204of the first and second endplates14,16. In addition, the angled surfaces246in the second end236of the central ramp18also push against the ramped surfaces228in the central extension224of each of the endplates14,16. This is best seen inFIGS.22-23. Since the expansion of the fusion device10is actuated by a rotational input, the expansion of the fusion device10is infinite. In other words, the endplates14,16can be expanded to an infinite number of heights dependent on the rotational advancement of the actuator assembly200. As discussed above, the central ramp16includes locking features for securing the endplates14,16. In the event the fusion device10needs to be repositioned or revised after being installed and expanded, the fusion device10can be contracted back to the unexpanded configuration, repositioned, and expanded again once the desired positioning is achieved. To contract the fusion device10, the actuator assembly200can be rotated in a second direction. As discussed above, actuator assembly200is in threaded engagement with the extension250of the central ramp18; thus, as the actuator assembly200is rotated in a second direction, opposite the first direction, the central ramp18moves with respect to the actuator assembly200and the first and second endplates14,16away from the flanged end253. As the central ramp18moves, the first and second endplates are pulled inwardly into the unexpanded position. Referring now toFIGS.33-38, an alternative embodiment of the expandable fusion device10is shown. In the illustrated embodiment, the fusion device includes a first endplate14, a second endplate16, a central ramp18, and an actuator assembly200. The fusion device10ofFIGS.33-38and its individual components are similar to the device10illustrated onFIGS.18-23with several modifications. The modifications to the device10will be described in turn below. Although the following discussion relates to the second endplate16, it should be understood that it also equally applies to the first endplate14as the second endplate16is substantially identical to the first endplate14in embodiments of the present invention. With additional reference toFIG.39, in an exemplary embodiment, the lower surface42of the second endplate16has been modified. In one embodiment, the central extension224extending from the lower surface42has been modified to include a second ramped surface258rather than a stop. In an exemplary embodiment, the second ramped surface258faces the second end41of the second endplate16. In contrast, ramped surface228on the central extension228faces the first end39of the second endplate. The concave surface228connects the ramped surface228and the second ramped surface258. With reference toFIGS.35-38, in an exemplary embodiment, the actuator assembly200has been modified to further include a driving ramp260. In the illustrated embodiment, the driving ramp260has a through bore262through which the extension254extends. In an embodiment, the driving ramp260is generally wedge-shaped. As illustrated, the driving ramp260may comprise a blunt end264in engagement with the flanged end253. In an exemplary embodiment, the driving ramp260further comprises angled surfaces266configured and dimensioned to engage the second ramped surface258of each of the endplates14,16and force apart the first and second endplates14,16. Referring now toFIGS.40-44, an alternative embodiment of the expandable fusion device10is shown. In the illustrated embodiment, the fusion device10includes a first endplate14, a second endplate16, a central ramp18, an actuator assembly200, and a driving ramp300. As will be discussed in more detail below, the actuator assembly200functions, in an embodiment, to pull the central ramp18and the driving ramp300together, which forces apart the first and second endplates14,16. In an embodiment, the expandable fusion device Although the following discussion relates to the first endplate14, it should be understood that it also equally applies to the second endplate16as the second endplate16is substantially identical to the first endplate14in embodiments of the present invention. With reference toFIGS.40-45, in an exemplary embodiment, the first endplate14has a first end39and a second end41. In the illustrated embodiment, the first endplate14further comprises an upper surface40connecting the first end39and the second end41, and a lower surface42connecting the first end39and the second end41. While not illustrated, in an embodiment, the first endplate14may comprise further comprises a through opening. The through opening, in an exemplary embodiment, is sized to receive bone graft or similar bone growth inducing material. In one embodiment, the upper surface40of the first endplate14is flat and generally planar to allow the upper surface40of the endplate14to engage with the adjacent vertebral body2. Alternatively, as shown inFIG.15, the upper surface40can be curved convexly or concavely to allow for a greater or lesser degree of engagement with the adjacent vertebral body2. It is also contemplated that the upper surface40can be generally planar but includes a generally straight ramped surface or a curved ramped surface. The ramped surface allows for engagement with the adjacent vertebral body2in a lordotic fashion. While not illustrated, in an exemplary embodiment, the upper surface40includes texturing to aid in gripping the adjacent vertebral bodies. Although not limited to the following, the texturing can include teeth, ridges, friction increasing elements, keels, or gripping or purchasing projections. In one embodiment, the first endplate14further comprises a first side portion202connecting the first end39and the second end41, and a second side portion204connecting the first end39and the second end41. In the illustrated embodiment, the first and second side portions202,204are extensions from the lower surface42. In an embodiment, the first and second side portions each have an interior surface302and an exterior surface304. In an exemplary embodiment, the first and second side portions202,204each include one or more ramped portions. In the illustrated embodiment, the first and second side portions202,204include first ramped portions306,308at the first end39of the endplate14and second ramped portions310,312at the second end41of the endplate. The first and second side portions202,204each can include a bridge portion314connecting the first ramped portions306,308and the second ramped portions310,312. In an embodiment, the first ramped portions306,308abut the exterior surface304of the respective side portions202,204, and the second ramped portions310,312abut the interior surface302of the respective side portions202,204. As illustrated, the first ramped portions306,308may include tongue portions316,318with the tongue portions316,318extending in an oblique direction with respect to the upper surface40of the endplate14. As further illustrated, the second ramped portions310,312may include tongue portions320,322that extend in an oblique direction with respect to the upper surface40of the endplate14. As best seen inFIG.45, the lower surface42of the second endplate16, in an embodiment, includes a central extension224extending along at least a portion of the lower surface. In the illustrated embodiment, the central extension224extends between the first and second side portions202and204. In an exemplary embodiment, the central extension224can extend generally between the first ramped portions306,308and the second ramped portions310,312. In one embodiment, the central extension224includes a generally concave surface226configured and dimensioned to form a through bore with the corresponding concave surface226(not illustrated) of the second endplate16. With reference toFIGS.43and44, the actuator assembly200includes a head portion324, a rod receiving extension326, and a connecting portion328that connecting portions that connects the head portion324and the rod receiving extension326. As illustrated, the head portion324may include one or more instrument gripping features330that can allow it to be turned by a suitable instrument. In addition, the head portion324has a larger diameter than the other components of the actuator assembly200to provide a contact surface with the driving ramp300. In the illustrated embodiment, the head portion324includes a rim332that provides a surface for contacting the driving ramp300. As can be seen inFIG.44, in an exemplary embodiment, the rod receiving extension326includes an opening sized and dimensioned to receive the extension336of the central ramp18. In an embodiment, the rod receiving extension326includes threading for threadingly engaging the extension336. In another embodiment, the rod receiving extension326includes ratchet teeth for engaging the extension336. In the illustrated embodiment, the head portion324and the rod receiving extension326are connected by connecting portion328which can be generally cylindrical in shape. With reference toFIGS.43,44, and46, the central ramp18includes expansion portion334and extension336. As best seen inFIG.46, the expansion portion334may include an upper portion338and side portions340,342that extend down from the upper portion338. In an embodiment, each of the side portions340,342include dual, overlapping ramped portions. For example, side portions340,342each include a first ramped portion344that overlaps a second ramped portion346. In the illustrated embodiment, the first ramped portion344faces the extension336while the second ramped portion344faces away from the extension336. In one embodiment, angled grooves348,350are formed in each of the first and second ramped portions344,346. In another embodiment, the angled grooves348,350are sized to receive the corresponding tongues316,318,320,322in the first and second endplates with angled grooves348receiving tongues320,322in the second endplate16and angled grooves350receiving tongues316,318in the first endplate14. Although the device10is described with tongues316,318,320,322on the endplates14,16and angled grooves348,350on the central ramp18, it should be understood that that device10can also be configured with grooves on the endplates14,16and tongues on the central ramp18, in accordance with one embodiment of the present invention. In an exemplary embodiment, the extension336is sized to be received within the rod receiving extension326of the actuator assembly200. In one embodiment, the extension336has threading with the extension336being threadingly received within the rod receiving extension326. In another embodiment, the extension336has ratchet teeth with the extension336being ratcheted into the rod receiving extension336. In an embodiment, the extension336include nose352at the end of the extension336. With reference toFIGS.47-49, in an exemplary embodiment, the driving ramp300includes an upper portion354having an upper surface356and an oblique surface358. In an embodiment, the driving ramp300further includes side portions360,362that extend from the upper portion354connecting the upper portion354with the lower portion364of the driving ramp300. As best seen inFIGS.48-49, the driving ramp300further includes a bore366, in an exemplary embodiment, sized to receive the connection portion328of the actuator assembly200. In one embodiment, the driving ramp300moves along the connection portion328when the actuator assembly200is pushing the driving ramp300. In an exemplary embodiment, the driving ramp300further includes contact surface368that engages the rim332of the head portion324of the actuator assembly200. In the illustrated embodiment, the contact surface368has a generally annular shape. In an exemplary embodiment, the side portions360,362of the driving ramp300each include overlapping ramped portions. For example, the side portions360,362each include first ramped portions370that overlap second ramped portions372. In the illustrated embodiment, the first ramped portions370face central ramp18while the second ramped portions372face the opposite direction. In one embodiment, angled grooves374,376are formed in each of the first and second ramped portions370,372.FIG.48is a perspective view of the driving ramp300that shows the top ends of the angled grooves374in ramped portions370.FIG.49is a perspective view of the driving ramp300that shows the top ends of the angled grooves376in ramped portions372. In an exemplary embodiment, the angled grooves374,376are sized to receive corresponding tongues316,318,320,322in the first and second endplates14,16with angled grooves370receiving tongues316,318in the second endplate16and angled grooves372receiving tongues320,322in the first endplate14. Although the device10is described with tongues316,318,320,322in the first and second endplates14,16and angled grooves370,372,374,376on the driving ramp300, it should be understood that that device10can also be configured with grooves on the second endplate16and tongues on the driving ramp300, in accordance with one embodiment of the present invention. Turning now toFIGS.40-42, a method of installing the expandable fusion device10ofFIGS.40-49is now discussed in accordance with one embodiment of the present invention. Prior to insertion of the fusion device, the disc space may be prepared as described above. The expandable fusion device10can then be inserted into and seated in the appropriate position in the intervertebral disc space. The expandable fusion device10is then introduced into the intervertebral space, with the end having the expansion portion334of the central ramp18being inserted. In an exemplary method, the fusion device10is in the unexpanded position when introduced into the intervertebral space. In an exemplary method, the intervertebral space may be distracted prior to insertion of the fusion device10. The distraction provide some benefits by providing greater access to the surgical site making removal of the intervertebral disc easier and making scraping of the endplates of the vertebral bodies2,3easier. With the fusion device10inserted into and seated in the appropriate position in the intervertebral disc space, the fusion device can then expanded into the expanded position, as best seen inFIG.42. To expand the fusion device10, an instrument is engaged with the head portion324of the actuator assembly200. The instrument is used to rotate actuator assembly200. As discussed above, actuator assembly200is threadingly engaged with the extension336of the central ramp18; thus, as the actuator assembly200is rotated in a first direction, the central ramp18is pulled toward the actuator assembly200. In an exemplary embodiment, the actuator assembly200is moved in a linear direction with the ratchet teeth engaging as means for controlling the movement of the actuator assembly200and the central ramp18. As the central ramp18is pulled towards the actuator assembly200, the first ramped portions344of the central ramp18push against the second ramped portions310,312of the second endplate16and the second ramped portions346of the central ramp18push against first ramped portions306,308of the first endplate14. In this manner, the central ramp18acts to push the endplates14,16outwardly into the expanded position. This can best be seen inFIGS.40-42. As the endplates14,16move outwardly the tongues316,318,320,322in the endplates14,16ride in the angled grooves348,350with the tongues320,322in the second endplate16riding in angled grooves348and the tongues316,318in the first endplate14riding in angled grooves350. As discussed above, the actuator assembly200also engages driving ramp300; thus, as the actuator assembly200is rotated in a first direction, the actuator assembly200pushes the driving ramp300towards the central ramp18in a linear direction. As the driving ramp300is pushed towards the central ramp18, the first ramped portions370of the driving ramp300push against the first ramped portions306,308of the second endplate16and the second ramped portions372of the driving ramp300push against the second ramped portions310,312of the first endplate14. In this manner, the driving ramp300also acts to push the endplates14,16outwardly into the expanded position. This can best be seen inFIGS.40-42. As the endplates14,16move outwardly the tongues316,318,320,322in the endplates14,16ride in the angled grooves370,372with the tongues316,318in the second endplate16riding in angled grooves370and the tongues320,322in the first endplate14riding in angled grooves372. Since the expansion of the fusion device10is actuated by a rotational input, the expansion of the fusion device10is infinite. In other words, the endplates14,16can be expanded to an infinite number of heights dependent on the rotational advancement of the actuator assembly200. Referring now toFIGS.50-54, an alternative embodiment of the expandable fusion device10is shown. In the illustrated embodiment, the fusion device10includes a first endplate14, a second endplate16, a central ramp18, an actuator assembly200, and a driving ramp300. As will be discussed in more detail below, the actuator assembly200functions, in an embodiment, to pull the central ramp18and the driving ramp300together, which forces apart the first and second endplates14,16. In an embodiment, the expandable fusion device may contain features, such as a through bore, that facilitate placement down an endoscopic tube. In an embodiment, the assembled fusion device10may be placed down the endoscopic tube and then expanded. Although the following discussion relates to the first endplate14, it should be understood that it also equally applies to the second endplate16as the second endplate16is substantially identical to the first endplate14in embodiments of the present invention. It should be understood that, in an embodiment, the first endplate14is configured to interlock with the second endplate16. With additional reference toFIG.55, in an exemplary embodiment, the first endplate14has a first end39and a second end41. As illustrated, the first end39may be wider than the second end41. In the illustrated embodiment, the first endplate14further comprises an upper surface40connecting the first end39and the second end41, and a lower surface42connecting the first end39and the second end41. As best seen inFIG.54, the lower surface42can be curved concavely such that the first and second endplates14,16form a through bore when the device10is in a closed position. In an embodiment, the first endplate14may comprise a through opening44. The through opening44, in an exemplary embodiment, is sized to receive bone graft or similar bone growth inducing material. In one embodiment, the upper surface40of the first endplate14is flat and generally planar to allow the upper surface40of the endplate14to engage with the adjacent vertebral body2. Alternatively, as shown inFIG.15, the upper surface40can be curved convexly or concavely to allow for a greater or lesser degree of engagement with the adjacent vertebral body2. It is also contemplated that the upper surface40can be generally planar but includes a generally straight ramped surface or a curved ramped surface. The ramped surface allows for engagement with the adjacent vertebral body2in a lordotic fashion. As illustrated, in an exemplary embodiment, the upper surface40includes texturing to aid in gripping the adjacent vertebral bodies. For example, the upper surface40may further comprise texturing400to engage the adjacent vertebral bodies. Although not limited to the following, the texturing can include teeth, ridges, friction increasing elements, keels, or gripping or purchasing projections. In one embodiment, the first endplate14further comprises a first side portion202connecting the first end39and the second end41, and a second side portion204connecting the first end39and the second end41. In the illustrated embodiment, the first and second side portions202,204are extensions from the lower surface42. In an embodiment, the first and second side portions202,204each include an interior surface302and an exterior surface304. In an embodiment, the first end39of the first endplate14is generally designed and configured to fit over the second end41of the second endplate16when the device10is in a closed position. As illustrated, the first and second side portions202,204each may include first ramped portions306,308, second ramped portions310,312, and/or central ramped portion402. In an embodiment, the first ramped portions306,308are proximate the first end39of the endplate14. In accordance with embodiment of the present invention, the first ramped portions306,308of the first endplate14are generally designed and configured to fit over the second ramped portions310,312of the second endplate16when the device10is in a closed position. In an exemplary embodiment, the first ramped portions306,308generally face the first end39and can extend in an oblique direction with respect to the upper surface40, for example. As illustrated, the first ramped portions306,308may include tongue portions316,318extending in an oblique direction with respect to the upper surface40of the endplate14. In an embodiment, the second ramped portions310,312are proximate the second end41of the endplate14. In an exemplary embodiment, the second ramped portions310,312can extend in an oblique direction with respect to the upper surface40and generally face the second end41. The first and second side portions202,204, in an embodiment, each can include a bridge portion314connecting the first ramped portions306,308and the second ramped portions310,312. As further illustrated, the second ramped portions310,312may include tongue portions320,322that extend in an oblique direction with respect to the upper surface40of the endplate14. In an embodiment, the endplate14further may include a central ramped portion402proximate the bridge portion314. In the illustrated embodiment, the endplate14includes a central ramped portion402proximate the bridge portion314of the second side portion204. In an exemplary embodiment, the central ramped portion402can extend in an oblique direction with respect to the upper surface40and face the first end39of the endplate14. As illustrated, the first ramped portions306,308may include tongue portions316,318with the tongue portions316,318extending in an oblique direction with respect to the upper surface40of the endplate14. With reference toFIGS.50-52and54, in an embodiment, the actuator assembly200includes a head portion324, an extension404, and a through bore406that extends longitudinally through the actuator assembly200. As illustrated, the head portion324may include one or more instrument gripping features330that can allow it to be turned by a suitable instrument. In addition, the head portion324has a larger diameter than the other components of the actuator assembly200to provide a contact surface with the driving ramp300. In the illustrated embodiment, the head portion324includes a rim332that provides a surface for contacting the driving ramp300. In an embodiment, the extension404is a generally rod-like extension. In another embodiment, the extension404includes ratchet teeth for engaging the extension336. With reference toFIGS.51,52, and56, the central ramp18has a first end408and a second end410. In an embodiment, the central ramp18includes a first expansion portion412, a second expansion portion414, a rod-receiving extension416, and a through bore418that extends longitudinally through the central ramp18. In an exemplary embodiment, first expansion portion412can be proximate the first end408of the central ramp18. As best seen inFIG.56, the first expansion portion412may include side portions420,422. In an embodiment, each of the side portions420,422includes dual, overlapping ramped portions that extend in oblique directions with respect to the through bore418. For example, side portions420,422each include a first ramped portion424that overlaps a second ramped portion426. In the illustrated embodiment, the first ramped portion424faces the rod-receiving extension416while the second ramped portion426faces the opposite direction. In one embodiment, angled grooves428,430are formed in each of the first and second ramped portions424,426. In an exemplary embodiment, the angled grooves428,430are sized to receive the corresponding tongues316,318,320,322in the first and second endplates14,16with angled grooves428receiving tongues320,322in the second endplate16and angled grooves430receiving tongues316,318in the first endplate14. Although the device10is described with tongues316,318,320,322on the endplates14,16and angled grooves428,430on the central ramp18, it should be understood that that device10can also be configured with grooves on the endplates14,16and tongues on the central ramp18, in accordance with one embodiment of the present invention. In an embodiment, the second expansion portion414is located on the rod-receiving extension416between the first end408and the second end410of the central ramp18. In an exemplary embodiment, the second expansion portion414includes central ramped portions432. In one embodiment, the second expansion portion414includes two central ramped portions432on opposite sides of the rod-receiving extension416. In an exemplary embodiment, the central ramped portions424extend in an oblique direction with respect to the through bore418and face the second end410of the central ramp18. The rod-receiving extension416extends from the first expansion portion412and has an opening434at the second end of the central ramp18. In an embodiment, the rod-receiving extension416is sized and configured to receive the extension404of the actuator assembly200. In an embodiment, the rod-receiving extension416has threading with the rod-receiving extension416threadingly receiving extension404of the actuator assembly200. In another embodiment, the rod-receiving extension416has ratchet teeth with the extension404being ratcheted into the rod-receiving extension416. With reference toFIGS.50-52and57, in an exemplary embodiment, the driving ramp300includes an upper portion354having an upper surface356and an oblique surface358. In an embodiment, the driving ramp300further includes a bore366, in an exemplary embodiment, sized to receive the extension404of the actuator assembly200. In the illustrated, embodiment, the upper portion354has a hole436that extends through the upper surface356to the bore366. Set screw438may be inserted through the hole436to secure the driving ramp300to the actuator assembly200. In one embodiment, the driving ramp300further includes contact surface368that engages the rim332of the head portion324of the actuator assembly200. In the illustrated embodiment, the contact surface368has a generally annular shape. In an embodiment, the driving ramp300further includes side portions360,362that extend from the upper portion354connecting the upper portion354with the lower portion364of the driving ramp300. In an exemplary embodiment, the side portions360,362of the driving ramp300each include a ramped portion438. In the illustrated embodiment, the ramped portion438faces central ramp300. In an embodiment, the ramped portion438is configured and dimensioned to engage the ramped portions306,308at the first end39of the second endplate16. In one embodiment, angled grooves440are formed in the ramped portions316,318. In an exemplary embodiment, the angled grooves440are sized to receive the corresponding tongues316,318in the second endplate16. Although the device10is described with tongues316,318on the second endplate16and angled grooves440on the driving ramp300, it should be understood that that device10can also be configured with grooves on the second endplate16and tongues on the driving ramp300, in accordance with one embodiment of the present invention. A method of installing the expandable fusion device10ofFIGS.50-57is now discussed in accordance with one embodiment of the present invention. Prior to insertion of the fusion device, the disc space may be prepared as described above. The expandable fusion device10can then be inserted into and seated in the appropriate position in the intervertebral disc space. In an embodiment, the device10is assembled prior to insertion. The expandable fusion device10can be introduced into the intervertebral space, with the end having the first end408of the central ramp18being inserted. In an exemplary method, the fusion device10is in the unexpanded position when introduced into the intervertebral space. In an exemplary method, the intervertebral space may be distracted prior to insertion of the fusion device10. The distraction provide some benefits by providing greater access to the surgical site making removal of the intervertebral disc easier and making scraping of the endplates of the vertebral bodies2,3easier. With the fusion device10inserted into and seated in the appropriate position in the intervertebral disc space, the fusion device can then expand into the expanded position. To expand the fusion device10, an instrument is engaged with the head portion324of the actuator assembly200. The instrument is used to rotate actuator assembly200. As discussed above, actuator assembly200is threadingly engaged with the rod receiving extension416of the central ramp18; thus, as the actuator assembly200is rotated in a first direction, the central ramp18is pulled toward the actuator assembly200. In an exemplary embodiment, the actuator assembly200is moved in a linear direction with the ratchet teeth engaging as means for controlling the movement of the actuator assembly200and the central ramp18. As the central ramp space18is pulled towards the actuator assembly200, the central ramp18acts to push endplates14,16outwardly into the expanded position. By way of example, the first ramped portions424, second ramped portions426, and central ramped portions432push against the corresponding ramped portions in the first and second endplates14,16. The first ramped portions424in the first expansion portion412of the central ramp18push against the second ramped portions310,312of the second endplate16with the corresponding tongues320,322in the second ramped portions310,312of the second endplate16riding in angled grooves428in the first ramped portions424in the first expansion portion412. The second ramped portions426in the first expansion portion412push against the first ramped portions316,318of the first endplate14with the corresponding tongues316,318in first ramped portions316,318of the first endplate14riding in angled grooves430in the second ramped portions426in the first expansion portion412. The central ramped portions432in the second expansion portion414push against the central ramped portion402in the first and second endplates14,16. As discussed above, the actuator assembly200also engages driving ramp300; thus, as the actuator assembly200is rotated in a first direction, the actuator assembly200pushes the driving ramp300towards the central ramp18in a linear direction. As the driving ramp300is pushed towards the central ramp18, the driving ramp300also acts to push the endplates14,16outwardly into the expanded position. By way of example, the ramped portions438of the driving ramp300push against ramped portions306,308at the first end39of the second endplate16. As the endplates14,16move outwardly, the tongues316,318in the ramped portions306,308of the second endplate16ride in the angled grooves440in the ramped portions438of the driving ramp300. It should also be noted that the expansion of the endplates14,16can be varied based on the differences in the dimensions of the various ramped portions in the central ramp18, the driving ramp300, and the first and second endplates14,16. As best seen inFIG.16, the endplates14,16can be expanded in any of the following ways: straight rise expansion, straight rise expansion followed by a toggle into a lordotic expanded configuration, or a phase off straight rise into a lordotic expanded configuration. In the event the fusion device10needs to be repositioned or revised after being installed and expanded, the fusion device10can be contracted back to the unexpanded configuration, repositioned, and expanded again once the desired positioning is achieved. To contract the fusion device10, the instrument can be used to rotate the actuator assembly200in a second direction that is opposite the first direction. Rotation of the actuator assembly200results in movement of the central ramp18and the driving ramp300away from one another. As the central ramp18and the driving ramp300move, the endplates14,16move inwardly into the unexpanded position. Although the preceding discussion only discussed having a single fusion device10in the intervertebral space, it is contemplated that more than one fusion device10can be inserted in the intervertebral space. It is further contemplated that each fusion device10does not have to be finally installed in the fully expanded state. Rather, depending on the location of the fusion device10in the intervertebral disc space, the height of the fusion device10may vary from unexpanded to fully expanded. It should be noted that, as well as the height being varied from an unexpanded state to an expanded state, the fusion10may be positioned permanently anywhere between the expanded state and the unexpanded state. Referring now toFIGS.58-65, an alternative embodiment of the expandable fusion device10is shown. In the illustrated embodiment, the fusion device10includes an upper endplate480, a lower endplate485, and actuator assembly445. The actuator assembly445comprises a front sloped height actuator450, a rear sloped height actuator455, and a linear actuator460. In an embodiment the linear actuator460functions to pull the front sloped actuator450and the rear sloped actuator455together, which forces apart the upper endplate480and lower endplate485. With reference toFIGS.58-59, in an exemplary embodiment of fusion device10, the actuator assembly445comprises a front sloped actuator450, a rear sloped actuator455, and a linear actuator460. As illustrated, the linear actuator460may comprise a head portion465and an extension466. In an embodiment, the extension466is a generally rod-like extension that comprises surface threads470. It should be understood that, while the surface threads470of the linear actuator460are referred to as threaded, the surface threads470may only be partially threaded in accordance with one embodiment. The linear actuator460of the actuator assembly445may extend through an opening456in the rear sloped actuator455where the surface threads470of the linear actuator460engage the complimentary threads500of the extension475of the front sloped actuator450. Thus, as the linear actuator460is rotated in a first direction, the actuator assembly445pulls the front sloped actuator450towards the rear sloped actuator455and consequently also towards the head portion465of the linear actuator460in a linear direction. As the front sloped actuator450is pulled towards the rear sloped actuator455, the sloped surfaces454,459respectively, of the front sloped actuator450and the rear sloped455actuator push the upper480and lower485endplates outwardly into the expanded position. With reference toFIGS.58-59and63, in an exemplary embodiment, the upper and lower endplates480,485may comprise two portions, such as two opposing mirrored halves. Both the upper endplate480and lower endplate485may comprise a front end481and a rear end482. The front and rear ends481,482of each portion of each endplate may be substantially similar to the front and rear ends481,482of every other portion of every other endplate. It should be understood that that references to the front and rear ends481,482of each endplate are with respect to the front and rear of the expandable fusion device10, which is with respect to the direction of placement into an intervertebral disc space with the front of the expandable fusion device10placed into the space first, followed by the rear of the expandable fusion device10. Each portion of the upper and lower endplates480,485further may comprise front ramped surface483and rear ramped surface484, as a component of the front and rear ends481,482of each portion of the upper and lower endplate480,485. The front ramped surface483may be located on the front end481of each half of the upper and lower endplates480,485. The rear ramped surface484may be located on the rear end482of each half of the upper and lower endplates485. With additional reference toFIGS.60and61, in the illustrated embodiment, the front and rear ends481,482of each portion of upper and lower endplates480,485contains a slot490that engages the corresponding elevated and angled tongues495of the front sloped actuator450and the rear sloped actuator455. The elevated and angled tongues495may be substantially identical in design and function for both the front sloped actuator450and the rear sloped actuator455. Because the elevated and angled tongues495are angled at a slant that directs away from the center of the expandable fusion device, as the front sloped actuator450is pulled towards the rear sloped actuator455by rotation of the linear actuator460, the ramped sections454,459of the front and rear sloped actuators450,455, in conjunction with the elevated and angled tongues495of the front and rear sloped actuators450,455pushes both portions of the upper and lower endplates480,485outward simultaneously in both horizontal and vertical directions. With reference toFIGS.58-62, front sloped actuator450may comprise a front end451and a rear end453. The front end451may comprise opposing sloped surfaces452. In some embodiments, the front end451of the front sloped actuator450is the section of the expandable fusion device10that is first inserted into an intervertebral disc space. The front sloped actuator450may also comprise a rear end453connected to extension475from the front slope actuator450. The rear end453of the front sloped actuator450also may comprise opposing sloped surfaces454. The opposing sloped surfaces454of the rear end453of the front sloped actuator450may be sloped towards the rear sloped actuator455. The opposing sloped surfaces454of the rear end453of the front sloped actuator450also comprises the elevated and angled tongues495that engage the slots490of the halves of the upper and lower endplates480,485, as described in the preceding paragraph. The front sloped actuator450also comprises a threaded screw opening463. As illustrated, the extension475from the front sloped actuator450may comprise extending threaded prongs476a,476b. The extension475is generally located in the center of the actuator assembly445, and with respect to the front end451of the front sloped actuator450, the extension475extends longitudinally towards the rear sloped actuator455and the linear actuator460. The extension475may be sized and configured to receive the extension466of the linear actuator460. The extension475may comprise threads500that engage with the threads470of the extension466of the linear actuator460. Turning the linear actuator460, rotates the threads470of the linear actuator460, which are threadingly engaged to the threads500of the extension475of the front sloped actuator450, and consequently can push or pull the extension475and therefore the front sloped actuator450towards or away from the rear sloped actuator455and the linear actuator460, dependent upon which direction the linear actuator460is rotated. With continued reference toFIGS.58-62, rear sloped actuator455may comprise an opening456. The opening456may be disposed in the center of the rear sloped actuator455and may run longitudinally throughout the entirety of the rear sloped actuator455. The opening456may be sized to receive the extension of the475of the front sloped actuator450with the extension466of the linear actuator460disposed therein. The rear sloped actuator455also contains a front side458which faces the extension475of the front sloped actuator450. The front side458of the rear sloped actuator455has opposing sloped surfaces459, that are sloped towards the extension475and consequently the front sloped actuator450. The front side458of the rear sloped actuator455also comprises the elevated and angled tongues495that engage the slots490of the halves of the upper480and lower485endplates, as described above. As best seen inFIGS.61and63, in an exemplary embodiment, the rear sloped actuator455comprises tool engagement surfaces510. Tool engagement surface510is a surface for engagement of a placement and positioning tool (not shown) which allows for insertion and adjustment of the fusion device10into an intervertebral space as best shown inFIG.1. Tool engagement surfaces510may be located horizontally on opposing sides of sloped rear actuator455. As discussed above, the linear actuator460may comprise a head portion465and an extension466. Surface threads470may be disposed on the extension466of the linear actuator460. Surface threads470are complimentary to and engage the threads500of the extension475of the front sloped actuator450. In another embodiment, the extension466includes ratchet teeth for engaging the front sloped actuator450. Linear actuator460also comprises opening468in the head portion465of linear actuator460. In the illustrated embodiment, the opening468includes one or more instrument gripping features472that can allow it to be turned by a suitable instrument. Linear actuator460may disposed in the opening456of the rear sloped actuator455with the extension466running through the opening456. The head portion465may be of a diameter that is too large to pass through the opening456and thus allows the linear actuator460to reach an endpoint where it, or from another perspective the front sloped actuator450, cannot be drawn closer through rotation of the linear actuator460. As best seen inFIGS.60-62, in an exemplary embodiment, the front sloped actuator450comprises an extension475further comprising threads500that engage the surface threads470of the linear actuator460. Thus, as the linear actuator460is rotated in a first direction by a threaded instrument (not shown), the front sloped actuator450moves toward the flanged end465of the linear actuator460. In the event the fusion device10needs to be repositioned or revised after being installed and expanded, the fusion device10can be contracted back to the unexpanded configuration, repositioned, and expanded again once the desired positioning is achieved. To contract the fusion device10, the thread locking screw460can be rotated in a second direction. As discussed above, actuator assembly445is in threaded engagement with the extension475of the front sloped actuator450; thus, as linear actuator460is rotated in a second direction, opposite the first direction, the front sloped actuator450moves with respect to the actuator assembly445and the upper and lower endplates480,485away from the flanged end465. With reference toFIGS.58-59, and63, in an exemplary embodiment the upper and lower endplates480,485may further comprise endplate pins515. As illustrated, the upper and lower endplates480,485may each comprise two endplate pins515. Endplate pins515may rest in slots disposed in each portion of the upper and lower endplates480,485. In the illustrated embodiment, the endplate pins515connect the portions of the upper endplate480and the portions of the lower endplate485. Endplate pins515can provide for even and simultaneous movement of endplate portions. With specific reference toFIGS.64(a) and64(b), endplate pins515can be seen in both the unexpanded fusion device configuration as shown inFIG.64(a)and the expanded fusion device configuration as shown inFIG.64(b). In an exemplary embodiment,FIG.65depicts bone graft hole520, which is shown disposed in upper endplate480. Bone graft hole520in conjunction with threaded hole470of the linear actuator460provides space for bone grafts that may be used in the intervertebral fusion procedure. A method of installing the expandable fusion device10ofFIGS.58-65is now discussed in accordance with one embodiment of the present invention. Prior to insertion of the fusion device10, the disc space may be prepared as described above. The expandable fusion device10can then be inserted into and seated in the appropriate position in the intervertebral disc space. In an embodiment, the device10is assembled prior to insertion. The expandable fusion device10can be introduced into the intervertebral space, with the end having the first end of the front sloped actuator450being inserted. In an exemplary method, the fusion device10is in the unexpanded position when introduced into the intervertebral space. In an exemplary method, the intervertebral space may be distracted prior to insertion of the fusion device10. The distraction provide some benefits by providing greater access to the surgical site making removal of the intervertebral disc easier and making scraping of the endplates of the vertebral bodies2,3easier as depicted inFIG.1. With the fusion device10inserted into and seated in the appropriate position in the intervertebral disc space, the fusion device10can then expand into the expanded position. To expand fusion device10, an instrument may be engaged with the instrument gripping features472the linear actuator460. The threaded instrument may rotate the linear actuator460in the first direction, drawing the front sloped actuator450and the rear sloped actuator455together and contracting the actuator assembly455. In an exemplary embodiment the front sloped actuator450and the linear actuator460may be drawn together in a linear fashion with the threads500of the extension475of the front sloped actuator450engaging the surface threads470of the linear actuator460as a means for controlling the movement of the contraction of the actuator assembly445and consequently the expansion of the upper and lower endplates480,485, which expand horizontally and vertically with contraction of the actuator assembly445. It should also be noted that the expansion of the upper and lower endplates480,485may be varied based on the differences in the dimensions of the sloped surfaces454and459and the direction of the angle in the elevated and angled tongues495. As best seen inFIG.16, the upper and lower endplates480and485can be expanded in any of the following ways: straight rise expansion, straight rise expansion followed by a toggle into a lordotic expanded configuration, or a phase off straight rise into a lordotic expanded configuration. Although the preceding discussion only discussed having a single fusion device10in the intervertebral space, it is contemplated that more than one fusion device10can be inserted in the intervertebral space. It is further contemplated that each fusion device10does not have to be finally installed in the fully expanded state. Rather, depending on the location of the fusion device10in the intervertebral disc space, the height of the fusion device10may vary from unexpanded to fully expanded. It should be noted that, as well as the height being varied from an unexpanded state to an expanded state, the fusion10may be positioned permanently anywhere between the expanded state and the unexpanded state. Referring now toFIGS.66-73, an alternative embodiment of the expandable fusion device10is shown. In the illustrated embodiment, the fusion device10includes an upper endplate570, a lower endplate580, and a collective actuator assembly520. The collective actuator assembly520comprises a front sloped actuator assembly530, a rear sloped actuator assembly540, and threaded locking screws550. In an embodiment a threaded instrument560functions to pull the front sloped actuator assembly530and the rear sloped actuator assembly540together, which forces apart the upper endplate570and lower endplate580. With reference toFIGS.66-68and71, in an exemplary embodiment of fusion device10, the collective actuator assembly520comprises a front sloped actuator assembly530, a rear sloped actuator assembly540, and threaded locking screws550. The threaded locking screws550have flanged ends551and surface threads552that extend at least partially through the collective actuator assembly520. It should be understood that, while the surface threads552of the threaded locking screws550are referred to as threaded, the surface threads552may only be partially threaded in accordance with one embodiment. The threaded locking screws550of the collective actuator assembly520may rest in an opening541in the rear width actuator542of the rear sloped actuator assembly540where the surface threads552of the threaded locking screws550engage threaded screw openings595of the front height actuator532of the front sloped actuator assembly530. The threaded instrument560(FIG.72) may extend through an instrument opening561in the rear width actuator542of the rear sloped actuator assembly540. As the threaded instrument560is rotated in a first direction, the collective actuator assembly520pulls the front sloped actuator assembly530towards the rear sloped actuator assembly540and consequently also towards the flanged ends551of the threaded locking screws550in a linear direction. As the front sloped actuator assembly530is pulled towards the rear sloped actuator assembly540, the front width actuator536and the rear width actuator542are pulled together. As they are pulled together, the front and rear width actuators536,542drive apart the portions of the upper endplate570and the portions of the lower endplate575. More particularly, the front and rear width actuators536542engage the front height actuators532and the rear height actuators546to force them horizontally outward, which in turn engage the upper and lower endplates570,575to force them horizontally outward. The front stop pins533may have one end disposed in the retaining bores534of the front height actuator532and opposite ends disposed in the front stop pint track535of the front width actuator536. The front stop pins533may slide in the front stop pin track535of the front width actuator536until they reach the end of the front stop pin track535and movement of the front width actuator536is stopped, thus restricting lateral expansion of the device10, as best seen onFIG.68. Simultaneously, the rear stop pins543disposed in the retaining bores544of the rear width actuator542, slide in the rear stop pin tracks545of the rear height actuators546until they reach the end of the rear stop pin tracks545and movement of the rear width actuator542is stopped, as best seen onFIGS.68and71. When the front width actuator536is stopped, the front sloped actuator assembly530may be pulled towards the rear sloped actuator assembly540, by simultaneously turning threaded locking screws550. As threaded locking screws550are rotated simultaneously in a first direction, the sloped surfaces537,547respectively, of the front height actuators532and the rear height actuator546push the upper570and lower580endplates vertically outward into the expanded position. With reference toFIGS.66-68, in an exemplary embodiment, the upper and lower endplates570,580may split into two portions, such as being bifurcated into two opposing mirrored halves. The portions of the upper endplate570maybe substantially identical to the portions of the lower endplate580in embodiments of the present invention. Both the upper and lower endplates570,580may comprise front and rear ends571,572. The front and rear ends571,572of each portion of each endplate may be substantially similar to the front and rear ends571,572of every other portion of every other endplate. It should be understood that that references to the front and rear ends571,572of each endplate are with respect to the front and rear of the expandable fusion device10, which is with respect to the direction of placement into an intervertebral disc space with the front of the expandable fusion device10placed into the space first, followed by the rear of the expandable fusion device10. Each portion of the upper and lower endplates570,580further comprises front and rear ramped surface portions573,574, as a component of the front and rear ends571,572of each portion of the upper and lower endplate570,580respectively. The front ramp surface573is located on the front end571of each portion of the upper and lower endplates570,580. The rear ramp surface574is located on the rear end572of each portion of the upper and lower endplates570,580. The front and rear ends571,572of each half of upper endplate570contains a slot575that engages the corresponding elevated tongues590of the front height actuator532and the rear height actuator546of the front sloped actuator assembly530and the rear sloped actuator assembly540respectively. The elevated tongues590may be substantially identical in design and function for both the front height actuator532and the rear height actuator546. As best seen inFIGS.66-67and69, the front sloped actuator assembly530may comprise a front width actuator536. As illustrated, the front width actuator536may be wedge-shaped. The front width actuator536may further comprise a sloped front end538. The sloped front end538may be the section of the expandable fusion device10that is first inserted into an intervertebral disc space. The front width actuator536may further comprise a front stop pin track535that is complimentary to the front stop pins533. The front width actuator536may also comprise a threaded instrument opening539. The threaded instrument opening539also comprises threads that engage the threaded instrument560. The front sloped actuator assembly530may also comprise a pair of front height actuators532. The front height actuators532may be mirrored analogues that have substantially the same function. The front width actuator536may be disposed between the pair of front height actuators532. The front height actuators532comprise a sloped surface537and elevated tongues590that vertically expand the upper570and lower580endplates. The front height actuators532additionally comprise a threaded screw opening595. The threaded screw opening595engages the threaded locking screws550. When threaded locking screws550are turned in a first direction, upper570and lower580endplates are expanded vertically, due to the contraction of the front sloped actuator assembly530and the rear sloped actuator assembly540. Front height actuators532may additionally comprise retaining bores534, wherein the front stop pins533are disposed. Rear sloped actuator assembly540may comprise a rear width actuator542. As illustrated, the rear width actuator542may be generally wedge-shaped. The rear width actuator542may further comprise an instrument opening561wherein the threaded instrument560may be inserted to operate the expandable fusion device10. The rear width actuator542may additionally comprise openings541. Threaded locking screws550may be inserted into openings541of the rear width actuator542and run through the collective actuator assembly520to connect to the threaded screw openings595in the front height actuators532. Rear width actuator542may additionally comprise retaining bores544which house the rear stop pins543. The rear stop pins543are fixed in the retaining bores544and do not move relative to and apart from the retaining bores544. The rear stop pins543and retaining bores544may be present in pairs, located on the top and bottom of the rear width actuator542. Rear stop pins543connect the rear width actuator542to the rear height actuators546. Rear height actuators546comprise rear stop pin tracks545in which the rear stop pins543may be disposed. When the threaded instrument560is turned in a first direction to contract the collective actuator assembly520and draw the front sloped actuator assembly530and the rear sloped actuator540, the rear stop pins543slide in the rear stop pin tracks545to expand the upper and lower endplates570,580horizontally, until the rear stop pins543contact the end of the rear stop pin tracks545. The rear sloped actuator assembly540may also comprise a pair of rear height actuators546. The rear height actuators546may be mirrored analogues that have substantially the same function. The rear width actuator542may be disposed between the pair of rear height actuators546. Rear height actuators546may comprise a sloped surface547and elevated tongues590that vertically expand the upper570and lower580endplates. Sloped surface547is sloped towards the front sloped actuator assembly530. Elevated tongues590engage the corresponding slots575of the upper570and lower580endplates. As discussed above, the threaded locking screws550of the collective actuator assembly520, may each comprise a flanged end551and surface threads552. Surface threads551are disposed on the front end553of the threaded locking screws. The front end553of the threaded locking screws550are longitudinally opposite the flanged ends551of the threaded locking screws550. Surface threads551are complimentary to and engage the threads of the threaded screw openings595of the front height actuators532of the front sloped actuator assembly530. Threaded locking screws550also comprise an instrument opening554in the flanged ends551of the threaded locking screws550. In an exemplary embodiment, the instrument opening554is configured and dimensioned to receive a locking screw instrument (not shown). Threaded locking screws550are disposed in the threaded screw openings541of the rear width actuator542with the front end553running through the threaded screw openings541. The flanged ends551may be of a diameter that is too large to pass through the threaded screw openings541and thus allows the threaded locking screws550to reach an endpoint where it, or from another perspective the front sloped actuator assembly530, cannot be drawn closer through rotation of the threaded locking screws550. As best seen inFIG.68, as the threaded locking screws550are rotated in a first direction by a locking screw instrument (not shown), the front height actuators532are pulled towards the flanged ends551of the threaded locking screws550. In the event the fusion device10needs to be repositioned or revised after being installed and expanded, the upper570and lower580endplates of fusion device10can be contracted back to the unexpanded configuration, repositioned, and expanded again once the desired positioning is achieved. To contract the endplates570,580of fusion device10, the threaded instrument560and the threaded locking screws550can be rotated in a second direction. As discussed above, rear sloped actuator assembly540is in threaded engagement with the front sloped actuator assembly530; thus, as the threaded instrument560is rotated in a second direction, opposite the first direction, the front sloped actuator assembly530is pushed away from the rear sloped actuator assembly540and the upper570and lower580endplates are pulled inward horizontally, this may continue until the front stop pins533and the rear stop pins543reach the end of their collective stop pin tracks535and545respectively. When the upper570and lower580endplates have been contracted to their initial unexpanded horizontal positions, the threaded locking screws550can be turned in a second direction opposite the first direction. Rotating the threaded locking screws550in a second direction will continue to push the front sloped actuator assembly530away from the rear sloped actuator assembly540. This can continue, until the endplates570,580are fully contracted into the default unexpanded configuration. With reference toFIGS.66-68, in an exemplary embodiment the upper and lower endplates570,580each comprise endplate pins600. As illustrated, the upper and lower endplates570,580each comprise two endplate pins600. Endplate pins600rest in slots disposed in each half of the upper and lower endplates605,610. Endplate pins600connect the halves of the upper endplate470and the halves of the lower endplate580. Endplate pins600provide for even and simultaneous movement of endplate halves. In an exemplary embodiment,FIGS.71(a)-71(c)depict bone graft hole615in the upper and lower endplates570,580. Bone graft hole615in conjunction with the threaded instrument opening561provides space for bone grafts that may be used in the intervertebral fusion procedure. A method of installing the expandable fusion device10ofFIGS.66-72is now discussed in accordance with one embodiment of the present invention. Prior to insertion of the fusion device, the disc space may be prepared as described above. The expandable fusion device10can then be inserted into and seated in the appropriate position in the intervertebral disc space. In an embodiment, the device10is assembled prior to insertion. The expandable fusion device10can be introduced into the intervertebral space, with the end having the first end of the front sloped actuator450being inserted. In an exemplary method, the fusion device10is in the unexpanded position when introduced into the intervertebral space. In an exemplary method, the intervertebral space may be distracted prior to insertion of the fusion device10. The distraction provide some benefits by providing greater access to the surgical site making removal of the intervertebral disc easier and making scraping of the endplates of the vertebral bodies2,3easier as depicted inFIG.1. With the fusion device10inserted into and seated in the appropriate position in the intervertebral disc space, the fusion device10can then expand into the expanded position. To expand fusion device10, a threaded instrument is inserted into the threaded instrument opening561and the threaded instrument opening539of the rear sloped actuator assembly540and the front sloped actuator assembly530respectively. The threaded instrument is rotated in the first direction, drawing the front sloped actuator assembly530and the rear sloped actuator540together and contracting the collective actuator assembly520. In an exemplary embodiment the front sloped actuator assembly530and the rear sloped actuator assembly540are drawn together in a linear fashion with the threads of the threaded instrument opening539of the front sloped actuator assembly530engaging the surface threads561of the threaded instrument560as a means for controlling the movement of the contraction of the collective actuator assembly520and consequently the horizontal expansion of the upper570and lower580endplates, which expand horizontally with contraction of the collective actuator assembly520. When horizontal expansion of endplates570and580has reached its maximum, threaded locking screws550may be rotated in a first direction simultaneously to further draw the front actuator assembly530towards the rear actuator assembly540. This contraction of the collective actuator assembly520expands the upper570and lower580endplates until they reach their maximum vertical expansion. It should also be noted that the expansion of the upper570and lower580endplates may be varied based on the differences in the dimensions of the sloped surfaces537and547. As best seen inFIG.16, the upper570and lower580endplates may be expanded in any of the following ways: straight rise expansion, straight rise expansion followed by a toggle into a lordotic expanded configuration, or a phase off straight rise into a lordotic expanded configuration. Although the preceding discussion only discussed having a single fusion device10in the intervertebral space, it is contemplated that more than one fusion device10can be inserted in the intervertebral space. It is further contemplated that each fusion device10does not have to be finally installed in the fully expanded state. Rather, depending on the location of the fusion device10in the intervertebral disc space, the height of the fusion device10may vary from unexpanded to fully expanded. It should be noted that, as well as the height being varied from an unexpanded state to an expanded state, the fusion10may be positioned permanently anywhere between the expanded state and the unexpanded state. The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims. Although individual embodiments are discussed, the invention covers all combinations of all those embodiments. | 90,691 |
11857438 | DETAILED DESCRIPTION OF THE INVENTION Referring toFIGS.1A-1E, in one embodiment a method for inserting an intervertebral disc prosthesis104into an intervertebral space IS between two adjacent vertebrae V first involves inserting the disc prosthesis104partway into the space IS while the prosthesis104is constrained (FIG.1A). By “constrained” it is meant that endplates106of the prosthesis104are not free to articulate (move) about a core112(FIGS.1B-1E) of the prosthesis104. To insert the prosthesis104partway under constraint, an insertion device102may be used. Such an insertion device102may suitably include a grasping member110coupled with an elongate shaft108. At an end opposite the grasping member110(not shown), the insertion device102may include a handle, an actuator to control the grasping member110and/or any other suitable features, some of which are described further below. The prosthesis104may be inserted as far into the intervertebral space IS under constraint as is desired. In some embodiments, for example, the prosthesis104is inserted under constraint approximately one-third of the way into the space IS. In other embodiments, the prosthesis104may be inserted less than one-third of the way, closer to one-half of the way, or any other suitable distance into the space IS. As shown inFIG.1B, once the prosthesis104is inserted partway under constraint, the insertion device102may be removed, thus releasing the prosthesis104from constraint. From this point forward, the endplates106of the prosthesis104are free to move about the prosthesis core112. Examples of such a prosthesis104with endplates106and core112are described by the assignees of the present application in U.S. patent application Ser. Nos. 10/855,817 and 10/855,253, previously incorporated by reference, although any other suitable prosthesis may be used in various embodiments. Referring now toFIGS.1C-1E, in some embodiments the insertion device102may be used to push the unconstrained prosthesis104farther into the intervertebral space. In some embodiments, one or more separate pusher devices (not shown) may be used in addition to or instead of the insertion device102for pushing the prosthesis104farther into the space IS.FIGS.1C and1Ddemonstrate that in one embodiment the grasping member110of the insertion device102is adapted to push individually against the upper (FIG.1C) and lower (FIG.1D) endplates106. As shown inFIG.1E, the grasping member110may also be adapted to push simultaneously against the upper and lower endplates106, thus pushing the prosthesis104as a unit farther into the intervertebral space IS. By inserting the prosthesis104farther into the space IS while it is unconstrained, thus allowing the endplates106to articulate about the core112, the method reduces the need for increasing the height of the intervertebral space IS by distracting the vertebrae V away from each other. Because the endplates106are free to articulate, the prosthesis104is better able to conform to the intervertebral space IS, thus reducing trauma to the vertebrae V and also limiting trauma to surrounding structures caused by over-distraction. The unconstrained prosthesis104may be inserted as far into the intervertebral space IS as is desired. In some embodiments, for example, the prosthesis104is pushed far enough into the space IS so that a center of rotation of the prosthesis104is closer to a posterior edge P (FIG.1E) of the vertebrae V than to an anterior edge A of the vertebrae V. In alternative embodiments, any other suitable insertion distance or depth may be used. Once a desired amount of insertion is achieved, the insertion device102is removed and the prosthesis104is in place between the two adjacent vertebrae V. In various embodiments, the method just described may include fewer steps or additional steps. For example, in one embodiment, a spreader device is inserted between the two vertebrae V to spread them apart before inserting the constrained prosthesis104. An example of such a spacing device is described in PCT Patent Application Number 2004/000171, previously incorporated by reference. In such embodiments, the insertion device102is typically sized to fit between opposing jaws of the spreader device. When the prosthesis104is partially inserted, the spreader device is removed from the intervertebral space IS, and the prosthesis104is released from constraint and inserted the rest of the way into the space IS. Also in some embodiments, a midline indicator device may be used to facilitate the location of a midline on one or both of the two adjacent vertebrae V. An example of such a midline indicator device is described in PCT Patent Application Number 2004/000170, previously incorporated by reference. Typically, the midline indicator is used before the disc prosthesis104is inserted. These and other steps or features may be included in various embodiments of the method without departing from the scope of the invention. Referring now toFIGS.2A-2C, one embodiment of an insertion device120for inserting an intervertebral disc prosthesis140suitably includes an elongate shaft126, a grasping member122coupled with the distal end of the shaft126, and a handle128at the proximal end of the shaft120, including one or more actuators130for controlling movement of the grasping member122. One or more rods124or other connectors extend from the grasping member122through the shaft126to the actuator130. In the embodiment shown, for example, the grasping member122comprises two opposable tongs or jaws, which may be moved closer together or farther apart (double-headed arrows) via the actuator130and rods124. The actuator130shown is a thumb screw. In alternative embodiments, scissor-type mechanisms, spring loaded tongs, a triggering mechanism or any other suitable grasping and actuating means may be used. Any suitable material or combination of materials may be used to manufacture the insertion device, including but not limited to stainless steel and/or other suitable metals. As shown inFIG.2B, the insertion device120may grasp a disc prosthesis140such that the grasping member122does not protrude beyond an outer edge141of the prosthesis140. In other words, the grasping member122holds onto an inner portion of the prosthesis140, so that it will not extend beyond the lateral edges141of the prosthesis140. This configuration is advantageous during insertion, as the grasping member122is essentially out of the way, within the outer edge141of the prosthesis140. FIG.2Cis a side view of a distal end of the insertion device120shown inFIGS.2A and2B. It is more readily seen that the disc prosthesis140includes a core146and two endplates142. Each endplate142includes an inner rim144that contacts the core146and a fin148for enhancing attachment to vertebral bone. The grasping member122of the insertion device120grasps the inner rims144of the endplates142, thus positioning it within the outer edges141of the endplates142. Of course, in various embodiments of the methods described herein, any suitable alternative prosthesis may be used, as well as any suitable insertion device (or devices). Referring now toFIG.3, in some embodiments a separate pusher device150may be used to push an unconstrained prosthesis140farther into an intervertebral space. The pusher device150is typically constructed of stainless steel or other suitable metal and suitably includes an elongate shaft152, a pusher member154at the distal end of the shaft152, and a handle158at the proximal end of the shaft152. The pusher member154includes a concave inner portion156for pushing against the inner rims144of endplates142of the prosthesis140. The concave portion156may be tapered and/or rounded to facilitate pushing against upper and lower endplates142individually while also allowing for simultaneous pushing against both endplates142. In alternative embodiments, the pusher device150may have any of a number of alternative configurations, shapes, sizes and the like. In some embodiments, multiple pusher devices150of different configurations and/or sizes are provided to allow a physician to select one or more desired devices150. Referring now toFIGS.4A-4E, a spreader device10for spreading adjacent vertebrae to facilitate intervertebral disc prosthesis30insertion is shown. Again, the device10is described in greater detail in PCT Patent Application Number 2004/000171, which was previously incorporated by reference. The spreader device10generally includes distally located opposable jaws12, a slidable pusher member45and an actuator15. The opposable jaws12are carried by arms14which form part of a scissors-type mechanism having a single hinge point15. Handles16on the proximal end of the device are used to manipulate the opposable jaws12. When the handles16are actuated, arms14translate the actuation motion to the single hinge point scissors type mechanism15. This causes the opposable jaws12to open or close. The jaws12have opposing surfaces18formed with ribs20and transverse slots22which extend for the height of the jaws as seen inFIG.4B. At their free ends, the jaws12are provided with relatively sharp tips or blades24having curved extremities26. FIGS.4A and4Billustrate how the handles14are inclined relative to the jaws12. Manipulation of the handles16by moving them causes the jaws12to open or close. Other embodiments include a double hinge instead of the single hinge15which would pivot the jaws apart from one another when the handles16are displaced towards one another. The insertion device10illustrated inFIGS.4A-4Eis designed for placement of an intervertebral prosthetic disc30. Such a prosthetic disc30comprises opposing endplates32which are located on opposite sides of a central core34. The opposing endplates32articulate about the central core34. The prosthetic disc30also comprises projecting fins36which are aligned with matching slots40in the vertebrae38during implantation. Typically slots40are saw cut into the vertebrae38. A method of inserting the intervertebral prosthesis is illustrated inFIGS.4D and5. In order to place the prosthesis30, the vertebrae38are distracted by a distance sufficient for at least partial insertion of the prosthesis30. To achieve this, the tips24of the opposable jaws12are inserted between the vertebrae38with the slots22in the opposable jaws12aligned with the slots in the vertebrae40. The handles16are then manipulated to force the opposable jaws12apart which also forces the vertebrae38apart from one another, creating a gap. The prosthesis30is then inserted into the gap42between the opposable jaws12where it is held therein with fins36engaged with the corresponding slots22. The prosthesis30is then slipped distally in the gap while being guided by the fins36cooperating with the slots22. The prosthesis30is moved through the inter jaw gap and past the jaw tips24in order to locate the prosthesis30between the vertebrae38with fins36in the vertebral cut slots40. The slots22in the opposable jaws12help to guide the fins36into the vertebral cut slots40. FIG.4Cillustrates the jaws12inclined towards one another, in the direction towards the tips24. The gap42between the jaws12at the top is large enough for insertion of the prosthesis30between them at that point. Therefore, in an alternative method of placing the prosthesis, the prosthesis30may be located initially in the gap42and then it may be pushed down towards the tip24, forcing the jaws12open and similarly forcing the vertebrae38apart from one another. A pusher45may be used to hold, position and drive the prosthesis30during the placement procedure. A force may be applied manually to pusher45or it may be tapped on the upper end to drive the prosthesis downward. Alternatively, the prosthesis placement procedure may be modified so that the initial distraction of the vertebra38is achieved by manipulation of the handles16and then a force may be applied manually to the pusher45or it may be tapped in order to create the final intervertebral gap and placement of the prosthesis30. The spreader device10serves both to facilitate insertion of the prosthesis30between the vertebrae38and also to ensure that the prosthesis30is accurately guided into position with its fins36lined up with the vertebral slots40. FIG.5shows in greater detail (solid-tipped arrows) the various motions involved in inserting the spreader device10into the intervertebral space and manipulating the handles16to force open the jaws12and thus increased the height of the intervertebral space between the two adjacent vertebrae38. As mentioned above, use of this or other spreader devices10is optional and is not required in all embodiments. FIGS.6A-6Dshow another optional device for use in the insertion methods of the present invention. As mentioned above, a midline indicator device210such as the one shown is described in greater detail in PCT Patent Application Number 2004/000170, which was previously incorporated by reference. The midline indicator210suitably includes an elongate shaft212and a body214coupled with one end of the shaft212. The shaft212may be made of one or more radiopaque materials, such as but not limited to stainless steel, titanium or the like. Alternatively, the shaft212may be radiolucent. The body214is made of one or more radiolucent materials, such as a polymer, so that it is not visible on radiographs. Embedded in the body214are two elongate radiopaque markers216, also made of any suitable radiopaque material(s). The markers216are parallel to the shaft212and are located on opposite sides and equidistant from the shaft212. FIGS.7A and7Bdemonstrate a method for using the midline indicator to find a vertebral body midline222.FIG.7Ashows, in anterior view, adjacent upper218and lower220vertebrae. To determine the midline222, the surgeon uses the shaft212to insert the body214between the vertebrae218,220. The surgeon then attempts to position the shaft212at the vertebral midline222, and a radiograph is taken of the vertebrae218,220and indicator210from the anterior-posterior (A-P) direction. The surgeon then examines the radiograph to determine whether the markers216are equidistant laterally from the lateral osseous edges223of the vertebrae218,220—i.e., that the distance225is the same on both sides, and that the markers216are aligned with the pedicles. Additionally, if the shaft212and markers216are properly aligned in the A-P direction, they will appear as dots on the radiograph. If the midline indicator210is turned, however, as is demonstrated by the dotted lines inFIG.7B, the shaft212and markers216will show up as lines or stretched-out dots on the radiograph. The A-P direction of the radiograph is shown by224, with misalignment of the indicator210shown by angles θ. By consulting one or more radiographs and manipulating the indicator210, the surgeon positions the handle212of the indicator210at the vertebral midline222. The surgeon may then make a mark226in one or more vertebrae218,220to indicate the midline222. The mark226may be made by any suitable means, such as by burning with an electrocautery device, marking with a marking pen, inserting a pin, or the like. After one or more midline marks226are made, the midline indicator210is removed and the disc prosthesis (not shown) is inserted. Again, the midline finding step is optional. Although the foregoing is a complete and accurate description of the invention, any suitable modifications, additions or the like may be made to the various embodiments without departing from the scope of the invention. Therefore, nothing described above should be interpreted as limiting the scope of the invention as it is described in the following claims. | 15,691 |
11857439 | To make the figures easier to interpret, the different elements are not necessarily shown to scale. DETAILED DESCRIPTION The present disclosure makes it possible to achieve better repeatability of the quality of the sleeve, particularly in terms of thickness, thanks to the use of a preform of consistent quality, and to the injection of an even layer of a polymer cross-linkable at low temperature around the preform, so as to incorporate the different components of the sleeve. FIG.1is a schematic representation of a mold1of the limb to be fitted up. Advantageously, the mold is reduced in relation to the limb, by applying a reduction rate defined by the correction nomograms currently used in the field of prosthesis design. The application of this reduction allows the final sleeve to be fitted with a slight gripping on the limb, in order to ensure a good hold of the sleeve. The mold can be manufactured using any known technique, for example, from a mold of the limb, or from a three-dimensional image of the limb. The mold can be of resin, plaster, polyurethane foam or any other material suitable for the implementation of the method described below. A preform made of an elastomeric material, such as a silicone gel, is provided. The preform has an open proximal end (to fit onto the limb) and a closed distal end (to accommodate the stump). The internal surface of the preform is designed to be in contact with the skin when the prosthesis is being worn. The polymer constituting the preform is chosen primarily for the comfort that it affords the individual, since it is in direct contact with the skin. A person skilled in the art is capable of choosing the appropriate hardness. This preform is manufactured beforehand in one or more standard sizes. It is not therefore specific to the patient. However, if various preforms are available, the practitioner can choose the most appropriate based on the morphology of the patient. Usually, the preform has a slightly smaller circumference than that of the mold, so as to slightly grip thereon on assembly. Advantageously, the preform has a non-uniform thickness specifically with areas of excess thickness to ensure improved comfort for the patient. The thickness is thus usually greater at the distal end of the preform and thinner at its proximal end. According to a variation, the preform has a uniform thickness. The preform is manufactured industrially using molding techniques that ensure an excellent repeatability of the thicknesses and, more generally, the quality of one preform to the next. FIG.2shows the preform2before it is positioned on the mold1. In the example shown, the preform comprises a reinforcement20shown by cross-hatching, formed by an excess thickness extending in a longitudinal direction. The practitioner then positions on the preform the various components intended to be integrated into the sleeve. These components may comprise:one of more reinforcements, which are generally in the form of polymer patches (silicone, for example);one or more layers of an elongation-preventing fabric, which is a fabric that can be stretched in one direction only, so that the elongation of the sleeve can be controlled;a cup intended to be positioned on the stump and consequently placed at the distal end of the preform, the cup possibly being provided with an element to secure the prosthesis (for example, a threaded end intended to retain the prosthesis by screwing);a sheath made, for example, of polyamide, having sufficiently large meshes to enable the discharge of the air contained between the preform and the sheath when creating the vacuum, which will be performed subsequently;possibly, a resilient fabric contributing to reinforce the sleeve and/or improve its appearance. Once this assembly has been completed, a vacuum cover is positioned around the preform. In a known way, the vacuum cover is made of an airtight material and allows a vacuum to be created around the preform, before the injection of a polymer cross-linkable at low temperature intended to connect all of the components to the preform and give the sleeve its final form. FIG.3thus shows, by way of example, the preform2on the mold1with a layer3of an elongation-preventing fabric and a polyamide discharge sheath4, as well as a distal cup5comprising a threaded end50, surrounded by a vacuum cover6. The injection of the polymer is shown diagrammatically by the arrow. The pressure reduction applied in the vacuum cover is typically in the order of 0 to minus 1013 hPa in relation to atmospheric pressure, which is here deemed to be equal to 1013 hPa. The application of this pressure reduction has the effect of flattening the walls of the cover against the preform, the discharge layer serving to hold the components while allowing the interstitial air to escape. The polymer injected into the vacuum cover is advantageously made of silicone or another polymer cross-linkable at room temperature. Such a silicone is usually referred to as Room Temperature Vulcanized (RTV). This silicone is formed by a mixture of two components, in the presence of a catalyst, which ideally cross-links at a temperature of between 20 and 25° C. This silicone must be compatible with the material of the preform, that is to say have good qualities of adhesion to the preform, in order to ensure the cohesion of the stump. The thickness of the silicone deposited around the preform is preferably in the order of 0.1 to 1 mm, but can be thicker depending on the elements placed on the preform. The vacuum cover ensures the uniformity of the layer of silicone deposited around the preform. Thus the quality of the final sleeve is not dependent on the skill of the technician. The necessary cross-linking time is in the order of 5 to 60 minutes, but can vary significantly depending on the polymers used. Thus, no heating is required in order to form the sleeve. However, it may be advantageous to use an oven to accelerate the cross-linking process. Moreover, curing of the silicones is strongly advised. Once the polymer has cross-linked, the technician will remove the vacuum cover and, if necessary, finish off the sleeve. This finishing off may consist in gluing on an elasthane-based fabric (shown by reference numeral7inFIGS.4and5, which represent two versions of a finished sleeve) and/or in applying a slippery paint. In the absence of such a covering to encourage sliding, talcum powder could be applied to the sleeve to encourage the silicone to slide on itself when positioning the sleeve onto the limb to be fitted up. The method according to the present disclosure thus makes it possible to manufacture a sleeve specific to the wearer of the prosthesis quickly and cheaply and with repeatable quality. REFERENCES FR 2 799 953FR 2 994 079 | 6,822 |
11857440 | DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION To avoid placement issues present in deploying two stents at different locations at different times, the proposed invention is to fixedly attach or alternatively, integrally attach, a single cylinder zigzag wire stent, or a modified Boston Scientific Z stent, or other modified Z stents, all hereinafter all referred to as a Z stent10(preferably 20 mm diameter when expanded) into a braided stent30, such as a Wallstent20(preferably 18 mm diameter when expanded). The combination50can be created with other braided stents and is not limited to the Wallstent20. The diameter sizes are exemplary to the specific location described below and not limiting. However, it is preferred that the Z stent wire thickness be thicker than the braided stent or Wallstent. The Z type stent to be attached is preferably a single cylinder2(seeFIG.3) of length 6-10 cm, where one or both of the upper and lower sutures connecting the Z struts which constrain stent expansion can be eliminated if desired. The single cylinder Z stent may also be joined exterior to or interior to the braided stent or Wallstent, with overlap between the two stents. Interior attachment is preferred, to allow the braided stent to act as an exterior sleeve restricting the full expansion of the Z-stent cylinder21and to provide additional resistance to compressibility. The Z stent join with the braided stent or Wallstent can also be coterminous or end to end, provided a secure joint can be achieved. This version is not preferred for extension into the vena cava as the Z stent cylinder21expansion is not restrained except at the join. Attachment of the two stents can be a weld, such as a laser weld, or a flexible metal braided suture type of attachment; or, a synthetic fiber suture, such as nylon, polyester, PVDF and polypropylene can be used to couple the two stents, as long as the stents are fixedly joined when the join is complete (cannot be separated in the intended use). Alternatively, the upper ends of the braided stent or Wallstent strands can be grouped in subsets where each subset can be wound around corresponding individual Z struts at the desired locations and then welded together, or a subset of the braided stent or Wallstent upper ends can be welded to corresponding Z struts. Attention should be paid to the selected weld locations or other join type locations to ensure the entire combined joined structure can be compressed for deployment, and then expanded later, without impairing the compression or expansion of the overall structure. Also, the weld must be compatible with both stent materials. Preferably, half the length of the Z stent single cylinder (1.5-5 cm) is projecting out of the top of the braided stent or Wallstent and the other half is deployed within the interior of the braided stent or Wallstent, thereby helping to constrain the Z stent from its full expansion and potentially eroding through the vein wall. The strong radial strength of the Z stent cylinder21corrects most of the structural deficiencies of the braided stent or Wallstent when located at the iliac-caval junction, as noted above. The other end of this combination stent would be the open bottom end of the braided stent or Wallstent. This combination will enable the modified stent to be deployed in one piece, reducing technical effort and cost and providing better positioning of the overall integrated stent structure. A new sheath design may be necessary for deployment as the push-pin sheath used with standard Wallstents may not work satisfactorily. The deficiencies can be corrected by using a larger sheath with the current push delivery mechanism. The venous system easily tolerates sheaths up to 18 Fr. with ease and negligible access site problems. A biaxial or triaxial sheath mechanism may be necessary. We recommend diameters of 20 mm, 18 mm, and 16 mm, with 9 cm and 6 cm lengths for the integrated stent deployment into the common iliac junction. These will typically be deployed in the common iliac vein. We also recommend 14 mm and 12 mm diameters in 6 cm and 4 cm lengths for the integrated stent for deployment into the external iliac and common femoral veins. The 14 mm length combination stent can be deployed in the external iliac vein with the Z stent cylinder21top striding across the internal iliac vein orifice, with the extended Z portion deployed in the standard Wallstents of existing design or other suitable braided stents and dimensions should still be available to incorporate the new design further if necessary.FIG.4shows the integrated stent system ofFIG.3sheathed for deployment. The radial expansion force of the Z stent cylinder21is greater than that of the braided stent or Wallstent. It is preferred that the braided stent or Wallstent constrain the Z stent, to avoid overexpansion of the Z stent portion of the system and possibly damaging the vein wall. It may be necessary to strengthen the terminating end of the Wallstent, for instance by using thicker braids at the terminating end to add radial resistance against the Z stent portion of the combination stent. Alternatively, a short stout stent or non-expansive sleeve, about 3 cm long, of the same diameter as the Wallstent, could be used external to the Wallstent terminal top end to provide the desired resistance to overexpansion of the Z stent cylinder21portion. Alternatively, the Z stent cylinder21could retain an expansive limiting band around the lower end (or both ends) to restrain Z stent cylinder21from full expansion. The band would have to survive the process of joining the two stents, such as by welding. The end-to-end combined stent embodiment described above may be most useful to reinforce other choke points in the iliac vein system, such as inguinal ligament crossing. In this case one of the Wallstent stents in the stack would extend several centimeters past this choke point (for instance, a 14 mm Wallstent). An end-to-end combination stent would then be inserted several centimeters into the prior-placed Wallstent; the terminating single cylinder or double cylinder Z stent cylinder21portion deployed so that the terminating end of the combined stent containing the Z stent cylinder21portion in the end-to-end combination, is positioned next to the ligament crossing in order to reinforce this weak point. In another embodiment, a single stent could be a laser cut, for instance from a nitinol, cylinder where the top of the cylinder is thicker than the remainder of the cylinder. The top should be more rigid and crush resistant and with large interstices, and the bottom would be laser cut so that the bottom end is very flexible to approximate the flexibility of a braided stent. The stent would be deployed with a portion of the more rigid top portion positioned in the vena cava proper. | 6,868 |
11857441 | DETAILED DESCRIPTION OF THE INVENTION Generally, various embodiments of the present invention are directed to devices and methods for achieving a predictable collapsed configuration or state for a collapsible and expandable support structure or stent as well as providing a mechanism for ensuring moisture retention within biological materials that may be attached or otherwise integrated with the collapsible and expandable support structure during the collapsing step. The support structure or stent has multiple functions to aid with the treatment of cardiac valve regurgitation (mitral or tricuspid). These functions include its function as a scaffold for the functioning 4C valve, apposition to the atrial anatomy, optimized radial force for compliance with atrial distension, ability to load and deploy from a minimally invasive delivery system, and geometry to support with mitigating against paravalvular leak (PVL). The design features of the stent are adapted to meet one or more of the functions identified above. Specific design features and attributes for exemplary stents are discussed in detail below to assist in understanding of the utility of the funneling loading device and related methods. As discussed above, the invention is not limited to prosthetic heart valves comprising stent support structures, but may also be applied to collapsible and expandable stents such as commonly used for intravascular procedures. Certain exemplary embodiment stent design concepts are intended to support minimally invasive procedures for the treatment of valvular regurgitation—mitral, tricuspid and/or otherwise. The stents may be self-expandable (e.g. nitinol or similar materials) or balloon expandable (e.g. cobalt chromium or similar materials). The stents are typically made of cells that may be open celled diamond like structures or continuous structures that have a working cell element. The stents may also be constructed using tubing, wires, braids or similar structures. Specific design features that aid with the functioning of the stent are described in detail below. Stent “Iris” Transition Cells With reference now toFIGS.2-3B, one embodiment of the stent100of the present invention comprises an outer section102—that may generally be circular though need not be a perfectly round circular structure when fully and/or partially expanded—and an inner valve support section104—which may be cylindrical but need not be a constant diameter cylinder and is adapted to support and retain prosthetic valve leaflets (not shown inFIG.2) within the inner valve support section104, most preferably at a point that located above the native annulus, e.g., the mitral valve annulus, though other attachment points for the prosthetic leaflets are within the scope of the present invention. Further, as discussed above, the stent100may be configured to supplement and/or replace the function of the tricuspid valve. A preferred construction comprises the prosthetic leaflets disposed above the native leaflets, wherein the prosthetic leaflets are attached and spaced sufficiently away from (above) the native leaflets so as to not physically interfere or interact with the native leaflets. However, certain embodiments contemplate some interaction with the native leaflets. Individual cells COforming the outer section102of stent100are visible inFIG.2as open cell regions defined by the material used to form the expandable stent100. Individual cells CIforming the inner valve support section104are also illustrated as open cells regions formed within an inner region R defined by outer section102, wherein the inner valve support section extends radially upward into the inner region R. As shown, individual cells CIare of a different size, and may comprise a different shape, than that of individual cells CO. The region of stent100that facilitates the radially inward transition of the stent100from the outer section102to the inner section104of the stent100is the transition cell region106. Transition cell region106may comprise cells CTthat may comprise a different size and/or shape that either the outer section cells COand/or the inner section cells CI. The outer and/or inner regions102,104, and/or transition cell region106of the stent100may be constructed from one continuous structure or may combine two or more structures to achieve intended design goals. Transition cell region106comprises generally a radially upward turn to allow the inner valve support section104to reside within the inner region102as shown inFIG.2. In some embodiments, the lower portion of inner valve support section104, that is the portion of the inner valve support section104that is in connection with the cells CTof transition cell region106may also comprise a curving shape to facilitate and/or complete the radially upward turn into the inner region102. The geometry and/or shape of the transition cells CTmay be substantially straight segments when expanded as inFIG.3Abelow or may, as shown inFIG.3B, incorporate an offset or a twist in the stent cell pattern when expanded to allow for a controlled compression of the stent. Exemplary cross-sectional geometry of the transition cell region106viewed from the bottom of stent100is represented schematically inFIGS.3A and3B. This transition cell region106of the stent100may be a strut, completed cell section or a partial cell section. The transition cell region106may have any number of struts (minimum of 3) or cell sections as generally required to meet design needs. Transition cells CTor struts may be evenly spaced and formed by substantially straight and equally spaced apart struts108as shown inFIG.3A, that extend away from the inner valve support section104with equal angles α on both sides of the strut108and equal angles β on both sides of strut108with respect to its intersection or integration with outer support section102. In a preferred embodiment, the struts108of transition section106may be straight as inFIG.3A, but with non-equal angles relative to the inner valve support section104and outer support section102as shown inFIG.3C. There, the straight struts108are slanted so that a smaller angle α and a larger angle α′ are provided relative to the inner valve support section104. Similarly, a smaller angle β′ and a larger angle β are provided relative to the outer support section102. This allows a compressed nesting of the slanted struts108of transition section106. In another preferred embodiment, the transition cell region106may comprise transition cell struts108′ that comprise transition cells CT that are formed by struts108′ having an offset, i.e., not straight, are twisted and/or curvilinear. The degree of offset and/or twist and/or curvature of the struts108′, and therefore the size and/or shape of the resultant expanded cells CT may be varied dependent on the number of cells/struts in the transition cell region106, packing density when the stent is collapsed, and stress/strain distribution limitations of the transition cell region106. The structure ofFIGS.3B and3Care preferred over the straight transition cell region106structure ofFIG.3Afor several reasons.FIG.4Ashows a transition cell region106in a collapsed form using the substantially straight struts108ofFIG.3Aand with, undesirable, gaps G between selected struts108. Though this resultant gapping collapsed transitional cell region106is workable, it is not optimal. Thus, the transition section106ofFIG.4B, using e.g., the offset and/or twisted and/or curved plurality of struts108′ ofFIG.3Bor the slanted straight struts108ofFIG.3C, allows for a controlled and predictable collapsed form of the stent, without gapping between the struts108′. This, in turn, minimizes the amount of stress/strain concentration at the lower region of the stent100during collapsing as is required for delivery of the expandable stent100to the heart region of interest. Additionally, the collapse of the cells is also symmetrical and uniform, which could aid with mitigating against damage to the valve tissue or fabric when it is attached to the stent cells. Reduction in overall stress/strain of the transition strut section may benefit the durability of the stent and the valve tissue. A feature of certain embodiments of the transition cell region106as shown inFIGS.3B and3C and4B, i.e., with offset, twisted and/or curved struts108′ or slanted straight struts108, is that, as best shown inFIG.3B, the struts108′ each comprise the same offset, twist and/or curvature. This, in turn, enables a close nesting of adjacent struts108′ as the stent100is collapsed down for delivery and subsequent expansion. Thus, as the stent is collapsed for loading into a delivery system, the transition section design allows for a controlled compression of the stent, and reduces the stress concentration on the stent cells. of the transition strut section may benefit the durability of the stent and the valve tissue. As the skilled artisan will now recognize from the above, the geometry of the exemplary stent's struts enables a transition from expanded to collapsed. The stent that may be collapsed using the following inventive embodiments is certainly not restricted to the exemplary cases described above. Any stent requiring collapsing from an expanded configuration to achieve a configuration that fits within the lumen of a delivery sheath may be collapsed with the present inventions. Thus,FIG.5illustrates an exemplary loading device200that may initiate the transition of the exemplary stent from expanded to collapsed, wherein the collapsed state or configuration is prepared and sufficient for translation into and along the delivery catheter or sheath to the targeted anatomical location. FIG.5therefore illustrates a loading funnel200on the proximal side of the image with a sheath300, which may comprise modifications to known delivery catheters as described herein. The loading funnel200and sheath300are illustrated as two separate elements that may be removably connected using known techniques. However, as the skilled artisan will recognize, the loading funnel200and sheath300may be preassembled and/or manufactured as an integrated unit in certain embodiments. The loading funnel200comprises a proximal decreasing diameter (from proximal to distal) section202, illustrated as conical but in other embodiments may comprise a curvilinear and or concave profile. In each case, the dimensional requirement is that the inner diameter D1′ of the proximal decreasing diameter section202comprises a lumen comprising a smoothly decreasing inner diameter moving from the proximal inner diameter D1′ to the distal inner diameter D2. Thus, proximal decreasing diameter section202comprises a maximum inner diameter (shown as D1′) at its proximal end and a minimum inner diameter at its distal end (shown as D2). And, as shown, proximal outer diameter D1of proximal section202is greater than proximal inner diameter D1′. The decreasing diameter proximal section202of loading funnel200transitions distally into a constant diameter section204, comprising an inner diameter D3that is substantially the same as the smallest inner diameter D2of the decreasing diameter proximal section202at its distal end, the transition therebetween preferably smooth to facilitate stressless translation of the collapsing exemplary stent therealong. Transitional sheath300comprises a proximal end portion P and a distal D end, an outer diameter D4and defining a lumen comprising inner diameter D5, wherein both D4and D5are substantially constant. The lumen for each of devices200and300is shown in dashed lines inFIG.5. Outer diameter D4of sheath300may be the same as, or smaller than, the inner diameter D3of the constant diameter section204of loading funnel200. Thus, as shown, the proximal end portion P of sheath300is adapted or configured to fit within at least a distal portion of the lumen of the constant diameter section204of the loading funnel200to create a lumen that is fluidly communicating from the proximal end of the loading sheath200to the distal end D of the sheath300. Generally, and without limitation, the various relevant diameter relationships are as follows, using the nomenclature provided above and inFIG.5: D1>D1′>D2=D3≥D4 Sheath300may be removably connected with the constant diameter section204in a variety of ways, including but certainly not limited to: a frictional fit and/or the illustrated detent male member206disposed on constant diameter section204of loading funnel200until engaged, and pushed radially outwardly, by the proximal end portion P of sheath300. Ultimately, when the male member206aligns with the slot or aperture302, male member206may, as the skilled artisan will recognize, drop or snap within the receiving aperture302and/or slot as illustratively defined in the outer wall of constant diameter section204of sheath300. In some cases, the slot302may allow relative rotation of the sheath300and loading funnel200within the slot302, thus enabling relative rotation within the limits of the length of the slot302between the loading funnel200and the transitional sheath300. As the skilled artisan will recognize, the above male member/slot or aperture arrangement may be effectively reversed: wherein the male member206may be disposed on the sheath300and the slot or aperture may be disposed on the constant diameter section204of loading funnel200. Other possible connection alternatives, within limitation, between loading funnel200and sheath300may comprise a threaded connection; and a frictional fit. Still more alternatively, the components200,300may be provided as a single unit, wherein the inner diameter of the single unit distal of the decreasing diameter section is constant. What is required in all cases is that the loading funnel200and sheath300are functionally connected to provide the dimensional features described above. In some embodiments, the proximal end portion P of sheath300when engaged within constant diameter section204of loading funnel may extends proximally to the distal end of loading funnel202, effectively sliding through the entire length of the lumen of constant diameter section204. In other embodiments, proximal end portion P engages only a portion of the length of the lumen of constant diameter section204. The collapsing of an exemplary collapsible stent from an expanded configuration may be achieved by translating the expanded stent distally into the lumen of loading funnel200progressively along and through the decreasing diameter section202, where the walls of loading funnel's lumen exert constant and equal pressure on the stent, causing a progressive, predictable and relatively stress-free collapsing and distal translation into the sheath300comprising lumen of inner diameter D5. At this stage, the exemplary stent is collapsed and ready for translation distally to the anatomical target. Release of the exemplary stent from the distal end of sheath300allows the stent, if self-expanding, to expand to its working expanded configuration. In other cases the stent may require additional assistance to expand, e.g., through push/pull wires and/or expanding balloons as is known in the art. FIG.6provides an alternative, clamshell type construction for the transitional sheath300′, wherein the transitional sheath300′ is formed from a planar sheet304that may have a precurved shape as illustrated. The loading funnel200is as described above in connection withFIG.5. As the planar sheet304is reduced in diameter to slidingly fit within the constant diameter section204of the loading funnel200, and form sheath300′, the male member206described above located on loading funnel200, may align with and fit within an aperture or slot302′ of transitional sheath300′ to provide a removable locking fit between transitional sheath300′ and loading funnel200as described above. As noted above in the embodiment ofFIG.5, male member206and aperture or slot302′ may reverse positions in the embodiment ofFIG.6. In the case of a302′, the loading funnel200may rotate relative to the sheath300′, as the male member206rotates within the slot302′. In certain cases, the clamshell type sheath300′ ofFIG.6may not reach complete closure along its length when reduced in diameter to fit within the constant diameter section204of transition sheath300′, thus leaving a longitudinal slot along the transitional sheath300′. The male member206of constant diameter section204may be guided along this longitudinal slot to the radial slot302′ shown inFIG.6, where it may be rotated to removably lock the two elements together, or the male member206and slot302′ may be reversed in position as described above. The structure of the loading device now explained, the skilled artisan will recognize the utility in effecting transition of a stent from an expanded size to a predetermined collapsed size with a predetermined diameter. Thus, the exemplary stent shown above may be slowly translated along the decreasing diameter section. As the stent is advanced, the inner walls of the decreasing diameter section202of loading funnel200exert a force that is circumferentially equal around the stent, thus enabling the stent to collapse along the points of least resistance and least stress. As discussed above, the circular and/or spiral struts will enable a predetermined, predictable and repeatable collapsing motion, leading to a predetermined, predictable and repeatable collapsed shape. When the stent has been collapsed within the constant diameter section204of loading funnel200and/or the constant diameter inner lumen of sheath300,300′, the collapsed stent may be translated therealong to the anatomical location of interest. When the collapsed stent is released from the distal end of the inner lumen of300,300′, it will be allowed to biasingly expand, effectively reversing the collapsing motion to reach an expanded state or configuration. In some cases, as discussed, sheath300,300′ may comprise a transitional sheath that provides a transition to connect with a delivery sheath or catheter comprising the same or similar inner diameter. In other cases, sheath300,300′ may form the delivery sheath or catheter. The loading device discussed above, e.g., loading funnel200and transitional sheath300,300′, further enables a stent to be pre-loaded for use. Thus, a stent may be collapsed and loaded into the loading funnel202lumen, together with fluid to keep the biological and/or biologically compatible material(s) properly wetted in preparation for translation, delivery and implant. In some embodiments, the distal end of the constant diameter section204(or distal end of sheath300,300′) may be capped or plugged to hold fluid in the lumen of decreasing diameter section202and/or constant diameter section204(and/or lumen of sheath300,300′) and in other embodiments a cap may be placed over the proximal end of decreasing diameter section202to further aid in holding fluid therein. This arrangement may provide a longer storage mechanism for collapsed, or partially collapsed, stents comprising moisture-sensitive, biologic material. Alternatively, the stent may be collapsed and translated into the lumen of sheath300,300′ as described above, filled with fluid and capped or plugged at both ends to retain fluid to assist in protecting moisture-sensitive biological material associated with the stent. Once loaded and fluid-immersed, the stent may be held for a period of time in the collapsed configuration and/or transported to the site of need. The description of the invention and its applications as set forth herein is illustrative and is not intended to limit the scope of the invention. Features of various embodiments may be combined with other embodiments within the contemplation of this invention. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives to and equivalents of the various elements of the embodiments would be understood to those of ordinary skill in the art upon study of this patent document. These and other variations and modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the invention. | 20,238 |
11857442 | DETAILED DESCRIPTION OF THE INVENTION The present invention relates to delivery systems for delivery of stents to vessel bifurcations having a main branch and a side branch, and is generally configured to at least partially cover a portion of a the side branch as well as a portion of the main branch. However, this is not intended to be limiting, and one of skill in the art will appreciate that the devices and methods described herein may be used for treating other regions of the body. The scientific community is slowly moving away from a main branch vs. side branch model and nomenclature. It is now well accepted that a “mother” vessel bifurcates into two “daughter vessels,” the two vessels that are anatomically after the carina. The vessel that appears to be the continuation of the mother vessel is usually less angulated. The other vessel is frequently smaller in diameter and may be commonly referred to as the side branch, or a daughter vessel. Therefore, in this specification, the terms “main branch,” “trunk,” or “mother vessel” may be used interchangeably. Also in this specification, the terms “side branch vessel” and “daughter vessel” may also be used interchangeably. The terms “main branch stent,” “trunk stent,” or “mother stent” are interchangeable, and the term “side branch stent” is also interchangeable with the term “daughter stent.” In the case where a main branch vessel bifurcates into two equally sized branches, one of the branches may still be considered to be the main branch or mother vessel, and the other branch may be considered a side branch or daughter vessel. A variety of catheter designs may be employed to deploy and position the mother and daughter stents. Such catheters may be used in connection with multiple guidewires that terminate in the mother and daughter vessels. These guidewires may be used to facilitate introduction of the catheter, any angioplasty balloons, any stents, and/or to properly orient the stent or balloon within the vessel. In general, the methods disclosed herein may utilize a catheter system comprising a catheter body having a mother vessel guidewire lumen and a daughter vessel balloon that is independently operable and coupled to the catheter body. The daughter balloon catheter portion has a daughter vessel guidewire lumen. The catheter system further includes a mother catheter balloon, and a stent is disposed over the balloon. The daughter catheter portion extends into the proximal opening of the mother stent and exits the mother stent through a side passage of the mother stent. According to one method, a mother vessel guidewire is inserted into the mother vessel until a distal end of the mother vessel guidewire passes beyond the ostium of the daughter vessel, and a daughter vessel guidewire is inserted into the mother vessel until a distal end of the daughter vessel guidewire passes into the daughter vessel. To prevent the crossing of guidewires, the two vessels are wired through a guidewire catheter with two lumens to keep the guidewires separate and untangled. The guidewire catheter is then removed and a wire separator is placed on the wires to keep the guidewires unwrapped. The catheter system is then advanced over the mother and daughter vessel guidewires, with the mother and daughter vessel catheters passing over the mother vessel guidewire and the daughter vessel guidewire. The catheter system is advanced on both wires with the daughter vessel balloon catheter portion distal to the mother balloon catheter portion, leading the system. As the catheter system advances over the wires, the daughter vessel balloon will enter the daughter vessel and may be positioned after or simultaneously with placement of the mother vessel balloon. The mother balloon catheter portion of the catheter system is then advanced distally as far as it can be advanced where it is stopped by the carina. It cannot be advanced beyond the bifurcation site because the tension of the daughter catheter on the mother stent will prevent the mother catheter from moving distally. At this time the distal portion of the mother stent is beyond the carina in the mother vessel and cannot be advanced any further. This method facilitates advancement of the catheter system to the bifurcation, which may be necessary for tortuous or calcified coronaries. Once the catheter system is in place the daughter vessel balloon catheter portion is then pulled back relative to the mother catheter so that the proximal part of the daughter balloon is partially within the mother stent. Alignment can be performed with radiopaque markers, in that the proximal markers on the two balloons are next to each other. The operator can then gently push the catheter system distal to maximize apposition to the carina. The daughter balloon which is now partially under the mother stent is then inflated to ensure proper alignment of the mother stent. The daughter balloon may also have a stent on its distal portion, which would result in the proximal portion of the mother stent and the daughter stent to expand simultaneously. The daughter balloon is then deflated. The mother balloon is then inflated which deploys the mother stent. Kissing, reinflation, of the two balloons is performed if necessary or for shifting plaque. The catheter system may be removed while the wires remain in place. In this embodiment, or any of the other embodiments disclosed herein, an angioplasty catheter may be used to predilate the vessel and lesion prior to stenting. In some embodiments, primary stenting is employed where the stent is deployed without the predilation. The two vessels may be angioplastied separately if predilatation is indicated on occasion. In an alternative method, the mother catheter can be mounted on the daughter vessel guidewire and the daughter catheter can be mounted on the mother vessel guidewire. In daughter vessels with a high degree of angularity, for example, when the bifurcation angle is greater than about 60-70°, the friction between catheters is lower when the operator needs to draw the daughter stent proximally along the main branch and into the mother stent, as opposed to the prior configuration where the daughter stent is drawn along the side branch into the mother stent. The catheter system is advanced so the daughter balloon catheter leads the system and passes the ostium of the daughter vessel, while remaining in the mother vessel. As the catheter system is advanced further, the mother balloon catheter will enter the daughter vessel. The catheter system can only be advanced a certain distance toward the bifurcation, until it is stopped by the carina. It cannot be advanced beyond the bifurcation site because the tension of the daughter catheter on the mother stent will prevent the mother catheter from moving distally. At this time the distal portion of the mother stent is beyond the ostium of the daughter vessel and cannot be advanced any further. While the mother catheter is held in place, the daughter catheter is drawn back such that the proximal portion of the daughter balloon is partially in the mother stent. Alignment can be performed with radiopaque markers, in that the proximal markers on the two balloons are next to each other. The operator can then gently push the catheter system distally to maximize apposition to the carina. A stent on the daughter balloon (which is now partially under the mother stent) is aligned so that when the daughter balloon is inflated the daughter stent and the proximal portion of the mother stent expand simultaneously and give complete coverage of the mother vessel. The daughter vessel balloon is then deflated. The mother vessel balloon is then inflated and the distal portion of the mother stent is expanded. A kissing procedure can also be performed if required. The mother vessel can be stented if necessary with any commercially available stent. A balloon on a wire could be used as an alternative to the daughter catheter. In an alternative embodiment, the catheter system can be arranged with the daughter balloon portion proximal to the mother balloon portion and advanced over the guidewires to the bifurcation. In the case of the mother catheter on the mother guidewire, the alignment of the mother stent with the ostium of the daughter vessel occurs because tension between the daughter guidewire and mother stent on the mother catheter prevents further advancement of the mother catheter. In the alternative case of the mother catheter on the daughter guidewire, the alignment of the mother stent with the ostium of the mother vessel occurs because tension between the mother guidewire and mother stent on the mother catheter (on the daughter guidewire) prevents further advancement of the mother catheter. In both cases the daughter stent is advanced into alignment with the mother stent and expanded. In preferred embodiments, the mother catheter is an over-the-wire (OTW) design and the daughter catheter is a rapid-exchange (RX) design with daughter catheter portion preferably distal thereto. The daughter balloon is placed just distal to the tip of the mother catheter, this arrangement minimizes the overall profile of the catheter system and allows maximal tracking of the arteries. The system may additionally have stents crimped over the balloons. The daughter stent may be any length, but in preferred embodiments is approximately half the length of the daughter balloon or mother stent. The proximal end of the mother stent may be crimped only slightly to allow the daughter catheter balloon portion to operate independently so that it may be pushed or pulled without dislodging the mother stent. An exemplary method comprises the following steps: 1. Advance the catheter system to bifurcation, daughter balloon catheter portion and mother balloon catheter portion in their respective vessels. 2. The mother catheter is no longer able to advance because of the tension between the mother stent and daughter catheter. 3. The daughter balloon proximal portion is drawn back into the mother stent and aligned with radiopaque markers. 4. While holding both the mother and daughter catheters tightly, the operator pushes forward lightly. 5. Inflate the daughter balloon and expand the daughter stent, approximately half of the daughter balloon distal portion will expand the “half-stent,” and half of the daughter balloon proximal portion will expand inside the mother vessel and partially expand the proximal portion of the mother stent. Expansion of the proximal portion of the mother stent and the daughter stent preferably occur simultaneously. 6. Once the daughter stent is fully deployed, then the mother balloon can be fully expanded to deploy the distal portion of the mother stent. 7. A conventional kissing procedure may be utilized to ensure full apposition. In one particular aspect, the daughter balloon catheter portion may be used without a stent. This allows perfect alignment of the mother stent around the ostium of the daughter vessel. The daughter balloon would be used for the alignment as outlined in step three above, and expands the proximal portion of the mother stent. In an alternative embodiment, the mother catheter is an over-the-wire (OTW) design and the daughter catheter is a rapid-exchange (RX) design with daughter catheter portion distal thereto. The system may additionally have stents crimped over the balloons. The daughter stent is preferably less than the length of the mother balloon or stent, although this is not intended to be limiting, and the daughter stent may be any length. The proximal end of the mother stent may be partially crimped to allow the daughter catheter balloon portion to operate independently, so that it may be pushed or pulled without restriction and minimum friction, and without dislodging or affecting the mother stent. An exemplary method comprises the following steps: 1. Looping the OTW so that one operator can hold both guide wires with one hand and then push both catheters with the other. 2. Advance the catheter system to bifurcation, daughter balloon catheter portion and mother balloon catheter portion aligned in their respective vessels, as disclosed in steps two through three in the above embodiment. 3. While holding both the mother and daughter catheters tightly, push the catheter system forward until the mother balloon catheter portion is stopped at the carina. 4. Inflate the daughter balloon and expand the daughter stent, approximately half of the daughter balloon distal portion will expand the “half-stent,” and half of the daughter balloon proximal portion will expand inside the mother vessel and partially expand the proximal portion of the mother stent. 5. Once the daughter stent is fully deployed, then the mother balloon can be fully expanded to deploy the distal portion of the mother stent. 6. A conventional kissing procedure may be utilized to ensure full apposition. In one particular aspect, the daughter balloon catheter portion may be used without a stent. This would allow perfect alignment of the mother stent around the ostium of the daughter vessel. The daughter balloon would be used for the alignment as outlined in step three above, and expand the proximal portion of the mother stent. In an alternative embodiment, the mother catheter is an over-the-wire design and the daughter catheter is a rapid-exchange design with daughter catheter portion distal thereto. The system may additionally have stents crimped over the balloons. The daughter stent may be approximately half the length of the mother balloon or stent, but this is not intended to be limiting, and the daughter stent may be any length. The proximal end of the mother stent may be partially crimped to allow the daughter catheter balloon portion to operate independently, so that it may be pushed or pulled without dislodging the mother stent. An exemplary method comprises the following steps: 1. Place the daughter catheter over the guidewire in the daughter vessel and slide the system into the guide catheter without placing the mother balloon over a guidewire at this time. After the leading daughter catheter enters the coronary artery and just before the mother catheter exits the guide catheter, insert the mother guidewire through the mother catheter and into the mother vessel, then push the system out of the guide catheter over the two guidewires. This method mitigates wire wrap. 2. Advance the catheter system to the bifurcation, daughter balloon catheter portion and mother balloon catheter portion aligned in their respective vessels. 3. Advance the catheter system to bifurcation, daughter balloon catheter portion and mother balloon catheter portion aligned in their respective vessels, as disclosed in step two in the above embodiment. Pull the daughter catheter back until the proximal markers on both balloons are aligned. 4. Inflate the daughter balloon and expand the daughter stent, approximately half of the daughter balloon distal portion will expand the “half-stent,” and half of the daughter balloon proximal portion will expand inside the mother vessel and partially expand the proximal portion of the mother stent. 5. Once the daughter stent is fully deployed, then the mother balloon can be fully expanded to deploy the distal portion of the mother stent. 6. A conventional kissing procedure may be utilized to ensure full apposition. In one particular aspect, the daughter balloon catheter portion may be used without a stent. This would allow perfect alignment of mother stent around the ostium of the daughter vessel. The daughter balloon would be used for the alignment as outlined in step three above, and expand the proximal portion of the mother stent. In an alternative embodiment the mother and daughter systems balloons are aligned. This embodiment could include the mother stent and daughter stent or either stent. When there is both a mother stent and a daughter stent, the daughter stent is preferably shorter than the mother stent, although it may be any length, and in preferred embodiments is approximately half the length of the mother stent so that the daughter stent could be mounted on the distal half of the daughter balloon. Furthermore, the proximal portion of the daughter catheter shaft is positioned under the non-uniformly crimped mother stent. The dual stent arrangement reduces the profile compared to a full length stent that covers the entire length of the daughter balloon. The methods described herein could alternatively include the step of flushing the catheters and the guidewire port to assist with maneuverability. The methods described herein could alternatively include the step of a couple of snap-on couplers that lock the two catheters together. In another particular aspect, each balloon catheter portion may include at least one radiopaque marker. With such a configuration, separation of the markers may be conveniently observed using fluoroscopy to indicate that the balloon catheter portions have passed beyond the ostium and the daughter balloon catheter portion has passed into the daughter vessel, thus aligning the passage of the stent with the ostium of the daughter vessel. In another particular aspect, the catheter systems design is contemplated to cover combinations of rapid exchange and over the wire; for visualization purposes the hybrid versions are preferred because they are easier to distinguish while using fluoroscopy. In another particular aspect, the proximal balloon may be differentially expandable, such that one end of the balloon may expand prior to the other end. In another particular aspect, the proximal balloon catheter portion may receive a stent that can be crimped under variable pressure to allow the distal balloon catheter portion freedom of movement. In another particular aspect, a stent may be crimped over the proximal balloon catheter portion and the stent may be designed to deploy with variable profile to better oppose the patient anatomy. In another particular aspect, the distal balloon catheter portion may be delivered via a pull away or peel away capture tube. All of the above embodiments may utilize mother vessel stents having any diameter, with diameter preferably ranging from about 2.5 to about 5 millimeters, and daughter vessel stent having any diameter, preferably ranging from about 2 to about 5 millimeters. The length of the stents may be any length, preferably in the range of about 4 to about 40 millimeters. The position of a stent on a catheter need not be fixed and may be positioned on either or both catheters. Catheter Configurations: FIG.1Aillustrates an exemplary embodiment of the catheter system100with a distal daughter balloon catheter portion comprising a balloon with a daughter stent crimped thereon. The daughter stent may be shorter than the mother stent, and it may not be centered on its corresponding balloon in this as well as any other embodiments disclosed herein. Thus, in preferred embodiments, a proximal portion of the daughter balloon remains uncovered by a stent, as will be discussed in greater detail below. In a particular embodiment the daughter stent is preferably about half the length of the mother stent. The distal daughter stent is crimped under standard conditions known in the art. The proximal mother balloon catheter portion comprises a mother balloon and a mother stent. The mother stent is crimped differentially along the longitudinal direction and circumferentially. In this exemplary embodiment, the distal half of the mother stent is crimped under typical conditions to ensure that the mother stent is not dislodged during the alignment with the distal daughter balloon. Further, the proximal portion of the mother stent is crimped under non-standard, relatively loose, conditions to allow the distal daughter balloon catheter portion freedom of movement even though a portion of the daughter balloon catheter portion is circumferentially enclosed. The mother and daughter catheters are slidably attached to each other via a hollow exchange port. The exchange port is embedded in the side of the mother over the wire catheter and has an inner diameter just large enough to allow the insertion of the rapid exchange daughter catheter and balloon. The exchange port may be any length that extends between a proximal portion of the balloons and a distal portion of the catheter connectors, and in this embodiment is about 10 centimeters long, but in preferred embodiments varies from about 1 centimeter to about 30 centimeters, and in more preferred embodiments is about 5 cm to about 10 cm long. The entry for the daughter catheter on the exchange port is proximal and the exit for the daughter catheter is on the distal end of the exchange port. The daughter catheter is loaded through the exchange port and the daughter balloon extends distally from the exit of the exchange port, preferably about 5 centimeters. However, it is possible to have the exchange port any distance from the mother balloon, but preferably about 1 to about 30 centimeters proximal to the mother balloon. The daughter stent can be crimped on to the balloon after it has been loaded through the exchange port. The exchange port preferably has a tight fit to reduce catheter profile and preferably has low friction to allow the operator to easily slide the catheters relative to each other. FIG.1Bmore clearly illustrates the features of the catheter system100inFIG.1A. The stent delivery system100includes a first catheter102, and a second catheter130. The first catheter102includes an elongate shaft104with a radially expandable balloon106disposed near a distal end of the elongate shaft104. A stent108having a proximal portion122, a distal portion114and a side hole120is disposed over the balloon106. The distal portion114is crimped to the balloon106to prevent ejection during delivery, while the proximal portion122is partially crimped to the balloon106so the second catheter130may be slidably advanced or retracted under the proximal portion122of stent108. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen112extending from the distal guidewire port110at the distal end of the elongate shaft104to the proximal end of the elongate shaft104into Y-adapter114having a connector116. The connector116is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen112exits via connector116. A second connector118, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon106via an inflation lumen (not shown) in the elongate shaft104. The first catheter102also includes a hollow exchange port tube124coupled to the elongate shaft104. The hollow exchange port tube124may be coextruded with the first shaft104, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft132. The hollow exchange port tube124includes a central channel126extending therethrough and is sized to slidably receive a portion of the second catheter130. Radiopaque markers may be placed at different locations along the shaft104, often near the balloon106and/or stent108, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter130includes an elongate shaft132with a radially expandable balloon140disposed near a distal end of the elongate shaft132. A stent142is disposed over balloon140. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent142is shorter than the working length of the balloon140so that a proximal portion of the balloon140is unconstrained by the stent142and this unconstrained portion of the balloon140may be slidably advanced or retracted through side hole120and under proximal portion122of stent108as will be discussed below. Stent142is crimped to balloon140to prevent ejection during delivery. At least a portion of balloon140, and stent142are distally offset relative to balloon106and stent108so as to minimize profile of the device. In this embodiment the distal stent142may be deployed in a main branch of the vessel and the other stent108may be deployed in a side branch of the vessel. Alternatively, the distal stent142may be deployed in a side branch of a vessel and the other stent108may be deployed in the main branch of a vessel. The second catheter130is a rapid exchange catheter (RX) having a guidewire lumen134extending from the distal guidewire port138at the distal end of the elongate shaft132to a proximal guidewire port136which is closer to the distal port138than the proximal end of the catheter shaft132. The proximal guidewire port136is also unobstructed by the hollow exchange tube124and preferably proximal thereto. A connector144, preferably a Luer connector is connected to the proximal end of the elongate shaft132and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft132for inflation of balloon140. A portion of shaft132is disposed in the central channel126of the hollow exchange tube124and this helps keep the two catheter shafts104,132parallel and prevents tangling during delivery and as shaft132is slidably advanced or retracted relative to shaft104. Also, another portion of shaft132is disposed under proximal portion122of stent108. The second catheter130may also be slidably advanced or retracted under the proximal portion122of stent108so that the shaft132passes through the side hole120in stent108. Radiopaque markers may be placed at different locations on the shaft132, often near the balloon140or stent142, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.2Aillustrates a cross sectional view of one embodiment of a catheter system200with the daughter catheter balloon portion distal to the mother balloon portion utilizing the same exchange port as described inFIG.1A. The mother balloon is preferably at least about 5 centimeters distal from the exit of the exchange port. As disclosed above the mother balloon could be distal from the exchange port from about 1 cm to about 30 centimeters. FIG.2Bmore clearly illustrates the features of the catheter system200inFIG.2A. The stent delivery system200includes a first catheter202, and a second catheter230. The first catheter202includes an elongate shaft204with a radially expandable balloon206disposed near a distal end of the elongate shaft204, and a stent208disposed over the balloon206. The stent208may be the same length as the working length of the balloon208, or it may be shorter. In preferred embodiments, the stent208is shorter than the working length of balloon206such that a proximal portion of balloon206remains unconstrained by stent208. The proximal portion of balloon206may be slidably advanced and retracted under stent242via side hole220. Stent208is crimped to the balloon206to prevent ejection during delivery. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen212extending from the distal guidewire port210at the distal end of the elongate shaft204to the proximal end of the elongate shaft204into Y-adapter214having a connector216. The connector216is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen212exits via connector216. A second connector218, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon206via an inflation lumen (not shown) in the elongate shaft204. The first catheter202also includes a hollow exchange port tube224coupled to the elongate shaft204. The hollow exchange port tube224may be coextruded with the first shaft204, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft232. The hollow exchange port tube224includes a central channel226extending therethrough and is sized to slidably receive a portion of the second catheter230. Radiopaque markers may be placed at different locations along the shaft204, often near the balloon206and/or stent208, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter230includes an elongate shaft232with a radially expandable balloon240disposed near a distal end of the elongate shaft232. A stent242having a proximal portion222, a distal portion214, and a side hole220is disposed over balloon240. The distal portion214is crimped to balloon240to prevent ejection during delivery, while the proximal portion222is partially crimped to balloon240so elongate shaft204may be slidably advanced or retracted under the proximal portion222of stent242. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. At least a portion of balloon206, and stent208are distally offset relative to balloon240and stent242so as to minimize profile of the device. In this embodiment the distal stent208may be deployed in a main branch of the vessel and the other stent242may be deployed in a side branch of the vessel. Alternatively, the distal stent208may be deployed in a side branch of a vessel and the other stent242may be deployed in the main branch of a vessel. The second catheter230is a rapid exchange catheter (RX) having a guidewire lumen234extending from the distal guidewire port238at the distal end of the elongate shaft232to a proximal guidewire port236which is closer to the distal port238than the proximal end of the catheter shaft232. The proximal guidewire port236is also unobstructed by the hollow exchange tube224and preferably proximal thereto. A connector244, preferably a Luer connector is connected to the proximal end of the elongate shaft232and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft232for inflation of balloon240. A portion of shaft232is disposed in the central channel226of the hollow exchange tube224and this helps keep the two catheter shafts204,232parallel and prevents tangling during delivery and as shaft232is slidably advanced or retracted relative to shaft204. Also, a portion of shaft204is disposed under proximal portion222of stent242. The first catheter202may be slidably advanced or retracted under the proximal portion222of stent242so that the shaft204passes through the side hole220in stent242. Radiopaque markers may be placed at different locations on the shaft232, often near the balloon240or stent242, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.3Aillustrates a cross sectional view of one embodiment of a catheter system300with the mother and daughter catheters both having a rapid exchange design. In this particular embodiment one of the catheters has a hollow exchange port embedded in its side and the other catheter is loaded through the exchange port. Typically, the catheter is loaded prior to having a stent crimped over the balloon portion. FIG.3Bmore clearly illustrates the features of the catheter system300inFIG.3A. The delivery system300includes a first catheter302, and a second catheter330. The first catheter302includes an elongate shaft304with a radially expandable balloon306disposed near a distal end of the elongate shaft304. A stent308having a proximal portion322, a distal portion314and a side hole320is disposed over the balloon306. The distal portion314is crimped to the balloon306to prevent ejection during delivery, while the proximal portion322is partially crimped to the balloon306so the second catheter330may be slidably advanced under the proximal portion322of stent308. The first catheter is a rapid exchange catheter (RX) having a guidewire lumen312extending from the distal guidewire port310at the distal end of the elongate shaft304to a proximal guidewire port311which is closer to the distal port310than the proximal end of the catheter shaft304. A connector316is coupled with the proximal end of the elongate shaft304. The connector316is preferably a Luer connector and this allows easy coupling with an Indeflator or other device for inflation of the balloon306. The first catheter302also includes a hollow exchange port tube324coupled to the elongate shaft304. The hollow exchange port tube324may be coextruded with the first shaft304, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft332. The hollow exchange port tube324includes a central channel326extending therethrough and is sized to slidably receive a portion of the second catheter330. Radiopaque markers may be placed at different locations along the shaft304, often near the balloon306and/or stent308, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter330includes an elongate shaft332with a radially expandable balloon340disposed near a distal end of the elongate shaft332. A stent342is disposed over balloon340. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent342is shorter than the working length of the balloon340so that a proximal portion of the balloon340is unconstrained by the stent342and this unconstrained portion of the balloon340may be slidably advanced or retracted through side hole320and under proximal portion322of stent308as will be discussed below. Stent342is crimped to balloon340to prevent ejection during delivery. At least a portion of balloon340, and stent342are distally offset relative to balloon306and stent308so as to minimize profile of the device. In this embodiment the distal stent342may be deployed in a main branch of the vessel and the other stent308may be deployed in a side branch of the vessel. Alternatively, the distal stent342may be deployed in a side branch of a vessel and the other stent308may be deployed in the main branch of a vessel. The second catheter330is a rapid exchange catheter (RX) having a guidewire lumen334extending from the distal guidewire port338at the distal end of the elongate shaft332to a proximal guidewire port336which is closer to the distal port338than the proximal end of the catheter shaft332. The proximal guidewire port336is also unobstructed by the hollow exchange tube324and may be distal thereto. A connector344, preferably a Luer connector is connected to the proximal end of the elongate shaft332and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft332for inflation of balloon340. A portion of shaft332is disposed in the central channel326of the hollow exchange tube324and this helps keep the two catheter shafts304,332parallel and prevents tangling during delivery and as shaft332is slidably advanced or retracted relative to shaft304. Also, another portion of shaft332is disposed under proximal portion322of stent308. The second catheter330may also be slidably advanced or retracted under the proximal portion322of stent308so that the shaft332passes through the side hole320in stent308. Radiopaque markers may be placed at different locations on the shaft332, often near the balloon340or stent342, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.4Aillustrates across sectional view of one embodiment of a catheter system400with the mother and daughter catheters both having an over the wire design. In this particular embodiment one of the catheters has a hollow exchange port embedded in its side and the other catheter does not have a hollow exchange port. The catheter without the exchange port is loaded onto the catheter with an exchange port. Typically, the catheter would have to be loaded prior to having a stent crimped over the balloon portion. FIG.4Bmore clearly illustrates the features of the catheter system400inFIG.4A. The stent delivery system400includes a first catheter402, and a second catheter430. The first catheter402includes an elongate shaft404with a radially expandable balloon406disposed near a distal end of the elongate shaft404. A stent408having a proximal portion422, a distal portion414and a side hole420is disposed over the balloon406. The distal portion414is crimped to the balloon406to prevent ejection during delivery, while the proximal portion422is partially crimped to the balloon406so the second catheter430may be slidably advanced under the proximal portion422of stent408. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen412extending from the distal guidewire port410at the distal end of the elongate shaft404to the proximal end of the elongate shaft404into Y-adapter414having a connector416. The connector416is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen412exits via connector416. A second connector418, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon406via an inflation lumen (not shown) in the elongate shaft404. The first catheter402also includes a hollow exchange port tube424coupled to the elongate shaft404. The hollow exchange port tube424may be coextruded with the first shaft404, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft432. The hollow exchange port tube424includes a central channel426extending therethrough and is sized to slidably receive a portion of the second catheter430. Radiopaque markers may be placed at different locations along the shaft404, often near the balloon406and/or stent408, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter430includes an elongate shaft432with a radially expandable balloon440disposed near a distal end of the elongate shaft432. A stent442is disposed over balloon440. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent442is shorter than the working length of the balloon440so that a proximal portion of the balloon440is unconstrained by the stent442and this unconstrained portion of the balloon440may be slidably advanced or retracted through side hole420and under proximal portion422of stent408as will be discussed below. Stent442is crimped to balloon440to prevent ejection during delivery. At least a portion of balloon440, and stent442are distally offset relative to balloon406and stent408so as to minimize profile of the device. In this embodiment the distal stent442may be deployed in a main branch of the vessel and the other stent408may be deployed in a side branch of the vessel. Alternatively, the distal stent442may be deployed in a side branch of a vessel and the other stent408may be deployed in the main branch of a vessel. The second catheter430is an over-the-wire (OTW) catheter having a guidewire lumen434extending from the distal guidewire port438at the distal end of the elongate shaft432to the proximal end of the elongate shaft432into Y-adapter446having a connector448. The connector448is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen434exits via connector448. A second connector444, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon440via an inflation lumen (not shown) in the elongate shaft432. A portion of shaft432is disposed in the central channel426of the hollow exchange tube424and this helps keep the two catheter shafts404,432parallel and prevents tangling during delivery and as shaft432is slidably advanced or retracted relative to shaft404. Also, another portion of shaft432is disposed under proximal portion422of stent408. The second catheter430may also be slidably advanced or retracted under the proximal portion422of stent408so that the shaft432passes through the side hole420in stent408. Radiopaque markers may be placed at different locations on the shaft432, often near the balloon440or stent442, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIGS.5A,6A,7A, and8Aillustrate an end to end capture tube that connects the catheters together. The capture tube keeps the catheters from tangling. The capture tube preferably remains in place during the entire clinical procedure. In these exemplary embodiments, the capture tube is a thin polymer hollow straw that covers the mother and daughter catheters from a point about 10 centimeters distal to the Indeflator attachment to a distal point that is about 10 centimeters proximal from the rapid exchange catheter's proximal rapid exchange port. FIG.5Aillustrates a catheter system500having a distal daughter catheter with a rapid exchange configuration and a proximal mother catheter with an over-the-wire configuration.FIG.5Bmore clearly illustrates the features of the catheter system500seen inFIG.5A. The stent delivery system500includes a first catheter502, and a second catheter530. The first catheter502includes an elongate shaft504with a radially expandable balloon506disposed near a distal end of the elongate shaft504. A stent508having a proximal portion522, a distal portion514and a side hole520is disposed over the balloon506. The distal portion514is crimped to the balloon506to prevent ejection during delivery, while the proximal portion522is partially crimped to the balloon506so the second catheter530may be slidably advanced under the proximal portion522of stent508. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen512extending from the distal guidewire port510at the distal end of the elongate shaft504to the proximal end of the elongate shaft504into Y-adapter514having a connector516. The connector516is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen512exits via connector516. A second connector518, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon506via an inflation lumen (not shown) in the elongate shaft504. The first catheter502is disposed in the central channel526of a capture tube524. Central channel526is sized to fit both shafts504,532and allow slidable movement thereof. Shaft504is slidable in the central channel526, or it may be locked with a locking collar525such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft504, often near the balloon506and/or stent508, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter530includes an elongate shaft532with a radially expandable balloon540disposed near a distal end of the elongate shaft532. A stent542is disposed over balloon540. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent542is shorter than the working length of the balloon540so that a proximal portion of the balloon540is unconstrained by the stent542and this unconstrained portion of the balloon540may be slidably advanced or retracted through side hole520and under proximal portion522of stent508as will be discussed below. Stent542is crimped to balloon540to prevent ejection during delivery. At least a portion of balloon540, and stent542are distally offset relative to balloon506and stent508so as to minimize profile of the device. In this embodiment the distal stent542may be deployed in a main branch of the vessel and the other stent508may be deployed in a side branch of the vessel. Alternatively, the distal stent542may be deployed in a side branch of a vessel and the other stent508may be deployed in the main branch of a vessel. The second catheter530is a rapid exchange catheter (RX) having a guidewire lumen534extending from the distal guidewire port538at the distal end of the elongate shaft532to a proximal guidewire port536which is closer to the distal port538than the proximal end of the catheter shaft532. The proximal guidewire port536is also unobstructed by the capture tube524and may be distal thereto. A connector544, preferably a Luer connector is connected to the proximal end of the elongate shaft532and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft532for inflation of balloon540. A portion of shaft532is disposed in the central channel526of the capture tube524and this helps keep the two catheter shafts504,532parallel and prevents tangling during delivery and as shaft532is slidably advanced in the central channel526. Compression fitting525may be used to lock elongate shafts504,532in the capture tube524to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, another portion of shaft532is disposed under proximal portion522of stent508. The second catheter530may also be slidably advanced or retracted under the proximal portion522of stent508so that the shaft532passes through the side hole520in stent508. Radiopaque markers may be placed at different locations on the shaft532, often near the balloon540or stent542, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.6Aillustrates a catheter system600having a distal daughter catheter with an over the wire design and a proximal mother catheter with a rapid exchange design.FIG.6Bmore clearly illustrates the features of the catheter system600inFIG.6A. The stent delivery system600includes a first catheter602, and a second catheter630. The first catheter602includes an elongate shaft604with a radially expandable balloon606disposed near a distal end of the elongate shaft604, and a stent608disposed over the balloon606. The stent608may be the same length as the working length of the balloon608, or it may be shorter. In preferred embodiments, the stent608is shorter than the working length of balloon606such that a proximal portion of balloon606remains unconstrained by stent608. The proximal portion of balloon606may be slidably advanced and retracted under stent642via side hole620. Stent608is crimped to the balloon606to prevent ejection during delivery. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen612extending from the distal guidewire port610at the distal end of the elongate shaft604to the proximal end of the elongate shaft604into Y-adapter614having a connector616. The connector616is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen612exits via connector616. A second connector618, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon606via an inflation lumen (not shown) in the elongate shaft604. The first catheter602is disposed in the central channel626of a capture tube624. Central channel626is sized to fit both shafts604,632and allow slidable movement thereof. Shaft604is slidable in the central channel626, or it may be locked with a locking collar625such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft604, often near the balloon606and/or stent608, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter630includes an elongate shaft632with a radially expandable balloon640disposed near a distal end of the elongate shaft632. A stent642having a proximal portion622, a distal portion614, and a side hole620is disposed over balloon640. The distal portion614is crimped to balloon640to prevent ejection during delivery, while the proximal portion622is partially crimped to balloon640so elongate shaft604may be slidably advanced or retracted under the proximal portion622of stent642. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. At least a portion of balloon606, and stent608are distally offset relative to balloon640and stent642so as to minimize profile of the device. In this embodiment the distal stent608may be deployed in a main branch of the vessel and the other stent642may be deployed in a side branch of the vessel. Alternatively, the distal stent608may be deployed in a side branch of a vessel and the other stent642may be deployed in the main branch of a vessel. The second catheter630is a rapid exchange catheter (RX) having a guidewire lumen634extending from the distal guidewire port638at the distal end of the elongate shaft632to a proximal guidewire port636which is closer to the distal port638than the proximal end of the catheter shaft632. The proximal guidewire port636is also unobstructed by the capture tube624and may be distal thereto. A connector644, preferably a Luer connector is connected to the proximal end of the elongate shaft632and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft632for inflation of balloon640. A portion of shaft632is disposed in the central channel626of the capture tube624and this helps keep the two catheter shafts604,632parallel and prevents tangling during delivery and as shaft604is slidably advanced in the central channel626. Compression fitting625may be used to lock elongate shafts604,632in the capture tube624to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, a portion of shaft604is disposed under proximal portion622of stent642. The first catheter602may be slidably advanced or retracted under the proximal portion622of stent642so that the shaft604passes through the side hole620in stent642. Radiopaque markers may be placed at different locations on the shaft632, often near the balloon640or stent642, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.7Ashows a catheter system700having dual rapid exchange mother and daughter catheters so the end point of the capture tube is preferably about 10 centimeters proximal from the rapid exchange port on the distal most catheter.FIG.7Bmore clearly illustrates the features of the catheter system700inFIG.7A. The stent delivery system700includes a first catheter702, and a second catheter730. The first catheter702includes an elongate shaft704with a radially expandable balloon706disposed near a distal end of the elongate shaft704. A stent708having a proximal portion722, a distal portion714and a side hole720is disposed over the balloon706. The distal portion714is crimped to the balloon706to prevent ejection during delivery, while the proximal portion722is partially crimped to the balloon706so the second catheter730may be slidably advanced under the proximal portion722of stent708. The first catheter is a rapid exchange catheter (RX) having a guidewire lumen712extending from the distal guidewire port710at the distal end of the elongate shaft704to a proximal guidewire port711which is closer to the distal port710than the proximal end of the catheter shaft704. A connector716is coupled with the proximal end of the elongate shaft704. The connector716is preferably a Luer connector and this allows easy coupling with an Indeflator or other device for inflation of the balloon706. The first catheter702is disposed in the central channel726of a capture tube724. Central channel726is sized to fit both shafts704,732and allow slidable movement thereof. Shaft704is slidable in the central channel726, or it may be locked with a locking collar725such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft704, often near the balloon706and/or stent708, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter730includes an elongate shaft732with a radially expandable balloon740disposed near a distal end of the elongate shaft732. A stent742is disposed over balloon740. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent742is shorter than the working length of the balloon740so that a proximal portion of the balloon740is unconstrained by the stent742and this unconstrained portion of the balloon740may be slidably advanced or retracted through side hole720and under proximal portion722of stent708as will be discussed below. Stent742is crimped to balloon740to prevent ejection during delivery. At least a portion of balloon740, and stent742are distally offset relative to balloon706and stent708so as to minimize profile of the device. In this embodiment the distal stent742may be deployed in a main branch of the vessel and the other stent708may be deployed in a side branch of the vessel. Alternatively, the distal stent742may be deployed in a side branch of a vessel and the other stent708may be deployed in the main branch of a vessel. The second catheter730is a rapid exchange catheter (RX) having a guidewire lumen734extending from the distal guidewire port738at the distal end of the elongate shaft732to a proximal guidewire port736which is closer to the distal port738than the proximal end of the catheter shaft732. The proximal guidewire port736is also unobstructed by the capture tube724and may be distal thereto. A connector744, preferably a Luer connector is connected to the proximal end of the elongate shaft732and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft732for inflation of balloon740. A portion of shaft732is disposed in the central channel726of the capture tube724and this helps keep the two catheter shafts704,732parallel and prevents tangling during delivery and as shaft732is slidably advanced in the central channel726. Compression fitting725may be used to lock elongate shafts704,732in the capture tube724to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, another portion of shaft732is disposed under proximal portion722of stent708. The second catheter730may also be slidably advanced or retracted under the proximal portion722of stent708so that the shaft732passes through the side hole720in stent708. Radiopaque markers may be placed at different locations on the shaft732, often near the balloon740or stent742, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.8Aembodies a catheter system800with dual over the wire designs, therefore the capture tube ending point ends preferably about 30 centimeters proximal from the balloon portion of the most distal catheter.FIG.8Bmore clearly illustrates the features of the catheter system800inFIG.8A. The stent delivery system800includes a first catheter802, and a second catheter830. The first catheter802includes an elongate shaft804with a radially expandable balloon806disposed near a distal end of the elongate shaft804. A stent808having a proximal portion822, a distal portion814and a side hole820is disposed over the balloon806. The distal portion814is crimped to the balloon806to prevent ejection during delivery, while the proximal portion822is partially crimped to the balloon806so the second catheter830may be slidably advanced under the proximal portion822of stent808. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen812extending from the distal guidewire port810at the distal end of the elongate shaft804to the proximal end of the elongate shaft804into Y-adapter814having a connector816. The connector816is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen812exits via connector816. A second connector818, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon806via an inflation lumen (not shown) in the elongate shaft804. The first catheter802is disposed in the central channel826of a capture tube824. Central channel826is sized to fit both shafts804,832and allow slidable movement thereof. Shaft804is slidable in the central channel826, or it may be locked with a locking collar825such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft804, often near the balloon806and/or stent808, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter830includes an elongate shaft832with a radially expandable balloon840disposed near a distal end of the elongate shaft832. A stent842is disposed over balloon840. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent842is shorter than the working length of the balloon840so that a proximal portion of the balloon840is unconstrained by the stent842and this unconstrained portion of the balloon840may be slidably advanced or retracted through side hole820and under proximal portion822of stent808as will be discussed below. Stent842is crimped to balloon840to prevent ejection during delivery. At least a portion of balloon840, and stent842are distally offset relative to balloon806and stent808so as to minimize profile of the device. In this embodiment the distal stent842may be deployed in a main branch of the vessel and the other stent808may be deployed in a side branch of the vessel. Alternatively, the distal stent842may be deployed in a side branch of a vessel and the other stent808may be deployed in the main branch of a vessel. The second catheter830is an over-the-wire (OTW) catheter having a guidewire lumen834extending from the distal guidewire port838at the distal end of the elongate shaft832to the proximal end of the elongate shaft832into Y-adapter846having a connector848. The connector848is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen834exits via connector848. A second connector844, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon840via an inflation lumen (not shown) in the elongate shaft832. A portion of shaft832is disposed in the central channel826of the capture tube824and this helps keep the two catheter shafts804,832parallel and prevents tangling during delivery and as shaft832is slidably advanced in the central channel826. Compression fitting825may be used to lock elongate shafts804,832in the capture tube824to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, another portion of shaft832is disposed under proximal portion822of stent808. The second catheter830may also be slidably advanced or retracted under the proximal portion822of stent808so that the shaft832passes through the side hole820in stent808. Radiopaque markers may be placed at different locations on the shaft832, often near the balloon840or stent842, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIGS.9A,10A,11A, and12Aillustrate a removable capture tube that is fitted over the dual catheters as described above but the capture tube has a polymer appendage. Once the operator has the catheter system placed near the bifurcation the operator can grab hold of the polymer appendage and pull the capture tube off of the catheters. FIG.9Aillustrates a catheter system900having a distal daughter catheter with a rapid exchange configuration and a proximal mother catheter with an over the wire configuration.FIG.9Bmore clearly illustrates the features of the catheter system900seen inFIG.9A. The stent delivery system900includes a first catheter902, and a second catheter930. The first catheter902includes an elongate shaft904with a radially expandable balloon906disposed near a distal end of the elongate shaft904. A stent908having a proximal portion922, a distal portion914and a side hole920is disposed over the balloon906. The distal portion914is crimped to the balloon906to prevent ejection during delivery, while the proximal portion922is partially crimped to the balloon906so the second catheter930may be slidably advanced under the proximal portion922of stent908. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen912extending from the distal guidewire port910at the distal end of the elongate shaft904to the proximal end of the elongate shaft904into Y-adapter914having a connector916. The connector916is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen912exits via connector916. A second connector918, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon906via an inflation lumen (not shown) in the elongate shaft904. The first catheter902is disposed in the central channel926of a capture tube924having a perforated region945along its longitudinal length. Central channel926is sized to fit both shafts904,932and allow slidable movement thereof. Shaft904is slidable in the central channel926, or it may be locked with a locking collar925such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft904, often near the balloon906and/or stent908, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The perforated region945along the capture tube924allows the capture tube to be easily peeled away from both catheter shafts904,932once the catheters have been properly positioned and when no longer needed. The second catheter930includes an elongate shaft932with a radially expandable balloon940disposed near a distal end of the elongate shaft932. A stent942is disposed over balloon940. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent942is shorter than the working length of the balloon940so that a proximal portion of the balloon940is unconstrained by the stent942and this unconstrained portion of the balloon940may be slidably advanced or retracted through side hole920and under proximal portion922of stent908as will be discussed below. Stent942is crimped to balloon940to prevent ejection during delivery. At least a portion of balloon940, and stent942are distally offset relative to balloon906and stent908so as to minimize profile of the device. In this embodiment the distal stent942may be deployed in a main branch of the vessel and the other stent908may be deployed in a side branch of the vessel. Alternatively, the distal stent942may be deployed in a side branch of a vessel and the other stent908may be deployed in the main branch of a vessel. The second catheter930is a rapid exchange catheter (RX) having a guidewire lumen934extending from the distal guidewire port938at the distal end of the elongate shaft932to a proximal guidewire port936which is closer to the distal port938than the proximal end of the catheter shaft932. The proximal guidewire port936is also unobstructed by the capture tube924and may be distal thereto. A connector944, preferably a Luer connector is connected to the proximal end of the elongate shaft932and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft932for inflation of balloon940. A portion of shaft932is disposed in the central channel926of the capture tube924and this helps keep the two catheter shafts904,932parallel and prevents tangling during delivery and as shaft932is slidably advanced in the central channel926. Compression fitting925may be used to lock elongate shafts904,932in the capture tube924to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, another portion of shaft932is disposed under proximal portion922of stent908. The second catheter930may also be slidably advanced or retracted under the proximal portion922of stent908so that the shaft932passes through the side hole920in stent908. Capture tube924may be peeled away from shaft932by severing the perforated region945. Radiopaque markers may be placed at different locations on the shaft932, often near the balloon940or stent942, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.10Aillustrates a catheter system1000having a distal daughter catheter with an over the wire design and a proximal mother catheter with a rapid exchange design.FIG.10Bmore clearly illustrates the features of the catheter system1000inFIG.10A. The stent delivery system1000includes a first catheter1002, and a second catheter1030. The first catheter1002includes an elongate shaft1004with a radially expandable balloon1006disposed near a distal end of the elongate shaft1004, and a stent1008disposed over the balloon1006. The stent1008may be the same length as the working length of the balloon1008, or it may be shorter. In preferred embodiments, the stent1008is shorter than the working length of balloon1006such that a proximal portion of balloon1006remains unconstrained by stent1008. The proximal portion of balloon1006may be slidably advanced and retracted under stent1042via side hole1020. Stent1008is crimped to the balloon1006to prevent ejection during delivery. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen1012extending from the distal guidewire port1010at the distal end of the elongate shaft1004to the proximal end of the elongate shaft1004into Y-adapter1014having a connector1016. The connector1016is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1012exits via connector1016. A second connector1018, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1006via an inflation lumen (not shown) in the elongate shaft1004. The first catheter1002is disposed in the central channel1026of a capture tube1024having perforated region1045. Central channel1026is sized to fit both shafts1004,1032and allow slidable movement thereof. Shaft1004is slidable in the central channel1026, or it may be locked with a locking collar1025such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft1004, often near the balloon1006and/or stent1008, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The perforated region1045along the capture tube1024allows the capture tube to be easily peeled away from both catheter shafts1004,1032once the catheters have been properly positioned and when no longer needed. The second catheter1030includes an elongate shaft1032with a radially expandable balloon1040disposed near a distal end of the elongate shaft1032. A stent1042having a proximal portion1022, a distal portion1014, and a side hole1020is disposed over balloon1040. The distal portion1014is crimped to balloon1040to prevent ejection during delivery, while the proximal portion1022is partially crimped to balloon1040so elongate shaft1004may be slidably advanced or retracted under the proximal portion1022of stent1042. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. At least a portion of balloon1006, and stent1008are distally offset relative to balloon1040and stent1042so as to minimize profile of the device. In this embodiment the distal stent1008may be deployed in a main branch of the vessel and the other stent1042may be deployed in a side branch of the vessel. Alternatively, the distal stent1008may be deployed in a side branch of a vessel and the other stent1042may be deployed in the main branch of a vessel. The second catheter1030is a rapid exchange catheter (RX) having a guidewire lumen1034extending from the distal guidewire port1038at the distal end of the elongate shaft1032to a proximal guidewire port1036which is closer to the distal port1038than the proximal end of the catheter shaft1032. The proximal guidewire port1036is also unobstructed by the capture tube1024and may be distal thereto. A connector1044, preferably a Luer connector is connected to the proximal end of the elongate shaft1032and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1032for inflation of balloon1040. A portion of shaft1032is disposed in the central channel1026of the capture tube1024and this helps keep the two catheter shafts1004,1032parallel and prevents tangling during delivery and as shaft1032is slidably advanced in the central channel1026. Compression fitting1025may be used to lock elongate shafts1004,1032in the capture tube1024to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, a portion of shaft1004is disposed under proximal portion1022of stent1042. The first catheter1002may be slidably advanced or retracted under the proximal portion1022of stent1042so that the shaft1004passes through the side hole1020in stent1042. Capture tube1024may be peeled away from shaft1032by severing the perforated region1045. Radiopaque markers may be placed at different locations on the shaft1032, often near the balloon1040or stent1042, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.1Aillustrates a catheter system1100having dual rapid exchange design with a removable capture tube.FIG.11Bmore clearly illustrates the features of the catheter system1100inFIG.11A. The stent delivery system1100includes a first catheter1102, and a second catheter1130. The first catheter1102includes an elongate shaft1104with a radially expandable balloon1106disposed near a distal end of the elongate shaft1104. A stent1108having a proximal portion1122, a distal portion1114and a side hole1120is disposed over the balloon1106. The distal portion1114is crimped to the balloon1106to prevent ejection during delivery, while the proximal portion1122is partially crimped to the balloon1106so the second catheter1130may be slidably advanced under the proximal portion1122of stent1108. The first catheter is a rapid exchange catheter (RX) having a guidewire lumen1112extending from the distal guidewire port1110at the distal end of the elongate shaft1104to a proximal guidewire port1111which is closer to the distal port1110than the proximal end of the catheter shaft1104. A connector1116is coupled with the proximal end of the elongate shaft1104. The connector1116is preferably a Luer connector and this allows easy coupling with an Indeflator or other device for inflation of the balloon1106. The first catheter1102is disposed in the central channel1126of a capture tube1124having a perforated region1145. Central channel1126is sized to fit both shafts1104,1132and allow slidable movement thereof. Shaft1104is slidable in the central channel1126, or it may be locked with a locking collar1125such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft1104, often near the balloon1106and/or stent1108, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The perforated region1145along the capture tube1124allows the capture tube to be easily peeled away from both catheter shafts1104,1132once the catheters have been properly positioned and when no longer needed. The second catheter1130includes an elongate shaft1132with a radially expandable balloon1140disposed near a distal end of the elongate shaft1132. A stent1142is disposed over balloon1140. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent1142is shorter than the working length of the balloon1140so that a proximal portion of the balloon1140is unconstrained by the stent1142and this unconstrained portion of the balloon1140may be slidably advanced or retracted through side hole1120and under proximal portion1122of stent1108as will be discussed below. Stent1142is crimped to balloon1140to prevent ejection during delivery. At least a portion of balloon1140, and stent1142are distally offset relative to balloon1106and stent1108so as to minimize profile of the device. In this embodiment the distal stent1142may be deployed in a main branch of the vessel and the other stent1108may be deployed in a side branch of the vessel. Alternatively, the distal stent1142may be deployed in a side branch of a vessel and the other stent1108may be deployed in the main branch of a vessel. The second catheter1130is a rapid exchange catheter (RX) having a guidewire lumen1134extending from the distal guidewire port1138at the distal end of the elongate shaft1132to a proximal guidewire port1136which is closer to the distal port1138than the proximal end of the catheter shaft1132. The proximal guidewire port1136is also unobstructed by the capture tube1124and may be distal thereto. A connector1144, preferably a Luer connector is connected to the proximal end of the elongate shaft1132and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1132for inflation of balloon1140. A portion of shaft1132is disposed in the central channel1126of the capture tube1124and this helps keep the two catheter shafts1104,1132parallel and prevents tangling during delivery and as shaft1132is slidably advanced in the central channel1126. Compression fitting1125may be used to lock elongate shafts1104,1132in the capture tube1124to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, another portion of shaft1132is disposed under proximal portion1122of stent1108. The second catheter1130may also be slidably advanced or retracted under the proximal portion1122of stent1108so that the shaft1132passes through the side hole1120in stent1108. Capture tube1124may be peeled away from shaft1132by severing the perforated region1145. Radiopaque markers may be placed at different locations on the shaft1132, often near the balloon1140or stent1142, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.12Aillustrates a catheter system1200having dual over the wire design with a removable capture tube.FIG.12Bmore clearly illustrates the features of the catheter system1200inFIG.12A. The stent delivery system1200includes a first catheter1202, and a second catheter1230. The first catheter1202includes an elongate shaft1204with a radially expandable balloon1206disposed near a distal end of the elongate shaft1204. A stent1208having a proximal portion1222, a distal portion1214and a side hole1220is disposed over the balloon1206. The distal portion1214is crimped to the balloon1206to prevent ejection during delivery, while the proximal portion1222is partially crimped to the balloon1206so the second catheter1230may be slidably advanced under the proximal portion1222of stent1208. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen1212extending from the distal guidewire port1210at the distal end of the elongate shaft1204to the proximal end of the elongate shaft1204into Y-adapter1214having a connector1216. The connector1216is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1212exits via connector1216. A second connector1218, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1206via an inflation lumen (not shown) in the elongate shaft1204. The first catheter1202is disposed in the central channel1226of a capture tube1224having a perforated region1245. Central channel1226is sized to fit both shafts1204,1232and allow slidable movement thereof. Shaft1204is slidable in the central channel1226, or it may be locked with a locking collar1225such as a Tuohy-Borst compression fitting. Radiopaque markers may be placed at different locations along the shaft1204, often near the balloon1206and/or stent1208, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The perforated region1245along the capture tube1224allows the capture tube to be easily peeled away from both catheter shafts1204,1232once the catheters have been properly positioned and when no longer needed. The second catheter1230includes an elongate shaft1232with a radially expandable balloon1240disposed near a distal end of the elongate shaft1232. A stent1242is disposed over balloon1240. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent1242is shorter than the working length of the balloon1240so that a proximal portion of the balloon1240is unconstrained by the stent1242and this unconstrained portion of the balloon1240may be slidably advanced or retracted through side hole1220and under proximal portion1222of stent1208as will be discussed below. Stent1242is crimped to balloon1240to prevent ejection during delivery. At least a portion of balloon1240, and stent1242are distally offset relative to balloon1206and stent1208so as to minimize profile of the device. In this embodiment the distal stent1242may be deployed in a main branch of the vessel and the other stent1208may be deployed in a side branch of the vessel. Alternatively, the distal stent1242may be deployed in a side branch of a vessel and the other stent1208may be deployed in the main branch of a vessel. The second catheter1230is an over-the-wire (OTW) catheter having a guidewire lumen1234extending from the distal guidewire port1238at the distal end of the elongate shaft1232to the proximal end of the elongate shaft1232into Y-adapter1246having a connector1248. The connector1248is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1234exits via connector1248. A second connector1244, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1240via an inflation lumen (not shown) in the elongate shaft1232. A portion of shaft1232is disposed in the central channel1226of the capture tube1224and this helps keep the two catheter shafts1204,1232parallel and prevents tangling during delivery and as shaft1232is slidably advanced in the central channel1226. Compression fitting1225may be used to lock elongate shafts1204,1232in the capture tube1224to prevent axial movement. The compression fitting may be a Tuohy-Borst fitting. Also, another portion of shaft1232is disposed under proximal portion1222of stent1208. The second catheter1230may also be slidably advanced or retracted under the proximal portion1222of stent1208so that the shaft1232passes through the side hole1220in stent1208. Capture tube1224may be peeled away from shaft1232by severing the perforated region1245. Radiopaque markers may be placed at different locations on the shaft1232, often near the balloon1240or stent1242, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIGS.13A,14A,15A, and16Aillustrates a zipper that allows one catheter to snap in to the other catheter. The zipper is essentially a groove that forms a concave receiving cross section and is carved into a catheter's outer surface in a straight line. The groove can be a single groove over a certain portion of a catheter or it can run from end to end. Alternatively, the catheter can have a series of short grooves of 1 to 10 centimeters in length that run the length of the catheter or only a certain portion. Full length end to end zippers will have reduced profile and reduced friction with the vessel. The resulting groove can receive another catheter and prevent the catheters from dislodging while the operator is advancing the catheters to the bifurcation. Once at the site the operator can still slidably move the catheters forward and back relative to each other. Mother catheters that utilize the groove can have fully crimped stents as described in several of the embodiments above; however, it is possible to allow operators to choose any commercially available catheter with or without a stent and mount the commercially available catheter via the zipper. The mother catheters with an empty zipper would have a mother stent fully crimped on the distal balloon portion. After loading the commercially available catheter the operator would have to crimp the proximal portion of the mother stent in situ prior to beginning the clinical procedure. This option may be extremely valuable to operators who can reduce their total inventory of catheters but have more options for treating bifurcated lesions. FIG.13Aillustrates a catheter system1300having a distal daughter catheter with an over the wire design and a proximal mother catheter with a rapid exchange design and a short zipper.FIG.13Bmore clearly illustrates the features of the catheter system1300inFIG.13A. The stent delivery system1300includes a first catheter1302, and a second catheter1330. The first catheter1302includes an elongate shaft1304with a radially expandable balloon1306disposed near a distal end of the elongate shaft1304. A stent1308having a proximal portion1322, a distal portion1314and a side hole1320is disposed over the balloon1306. The distal portion1314is crimped to the balloon1306to prevent ejection during delivery, while the proximal portion1322is partially crimped to the balloon1306so the second catheter1330may be slidably advanced under the proximal portion1322of stent1308. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen1312extending from the distal guidewire port1310at the distal end of the elongate shaft1304to the proximal end of the elongate shaft1304into Y-adapter1314having a connector1316. The connector1316is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1312exits via connector1316. A second connector1318, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1306via an inflation lumen (not shown) in the elongate shaft1304. The first catheter1302also includes a zipper or snap fitting1324coupled to the elongate shaft1304. The snap fit tube1324may be coextruded with the first shaft1304, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit1324may alternatively be coupled with the other shaft1332. The snap fitting1324includes a central channel1326extending therethrough and is sized to slidably receive a portion of the second catheter1330. An elongate slot1345extends along the entire length of the snap fitting1324and is sized so that shaft1336may snapped into the central channel1326.FIG.13Cillustrates a partial cross-section ofFIG.13Btaken along the line C-C and shows shaft1304with the snap fitting1324. Radiopaque markers may be placed at different locations along the shaft1304, often near the balloon1306and/or stent1308, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter1330includes an elongate shaft1332with a radially expandable balloon1340disposed near a distal end of the elongate shaft1332. A stent1342is disposed over balloon1340. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent1342is shorter than the working length of the balloon1340so that a proximal portion of the balloon1340is unconstrained by the stent1342and this unconstrained portion of the balloon1340may be slidably advanced or retracted through side hole1320and under proximal portion1322of stent1308as will be discussed below. Stent1342is crimped to balloon1340to prevent ejection during delivery. At least a portion of balloon1340, and stent1342are distally offset relative to balloon1306and stent1308so as to minimize profile of the device. In this embodiment the distal stent1342may be deployed in a main branch of the vessel and the other stent1308may be deployed in a side branch of the vessel. Alternatively, the distal stent1342may be deployed in a side branch of a vessel and the other stent1308may be deployed in the main branch of a vessel. The second catheter1330is a rapid exchange catheter (RX) having a guidewire lumen1334extending from the distal guidewire port1338at the distal end of the elongate shaft1332to a proximal guidewire port1336which is closer to the distal port1338than the proximal end of the catheter shaft1332. The proximal guidewire port1336is also unobstructed by the snap fitting1324and preferably proximal thereto. A connector1344, preferably a Luer connector is connected to the proximal end of the elongate shaft1332and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1332for inflation of balloon1340. A portion of shaft1332is snapped into the central channel1326of the snap fitting1324via slit1345, and thus shaft1332may slide in channel1326. This helps keep the two catheter shafts1304,1332parallel and prevents tangling during delivery and as shaft1332is slidably advanced or retracted relative to shaft1304. Also, another portion of shaft1332is disposed under proximal portion1322of stent1308. The second catheter1330may also be slidably advanced or retracted under the proximal portion1322of stent1308so that the shaft1332passes through the side hole1320in stent1308. Radiopaque markers may be placed at different locations on the shaft1332, often near the balloon1340or stent1342, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.14Aillustrates a catheter system1400having a proximal mother catheter with a rapid exchange configuration and a distal daughter catheter having an over-the-wire configuration and a short zipper or snap fitting.FIG.14Bmore clearly illustrates the features of the catheter system1400inFIG.14A. The stent delivery system1400includes a first catheter1402, and a second catheter1430. The first catheter1402includes an elongate shaft1404with a radially expandable balloon1406disposed near a distal end of the elongate shaft1404, and a stent1408disposed over the balloon1406. The stent1408may be the same length as the working length of the balloon1408, or it may be shorter. In preferred embodiments, the stent1408is shorter than the working length of balloon1406such that a proximal portion of balloon1406remains unconstrained by stent1408. The proximal portion of balloon1406may be slidably advanced and retracted under stent1442via side hole1420. Stent1408is crimped to the balloon1406to prevent ejection during delivery. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen1412extending from the distal guidewire port1410at the distal end of the elongate shaft1404to the proximal end of the elongate shaft1404into Y-adapter1414having a connector1416. The connector1416is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1412exits via connector1416. A second connector1418, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1406via an inflation lumen (not shown) in the elongate shaft1404. The first catheter1402also includes a zipper or snap fitting1424coupled to the elongate shaft1404. The snap fit tube1424may be coextruded with the first shaft1404, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit1424may alternatively be coupled with the other shaft1432. The snap fitting1424includes a central channel1426extending therethrough and is sized to slidably receive a portion of the second catheter1430. An elongate slot1445extends along the entire length of the snap fitting1424and is sized so that shaft1436may be snapped into the central channel1426.FIG.14Cillustrates a partial cross-section ofFIG.14Btaken along the line C-C and shows shaft1404with the snap fitting1424. Radiopaque markers may be placed at different locations along the shaft1404, often near the balloon1406and/or stent1408, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter1430includes an elongate shaft1432with a radially expandable balloon1440disposed near a distal end of the elongate shaft1432. A stent1442having a proximal portion1422, a distal portion1414, and a side hole1420is disposed over balloon1440. The distal portion1414is crimped to balloon1440to prevent ejection during delivery, while the proximal portion1422is partially crimped to balloon1440so elongate shaft1404may be slidably advanced or retracted under the proximal portion1422of stent1442. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. At least a portion of balloon1406, and stent1408are distally offset relative to balloon1440and stent1442so as to minimize profile of the device. In this embodiment the distal stent1408may be deployed in a main branch of the vessel and the other stent1442may be deployed in a side branch of the vessel. Alternatively, the distal stent1408may be deployed in a side branch of a vessel and the other stent1442may be deployed in the main branch of a vessel. The second catheter1430is a rapid exchange catheter (RX) having a guidewire lumen1434extending from the distal guidewire port1438at the distal end of the elongate shaft1432to a proximal guidewire port1436which is closer to the distal port1438than the proximal end of the catheter shaft1432. The proximal guidewire port1436is also unobstructed by the snap fitting1424and preferably proximal thereto. A connector1444, preferably a Luer connector is connected to the proximal end of the elongate shaft1432and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1432for inflation of balloon1440. A portion of shaft1432is snapped into the central channel1426of the snap fitting1424via slit1445, and thus shaft1432may slide in channel1426. This helps keep the two catheter shafts1404,1432parallel and prevents tangling during delivery and as shaft1432is slidably advanced or retracted relative to shaft1404. Also, a portion of shaft1404is disposed under proximal portion1422of stent1442. The first catheter1402may be slidably advanced or retracted under the proximal portion1422of stent1442so that the shaft1404passes through the side hole1420in stent1442. Radiopaque markers may be placed at different locations on the shaft1432, often near the balloon1440or stent1442, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.15Aillustrates a catheter system1500having dual rapid exchange design with a short zipper or snap fitting.FIG.15Bmore clearly illustrates the features of the catheter system1500inFIG.15A. The stent delivery system1500includes a first catheter1502, and a second catheter1530. The first catheter1502includes an elongate shaft1504with a radially expandable balloon1506disposed near a distal end of the elongate shaft1504. A stent1508having a proximal portion1522, a distal portion1514and a side hole1520is disposed over the balloon1506. The distal portion1514is crimped to the balloon1506to prevent ejection during delivery, while the proximal portion1522is partially crimped to the balloon1506so the second catheter1530may be slidably advanced under the proximal portion1522of stent1508. The first catheter is a rapid exchange catheter (RX) having a guidewire lumen1512extending from the distal guidewire port1510at the distal end of the elongate shaft1504to a proximal guidewire port1511which is closer to the distal port1510than the proximal end of the catheter shaft1504. A connector1516is coupled with the proximal end of the elongate shaft1504. The connector1516is preferably a Luer connector and this allows easy coupling with an Indeflator or other device for inflation of the balloon1506. The first catheter1502also includes a zipper or snap fitting1524coupled to the elongate shaft1504. The snap fit tube1524may be coextruded with the first shaft1504, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit1524may alternatively be coupled with the other shaft1532. The snap fitting1524includes a central channel1526extending therethrough and is sized to slidably receive a portion of the second catheter1530. An elongate slot1545extends along the entire length of the snap fitting1524and is sized so that shaft1536may snapped into the central channel1526.FIG.15Cillustrates a partial cross-section ofFIG.15Btaken along the line C-C and shows shaft1504with the snap fitting1524. Radiopaque markers may be placed at different locations along the shaft1504, often near the balloon1506and/or stent1508, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter1530includes an elongate shaft1532with a radially expandable balloon1540disposed near a distal end of the elongate shaft1532. A stent1542is disposed over balloon1540. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent1542is shorter than the working length of the balloon1540so that a proximal portion of the balloon1540is unconstrained by the stent1542and this unconstrained portion of the balloon1540may be slidably advanced or retracted through side hole1520and under proximal portion1522of stent1508as will be discussed below. Stent1542is crimped to balloon1540to prevent ejection during delivery. At least a portion of balloon1540, and stent1542are distally offset relative to balloon1506and stent1508so as to minimize profile of the device. In this embodiment the distal stent1542may be deployed in a main branch of the vessel and the other stent1508may be deployed in a side branch of the vessel. Alternatively, the distal stent1542may be deployed in a side branch of a vessel and the other stent1508may be deployed in the main branch of a vessel. The second catheter1530is a rapid exchange catheter (RX) having a guidewire lumen1534extending from the distal guidewire port1538at the distal end of the elongate shaft1532to a proximal guidewire port1536which is closer to the distal port1538than the proximal end of the catheter shaft1532. The proximal guidewire port1536is also unobstructed by the snap fitting1524and may be distal thereto. A connector1544, preferably a Luer connector is connected to the proximal end of the elongate shaft1532and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1532for inflation of balloon1540. A portion of shaft1532is snapped into the central channel1526of the snap fitting1524via slit1545, and thus shaft1532may slide in channel1526. This helps keep the two catheter shafts1504,1532parallel and prevents tangling during delivery and as shaft1532is slidably advanced or retracted relative to shaft1504. Also, another portion of shaft1532is disposed under proximal portion1522of stent1508. The second catheter1530may also be slidably advanced or retracted under the proximal portion1522of stent1508so that the shaft1532passes through the side hole1520in stent1508. Radiopaque markers may be placed at different locations on the shaft1532, often near the balloon1540or stent1542, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.16Aillustrates a catheter system1600having a dual over the wire design with a short zipper or snap fitting.FIG.16Bmore clearly illustrates the features of the catheter system1600inFIG.16A. The stent delivery system1600includes a first catheter1602, and a second catheter1630. The first catheter1602includes an elongate shaft1604with a radially expandable balloon1606disposed near a distal end of the elongate shaft1604. A stent1608having a proximal portion1622, a distal portion1614and a side hole1620is disposed over the balloon1606. The distal portion1614is crimped to the balloon1606to prevent ejection during delivery, while the proximal portion1622is partially crimped to the balloon1606so the second catheter1630may be slidably advanced under the proximal portion1622of stent1608. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen1612extending from the distal guidewire port1610at the distal end of the elongate shaft1604to the proximal end of the elongate shaft1604into Y-adapter1614having a connector1616. The connector1616is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1612exits via connector1616. A second connector1618, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1606via an inflation lumen (not shown) in the elongate shaft1604. The first catheter1602also includes a zipper or snap fitting1624coupled to the elongate shaft1604. The snap fit tube1624may be coextruded with the first shaft1604, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit1624may alternatively be coupled with the other shaft1632. The snap fitting1624includes a central channel1626extending therethrough and is sized to slidably receive a portion of the second catheter1630. An elongate slot1645extends along the entire length of the snap fitting1624and is sized so that shaft1636may snapped into the central channel1626.FIG.16Cillustrates a partial cross-section ofFIG.16Btaken along the line C-C and shows shaft1604with the snap fitting1624. Radiopaque markers may be placed at different locations along the shaft1604, often near the balloon1606and/or stent1608, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter1630includes an elongate shaft1632with a radially expandable balloon1640disposed near a distal end of the elongate shaft1632. A stent1642is disposed over balloon1640. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent1642is shorter than the working length of the balloon1640so that a proximal portion of the balloon1640is unconstrained by the stent1642and this unconstrained portion of the balloon1640may be slidably advanced or retracted through side hole1620and under proximal portion1622of stent1608as will be discussed below. Stent1642is crimped to balloon1640to prevent ejection during delivery. At least a portion of balloon1640, and stent1642are distally offset relative to balloon1606and stent1608so as to minimize profile of the device. In this embodiment the distal stent1642may be deployed in a main branch of the vessel and the other stent1608may be deployed in a side branch of the vessel. Alternatively, the distal stent1642may be deployed in a side branch of a vessel and the other stent1608may be deployed in the main branch of a vessel. The second catheter1630is an over-the-wire (OTW) catheter having a guidewire lumen1634extending from the distal guidewire port1638at the distal end of the elongate shaft1632to the proximal end of the elongate shaft1632into Y-adapter1646having a connector1648. The connector1648is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1634exits via connector1648. A second connector1644, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1640via an inflation lumen (not shown) in the elongate shaft1632. A portion of shaft1632is snapped into the central channel1626of the snap fitting1624via slit1645, and thus shaft1632may slide in channel1626. This helps keep the two catheter shafts1604,1632parallel and prevents tangling during delivery and as shaft1632is slidably advanced or retracted relative to shaft1604. Also, another portion of shaft1632is disposed under proximal portion1622of stent1608. The second catheter1630may also be slidably advanced or retracted under the proximal portion1622of stent1608so that the shaft1632passes through the side hole1620in stent1608. Radiopaque markers may be placed at different locations on the shaft1632, often near the balloon1640or stent1642, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.17Aillustrates a catheter system1700having a distal daughter catheter with a rapid exchange configuration a proximal mother catheter with an over-the-wire configuration and an end to end zipper, or snap fitting. This embodiment is similar to that shown inFIGS.13A-13B, with the major difference being the length of the snap fitting and the location of one of the guidewire ports.FIG.17Bmore clearly illustrates the features of the catheter system1700inFIG.17A. The stent delivery system1700includes a first catheter1702, and a second catheter1730. The first catheter1702includes an elongate shaft1704with a radially expandable balloon1706disposed near a distal end of the elongate shaft1704. A stent1708having a proximal portion1722, a distal portion1714and a side hole1720is disposed over the balloon1706. The distal portion1714is crimped to the balloon1706to prevent ejection during delivery, while the proximal portion1722is partially crimped to the balloon1706so the second catheter1730may be slidably advanced under the proximal portion1722of stent1708. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen1712extending from the distal guidewire port1710at the distal end of the elongate shaft1704to the proximal end of the elongate shaft1704into Y-adapter1714having a connector1716. The connector1716is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1712exits via connector1716. A second connector1718, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1706via an inflation lumen (not shown) in the elongate shaft1704. The first catheter1702also includes a zipper or snap fitting1724coupled to the elongate shaft1704. The snap fit tube1724may be coextruded with the first shaft1704, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit1724may alternatively be coupled with the other shaft1732. The snap fitting1724includes a central channel1726extending therethrough and is sized to slidably receive a portion of the second catheter1730. An elongate slot1745extends along the entire length of the snap fitting1724and is sized so that shaft1736may snapped into the central channel1726. The snap fitting1724may extend from the distal end of connectors1714,1744to the proximal end of balloon1706, or it may be shorter, extending only partially between the connectors1714,1744and the balloon1706.FIG.17Cillustrates a partial cross-section ofFIG.17Btaken along the line C-C and shows shaft1704with the snap fitting1724. Radiopaque markers may be placed at different locations along the shaft1704, often near the balloon1706and/or stent1708, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter1730includes an elongate shaft1732with a radially expandable balloon1740disposed near a distal end of the elongate shaft1732. A stent1742is disposed over balloon1740. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent1742is shorter than the working length of the balloon1740so that a proximal portion of the balloon1740is unconstrained by the stent1742and this unconstrained portion of the balloon1740may be slidably advanced or retracted through side hole1720and under proximal portion1722of stent1708as will be discussed below. Stent1742is crimped to balloon1740to prevent ejection during delivery. At least a portion of balloon1740, and stent1742are distally offset relative to balloon1706and stent1708so as to minimize profile of the device. In this embodiment the distal stent1742may be deployed in a main branch of the vessel and the other stent1708may be deployed in a side branch of the vessel. Alternatively, the distal stent1742may be deployed in a side branch of a vessel and the other stent1708may be deployed in the main branch of a vessel. The second catheter1730is a rapid exchange catheter (RX) having a guidewire lumen1734extending from the distal guidewire port1738at the distal end of the elongate shaft1732to a proximal guidewire port1736which is closer to the distal port1738than the proximal end of the catheter shaft1732. The proximal guidewire port1736is also unobstructed by the snap fitting1724and preferably distal thereto. A connector1744, preferably a Luer connector is connected to the proximal end of the elongate shaft1732and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1732for inflation of balloon1740. A portion of shaft1732is snapped into the central channel1726of the snap fitting1724via slit1745, and thus shaft1732may slide in channel1726. This helps keep the two catheter shafts1704,1732parallel and prevents tangling during delivery and as shaft1732is slidably advanced or retracted relative to shaft1704. Also, another portion of shaft1732is disposed under proximal portion1722of stent1708. The second catheter1730may also be slidably advanced or retracted under the proximal portion1722of stent1708so that the shaft1732passes through the side hole1720in stent1708. Radiopaque markers may be placed at different locations on the shaft1732, often near the balloon1740or stent1742, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.18Aillustrates a catheter system1800having a proximal mother catheter with a rapid exchange configuration and a distal daughter catheter with an end to end zipper or snap fitting.FIG.18Ais similar to the embodiment ofFIGS.14A-14B, with the major difference being the length of the snap fitting and the location of one of the guidewire ports.FIG.18Bmore clearly illustrates the features of the catheter system1800inFIG.18A. The stent delivery system1800includes a first catheter1802, and a second catheter1830. The first catheter1802includes an elongate shaft1804with a radially expandable balloon1806disposed near a distal end of the elongate shaft1804, and a stent1808disposed over the balloon1806. The stent1808may be the same length as the working length of the balloon1808, or it may be shorter. In preferred embodiments, the stent1808is shorter than the working length of balloon1806such that a proximal portion of balloon1806remains unconstrained by stent1808. The proximal portion of balloon1806may be slidably advanced and retracted under stent1842via side hole1820. Stent1808is crimped to the balloon1806to prevent ejection during delivery. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen1812extending from the distal guidewire port1810at the distal end of the elongate shaft1804to the proximal end of the elongate shaft1804into Y-adapter1814having a connector1816. The connector1816is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen1812exits via connector1816. A second connector1818, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon1806via an inflation lumen (not shown) in the elongate shaft1804. The first catheter1802also includes a zipper or snap fitting1824coupled to the elongate shaft1804. The snap fit tube1824may be coextruded with the first shaft1804, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit1824may alternatively be coupled with the other shaft1832. The snap fitting1824includes a central channel1826extending therethrough and is sized to slidably receive a portion of the second catheter1830. An elongate slot1845extends along the entire length of the snap fitting1824and is sized so that shaft1836may be snapped into the central channel1826.FIG.18Cillustrates a partial cross-section ofFIG.18Btaken along the line C-C and shows shaft1804with the snap fitting1824. The snap fitting1824may extend from the distal end of connectors1814,1844to the proximal end of balloon1840, or it may be shorter, extending only partially between the connectors1814,1844and the balloon1806. Radiopaque markers may be placed at different locations along the shaft1804, often near the balloon1806and/or stent1808, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter1830includes an elongate shaft1832with a radially expandable balloon1840disposed near a distal end of the elongate shaft1832. A stent1842having a proximal portion1822, a distal portion1814, and a side hole1820is disposed over balloon1840. The distal portion1814is crimped to balloon1840to prevent ejection during delivery, while the proximal portion1822is partially crimped to balloon1840so elongate shaft1804may be slidably advanced or retracted under the proximal portion1822of stent1842. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. At least a portion of balloon1806, and stent1808are distally offset relative to balloon1840and stent1842so as to minimize profile of the device. In this embodiment the distal stent1808may be deployed in a main branch of the vessel and the other stent1842may be deployed in a side branch of the vessel. Alternatively, the distal stent1808may be deployed in a side branch of a vessel and the other stent1842may be deployed in the main branch of a vessel. The second catheter1830is a rapid exchange catheter (RX) having a guidewire lumen1834extending from the distal guidewire port1838at the distal end of the elongate shaft1832to a proximal guidewire port1836which is closer to the distal port1838than the proximal end of the catheter shaft1832. The proximal guidewire port1836is also unobstructed by the snap fitting1824and preferably distal thereto. A connector1844, preferably a Luer connector is connected to the proximal end of the elongate shaft1832and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1832for inflation of balloon1840. A portion of shaft1832is snapped into the central channel1826of the snap fitting1824via slit1845, and thus shaft1832may slide in channel1826. This helps keep the two catheter shafts1804,1832parallel and prevents tangling during delivery and as shaft1832is slidably advanced or retracted relative to shaft1804. Also, a portion of shaft1804is disposed under proximal portion1822of stent1842. The first catheter1802may be slidably advanced or retracted under the proximal portion1822of stent1842so that the shaft1804passes through the side hole1820in stent1842. Radiopaque markers may be placed at different locations on the shaft1832, often near the balloon1840or stent1842, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.19Aillustrates a catheter system1900having a dual rapid exchange design with an end to end zipper or snap fitting.FIG.19Ais similar to the embodiment ofFIGS.15A-15B, with the major difference being the length of the snap fitting.FIG.19Bmore clearly illustrates the features of the catheter system1900inFIG.19A. The stent delivery system1900includes a first catheter1902, and a second catheter1930. The first catheter1902includes an elongate shaft1904with a radially expandable balloon1906disposed near a distal end of the elongate shaft1904. A stent1908having a proximal portion1922, a distal portion1914and a side hole1920is disposed over the balloon1906. The distal portion1914is crimped to the balloon1906to prevent ejection during delivery, while the proximal portion1922is partially crimped to the balloon1906so the second catheter1930may be slidably advanced under the proximal portion1922of stent1908. The first catheter is a rapid exchange catheter (RX) having a guidewire lumen1912extending from the distal guidewire port1910at the distal end of the elongate shaft1904to a proximal guidewire port1911which is closer to the distal port1910than the proximal end of the catheter shaft1904. A connector1916is coupled with the proximal end of the elongate shaft1904. The connector1916is preferably a Luer connector and this allows easy coupling with an Indeflator or other device for inflation of the balloon1906. The first catheter1902also includes a zipper or snap fitting1924coupled to the elongate shaft1904. The snap fit tube1924may be coextruded with the first shaft1904, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit1924may alternatively be coupled with the other shaft1932. The snap fitting1924includes a central channel1926extending therethrough and is sized to slidably receive a portion of the second catheter1930. An elongate slot1945extends along the entire length of the snap fitting1924and is sized so that shaft1932may snapped into the central channel1926.FIG.19Cillustrates a partial cross-section ofFIG.19Btaken along the line C-C and shows shaft1904with the snap fitting1924. Radiopaque markers may be placed at different locations along the shaft1904, often near the balloon1906and/or stent1908, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter1930includes an elongate shaft1932with a radially expandable balloon1940disposed near a distal end of the elongate shaft1932. A stent1942is disposed over balloon1940. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent1942is shorter than the working length of the balloon1940so that a proximal portion of the balloon1940is unconstrained by the stent1942and this unconstrained portion of the balloon1940may be slidably advanced or retracted through side hole1920and under proximal portion1922of stent1908as will be discussed below. Stent1942is crimped to balloon1940to prevent ejection during delivery. At least a portion of balloon1940, and stent1942are distally offset relative to balloon1906and stent1908so as to minimize profile of the device. In this embodiment the distal stent1942may be deployed in a main branch of the vessel and the other stent1908may be deployed in a side branch of the vessel. Alternatively, the distal stent1942may be deployed in a side branch of a vessel and the other stent1908may be deployed in the main branch of a vessel. The second catheter1930is a rapid exchange catheter (RX) having a guidewire lumen1934extending from the distal guidewire port1938at the distal end of the elongate shaft1932to a proximal guidewire port1936which is closer to the distal port1938than the proximal end of the catheter shaft1932. The proximal guidewire port1936is also unobstructed by the snap fitting1924and may be distal thereto. A connector1944, preferably a Luer connector is connected to the proximal end of the elongate shaft1932and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft1932for inflation of balloon1940. A portion of shaft1932is snapped into the central channel1926of the snap fitting1924via slit1945, and thus shaft1932may slide in channel1926. This helps keep the two catheter shafts1904,1932parallel and prevents tangling during delivery and as shaft1932is slidably advanced or retracted relative to shaft1904. Also, another portion of shaft1932is disposed under proximal portion1922of stent1908. The second catheter1930may also be slidably advanced or retracted under the proximal portion1922of stent1908so that the shaft1932passes through the side hole1920in stent1908. Radiopaque markers may be placed at different locations on the shaft1932, often near the balloon1940or stent1942, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.20Aillustrates a catheter system2000having a dual over the wire design with an end to end zipper or snap fitting.FIG.20Ais similar to the embodiment ofFIGS.16A-16B, with the major difference being the length of the snap fitting.FIG.20Bmore clearly illustrates the features of the catheter system2000inFIG.20A. The stent delivery system2000includes a first catheter2002, and a second catheter2030. The first catheter2002includes an elongate shaft2004with a radially expandable balloon2006disposed near a distal end of the elongate shaft2004. A stent2008having a proximal portion2022, a distal portion2014and a side hole2020is disposed over the balloon2006. The distal portion2014is crimped to the balloon2006to prevent ejection during delivery, while the proximal portion2022is partially crimped to the balloon2006so the second catheter2030may be slidably advanced under the proximal portion2022of stent2008. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen2012extending from the distal guidewire port2010at the distal end of the elongate shaft2004to the proximal end of the elongate shaft2004into Y-adapter2014having a connector2016. The connector2016is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen2012exits via connector2016. A second connector2018, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon2006via an inflation lumen (not shown) in the elongate shaft2004. The first catheter2002also includes a zipper or snap fitting2024coupled to the elongate shaft2004. The snap fit tube2024may be coextruded with the first shaft2004, or it may be bonded or otherwise attached thereto using techniques known to those skilled in the art. The snap fit2024may alternatively be coupled with the other shaft2032. The snap fitting2024includes a central channel2026extending therethrough and is sized to slidably receive a portion of the second catheter2030. An elongate slot2045extends along the entire length of the snap fitting2024and is sized so that shaft2036may snapped into the central channel2026.FIG.20Cillustrates a partial cross-section ofFIG.20Btaken along the line C-C and shows shaft2004with the snap fitting2024. Radiopaque markers may be placed at different locations along the shaft2004, often near the balloon2006and/or stent2008, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter2030includes an elongate shaft2032with a radially expandabl balloon2040disposed near a distal end of the elongate shaft2032. A stent2042is disposed over balloon2040. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent2042is shorter than the working length of the balloon2040so that a proximal portion of the balloon2040is unconstrained by the stent2042and this unconstrained portion of the balloon2040may be slidably advanced or retracted through side hole2020and under proximal portion2022of stent2008as will be discussed below. Stent2042is crimped to balloon2040to prevent ejection during delivery. At least a portion of balloon2040, and stent2042are distally offset relative to balloon2006and stent2008so as to minimize profile of the device. In this embodiment the distal stent2042may be deployed in a main branch of the vessel and the other stent2008may be deployed in a side branch of the vessel. Alternatively, the distal stent2042may be deployed in a side branch of a vessel and the other stent2008may be deployed in the main branch of a vessel. The second catheter2030is an over-the-wire (OTW) catheter having a guidewire lumen2034extending from the distal guidewire port2038at the distal end of the elongate shaft2032to the proximal end of the elongate shaft2032into Y-adapter2046having a connector2048. The connector2048is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen2034exits via connector2048. A second connector2044, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon2040via an inflation lumen (not shown) in the elongate shaft2032. A portion of shaft2032is snapped into the central channel2026of the snap fitting2024via slit2045, and thus shaft2032may slide in channel2026. This helps keep the two catheter shafts2004,2032parallel and prevents tangling during delivery and as shaft2032is slidably advanced or retracted relative to shaft2004. Also, another portion of shaft2032is disposed under proximal portion2022of stent2008. The second catheter2030may also be slidably advanced or retracted under the proximal portion2022of stent2008so that the shaft2032passes through the side hole2020in stent2008. Radiopaque markers may be placed at different locations on the shaft2032, often near the balloon2040or stent2042, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIGS.21A,22A,23A, and24Aillustrate catheters that can be used with an alternative embodiment where the mother catheter is provided to the operator with a mother stent that is crimped on the distal portion of the mother catheter balloon. The proximal portion of the mother stent is uncrimped or partially crimped. The operator can mount any commercially available catheter or balloon on a wire through the mother stent proximal end and exit out the side hole of the mother stent. The operator can align the catheters to suit the patient's anatomy and crimp the proximal portion of the mother stent. The operator can crimp the stent tightly so that the catheters do not move relative to each other. It is possible for the operator to place the catheters at the bifurcation and if necessary pullback on the commercially available catheter to adjust the alignment if necessary. Then the operator can gently push the system distally to ensure complete apposition. FIG.21Aillustrates a catheter system2100having a distal daughter catheter with a rapid exchange configuration and a proximal mother catheter with an over-the-wire configuration.FIG.21Bmore clearly illustrates the features of the catheter system2100inFIG.21A. The stent delivery system2100includes a first catheter2102, and a second catheter2130. The first catheter2102includes an elongate shaft2104with a radially expandable balloon2106disposed near a distal end of the elongate shaft2104. A stent2108having a proximal portion2122, a distal portion2114and a side hole2120is disposed over the balloon2106. The distal portion2114is crimped to the balloon2106to prevent ejection during delivery, while the proximal portion2122is partially crimped to the balloon2106so the second catheter2130may be slidably advanced under the proximal portion2122of stent2108. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen2112extending from the distal guidewire port2110at the distal end of the elongate shaft2104to the proximal end of the elongate shaft2104into Y-adapter2114having a connector2116. The connector2116is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen2112exits via connector2116. A second connector2118, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon2106via an inflation lumen (not shown) in the elongate shaft2104. Radiopaque markers may be placed at different locations along the shaft2104, often near the balloon2106and/or stent2108, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter2130includes an elongate shaft2132with a radially expandable balloon2140disposed near a distal end of the elongate shaft2132. A stent2142is disposed over balloon2140. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent2142is shorter than the working length of the balloon2140so that a proximal portion of the balloon2140is unconstrained by the stent2142and this unconstrained portion of the balloon2140may be slidably advanced or retracted through side hole2120and under proximal portion2122of stent2108as will be discussed below. Stent2142is crimped to balloon2140to prevent ejection during delivery. At least a portion of balloon2140, and stent2142are distally offset relative to balloon2106and stent2108so as to minimize profile of the device. In this embodiment the distal stent2142may be deployed in a main branch of the vessel and the other stent2108may be deployed in a side branch of the vessel. Alternatively, the distal stent2142may be deployed in a side branch of a vessel and the other stent2108may be deployed in the main branch of a vessel. The second catheter2130is a rapid exchange catheter (RX) having a guidewire lumen2134extending from the distal guidewire port2138at the distal end of the elongate shaft2132to a proximal guidewire port2136which is closer to the distal port2138than the proximal end of the catheter shaft2132. A connector2144, preferably a Luer connector is connected to the proximal end of the elongate shaft2132and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft2132for inflation of balloon2140. Having a portion of shaft2132disposed under proximal portion2122of stent2108helps keep catheter shafts2104,2132parallel and prevents tangling during delivery and as shaft2132is slidably advanced or retracted relative to shaft2104. Also, another portion of shaft2132is disposed under proximal portion2122of stent2108. The second catheter2130may also be slidably advanced or retracted under the proximal portion2122of stent2108so that the shaft2132passes through the side hole2120in stent2108. Radiopaque markers may be placed at different locations on the shaft2132, often near the balloon2140or stent2142, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.22Aillustrates a catheter system2200having a proximal mother catheter with an over the wire design and a distal daughter catheter with an over-the-wire configuration.FIG.22Bmore clearly illustrates the features of the catheter system2200inFIG.22A. The stent delivery system2200includes a first catheter2202, and a second catheter2230. The first catheter2202includes an elongate shaft2204with a radially expandable balloon2206disposed near a distal end of the elongate shaft2204, and a stent2208disposed over the balloon2206. The stent2208may be the same length as the working length of the balloon2208, or it may be shorter. In preferred embodiments, the stent2208is shorter than the working length of balloon2206such that a proximal portion of balloon2206remains unconstrained by stent2208. The proximal portion of balloon2206may be slidably advanced and retracted under stent2242via side hole2220. Stent2208is crimped to the balloon2206to prevent ejection during delivery. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen2212extending from the distal guidewire port2210at the distal end of the elongate shaft2204to the proximal end of the elongate shaft2204into Y-adapter2214having a connector2216. The connector2216is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen2212exits via connector2216. A second connector2218, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon2206via an inflation lumen (not shown) in the elongate shaft2204. Radiopaque markers may be placed at different locations along the shaft2204, often near the balloon2206and/or stent2208, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter2230includes an elongate shaft2232with a radially expandable balloon2240disposed near a distal end of the elongate shaft2232. A stent2242having a proximal portion2222, a distal portion2214, and a side hole2220is disposed over balloon2240. The distal portion2214is crimped to balloon2240to prevent ejection during delivery, while the proximal portion2222is partially crimped to balloon2240so elongate shaft2204may be slidably advanced or retracted under the proximal portion2222of stent2242. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. At least a portion of balloon2206, and stent2208are distally offset relative to balloon2240and stent2242so as to minimize profile of the device. In this embodiment the distal stent2208may be deployed in a main branch of the vessel and the other stent2242may be deployed in a side branch of the vessel. Alternatively, the distal stent2208may be deployed in a side branch of a vessel and the other stent2242may be deployed in the main branch of a vessel. The second catheter2230is a rapid exchange catheter (RX) having a guidewire lumen2234extending from the distal guidewire port2238at the distal end of the elongate shaft2232to a proximal guidewire port2236which is closer to the distal port2238than the proximal end of the catheter shaft2232. A connector2244, preferably a Luer connector is connected to the proximal end of the elongate shaft2232and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft2232for inflation of balloon2240. Having a portion of shaft2204disposed under proximal portion2222of stent2208helps keep catheters2202,2232parallel and prevents tangling during delivery and as shaft2204is slidably advanced or retracted relative to shaft2232. The first catheter2202may be slidably advanced or retracted under the proximal portion2222of stent2242so that the shaft2204passes through the side hole2220in stent2242. Radiopaque markers may be placed at different locations on the shaft2232, often near the balloon2240or stent2242, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.23Aillustrates a catheter system2300having a dual rapid exchange design.FIG.23Bmore clearly illustrates the features of the catheter system2300inFIG.23A. The stent delivery system2300includes a first catheter2302, and a second catheter2330. The first catheter2302includes an elongate shaft2304with a radially expandable balloon2306disposed near a distal end of the elongate shaft2304. A stent2308having a proximal portion2322, a distal portion2314and a side hole2320is disposed over the balloon2306. The distal portion2314is crimped to the balloon2306to prevent ejection during delivery, while the proximal portion2322is partially crimped to the balloon2306so the second catheter2330may be slidably advanced under the proximal portion2322of stent2308. The first catheter is a rapid exchange catheter (RX) having a guidewire lumen2312extending from the distal guidewire port2310at the distal end of the elongate shaft2304to a proximal guidewire port2311which is closer to the distal port2310than the proximal end of the catheter shaft2304. A connector2316is coupled with the proximal end of the elongate shaft2304. The connector2116is preferably a Luer connector and this allows easy coupling with an Indeflator or other device for inflation of the balloon2306. Radiopaque markers may be placed at different locations along the shaft2304, often near the balloon2306and/or stent2308, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter2330includes an elongate shaft2332with a radially expandable balloon2340disposed near a distal end of the elongate shaft2332. A stent2342is disposed over balloon2340. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent2342is shorter than the working length of the balloon2340so that a proximal portion of the balloon2340is unconstrained by the stent2342and this unconstrained portion of the balloon2340may be slidably advanced or retracted through side hole2320and under proximal portion2322of stent2308as will be discussed below. Stent2342is crimped to balloon2340to prevent ejection during delivery. At least a portion of balloon2340, and stent2342are distally offset relative to balloon2306and stent2308so as to minimize profile of the device. In this embodiment the distal stent2342may be deployed in a main branch of the vessel and the other stent2308may be deployed in a side branch of the vessel. Alternatively, the distal stent2342may be deployed in a side branch of a vessel and the other stent2308may be deployed in the main branch of a vessel. The second catheter2330is a rapid exchange catheter (RX) having a guidewire lumen2334extending from the distal guidewire port2338at the distal end of the elongate shaft2332to a proximal guidewire port2336which is closer to the distal port2338than the proximal end of the catheter shaft2332. A connector2344, preferably a Luer connector is connected to the proximal end of the elongate shaft2332and allows an Indeflator or other device to be coupled with an inflation lumen (not shown) in elongate shaft2332for inflation of balloon2340. Having a portion of shaft2332disposed under proximal portion2322of stent2208helps keep catheters2302,2332parallel and prevents tangling during delivery and as shaft2332is slidably advanced or retracted relative to shaft2304. The second catheter2330may also be slidably advanced or retracted under the proximal portion2322of stent2308so that the shaft2332passes through the side hole2320in stent2308. Radiopaque markers may be placed at different locations on the shaft2332, often near the balloon2340or stent2342, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. FIG.24Aillustrates a catheter system2400having a dual over the wire design.FIG.24Bmore clearly illustrates the features of the catheter system2400inFIG.24A. The stent delivery system2400includes a first catheter2402, and a second catheter2430. The first catheter2402includes an elongate shaft2404with a radially expandable balloon2406disposed near a distal end of the elongate shaft2404. A stent2408having a proximal portion2422, a distal portion2414and a side hole2420is disposed over the balloon2406. The distal portion2414is crimped to the balloon2406to prevent ejection during delivery, while the proximal portion2422is partially crimped to the balloon2406so the second catheter2430may be slidably advanced under the proximal portion2422of stent2408. The first catheter is an over-the-wire (OTW) catheter having a guidewire lumen2412extending from the distal guidewire port2410at the distal end of the elongate shaft2404to the proximal end of the elongate shaft2404into Y-adapter2414having a connector2416. The connector2416is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen2412exits via connector2416. A second connector2418, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon2406via an inflation lumen (not shown) in the elongate shaft2404. Radiopaque markers may be placed at different locations along the shaft2404, often near the balloon2406and/or stent2408, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. The second catheter2430includes an elongate shaft2432with a radially expandable balloon2440disposed near a distal end of the elongate shaft2432. A stent2442is disposed over balloon2440. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the balloon working length. In preferred embodiments, the stent2442is shorter than the working length of the balloon2440so that a proximal portion of the balloon2440is unconstrained by the stent2442and this unconstrained portion of the balloon2440may be slidably advanced or retracted through side hole2420and under proximal portion2422of stent2408as will be discussed below. Stent2442is crimped to balloon2440to prevent ejection during delivery. At least a portion of balloon2440, and stent2442are distally offset relative to balloon2406and stent2408so as to minimize profile of the device. In this embodiment the distal stent2442may be deployed in a main branch of the vessel and the other stent2408may be deployed in a side branch of the vessel. Alternatively, the distal stent2442may be deployed in a side branch of a vessel and the other stent2408may be deployed in the main branch of a vessel. The second catheter2430is an over-the-wire (OTW) catheter having a guidewire lumen2434extending from the distal guidewire port2438at the distal end of the elongate shaft2432to the proximal end of the elongate shaft2432into Y-adapter2446having a connector2448. The connector2448is preferably a Luer connector and this allows easy coupling with a syringe or other device for lumen flushing or injecting contrast media. When unconnected, the guidewire lumen2434exits via connector2448. A second connector2444, also preferably a Luer connector allows attachment of an Indeflator or other device to the catheter for inflation of the balloon2440via an inflation lumen (not shown) in the elongate shaft2432. Having a portion of shaft2432disposed under proximal portion2422of stent2408helps keep catheters2402,2430parallel and prevents tangling during delivery and as shaft2432is slidably advanced or retracted relative to shaft2404. The second catheter2430may also be slidably advanced or retracted under the proximal portion2422of stent2408so that the shaft2432passes through the side hole2420in stent2408. Radiopaque markers may be placed at different locations on the shaft2432, often near the balloon2440or stent2442, to help mark the proximal and distal ends of the stent or balloon, as well to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere in this specification. In any of the embodiments disclosed herein, commercially available catheters and commercially available stents may be matched up to form the systems illustrated. In still other embodiments, commercially available catheters that are single use devices for treating a single vessel may be mated together in various combinations and coupled together with a polymer sleeve. The operator chooses the two catheters for the patient's anatomy then slides a sized polymer sleeve over both catheters from the distal ends. Once the operator has the catheters aligned the polymer sleeve can be treated with a heat or light source to shrink and bond the two catheters together with friction. The polymer sleeve is made of typical polymers that can act as shrink wrap when treated with a heat or light source. The polymer of the polymer sleeve for example could be manufactured with polyolefin, a chemical used in manufacturing shrink wrap. The polymer sleeve would not crosslink or covalently attach to the catheters, several types of polymers are commercially available and have the requisite properties, thin, strong, not adhesive, and reaction times to their source of ten minutes or less. The polymer sleeves are typically 15 centimeters in length and have various diameters to suit typical catheter diameters 4 French to 20 French. The operator can test that the bond is holding by applying slight pressure prior to the procedure. If the polymer sleeve does not hold tightly the operator may elect to use a smaller diameter polymer sleeve or use more than one polymer sleeve by placing the polymer sleeves adjacent to each other. Alternatively, several smaller sleeves from 1 to 10 centimeters in length could be placed over several different portions of the catheters. In any of the embodiments discussed herein, a therapeutic agent may be disposed on the stent or balloon and eluted therefrom in a controlled manner into the target treatment area such as a stenotic lesion. Exemplary therapeutic agents help inhibit restenosis, hyperplasia or have other therapeutic benefits. Exemplary anti-hyperplasia agents include anti-neoplastic drugs, such as paclitaxel, methotrexate, and batimastal; antibiotics such as doxycycline, tetracycline, rapamycin, everolimus, biolimus A9, novolimus, myolimus, zotarolimus, and other analogs and derivatives of rapamycin, and actinomycin; amino suppressants such as dexamethasone and methyl prednisolone; nitric oxide sources such as nitroprussides; estrogen; estradiols; and the like. Methods for applying the therapeutic agent to the stent or balloon are well known to those skilled in the art, and have been described in the patent and scientific literature. Stent Delivery: FIGS.25A-30Billustrate an exemplary delivery sequence of a preferred embodiment in eight steps. Step1illustrates the introduction of a 0.035 inch guidewire up to the bifurcation. Step2illustrates the tracking of a guide catheter over the guidewire. Step3illustrates the removal of the guidewire and placement position of the guide catheter. Step4illustrates the tracking and placement of a rapid exchange compatible wire in the daughter vessel and an over the wire compatible wire in the mother vessel. Step5A &5B illustrate tracking of the catheter system distally over both the guidewires. Step6A illustrates the inflation of the daughter balloon and placement of the daughter stent and partial deployment of the mother stent. Step6B illustrates the inflation of the mother balloon to place the distal portion of the mother stent in the mother vessel. Step7A illustrates mother stent in the main branch with side hole facing the daughter vessel. Step7B illustrates the bifurcated stent partially in the daughter vessel and daughter ostium completely opened and continuing on to the mother vessel. In an alternative embodiment the delivery catheter mother balloons having tapered ends to accommodate balloons and stents with non-uniform profiles. For example, the proximal end of the daughter vessel stent may be designed to have a larger circumference than the distal end to compensate for the natural bifurcation anatomy. The daughter vessel balloon would likewise have a taper to properly expand the stent and ensure complete apposition. Additionally, it is possible to design the mother stent to expand differentially along its profile to compensate for a larger arterial diameter at the carina or ostium. In other words, the proximal and distal ends of the mother vessel balloon and mother vessel stent would be smaller in circumference while the center portion of the mother vessel stent would have a larger circumference. In an alternative embodiment the mother vessel balloon has tapered ends to accommodate the distal balloon catheter portion and guidewire lumen. Further, the mother vessel balloon may be designed for differential expansion to accommodate natural vessel anatomy. In a preferred embodiment the distal (daughter) balloon catheter portion is crimped with a half stent on a rapid exchange catheter. The daughter vessel stent is about 4-20 millimeters long and the daughter vessel balloon is approximately twice as long in length. The mother vessel stent is about 10-30 millimeters long, and is differentially crimped to allow independent operation of the daughter balloon catheter portion. The distal portion of the mother vessel stent is crimped tightly enough to keep the entire stent from unintentionally dislodging during the procedure. The proximal portion of the mother vessel stent is crimped just tightly enough to reduce the crossing profile and to allow the daughter balloon catheter portion to be moved distal or proximal relative to the mother balloon catheter portion. The proximal (mother) balloon catheter portion is an over the wire type design with the mother vessel balloon preferably about 3 centimeters proximal to the daughter vessel balloon. In an alternative embodiment a stent is designed to allow differential expansion of the middle portion of the stent relative to the proximal and distal ends. In particular, the design facilitates the placement of the stent across a bifurcation lesion in the mother vessel because it has a larger circumference in the middle portion relative to the ends than a stent with a constant profile. Further, the profile can be adjusted so that the largest circumference can be placed proximal or distal to the midpoint of the stent. In the particular embodiment the largest circumference is distal to the midpoint of the stent, but could be easily reversed for variable patient anatomy. Partial crimping has the following features that make it possible to maintain sufficient stent retention during delivery and placement and still allows the secondary system adjustability and deliverability. FIG.31shows a partially crimped bifurcation stent prior to placement on any balloon catheter.FIG.32-34illustrate an embodiment of the present invention in three steps. First, the bifurcation stent is partially crimped over approximately one-third its distal portion onto the mother catheter balloon and the daughter catheter is loaded through the mother catheter and mother stent where the daughter stent can be crimped separately. Second, the daughter stent is crimped and pulled back proximally to align the daughter stent proximal end near the mother stent distal end. Third and final the proximal portion of the mother stent can be crimped to reduce the outer diameter; yet still allow independent movement of the two catheters relative to each other. FIG.35illustrates a cross section of a mother and daughter balloon catheter system without a daughter stent. The daughter catheter is on top of the mother catheter. The mother stent is differentially crimped around the mother catheter balloon and daughter catheter because the daughter catheter profile is smaller than the mother catheter. The differential crimping is non-uniform and can create various cross sectional shapes to accommodate different catheter designs, balloon designs, and stent designs. For example, pear shaped or a figure eight are possible configurations. The current embodiment is designed to reduce the profile as much as possible. In one preferred method of manufacturing a protective sheet is placed between the two catheters. The protective sheet only needs to cover the portions that will come in contact during the crimping process, then the protective sheet can be removed. FIG.36Illustrates a side view of the mother stent mounted on the mother catheter balloon and the daughter catheter mounted on the mother catheter through the mother stent. The distal portion of the mother stent will be crimped under standard conditions to hold the stent firmly to the mother balloon and mother catheter. The proximal portion of the mother stent is partially crimped to reduce the profile; but still allows the daughter catheter freedom to move proximal or distal relative to the mother catheter. This embodiment illustrates that the stent is differentially crimped in both the circumferential and longitudinal direction. The amount of crimping will be determined by the stent design and size, catheter dimensions, and balloon dimensions; thus the crimping is differential along the longitudinal axis. FIG.37illustrates a side view of the mother stent mounted on the mother catheter balloon and the daughter catheter mounted on the mother catheter through the mother stent. The daughter catheter also includes a stent that can be crimped under standard conditions. The distal portion of the mother stent will be crimped under standard conditions to hold the stent firmly to the mother balloon and mother catheter. In one experiment, this arrangement was tested to determine the strength of the distal crimping of the mother stent by pulling the daughter catheter and stent proximally; the results were that the daughter catheter successfully passed through the crimped mother stent and still retained the daughter stent as well. Additional features may be utilized during the crimping process such as adding a slight positive internal pressure to the balloon so that the final balloon surface pillows about 0.002 inch beyond the outer diameter of the stent. This process can yield a design that protects the stent from engaging with the vessel thus reducing friction and improving stent retention at the same time. Further, this process improves safety and reduces trauma to the vessel. While the above embodiment discloses a bifurcation stent that is crimped at or about its distal half; this is not a limitation. The stent could be differentially crimped along its axis depending upon stent design, for example; if a hole in the side of a stent was not centered along the axis. It may be preferential to have the distal crimped portion of the bifurcation stent extend just distal of the hole that the daughter catheter to pass through. Alternatively, the distal crimped portion could extend partially or entirely over the hole that the daughter catheter passes through. FIGS.38A-38Mmore clearly illustrate an exemplary method of treating a bifurcated vessel such as a bifurcated coronary artery. InFIG.38Athe bifurcated vessel BV includes a side branch vessel SB and a main branch vessel MB. The main branch has a main branch lesion ML, and the side branch has a side branch lesion SL. The angle between the side branch and the main branch is referred to as the bifurcation angle, and is indicated by θ. When the bifurcation angle θ is less than about 60 to 70 degrees, the distal most stent of the system can be effectively positioned in the side branch. However, when the bifurcation angle is greater than or equal to about 60 to 70 degrees, it becomes more challenging to position the distal most stent in the side branch. Moreover, when the distal stent is retracted proximally toward the stent having the side hole (discussed below), the catheter shaft may bind against the side hole resulting in damage to the catheter shaft and/or stent. Therefore, in preferred embodiments, when the bifurcation angle is less than about 60 to 70 degrees, the distal most stent is preferably positioned in the side branch and the proximal most stent is advanced into the main branch. When the bifurcation angle is greater than or equal to about 60 to 70 degrees, the distal most stent is positioned in the main branch and the other stent is positioned partially in the main branch and partially in the side branch. This is not intended to limit the use of the catheter system, and either stent may be placed in either side branch or main branch depending on operator preference. InFIG.38B, a guidecatheter3802is advanced distally until its distal end is adjacent the bifurcation. A pair of guidewires GW1, GW2are then advanced from the guidecatheter3802distally toward the bifurcation such that the first guidewire GW1is advanced into the side branch SB and so that the distal tip of the first guidewire GW1is distal of the side branch lesion SL. Similarly, the second guidewire GW2is also advanced distally in the main branch MB until the distal tip of the second guidewire GW2is distal of the main branch lesion ML. InFIG.38C, a stent delivery system having a first catheter3804and a second catheter3824are advanced distally from the guidecatheter3802toward the bifurcation. The first delivery catheter3804includes an elongate catheter shaft3806and a radially expandable balloon3808disposed over a distal portion of elongate shaft3806. A balloon expandable stent3816is disposed over the balloon3808. In this exemplary embodiment, the stent is shorter than the working length of the balloon3808, therefore a proximal portion3810of the balloon3808and a distal portion3812are 30 unconstrained by the stent3816. The proximal portion3810may be retracted under a portion of the second stent3842and thus when balloon3808is inflated, it will radially expand stent3816and a portion of stent3842. However, this is not intended to be limiting, and the stent length may be substantially equal to the working length of the balloon, or it may have shorter length as previously discussed. Proximal radiopaque marker3820and distal radiopaque marker3818help define proximal and distal ends of the stent3816as well as proximal and distal ends of the balloon3808. The radiopaque markers will also be used to help align the two catheters during treatment of the bifurcation, as will be discussed below. The distal tip3814may be a soft durometer polymer thereby minimizing trauma to the vessel during delivery. A distal guidewire port3822extends from the distal tip3814and allows guidewire GW1to exit or enter a guidewire lumen (not shown) in the elongate shaft3806. The first catheter3804may be a rapid exchange catheter or an over-the-wire catheter, examples of which have been disclosed above. The second catheter3824(best seen inFIG.38D) includes an elongate catheter shaft3826with a radially expandable balloon3828disposed over a distal region of the elongate shaft3826. A stent3842having a side hole3844is disposed over the balloon3828. The length of the stent3842may be substantially the same as the working length of the balloon3828or it may be less than the working length. In this exemplary embodiment, the stent3842has a length shorter than the working length of the balloon3828thus a proximal portion3830and a distal portion3832remain unconstrained by the stent3842. Proximal radiopaque marker3836and distal radiopaque marker3834help define the proximal and distal ends of the stent3842as well as the proximal and distal ends of the balloon3828. The radiopaque markers will also be used to help align the two catheters during treatment of the bifurcation, as will be discussed below. The distal tip3838may be a soft durometer polymer thereby minimizing trauma to the vessel during delivery. A distal guidewire port3840extends from the distal tip3838and allows guidewire GW2to exit or enter a guidewire lumen (not shown) in the elongate shaft3826. The second catheter3824may be a rapid exchange catheter or an over-the-wire catheter, examples of which have previously been disclosed above. Referring back toFIG.38C, the bifurcation angle is less than about 60 to 70 degrees, and the first catheter3804and the second catheter3824are further advanced distally so that the first catheter tracks over the first guidewire GW1into the side branch SB while the second catheter3824tracks over the second guidewire GW2in the main branch MB toward the main branch lesion ML. Because the first catheter3804is coupled with the second catheter3824via stent3842, both catheters are advanced distally simultaneously thereby reducing procedure time, although this is not meant to be limiting, as each catheter may be advanced independently of the other. In this embodiment the first balloon3808and first stent3816are distal to the second balloon3828and second stent3842. This axial offset minimizes the system profile. InFIG.38D, both catheters3804,3824are advanced further distally toward the bifurcation until the first stent3816is distal to the side branch lesion SL and the second stent3842traverses the main branch lesion M L and the side hole3844is adjacent the ostium of the side branch SB. Advancement of both catheters3804,3824is again performed simultaneously, although they could also be advanced independently of one another. The operator will feel resistance against further advancement of the catheters3804,3824because as the catheters are advanced further distally, the two catheter shafts3806,3826will spread apart relative to one another as they are forced against the carina of the bifurcation. However, a portion of the first elongate shaft3806is disposed under a portion of the second stent3842, therefore the two shafts3806,3826can only spread apart so far. Thus, when an operator feels resistance against further advancement of the catheter shafts, the operator knows that both catheters3804,3824and their associated stents and balloons are properly positioned relative to the bifurcation. InFIG.38E, the first catheter3804is retracted proximally relative to the second catheter3824. Because a portion of the first catheter shaft3806is disposed under a portion of the second stent3842, the first shaft3806is slidably retracted into side hole3844and the first shaft3806and proximal portion3810of balloon3808are slidably retracted under a portion of second stent3842. The first shaft is proximally retracted until proximal radiopaque marker3820lines up with proximal radiopaque marker3836so that a proximal end of the first stent3816will be aligned with the side hole3844in the second stent3842. An operator may feel resistance during retraction of the first elongate shaft3806relative to the second elongate shaft3826when the ends of the stents3816,3842engage one another. Stent3842has a distal portion crimped to balloon3828to prevent ejection during delivery, and a proximal portion is partially crimped thereto or uncrimped to allow catheter3804to slide thereunder. Crimping of the stent is disclosed in greater detail in U.S. patent applications previously incorporated by reference above. The ends of the stents may butt up against one another, overlap with one another, interleave with one another, or combinations thereof. Additional details related to the engagement of the stents is disclosed in U.S. patent applications previously incorporated by reference above. Both stents3816,3842are disposed adjacent their respective lesions SL, ML, and the side hole3844is in rough alignment with the ostium to the side branch SB and the side branch stent3816. InFIG.38F, the balloon3808is radially expanded, often with contrast medium, saline, or a combination thereof thereby radially expanding the first stent3816into engagement with the side branch lesion SL and the walls of the side branch. A proximal portion3810and a distal portion3812of the balloon3808will also expand, thus a proximal portion of the second stent3842will also be radially expanded. Expansion of the stents occurs simultaneously. Since a portion of balloon3808also passes through side hole3844, expansion of balloon3808also partially expands the side hole3844and also aligns the side hole3844with the ostium of the side branch. InFIG.38Gthe balloon3808is contracted, and then inFIG.38Hthe other balloon3828is radially expanded, with contrast medium, saline, or a combination thereof, thereby further radially expanding the second stent3842. Expansion of balloon3828expands the proximal portion of the stent3842into engagement with the main branch vessel wall and main branch lesion ML, and the distal portion of the stent3842is also radially expanded into the main branch vessel wall as well as the main branch lesion ML. The side hole3844is also further aligned with the ostium of the side branch SB. Referring now toFIG.38I, balloon3828is contracted and then both balloons are simultaneously inflated in a “kissing balloon” technique as seen inFIG.38J. Both balloons3808,3828are inflated with contrast medium, saline, or combinations thereof until they engage one another and are fully expanded in the main branch MB and side branch SB. The kissing balloon technique ensures that both stents3816,3842are fully expanded and in full apposition with their respective vessel wall and lesion. Additionally, the kissing balloon technique lines up the proximal end of the first sent3816with the side hole3844in the second stent3842, thereby ensuring that continuous and smooth scaffolding from the main branch MB into the side branch SB. Also, the kissing balloons technique ensures that the side hole does not block the ostium to the side branch thereby avoiding “stent jailing,” or disrupting blood flow into the side branch. InFIG.38K, both balloons3808,3828are contracted, and inFIG.38Lboth catheters3804,3824are retracted proximally. The catheters may be retracted simultaneously or independently of one another. The first catheter3804is retracted through both stents3816,3842and also passes through the side hole3844. The second catheter3824is retracted through the second stent3842. InFIG.38M, both catheters3804,3828have been removed, as well as the guidecatheter3802and both guidewires GW1, GW2. Stents3816,3842remain implanted in at the bifurcation. Optionally, the stents or balloons may contain therapeutic agents such as those previously discussed, and these may elute out into the lesion at a controlled rate in order to help prevent restenosis. FIGS.39A-39Mmore clearly illustrate another exemplary embodiment of a method for treating a bifurcated vessel. This method is similar to that previously disclosed, with the major difference being that the distal-most catheter is used to treat the main branch vessel, and the proximal-most catheter is used to treat the side branch vessel. In the previous embodiment, the distal-most catheter is used to treat the side branch vessel and the proximal-most catheter is used to treat the main branch. InFIG.39A, the bifurcated vessel BV includes a side branch vessel SB and a main branch vessel MB. The main branch has a main branch lesion ML, and the side branch has a side branch lesion SL. The angle between the side branch and the main branch is referred to as the bifurcation angle, and is indicated by θ. When the bifurcation angle θ is less than about 60 to 70 degrees, the distal most stent of the system can be effectively positioned in the side branch. However, when the bifurcation angle is greater than or equal to about 60 to 70 degrees, it becomes more challenging to position the distal most stent in the side branch. Moreover, when the distal stent is retracted proximally toward the stent having the side hole (discussed below), the catheter shaft may bind against the side hole resulting in damage to the catheter shaft and/or stent. Therefore, in preferred embodiments, when the bifurcation angle is less than about 60 to 70 degrees, the distal most stent is preferably positioned in the side branch and the proximal most stent is advanced into the main branch. When the bifurcation angle is greater than or equal to about 60 to 70 degrees, the distal most stent is positioned in the main branch and the other stent is positioned partially in the main branch and partially in the side branch. This is not intended to limit the use of the catheter system, and either stent may be placed in either side branch or main branch depending on operator preference. InFIG.39B, a guidecatheter3902is advanced distally into the vessel until it is adjacent the bifurcation and the lesions ML, SL. A first guidewire GW1is advanced distally in the main branch MB until it is distal of the main branch lesion M L. A second guidewire is also advanced distally until it enters the side branch SB and it is distal of the side branch lesion SL. InFIG.39C, a treatment system having a first catheter3904, and a second catheter3924are advanced distally through the guidecatheter3902toward the bifurcation. The two catheters3904,3924may be advanced independently of one another, or the two catheters may preferably be advanced simultaneously. The first catheter3904includes an elongate shaft3906with a radially expandable balloon3908on a distal portion of the elongate shaft3906. A stent3922is disposed over the balloon3908. The length of the stent3922may substantially match the working length of the balloon3908, or the length of the stent3922may be less than the working length of the balloon3908such that a proximal portion3910and a distal portion3912of the balloon remains unconstrained by the stent3922. A proximal radiopaque marker3916and a distal radiopaque marker3914may be used to help determine the proximal and distal ends of the balloon3908as well as the proximal and distal ends of the stent3922. A soft durometer polymer tip may be used on the distal portion of the catheter shaft3906so as to prevent trauma to the vessel during delivery, and the catheter shaft3906has a distal guidewire port3920to allow a guidewire GW1to enter or exit a guidewire lumen (not shown) in the catheter shaft3906. The first catheter3904may be a rapid exchange catheter or it may be an over-the-wire catheter. The second catheter3924(best seen inFIG.39D) includes an elongate shaft3926having a radially expandable balloon3928on a distal portion thereof. A second stent3934is disposed over the second balloon3928. The stent length may substantially match the working length of the balloon, or it may be less. In this embodiment, the length of stent3934is less than the working length of balloon3928, thus a proximal portion3930and a distal portion3940of the balloon remain unconstrained by the stent3934. A portion of the first elongate shaft3906is disposed under a proximal portion of the second stent3934, and the stent3934also has a side hole3936so that the first elongate shaft3906may exit therefrom. The first elongate shaft3906may slide under the stent3934relative to the second elongate shaft3926, thus a proximal portion3910of balloon3908is also disposed under stent3934. When balloon3908is expanded, a proximal portion of stent3934will also be expanded. The second catheter shaft3926also includes a proximal radiopaque marker3932and a distal radiopaque marker3938that help identify the proximal and distal ends of the balloon3928and the proximal and distal ends of the stent3934. The second catheter3924also has a soft durometer polymer tip3942that helps minimize trauma to the vessel during delivery, and a distal guidewire port3944allows a guidewire to be inserted or to exit from a guidewire lumen (not shown) in the elongate shaft3926. The second catheter3924may be an over-the-wire catheter or it may be rapid exchange. The first stent3922and balloon3908are distal to the second stent3939and second balloon3928. InFIG.39D, the bifurcation angle θ is greater than about 60 to 70 degrees. Both catheters3904,3924are further advanced distally toward the bifurcation until the first stent3922is distal to the main branch lesion ML, and the second stent3934is partially disposed in the side branch SB adjacent the side branch lesion SL, and the stent3934is also disposed in the main branch MB adjacent the main branch lesion ML. The side hole3936also faces generally in the direction of the main branch vessel MB. Advancement of both catheters is preferably performed simultaneously, although they could also be advanced independently of one another. The operator will feel resistance against further advancement of the catheters3904,3924because as the catheters are advanced further distally, the two catheter shafts3906,3926will spread apart relative to one another as they are forced against the carina of the bifurcation. However, a portion of the first elongate shaft3906is disposed under a portion of the second stent3934, therefore the two shafts3906,3926can only spread apart so far. Thus, when an operator feels resistance against further advancement of the catheter shafts, the operator knows that both catheters3904,3924and their associated stents and balloons are properly positioned relative to the bifurcation. InFIG.39Ethe first catheter3904is retracted proximally relative to the second catheter3924so a proximal portion3910of balloon3908is disposed under stent3934. Stent3934has a distal portion crimped to balloon3928so that it will not be ejected during delivery, and a proximal portion is partially crimped or uncrimped over balloon3928to allow shaft3906to slidably pass thereunder. Stent crimping is described in greater detail in U.S. patent applications previously incorporated by reference above. Because a portion of the first catheter shaft3906is disposed under a portion of the second stent3934, the first shaft3906is slidably retracted into side hole3936and the first shaft3906is also slidably retracted under a portion of second stent3934. The first shaft is proximally retracted until proximal radiopaque marker3916lines up with proximal radiopaque marker3932so that a proximal end of the first stent3922will be aligned with the side hole3936in the second stent3934. An operator may feel resistance during retraction of the first elongate shaft3906relative to the second elongate shaft3926when the ends of the stents3922,3934engage one another. The ends of the stents may butt up against one another, overlap with one another, interleave with one another, or combinations thereof. Additional details related to the engagement of the stents are disclosed in U.S. patent applications previously incorporated by reference above. Both stents3922,3934are disposed adjacent their respective lesions SL, ML, and the side hole3936is in rough alignment with the main branch vessel MB. InFIG.39F, the balloon3908is radially expanded, often with contrast medium, saline, or a combination thereof thereby radially expanding the first stent3922into engagement with the main branch lesion ML and the walls of the main branch. A proximal portion of the second stent3934is also expanded into engagement with the main branch lesion ML and the walls of the main branch, while a distal portion of the second stent3934remains unexpanded in the side branch SB. The first stent3922and the proximal portion of the second stent3934are radially expanded simultaneously. The inner surfaces of both stents form a smooth lumen for blood flow through the main branch. Since a portion of balloon3908also passes through side hole3936, expansion of balloon3908also partially expands the side hole3936and also aligns the side hole3936with the main branch lumen. InFIG.39Gthe balloon3908is contracted, and then inFIG.39Hthe other balloon3928is radially expanded, with contrast medium, saline, or a combination thereof, thereby further radially expanding the second stent3934. Expansion of balloon3928expands a distal portion of stent3934into engagement with the side branch vessel wall and side branch lesion SL. The proximal portion of stent3934and side hole3936may also be further expanded and aligned with the first stent3922. The side hole is also further aligned with the lumen of the main branch. Referring now toFIG.39I, balloon3928is contracted and then both balloons are simultaneously inflated in a “kissing balloon” technique as seen inFIG.39J. Both balloons3908,3928are inflated with contrast medium, saline, or combinations thereof until they engage one another and are fully expanded in the main branch MB and side branch SB. The kissing balloon technique ensures that both stents3922,3934are fully expanded and in full apposition with their respective vessel wall and lesion. Additionally, the kissing balloon technique lines up the proximal end of the first sent3922with the side hole3936in the second stent3934, thereby ensuring that continuous and smooth scaffolding from the main branch MB into the side branch SB. Alignment of the two stents is disclosed in greater detail in U.S. patent applications previously incorporated by reference above. Also, the kissing balloons technique ensures that the side hole does not block the main branch or disrupting blood flow across the bifurcation. InFIG.39K, both balloons3908,3928are contracted, and inFIG.39Lboth catheters3904,3924are retracted proximally. The catheters may be retracted simultaneously or independently of one another. The first catheter3904is retracted through both stents3922,3934and also passes through the side hole3936. The second catheter3924is retracted through the second stent3934. InFIG.39M, both catheters3904,3924have been removed, as well as the guidecatheter3802and both guidewires GW1, GW2. Stents3922,3934remain implanted in at the bifurcation. Optionally, the stents or balloons may contain therapeutic agents such as those previously discussed, and these may elute out into the lesion at a controlled rate in order to help prevent restenosis. Any of the methods described above may use any of the stents disclosed herein in any of the system configurations described. Additionally, any of the features previously described above may also be used. Therefore, one of skill in the art will appreciate that any number of combinations may made. For example, catheter systems may have any combination of rapid exchange or over-the-wire configurations, with any of the stents disclosed herein, with or without a therapeutic agent on a stent or a balloon, and with or without any of the hollow exchange port, capture tube, removable capture tube, or snap fittings described above. Stents: The catheter systems and methods described above may use a commercially available stent for either the proximal or distal stent in the system. When a commercially available stent is used for the distal stent, it need only be crimped to the distal balloon catheter. When the commercially available stent is used for the proximal stent it may be partially crimped to the proximal balloon such that a portion of a second catheter shaft is slidably disposed under the stent and a portion of the second catheter shaft slidably passes through a side hole in the stent. The stent is crimped to the proximal balloon so that it is not displaced from the balloon during delivery, and also so the second catheter shaft can slide thereunder.FIGS.40A-40Eillustrate several examples of commercially available stents that may be used in catheter system configurations and methods described above, either as is, or with slight modification. For example,FIG.40Aillustrates the Abbott Vascular Xience® drug eluting stent4102a. A portion of a catheter shaft may be disposed under the stent through its central channel and the catheter may exit a side hole in the stent. A side hole may be the gap4104acreated between adjacent struts in a cell, or the gap4106abetween axially adjacent cells.FIG.40Billustrates the Cordis Cypher® stent4102b. Again a portion of a catheter shaft may be disposed under the stent through its central channel and the catheter may exit a side hole in the stent. A side hole may be the gap4104bcreated between adjacent struts in a cell, or the gap4106bbetween axially adjacent cells.FIG.40Cillustrates the Boston Scientific Taxus® Liberte® stent4102c. A portion of a catheter shaft may be disposed under the stent through its central channel and the catheter may exit a side hole in the stent. A side hole may be the gap4104ccreated between adjacent struts in a cell, or the gap4106cbetween axially adjacent cells.FIG.40Dillustrates the Medtronic Endeavor® stent4102d. A portion of a catheter shaft may be disposed under the stent through its central channel and the catheter may exit a side hole in the stent. A side hole may be the gap4104dcreated between adjacent struts in a cell, or the gap4106dbetween axially adjacent cells.FIG.40Eillustrates a Palmaz-Schatz® stent4104e. A portion of a catheter shaft may be disposed under the stent through its central channel and the catheter may exit a side hole in the stent. A side hole may be the gap4104ecreated between adjacent struts in a cell, or the gap4106ebetween axially adjacent segments. Other stents have been designed with side holes that are specifically intended to treat bifurcations. These stents may also be used with the systems and method disclosed herein. For example,FIGS.40F-40Hillustrate several embodiments of stents from Boston Scientific and are disclosed in detail in U.S. Pat. No. 7,678,142.FIG.40Fshows a stent4102fafter it has been unrolled and flattened having a side hole4106f.40F illustrates a stent geometry (unrolled, plan view) where the struts create a side hole4106fthat allows access to a side branch, and that can accommodate a catheter shaft as described herein. The side hole may be formed by the spaces4104f,4108fbetween struts.FIG.40Gillustrates another stent geometry (unrolled, plan view) having a side hole4106g. Alternatively, the side hole may be formed by the spaces4104g,4108gbetween struts or axial connectors.FIG.40Hillustrates still another stent geometry (unrolled, plan view) having a side hole4106h. The side hole may also be formed by the space between struts4104hor axial connectors4108h. In any of these embodiments, a catheter shaft may be slidably disposed under a portion of the stent, and the catheter shaft may exit the side hole. Additionally, any of the stents or balloons disclosed herein may carry a therapeutic agent such as those described above for local drug delivery. Also, while the stents disclosed herein are preferably balloon expandable, one of skill in the art will appreciate that self-expanding, and hybrid balloon expandable/self-expanding stents may also be used. Stent Alignment: FIGS.42A-42Cillustrate various ways a side branch stent can lineup with a main branch stent. InFIG.42A, the side branch SB is substantially perpendicular to the main branch MB, therefore the bifurcation angle θ is about 90 degrees. In this situation, the proximal end4206of the side branch stent4202will be substantially flush with the side hole4208in the main branch stent4204(assuming proper deployment of both stents). This is desirable since there are no gaps and hence no unscaffolded regions between the two stents4202,4204. However, when the bifurcation angle θ increases (FIG.42B) or decreases (FIG.42C), a portion of the side branch will remain unstented. For example, inFIG.42Bthe bifurcation angle increases and because of the right cylindrical shape of the stent, in which the end is perpendicular to the sidewalls of the stent, a gap4210exits between the proximal end4206of the side branch stent4202and the side hole4208of the main branch stent4204. Similarly, inFIG.42C, when the bifurcation angle decreases, there is also a gap4212between the proximal end4206of stent4202and the side hole4208of stent4204.FIG.42Cis typical of human anatomy, therefore the gap4212often is upstream of the bifurcation. Gaps are undesirable since they are unscaffolded and recoil and restenosis may occur in this region. Additionally, in the case where a stent is used for drug elution, the gap region may not receive any of the drug. One possible solution for ensuring that the gap between a side branch stent and a main branch stent is eliminated or reduced is shown inFIG.43A. The side branch stent4302is a right cylindrical sent. The main branch stent4304has a side hole4306with struts that expand outwardly into the gap region, thereby ensuring continuous scaffolding. An alternative solution inFIG.43Bis to fabricate the proximal end4310of the side branch stent4308with its proximal end non-perpendicular to the central axis of the stent so that the proximal end of the side branch stent lines up with the side hole in the main branch stent4312. Even using the geometries illustrated inFIG.43A-43Bstill requires careful alignment of the side branch stent with the main branch side hole. Therefore, it would be desirable to provide a stent geometry that facilitates alignment. The ends of the side branch stent and the main branch stent may intersect in several different ways thereby providing continuous and uniform coverage of the bifurcation. For example, inFIG.44, a portion4406of side branch stent4402may be disposed inside main branch stent4404.FIG.45shows a portion4506of the main branch stent4504disposed inside the side branch stent4502. Neither situation inFIG.44or45are ideal as overlapping of stents may result in metal rubbing on metal as well as possibly disrupting blood flow or causing stagnation points. A more desirable interface between stents is shown inFIG.46where the end of the side branch stent4602butts up against the side hole in main branch stent4604. The interface region4606is desirable since it provides continuous scaffolding of the vessel without gaps between ends of the stents. However, depending on the stent geometry, gaps may still exist between stents. Therefore, in preferred embodiments, the ends of the stents will interleave or interdigitate with one another. FIGS.47A-47Dillustrate several exemplary embodiments where the ends of the side branch stent and the side hole of the main branch stent interleave with one another or interdigitate. For example, inFIG.47A, a proximal end4704of side branch stent4702has a series of axially extending elements or fingers4712which interdigitate or interleave with the laterally extending elements or fingers4716that extend laterally from the side hole4708of main branch stent4706.FIG.47Billustrates an exemplary embodiment of interdigitating axial and lateral elements. A proximal end4704of side branch stent4702has a plurality of axially extending elements4712. The axially extending elements4712are formed from a plurality of interconnected stent struts4714, in this case forming a triangular shape. Similarly, the side hole4708of the main branch stent4706has a plurality of laterally extending elements4716that are formed from a plurality of interconnected stent struts4718. In this case the laterally extending elements4716are formed into a triangular shape. Thus the apex of one triangular shaped element fits in between adjacent elements on the adjacent stent. Or alternatively, the peaks fit in the valleys, and the valleys receive the peaks. FIG.47Cillustrates still another exemplary embodiment of interleaving or interdigitating elements. The proximal end4704of the side branch stent4702includes a strut4720formed into a series of peaks and valleys. Similarly, the side hole4708of the main branch stent4706will also have a strut4722that has been formed into a series of peaks and valleys. Therefore, the peaks of the side branch stent will fit into the valleys of the adjacent main branch stent side hole, and similarly the valleys of the side branch stent receive the peaks of the side hole.FIG.47Dillustrates yet another exemplary embodiment of interleaving or interdigitation of stent ends. The proximal end4704of side branch stent4702includes a strut4724formed into a series of rectangular peaks and valleys. The side hole4708of the main branch stent4706also has a strut4726formed into a series of rectangular peaks and valleys. The peaks and valleys interleave and interdigitate with one another. Balloon Configurations: The balloons used to radially expand the stents described herein may be cylindrical balloons having a constant diameter along the working length, or diameter may vary. When stenting a tapered vessel, it may be advantageous to use a balloon which has a variable diameter balloon that more closely matches the vessel anatomy. For example, inFIG.41A, a tapered balloon5006is attached to the distal portion of shaft5002. A soft durometer tip5004prevents vessel trauma during delivery. The balloon is tapered such that a proximal portion5010of the balloon has a larger diameter than a distal portion5006. Any taper may be used.FIG.41Billustrates another embodiment of a balloon5012having a plurality of stepped regions5014. The stepped regions may be incremented in any amount, and in preferred embodiments, a proximal portion5016of the balloon has a larger diameter than a distal portion5018. Any of these embodiments, or combinations thereof may be used in the systems and methods described herein to treat a bifurcation. Use of a tapered or stepped balloon allows a stent to be expanded to more closely match the vessel walls, where a proximal portion of the expanded stent has a larger diameter than a distal portion of the stent. In addition to using catheters having rapid exchange or over-the-wire guidewire lumens, and tapered or stepped balloons, the balloon catheters may not always employ a guidewire lumen. Instead, a fixed wire may be attached to a distal end of the catheter. For example,FIG.48illustrates an exemplary embodiment of a fixed wire catheter5102having a balloon5106attached to a distal portion of the shaft5104. A section of guidewire5108is fixedly attached to the distal end of the catheter and this fixed wire helps the catheter track through the vessels. The fixed wire may have any number of shapes including straight, curved, J-tip, etc. This embodiment may be used with any of the systems and methods disclosed herein, and it may or may not have a stent crimped to the balloon. The fixed wire catheter may be used in the main branch, or more preferably it may be used in the side branch. While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims. | 192,887 |
11857443 | Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS Referring toFIGS.1-3, some embodiments of a stent graft device100are configured for deployment in a blood vessel10, such as in the aorta, other arterial vessels, and/or venous vessels. In some embodiments, as described further below, the stent graft device100can allow precise control of the blood flow through blood vessel10. The stent graft device100includes a catheter110, a stent120, and a balloon130. The catheter110is coupled to the stent120and/or to the balloon130. The catheter110includes at least one lumen through which inflation media (e.g., liquid or gas) can be passed to inflate and/or deflate the balloon130. At least a portion of the balloon130is located within the interior of the stent120. In the depicted embodiment, a majority of the balloon130is located within the interior of the stent120. The stent graft device100is expandable between a low-profile configuration and a diametrically expanded, deployed configuration. For example,FIG.2shows the stent graft device100in a low-profile configuration, andFIGS.1and3show the stent graft device100in a diametrically expanded, deployed configuration. In the diametrically expanded, deployed configuration an outer periphery of the stent120is in contact with an inner wall surface12of the blood vessel. In some embodiments, the stent graft device100can be deployed into the vasculature (e.g., blood vessel10) using a delivery sheath. With the balloon130fully deflated, the stent graft device100can be diametrically compressed into the low-profile configuration for containment within a lumen of the delivery sheath. A distal portion of the delivery sheath containing the stent graft device100can be passed into the patient's vasculature via a percutaneous access site such as, but not limited to, a femoral artery, a radial artery, a subclavian artery, and the like. The approach can be retrograde or antegrade. In some embodiments, the delivery sheath can be navigated within the vasculature using one or more imaging modalities such as, but not limited to, x-ray fluoroscopy, ultrasound, and the like. In some embodiments, a guidewire may be placed within the vasculature first and the delivery sheath can be deployed over the guidewire. When the stent graft device100(within the delivery sheath) is positioned at a target location in the vasculature, the delivery sheath can be pulled back while the position of the catheter110is maintained substantially stationary. Alternatively, or additionally, the catheter110can be advanced distally in relation to the delivery sheath. Such relative motions of the catheter110and the delivery sheath can cause the stent graft device100to be expressed from the delivery sheath at the target site. In some embodiments, the stent120will self-expand to the deployed configuration such that the outer periphery of the stent120is in contact with the inner wall surface12of the blood vessel10. Alternatively, or additionally, in some embodiments, the balloon130(or another balloon) can be used to expand the stent120such that the outer periphery of the stent120is in contact with the inner wall surface12of the blood vessel10. While the stent120is in contact with the inner wall surface12of the blood vessel, the stent graft device100is temporarily anchored in relation to the blood vessel10. The stent graft device100is retrievable from the patient's vasculature. That is, the stent graft device100can be recaptured into a sheath and then the sheath containing the stent can be removed from the patient's vasculature. Hence, the stent graft device100is configured to be temporarily implanted. The catheter110is an elongate flexible member that defines at least one lumen (for carrying inflation media). The catheter110can comprise a tubular polymeric or metallic material. For example, in some embodiments the catheter110can be made from polymeric materials such as, but not limited to, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), HYTREL®, nylon, PICOFLEX®, PEBAX®, TECOFLEX®, and the like, and combinations thereof. In alternative embodiments, the catheter110, or portions thereof, can be made from metallic materials such as, but not limited to, nitinol, stainless steel, stainless steel alloys, titanium, titanium alloys, and the like, and combinations thereof. In some embodiments, the catheter110can be made from combinations of such polymeric and metallic materials (e.g., polymer layers with metal braid, coil reinforcement, stiffening members, and the like, and combinations thereof). In particular embodiments, some longitudinal portions of the catheter110may be configured to have different mechanical properties than other longitudinal portions of the catheter110. For example, some portions may be stiffer, more lubricious, have greater column strength, may be more flexible, may have a smaller or larger diameter, and the like, as compared to other portions of the catheter110. In some embodiments, one or more radiopaque markers can be located on the catheter110. The stent120is made of one or more elongate members. In some embodiments, the elongate members of the stent120, are formed from a single piece of precursor material (e.g., sheet or tube) that is cut, expanded, and then shape-set in the expanded configuration. For example, some embodiments are fabricated from a tube that is laser-cut (or machined, chemically etched, water-jet cut, etc.) and then expanded and heat-set into its final expanded size and shape. In some embodiments, the stent120is created compositely from multiple elongate members (e.g., wires or cut members) that are joined together to form the stent120. In some embodiments, the stent120is made of one or more wires that is/are braided or woven to form a mesh-like structure. The elongate members of the stent120can be comprised of various materials and combinations of materials. In some embodiments, nitinol (NiTi) is used as the material of the elongate members of the stent120, but other materials such as stainless steel, L605 steel, polymers, MP35N steel, stainless steels, titanium, cobalt/chromium alloy, polymeric materials, Pyhnox, Elgiloy, or any other appropriate biocompatible material, and combinations thereof can be used. The super-elastic properties of NiTi make it a particularly good candidate material for the elongate members of the stent120because, for example, NiTi can be heat-set into a desired shape. That is, NiTi can be heat-set so that the stent120tends to self-expand into a desired shape when the stent120is unconstrained, such as when the stent120is deployed out from the delivery sheath. A stent120made of NiTi, for example, may have a spring nature that allows the stent120to be elastically collapsed or “crushed” to a low-profile delivery configuration as shown inFIG.2, and then to reconfigure to the expanded configuration as shown inFIGS.1and3. The stent120may be conformable, fatigue resistant, and elastic such that the stent120can conform to the topography of the surrounding vasculature when the stent120is deployed in a vessel10of a patient. In some embodiments, the diameter or width/thickness of one or more of the elongate members forming the stent120may be within a range of about 0.008″ to about 0.015″ (about 0.20 mm to about 0.40 mm), or about 0.009″ to about 0.030″ (about 0.23 mm to about 0.76 mm), or about 0.01″ to about 0.06″ (about 0.25 mm to about 1.52 mm), or about 0.02″ to about 0.10″ (about 0.51 mm to about 2.54 mm), or about 0.06″ to about 0.20″ (about 1.52 mm to about 5.08 mm). In some embodiments, the elongate members forming the stent120may have smaller or larger diameters or widths/thicknesses. In some embodiments, each of the elongate members forming the stent120has essentially the same diameter or width/thickness. In some embodiments, one or more of the elongate members forming the stent120has a different diameter or width/thickness than one or more of the other elongate members of the stent120. In some embodiments, one or more portions of one or more of the elongate members forming the stent120may be tapered, widened, narrowed, curved, radiused, wavy, spiraled, angled, and/or otherwise non-linear and/or not consistent along the entire length of the elongate members of the stent120. In some embodiments, the stent120includes one or more eyelets or other types of attachment features. In particular embodiments, the stent120includes a lasso-like member threaded through multiple portions of the stent120such that the stent120can be cinched to a smaller diameter by tensioning the lasso member to assist in retrieval of the stent120. One or more radiopaque markers may be included on some embodiments of the stent120. In some embodiments, the stent120includes a covering material on at least a portion of the stent120, or on the entire stent120. Hence, in some cases the stent120may be referred to as a stent graft device120. It should be understood, that such a covering material is optional. That is, in some embodiments the stent120is a bare stent. The covering material may provide enhanced sealing between the stent120and the vessel wall12in some cases. In some embodiments, two or more portions of covering material, which can be separated and/or distinct from each other, can be disposed on the stent120. That is, in some embodiments a particular type of covering material is disposed on some areas of the stent120and a different type of covering material is disposed on other areas of the stent120. In some embodiments, the covering material, or portions thereof, comprises a hydrophobic fluoropolymer, such as an expanded polytetrafluoroethylene (ePTFE) polymer. In some embodiments, the covering material, or portions thereof, comprises a polyester, a silicone, a urethane, ELAST-EON™ (a silicone and urethane polymer), another biocompatible polymer, DACRON®, polyethylene terephthalate (PET), copolymers, or combinations and subcombinations thereof. In some embodiments, the covering material is manufactured using techniques such as, but not limited to, electrospinning, extrusion, expansion, heat-treating, sintering, knitting, braiding, weaving, chemically treating, and the like. In some embodiments, the covering material, or portions thereof, comprises a biological tissue. For example, in some embodiments the covering material can include natural tissues such as, but not limited to, bovine, porcine, ovine, or equine pericardium. In some such embodiments, the tissues are chemically treated using glutaraldehyde, formaldehyde, or triglycidylamine (TGA) solutions, or other suitable tissue crosslinking agents. In some embodiments, the covering material is disposed on the interior and the exterior of the framework of the stent120. In some embodiments, the covering material is disposed on the just the exterior of the framework of the stent120. In some embodiments, the covering material is disposed on the just the interior of the framework of the stent120. In some embodiments, some portions of the framework of the stent120are covered by the covering material in a different manner than other portions of the framework of the stent120. In some embodiments, the covering material is attached to at least some portions of the framework of the stent120using an adhesive. In some embodiments, epoxy is used as an adhesive to attach the covering material to the framework of the stent120, or portions thereof. In some embodiments, wrapping, stitching, lashing, banding, and/or clips, and the like can be used to attach the covering material to the framework of the stent120. In some embodiments, a combination of techniques is used to attach the covering material to the framework of the stent120. The stent graft device100also includes the balloon130. In some embodiments, the balloon130is made of silicone. But materials such as, but not limited to, latex, fluoroelastomers, polyurethane, polyethylene terephthalate (PET), and the like, are used in some embodiments. The balloon130can be inflated to fully occlude the interior of the stent120. In such a case, essentially no blood will be allowed to flow through the stent120. The balloon130can also be deflated to a very small size such that it only minimally impedes blood flow through the stent120. Further, the balloon130can be selectively inflated to a partially inflated configuration such that the balloon130partially occludes the interior of the stent120. That is, the size of the balloon130can be adjusted by a clinician, or an automated control unit (described further below), by selectively filling the balloon130with an amount of inflation media (e.g., saline, CO2, etc.) that only partially fills the capacity of the balloon130. In that manner, the extent of occlusion of the stent120by the partially inflated balloon130can be selected/controlled, and therefore the amount of blood flow through the stent120can be modulated. Referring toFIG.4, some embodiments of an endovascular stent graft device200can be configured for deployment in a blood vessel10, whereat the endovascular stent graft device200can be operated in a manner that reduces blood loss through an injured vessel while allowing blood flow to downstream organs and tissues. The endovascular stent graft device200includes a catheter201, a stent graft202, a first balloon210, a second balloon220, a third balloon230, a catheter hub240, a first sensor250, and a second sensor260. In some embodiments, a control unit280is coupleable to the endovascular stent graft device200to comprise a system for controlling catastrophic bleeding from blood vessels. The stent graft202defines a lumen that extends between the ends of the stent graft202(between the proximal and distal ends which are open). The catheter201is coupled to the catheter hub240and to the stent graft202. The first balloon210and the second balloon220are coupled around an outer periphery of the stent graft202. As such, the first balloon210and the second balloon220do not occlude the lumen of the stent graft202. The third balloon230is disposed within the lumen of the stent graft202. Therefore, when the third balloon230is inflated, the third balloon230can occlude the lumen of the stent graft202(e.g., like the balloon130of stent graft device100described above in reference toFIGS.1-3). Depending on the extent of inflation (as controlled by the clinician or control unit280), the third balloon230can either partially or fully occlude the lumen of stent graft202. The catheter hub240is coupleable to the control unit280. The endovascular stent graft device200is expandable between a low-profile configuration and a diametrically expanded, deployed configuration.FIG.4shows the endovascular stent graft device200in the diametrically expanded, deployed configuration. In the deployed configuration, some portions of the stent graft202may make full peripheral contact with the inner wall surface of the vessel10, while some other portions may not make full peripheral contact with the inner wall surface of the vessel10. In some embodiments, the endovascular stent graft device200can be deployed into the vasculature (e.g., blood vessel10) using a delivery sheath. A distal portion of the delivery sheath containing the endovascular stent graft device200can be passed into the patient's vasculature via a percutaneous access site such as, but not limited to, a femoral artery (as shown inFIG.4), femoral vein, a radial artery, a subclavian artery, and the like. The approach can be retrograde or antegrade. In some embodiments, the delivery sheath can be navigated within the vasculature using one or more imaging modalities such as, but not limited to, x-ray fluoroscopy, ultrasound, and the like. In some embodiments, a guidewire may be placed within the vasculature first and the delivery sheath can be deployed over the guidewire. While the endovascular stent graft device200is depicted as being deployed within an aorta (blood vessel10), it should be understood that other vessels may be treated using the endovascular stent graft device200. That is, the endovascular stent graft device200is scalable to smaller sizes for use in other areas of a patient's vasculature. Moreover, the endovascular stent graft device200can be used to treat venous bleeding (such as retrohepatic vena cava injuries), pelvic hemorrhages or fractures, and uterine or gastrointestinal bleeding, to provide a few examples. When the endovascular stent graft device200(within the delivery sheath) is positioned at a target location in the vasculature, the delivery sheath can be pulled back while the position of the catheter201is maintained substantially stationary. Alternatively, or additionally, the catheter201can be advanced distally in relation to the delivery sheath. Such relative motions of the catheter201and the delivery sheath can cause the endovascular stent graft device200to be expressed from the delivery sheath at the target site. In some embodiments, the stent graft202will self-expand to the deployed configuration. Alternatively, or additionally, in some embodiments, one or more balloons can be used to expand some or all of the stent graft202. While the stent graft202is deployed and in the expanded configuration inside of the blood vessel10, in some cases the endovascular stent graft device200is temporarily anchored in relation to the blood vessel10. The endovascular stent graft device200is retrievable from the patient's vasculature. That is, the endovascular stent graft device200can be recaptured into a sheath and then the sheath containing the stent graft device200can be removed from the patient's vasculature. Hence, the endovascular stent graft device200is configured to be temporarily implanted. In some embodiments, the catheter201includes multiple lumens through which inflation media (e.g., liquid or gas) can be passed, to individually and independently inflate and deflate the balloons210,220, and230(and any additional balloons that are included in some embodiments but not depicted herein). The catheter210can be made of any of the materials described above in reference to catheter110. In some embodiments, rather than using a single multi-lumen catheter201, two or more separate catheters may be included with lumens for supplying inflation media to the balloons210,220, and/or230(and other balloons if so configured). In some embodiments, the stent graft202is an elongate stent graft comprising an expandable tubular metallic frame and a covering material disposed on at least a portion of the metallic frame. The stent graft202(e.g., the elongate members and covering material) can be made of any of the materials described above in reference to stent120. The first and second balloons210and220are disposed around the outer periphery of the stent graft202. The first and second balloons210and220are spaced apart from each other (with the third balloon230disposed between the first and second balloons210and220). The first and second balloons210and220can be inflated such that the outer peripheries of the first and second balloons210and220make full peripheral contact with the inner wall surface of the vessel10. Hence, while the first and second balloons210and220are inflated, a seal between the first and second balloons210and220and the vessel10is created. Therefore, blood flowing through the vessel10will be directed (shunted) into the lumen of the stent graft202while the first and second balloons210and220are inflated and in full peripheral contact with the inner wall surface of the vessel10. The third balloon230is disposed within the lumen of the stent graft202. The third balloon230can be inflated to fully occlude the interior of the stent graft202. In such a case, essentially no blood will be allowed to flow through the lumen of the stent graft202. In addition, the third balloon230can be partially inflated to partially occlude the interior lumen of the stent graft202. Hence, the extent of inflation of the third balloon can be selectively controlled to modulate the blood flow through the lumen of the stent graft202. The third balloon230can also be deflated to a very small size such that it only minimally impedes blood flow through the lumen of the stent graft202. The balloons210,220, and230(and/or any additional balloons included but not depicted in the figures) can be made of any of the materials described above in reference to balloon130. Again, the third balloon230can be selectively inflated to a partially inflated configuration such that the third balloon230partially occludes the interior of the stent graft202. That is, the size of the third balloon230can be adjusted by a clinician, or by the automated control unit280, by selectively filling the third balloon230with an amount of inflation media (e.g., saline, CO2, etc.) that only partially fills the capacity of the third balloon230. In that manner, the extent of occlusion of the lumen of the stent graft202by the partially inflated third balloon230can be selected/controlled, and therefore the amount of blood flow through the lumen of the stent graft202can be modulated. Referring also toFIG.7, the distal end portion of endovascular stent graft device200is shown within the vessel10. The depicted distal end portion of endovascular stent graft device200includes the stent graft202, the first balloon210disposed around the exterior of the stent graft202, and the third balloon230disposed within the interior lumen of the stent graft202. The catheter201and sensors250and260are also shown. The second balloon220(since it is located proximal to the third balloon230) is not visible in this view of the distal end portion of endovascular stent graft device200. In the depicted configuration, both the first balloon210and the third balloon230are deflated. This configuration would allow blood to flow around the first balloon210(between the exterior surface of the first balloon210and the inner wall12of the vessel10) because the first balloon210is not in contact with the inner wall12. In addition, this configuration would allow blood to flow through the lumen of the stent graft202because the exterior surface of the third balloon230is not in contact with the inner wall of the stent graft202. Referring also toFIG.8, again the distal end portion of endovascular stent graft device200is shown within the vessel10. In the depicted configuration, both the first balloon210and the third balloon230are inflated. This configuration would block blood from flowing through the vessel10, and block blood from flowing through the lumen of the stent graft202. That is, with the first balloon210inflated such that the exterior surface of the first balloon210is in contact with the inner wall12of the vessel10, blood is blocked from flowing therebetween. The inflated first balloon210(being disposed around the exterior of the stent graft202) does not block the lumen of the stent graft202. However, that said, in the depicted configuration the third balloon230is also inflated. Therefore, blood is blocked from flowing through the lumen of the stent graft202because the exterior surface of the third balloon230is in contact with the inner wall of the stent graft202. In other words, in the depicted configuration the third balloon230is inflated so as to fully occlude the lumen of the stent graft202. In should be understood that in some cases the third balloon230can be partially inflated to modulate the flow of blood through the lumen of the stent graft202. Referring also toFIGS.9-11, distal end views (as viewed from vantage point A-A shown inFIGS.7and8) of the endovascular stent graft device200are depicted to illustrate the endovascular stent graft device200in various configurations. InFIG.9, both the first balloon210and the third balloon230are deflated. Hence, blood can flow between the exterior surface of the first balloon210and the inner wall12of the vessel10. Additionally, blood can flow between the exterior surface of the third balloon230and the inner wall of the stent graft202. This arrangement is like that ofFIG.7. InFIG.10, the first balloon210is inflated such that its exterior surface is in contact with the inner wall12of the vessel10, but the third balloon230is deflated (or at least partially deflated). Hence, blood is blocked from flowing between the first balloon210and the inner wall12of the vessel10. However, the inflation of the first balloon210does not prevent blood from flowing into the lumen of the stent graft202. Moreover, since the exterior surface of the third balloon230is not in contact with the inner wall of the stent graft202, the third balloon230is not fully occluding blood from flowing through the lumen of the stent graft202. That is, in the depicted configuration blood is allowed to flow within the lumen of the stent graft202because neither the first balloon210nor the third balloon230is fully occluding the lumen of the stent graft202. It can be said that the configuration ofFIG.10allows blood to be shunted from the vessel10using the lumen of the stent graft202. InFIG.11, both the first balloon210and the third balloon230are inflated. Hence, blood cannot flow between the exterior surface of the first balloon210and the inner wall12of the vessel10. Additionally, blood cannot flow between the exterior surface of the third balloon230and the inner wall of the stent graft202. This arrangement is like that ofFIG.8. Referring again toFIG.4, the endovascular stent graft device200also includes the catheter hub240. The catheter hub240provides individual end ports for the multiple lumens of the catheter210. In some embodiments, the catheter hub240may be configured for attachment with one or more mating members, such as attachment to the control unit280. In some embodiments, the endovascular stent graft device200also includes the first sensor250and/or the second sensor260(see alsoFIGS.12and13). The sensors250and260are optional. The sensors250and260can be various types of sensors. Each of the sensors250and260can represent one or more actual detection devices for detecting one or more different parameters. For example, in some embodiments, one or both of the sensors250and260can detect fluid pressure and/or flow (but not any other parameters). In some embodiments, one or both of the sensors250and260can detect two or more parameters. Such parameters can include, but are not limited to, fluid pressure, flow rate, blood gases (e.g., O2, CO2, etc.), temperature, pH, heart rate, and the like. The sensors250and260can be located at any positions along the stent graft202. In the depicted embodiment, the sensor250is located distal of the first balloon210, and the second sensor260is located between the second balloon220and the third balloon230. In some embodiments, more than two sensors are included (and such sensors can be located at any position(s) along the stent graft202). The sensors250and260can be in communication with the control unit280such that one or more signals from the sensors250and260are received by the control unit. In some embodiments, the sensors250and260may be in communication with one or more other monitoring devices. The optional control unit280can be coupled with the catheter hub240in some embodiments. The control unit280can provide computerized (automatic or semi-automatic) control of the endovascular stent graft device200. That is, the control unit280can individually inflate and/or deflate balloons210,220, and230to selectively isolate segments of the vessel10to diagnose the location of a hemorrhage and to stop or slow hemorrhage. Moreover, the sensors250and260can sense pressure and/or flow differences within the vessel10to determine or diagnose the location of bleeding and re-establish blood flow to unaffected areas. In doing so, the control unit280in conjunction with the endovascular stent graft device200can reduce blood loss through the injured vessel10while maintaining its integrity to nourish the downstream organs and tissues. The external computerized control unit280consists of hardware and software that are integrated with the catheter sensors250and260and an effector system that can rapidly inflate or deflate the balloons210,220, and230(individually) with liquid or gaseous inflation media. The control unit280in conjunction with the endovascular stent graft device200can sense and precisely isolate the area of injury while preserving blood flow to critical downstream organs and tissues. This can serve both as an endovascular intracorporeal-vascular shunt as well as a complete occlusion device to aid in the localization and rapid cessation of a non-compressible hemorrhage. In some embodiments, one or more additional balloons (configured like balloons210and220) can be located on the stent graft202. In such a case, the particular balloons selected for use can be made based on the size of the vessel (or size of the patient) and the patient's particular arterial branching locations. Said differently, by including one or more additional balloons (configured like balloons210and220) located on the stent graft202, the endovascular stent graft device200can be more of a one-size-fits-all device. In some embodiments, the stent graft202includes an uncovered portion204. Such an uncovered portion204can make for easier retrieval of the endovascular stent graft device200in some cases. In some embodiments, the entire length of the stent graft202between the second balloon220and the catheter hub240is an uncovered portion204. In some embodiments, only a proximal-most portion (as shown) of the stent graft202is an uncovered portion204. Still referring toFIG.4, in some embodiments, provisions can be made to perfuse a branch vessel such as the contralateral iliac artery16. For example, when the entire length of the stent graft202between the second balloon220and the catheter hub240is an uncovered portion204, the contralateral iliac artery16will receive perfusion. That is the case because blood flowing through the lumen of the stent graft202will be allowed to exit the stent graft202in the uncovered area(s) proximal to the second balloon220and to then flow into the contralateral iliac artery16. Alternatively, the stent graft202can include one or more open areas (not occluded by covering material; e.g., perforations, fenestrations, etc.) in the region proximal to the second balloon220near to where the contralateral iliac artery16branches off from the aorta10. In that arrangement, blood flowing through the lumen of the stent graft202will be allowed to exit the stent graft202through the open areas proximal to the second balloon220and to then flow into the contralateral iliac artery16. Referring also toFIGS.5and6, in some implementations, the endovascular stent graft device200is configured to serve as an endovascular-vascular shunt to aid in rapid cessation of various types of non-compressible hemorrhages associated with the aorta or other vessels. Alternative configurations of the endovascular stent graft device200can be implemented to provide occlusions of vessels dependent on the site of injury. In some embodiments, such alternative configurations can be automatically made by the control unit280in conjunction with the endovascular stent graft device200. For visceral injuries (as shown inFIG.5), the first and second balloons210and220are inflated to prevent blood flow to the injury290, while the third balloon230remains deflated, which allows blood perfusion of the lower extremities and pelvis by shunting blood through the stent graft202. In the event of a pelvic injury (as depicted byFIG.6), the endovascular stent graft device200can be deployed and configured to allow blood flow to upstream branch vessels and the adjacent branching pelvic vessel while mitigating hemorrhage from the injury292in the branching leg vessel16. In a first example, pertaining to the depicted embodiment that includes a fully covered stent graft202between the second balloon220and the uncovered portion204, both the first balloon210and the third balloon230can be deflated (while the second balloon220is inflated). In result, blood will be allowed to flow between the exterior surface of the first balloon and the inner wall of the vessel10. Such blood flow will thereby nourish branch vessels (such as the renal arteries, etc.). In addition, blood will flow within the lumen of the stent graft202to nourish the adjacent branching pelvic vessel. However, blood flow to the injury292in the branching leg vessel16will be substantially cut off. In a second example, pertaining to embodiments that have uncovered or open areas in the stent graft202proximally adjacent to the second balloon220, the first balloon210can be deflated and the third balloon230can be inflated (while the second balloon220is inflated). By deflating the first balloon210, blood flow will thereby be allowed to nourish branch vessels (such as the renal arteries, etc.) that are upstream of second balloon220. By inflating third balloon230, blood will be prevented from flowing through the lumen of the stent graft202and exiting through open or uncovered areas of the stent graft202to flow into the branching leg vessel16. Hence, blood flow to the injury292will be substantially cut off. In some embodiments, sensors250and260embedded in or coupled to the stent graft202can determine the location of the injury (e.g., injury290, injury292, and the like) by detecting hemodynamic changes within the patient's vasculature to determine and automatically (or semi-automatically) control the selective function of the separate balloons210,220, and230. Referring toFIGS.12and13, again the distal end portion of endovascular stent graft device200is shown within the vessel10. In the depicted configurations, both the first balloon210and the third balloon230are deflated. These figures illustrate that the construction of the stent member of stent graft202can differ at various locations along the stent graft202. For example, inFIG.12, the stent member is one or more braided wires, and the angle of the braid differs at various locations along the stent graft202. In particular, the braid angle is more radial at the locations of the balloons210and230, while the braid angle is more longitudinal at non-balloon locations. In the example ofFIG.13, portions of the stent member are made of expanded metallic material while other portions are made of braided metallic wire. In particular, the portion of the stent member underlying the first balloon210is braided wire, while the other portions of the stent member are expanded material. It should be understood that any and all combinations of stent constructions, and locations of such stent constructions, are envisioned within the scope of this disclosure. FIG.14provides a flowchart of an example method300for controlling the endovascular device200ofFIG.4by a computerized control unit (e.g., control unit280). The method300is performed while the endovascular device200is within the vasculature of the patient and the computerized control unit is coupled with the endovascular device200. It should be understood that automating the control of the endovascular device200can be particularly advantageous in the emergency care setting. That is the case because emergency situations can be quite chaotic, and humans may have difficulties properly diagnosing and treating hemorrhage conditions is such situations. Hence, by automating or semi-automating the use of the endovascular device200, better patient outcomes may be realized in some cases. At step310, the computerized control unit receives input signals from one or more sensors of the endovascular device. For example, at step310the computerized control unit can receive signals that are indicative of blood pressure and/or blood flow rates from one or more sensors such as the sensors250and/or260of the endovascular device200. Such one or more sensors can additionally or alternatively be located at one or more other locations along the endovascular device200. In addition, as described above, signals that are indicative of various other relevant parameters (blood gases (e.g., O2, CO2, etc.), temperature, pH, heart rate, etc.) can be received by the computerized control unit. At step320, the computerized control unit controls the inflation and deflation of the balloons of the endovascular device. For example, using the endovascular device200to illustrate this step, in some cases the computerized control unit may inflate first balloon210, inflate third balloon230, and deflate second balloon220. After doing so, the method300can revert to step310and the computerized control unit can receive a second round of input signals from the one or more sensors250and260of the endovascular device200. The control unit, knowing which balloons are inflated and deflated, can use the second round of input signals from the one or more sensors250and260in step330described below. After receiving the second round of input signals, the control unit may control the inflation of the balloons again (e.g., in another configuration) per step320. Thereafter, the control unit can once again receive another round of input signals (per step310) from the one or more sensors250and260of the endovascular device200. The steps320and310can be repeated for multiple cycles. In some cases, for each time step320is performed, the particular configuration of balloon inflation/deflation can be different. By performing these repetitive steps, in some cases the control unit can obtain the data it needs to diagnose the location of a hemorrhage. At step330, the computerized control unit uses the data from the repetitive performance of steps310and320(as described above) to determine a preferred balloon inflation and/or deflation configuration. For example, using the endovascular device200to illustrate this step, the data from the repetitive performance of steps310and320may indicate that a hemorrhage may be located between the first and second balloons210and220(as exemplified inFIG.5). Using such information, the computerized control unit may determine that the preferred balloon inflation and/or deflation configuration is to inflate first balloon210, inflate second balloon220, and deflate balloon230. It should be understood that this is merely one non-limiting example of how the computerized control unit can perform step330. At step340, after determining the preferred balloon inflation and/or deflation configuration in step330, the control unit controls the inflation and/or deflation of the balloon(s) to implement the preferred balloon inflation and/or deflation configuration. For example, the control unit may inflate first balloon210, inflate second balloon220, and deflate balloon230(e.g., perFIG.5). In another example, the control unit may deflate first balloon210, inflate second balloon220, and deflate third balloon230(e.g., perFIG.6). It should be understood that multiple other variations of the preferred balloon inflation and/or deflation configuration that can be implemented in step340are also envisioned within the scope of this disclosure. A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the scope of the invention. Accordingly, other embodiments are within the scope of the following claims. | 39,473 |
11857444 | DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. Stated differently, other methods and apparatuses can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not all drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. Finally, although the present disclosure may be described in connection with various principles and beliefs, the present disclosure should not be bound by theory. The terms “endoprosthetic device,” “endoprosthesis,” “vascular device,” and the like can refer, throughout the specification and in the claims, to any medical device capable of being implanted and/or deployed within a body lumen. In various embodiments, an endoprosthesis can comprise a stent, a stent-graft, a graft, a filter, an occluder, a balloon, a lead, and energy transmission device, a deployable patch, an indwelling catheter, and the like. In addition, throughout this specification and claims, the delivery systems described herein can, in general, include an endoprosthesis constrained by a “covering member” or “sheath.” The covering member or sheath can, in various embodiments, comprise a sheet of material that is fitted about an endoprosthesis. As used throughout the specification and in the claims, the term “elongate member” can refer to a shaft-like structure such as a catheter, guidewire, introducer sheath, or the like. In various embodiments, an endoprosthesis can be mounted or loaded on a catheter, also referred to herein as an inner shaft, and, in a constrained diameter, fit within an introducer sheath, also referred to herein as an outer shaft. Further, the term “distal” refers to a relative location that is farther from a location in the body at which the medical device was introduced. Similarly, the term “distally” refers to a direction away from a location in the body at which the medical device was introduced. The term “proximal” refers to a relative location that is closer to the location in the body at which the medical device was introduced. Similarly, the term “proximally” refers to a direction towards a location in the body at which the medical device was introduced. With continuing regard to the terms proximal and distal, this disclosure should not be narrowly construed with respect to these terms. Rather, the devices and methods described herein may be altered and/or adjusted relative to the anatomy of a patient. As used herein, the term “constrain” may mean (i) to limit expansion, occurring either through self-expansion or expansion assisted by a device, of the diameter of an expandable implant, or (ii) to cover or surround, but not otherwise restrain, an expandable implant (e.g., for storage or biocompatibility reasons and/or to provide protection to the expandable implant and/or the vasculature). As used herein, the term “vessel” refers to any luminal or tubular structure within the body to which these constructs can be utilized. This includes, but is not limited to, vascular blood vessels, vascular defects such as arteriovenous malformations, aneurysm, or others, vessels of the lymphatic system, esophagus, intestinal anatomy, sinuous cavity, urogenital system, or other such systems or anatomical features. Embodiments of the present invention are also suitable for the treatment of a malignant disease (e.g., cancer) within or associated with a vessel. With initial reference toFIGS.1A and1B, an endoprosthesis100is illustrated. Endoprosthesis100may comprise, for example, an expandable stent-graft. In various embodiments, endoprosthesis100comprises a balloon expandable stent-graft. Although endoprosthesis100will be herein described as a balloon expandable stent-graft, endoprosthesis100may comprise other implantable, expandable medical devices, including a self-expandable stent-graft. In various embodiments, stent-graft100comprises a stent member102. For example, stent member102can comprise one or more ringed stent elements104. As will be discussed in greater detail, ringed stent elements104can be positioned adjacent to one another along a longitudinal axis192of stent-graft100. In various embodiments, ringed stent elements104are evenly spaced from each other (i.e., uniformly distributed along the longitudinal axis). In other embodiments, one or more ringed stent elements104can be spaced apart from one another at different spacing along longitudinal axis192(i.e., non-uniformly distributed along the longitudinal axis). Any arrangement of ringed stent elements104is within the scope of the present disclosure. Ringed stent elements104can comprise, for example, interconnected wire frames106arranged in a circular pattern. For example, ringed stent elements104can comprise a single row of interconnected wire frames106. One or more points118of a wire frame106can be in contact with and connected to points118of adjacent wire frames106. In various embodiments, ringed stent elements104can comprise a multiplicity of individual wire frames106formed independently of one another and connected to each other at one or more points118. In other embodiments, wire frames106are formed together as a single interconnected stent element104. In various embodiments, ringed stent elements104can vary from each other in stiffness. For example, one or more ringed stent elements104having an increased stiffness can be located at a distal and/or proximal end of stent-graft100. Further, one or more ringed stent elements104having reduced stiffness can be located away from a distal and/or proximal end of stent-graft100. Any combination of ringed stent elements104, including multiple elements comprising different stiffness from each other, is within the scope of the present disclosure. Wire frames106can comprise a polygon, such as, for example, a parallelogram. In various embodiments, wire frames106comprise a diamond shape. In other embodiments, wire frames106can comprise a square or rectangular shape. Any shape of wire frames106, including shapes that are not polygonal (such as ovoid or rounded shapes) or shapes that include undulations or bends, are within the scope of the present disclosure. In various embodiments, wire frames106comprise a metal material. For example, wire frames106can comprise a steel, such as stainless steel or other alloy. In other embodiments, wire frames106can comprise a shape memory alloy, such as, for example, Nitinol. In yet other embodiments, wire frames106comprise a non-metallic material, such as a polymeric material. Further, the material of wire frames106can be permanent (i.e., non-bioabsorbable) or bioabsorbable. Any material of wire frames106having sufficient strength is within the scope of the present disclosure. For example, ringed stent elements104can, for example, be cut from a single metallic tube. In various embodiments, ringed stent elements104are laser cut from a stainless steel tube. However, any manner of forming ringed stent elements104and/or wire frames106is within the scope of the present disclosure. Endoprosthesis100can further comprise a graft member114. Graft member114may, for example, provide a lumen through which blood may flow from one end to another. Further, as will be discussed in greater detail, graft member114can comprise a number of layers or elements secured together to form a single graft member114. Graft member114can comprise, for example, an inner graft element108. In various embodiments, stent member102is positioned concentrically around inner graft element108. For example, inner graft element108can comprise a layer of polymeric material having a luminal surface110that is in contact with blood flow within a vessel. Stent member102can surround, be in contact with, and provide support to inner graft element108. In various embodiments, inner graft element108comprises a polymeric membrane capable of providing a bypass route to avoid vessel damage or abnormalities, such as aneurysms. Inner graft element108can comprise, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perfluoroelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other embodiments for a graft member material can include high strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). Any graft member that is capable of providing a lumen for fluid flow within the body of a patient is within the scope of the present disclosure. Inner graft element108can comprise, for example, one or more layers of a polymeric material. In various embodiments, inner graft element108comprises a polymeric material continuously wrapped over a substrate or mandrel to form a generally tubular member. For example, inner graft element108can be constructed with circumferential-, helical-, or axial-orientations of the polymeric material. “Orientations,” as used herein, generally refers to a directional property of a component or material (e.g., the polymetric material) often with reference to the longitudinal axis192. Orientations may also be used to refer to directional properties of certain features, such as, for example, orientations of the strength of the material. In the embodiments discussed above, the polymeric material can be wrapped generally perpendicular to the longitudinal axis of the mandrel or substrate, i.e., circumferentially wrapped. In other embodiments, the material can be wrapped at an angle between greater than 0 degrees and less than 90 degrees relative to the longitudinal axis of the mandrel or substrate, i.e., helically wrapped. In yet other embodiments, the polymeric material can be wrapped generally parallel to the longitudinal axis of the mandrel or substrate, i.e., axially (or longitudinally) wrapped. In various embodiments, inner graft element108may comprise a coating on luminal surface110. For example, a therapeutic agent such as antithrombogenic coating may be applied to luminal surface110. In various embodiments, a heparin coating is applied to luminal surface110. Graft member114can further comprise, for example, an outer graft element112. In various embodiments, outer graft element112concentrically surrounds at least a portion of stent member102. For example, outer graft element112can concentrically surround stent member102and inner graft element108, essentially sandwiching ringed stent elements104of stent member102between the two graft elements108and112. Similarly to inner graft element108, outer graft element112can comprise, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perfluoroelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Outer graft element112can include high strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). Further, outer graft element112can comprise one or more layers of polymeric material, and may be a tube or a wrapped element as described in connection with inner graft element108. In various embodiments, inner graft element108and outer graft element112comprise the same polymeric material. In other embodiments, inner graft element108and outer graft element112comprise different polymeric materials. In such embodiments, inner graft element108and outer graft element112can orient and maintain the position of each of a multiplicity of ringed stent element104. For example, each ringed stent element104of stent member102can be positioned at a desired location along inner graft element108and then surrounded by outer graft element112. In various embodiments, after ringed stent elements104are properly positioned along inner graft element108, inner graft element108and outer graft element112are bonded together. For example, heat can be applied to bond inner graft element108and outer graft element112together, thereby maintaining the position of ringed stent elements104with respect to graft member114. In various embodiments, ringed stent elements104are spaced apart at a desired distance from each other. For example, each of ringed stent element104can be positioned at between about 0 mm (i.e., one ringed stent element104abutting another) and about 4 mm apart from each other. In various embodiments, each of ringed stent element104can be between about 1.0 mm and about 2.0 mm apart from each other, and in particular embodiments are between about 1.1 mm and 1.5 mm from each other. Although described with reference to specific embodiments, ringed stent elements104of stent member102can be spaced any distance apart, including multiple different spacings within the same stent member102. Further, in embodiments in which stent member102comprises spaced apart ringed stent element104, stent-graft100can comprise one or more intra-ring graft segments120. For example, intra-ring graft segments120can comprise the portion of inner graft element108and outer graft element112located between adjacent ringed stent element104. As will be discussed further, the properties of intra-ring graft segments120, including the length of segments120, can be manipulated to provide desired properties to stent-graft100. In various embodiments, a first ringed stent element106acomprises a first apex120aand a second ringed stent element106bcomprises a second apex120b. First apex120aand second apex120bcan be adjacent to each other. For example, first ringed stent element106aand second ringed stent element106bcan be oriented with respect to each other such that first apex120aand second apex120bare in a common plane190orthogonal to a longitudinal axis192. Stated another way, first apex120aand second apex120bare in phase with each other. In other embodiments, first apex120aand second apex120bare not in a common plane orthogonal to longitudinal axis192(i.e., apices120aand120bare out of phase, or are otherwise not coplanar with each other). Although described with reference to specific embodiments, any orientation of ringed stent elements104, including multiple different orientations with the same medical device (i.e., stent-graft) is within the scope of the present disclosure. Stent-graft100can be delivered to and deployed within a treatment area of a patient. For example, with initial reference toFIGS.2A and2B, stent-graft100can be prepared and mounted to a catheter assembly260comprising a catheter tube262with a continuous lumen264. A cover266can coaxially surround a balloon268, which is coupled to catheter tube262and continuous lumen264at or near the distal end of catheter tube262. Attachment of cover266to catheter tube262can be accomplished in various ways, including adhering the proximal and distal ends of cover266to catheter tube262using an adhesive, such as, for example, a cyanoacrylate adhesive. Further, polymeric tape and/or film may be used to secure the proximal and distal ends of cover266to catheter tube262. Balloon268can comprise, for example a generally tubular shaped balloon capable of inflating within the vasculature of a patient upon pressurization. For example, a biocompatible fluid, such as, for example, water or saline, can be introduced into catheter tube262, pass through continuous lumen264and through an inflation port (not shown) in catheter tube262located at the interior of balloon268, and pressurize balloon268. As pressure to balloon268is increased, the diameter of balloon268is also increased. Balloon268can comprise, for example, a non-compliant, generally inelastic balloon. In such embodiments, balloon268can comprise a material that is configured to allow balloon268to expand to a chosen diameter upon sufficient pressurization and remain at or near the chosen diameter under further pressurization until a burst pressure is reached, such as, for example, nylon, polyethylene, polyethylene terephthalate (PET), polycaprolactam, polyesters, polyethers, polyamides, polyurethanes, polyimides, ABS copolymers, polyester/poly-ether block copolymers, ionomer resins, liquid crystal polymers and rigid rod polymers. In various embodiments, balloon268can comprise a compliant, relatively elastic balloon. In such embodiments, balloon268can comprise a material that is configured to allow balloon268to continuously increase in diameter as pressure to balloon268is increased, such as, for example polyurethanes, latex and elastomeric organosilicone polymers, such as, polysiloxanes. When a distension limit is reached, balloon268can rupture. In yet other embodiments, balloon268comprises a semi-compliant balloon. In such embodiments, balloon268behaves in a combination of compliant and non-compliant attributes. Although described in connection with compliant and non-compliant embodiments, any material or configuration that allows balloon268to inflate in a predictable manner within the body of a patient, including in a combination of compliant and non-compliant behavior, is within the scope of the present disclosure. With reference toFIG.3, in various embodiments, balloon268can comprise a plurality of pleats370. Pleats370can comprise, for example, folds or inflection points in the material of balloon268extending generally along at least a portion of longitudinal axis192. In such embodiments, balloon268comprises a generally tubular shape having one or more pleats370. In various embodiments, balloon268can be coaxially surrounded by cover266. Cover266can comprise an inner surface that can substantially conform to an outer surface of balloon268, such that both balloon268and cover266comprise substantially the same shape, including when balloon268is deflated. However, in other embodiments, cover266can comprise a different shape or configuration from balloon268. In various embodiments, cover266can comprise a plurality of pleats372. Similarly to balloon268, pleats372can comprise, for example, folds or inflection points in the material of cover266extending generally along at least a portion of the longitudinal axis. In such embodiments, cover266comprises a generally tubular shape having two or more pleats372. In various embodiments, cover266comprises the same number of pleats372as balloon268. In various embodiments, along at least a section of or the entire working length of balloon cover266, the inner surface of balloon cover266interfaces with the outer surface of balloon268in both the pleated, collapsed configuration and the un-pleated, inflated configuration. In other words, and as shown inFIG.3, the pleated portions of the cover266substantially correspond in their configurations to the corresponding pleated portions of the balloon268, and the non-pleated portions of the cover266substantially correspond in their configurations to the corresponding non-pleated portions of the balloon268. Pleats370and372can be formed in cover266and balloon268simultaneously. For example, balloon268can be coaxially surrounded by cover266, and pleats370and372can then be formed in both balloon268and cover266, respectively. In other embodiments, pleats372can be formed in cover266after pleats370are formed in balloon268. For example, a pre-pleated balloon268can be coaxially surrounded by cover266. In such embodiments, both cover266and pre-pleated balloon268can be inflated together to a working pressure, after which cover266and balloon268are subjected to a mechanical pleat forming process that can form, for example, the same number and configuration of pleats in cover266as in pre-pleated balloon268. While forming pleats372in cover266, both cover266and balloon268can be deflated and compacted for delivery into the body of a patient. Although described in specific embodiments, any manner of forming pleats in cover266is within the scope of the present disclosure. In yet other embodiments, balloon268can comprise a plurality of pleats370and cover266can comprise no pleats372. In such embodiments, pleats370can be formed in balloon268, followed by cover266being placed coaxially around the outer surface of balloon268. Although described in connection with specific examples (i.e., balloon268and cover266both comprising pleats, or only balloon268or cover266comprising pleats), any configuration in which balloon268and/or cover266comprises a plurality of pleats is within the scope of the present disclosure. Cover266can comprise, for example, a polymer such as, for example, expanded fluoropolymers, such as, expanded polytetrafluoroethylene (ePTFE), modified (e.g., densified) ePTFE, and expanded copolymers of PTFE. In various embodiments, the polymer can comprise a node and fibril microstructure. In various embodiments, the polymer can be highly fibrillated (i.e., a non-woven web of fused fibrils). Although described in connection with specific polymers, any material or configuration that allows cover266to inflate in a predictable manner within the body of a patient is within the scope of the present disclosure. In various embodiments, cover266can comprise multiple layers of a polymeric material. For example, cover266can comprise a polymeric material continuously wrapped over a substrate or mandrel to form a generally tubular member. In various embodiments, cover266can be constructed with circumferential-, helical-, or axial-orientations of the polymeric material. In such embodiments, the polymeric material can be wrapped generally perpendicular to the longitudinal axis of the mandrel or substrate, i.e., circumferentially wrapped. In other embodiments, the material can be wrapped at an angle between greater than 0 degrees and less than 90 degrees relative to the longitudinal axis of the mandrel or substrate, i.e., helically wrapped. In yet other embodiments, the polymeric material can be wrapped generally parallel to the longitudinal axis of the mandrel or substrate, i.e., axially (or longitudinally) wrapped. With reference toFIG.2B, cover266can, for example, have a length282that is greater than a length280of balloon268. In various embodiments, cover266is placed around balloon268such that a first cover end270and a second cover end272extend beyond a first balloon end274and second balloon end276. In such embodiments, a segment284of the material of cover266positioned at first cover end270or second cover end272can be compressed along longitudinal axis192(i.e., axially compressed). For example, with reference toFIGS.4A and4B, segment284of the material of cover266can be axially compressed (e.g., scrunched) at first cover end270and a segment286can be axially compressed at second cover end272. As shown inFIGS.4A and4B, segment284and/or segment286are aligned with a first balloon shoulder290and/or a second balloon shoulder292. In other embodiments, the segments284and/or286are aligned with different portions of the balloon268. InFIGS.4A and4B, the first balloon shoulder290and/or second balloon shoulder292are cone-shaped shoulders. Although described with reference to a specific embodiment, any shape of balloon shoulder is within the scope of the present disclosure. Segment284can, for example, be positioned such that it at surrounds at least a portion of first balloon shoulder290, and segment284can be positioned such that it at surrounds at least a portion of second balloon shoulder292. Providing additional axially compressed (e.g., scrunched) material around balloon shoulders (such as balloon shoulders290and292) can increase the thickness and/or density of cover266in the general area of the balloon shoulders. Furthermore, having additional axially compressed material of the cover266over the balloon shoulders allows for radial expansion of balloon268while limiting axial compression to the balloon during inflation. For example, without having those compressed portions, the shoulders of the balloon will inflate before the body of the balloon and cause axial compression of the balloon and endoprosthesis. But with the axially compressed material, the shoulders of the balloon can expand in a manner that causes less axial compression of the endoprosthesis (e.g., due to the changed angle between the expanded portion of the balloon and the unexpanded or less expanded portion of the balloon) until the pressure within the balloon as a whole is sufficient to more fully expand the cover and the endoprosthesis surrounding the body of the balloon. Further, increased thickness and/or density in the general region of balloon shoulders290and292can provide additional radial strength to the balloon shoulders to achieve a similar effect. As previously described above, the balloon268can be inflated by providing pressurized fluid into balloon268.FIGS.5A-5Fillustrate one example of the cover266restricting expansion of balloon268to one desired inflation profile as the balloon268is inflated. The intermediate portion200of the stent-graft100imparts a resistance to expansion of the balloon268at the intermediate portion20of the stent-graft100, as well as at, or proximate to, the free ends196,198. The cover266also imparts a resistance to expansion of the balloon to reduce a difference in an expansion rate of the balloon268at the free ends196,198of the stent-graft100relative to an expansion rate of the balloon268at the intermediate portion200of the stent-graft100so as to reduce longitudinal compression of the stent-graft100as the balloon268expands the stent-graft100from its undeployed state (FIG.5A) to its deployed state (FIG.5F). In some embodiments, the cover266acts to equalize the expansion rate of the balloon268at the intermediate portion200of the stent with the expansion rate of the balloon at, or proximate to the free ends196,198(e.g., proximate or at the shoulders). For example, in some embodiments axially compressed segments284and/or286are configured to provide additional resistance to the expansion of balloon shoulders290and292, causing a middle portion294of balloon268to inflate more readily than it would without such segments284and286, which limits the expansion of the balloon shoulders to more closely match the expansion of the middle portion294of the balloon268. Axially compressed segments284and/or286can also substantially impede inflation of balloon shoulder290and/or292. In various embodiments, this has the effect of controlling the extent of balloon inflation in these regions which, in turn, controls the expansion profile of balloon268and/or stent-graft100. In various embodiments, the expansion of balloon268can be controlled by covered segments284and/or286in a manner that may reduce undesirable expansion characteristics of stent-graft100. For example, covered segments284and/or286may reduce the degree of foreshortening of stent-graft100during expansion. In particular, segments284and/or286may be configured to force the balloon to into a specific inflation profile in which axial forces resulting from inflating balloon shoulders are significantly reduced, for example, due to the diminished angle between the shoulder portions of the balloon and the middle portion of the balloon or the stent-graft. Further, covered segments284and/or286may reduce or prevent stacking (e.g., reduction of spacing between ringed stent elements106during expansion) of stent-graft100. With reference toFIGS.2A and2B, after balloon268is surrounded by cover266, stent-graft100can be loaded on to balloon268and cover266. For example, stent-graft100can be positioned to concentrically surround a portion of balloon268and cover266. In various embodiments, once stent-graft100is properly positioned around balloon268and cover266, stent-graft100is radially compressed to an undeployed diameter242. For example, stent-graft100can be compacted to undeployed diameter242to reduce the profile of stent-graft100during implantation within a treatment area. Further, stent-graft100can be compacted onto balloon268and cover266so as to resist movement of the stent-graft on balloon268prior to deployment. In various embodiments, upon compaction, stent-graft100can imbed itself into cover266. For example, by imbedding itself into cover266, stent-graft100may exhibit improved stent retention. Such improved stent retention may, for example, assist in maintaining proper positioning of stent-graft100relative to cover266and/or balloon268during deployment to the treatment area of a patient. Another way to limit any reduction in the length of the endoprosthesis (e.g., as measured between one free end196and the opposite free end198) between its compressed and expanded configurations is by altering the position and/or orientation of the ringed stent elements104of a stent member102. In particular, in some embodiments the position and/or orientation of one or more ringed stent elements104of stent member102can be altered prior to compaction of stent-graft100. For example, the distance between two or more adjacent ringed stent element104may be reduced prior to compaction of stent-graft100. For more particular examples, one or more ringed stent elements104can be moved so that they are each less than about 1 mm apart from each other or even so that they are in contact with one another (i.e., spaced 0 mm apart from each other). In other embodiments, the position and/or orientation of ringed stent elements104may be altered after compaction of the stent-graft100. For example, and with reference toFIG.2A, stent-graft100has a length that can be changed by reducing the longitudinal spacing of two or more ringed stent element104. Reducing the longitudinal spacing between adjacent ringed stent element104can, for example, create stored longitudinal length that is recovered when the stent element104is expanded into its deployed state. For example, stored longitudinal length may be defined as the length or segment of graft material of intra-ring graft segments120axially compressed between adjacent ringed stent elements104which is retrieved (i.e., axially expanded) upon expansion and deployment of stent-graft100. The “undeployed length” of the stent-graft100generally refers to the stent-graft100in the compressed state prior to delivery and the “deployed length” of the stent-graft100generally refers to the stent-graft100in the expanded state. In some embodiments, changing the spacing of the ringed stent elements104creates a new length that may be referred to as the undeployed length (e.g., length240inFIG.2A). Stated another way, reducing the spacing between adjacent stent elements104can axially compress or scrunch intra-ring graft segments120. By creating stored length by axial compression, the outside diameter of the stent-graft100is not increased. By not increasing the diameter of the device while creating stored length, the transverse-cross section of the device remains minimal and thus does not adversely affect delivery of the stent-graft through the vasculature. At the same time, recovery of the stored length increases the ability of the stent-graft to reduce or offset any loss of length, e.g., due to axial compression forces from inflating the balloon. Upon delivery of stent-graft100to the treatment area of a patient, stent-graft100can be deployed. In various embodiments, stent-graft100is deployed by inflating balloon268to a desired diameter, thereby increasing the diameter of stent-graft100from an undeployed diameter242to a deployed diameter146. This process further increases the length of the stent-graft from the undeployed length240to a deployed length148. After balloon268is sufficiently inflated, so that deployed diameter146is achieved, balloon268can be deflated, allowing for removal of catheter assembly260from the body of the patient. Deployed length148can, for example, be less than undeployed length240. For example, deployed length148can be about 60% to about 95% of undeployed length240, and further, about 80% to about 90% of undeployed length240. Testing has shown that certain embodiments have achieved deployed lengths148greater than 99% the undeployed length, thus demonstrating a foreshortening length of less than 1%. The ability of a stent-graft to achieve a high percentage of its undeployed length is also referred to herein as longitudinal efficiency. Expanding stent-graft100from the undeployed configuration to the deployed configuration can also, for example, increase an internal angle of one or more wire frames106of ringed stent elements104. For example, when stent-graft100is in the deployed configuration, internal angle188of wire frames106of ringed stent elements104can be between about 70 and 110 degrees, and further, between about 80 and 100 degrees. Example 1—Bend Radius Various stent-grafts in accordance with the present disclosure were tested to evaluate their flexibility in the deployed configuration. Specifically, the stent-grafts were tested to determine the bend radius that the stent-graft can accommodate without kinking and can recover its original size and shape after testing. Kinking occurs at the point at which the stent-graft exhibits a diameter reduction of greater than 50%, or where it cannot recover its original size and shape after testing. The stent-grafts were tested according to ISO25539-2 (2009), section D.5.3.6, method A with the following exceptions: 1) testing was not performed in a tube of the minimum nominal indicated vessel diameters or at maximum indicated vessel diameter, and 2) overlapped condition testing was not performed. The stent-grafts comprise stainless steel ringed stent elements spaced apart at approximately 0.5 mm to 1.5 mm from each other. The stents were approximately 59 mm long. The inner and outer graft elements comprised ePTFE, and the stent-grafts were mounted on a nylon balloon surrounded by an ePTFE cover having scrunched proximal and distal ends. The results of the bend radius testing are summarized below in Table 1. TABLE 1BendNominalRadius (mm)Diameter (mm)510Mean47Maximum48Minimum46Sample Size1010 Example 2—Radial Strength Various stent-grafts in accordance with the present disclosure were tested to evaluate their radial strength in the deployed configuration. Specifically, the stent-grafts were tested to determine the radial compressive pressure at which the stent-grafts would become irrecoverably deformed. The stent-grafts were tested according to ISO25539-2:2009, section D.5.3.4 with the following exceptions: 1) pressure was reported in pounds per square inch, and 2) testing was conducted until a 50% reduction in the nominal device diameter was achieved. The stent-grafts comprise stainless steel ringed stent elements spaced apart at approximately 0.5 mm to 1.5 mm from each other. The stents were approximately 59 mm long. The inner and outer graft elements comprised ePTFE, and the stent-grafts were mounted on a nylon balloon surrounded by an ePTFE cover having scrunched proximal and distal ends. The results of the radial strength testing are summarized below in Table 2. TABLE 2RadialNominalStrength (psi)Diameter (mm)510Mean18.311.9Maximum20.912.6Minimum14.411.2Sample Size88 While particular embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims. Numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, materials, elements, components, shape, size, and arrangement of parts including combinations within the principles of the invention, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein. | 36,659 |
11857445 | DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown inFIG.1one exemplary embodiment of a system20constructed in accordance with one exemplary preferred embodiment of this invention including a sizing device or instrument for performing a bariatric procedure on a patient.FIG.11shows an alternative sizing tube of another system of this invention. All of the systems of this invention are particularly suitable for use in bariatric metabolic surgeries, such as a sleeve gastrectomy. However, the systems and instruments of the subject invention are not limited to such usage. Thus, the systems and instruments of the subject invention can be used with other types of medical procedures where suction is to be applied to the stomach or a fluid introduced into the stomach The system20comprises a flexible sizing tube22, a valve24and a perforated tip26. InFIG.11there is shown an alternative and preferred sizing tube122. In both embodiments the sizing tube22and122is an elongated flexible member having a central passageway22A (FIGS.1and3B) formed, e.g., extruded, of any suitable material. One particularly suitable material is a second generation styrenic block copolymer with a hydrogenated midblock of styrene-ethylene/butylene-styrene (SEBS) or styrene-ethylene/propylene-styrene (SEPS), such as sold by Kraton Performance Polymers, Inc. under the trade designation Kraton grade G2705. The sizing tube22and122is somewhat long, e.g., approximately 76 cm, so that it can be extended through a patient's mouth into the patient's stomach and preferably comes in plural sizes, with the appropriate size being selected for the particular patient to form a desired size stomach. For example, the outside diameter of the sizing tube may be available in 32, 36 or 40 French sizes, while the inside diameter (i.e., the diameter of passageway22A) is approximately 0.200 inch to 0.25 inch (depending on the outside diameter of the sizing tube). The sizing tube may include indicia or markings22B at 30, 40 and 50 cm on its outer surface measured from its distal end to provide the user with information as to the depth that the sizing tube has been inserted into the patient's stomach. That indicia may be pieces of suture inserted into the wall of the sizing tube after it has been extruded. Alternatively, the indicia may be molded into the sizing tube (e.g., be in the form of a short section of suture molded into the material making up the sizing tube) or may be applied (e.g., printed) on the outside of the tube if suitable. The perforated tip26of the sizing tube22and122is located at the distal end28and comprises a plurality of small apertures30extending through the side wall of the tube22and in fluid communication with the tube's central passageway22A. The central passageway extends the entire length of the tube22and122from its proximal end31, at which the valve24is located to the distal end28of the tip26. As best seen inFIGS.1,11and12, the distal end28of the tip26is closed and is rounded, e.g., of hemispherical shape. The valve24is in the form of a slide valve having a vent. The slide valve includes a body32having a first coupling34which is tubular and arranged to be disposed (e.g., frictionally fit) within the hollow proximal end30of the sizing tube22. The body32includes a second coupling36which is also a tubular member. The two couplings34and36are axially aligned with each other and project radially outward from diametrically opposed locations on the body32of the valve. The body32is a hollow member in which a slide38is disposed. The slide38is arranged to be slid into one of two positions to cause the valve24to be in either an open (“on”) position or a closed (“off”) position. To that end, the slide38is a hollow tubular member having a first end cap or head38A at one end thereof and a second end cap or head38B at the opposite end thereof and a pair of diametrically aligned openings (not shown) located in the side wall of the slide half way between the heads38A and38B. Each of the openings is of approximately the same internal diameter as the internal diameter of the couplings34and36. When the slide38is in the position shown inFIG.2the valve is in its open or on position, whereupon the openings (not shown) in the slide38are aligned with the hollow interior of both of the couplings34and36thereby providing a fluid path therethrough. However, when the slide is in the position shown inFIG.1the valve is in its closed or off position, whereupon the openings (not shown) in the slide38are not aligned with the hollow interior of both of the couplings34, so that respective portions of the side wall of the slide block the interior of the two couplings34and36, thereby isolating the coupling from each other. As mentioned earlier the valve24includes a vent. To that end, the slide38includes a pair of apertures38C and38D (FIG.2). Aperture38C is disposed in the side wall of the slide38adjacent the cap38B, whereas aperture38D is disposed in the sidewall slightly inward of the aperture38C and approximately 90 degrees from it. The body32includes an aperture40. The aperture40along with aperture38C serves as a vent for the valve when the valve is in its “off” or closed position. In particular, when the head38B of the slide is pushed inward so that the slide is in the position like shown inFIG.1, the aperture38C of the slide will be aligned with the aperture40of the valve's body and the aperture38D will be aligned with the hollow interior of the coupling34. Accordingly, ambient air can flow through aligned apertures40and38C into the interior of the slide and from there through aperture38D into the interior of the coupling34. Hence the interior of the sizing tube22will be at atmospheric or ambient conditions when the slide switch is in the closed or off position. The coupling36is arranged to be selectively connected to a source of suction, e.g., a suction tube connected to a hospital's wall suction line (not shown), when suction is to be applied via the instrument to the stomach of the patient, or to a hand pump assembly38(FIG.8), which will be described later, when a fluid, e.g., air, is to be applied into the patient's stomach. The coupling36is tubular and arranged to be disposed (e.g., frictionally fit) within either the hollow end of a suction tube connected to a source of suction or to a coupling (to be described later) forming a portion of the pump assembly42shown inFIG.8. The source of suction may be a wall suction line that is typically provided in a hospital. The pump assembly42is used to pump air or some other gas or liquid into the patient's stomach via the instrument22for reasons to be discussed later. The pump assembly42basically comprises a manually compressible bulb44, an associated pressure indicator46or gauge and an adapter48. The bulb44is arranged when squeezed to force any air within it out through an outlet port and into the adapter48. The adapter48is arranged to be connected to the coupling36to releasably connect the pump assembly to the instrument22. The bulb includes an inlet port through which air passes when the bulb is relaxed. The pressure gauge46is coupled to the outlet port of the bulb to provide an indication of the level of air pressure produced by squeezing the bulb. The pressure gauge typically indicates pressures in the range of 0-100 mmHg. The details of the apertures30will now be described with reference toFIGS.1and3A. The apertures30are of a constant diameter along their entire length, are small in size and are arranged in a symmetrical array50about the periphery of the distal end portion of the sizing tube closest to the distal or free end28. The spacing between the apertures30in the array portion50is shown inFIG.3. However, in the area of the sizing tube22just proximally of the symmetric array50, the apertures30are disposed in a helical or spiral configuration52, with the spacing between adjacent apertures in the spiral configuration being greater than in the array50, yet still equidistant. There are more apertures in the array area50to provide increased flexibility to the distal end of the sizing tube, so that it can be more easily directed to the appropriate location in the stomach. Typically this is done with laparoscopic graspers. In the area52the apertures are more spread out allowing suction to be applied at those portions of the tube. However, since they are spread out the tube is stiffer at this location. Having the tube be appropriately stiff is important because it has to be inserted in the patient's mouth adjacent a breathing tube, through the upper esophageal sphincter, through the esophagus and then through lower esophageal sphincter into the stomach. It should be pointed out at this juncture that there are a sufficient number of apertures extending about the periphery of the sizing tube and along a substantial portion of the length of the sizing tube to ensure that when suction is applied the sizing tube is held in place by the suction and a clear line of delineation or demarcation of the sizing tube within the stomach is achieved (as will be described later). The following constitutes various preferred exemplary diameters of the apertures30. In particular, a preferred range of diameters for each aperture30is 0.05 inch to 0.25 inch, more preferred range of 0.030 to 0.200 inch, with the most preferred aperture diameter range being 0.07 inch to 0.15 inch. Thus, an embodiment of this invention can make use of apertures30of approximately 0.10 inch, whereupon the area of a single aperture is approximately 0.008 square inches. It should be pointed out at this juncture that the apertures30need not be of a constant diameter. In fact, it may be desirable to make use of apertures that are flared so that the diameter of each of the apertures on the outer surface of the sizing tube is larger than the diameter of the apertures on the inner surface of the sizing tube. Such an arrangement is shown inFIG.3B. The apertures30A should facilitate the release of the sizing tube from the gastric tissue2when such action is desired since gastric tissue can more readily pull out of a flared hole30A than a straight hole30or an inwardly tapered hole. For a 36 French sizing tube122the diameter at the outer end of each aperture30A is approximately 0.11 inch, while the diameter at the inner end of each aperture30A is approximately 0.08 inch and the thickness of the wall of the sizing tube is approximately 0.13 inch. In the illustrated embodiment ofFIG.1there are seventy-two apertures30in the first 2.5 inches of the length of the sizing tube22, starting at its distal end, and sixteen apertures in the next 3.5 inches of the tube's length for a combined total of eighty-eight apertures. Another embodiment (FIG.11) contemplated is a sizing tube including one hundred fifty-two apertures30, each of a diameter of 0.10 inches and spread out uniformly in an array over the first five inches of the sizing tube's length. InFIG.11, an alternative sizing tube with a different configuration of aperture30is shown and will be described in detail later. When a sizing tube constructed in accordance with any embodiment of this invention is in place in the stomach and suction applied, the applied suction creates a force that holds the sizing tube at that position. During laparoscopic surgery air pressure is used to inflate the abdominal cavity in order to provide an internal work space. Typically this air pressure is in the range of 0.1-0.4 psi. Suction applied to the sizing tube creates a negative pressure within the sizing tube and at the tube's apertures. The resulting force holds the sizing tube in place and anchors it to the stomach wall. This force is a function of: (1) the differential pressure between the abdominal cavity and the sizing tube and (2) the combined area of the apertures. For example, a sizing tube with eighty-eight apertures, each of a diameter 0.10 inches, equals an area of 0.7 square inches. With a positive pressure of 0.2 psi in the abdominal cavity and a negative pressure of 1.5 pounds (78 mm HG) in the sizing tube there is a differential pressure of 1.7 psi. The force is equal to 0.7 square inches×1.7 psi or 1.2 pounds. It is preferred that the force holding the sizing tube in position be in the range of 0.1 to 200 pounds, more preferably between 0.3 and 20 pounds and most preferably between 0.5 and 8 pounds. The force applied to the stomach by the sizing tube with suction applied may also be considered independently of the positive pressure that is applied within the peritoneal cavity to facilitate laparoscopic surgery. As such, the suction force is the aperture area multiplied by the applied suction pressure. For example, if there are eighty-eight (88) apertures with a diameter of 0.1 inches, the aperture area is 0.7 square inches. With suction applied at a level of 2.4 psi (125 mmHg) the suction force applied by such a sizing tube is 0.7 square inches times 2.4 psi=1.7 pounds. That suction force is merely exemplary of many suction forces that are contemplated by the subject invention. To that end, a preferred range of suction force applied is 0.05 to 200 pounds, with a more preferred range being 0.1 to 100 pounds, and an even more preferred range being 0.3 to 20 pounds. The most preferred range is 0.5 to 8 pounds. The suction force per unit length applied at the apertured portion of the device is another important parameter of the invention. For example, if there are one-hundred-fifty-two (152) apertures each with a diameter of 0.1 inches spread across a five (5) inch long longitudinal section of the sizing tube, the aperture area is 1.2 square inches. With suction applied at a level of 2.4 psi (125 mmHg) the suction force applied is 2.9 pounds. Thus the suction force per unit length applied at the apertured portion is 2.9 pounds divided by 5 inches or 0.58 pounds per inch length. That suction force per unit length is merely exemplary of many that are contemplated by the subject invention. To that end, a preferred range of suction force per unit length is 0.02 pounds per inch length to 21 pounds per inch length, with a more preferred range from 0.1 to 10 pounds per inch length, and with the most preferred range is from 0.2 to 5 pounds per inch. As should be appreciated by those skilled in the art the distal end portion of the sizing tube22encompassing the array50of apertures will be subject to some degree of longitudinal collapse due to the multitude of apertures in that portion of the sizing tube. Thus, to prevent such collapse, which could be detrimental to the placement of the sizing tube within the patient's stomach, a helical anti-compression spring (not shown inFIG.1but shown inFIG.11and which will be described later) may be located within the distal end of the sizing tube in the area making up the array of apertures. Turning now toFIGS.4-7the use of the systems of this invention will now be described. To that end, the distal end28of the sizing tube22or122is introduced through the patient's mouth and down through the patient's esophagus10A into the interior of the patient's stomach10B. The presence of the multiple apertures30in the distal end of the sizing tube renders that end quite flexible to facilitate the placement of it in the patient's stomach. If it is desired to “decompress” the patient's stomach (e.g. remove air from the stomach) or to remove any liquid from the stomach, the instrument22is attached via its coupling36to a suction line connected to a source of suction, e.g., a hospital wall suction line. The amount of suction provided may be controlled by use of the devices disclosed in U.S. Pat. Nos. 5,992,239 and 7,686,785, which are assigned to the same assignee as the subject invention and whose disclosures are incorporated by reference herein. The slide38of the valve24can then be moved to the open or on position. In particular, the user presses on the head38A of the slide to move the slide to the position shown inFIG.2, whereupon the ports in the side wall of the slide are aligned with the passageways through the couplings34and36so that suction will be applied down the interior of the sizing tube22and out through its apertures30to draw air and/liquid out of the stomach through the instrument22. If after such decompression/stomach evacuation procedure has been accomplished (or if no such procedure has been accomplished), if it is desired to perform a sleeve gastrectomy procedure on the patient, the distal end of the instrument should be moved to the position shown inFIG.4, if it is not already in that position. In that position the distal end of the instrument is located against the lesser curvature10A of the stomach. If the valve24is not in the open position, its slide can be moved to that position to couple the source of suction to the sizing tube. The suction serves to hold the distal end of the instrument in position in the stomach and brings adjacent portions of the stomach into close engagement with the periphery of the distal end portion of the instrument. This action provides the surgeon with a clear line of delineation or demarcation of the instrument within the stomach, which can be readily seen by the surgeon via a laparoscope. InFIG.5this line of demarcation showing the position of the instrument in the stomach is represented by the broken line12. The level of suction to be applied is typically in the range of 25-200 mm Hg, most preferably 50-150 mm Hg, but could be in the range of 1 mm Hg to 700 mm Hg. The outer diameter of the instrument (sizing tube) used, e.g., whether 32, 36 or 40 French, is selected so that when the adjacent portions of the patient's stomach are brought into engagement with the distal end portion of instrument by the suction that distal portion of the instrument defines or establishes the size to which the patient's stomach is to be reduced. Accordingly, the surgeon can then use a conventional resecting stapler14or other conventional instrument to resect the stomach along, i.e., closely parallel to, the delineation line12to cut away a major portion10D of the patient's stomach as shown inFIG.6, with the marginal edges of the remaining stomach being stapled or otherwise joined along a seal line, thereby leaving the patient with a reduced size or residual stomach10E as shown inFIG.7. In accordance with one preferred methodology of this invention, the seal line extends at least 0.5 cm (more preferably 1.0 cm) from said delineation line on the opposite side of the delineation line from the position of the sizing tube in the vicinity of the gastric esophageal junction (GEJ) and the Angle of HIS in order to minimize the chance of leakage along the seal line in that region. Thus, if the seal line is to be accomplished by use of a resecting stapler, the staple line should be laterally to the fat pad at the GEJ away from the delineation line to avoid stapling onto the GEJ and consequently prevent leaks. Moreover, the seal line should not compromise the width of the residual portion of the patient's stomach (the “sleeve”) near the incisura angularis. In this regard it is important that there is no further narrowing or obstruction of the gastric outlet or body of the stomach, since that action may result in or perpetuate a proximal staple line disruption. To that end, it is suggested to start 2 cm to 6 cm from the pyloris and to angle the stapler to prevent narrowing at the incisura angularis. In addition, it is suggested that the seal line be formed at least 0.5 (more preferably 1) cm from the delineation line on the opposite side of the delineation line from the position of the sizing tube in the vicinity of the incisura angularis to reduce the chance of the formation of a stricture thereat. After the sizing procedure has been accomplished, the integrity of the patient's reduced size (residual) stomach10E can then be checked for leaks. In particular, the suction tube from the source of suction may be disconnected from the coupling36while the valve24is in its open state or else the valve may be moved to the closed state by pushing on the cap38B to the position shown inFIG.1. In either case this action removes suction from the interior of the sizing tube and allows the sizing tube to vent, to enable any residual suction or pressure within the stomach to equilibrate to ambient atmospheric levels. The pump assembly42may then be connected to the instrument and the slide of the valve24moved to the open or on position, if it is not already in that position. At this point the user can manually squeeze the bulb44to force air from the bulb44into the instrument20down through the sizing tube22and out through the apertures30, thereby insufflating the stomach to a desired pressure. That pressure is indicated on the pressure gauge46. At the same time that the bulb is being squeezed to pressurize the stomach saline solution can be applied to the outer surface of the stomach along the suture/staple line. Thus, if there are any leaks, air bubbles will be produced at the site of the leak(s), which can be readily observed by the surgeon via the laparoscope. Alternatively, a leak test can be performed by merely opening the valve24and introducing a suitably colored liquid, e.g., saline solution with methylene blue dye, through the instrument into the stomach of the patient. Any leak will be readily observable via the laparoscope by the egress of blue dyed saline through the leak site(s). During bariatric surgery it is necessary to mobilize the greater curvature of the stomach by separating it from the omentum and other parts of the anatomy where it is connected. This requires manipulation of the stomach and lifting the lesser curvature. After mobilization the stomach may be less spread out than before mobilization resulting in bunching and folding of the stomach. In such a case, once the sizing tube of this invention is in place and suction applied it may be difficult to determine exactly where the sizing tube is as the folds of the stomach might make it harder to discern the precise position of the sizing tube or if the fold(s) is/are large enough such fold(s) could appear to be the sizing tube itself. Accordingly, to overcome the problem of stomach bunching, should it occur during a sizing procedure, the application of suction, if applied, should be discontinued. Then air or saline should be introduced into the stomach via the sizing tube to expand the stomach and thereby “unfold” it. Once that has been accomplished the air or saline can then be removed by reapplying suction to thereby decompress the stomach and provide proper delineation of the sizing tube. It should be pointed out at this juncture, that in lieu of the components described above, the system can be configured with the sizing tube, hand pump and suction connector and a selector valve all integral, allowing the user to select between the three functions of suction, inflation and vent. Other sources of suction can be used in place of the suction source typically found in a hospital. For example it is contemplated that a system constructed in accordance with this invention may include a portable pump having a suction controller to be able to provide suction levels up to 700 mm Hg vacuum. In U.S. Pat. No. 7,857,806, whose disclosure is incorporated by reference herein, there is disclosed a portable pump which can be modified for use with the subject invention. In typical operation of a gastric sizing tube of this invention the level of suction applied is approximately 100 mm Hg vacuum. However, it is desirable to go as high as 700 mm Hg to increase securement force and delineation. This level of suction can be considered safe when it is only being applied for a short period of time. It is also desirable that the source of suction have good flow. In many cases, the lower esophageal sphincter and/or the upper esophageal sphincter seal around the gastric sizing tube. Sometimes, it is possible that a seal may not exist or be very good because the sphincters are relaxed or open. In such a scenario air would flow into the mouth and then into the sizing tube. A suction source with good flow capacity should overcome any such air leaks. It is believed that adequate flow output is at least 1 LPM at 100 mm Hg vacuum. A higher flow rate, e.g., 10 LPM at 100 Hg would likely be better. It should be pointed out at this juncture that at the beginning of the sleeve gastrectomy procedure the sizing tube is placed in the stomach as described above. Some clinicians do this before establishing pneumoperitoneum and laparoscopic visualization, while others do this after establishing pneumoperitoneum and laparoscopic visualization. Once the sizing tube is placed in the stomach, suction is applied to decompress the stomach by removing air and liquid that is in the stomach. To that end, some clinicians like to move the sizing tube around to various parts of the stomach with suction applied in order to be certain that all stomach contents have been removed. After decompression of the stomach the sizing tube can be moved to the lesser curvature of the stomach and suction applied to secure the sizing tube in position and to create a visually perceptible line of demarcation, such as described previously. Prior to sizing and resecting the stomach there are a number of other preparatory surgical steps such as dissecting the greater curvature of the stomach from the omentum, dissecting and sealing the blood vessels of the greater curvature, etc. These steps are typically done after decompression of the stomach but before sizing of the stomach sleeve. They can be done with the sizing tube secured against the lesser curvature or with the sizing tube at another location within the stomach. Ultimately, prior to sizing and resecting the stomach the sizing is placed against the lesser curvature with suction applied to secure the device and provide the visually perceptible line of demarcation. Using the visual demarcation line, the stomach can be resected with a cutting stapler that simultaneously seals and cuts the stomach into the correct shape. Typically the stapling follows the demarcation line and because the line of demarcation is clear the stapler can be positioned slightly away from the demarcation line, such as at the incisura anuglaris and the gastroesophageal junction, as described above. After the stomach has been sized, some surgeons perform a leak test, which can be performed as also described above. Turning now toFIGS.9and10, the details of an alternative system120will now be described. The system120makes use of a sizing tube or instrument22or122and valve24like those described above plus the addition of an integrated suction controller or regulator200. In the interest of brevity the components and features of the system120that are the same as the system20will be given the same reference characters and the details of their construction, arrangement, function and operation will not be reiterated. As can be seen inFIG.9the integral suction controller200is positioned between the sizing tube22(or122, as the case may be) and the valve24. Alternatively, it may be positioned connected to the valve, so that the order of components is as follows: sizing tube22(or122), valve24and controller200. The suction controller serves to ensure that a desired level of suction is applied to the sizing tube22(or122) when the valve24is open to ensure proper and safe operation of the sizing tube. The suction controller200has a suction source side which is designated by the reference number201and is arranged to be connected to a source of suction such as a hospital's wall suction line, with the valve24interposed therebetween. The coupling36of the valve24is connected to a conduit or suction line122which is in turn connected to some source of suction (e.g., the hospital wall suction line—not shown). The opposite side of the controller200is designated by the reference number202and is arranged to be connected to the proximal end31of the sizing tube22. The controller200is housed within a hollow housing203, which includes a cover204. The housing and the cover are each formed of a rigid plastic, such as ABS. A piston205is disposed within the housing and is also formed of a rigid plastic, such as ABS. The piston includes a top portion206which extends through an opening210in the cover. The space between the outer periphery of the top portion206and the opening210forms a vent or port to the ambient atmosphere so that the chamber213will be at the pressure of the ambient atmosphere. A spring207is located within the housing under the piston205and serves to bias the piston upward in the housing. The spring is formed of any suitable material, e.g., stainless steel. A rolling diaphragm208is coupled to the piston205and the housing203. Diaphragm208is engaged in a sealing fashion between housing203and cover204. The diaphragm can be formed of any suitable material, e.g., Nitrile. A seal209is located on the underside of the piston and is arranged to engage a seat215when excess suction is applied (as will be described later). The seal is formed of any suitable material, e.g., silicone rubber. The interior of the housing just below the cover204and above diaphragm208forms a first chamber213, while the portion of the housing below the diaphragm forms a second chamber214, with the diaphragm isolating the two chambers from each other. The seat extends about the periphery of the conduit211. Operation of the controller200is as follows. Suction is applied from the suction source (not shown) through the open valve24and into a conduit211at the suction side201of the controller and to the patient side202via the conduit212. The proximal end31of the sizing tube22is connected to the conduit212, so that suction is delivered to the sizing tube and subsequently to the patient. The controller200is configured to limit the amount of suction applied to the patient to a predetermined, desired level, even if a suction level greater than the predetermined level is applied via that conduit211from the suction source. The predetermined or desired suction level is established by the spring207and dimensions of the housing203, the piston205and the seal209. In this regard the pressure within chamber213will be equal to atmospheric pressure by virtue of the communication of the chamber213with the ambient atmosphere via the vent210. With suction applied, the pressure differential between the chambers213and214forces the diaphragm208and the piston205downward toward the seat215of the housing203against the bias of the spring207. If the suction applied via conduit211is greater that the predetermined level the piston205and diaphragm208will move such that the seal209on the bottom of the piston comes into engagement with the seat215thereby isolating chamber214from the vacuum source. This action thereby limits the level of suction in chamber214and ultimately at the patient to the predetermined level. If, however, the suction applied via conduit211is less than the predetermined level the piston205and diaphragm208will only move part of the way downward. As such the level of suction applied to conduit211will equal that in conduit212and that applied to the patient. The controller200is arranged to provide an indication as to whether or not the suction applied is equal to or less than the predetermined, desired, level. Thus, the top surface of the portion206of the piston205is in the form of a colored tape206A. The color of the tape is selected to provide a distinctive appearance from the rest of the piston, e.g., the periphery of the top portion206. For example, in a preferred embodiment the tape206A at the top portion206of the piston is colored white, while the remainder of at least the top portion206of the piston, if not the entire piston, is colored red. The cover204is preferably the same color as the tape206A, e.g., white, or some other color that will readily contrast with the color of the top surface (i.e., the tape206A) of the piston. The choice of a contrasting appearance, e.g., color, of the piston from the appearance of its tape top surface and the cover serves to facilitate visualization of the level of suction applied. For example, when the suction level in chamber214has not reached the predetermined, desired level the top portion206of the piston205will protrude above the top surface of the cover204and a red band (the periphery of the top portion206) will be readily visible. When the level of suction in the chamber equals the predetermined set point (i.e., the desired level) the piston205will be at or below the surface of the cover204and the red band will not be clearly visible. Turning now toFIGS.9A and10Athere is shown an alternative suction controller or regulator300constructed in accordance with this invention and forming a portion of an alternative preferred system of this invention. The controller300is constructed similarly to the controller200except that it does not include any mechanism for indicating the level of suction applied. It does, however, include structure (to be described shortly) which ensures that the upper chamber213is always at atmospheric pressure. In addition, it includes means to prevent the piston205from becoming stuck for an extended period of time on the seat215in the event of what will be referred to hereinafter as an over-travel situation. Since many of the components of the controller300are also found in the controller200, in the interest of brevity the common components of the controller300with the controller200will be given the same reference numbers and the details of the structure, arrangement and operation of those components will not be reiterated. As can be seen inFIGS.9A and10A, the cover204includes a hole or port302, which will be referred to as the atmospheric reference port. The port302extends through the thickness of the cover and is in fluid communication with the interior of upper chamber213to maintain that chamber at atmospheric pressure. Inasmuch as the port302is located in the top surface of the cover, it is susceptible to being blocked or covered by a sticker, some other object or even the finger of a user. To prevent such an occurrence the cover204includes structure to prevent blockage of the port302. In particular, the cover204includes a thickened portion304located adjacent the port302with an elongated shallow slot306extending through the thickened portion304. The outer or top end of the atmospheric reference port is located at the bottom of the slot306and is in fluid communication therewith. Each end of the slot is open. Thus if something should be on the top surface of the thickened portion304of the cover204disposed over the port302air can still enter into the port via either open end of the slot. It has been determined that if the controller300is operated in a manner such that a high level of suction is applied very rapidly, the piston305may experience an over-travel wherein it moves downward very quickly such that the seal209on the underside of the piston becomes stuck on the seat215. Under this condition the line212to the patient would have a higher level of vacuum than the controller was set to provide. The controller could stay in that state for an extended and indefinite period of time, particularly if the apertures30A in the sizing tube22are blocked, e.g., are in tight engagement with the surrounding gastric tissue or are otherwise blocked. To prevent such an occurrence, the controller300includes two bleed holes. In particular, as can be seen inFIG.10Athe diaphragm208includes a bleed hole308in the central portion thereof. The piston205of this embodiment is somewhat different in construction than the piston205of the controller200in that it includes a hollow portion defined by a side wall310. The sidewall310includes a bleed hole312extending radially therethrough. Thus, the interior of the hollow portion of the piston205is in fluid communication with the lower chamber214via bleed hole312. Since the diaphragm208includes the bleed hole308, which is in communication with the upper chamber213, that chamber will be in fluid communication with the lower chamber via the bleed hole308. Hence, if the piston should become stuck on the seat, air which enters into the upper chamber213via the port302can then pass through the bleed hole308into the interior of the piston and from there through the bleed hole312into the lower chamber214. The ingress of air into the chamber214will decrease the vacuum within the chamber, thus enabling the spring207to move the piston205upward and off of the seat215. In accordance with one exemplary preferred embodiment of the controller300, the bleed hole308is approximately 0.1 inch in diameter, while the bleed hole312is approximately 0.015 inch in diameter. During typical operation the flow rate of air into chamber214via bleed hole312is in the range of 10 standard cubic feet per hour (SCFH) or lower. As best seen inFIG.10Athe underside of the cover204includes a disk314located thereon. The disk314is formed of the same material as the material of the seal209. The disk314serves to seal the diaphragm bleed hole308when the piston is in its maximum up position. The seal314serves to prevent the ingress of liquid into the upper chamber213when the system is being used to determine if the sealed residual portion of the patient's stomach has any leaks. In this regard, as discussed earlier a dyed liquid can be pumped into the patient's residual stomach via the sizing tube. If that procedure is accomplished using a system like the system shown inFIGS.9A and10A, the dyed liquid will be introduced into the chamber214and from there through line212to the sizing tube. Since the diaphragm208includes the bleed hole308, the dyed liquid within the chamber could leak out of the chamber through the bleed hole into the upper chamber213, but for the presence of the disk314preventing that from occurring. It has been determined that when a gastric sizing tube, like that described above, is in the stomach of a patient, with suction applied, on some occasions the gastric tube may become clogged. In particular, it is suspected that mucosa from the stomach gets pulled into the apertures or perhaps there is some clotted blood in them. When the apertures are significantly clogged, the sizing tube appears to be stuck to the inside of the stomach, even when suction has been turned off and the sizing tube is vented. Such action is concerning if the withdrawal or removal of the “stuck” tube would damage the stomach by pulling on it. Using the bulb44to send air pressure into the sizing tube may unclog some of the holes and then air can enter the stomach. Pumping more air into the stomach expands the stomach, separating the inner lining of the stomach from the outside diameter of the tube. As such, the tube is then freed up for removal from the stomach. However, there are some situations in which the apertures cannot be unclogged by just squeezing the bulb as not enough pressure is generated even if the user squeezes really hard and multiple times. One solution to this potential problem is the addition of at least one one-way valve at the distal portion of the sizing tube. An exemplary embodiment of a sizing tube incorporating a pair of such valves is shown inFIGS.11and12, with each valve being designated by the reference number122. The sizing tube122is similar to the sizing tube22described heretofore, except for the inclusion of the one-way valve(s), each of which is designated by the reference number124, and a spring, which is designated by the reference number126. In the interest of brevity the common features of the sizing tubes22and122will be given the same reference numbers and the details of their construction, arrangement and function will not be reiterated. To that end, as can be seen inFIGS.11and12the spring126is located within the distal end portion of the sizing tube122and extends from just distally of the distal-most apertures30to a point slightly proximally of the proximal-most apertures, e.g., approximately 1 to 1.5 inches beyond the proximal-most apertures. The spring126can be formed of any suitable material. One exemplary material is stainless steel 302. In that embodiment the free length of the spring is approximately 5.75±0.25 inches, with an outside diameter of approximately 0.215±0.10 inch, with closed ends, a wire diameter of 0.015 SS±0.001 inch, and with 8 active coils per inch±1. Each of the one-way valves124basically comprises a slit in the wall of the sizing tube122. The slits are located proximally of the proximal-most apertures30so that they do not engage any of those apertures. The slits extend parallel to the longitudinal axis of the sizing tube and are disposed diametrically to each other. Each slit is approximately 0.440±0.60 inch in length, with the opposing edge portions of the sizing tube's sidewall contiguous with each slit being in engagement so that each slit is normally closed as a result of the resiliency of the material making up the sizing tube. In the exemplary embodiment shown the two one-way valves124are located in the area encompassed by the internal spring126, which provides support to the sizing tube to prevent it from kinking or collapsing. When suction is applied to the sizing tube the valves124are normally (automatically) closed. Upon the application of pressure, e.g., the introduction of a fluid, such as air or saline that is pumped into the sizing tube from the bulb44, the slits open and the fluid is enabled to pass therethrough out of the sizing tube into the patient's stomach. It should be pointed out at this juncture, that while the embodiment122makes use of two one-way valves124, other arrangements are contemplated. Thus, the sizing tube can make use of only a single one-way valve or more than two one-way valves. Moreover, while each one-way valve being formed of a slit is preferred due to its simplicity other types of one-way valves can be used. For example, the one-way valve could be spring-loaded momentary valve. Since the one-way valves124are configured so that they allow fluid to pass from inside the sizing tube to outside the sizing tube, but not the reverse, the valves do not pull anything in from the patient's stomach, so that they should not get clogged by materials getting sucked into the sizing tube during the application of suction. If the apertures30get clogged and the sizing tube gets “stuck” a fluid, e.g., air or saline, can be easily pumped from the bulb44into the sizing tube through the one-way valves, thereby expanding the stomach to free the sizing tube so that is no longer stuck. The one-way valves124can be operated to pump a fluid therethrough into the patient's stomach before or after the resection of the stomach, depending upon if and when the sizing tube becomes stuck. In fact, if during the bariatric procedure the stomach becomes folded with at least one fold to obscure or interfere with the visualization of a visually perceptible delineation line, the application of suction to the patient's stomach via the sizing tube can be halted, and a fluid, e.g., air or saline, pumped into the patient's stomach via the one-way valves to thereby remove the at least one fold, whereupon suction can be reapplied to the patient's stomach to hold those portions of the patient's stomach in such engagement with the sizing tube to thereby provide the visually perceptible delineation line used to resect the stomach. Turning back toFIG.1, it can be seen that the system20shown therein (or any system constructed in accordance with this invention for that matter), may include a flow meter400to monitor the flow of fluid through the system and thus enable one to infer the level of suction in the distal end of sizing tube. The flow meter400may be of any conventional construction, one particularly effective flow meter is that shown in U.S. Pat. No. 7,438,705 (Karpowicz et al.), which is assigned to the same assignee as the subject invention and whose disclosure is incorporated by reference herein. When using this flow meter it may be desirable to have a reservoir or fluid trap between the sizing tube and the flow meter, so that liquid from the stomach does not interfere with the operation of the flow meter. As an alternative to use of a flow meter to determine the level of suction within the distal end of the sizing tube, the sizing tube may be constructed to include a passageway or lumen in communication with hollow passageway22A at the distal end of the sizing tube. Such an arrangement is shown inFIG.13A. In particular, a lumen402extends down through the passageway22A of the sizing tube122the proximal end of the sizing tube to a position ending just before the distal end of the sizing tube. The lumen402is open at its distal end. Thus, one can measure the level of suction at the distal end of the sizing tube by coupling a suitable device at the proximal end of the lumen402. The lumen402can be used for another purpose, in lieu of or in addition to the purpose of determining the level of suction within the distal end portion of the sizing tube. In particular, the lumen402can be used to clear the hollow passageway22A at the distal end of the sizing tube of any secretions, e.g., mucous, which may gain ingress into the sizing tube. That passageway may be connected to a receptacle (not shown) for the collection of such secretions. A receptacle can also form a portion of any system of this invention to be used to collect any gastric fluids from the patient. In such a case, the receptacle will be coupled to the distal end portion of the sizing tube via any suitable means to enable any gastric fluids drawn into the sizing tube to be carried into the receptacle. That system may also include an overflow detector of any suitable construction to provide an indication that the amount of gastric fluid within receptacle has reached a predetermined threshold, e.g., is about to overflow, and/or to provide a signal to a controller stop to halt the operation of the sizing tube so that no further fluid is drawn into the receptacle until it can be emptied. As should be appreciated by those skilled in the art, systems and instruments for use in bariatric surgery should provide one or more of the following functions, with the more functions provided the better. They should be constructed for enabling atraumatic insertion into the stomach with a reduced number of insertions and atraumatic removal, with a reduced number of removals. They should enable one to readily decompress the stomach by removing air and other materials. They should enable one to draw stomach tissue together and stabilize and secure the stomach tissue for resection. They should provide sufficient delineation of the stomach tissue to enable accurate resection of the tissue, and minimize risk of accidental stapling. They should enable ease of positioning about the lesser curvature of the stomach and also enable one to readily relieve suction periodically to release the stomach tissue for repositioning, if necessary. The suction applying apertures of such systems/instruments should be properly sized to minimize the amount of tissue being drawn into the apertures upon the application of suction. And, they should enable one to infuse fluids into the stomach for various purposes, e.g., leak testing. The systems and instruments constructed in accordance with this invention meet all of those criteria. In particular, with respect to the matter of atraumatic insertion and removal, it is clear that the sizing tubes of this invention achieve that end by providing a radiused distal end or tip, with the material making up the sizing tube being soft and pliable, and with a smooth exterior surface to minimize friction. Moreover, the sizing tube is sufficiently stiff to enable pushing of it into place through the patient's body, e.g., its apertures are configured and arranged to maintain stiffness parallel to its longitudinal axis. The valve and the suction controller enable the ready application, control and removal of suction. The application of suction facilitates tissue delineation and/or fluid removal. When suction is not applied the sizing tube can readily deliver fluid. With respect to the function of decompressing the stomach by removing air and other materials from it, the instruments of this invention achieve that end by virtue of the fact that the source of suction can be controlled, with a valve being provided for the application and removal/venting of suction, and with the sizing tube being resistant to longitudinal collapse. Moreover, the sizing tube's apertures are properly sized to maximize fluid and debris removal. For example, the apertures are confined to only the stomach area. Moreover, in one embodiment they exhibit a maximal open area to sizing element total area, e.g., the aggregate area of the apertures is at least 10% of the area of the portion of the sizing tube in which the apertures are located. The array of apertures can be made to extend for at least approximately 1 inches of the sizing tube measured parallel to the longitudinal axis of the sizing tube. Preferably the array extends for approximately 2-5 inches and can extend up to 10 inches. The array of apertures can comprise a first region of at least approximately 2 inches in length measured along the longitudinal axis and wherein the aggregate area of the apertures in the first region is at least 10% of the area of the first region. In addition, the array of apertures can comprise a second region of at least approximately 3 inches in length measured along the longitudinal axis and located proximally of the first region, wherein the aggregate area of the apertures in the second region is at least 2% of the area of the second region. The sizing tube can have an outside diameter of at least 0.375 inch and can be in 32, 36 and 40 French sizes. With respect to the function of drawing the stomach tissue together and into engagement with the sizing tube to stabilize and secure the stomach tissue for resection, the instruments of this invention achieve that end by virtue of the fact that the apertures are properly sized to minimize tissue trauma, are only in the stomach area, and the suction is controlled. Moreover the instruments include a valve for the application and removal/venting of suction. Moreover, the sizing tubes provide sufficient flow to overcome leaks around the esophageal sphincters and are resistant to longitudinal collapse. With respect to the function of delineating the sizing tube in the stomach tissue to enable more accurate resection of the tissue and minimize risk of stapling of the sizing tube, the instruments of this invention achieve that end by having apertures of the sizing tube that are properly sized, confining them to the stomach area and having them extend along and about a sufficient length of the sizing tube to ensure than when suction is applied the sizing tube is held securely in place. Moreover, the apertures can be arranged in arrays that are uniform, circumferential and patterned for optimal suction application to draw stomach tissue together and hold the sizing tube in place. The controlled source of suction with sufficient flow acts to overcome leaks around upper and lower gastric sphincters. In addition, the valve serves to enable the application and removal/venting of suction. Relief of suction periodically facilitates the release the tissue for ease in repositioning. With respect to the function of facilitating the infusion of fluids for various purposes, such as leak testing and unfolding, the instruments of this invention achieve that end by confining the apertures to the stomach area and providing a valve for the delivery of such fluids With respect to the function of enabling ease of positioning about the lesser curvature of the stomach, the instruments of this invention achieve that end by having their apertures patterned and with a density to facilitate flexibility perpendicular to the longitudinal axis of the sizing tube. If desired, a spring may be included in the sizing tube (such as described above) to facilitate flexibility perpendicular to the longitudinal axis of the sizing tube while at the same time preventing longitudinal conduit collapse due to perpendicular flexion. Such action enables the application of uninterrupted suction, or delivery of fluids. With respect to the function of enabling atraumatic removal and reducing number of removals necessary, the instruments of this invention achieve that end by providing a valve removal/venting of suction and release of tissue. In addition, the apertures are properly sized to minimize tissue being drawn into them and the sizing tube is smooth for minimal friction on tissue. Systems and instruments that are constructed in accordance with this invention should provide a means to reduce or otherwise solve leakage issues inherent in a sleeve gastrectomy or other a stomach resection procedures. In particular, it is believed that the instruments of the subject invention enable the applied suction to approximate the gastric tissues prior to staple clamping, thus enabling more effective “stress relaxation” of the compressed tissue. Moreover, it is believed that the subject invention reduces need for excess movement of the tissues/repositioning of the stapler. Once the surgeon has properly aligned the instrument with the lesser curvature of the patient's stomach, and the anesthesiologist has applied suction, the suction causes the gastric tissues to wrap around and cling tightly to the sizing tube nearest the lesser curvature, while effectively decompressing and emptying the stomach. The suction enables this positioning to be maintained throughout mobilization of the stomach, inspection of the anterior and posterior aspects of the stomach, as well as during stapler positioning, compression, firing, and removal. Due to this maintenance of positioning, the surgeon is no longer required to constantly pull on, or adjust the gastric tissue around a bougie or within the jaws of the stapler as has characterized the prior art, in order to keep the anterior and posterior aspects aligned properly, to locate the bougie, or ensure adequate compression of the tissue. Reducing the need to pull on and move the gastric tissues reduces the risk of gastric puncture, formation of scar tissue, technical error. Moreover, it may also reduce post-operative gastric inflammation, all of which may otherwise lead to gastric leaks. Reducing the pulling on the tissue may also enable fluid dispersion out of the compressed tissue to be more consistent and regular, resulting in the formation of a more secure seal, e.g., staple, line, and reducing the risk of leaks. Another advantage of the subject invention is that it should act to prevent stretching of the gastric tissues during and after the procedure. In particular, with the gastric tissues tightly wrapped around the circumference of a sizing tube instrument constructed in accordance with this invention, the gastric tissues should not slide around the instrument. This gives the surgeon confidence in the alignment of the posterior and anterior portions of the stomach along the lateral side of the sizing tube, without excess pulling on the greater curvature of the patient's stomach. This reduced need to pull on the gastric tissues should result in tissue that is less taut and less stressed than can result from prior art techniques. Therefore, the tissue meets with lower-stress compression, resulting in less stress on the staple line, thus reducing the chance of leaks. Reduced stretching of the tissues also reduces the likelihood of technical errors, which may cause a stricture due to uneven stretching of the gastric tissue. As increases in intra-lumenal pressure, and stricture is often associated with leak, the reduction of strictures should also result in a reduction of leaks. Still another advantage of the subject invention is that the suction produced by the sizing tube clarifies proper staple positioning, thus enabling a more accurate sleeve gastrectomy procedure. In this regard, with the application of suction, the gastric tissue wraps around and clings to the sizing tube. This action causes the remainder of the stomach to lie fairly flat, with a distinct delineation or demarcation line resulting along the lateral side of the sizing tube and marking the outside of the sizing tube. This easily visibly perceived delineation or demarcation line can thus be used as a clear guide for the stapler to follow, enabling a smooth, even staple line closely approximating the sizing tube's calibrated size. A clearly visible line of demarcation also helps to preclude inadvertent stapling of the sizing device such as was common with prior art devices due to an inability to determine the exact location of the devices within the stomach. Following the delineation line, with minimal required tissue manipulation may reduce the amount of staple overlap/crossing, which could otherwise contribute to leaks. The readily visually perceivable delineation line formed by the instrument of this invention is particularly useful for sealing the stomach in the vicinity of the gastro-esophogeal junction GEJ. In particular, the delineation line merges with the outside of the esophagus at the GEJ, enabling a clear identification of the GEJ, and Angle of HIS. This clarity of GEJ identification allows the surgeon to more accurately staple the remaining portion of the stomach without fear of stapling the weaker esophageal tissue. It must be pointed out at this juncture that the various components of the instruments shown and described above are merely exemplary of various components that may be used in accordance with this invention to provide the capabilities as discussed above. Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service. | 58,399 |
11857446 | DETAILED DESCRIPTION According to various embodiments the first positive-locking element and the second positive-locking element preferably feature frontal projections and/or recesses. This is the case, for instance, with spur gearwheels. A spur gearwheel is understood to mean a gearwheel whose teeth protrude in the axial direction. The teeth of conventional gearwheels are arranged on the outer circumference of the gearwheel and protrude in the radial direction. The spur gearwheel, like a conventional gearwheel has a rotational axis, about which the gearwheel is rotatably mounted and in relation to which the terms axial and radial are to be understood. The teeth of a spur gearwheel, however, are situated on a front surface of the gearwheel and therefore protrude in the axial direction. If two such spur gearwheels are engaged with one another, all the teeth of one gearwheel preferably engage with the teeth of the other gearwheel, resulting in a considerably larger contact area than with conventional gearwheels, whose teeth are arranged on the external circumference. This allows a greater force to be transmitted. In accordance with disclosed embodiments, when #two such spur gearwheels whose teeth are not optimally positioned in relation to one another are being engaged with one another, this positioning can be corrected by rotating the two gearwheels relative to each other. In this case, the required rotation is preferably small, specifically smaller than 5°, preferably smaller than 3°, especially preferably smaller than 2°. This also applies to positive-locking elements that are not gearwheels with teeth, but which feature other recesses and/or projections. It is especially preferable if the safety device features a guide spindle that protrudes axially from one of the positive-locking elements and which has frontal recesses and/or projections, specifically spur gearing that is configured to engage with the respective other positive-locking element. It is advantageous if the guide spindle can be displaced in the axial direction relative to the positive-locking element from which it protrudes axially, the guide spindle being designed in such a way that, upon axial displacement, the guide spindle is rotated about its longitudinal axis such that a torque is applied to the positive-locking element that engages with the frontal projections and/or recesses of the guide spindle. In such a configuration, the guide spindle protrudes axially from the front surface of one of the two positive-locking elements when the two positive-locking elements are not engaged with one another. If the two positive-locking elements are now to be brought into engagement with one another, one of the two positive-locking elements—preferably the one with no guide spindle protruding from it—moves towards the respective other positive-locking element. The frontal projections and/or recesses, in particular the spur gearing of the guide spindle, first come into contact with the frontal recesses and/or projections of the other positive-locking element. However, this does not stop the movement of the other positive-locking element towards the positive-locking element with the guide spindle: rather, the guide spindle is displaced in the axial direction and moved into the positive-locking element on which it is arranged. Preferably the frontal projections and/or recesses, in particular the spur gearing of the guide spindle with the frontal recesses and/or projections, in particular with the spur gearing of its positive-locking element, form a continuous toothing when the guide spindle is axially displaced into its gear wheel to such extent that a single continuous front surface is formed. If the projections and/or recesses of the other positive-locking element, which has been displaced towards the guide spindle, do not engage optimally in its projections and/or recesses, the guide spindle exerts a torque on this positive-locking element, thereby rotating it into the optimal position for engaging in the recesses and/or projections of the other positive-locking element. This optimal position is reached when the guide spindle is completely recessed in its positive-locking element. This ensures that the projections and/or recesses of the two positive-locking elements engage with one another in the optimal position relative to one another, irrespective of the position of the two positive-locking elements relative to one another when they are to be brought into engagement. Alternatively or additionally, the first positive-locking element and/or the second positive-locking element has two partial positive-locking elements, such as two partial gearwheels, which can be moved independently of each other in the axial direction. If the two positive-locking elements in this configuration are moved towards one another in order to engage them, one of the partial positive-locking elements of a positive-locking element engages in the projections and/or recesses of the other positive-locking element before the remaining partial positive-locking elements do the same. The partial positive-locking elements are preferably arranged at an offset to each other in the circumferential direction, so that the projections and/or recesses, particularly teeth of each of the partial positive-locking elements, are arranged equidistant from one another, but there is an angular offset between the projections and/or recesses, particularly between teeth of adjacent partial positive-locking elements. This ensures that the projections and/or recesses of different partial positive-locking elements engage with the projections and/or recesses of the other positive-locking element to varying degrees when the two positive-locking elements are brought into engagement with one another. Therefore, if the projections and/or recesses of the first partial positive-locking element engage optimally in the projections and/or recesses of the other positive-locking element, it is sufficient for transmitting the forces that are to be applied. However, if this is not the case, since the projections and/or recesses of the first partial positive-locking element are only engaged with the other recesses and/or projections of the other positive-locking element in the vicinity of the tips, for instance, the projections and/or recesses of one of the other partial positive-locking elements engages more effectively in the other positive-locking element. If the contact between the tips of the projections and/or recesses of the first partial positive-locking element and the tips of the projections and/or recesses of the other positive-locking element is not enough to securely transmit the acting forces, the two positive-locking elements “slip”. However, after a relative movement of just a few degrees, this is absorbed by the projections and/or recesses of one of the other partial positive-locking elements, which engage better in the projections and/or recesses of the other partial positive-locking element due to the angular offset between the projections and/or recesses of different partial positive-locking elements. The at least two partial positive-locking elements therefore preferably feature the same projections and/or recesses, in particular the same toothing, but offset from each other in the circumferential direction. The offset is preferably smaller than 10°, preferably smaller than 7°, especially preferably smaller than 5°. In this context, the same toothing means that the teeth have the same depth, the same flank profile and the same angular offset to each other. In a preferred configuration, the at least two partial positive-locking elements are spaced apart from one another in the axial direction when the first positive-locking element and the second positive-locking element are not engaged with one another. In this way it is ensured which of the at least two partial positive-locking elements is the first partial positive-locking element to come into contact with other positive-locking elements. In this case, a partial positive-locking element is shaped like a piece of pie. It preferably has two straight edges and one curved edge. It is preferably a segment of a circle. The toothing, which is preferably also shaped like a segment of a circle, is preferably situated on the front surface. Preferably, the first joint element is an upper body element and the second joint element is an upper leg element. The device also features a pelvic element, wherein the two positive-locking elements can be brought in and out of engagement with one another by moving the upper body element relative to the pelvic element. This configuration of the invention is based on the knowledge that the lower back does not always need supporting when an angle between an upper body element, which is arranged, for instance, in the chest or back area of the upper body of the wearer, and the lower leg of the wearer is smaller than a predetermined angle, i.e. when the two body parts are swivelled against one another. Rather, support is only necessary when a swivelling occurs between the upper body, i.e. the chest, of the wearer, and the pelvis of the wearer. This configuration of the device thus ensures that a supporting force is always exerted when this swivelling between the upper body and the pelvis of the wearer occurs. Conversely, if the upper body swivels relative to the upper leg such that it does not cause a movement of the upper body relative to the pelvis, a force should not be exerted. In this case, the two gearwheels are not engaged with one another. Preferably, at least two magnets are arranged on the pelvic element or the upper leg element and at least one magnet is arranged on the respective other element in such a way that they exert a force on one another, the direction of which changes when, during a movement of the upper body element relative to the pelvic element, the angle passes the predetermined limit angle. In this configuration, the displacement device thus features the magnets specified. On the element on the upper body element or the pelvic element on which two magnets are arranged, said magnets are preferably arranged in a different orientation. This means that for at least one of the magnets, the north pole is directed towards the respective other element of the orthopedic device and for at least one other magnet, the south pole is directed towards the respective other element. If the angle between the upper body element and the pelvic element is greater than the predetermined limit angle, the two positive-locking elements are not engaged with one another. The magnets preferably cause the application of a force that keeps the two positive-locking elements apart. This may be achieved by the magnets exerting a force on one another. For example, this may be a repelling force. This is achieved by positioning one magnet of the pelvic element and one magnet of the upper leg element close to each other, so that the same poles, i.e. the south pole or the north pole, are directed towards one another. If the pelvic element is now moved relative to the upper leg element, the magnets arranged on the respective elements are also moved. This results in a displacement of the moving magnets towards each other. At the point at which the angle of the upper body element relative to the pelvic element passes the predetermined limit angle, a second magnet of the pelvic element or the upper leg element preferably moves into the range of the at least one magnet of the respective other element. This results in an attractive force, as opposite poles of the two magnets are directed towards one another. Preferably, at least some, but preferably all, projections and/or recesses of one of the positive-locking elements, but preferably of both positive-locking elements, feature undercut-toothing. This means that both flanks of a recess and/or projection are preferably tilted in the same direction. As a result, a torque can be applied to one of the positive-locking elements by the transmitted forces alone, which is converted into a force that has an axial component. This pulls the two positive-locking elements closer together, thus increasing the strength of the toothing, i.e. the engagement of the two positive-locking elements with each other. The positive-locking elements can preferably be brought into engagement with each other by moving one of the positive-locking elements towards the other positive-locking element, which is mounted relative to the component on which it is arranged such that it can be rotated in one direction. The mounting_is preferably a floating bearing, which allows a slight rotation of, for example, less than 15°, preferably less than 10°, particularly preferably less than 5°, thus ensuring that the optimum position and orientation of the two positive-locking elements relative to each other can be achieved. The orthopedic device preferably features an upper body element, an upper leg element and a first passive actuator, which is configured to apply a force to the upper leg element and/or the upper body element when an angle between the upper leg element and the upper body element is within a first predetermined angular range. It is especially preferable if the device features at least a second passive actuator, which is configured to apply a force to the upper leg element and/or the upper body element when the angle is within a predetermined second angular range that is different to the first angular range. The skilled selection of the first angular range and the second angular range allows the device according to the invention to be used, for instance, for both movement sequences described above. If the wearer of the orthopedic device bends only a little, for example, or works in a bent position, this preferably corresponds to the first angular range, so that the first passive actuator exerts the necessary force. However, if the wearer of the orthopedic device bends to pick something up off the ground, for instance, the resulting angle between the upper leg element and the upper body element preferably corresponds to the second angular range, so that the second passive actuator exerts the force. The first and second angular range preferably overlap. In other words, there are angles between the upper leg element and the upper body element at which both passive actuators exert a force. Preferably, the first passive actuator and/or the second passive actuator comprise(s) at least one mechanical energy store and/or one damper. For example, this can be an elastic element such as a spring element, preferably a tension spring. The first passive actuator and/or the second passive actuator may be designed to transmit a constant force across the respective angular range in which the respective actuator exerts the force. To this end, the respective actuator may have, for instance, a constant force spring. Alternatively or additionally, however, the actuator can also be designed in such a way that a force that increases as the angle decreases, rather than a constant force, is applied within the respective angular range. A decreasing angle means a more pronounced bend, so that in this case, the force exerted by the respective actuator increases the deeper the user of the device bends down. In another configuration, the force can also exhibit its maximum at an angle within the respective angular range and drop at larger angles and at smaller angles. The first and second passive actuator are preferably designed to be different. Specifically, the elastic elements of both actuators may exhibit different elasticities, in particular different spring constants, and/or different degrees of damping. In addition, they may also be different lengths, wherein the length of the elastic element is measured in the slackened state. Preferably, the first passive actuator and/or the second passive actuator are arranged at at least one point of application on the upper leg element and/or the upper body element, each of which is adjustable. In this way, the respective predetermined angular range, within which the respective actuator exerts the force, can be adjusted. In addition, a preload of the respective passive actuator can be achieved, so that the size of the respective force to be applied can be adjusted. To be able to apply different forces, it is advantageous if the first passive actuator and the second passive actuator are arranged at different points of application on the upper leg element and/or the upper body element and/or they have different lengths. As such, when the device is mounted, it is particularly easy to recognize which actuator exerts its force in which angular range and/or which actuator exerts a greater or smaller force. Of course, it is also possible to have both actuators strike at the same point of application or to use two actuators of the same length. This is possible, for example, if both actuators have different spring constants and/or elasticities. In a preferred configuration, the upper body element features a first force transmission element and the upper leg element a second force transmission element. Both force transmission elements can be engaged with and disengaged from one another. The first mechanical energy store and the second mechanical energy store can be charged and discharged by swivelling the upper leg element relative to the upper body element, provided that the first force transmission element is engaged with the second force transmission element. Otherwise, the upper leg element and the upper body element can be swivelled against each other without charging one of the two mechanical energy stores with energy. This configuration renders it possible to swivel the upper leg element relative to the upper body element without charging the respective energy store with energy. In this state, no force is exerted by the energy store, i.e. the respective passive actuator. This is advantageous for certain movement sequences. If the user of the device climbs a step, for instance, he must raise his upper legs and therefore also the upper leg elements arranged on the upper legs. In other words, he has to swivel an upper leg element relative to the upper body element. If the two force transmission elements were engaged with one another in this state, raising the upper leg element would charge the mechanical energy store and extending the leg to the next step would discharge it again. However, if the device is not to provide support when climbing stairs, it is advisable to allow the two force transmission elements to disengage during this movement. In many cases, the support offered by the orthopedic device should only be provided when lifting or standing up from a squatting position. To guarantee this, it must be ensured that the two force transmission elements only engage with each other in these states. This can be achieved, for example, by having a pelvic element and bringing the two force transmission elements into engagement with one another as soon as an angle between the pelvic element or a component of the pelvic element and the upper body element exceeds a predetermined limit angle. The device therefore preferably has a pelvic element, wherein the upper body element is movably arranged relative to the pelvic element. In this case, the first force transmission element is engaged with and disengaged from the second force transmission element by moving the upper body element relative to the pelvic element. If the angle between the pelvic element and the upper body element gets reduced below a predetermined limit angle, the two force transmission elements are brought into engagement with each other. If the angle then exceeds the predetermined limit angle, the force transmission elements are disengaged again. In preferred configurations, the first passive actuator and the second passive actuator are each arranged at one force application point on one force application lever. This is preferably arranged on the pelvic element or the upper body element. In these configurations, the two passive actuators preferably act on the upper leg element, i.e. they are arranged with one of their ends on the upper leg element and with the other end on the respective force application lever. If the two force transmission elements are disengaged, the force application levers can be freely swivelled relative to the pelvic element. If the upper leg element is swivelled relative to the pelvic element and thus also relative to the upper body element in this state, the force transmission levers follow this swivelling, such that the passive actuators and the mechanical energy stores preferably contained within them are not charged with energy. This results in no force and no support. However, if the two force transmission elements do engage with each other, the force transmission levers are positioned on the pelvic element such that they are torque proof and can no longer follow the swivel movement of the upper leg element. The distance between the force application point on the force application lever on the one hand and the point of application on the upper leg element on the other thus increases with the movement, so that the mechanical energy store is charged with mechanical energy and exerts a supporting force. Preferably, an orientation and/or position of the two force transmission levers in relation to one another and/or at least one of the two, but preferably both, force application points is adjustable. The movement, for instance swivelling, of the two force application levers relative to each other enables the adjustment of the angular range in which the respective passive actuator exerts its force. A displacement of the force application point on the force application lever, for instance towards the swivel axis of the upper leg element relative to the pelvic element or away from it, enables the adjustment of the strength of the force to be applied. By adjusting the force application point on the force application lever differently, for instance in the circumferential direction with respect to the above-mentioned swivel axis, it is also possible to achieve a preload of the respective passive actuator. A preload of the first actuator and/or a preload of the second actuator is preferably adjustable. Preferably the pattern of the force applied by the first actuator and/or the force applied by the second actuator extends depends on the angle; in particular, said pattern is curved, especially preferably sinusoidal. Preferably the force exerted by the first actuator and the force exerted by the second actuator exhibit a maximum at different angles. For angles smaller than the respective predetermined angular, the force exerted by the respective actuator is preferably zero, or essentially zero. In this case, the more the upper body is bent relative to the upper leg, the smaller the angle. Preferably, the first and second passive actuator each act on one force application lever. The two force application levers are preferably designed to be length-adjustable, so that the size of the torque applied by the respective actuator or the strength of the respective force can be adjusted. Additionally or alternatively, the force application levers are designed to be adjustable relative to each other and/or relative to a pelvic element so that the position of the predetermined first angular range and/or the position of the predetermined second angular range can be adjusted. When the upper body element bends relative to the upper leg element, the respective actuator, which can be a spring element for instance, is charged with mechanical energy and can thus exert the force. Here, the distance between the first end of the respective actuator and the second end of the actuator is greater. The device preferably features an end stop, which can be arranged on a pelvic element, for example, and on which the first passive actuator and/or the second passive actuator strikes when the respective force application lever has reached a certain position, especially relative to the upper leg element. As a result, the respective actuator is still tensioned and charged with mechanical energy, but said energy preferably acts directly on the rotational axis between the upper body element and the upper leg element, provided that the end stop is arranged on this rotational axis. A force is thus exerted but it no longer leads to a torque; therefore, it also does not lead to a support of the back. The orthopedic device for supporting a lower back of a user comprises at least one mechanical energy store, a pelvic element, a torso element and an upper leg element, wherein the mechanical energy store can be charged and discharged by swivelling the upper leg element relative to the torso element. Preferably, the upper body element is arranged on the pelvic element by means of two rail elements, wherein the rail elements are each arranged with a first end on the pelvic element such that they can swivelled about at least a first swivel axis and with a second end opposite the first end on the upper body element such that they can be swivelled about at least a second swivel axis. The pelvic element is preferably designed as a pelvic harness or hip harness and therefore extends fully around the body at the height of the pelvis or hips. Between the two first ends of the two rail elements, which are arranged on the pelvic element, extends a part of the pelvic element, which is preferably not or at least largely not variable in length when the device is in use. In a structurally simple and therefore preferred configuration, the distance between the first end and the second end of the respective rail element is also designed to be not or at least largely not variable in length when the device is in use. This also applies for the distance between the two second ends of the rail elements. This results in a parallelogram which, due to the articulated arrangement of the respective parts, is movable. In a preferred embodiment, the freedom of movement of the user's upper body and in particular the user's spinal column is not or at least largely not restricted. Preferably, at least one of the specified variables is designed to be adjustable. The respective variable can therefore be adjusted to fit a body part of the user. After adjustment, it is set to the individually desired value and then fixed, e.g. locked, in such a way that it does not change or at least largely does not change when the device is used. It is preferable if several, but especially preferable if all, specified variables can be adjusted and locked in this manner. It is particularly preferable if the upper body element is arranged on the pelvic element in such a way that the lateral flexion of the spinal column and the rotation of the spinal column about a rotational axis in the sagittal plane is possible. In this case, the freedom of movement of the spinal column of the user is not restricted at all, so that all movements that the user of the orthopedic device can execute with his spinal column without the orthopedic device are also possible with the orthopedic device. A rotational axis in the sagittal plane is understood particularly to mean a vertical rotational axis which lies in the median plane, and thus in the central sagittal plane, when a user is standing up straight. It could also be described as the longitudinal axis of the spinal column, wherein the spinal column of a human, due to its geometric form, does not have a longitudinal axis in the mathematical sense. Of course, rotational axes displaced parallel to this axis also lie in a sagittal plane. If the freedom of movement of the user's spine is not restricted by the device, it is understood particularly to mean that both flexion and extension are possible. These movements are also referred to as ventral flexion and dorsal extension, or inclination and reclination. A flexion is the leaning forward of the upper body, and thus of the spinal column and the head, while extension is the opposite movement. In this case, other movements of the upper body and therefore the spinal column, such as lateral flexion and rotation, are also not restricted by the orthopedic device. Movements of the spinal column, particularly a leaning of the spinal column to the side and/or forwards and backwards and/or a twisting of the spinal column about its longitudinal axis, are preferably also not prevented, restricted or rendered impossible by the orthopedic device. All of the movements described here are preferably restricted by the orthopedic device in neither their maximum movement deflection nor in a sequence of movement. If the upper leg element is swivelled relative to the upper body element in a first direction, the mechanical energy store, which can be, for instance, an elastic element such as a tension spring, is charged with energy. The first direction corresponds, for example, to raising the upper leg element, for instance to climb a step. However, it is preferable to have the device in a deactivated state when climbing stairs, so that no supporting force is applied when climbing stairs. Bending forward (flexion) of the upper body also swivels the upper body element relative to the upper leg element accordingly. The first direction is thus characterized in that an angle between the upper leg element and the upper body element decreases due to the swivelling. The energy that charges the mechanical energy store can be, for instance, an elastic or potential energy. In this state, the mechanical energy store preferably applies a force to the upper leg element and/or the upper body element which acts in the second direction that is opposite to the first. If the upper leg element is swivelled relative to the upper body element in this second direction, the mechanical energy store is discharged and the energy released supports the movement of the upper leg element relative to the upper body element. This second direction refers, for instance, to the lowering of the upper leg element or an extension of the leg, or a straightening (extension) of the upper body. In all these movements, the upper leg element is swivelled relative to the upper body element in the second direction. If the user of the orthopedic device wants to lift a heavy object, for example, he bends his knees and grabs the object. Here, both upper legs and therefore also the respective upper leg element are swivelled relative to the upper body and thus to the upper body element in the first direction. The angle between the upper leg and the upper body decreases. This causes the mechanical energy store to be charged with potential energy. To lift the object, the user of the orthopedic device must now extend his legs, wherein the upper leg is swivelled relative to the upper body in the opposite second direction. The potential energy stored in the mechanical energy store is released and supports the corresponding movement. Preferably, the first swivel axes extend at least largely in frontal planes, but preferably in a common frontal plane. It is especially preferable if the first swivel axes extend through the hip joint of the user, so that the first ends of the rail elements are arranged laterally, i.e. externally. Conversely, the second ends of the rail elements are arranged dorsally, i.e. at the back, on the upper body element. The rail elements preferably extend in such a way that the first end is rotated by 90° relative to the second end. Here, the rail elements are preferably configured and arranged to be mirror-symmetrical to one another. The second swivel axes preferably extend at least largely in the sagittal plane. Here, it is especially preferable for them to extend from dorsal to ventral, i.e. from back to front. As a result, an inclination of the body and the spinal column to the side is also possible without restricting the freedom of movement. In a preferred configuration, the rail elements feature at least two partial rails, which are arranged on each other such that they can be swivelled about a third swivel axis. The three swivel axes preferably extend largely in sagittal planes. It is especially preferable if, when the orthopedic device is mounted, they extend largely parallel to the second swivel axes when the user of the orthopedic device stands upright. The swivel joints, which enable a movement of the partial rails relative to one another, are preferably arranged closer to the first end than the second end of the respective rail elements. It is especially preferable if these joints are positioned to the side of the body of the user, so that an imagined extension of the third swivel axis leads past the user's body. When the orthopedic device is mounted, the second ends of the rail elements are preferably arranged in the region of the shoulder blades, but especially preferably in the region of the lower angles of the user's shoulder blades. When the spinal column bends right or left, this region exhibits the starkest deviation from a straight line, so that the joints, which connect the second ends to the upper body element in this region, are optimally positioned. In a preferred configuration, a distance between joints, with which the second ends of the rail elements are arranged on the upper body element, is adjustable. The joints are preferably arranged on the upper body element such that they can be displaced. This is achieved, for instance, by arranging the respective joint on a slider that can be displaced along a guide, such as an elongated hole or link arranged in or on the upper body element. Preferably, the second ends of the rail elements are arranged on the upper body element in such a way that they can be swivelled about two different swivel axes, one of which preferably extends in the dorsal-ventral direction and the other in the medial-lateral direction. The first of these two swivel axes allows the user of the orthopedic device to incline his upper body to the right and left, while the second of the two swivel axes is required to bend the user's upper body forwards or backwards. In preferred embodiments, the two ends of the rail elements are arranged on the upper body element by means of ball joints. As a result, freedom of movement is further increased, as is the degree of acceptance of the orthopedic device by the user. When the orthopedic device is mounted, the upper body element preferably extends completely around the user's upper body. It is preferably designed to be so dimensionally stable that its diameter in the medial-lateral direction does not or largely does not change when the upper body bends over. If the at least one mechanical energy store is to be charged with energy, the upper body element must be swivelled relative to the upper leg element. Where applicable, an activation device must also be activated, which may be achieved, for instance, via a movement of the upper body element relative to the pelvic element. If the energy store, which comprises a spring element for example, is charged, a force must be exerted, which can be caused by the upper body bending over. In the examples of embodiments specified, the upper body then exerts a tensile force on the upper body element. The upper body element preferably comprises a chest section which, when the orthopedic device is mounted, rests on the user's chest at at least two spaced points on different sides of the user's sternum. The force is transmitted via these points from the upper body to the upper body element. Of course, this is also possible if the upper body element only comes into contact with the user's chest at a single point or at more than two points. To charge the energy store with energy, a tensile force is exerted on the upper body element via the upper body and thus via the user of the orthopedic device. When the energy store is discharged, a tensile force is exerted on the upper body via the upper body element; said tensile force acts to support the user's lower back, for instance when straightening up. In this case, the tensile force is preferably transmitted via the rail elements to the upper body element and from here to the upper body. Since the rail elements are arranged dorsally, i.e. on the user's back, the tensile force is transmitted to the dorsal section of the upper body element and from there to the frontal section of the upper body element. This tensile force is transmitted to the upper body via the points at which this frontal section comes into contact with the upper body, i.e., preferably to the right and left of the user's sternum. Sufficient dimensional stability ensures that there is no constriction of the user's upper body when the tensile force is applied to the dorsal part of the upper body element. If the dimensional stability is too small, it is actually transferred to the upper body from frontal to dorsal through the parts of the upper body element that pass the sides of the upper body, like a sling to which a tensile force is applied. In this case, part of the force is transferred into a medially acting force, which can have painful effects. Preferably, the part of the upper body element that surrounds the upper body is not completely dimensionally stable; rather, it exhibits a small degree of flexibility and preferably elasticity. This ensures that the orthopedic device and the upper body element is suitable for different people with different chest measurements, and can be designed to allow for the adjustment of this variable. It may be sufficient to connect individual rigid and inflexible elements to one another in a flexible and preferably elastic way, e.g. using half-shells or shell elements that surround parts of the upper body in a dimensionally stable and rigid manner. Alternatively, the upper body element can also be designed without any rigid elements. In a preferred configuration, the orthopedic device features a first and a second upper leg element, and a first and a second mechanical energy store. Here, the first mechanical energy store can be charged and discharged by swivelling the first upper leg element relative to the upper body element. The second mechanical energy store can be charged and discharged by swivelling the second upper leg element relative to the upper body element. This configuration enables independent movement of the upper leg relative to the upper body element. The mechanical energy store only applies a force to the upper leg which has been swivelled relative to the upper body element. Preferably, every upper leg element is arranged on the pelvic element by means of a joint arrangement such that it can be swivelled about a joint axis. The joint arrangement is preferably positioned in such a way that the joint axis extends through a hip joint of the user. The upper leg element preferably features at least one mounting element for mounting it on the upper leg and at least one compressive force transmission element, via which the mounting element is connected to the joint arrangement. In a preferred embodiment, the compressive force transmission element is a rod or rail; it is particularly preferable if it is ergonomically formed. The mounting element is preferably connected to each joint arrangement by at most one compressive force transmission element. It is advantageous if each of the rail elements used is arranged on the upper body element such that it can be swivelled about at least two swivel axes, wherein at least two of the swivel axes are preferably perpendicular to each other. It is particularly preferable if at least one of the rail elements is arranged on the upper body element via a ball joint. All rail elements are preferably each arranged on the upper body element via one ball joint. Preferably at least one rail element, but especially preferably every rail element, is arranged on the respective joint arrangement, which is arranged on the pelvic element, such that it can swivelled about an axis of movement, wherein the axis of movement is preferably perpendicular to the joint axis of the respective joint arrangement. The various movable configurations are designed so that the movements of the user's upper body, and in particular the spinal column, can be followed and, irrespective of the position of the upper body element relative to the pelvic element and/or relative to the at least one upper leg element, the force applied by the mechanical energy store in the charged state can act. In an especially preferred configuration, the at least one rail element is designed to be adjustable in length. It is particularly preferable if all rail elements are adjustable in length. The orthopedic device can thus be used for people of different sizes. The length-adjustable rail element can preferably be fixed at different length settings, so that the length can be adjusted but then remains unchangeable. The mechanical energy store preferably comprises at least a spring element, a pressure accumulator, a pneumatic and/or hydraulic system and/or a hydraulic energy store. Elastic elements in the form of elastic cords, such as rubber cords, are also conceivable. Of course, other elements, such as gas springs or compression springs, are also conceivable, for which a deflection is used to transform the compressive force coming from the compression spring into a tensile force. mechanical energy store can be arranged at various positions on the device. Preferably, a position is selected at which the installation space required for the energy store is available and the energy store does not cause any disruption, even while the user's leg is moving. For instance, it may be arranged on the upper leg. For arranging the upper body element on the user's upper body, a shoulder element for mounting on the shoulder, which can be in the form of rucksack straps or braces, for example, is particularly suitable. It allows for an especially small design of the orthopedic device. The upper leg element preferably comprises an upper leg shell that is preferably arranged on a spacer element. This spacer element, as part of the upper leg element, is preferably connected to the pelvic element. The lengths of the compressive force transmission element, which is designed as a rail or rod for example, and where applicable of the spacer element, which is also designed as a rod or rail, are preferably selected such that the entire angular range of the potential movement of the wearer's lower leg is covered. The upper leg shell is preferably flexibly arranged on the spacer element to render the device as comfortable as possible to wear. In a preferred configuration, the passive actuator is configured to generate a force, irrespective of a position and/or orientation of the at least one leg support element relative to the pelvic element and/or the upper body element. In a preferred configuration, the upper leg shell for mounting on the user's upper leg is preferably arranged on the upper leg element, but preferably on each upper leg element. Said shell is preferably designed to be padded to render it as comfortable as possible to wear. The upper leg shell is preferably arranged by means of a ball joint. This ensures the greatest possible freedom of movement in relation to the rest of the device, which is particularly advantageous when the user moves. By means of the ball joint, the upper leg shell can be arranged directly on a rail element or spacer element of the upper leg element. Alternatively, it is positioned on a holding bracket. The upper leg shell can preferably be swivelled relative to the upper leg element about a rotational axis, preferably against a force of a spring element, wherein the rotational axis preferably extends in the medial-lateral direction. This is rendered particularly feasible by way of the positioning of the upper leg shell on the holding bracket, which is arranged on another component of the upper leg element such that it can be swivelled about the rotational axis. BRIEF DESCRIPTION In the following, some examples of embodiments of the present invention will be explained in more detail by way of the attached figures. FIG.1schematically depicts various elements of an orthopedic device according to an example of an embodiment of the present invention. It shows a first positive-locking element, which is designed as a first gearwheel2, which can be displaced along guide rods4on the component on which it is arranged. It is displaced along these guide rods4when the first gearwheel2is to be engaged with the second positive-locking element, which is designed as a second gearwheel6. The first gearwheel2and the second gearwheel6feature schematically indicated teeth10on their end faces8, which are designed to correspond to each other. A guide spindle12protrudes from the end face8of the second gearwheel6in the axial direction, meaning parallel to the axis “AX” about which the first gearwheel2and thesecond gearwheel6can rotate as described herein. In theFIG.1example, teeth are arranged on the end face14of the guide spindle12. The toothing on the end face14of the guide spindle12corresponds to the toothing on the end face8of the second gearwheel6. A toothing is also arranged on a lateral surface16of the guide spindle12, which ensures that the guide spindle12is set in rotation about axis AX when the guide spindle12is moved in the axial direction with respect to the second gearwheel6until it is received in the second gearwheel6. When the first gearwheel2is moved along the guide rods4towards the second gearwheel6, the teeth of the end face14of the guide spindle12first engage with the teeth10of the end face8of the first gearwheel2. The guide spindle12is then pushed into the second gearwheel6and set in rotation, shown due to the teeth of the lateral surface16. The first gearwheel2is mounted so that it can follow the only slight rotation of the guide spindle12, so that it reaches the optimum position relative to the second gearwheel6as soon as the guide spindle12is received in the second gearwheel6. FIG.2schematically depicts an embodiment of the various teeth. It shows the end face14of the guide spindle12on the left and the end face8of the first gearwheel2on the right. The very differently shaped teeth ensure that, regardless of the position in which the first gearwheel2meets the guide spindle12, the respective teeth always engage with each other. FIG.3shows another configuration. The first gearwheel2has a central bore18, the inner wall 20 of which features grooves or a toothing, which can also be designed as internal thread. The toothing on the lateral surface16shown inFIG.1can also be designed in the form of an outer thread. In the example of an embodiment shown inFIG.3, the second gearwheel6features a guide spindle12; however, it is not arranged such that it can be displaced relative to the second gearwheel6. Instead, the lateral surface16of the guide spindle12is designed with an outer thread which is designed to correspond to the inner thread of the internal wall20of the central bore18. If, in this configuration, the first gearwheel2is moved along the guide rods4towards the second gearwheel, the outer thread of the lateral surface16engages in the inner thread of the inner wall20of the central bore18of the first gearwheel2. Further displacement of the first gearwheel2towards the second gearwheel6causes a rotation of the first gearwheel2relative to the second gearwheel6, which again ensures that the teeth10of the first gearwheel2engage as optimally as possible in the teeth10of the second gearwheel6. FIGS.4and5depict a schematic representation of parts of a safety device, one of the gearwheels of which comprises partial gearwheels. In the left-hand area ofFIG.5, one of the gearwheels features two partial gearwheels22, which are arranged co-axially. The partial gearwheels22are arranged via schematically depicted elastic elements24in the axial direction, i.e. perpendicular to the drawing plane, such that they can be displaced. The teeth of the partial gearwheels22are arranged at a slight offset to each other. In particular, the offset is preferably half a tooth length. If a gearwheel now engages in the teeth of these partial gearwheels22, which preferably protrude to different degrees in the axial direction, the situation shown inFIG.4occurs. The partial gearwheels22each have teeth which are separated from each other by the offset26and therefore engage to different extents with the teeth10of the respective other gearwheel. In the area28there is only very little contact between the teeth of the partial gearwheel22and the teeth10of the respective gearwheel. If the force to be applied is too great, the teeth slip off each other at this point. However, the two components can only be moved against each other until, in the area30, the teeth of the other partial gearwheel22are engaged with the teeth10of the gearwheel. Since the partial gearwheels22are displaced against each other in the axial direction, the teeth of the different partial gearwheels engage with the teeth of the gearwheel to different extents. In the right-hand section ofFIG.4, the gearwheel features four partial gearwheels22, each of which is elastically mounted in the axial direction via an elastic element24.FIG.6schematically depicts a combination of a first gearwheel2comprising four partial gearwheels22and a second gearwheel6, which is a simple spur gearwheel. The four partial gearwheels22correspond to the arrangement shown inFIG.5and are arranged in the axial direction at a stark offset and not true to scale. FIG.7shows another configuration, wherein the second gearwheel6has two partial gearwheels, which are shown as a second inner partial gearwheel22A and a second outer partial gearwheel22b(collectively “second gearwheel6partial gearwheels22”) arranged axially at a slight offset to each other, but fixed to each other. The first gearwheel2of theFIG.7embodiment also features two partial gearwheels, comprising a first inner partial gearwheel23A and a first outer partial gearwheel23B (collectively “first gearwheel partial gearwheels23” which, like the second gearwheel6partial gearwheels22, are arranged coaxially to each other and can be axially displaced via indicated spring elements32. In the embodiment shown, if the first gearwheels2and the second gearwheel6as depicted are moved towards each other, the first inner partial gearwheel23A initially engages in the teeth of the second inner partial gearwheel22A. Only when the first gearwheel2is axially displaced further in the direction of the second gearwheel6do the first and second outer partial gearwheels23B and22B engage with each other. Due to the offset toothing, the schematically depicted situation inFIG.4occurs. If the engagement of the first and second inner partial gearwheels23A and22A with each other corresponds to the situation shown in area28, it is ensured that the outer partial gearwheels22engage with each other according to the situation shown in area30ofFIG.4. FIG.8depicts various forms of tooth that can be used. FIG.9shows the first gearwheel2and the second gearwheel6as shown inFIG.1. Again, the first gearwheel2is arranged such that it can be displaced along the guide rods4. In the example of an embodiment shown, the teeth10are designed as an undercut toothing. InFIG.10, the first gearwheel2and the second gearwheel6each have a guide spindle12. Each guide spindle protrudes from the respective gearwheel2,6at the front. The two guide spindles12have frontal projections and/or recesses which can be brought into engagement with one another. Instead of the toothing shown in the other figures, there are elongated holes34in the end face8of the second gearwheel6, which are designed in such a way that pins36, which protrude from the end face of the first gearwheel2, can engage in them. FIG.11shows the end faces of the first gearwheel2and the second gearwheel4, which each feature projections38between which recesses are arranged, so that the projections38of the two gearwheels can engage with each other. Magnets40are shown schematically in the central area of the end faces, wherein said magnets are arranged in such a way that poles of the same name are directed towards each other. This produces a repellent effect, which is minimal if the magnets40of one gearwheel, preferably arranged equidistantly, are placed exactly between the magnets of the other gearwheel. The two gearwheels2,6can also be aligned in relation to one other in this way. FIG.12shows an orthopedic device in an applied state, with which structures shown inFIGS.1-11may be used. TheFIG.12device comprises an upper leg element42, which is arranged on an upper leg of the user, and an upper body element44, which is arranged on the upper body. The device also features a pelvic element46, which is arranged on the pelvis of the user. Both the pelvic element46and the upper leg element42as well as the upper body element44are arranged on the respective body part of the user. The orthopedic device also has a joint device50, which performs several functions in the example of an embodiment shown. On the one hand, the upper leg element42is arranged about a first swivel axis54on the pelvic element46via a first splint52. The upper body element44is also arranged on the pelvic element46via a second splint56such that it can be swivelled, wherein the swivel axis coincides with the first swivel axis54in this example of an embodiment. The orthopedic device also has a mechanical energy store58, which is a tension spring in the example of an embodiment shown. FIG.13depicts an enlarged representation of the pelvic element46. One recognizes a first connection element60, on which the first splint52of the upper leg element42is to be arranged, and a second connection element62, on which the second splint56of the upper body element44is arranged. A lever64is provided, on which the mechanical energy store58is positioned. FIG.14depicts a side view of the device fromFIG.13. A first force transmission element66, which is designed as a front gearwheel in the example of an embodiment shown, is situated on the second connection62, which forms part of the upper body element44. A corresponding second force transmission element68is positioned on the lever64, which forms part of the upper leg element42. The exploded view inFIG.15shows how it functions. The second force transmission element68is situated on the lever64. The first force transmission element66is found as a separate component on the second connection element62. The first force transmission element features four projections70, which engage in four specially provided openings72on the second connection element62. InFIG.15, it can be recognized that a magnet74is arranged on two of the projections70, wherein said magnet protrudes through the respective openings72when in the applied state. A displacement device76is arranged on the actual cover element such that it is torque-proof. The displacement device76also comprises a series of magnets78. In the example of an embodiment shown, the magnets78extend across the entire circumference of the displacement device76, thereby affecting the magnets74on the first force transmission element66. At the upper end of the displacement device76shown inFIG.15, a positioning magnet80is depicted, which interacts with corresponding counter-magnets82that are arranged on the pelvic element46. The positioning magnet40and the counter-magnets42are arranged such that opposite poles are directed towards one another. In the example of an embodiment shown, the displacement device76can thus be fixed on four different positions relative to the pelvic element46such that it is torque-proof. If the upper body element44and therefore the second connection element62is now twisted relative to the pelvic element46, the position of the magnets74relative to the magnets78also changes. These are arranged in such a way that at a certain angle, at which the upper body element44is twisted relative to the pelvic element46, the polarity of the magnets78changes, so that an attractive force acts between the magnets74and78up until this angle and a repelling force acts from this angle and beyond. At the point at which an attractive force becomes a repelling force, the first force transmission element66moves out of the position shown inFIG.14and engages with the second force transmission element68. A locking device74, which can be displaced in the circumferential direction, can be used to fix the position of the first force transmission device66relative to the second force transmission device, so that a displacement of one of the two force transmission elements is no longer possible. This prevents the two force transmission elements66,68from either engaging or disengaging. REFERENCE LIST 2first gearwheel4guide rod6second gearwheel8end face10tooth12guide spindle14end face16lateral surface18central bore20inner wall22partial gearwheel(s)22A second inner partial gearwheel22B second outer partial gearwheel23A first inner partial gearwheel23B first inner partial gearwheel24elastic element26offset28area30area32spring element34elongated hole36pin38projection40magnet42upper leg element44upper body element46pelvic element50joint device52first splint54first swivel axis56second splint58mechanical energy store60first connection element62second connection element64lever66first force transmission element68second force transmission element70projection72openings74magnets76displacement device78magnets80positioning magnets82counter-magnets | 57,874 |
11857447 | DETAILED DESCRIPTION Initially in reference toFIG.1, a side perspective view is shown of a single splint100consistent with present principles. The splint100may be rigid or semi-rigid. The splint100may be made of plastic and/or another polymer such as silicone, hardened rubber, metal such as aluminum, and/or other suitable material. The splint100may define a proximal-to-distal dimension and a lateral dimension orthogonal to the proximal-to-distal dimension. The splint100may also define a third, dorsal-to-volar dimension. The splint100may be integral as formed via injection molding, three-dimensional (3D) printing, and/or other manufacturing methods. As shown inFIG.1, the splint100may be generally arcuate. The splint100may include a first arcuate band110, a second arcuate band120, and a third arcuate band130. When placed on a finger, the second arcuate band120is to extend laterally over a dorsal area of a fractured finger joint while the first and third arcuate bands110,130extend laterally under volar areas of the finger that are proximal and distal to the joint. The bands110-1130may be connected to each other via arcuate side members140,150that include center apices pointing up dorsally, with the side members140,150extending between ends of the bands110-130in the proximal-to-dorsal dimension. As such, ends of the bands110,130may terminate at integral proximal and distal ends of the respective members140,150. Additionally, the center apices of the members140,150may transition to integral ends of the band120. As also shown inFIG.1and as mentioned above, the bands110-130may be spaced apart from each other on the splint100in the proximal-to-distal dimension so that the bands110-130contact a finger at three spaced-apart locations of the finger, proximal-to-distal, to stabilize the finger for finger fracture recovery. In some specific examples, only three lateral bands may be used (e.g., the bands110-130) and the bands may contact the finger at only the three spaced-apart locations of the finger and no other locations of the finger. The three spaced-apart locations may therefore be longitudinally spaced from each other along the finger and may not establish other portions of the finger at spaces in between. As further shown inFIG.1, the bands110and130may extend volarly downward to engage volar area/palmar surface locations of the finger, while the band120may extend dorsally upward to engage a dorsal area/top surface location of the finger. Thus, in addition to the bands110-130being spaced apart from each other in the proximal-to-distal dimension, the bands110,1130may have center apices pointing volarly and the band120may have a center apex pointing dorsally. As for the inner surfaces of the splint100, they may be smooth and configured to sit flat against the finger itself when engaged therewith. In some examples, proximal-to-distal subsections of the bands110-130may be straight in the proximal-to-distal dimension while arcuate in the dorsal/volar-lateral plane. The bands110-130may also have a thickness, generally dorsal-volar, that is less than the proximal-to-distal subsections are long. FIG.2shows the splint100again, but from a top perspective view.FIG.3shows the splint100from a side elevational view. FIG.4then shows the splint100placed on a finger400to stabilize a fracture to a proximal phalanx joint of an index finger400. As may be appreciated fromFIG.4, the band120sits flat and smoothly against a dorsal surface of the finger400directly above the joint, while bands110,130sit flat and smoothly against spaced-apart volar/palmar surfaces of the finger400and the members140,150sit flat and smoothly against side areas of the finger400. It may be appreciated that the configuration of the splint100with the three bands110-130may therefore immobilize the joint so that the finger400is impeded or prevented from bending at the joint due to the pressure points created by the spaced apart contact of the bands110-130with the finger400. This is further demonstrated inFIG.5, where the person is attempting to bend his/her finger400at the joint. FIG.6then shows an example embodiment where at least a first foam pad600may be configured for removable engagement with the band120. The pad600may be resilient and deformable, and may be configured to circumscribe the band120in the dorsal/volar-proximal/distal plane. The pad600may also be configured to extend in the lateral dimension along some or all of the band120when engaged therewith. The pad600may thus be removably insertable between the splint100and the finger400via a lateral slit700or other opening in the pad600to accept a segment of the splint100(the band120or even one of the bands110,130). The pad600with slit700is also shown by itself in the pad perspective view ofFIG.7. And note that while the pad600itself may be made of foam as shown, it may additionally or alternatively be made of plastic, fabric, or another suitable material. Additionally, if desired, external surfaces of the pad600may have a smooth exterior finish. The finish may be made of the same material as the insides of the pad600(e.g., foam) and/or made of a wrapping such as surgical tape or a mesh. In addition to having a smooth exterior finish, the pad600may also be deformable to conform to the exterior contours of the finger400to comfortably engage the finger400as shown inFIG.6when the splint100is positioned around a fractured joint. Thus, regardless of what type of material the pad600is made of, the pad600may be deformable, compressible, and/or spongy to conform to the different contours of the finger400around the proximal phalanx joint (or other joint). Therefore, while different 3D shapes may be used, in many example embodiments the pad600may be cylindrical. In other example embodiments it might be arcuate at a same degree or similar degree as the arc of the band120itself. But whether cylindrical or arcuate, the respective pad may also, in some but not necessarily all cases, form a hollow inner cylindrical or arcuate area in which a respective band of the splint100may reside once the band is slid into the hollow inner area through the aforementioned slit700. Thus, here the pad600may establish a foam tube, cylindrical or arcuate. However, as alluded to above, in other embodiments the pad600may be solid on the inside, save for the slit700. Either way, the pad600might be referred to as a “backer rod” in non-limiting examples. Additionally, example pads600of different thicknesses (e.g., for a kit) may be established by respective pads (hollow or not) having a transverse outer diameter of four sixteenths (4/16) of an inch, five sixteenths (5/16) of an inch, and six sixteenths (6/16) of an inch, with a respective slit running longitudinally in a straight line on one side of each pad. The respective slit may extend to a depth of the center point of the respective rod/pad according to the transverse dimension. The slit to the center may therefore result in an effective padding thickness between the finger and respective splint component (e.g., band120) of two sixteenths (2/16) of an inch, two and half sixteenths (2.5/16) of an inch, and three sixteenths (3/16) of inch, respectively. In brief reference toFIG.8, it may be appreciated that with the pad600still engaged with the splint100, the finger400is impeded or prevented from bending at the proximal interphalangeal (PIP) joint despite significant force, in fact enough force to flex through the distal interphalangeal (DIP) joint. In contrast, without the modular pads, a flexion force through the finger may result in flexion motion through the PIP joint. The pads thus demonstrate significant enhancement of the stabilization force on the finger. In the event of an avulsion of the extensor tendon from the dorsal face of the distal phalanx, without the pads the brace may only immobilize the DIP in neutral position, while applying modular pads with the brace slid distally from the PIP joint to the DIP joint may affect an ideal hyperextension of the DIP joint, the correct position for healing of an extensor tendon avulsion. Now in reference toFIG.9, a bottom perspective view is shown of the splint100with pad600. An additional aspect consistent with present principles is also shown inFIG.9, which is a hollow ring900engaged with the splint100. The hollow ring900is also shown by itself in the perspective view ofFIG.9A. As best shown inFIG.9, the hollow ring900may be removably engaged with a palmar portion of the splint100. Specifically, the ring900may be engaged with the band110or band130. In specific non-limiting examples, a physician or patient may mechanically engage the ring900with whichever band110or130will be used as a distal-most band when the splint100is engaged with the finger. As also shown inFIG.9, the ring900may circumscribe the band110/130in the dorsal/volar-proximal/distal plane. In some examples, the ring900may be established by a key ring with a clasp to open and close the ring900to engage and disengage the ring900with the splint100. Additionally or alternatively, another type of mechanism may also be used to open and close the ring900, such as a circle cotter mechanism or kickout ring mechanism. The ring900may be opened to both engage the ring900with the band110or130, and to also engage the ring900with a strap1000or other connector as shown inFIG.10. Additionally, note that the ring900itself may be rigid and made of metal, plastic, hardened silicone or another polymer, hardened or even soft rubber, or another suitable material. Before describing the aforementioned strap1000in more detail, also note that another type of element other than a ring900may be used instead. For example, the element connecting the splint100to the strap1000may be established by another strap or other intermediary component between the splint100and strap1000to mechanically couple the splint100to the strap1000. Or as another example embodiment, the strap1000may be coupled directly to the splint100without an intermediary component like the ring900. In any case, assuming the hollow ring900is used and now in reference toFIG.10, the strap1000itself may be adjustable in length and non-rigid (e.g., pliable, flexible, and/or string-like). Once set or locked to a desired length, the strap1000may remain at the selected fixed length until further manual adjustment by the physician or patient. The strap1000may be made of a flat hard plastic, hard or soft rubber, a string, or other material. In the present example, the strap1000is also shaped long and flat as shown. The length of the strap1000itself may be adjusted using a buckle, velcro, buttons, a snapback mechanism, or other mechanism arranged on the strap1000. For velcro hook-and-loop fasteners, the same or opposing flat surfaces of the strap1000may be layered with reciprocal velcro elements, one with hooks and one with loops, to engage each other. Thus, the strap1000may be connected to both the ring900and to a wrist band1100, with the opposing ends of the strap1000fed through the ring900and an opening1105in the band1100and then extended/folded over each other for the reciprocal velcro components to engage each other (once the strap1000has been set at a desired length as looped through both the ring900and opening1105). A similar connection and fixation at desired length may be established using non-velcro elements as well, such as a buckle or buttons as discussed above. Note thatFIG.10Ashows the band1100by itself for additional illustration. Also note that the opening1105may be a slit or even a circular opening. In either case, a grommet made of metal or other material may circumscribe or otherwise surround the inner periphery of the opening1105for resilience of the band1100when the strap1000is engaged therewith. In cross-reference toFIGS.10and10A, the band1100is a wrist band as shown. However, the band1100may also be configured for engagement with other non-finger portions of the arm as well. The band1100may be made of a soft, pliable material such as felt and/or other cloth, soft rubber, polyester and/or other polymer, or other suitable material. The band1100may be generally rectangular in shape as shown, though other configurations may also be used such as an oval-shaped band. In various examples, the band1100may be nine to twelve inches long for an adult-sized band and five and a half to nine inches long for a child-sized band. The band1100may have engagement members1110,1120at opposing end portions according to the band's longitudinal dimension. In some examples, the members1110,1120may be reciprocal hook-and-loop velcro components as shown. In other examples, the members1110,1120might be established by reciprocal button fasteners, a snapback mechanism, or other mechanism. Describing the hook-and-loop velcro components1110,1120shown inFIG.10A, a first flat face at a first end portion of the band1100may bear a layer of hooks while an opposing, second flat face at a second end portion of the band1100may bear a layer of loops. Then as demonstrated byFIG.10, the ends of the band1100may be engaged with each other via the velcro components1110,1120so that the band1100circumscribes and surrounds the person's wrist and is fixed thereto until the components1110,1120are manually disengaged from each other. In specific examples, the band1100may be engaged with the wrist in a snug fit so that there is little or no slack in the band1100. As alluded to above, although a wrist band is shown as the band1100according toFIGS.10and10A, the band1100may be configured to surround or otherwise mechanically engage with other non-finger portions of the same arm as where the finger fracture is located as well. For example, the band1100may be a hand band that laterally circumscribes and surrounds a portion of the person's hand proximal to the metacarpophalangeal joints of the four fingers and distal to the metacarpophalangeal joint of the thumb, with the thumb itself remaining free and not strapped down. Or the band1100may be a forearm band that laterally circumscribes and surrounds a portion of the person's forearm proximal to the wrist. Turning toFIG.11, the band1100is again shown, but here the connector used to couple the ring900to the band1100is a metal chain1150rather than a long, flat strap according toFIGS.10and10A. The chain1150may be anchored at a first end to a first flat surface of the band1100using glue or other fastening mechanism, and/or the chain1150may be looped through an opening in the band1100like the opening1105described above and then anchored or chain-linked to itself. The chain1150may also include a second end terminating in a hook or clasp or other mechanical element1170for the chain1150to connect to the ring900at the second end.FIG.12shows this band1100/chain1150combination with the band1100wrapped around and secured to a person's wrist on the same arm as the finger fracture, sans splint100, pad600, and ring900for illustration. Referring now toFIGS.13and14, respective side and palmar views are shown of an assembled brace device with components described above as engaged with a finger1300and wrist1400on a person's arm. Note that while the ring900, strap1000, and wrist band1100are shown, alternatives as disclosed above may also be used (e.g., the chain1150rather than strap1000). In any case, it may be appreciated fromFIGS.13and14that the strap1000or other connector has been set and fixed at a length to hold the finger1300at a desired flexion at the metacarpophalangeal joint and with respect to the hand. In preferred but non-limiting examples, the desired flexion may be ninety degrees in the palmar direction relative to a longitudinal axis of the hand/arm itself, or at least in the range of eighty to one hundred degrees. Now in cross-reference toFIGS.15-17, another example splint embodiment is shown consistent with present principles.FIG.15shows a top plan view of this embodiment,FIG.16shows a side elevational view of this embodiment, andFIG.17shows a top perspective view of this embodiment. According to this embodiment, first and second splints1500,1600are used. Each of the splints1500,1600may be configured the same as the splint100described above, save for the splints1500,1600being integral with each other as shown. For example, the splints1500,1600may be molded together or otherwise laterally connected to each other as shown. Thus, for example, a distal arcuate band of the splint1500and arcuate side member of the splint1500may be molded integrally with a proximal arcuate band of the splint1600and arcuate side member of the splint1600. Note that the distal arcuate band of the splint1500and proximal arcuate band of the splint1600may be similar to the bands110,130as described above and, as such, may each extend volarly downward to engage a volar area/bottom surface of the respective finger. Also note that the respective side members of the splints1500,1600may be similar to the side members140,150described above. The splints1500,1600may be configured for respective engagement with adjacent fingers and may therefore have inner heights and widths that vary slightly from each other. Each splint1500,1600may therefore still be configured to contact the respective finger at three spaced-apart locations of the respective finger. In the particular example shown, the splint1600is lateral to the splint1500, with the splint1600being offset from the splint1500in the proximal-to-distal dimension. However, in another example embodiment, the splint1600may not be offset from the splint1600in a proximal-to-distal dimension and instead the splints1500,1600may be laterally connected and even with each other in the proximal-to-distal dimension. FIG.18then shows the splints1500,1600with a ring900coupled to the splint1600, with it being assumed per this example that the respective finger to be engaged with the splint1600is the one with the fracture being immobilized. Hence, the ring900is engaged with a distal arcuate band of the splint1600. But if the splint1500were the one used to engage the fractured finger, the ring900might instead be engaged with a distal arcuate band of the splint1500. FIGS.19and20next show an offset two-splint device as described above, but with splints1900,2000engaged with adjacent fingers on a person's left hand and with the PIP joint of the ring finger being the fractured joint for which immobilization is sought per this example. Specifically,FIG.19shows a palmar bottom view of the hand with splints1900,2000engaged with and immobilizing respective PIP joints of the hand, whileFIG.20shows a palmar perspective view of the same. Additionally, if desired a respective foam pad2100,2200as shown inFIGS.21and22may be engaged with respective arcuate bands of one of the splints1900,2000(the splint that is to immobilize a fractured finger). Each pad2100,2200may be configured similar to the pad600as described above.FIG.21shows a top perspective view of the two-splint device with foam pads by themselves, andFIG.22shows a side elevational view of the two-splint device with foam pads as engaged with a left ring finger and pinkie finger of a person's hand. As may be appreciated fromFIGS.21and22, the pad2100has been mechanically engaged with an arcuate band like the band120described above that extends dorsally upward to engage a dorsal area/top surface of the respective finger, while the pad2200has been mechanically engaged with a proximal arcuate band like one of the bands110,130described above that extends volarly downward to engage a volar area/bottom surface of the same finger. And though not shown in the present example, further note that another foam pad might be engaged with the distal arcuate band extending volarly downward so that a respective pad is engaged with each arcuate, lateral band of the splint1900. Also if desired, one or more similar foam pads may be engaged with one or more of the arcuate, lateral bands of the splint2000as well. Indeed, all combinations of one pad, two pads, or three pads for each splint are envisioned according to present principles, depending on implementation. For example, one pad may be engaged with any one of the three arcuate bands of the respective splint, two pads may be respectively engaged with any two respective arcuate bands of the same respective splint, or three pads may be respectively engaged with a respective one of each of the three arcuate bands of the respective splint. Also note that this applies to single-splint embodiments as well (such as those described above with reference toFIGS.1-6) in addition to the two-splint embodiment presently being described. Thus, one, two or three pads may be used for a given splint depending on desired fit and comfort for the particular person using the device, as well as depending on which pad combination results in the respective splint being stabilized in close fit with the respective finger itself (e.g., to prevent jostling or unintended movement of the splint with respect to the finger). Now in reference toFIG.23, it shows a palmar perspective view of an example two-splint brace/device engaged with a left arm of a person. Thus, the band1100is wrapped around the left wrist, with the chain1150mechanically connecting the band1100to the ring900. The ring900itself is engaged with a distal, volarly-extending arcuate band of the splint1900. The splint1900is engaged with a ring finger of the left hand as shown, while the splint2000is engaged with a pinkie finger of the left hand. The pads2200,2100are also engaged with the splint1900, such as via respective slits in the pads2200,2100to accept a respective segment of the splint1900to removably and individually engage each foam pad with the splint such that a user can select which foam pad to engage with the splint depending on desired comfort and stabilization levels. It may thus be appreciated that the fractured ring finger is held at a desired flexion at the metacarpophalangeal joint, with again may be ninety degrees extending volarly downward. Accordingly, it may be appreciated that a one-splint device or two-splint device consistent with present principles may be used for stabilization and correction of finger injuries and deformities as well as reduction and stabilization of finger fractures. Each splint may be a three-point finger splint in that each splint may have bands contacting the respective finger at three spaced-apart areas (that are more than respective single geometric points per se) Thus, in reference to a single-splint device consistent with present principles (such as the splint described above in reference toFIGS.1-6), the splint may include a single arcuate body, created by injection molding, from a semi rigid material. The splint can be applied over the proximal interphalangeal (PIP) or distal interphalangeal (DIP) joints, treating both flexion and hyperextension deformities and instabilities as well as instabilities and deformities related to arthropathies and fractures. For example, the splint may be placed over the PIP joint with the center band dorsal for PIP flexion contractures, and/or over the PIP joint with the central band volar for PIP hyperextension deformities (AKA “swan neck” deformities as might be seen in patients with rheumatoid arthritis). These splints can thus be used for different fractures or other conditions of the PIP joint. Each splint may be sold individually as a single size, or multiple splints of multiple sizes may be sold in a kit/packet. Indeed, this is also true for a two-splint device as well in that multiple different sizes may be sold in a single kit. Either way, the kit may be provided or manufactured by a medical device supplier or other third party such as a drug store, hospital, physician, etc. Thus, rather than a person buying several different splint sizes individually to find the a given splint that is snug but does not cut off blood supply (which could result in death of the finger and need for amputation), a packet of splints of multiple sizes may be purchased. The sizes may vary in width and height as defined by the spaced-apart arcuate bands extending in opposite directions. Length in the proximal-to-distal dimension might also vary among the splint sizes provided in the packet. Accordingly, a snug fit may be realized that provides comfort and/or stability during use of the finger while the splint is engaged thereon. In addition, recognizing that the finger might go through periods of increased or decreased swelling during healing while the splint is engaged with the finger (e.g., if a tendon is torn or a bone is fractured, the finger would be expected to progressively swell over a period of six days), different pads of different thicknesses may be included in the kit along with the different-sized splints. Thus, pads of a certain thickness may be used that result in stabilization of the splint, but still with the pads being deformable and resilient to accommodate increased or decreased swelling. This prevents the splint from becoming dangerously tight to a point of causing a tourniquet effect. Additionally, owing to the modular nature of the pads, if the swelling increase or decrease is so great that the splint becomes too loose or tight anyway, less-thick or more-thick pads may be exchanged for the ones currently on the splint. Thus, even if the splint was applied at a time of maximal swelling where subsequent decline in swelling would result in splint loosening and therefore loss of splint effectiveness at stabilizing the joint, the kit may still be used to apply different splints of different sizes and/or different pads of different thicknesses that again result of secure, snug fit of the respective splint to stabilize the joint. Accordingly, in one specific example, one or more slit tubular foam pads may be made available in varying thickness and included in a kit. The pads can be applied to the contact surfaces of the three-point finger splint. By way of example, the tubular foam pads may be offered in a packet having several pads of three different diameters. Per non-limiting examples below, a contact surface may be or include the portion of the three-point finger splint that laterally extends across the dorsal or palmar side of the finger. Thus, first a three-point finger splint may be selected so that the fit is slightly loose about the injured finger. Next, respective tubular foam pads may be positioned about one or more of the three contact points of the splint until a snug, comfortable fit is achieved. The foam pads may thus create a more comfortable contact surface to the finger, and the result may be a more-snug fit than can be achieved by use of a three-point finger splint alone. This custom fit may allow much greater stabilization of the affected area with greater comfort and relatively little to no compromise of safety. The foam pads can also be quickly replaced with a thinner or thicker pad as needed. The slit in each cushion/pad permits the cushion to be positioned about the contact surface and then rotated so the slit is away from the contact surface. For example, if there should be increased swelling of the injured finger, the existing pad can be replaced with a thinner pad; or the pad can be removed entirely. This ability to replace or remove the existing pad can prevent a painful and potentially dangerous overly-tight splint that could cause a tourniquet effect and potential loss of the finger. Conversely, if swelling of the injured finger should decrease, the existing pads can be exchanged for thicker pads, thus maintaining the snug fit and stabilization of the finger. Before the patient goes to sleep, when there is less conscious awareness of a potential tourniquet effect, the existing pads can be exchanged for thinner pads to decrease the risk of necrosis and need for amputation. Then the thicker pads can be exchanged back after waking from sleep. Present technology can also be used to treat contractures of the finger joints by adding successively thicker pads to the three pressure points of the contracted joint to maintain constant corrective force while the contracture improves. Additionally, often-injured fingers often do not conform to the size and shape of a non-injured finger. For example, if a person has a finger deformity from rheumatoid arthritis or osteoarthritis, there is often severe swelling of one joint and gross instability and displacement of the finger in multiple planes. This differential swelling and deformity might otherwise prevent a snug fit of a three-point splint, absent present principles. In addition, the same custom slit tubular pads can be spun laterally to one side or another, affecting a corrective force in the side-to-side plane, not just the flexion extension plane. Thus, while injured fingers can each be unique and each finger on each person has its own shape, deformity and instability, a splint and kit consistent with present principles allows the user to customize the device/brace to their specific finger. Still further, according to another embodiment, a custom fitting three-point splint can be used to allow reduction (correction of the alignment of the fractured bone) and immobilization of proximal phalanx fractures (and/or proximal phalanx volar plate avulsion fractures). So rather than treating proximal phalanx fractures with buddy-taping (taping the injured finger to the adjacent finger), which does not correct the alignment of the displaced fracture nor does it stabilize the finger in the correct position of 90 degrees flexion at the metacarpophalangeal (MCP) joint, a splint device consistent with present principles may be used. The fracture of the proximal phalanx may be a hyperextension injury from bending a finger back, such as attempting to catch a basketball. The reduction maneuver therefore involves the opposite motion, or flexion of the finger through the MCP. Buddy-taping does not flex the finger through the MCP joint, nor does it immobilized the finger with the MCP flexed. Accordingly, this embodiment of the custom finger splint may use a velcro wrist strap positioned about the wrist and having an extension for attachment to a ring positioned on the three-point finger splint, as described above. When an injured finger is positioned in the three-point finger splint, this will immobilize the injured finger flexed to a ninety-degree position across the metacarpal phalangeal (MCP) joint. The proximal end of the finger splint acts as a fulcrum, at the apex of the dorsally angulated fracture, such that flexion of the finger affects a reduction of the fracture as the fracture “bends over” the proximal end of the finger splint as the finger is flexed. The finger is then held in this flexed position by attaching the tether from the wrist band. Other iterations can involve passing the tether around the distal part of the splint without use of a ring, or use of a chain instead of a velcro strap. Notably, the finger splint can be constantly and rapidly adjusted as the fractured finger goes through phases of increased swelling and then resolution of swelling. Also, the degree of flexion can be modified to both adjust the alignment of the fracture and accommodate for increased or decreased swelling of the hand and finger. An example ideal position for immobilization is with the MCP flexed at ninety degrees, as this may provide better alignment of the fracture and prevent loss of motion of the MCP joint. The proximal end of the MCP joint has a cam shape, such that the side ligaments can become tight if the MCP joint is immobilized in extension, with permanent loss of ability to flex through the MCP joint. This embodiment immobilizes the finger in flexion through the MCP and allows rapid modification or complete release of the flexion. Temporary complete release of the flexion may be used for activities such as reaching into a pocket, typing on a computer, or washing one's hair. Thus, the entire brace need not be removed to allow such activities, and instead the flexion may simply be released while the splint itself remains fully engaged and supporting the injured joint. Now according to yet another example embodiment involving a double-splint device such as the one described above in reference toFIGS.15-23, a brace and non-surgical method are realized for reducing and stabilizing a metacarpal fracture of the ring finger or the little finger of a human hand (e.g., fracture of the metacarpal neck). Medical risks and costs associated with surgical treatment may be avoided. The risk of a permanent loss of MCP flexion resulting from immobilization of the metacarpal phalangeal (MCP) in full extension may also be avoided. The risk of finger necrosis and subsequent amputation from tubular or 2/3 tubular designs causing a tourniquet effect may be avoided. The risk of shear or “degloving” injury from tangential force on the surface of the skin from tubular or 2/3 tubular designs may be avoided. Minimal coverage of the skin of the fingers and no coverage at all of the skin of the hand may allow constant assessment for potential infection and prevent delay in detection of infection that can otherwise occur should the skin of the fingers and/or hand be covered. This may decrease the potential for chronic infections of the extensor tendons or MCP joints which can result in permanent loss of the extensor tendons and/or destruction of the MCP joint. The loss of extensor tendons and MCP joints causes severe loss of hand function. The fit of the staggered splint may be rapidly modifiable using interchangeable tubular foam pads to adjust for increased or decreased swelling, thus maintaining a snug fit without causing discomfort or placing the finger at risk of pressure or tourniquet necrosis. Additionally, in certain specific examples, no pad may be used for the splint on the finger of the fractured metacarpal, as the axial force combined with the flexion of the MCP reduces the fracture, and instead only pads may be used on the second splint for the healthy finger. The brace may reduce and stabilize the fractured metacarpal by maintaining the MCP joint of the fractured finger in a ninety-degree flexion while applying an axial force along the length of the finger, through the base of the proximal phalanx, onto the palmar aspect of the metacarpal head on the distal end of the fractured metacarpal. The application and maintenance of this axial force along the length of the finger “reduces” (corrects the alignment) of the fracture and maintains alignment until the fracture heals. The brace stabilizes the “reduced” fracture, preventing motions (rotational, flexion/extension, abduction/adduction) that can cause pain and result in non-union or malunion. Thus, rather than immobilizing all fingers and wrist in a cast or splint, immobilization can be limited to the fractured finger and the larger adjacent finger so that use of the wrist, thumb, index and either middle or small finger is not inhibited. In various non-limiting examples, a “larger adjacent finger” may be either the ring finger, if the metacarpal fracture is of the fifth metacarpal; or the middle finger, if the metacarpal fracture is of the fourth metacarpal. Additionally, this minimal immobilization of the ring and little finger MCP joints can be rapidly released with the wrist band/adjustable MCP flexion strap. This embodiment can therefore be used to reduce or correct the metacarpal fracture alignment without placing the finger at risk for tourniquet necrosis or degloving injury. It may also allow constant direct visualization of the entire hand and a majority of the injured finger to allow rapid detection and treatment of infection (indeed this goes for a single-splint embodiment consistent with present principles as well). It may also allow custom fit to the finger using interchangeable tubular pads, decreasing the number of “foundational” splints used for a snug fit and allowing immediate adaptation of the splint in the event of increase or decrease in swelling, thus decreasing risk of finger necrosis and need for amputation. This embodiment may also allow immediate adjustment or release of the MCP flexion to compensate for swelling of the hand or to allow common activities such as reaching into a pocket, typing on a computer, or washing hair. The brace may include a wrist band/adjustable MCP flexion strap component and a staggered finger splint component. The splint may thus include two arcuate bodies that each capture a different finger. The two arcuate bodies may be connected in a staggered configuration where two three-point finger splints may be used as possibly, maybe even preferably, fabricated as a single unit. Thus, a “staggered” healthy finger may be offset distally relative to the finger of the fractured metacarpal. It is this offset positioning with the two-splint implementation that provides the proximal axial compressive force along the length of the finger, through the base of the proximal phalanx and onto the palmar side of the metacarpal head of the metacarpal fragment distal to the fracture. The two-finger splint may thus capture and restrict the movement of each finger, immobilizing both fingers in full extension across the respective PIP joints. Two apertures may be present for each finger to slide through for proper positioning of the component. The palmar aspect of each arcuate band (of each three-point splint) may apply pressure to the palmar aspect of each finger, proximal and distal to the PIP joint. The dorsal aspect of each arcuate band may apply pressure on the dorsal aspect of each PIP joint. The staggered configuration of the finger splint may therefore create an axial force along the length of the finger of the fractured metacarpal in a direction toward the MCP joint. The fractured finger and larger adjacent finger, inside the staggered splint, may then be then flexed ninety degrees at the MCP joint, resulting in “reduction” and stabilization of the metacarpal fracture. The pathological severe fracture bow may be “reduced” to an anatomic pre-injury mild bow. This ninety-degree flexed position may be maintained by the use of the wrist cuff with an MCP flexion strap which is preferably adjustable in non-limiting examples. The strap is connected on one end to the palmar side of the wrist cuff and on the other end connected to the palmar side of the staggered finger splint. In one embodiment, the strap may be a small link chain that is connected to a ring which is positioned about the palmar aspect of an arcuate band of the staggered splint (e.g., as shown inFIG.23). This connection may result in secured flexion of the MCP joints. The velcro may allow for rapid release of the strap or modification of the length of the strap, thus allowing immediate adjustment of the degree of MCP flexion (as may be needed in patients with severe swelling, with initial minimal flexion and progressive flexion as swelling subsides) or temporary complete release of flexion (as may be required for multiple activities of daily living such as reaching into a pocket, typing on a computer, or washing one's hair). Other embodiments may involve use of clips or chains and hooking or connecting the chain at various points to the other respective brace components to achieve different degrees of MCP flexion. Other embodiments may involve the use of modular velcro pads that can be connected to the skin side of the wrist cuff to decrease irritability from the proximal edge related to traction force from the MCP flexion strap. The splints can be offered in several “off the shelf” sizes and the proper selected size may be slightly loose so that the cushioned tubular foam pads can be attached. The two-finger, staggered connection, arcuate splint is then slid over the finger of the fractured metacarpal and the adjacent larger finger. The tubular foam pads may be provided in a variety of varying diameters. Each foam pad may have a slit along its longitudinal access so that the foam pad can be positioned about a respective palmar aspect or dorsal aspect of each arcuate band so a tubular foam pad will be positioned about the six total contact points of the two staggered three-point splints, thereby creating a modular custom fit. The availability of tubular foam pads of varying diameter may thus decrease the number of sizes of splints otherwise manufactured or purchased for achieving a custom fit. Further, if the swelling across the person's finger changes, the foam pads can be changed as necessary. For example, if swelling dissipates, the tubular pads on the splint can be replaced with pads having a larger diameter. This well-padded snug fit may hold the fingers in full extension through the PIP joints while being snug enough to “capture” each finger such that the staggered relationship between the two arcuate components creates a significant longitudinal force along the length of the finger of the fractured metacarpal. This may be achieved without causing a tourniquet effect, without causing a shear/degloving stress to the skin, and/or without covering the skin of the finger or the hand so as to allow constant visualization of the skin for potential infection. If the finger should swell, thicker tubular pads can be exchanged for thinner tubular pads, or the splint can be exchanged for a larger splint, thus maintaining a snug fit with maximal comfort and safety. The normal anatomy of the metacarpal shaft is of an arch, apex dorsal. Due to this arch, when there is axial pressure on the distal end of the metacarpal without flexion of the MCP, the apex dorsal fracture deformity will increase. Thus, an objective of a physician may be to decrease this apex dorsal deformity and straighten or restore the mild apex dorsal arch of the metacarpal. This can be achieved through flexion of the MCP to ninety degrees so that the axial force from the finger is applied to the palmar side of the head of the metacarpal and not the distal end of the head of the metacarpal. The result may be an upward or dorsally directed force on the distal end of the fractured metacarpal, and “reduction” of the fracture. A counter-force may be created by the soft tissue connections between the metacarpal shafts. As the distal fragment of the fractured metacarpal is pushed dorsally, the soft tissues may hold the shaft in place causing a downward or palmar counter force that results in reduction of the fracture. It is for this reason that no direct pressure or downward force is needed on the back side of the hand. Thus, a dorsal pad or force over the fracture site (that might be unnecessary and potentially dangerous in that it could cause pressure sores over the thin skin on the back of the hand and obstruct direct visualization of the hand necessary for rapid recognition of infection) can be avoided. Accordingly, a reduction brace consistent with present principles can maintain the proper set position of the fractured metacarpal for correct restoration of the mild apex dorsal arch. With the component parts of the reduction brace described above, a method for reducing and immobilizing a metacarpal fracture of the ring or little finger of a human hand may be appreciated to include the steps of positioning a velcro cuff with attached MCP flexion strap around the wrist of the affected hand, with/without attachment of modular velcro pads on the palmar proximal edge of the cuff. The method may then include positioning a staggered two-finger splint component about the finger of the fractured metacarpal (e.g., ring or little) and the adjacent larger finger, where correct position may be for the dorsal components of the splint to be over the PIP joints of each finger. The method may then include assessing the two-finger splint for comfort and snugness of fit. If the splint is too loose, slit tubular foam pads can be applied to any or all of the six points of contact of the splint with the two fingers. Flexion of the metacarpophalangeal joints of the fractured metacarpal and adjacent non-fractured metacarpal to ninety degrees may be performed (e.g., if possible) and less flexion may be used if there is severe swelling. The method may then include passing the MCP flexion strap through the ring on the palmar side of the staggered splint, attaching the strap back to itself with a velcro surface. The strap can be progressively pulled through more, creating more MCP flexion, as swelling decreases, or released slightly, creating less MCP flexion if swelling increases. The finger splint size and tubular pad applications can be used to create a modular custom fit and adapt for increased or decreased swelling of the fingers, so as to maintain a snug fit without placing the fingers at risk for necrosis. Accordingly, one embodiment of the brace allows for application of an extra-large slit tubular foam pad to the proximal-most bar (of the finger of the fractured metacarpal) of the staggered finger splint so that direct pressure can be applied to the palmar aspect of the palmar surface of the distal fractured metacarpal, as opposed to only axial force from the base of the proximal phalanx onto the palmar aspect of the metacarpal head of the fractured metacarpal. Another embodiment of the brace may allow adjustment of the diameter or length of the finger splint components to allow fine tuning of the fit (e.g., by placing different components of each splint on tracks that can then lock the components into place with respect to each other). Another embodiment of the brace may permit separate finger splints to be removably connected to each other through a snap fit or other connection to allow ease of reduction or release of pressure. Yet another embodiment of the brace may allow changes to the relative position of each finger splint, for example, further or less staggering between the two finger splints, or a change in the angle between the two splints (e.g., using one or more tracks that couple the two splints). Therefore, according to various examples, a reduction brace may include a two-finger component, a wrist band, and an adjustable MCP flexion strap. The MCP flexion strap can take various forms. In one embodiment, the MCP flexion strap may be a chain connected to the wrist band and two-finger component. Thus, reduction of the most common metacarpal fracture, which is for the 5th metacarpal (commonly referred to as the little finger metacarpal) may be realized. The procedure may be the same if the fourth metacarpal or ring finger were fractured. The only difference might be that the size of the two-finger component may be larger to accommodate the ring finger and adjacent middle finger. Both sizes of the two-finger component may be included in a single kit, if desired. A velcro wrist band with attached adjustable MCP flexion strap may include a velcro wrist strap with areas on the skin side of the volar proximal edge for potential attachment of further padding, and a long strap, with a velcro surface, attached to the palmar side of the wrist band. The two-finger component may include a pair of arcuate annular bodies integrated with one another. A common wall may define a portion of the arcuate bodies, which may be in a staggered relationship to one another. The two-finger component may be created by an injection molded process or other process, and may be semi-rigid. Each arcuate body portion may have a pair of apertures for a respective finger to be slidably received and immobilized across the PIP joint of the fractured finger and larger adjacent finger. Finger contact areas may contact the palmar side of the finger of the fractured metacarpal proximally and distally to the PIP joint (e.g., as shown generally inFIG.19) and there may be a contact area that makes contact with the dorsal surface of the PIP joint on the finger of the fractured metacarpal as illustrated inFIG.20. Similarly, contact areas are on each side of the PIP joint on the palmar surface of the adjacent larger finger and contact area may be on the dorsal surface of the PIP joint. The configuration of each arcuate body can thus have a pair of elliptical apertures which can be seen inFIG.17. The assembled reduction brace illustrated inFIG.23may be assembled by first applying the wrist band with attached adjustable MCP flexion strap around the wrist of the injured hand. The wrist band may be applied with a dorsal velcro surface. A connector ring may be positioned around the two-finger component. The connector ring may be used to connect the MCP flexion strap to the wrist band. Care may be taken to have the band in such position that the adjustable MCP flexion strap may be on the palmar side of the wrist. The finger of the fractured metacarpal and the adjacent larger finger may then be slid into the arcuate bodies of the two-finger splint component to the desired position. Once the fingers are positioned within the two-finger component, because of the staggered position of the two fingers, an axial compressive force is applied and maintained along the length of the finger of the fractured metacarpal. However, when the fingers held in the two-finger component are flexed to a ninety-degree position across the MCP joint, the compressive force contact surface may be changed from the distal end of the metacarpal head to the palmar side of the metacarpal head, pushing the head of the fractured metacarpal dorsally, decreasing the apex dorsal deformity. The flexed position of ninety degrees may be maintained by attaching the adjustable MCP flexion strap to an eyelet on the palmar side of the two-finger splint. An additional force can be utilized to enhance reduction of the fractured metacarpal if optional tubular foam pads are incorporated. The force may be applied by engagement of both tubular foam pads when the fingers are flexed ninety degrees across the MCP joint. Therefore, a brace may be provided for reducing and immobilizing a metacarpal fracture of either the little finger or ring finger of a human hand and using the adjacent larger finger for reduction and stabilization. The brace may include a two-finger component including a pair of arcuate annular bodies, each sharing a common wall where the arcuate bodies are in a staggered relation to one another, each arcuate body having a pair of apertures sized to slidably receive a respective finger, immobilize the finger in full extension, where each annular body has separate finger contact areas for positioning: on opposing sides of a respective proximal interphalangeal joint for contact with the palmar surface, and upon the dorsal side of a respective proximal interphalangeal joint; and where the two-finger component maintains an axial compressive force to the finger of the injured metacarpal in a direction toward the metacarpophalangeal joint. Tubular foam pads can be provided for placement over the six contact points of the two-finger component, increasing comfort and reducing the variety of sizes of two-finger components that might be tried to achieve custom fit. The tubular foam pads may have a longitudinal slit for placement of each foam pad about the contact point. This may also permit the foam pads to be replaced if necessary if the swelling of the finger increases or decreases. The adjustable MCP flexion strap component may be passed through the eyelet component and attached to itself allowing for varying degrees of MCP flexion and rapid reversible release of MCP flexion without need for removal of the brace. An adjustable MCP flexion strap component with a long velcro surface may be used to allow varying amounts of the strap to be passed through the eyelet, allowing varying amounts of flexion of the MCP, rapid change in the degree of flexion of the MCP, and rapid reversible release of the MCP flexion for brief periods to allow activities of daily living (such as reaching into a pocket, typing on a computer, or washing one's hair) without need for removal of the brace. Accordingly, in one aspect a brace for reducing and immobilizing a metacarpal fracture of either the little finger or ring finger of a human hand and using the adjacent larger finger for reduction and stabilization may include a two-finger component. The two-finger component may include a pair of arcuate annular bodies sharing a common wall where the arcuate bodies are in a staggered relation to one another, each arcuate body having a pair of apertures sized to slidably receive a respective finger and immobilize the finger about its proximal interphalangeal joint, where each annular body has separate finger contact areas for positioning: a) on opposing sides of a respective proximal interphalangeal joint for contact with the palmar surface, and, b) upon the dorsal side of a respective proximal interphalangeal joint; and where the two-finger component maintains an axial longitudinal force along the finger of the fractured metacarpal in a direction toward the metacarpophalangeal joint. Also in one aspect, a brace for reducing and immobilizing a metacarpal fracture of either the little finger or ring finger of a human hand and using the adjacent larger finger for reduction and stabilization may include a wrist band component. The wrist band component may have an attached adjustable MCP flexion strap that includes a velcro wrist band with velcro connection on the dorsal aspect of the wrist band and a long velcro covered strap attached to the palmar side of the band. The wrist band can accept modular pads, attached by velcro to pad all areas, including the distal skin side edge of the wrist band, thus increasing comfort and decreasing risk of pressure sores in the area where the adjustable MCP flexion strap is applying traction. The brace may also include an eyelet component that may be incorporated in the palmar side of the two-finger component such that the adjustable MCP flexion strap can be passed through the eyelet and connected to its own velcro surface, holding the MCP in a flexed position. Further, in one aspect a finger and hand splint system may be realized, where the system may be provided as a kit. This kit may be designed to treat several common finger and hand injuries and conditions, including the potential improved alignment of the two most-common fractures of the hand (the fracture of the little finger metacarpal (Boxer's Fracture) and the fracture of the base of the finger). The same kit may also be used to treat deformities of the DIP and PIP joints related to trauma (e.g., fracture, ligament, or tendon injuries), or rheumatoid or osteo arthropathies. The same kit is able to treat flexion or extension contractures of the PIP and DIP joints and avulsion injuries of the extensor tendons (both distal insertion into the base of the distal phalanx and the central slip insertion into the base of the middle phalanx). The modular pads may allow a custom, safe and comfortable fit to the individual person's finger (as all fingers may be unique). The ability to rapidly interchange the pads may allow rapid accommodation of increased or decreased swelling, and/or can be used to apply progressive pressure when treating contractures. Additionally, the wrist cuff and tether may allow easy, rapid release or adjustment of the MCP flexion to achieve the best desired fracture reduction and accommodate to increased or decreased swelling. All conditions of the hand may be initially evaluated by a physician, with application of this splint system and explanation of the correct position of the splint being provided along with the risks and benefits associated with use of splints. Accordingly, some of the many hand conditions that can be treated with this system include the following. Mallet Finger—this may be a detachment of the extensor tendon from the base of the bone on the end of one's finger. The result is that the tip of the finger flexes down and cannot be extended. The physician can decide best treatment, surgery or splinting. If splinting is recommended, the finger may be placed into a splint device as described herein and pads may be applied to extend the finger through the far (DIP) joint. Boutonniere Injury—this may be a detachment of the extensor tendon from the base of the bone in the mid finger, such that the finger flexes at this joint and extends at the end joint. The physician can decide best treatment, surgery then splinting or just splinting. If splinting is recommended, the finger may be placed into a splint device as described herein and pads may be applied to extend the finger through the near (PIP joint). Fracture of the base of the finger—the finger bone closest to the hand, the proximal phalanx, can be treated with surgery and splinting or just splinting. If the physician recommends splinting, the finger may be placed in a splint device as described herein and pads may be applied for a snug but comfortable fit. A cuff may then be placed around the wrist and the tether from the cuff may be attached to the splint to hold the finger flexed and the knuckle (MCP joint). The amount of flexion can be modified to achieve best alignment of the fracture and most comfort during periods of swelling. Fractures of the near joint (PIP joint) of the finger—as with all conditions, the physician can recommend best treatment. If use of a splint is recommended, a splint device as described herein can be placed across the PIP joint. If the finger is displaced to one side or the other, a splint device as described herein can be spun to one side or the other and pads applied, to affect correction of the deformity. Fractures of the metacarpal neck (e.g., Boxer's Fracture)—If splinting is recommended, there may be two treatment options. As a first option, less-displaced fractures can be treated with a single finger splint as described above, which may be placed over the fractured finger, buddy taped to the adjacent finger, and attached to the wrist cuff tether. This may allow for X-rays to be taken in the splint to assess fracture alignment. As a second option, more severely-displaced fractures can be treated with the staggered two-splint system described above. A kit consistent with present principles may be provided with one or more two-splint components for right and left hands (e.g., with right hand or left hand being marked on the exterior surface of the splint if desired). The splint may be placed over the finger or the broken metacarpal and the adjacent larger finger. Pads may be applied to create a snug but comfortable fit, and the wrist cuff tether may then be attached to hold the knuckle (MCP) flexed. Additional padding can be placed on the palm end of the splint to increase the reduction force. Finger deformities related to osteoarthritis and rheumatoid arthritis—each person's finger deformity may be unique to them and can be stabilized and partially realigned with use of a finger splint system consistent with present principles. The splint may be placed over the deformed finger and the splint may be slid up the finger and spun to the side until the middle of the splint is at the apex of the deformity. Pads may then be applied to create gentle corrective pressure. Accordingly, in one specific example a finger splint kit consistent with present principles may include four base sizes of splints (single and/or double-splints) with attached connection ring(s). Also included may be three baggies of slit tubular foam pads, color-coded for diameter. For example, thin pads may be color-coded in yellow, medium (thicker) pads may be color-coded in red, and thick (thickest) pads may be color-coded in blue. The kit may also include a wrist cuff with attached tether. In addition, that kit or an accessory/companion metacarpal brace kit may include four base sizes of right hand and left hand staggered splints. Also included may be three baggies of slit tubular foam pads, color-coded for diameter (e.g., again with thin pads color-coded in yellow, medium (thicker) pads may be color-coded in red, and thick (thickest) pads may be color-coded in blue). A wrist cuff with attached tether may also be included. According to another example aspect, a three-point splint may be used consistent with present principles, where the splint involves a single arcuate body, created by injection molding, from a semi-rigid material. The splint can be applied over the PIP or DIP joints, treating both flexion and hyperextension deformities and instabilities. For example, the splint may be placed over the PIP joint with the center band dorsal for PIP flexion contractures and over the PIP joint with the central band volar for PIP hyperextension deformities. These splints can be used for fractures of the PIP joint. The splints can be purchased as a single size, or in a packet of multiple sizes. Present principles provide comfort and stability during use of the finger. In addition, if the finger should have increased or decreased swelling, the splint may be adjusted so as to not become dangerously tight or loose to a point of losing effectiveness at stabilizing the joint. Present principles also recognize that pathologic fingers often do not have a shape comparable to a healthy finger. For example, a person with an arthritic PIP joint may have severe swelling of the PIP joint but no swelling proximal or distal. Here, slit tubular foam pads of varying thickness can be applied to the contact surfaces of the three contact point finger splint. The consumer may buy a packet with three sizes, for example. Each splint may then be applied until a fit is found that is slightly loose. The slit foam pads may then be applied to any or all of the three contact points of the splint until there is a snug comfortable fit. The foam pads may create a more comfortable surface, and a more-snug fit. The foam pads may be interchanged quickly as desired. If there should be increased swelling, a thicker pad can be exchanged for a thinner pad, or the pad can be removed entirely, thus preventing a painful and potentially dangerous overly tight splint that could cause a tourniquet effect and potential loss of the finger. If swelling should decrease, the pads can be exchanged for thicker pads, thus maintaining the snug fit and stabilization of the finger. At night time, when there is less conscious awareness of a potential tourniquet effect, the thicker tubular pads can be exchanged for thinner pads to decrease the risk of necrosis and need for amputation. Present technology can also be used to treat contractures of the finger joints by adding successively thicker pads to the pressure point on the apex of the contracted joint. Yet another iteration of a finger splint and strap system consistent with present principles may be used for fractures of the base of the proximal phalanx. A common orthopedic injury is the fracture of the base of the proximal phalanx of the finger. The most common deformity is angulation of the fracture, apex volar (palmar) or bending of the finger dorsally or back. Thus, a device/brace consistent with present principles may use a splint as described herein and add a connection ring on the palmar aspect of the finger splint, and use a wrist band with adjustable flexion strap to hold the injured finger flexed through the MCP joint. This may not require immobilization of the non-injured fingers, or wrist, and thus causes fewer limitations to activities of daily living. The extension fracture deformity is corrected by flexing the finger through the MCP joint, over the proximal end of the three-point splint. This corrected or “reduced” fracture is then held in the appropriate ninety degree of flexion through the MCP joint with the wrist band and adjustable strap. The pads on the splint can be interchanged as the swelling of the fractured finger increases and decreases, and the flexion of the injured finger relative to the palm can be instantly modified or temporarily released and reconnected to allow response to increased swelling of the injured finger and hand and to allow brief activities of daily living such as reaching into a pocket, typing, or washing one's hair. The splint and strap also allow less bulk to enable better-quality X-rays with the splint still in place. Another iteration may involve two splints attached side to side (e.g., in a non-staggered fashion), thus affecting a buddy tape type immobilization, and to have a flexion strap connected to one of both of the finger splints. Thus, a device/system consistent with present principles may be versatile in that it can correct tendon injuries in both the distal and middle phalanx of the finger, a bone break in the proximal metacarpal of the finger, and a lateral deformity in a finger because of arthritis (e.g., by putting a single-splint device on sideways), without unduly limiting use of the entire hand. Methods of manufacturing, providing, instructing placement, and/or fitting onto a patient of the devices disclosed herein are also included. Also consistent with present principles, two different kits might be provided in some implementations. A “standard” kit may be used for finger fractures, where this kit may include four base three-point splints, three baggies of thin, medium and thick slit tubular pads, a velcro wrist strap, and a tether with connection ring (and/or the tether can simply be passed around the distal aspect of the splint). The second kit may be a metacarpal kit. It may have four base two-splint combinations, staggered, for the right hand. It may also have four base two-splint combinations, staggered, for the left hand. The second kit may also include three baggies of slit tubular pad, a velcro wrist strap, and a tether with connection ring. If desired, a “master” kit might also be provided (e.g., to emergency rooms) that would be a combination of both of these two kits. Now in reference toFIG.24, this figure shows a mallet finger injury mechanism/anatomy. As may be appreciated from this figure, there has been refraction of the fractured fragment (A2) of the extensor tendon2400, and fracture of attachment of the extensor tendon (A1). Arrow2410indicates a direction of the injury/mechanism jamming the finger. A flexed injured finger tip2420with inability to extend is also shown, with the tip2420forming part of a finger2430. FIG.25then shows a splint100consistent with present principles as disposed on the finger2430. This helps some with fracture reduction, however there may be a persistent gap between the finger2430and splint100at the fracture site. Put another way, use of the splint100alone may result in non-union of the fracture from the persistent gap due to retraction of the tendon and fragment of the bone. Accordingly,FIG.26demonstrates improvement overFIG.25in that pads600as described above have been placed on the bands110-130of the splint100, reducing or eliminating the persistent gap. Use a kit consistent with present principles may therefore allow hyperextension of the DIP (distal interphalangeal joint), thus bringing the site of the fracture to the retracted fragment, allowing it to heal. FIG.27demonstrates another example fracture that might occur to an index finger2700based on force from a palmer-to-dorsal direction2710as shown. Here, the fracture is a proximal phalanx hyperextension fracture. FIG.28then shows a splint100with a pads600on the palmar proximate band110of the splint100, with the distal band130being coupled to a ring900, which itself is coupled to a tether1000, itself coupled to a wrist band1100for wearing by the patient. Use of the pad600on the palmar proximate band110thus results in a reduced fracture2810, with the fracture2810levered via the metacarpophalangeal (MCP) joint2800over the pad600as held in place by the wrist strap1100and tether1000. Accordingly, application of a kit/device consistent with present principles may allow flexion of the fracture over the fulcrum of the pad600placed under the proximal end of the splint (e.g., band110). This helps correct the alignment of the fracture2810and immobilizes the fracture2810in the correct position for healing. FIGS.29Aand B show a mechanism of injury for a metacarpal neck fracture (e.g., Boxer's Fracture). FIGS.30A-Cthen show an intraoperative reduction maneuver involving flexion of the MCP (metacarpophalangeal) joint and upward pressure along the length of the finger onto the palmar side of the metacarpal head. These figures thus show the correction of the alignment as one progresses fromFIG.30A to30C. Turning toFIG.31, it shows use of staggered/connected finger splints1500/1600and a pad600on a dorsal transverse band (like the band120) of the splint1600consistent with present principles. Another pad600is also wrapped around a proximal end palmar band (like the band110) of the splint1500(engaged with the non-injured finger used for stabilization). The pads600and splints1500,1600thus help stabilize the fracture3100of the metacarpal neck due in part to the snug fit this arrangement establishes. A wrist strap1100is also shown as attached to a tether1000to hold the little and ring fingers flexed through the MCP joint. This reproduces the intraoperative reduction maneuver and maintains this reduced position while the fracture3100of the metacarpal neck heals. Thus, a reduction force is created that is equal to a surgical reduction maneuver to correct the alignment of a metacarpal neck fracture and stabilize the metacarpal neck fracture consistent with present principles. While particular techniques are herein shown and described in detail, it is to be understood that the subject matter which is encompassed by the present invention is limited only by the claims. Components included in one embodiment can be used in other embodiments in any appropriate combination. For example, any of the various components described herein and/or depicted in the Figures may be combined, interchanged or excluded from other embodiments. “A system having at least one of A, B, and C” (likewise “a system having at least one of A, B, or C” and “a system having at least one of A, B, C”) includes systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc. | 70,464 |
11857448 | All Figures disclosed herein are © Copyright 2018-2019 Arni Thor. All rights reserved. DETAILED DESCRIPTION Implementations of the present technology will now be described in detail with reference to the drawings, which are provided as illustrative examples so as to enable those skilled in the art to practice the technology. Notably, the figures and examples below are not meant to limit the scope of the present disclosure to any single implementation or implementations, but other implementations are possible by way of interchange of, substitution of, or combination with some or all of the described or illustrated elements. Wherever convenient, the same reference numbers will be used throughout the drawings to refer to same or like parts. Moreover, while embodiments described herein are primarily discussed in the context of an orthopedic device having a hinge positioned on the medial side of the device with the straps positioned on the lateral side of the knee brace, it would be readily apparent to one of ordinary skill that the orthopedic devices described herein are not so limited. Alternative arrangements would be readily understood by one of ordinary skill given the contents of the present disclosure that the orthopedic device may be configured to reduce or cure both medial and/or lateral knee joint infirmities. For example, the hinge may be positioned on the lateral side of the knee brace and the straps may be positioned on the medial side of the knee brace in some implementations. These and other arrangements would be readily understood given the contents of the present disclosure. Referring now toFIGS.1A-1Ivarious unloading style braces (orthopedic devices100) that may include a wraparound sleeve, a single upright frame (170,154,168,156,162,164) and a Y strap unloading feature102,118are shown and described in detail. Implementations of the orthopedic device100described herein provide for a knee brace of an unloading type which harmonizes the use of a dynamic force strap102with a sleeve-type brace in order to unload a knee that may have, for example, osteoarthritis while simultaneously resisting rotation caused by the tightening of the dynamic force strap102. As a brief aside, prior orthopedic devices (such as that described in U.S. Pat. No. 5,277,698, the contents of which were previously incorporated herein by reference in its entirety) tend to cause the orthopedic device to rotate about the leg when the strap on these devices was tightened. Contrast with the Y strap unloading feature102,118depicted which may be constructed from an elastic (or semi-elastic) material in some implementations unlike prior devices which utilize an inelastic strap. The Y strap unloading feature102,118provides for a distinct advantage over prior orthopedic devices. Additionally, the second strap118advantageously avoids the popliteal region of a wearer's anatomy (i.e., the hollow at the back of the knee) in some implementations. This makes the orthopedic device100more comfortable to wear as the placement of the second strap118avoids irritating this region of a wearer's anatomy. Additionally, the orthopedic devices100described herein may provide sufficient compression about the leg and knee while containing various features that enable adjustability so as to accommodate a wide variety of unique anatomies. In some implementations, the orthopedic device100is placed around the leg and knee via the wrapping of the orthopedic device100around the leg and knee. This has advantages over prior devices as these prior device were often of a fixed tubular shape and hence necessitated that the device be pulled up over the foot and placed over the leg and knee. However, it would be readily apparent to one of ordinary skill the orthopedic device100may be adapted to have a fixed tubular shape in some implementations. A single dynamic force strap may be effective to unload the knee in a soft dynamic way, however it may also tend to cause the brace to rotate around the leg. Implementations of the present disclosure utilize the Y strap configuration which uses a dynamic force strap102and a second strap118that connects to the dynamic force strap above the popliteal, opposite of the hinge, spirals around the leg to the thigh shell164on the opposite site of where the dynamic force strap connects to the thigh shell and therefore resists the rotation forces without creating bulk or discomfort in the popliteal region as is present in prior devices. Additionally, such a Y strap unloading feature may reduce the complexity of donning and doffing as compared with prior devices. In some implementations, the orthopedic device100may be provided for low to moderate active users with mild-to-moderate symptoms of unicompartmental osteoarthritis, although it is not limited to such uses. The closure system which consists of the two flaps104,106on the second panel108as well as the individual flaps110on the first strap112and individual flap114on the second strap116of the wrap around configured orthopedic device100may be provided to assist patients with poor hand strength or dexterity while still providing improved compression and suspension of the orthopedic device100as compared with prior devices. The orthopedic device100has a wrap-around design arranged for easily wrapping about a wearer's leg, and enables a simple donning procedure. Unloading of the wearer's knee by the orthopedic device is achieved by a dynamic force strap102which is simple to adjust and may provide a gentle force applied to the knee. Rotation and additional unloading is then controlled by a second force strap118that connects from around the center120of the dynamic force strap102, opposite of the frame assembly122and transfers up the leg to connect to the thigh frame124, opposite from the connection of the dynamic force strap. This second force strap118therefore creates an opposite force at the thigh to combat the rotation which occurs when the dynamic force strap102is tightened. In some implementations, the orthopedic device100may include a first panel126composed of opposed first128and second sides130, a second panel132having a first end134secured to the first side of the first panel along a seam136, and a second end138securable to the second side of the first panel at a location site140. The first panel126and the second panel132may be constructed from similar materials as the aforementioned straps102,118. A first strap112has a first end142secured to the first side of the first panel along the seam and lies underneath the second panel132, and a second end144securable to the second side of the first panel at the location site146at the thigh. A second strap116has a first end148secured to the first side of the first panel126along the seam136and lies underneath the second panel132, and a second end150securable to the second side of the first panel at the location site152which is disposed at the calf when worn by a user. A dynamic force strap102helically extends between upper and lower portions of the orthopedic device100and connects to the first panel126. The second force strap118connects to the center120of the dynamic force strap102at a location opposite of the hinge assembly154, travels up the leg, opposite of the dynamic force strap102and connects to the thigh frame156, opposite of the dynamic force strap connection. The hinge assembly154secures to the first panel126and extends between upper and lower portions of the orthopedic device. The dynamic force strap102has first158and second ends160securing to first162and second frames164of the hinge assembly that are spaced apart by first166and second struts168connected to one another by a hinge170. An orthopedic device100may include a hinge154attached to a thigh shell164and a calf shell162(see alsoFIGS.2A-2E). Such a frame may be attached to a sleeve that includes a first panel126defining opposed first128and second sides130. A second panel108has a first end148secured to the first side of the first panel along a seam128between the upper178and lower corners180of the seam, and a second end138defining at least one flap104securable to the second side of the first panel at a location site146. A first strap112has a first end142secured to the first side of the first panel below the second panel. A second strap116has a first end148secured to the first side of the first panel below the second panel and overlays at least a portion of the first strap. A dynamic Y force strap helically extends between the upper and lower portions of the orthopedic device and connects to the first panel. Such a strap splits into a second strap around knee center, above the popliteal, opposite of the hinge, which spirals in the opposite direction of the first end to attach on the opposite side of the first panel. Such an orthopedic device may contain a height adjustment mechanism so that the frame could be lengthened or shortened without tools in order to accommodate different leg lengths. FIGS.1A-1Cshow the Y strap configuration using a connection mechanism such as, for example, Velcro. The so called half strap118that creates the Y can be attached to the dynamic force strap102using Velcro or any other means of removable (or fixed) attachment that would be readily understood by one of ordinary skill given the contents of the present disclosure. In some implementations, the straps102,118are made from a class of materials that are soft to the touch and have good elasticity and bounce back in order to provide, inter alia, sufficient compression around the leg. Such elasticity provides additional comfort for the wearer of the orthopedic device as compared with prior devices that utilize a non-elastic strap. In some implementations, the materials chosen for the straps102,118enable good breathability. As a brief aside, breathability is the ability of a fabric to allow moisture vapor to be transmitted through the material. Note that while air permeable fabrics tend to have relatively high moisture vapor transmission, a breathable material doesn't necessarily require that the fabric be air permeable in some implementations. Exemplary materials include, for example, neoprene (preferably neoprene that has been ventilated for increased breathability), an Aerospacer base mesh fabric (which may be constructed from Nylon and spandex fibers), a laminate material constructed from nylon, spandex, polyester and/or lycra, or other materials that provide, for example, good elasticity and bounce back as well as breathability. A semi rigid (or rigid) plate164may be attached to the dynamic unloading strap102via a variety of means. For example, in some implementations this attachment may be accomplished with a keyhole (see e.g., keyhole210onFIG.2E). One end of the short strap118may also include a variety of means for attachment. For example, in some implementations this attachment may be realized via a button hook that is secured (e.g., sewn) so that it may “snap” onto the thigh plate182that is attached firmly to the dynamic unloading strap102. This allows the short strap118to pivot and align with the thigh to wrap around and attach to the thigh plate164. Both strap ends attach to the thigh plate164as can be seen onFIG.1C. Both straps may be adjusted using, for example, Velcro, Velcro through a D ring, BOA cable mechanism, ratchet, combinations of the foregoing or any other form of tightening/attaching mechanism. FIGS.1D and1Eshow how the Y strap can be controlled with a single tensioning mechanism125(e.g., a BOA mechanism). In this illustrated configuration, a single BOA dial or any other form of a tightening mechanism may be placed at the location where the strap separates into two straps. Cables may be embedded into the fabric of the sleeve or be visible and attached with guides on the outside of the sleeve. The offloading component may therefore, be controlled through tightening of, for example, a single dial and all strap ends may be fixed to the frame (e.g., two at the thigh shell and one on the calf shell). There may additionally, include an initial adjustment feature on both strap ends located on the thigh shell to ensure that the straps are adjusted enough to provide proper and even unloading when the tightening occurs. FIGS.1F-1Hillustrate how the sleeve may be constructed using a wraparound sleeve configuration that includes three to four attachments respectively.FIG.1Fshows a three-flap configuration with a single wide flap at the thigh and two tabs on the calf. Such a configuration may aid the user with donning of the device, especially on the calf by providing, for example, a secure elastic suspension strap112that is easy for the user to pull on. The number of steps required to don the brace may be fewer as compared to, for example, a four-flap design. FIG.1Fshows a flat view of the three-flap configuration with one wide thigh flap184that connects to the upper calf flap186and then a separate lower calf strap188which can either sit underneath or above the thigh/calf panel flaps. This lower calf strap could also be positioned as the upper calf strap (not shown) to provide very secure suspension and sit underneath the thigh/calf flap. In that configuration the thigh/calf flap would consist of the thigh flap and the lower calf flap. According to an embodiment, in an open, flat configuration, the first flap is located at least in part above the second end of the first strap, and the second flap is located at least in part below the second end of the second strap relative to the upper corner of the seam. In a closed, wrapped configuration, the first flap is still located above the second end of the first strap and borders the patella opening of the orthopedic device100. Tensioning of the first and second straps is arranged independently of tensioning of the second panel via the first and second flaps. The first strap is arranged to be secured to the second side of the first panel independently from the second strap such that the first and second straps are separated by a clearance at the seam. The straps engage the first panel prior to the second panel flaps in a closed wrap configuration. The second strap acts as a suspension strap right above and around the belly of the calf and is attached first. Second is the first strap that comes above the knee on the lower thigh section. Finally the second panel flaps are engaged, first the lower one at the bottom of the calf and then the upper flap at the top of the thigh. In the configuration illustrated inFIG.1G(an outer flat view), the user starts by applying two straps, one above the calf and one on the lower thigh. The patient applies a wide panel that includes the bottom calf attachment106and the top thigh attachment104. The two straps sit underneath the wide outer panel108. Prior to donning the brace, the user (or fitter) may use predetermined trim lines146shown in order to adjust the brace to the appropriate circumference size for both thigh and calf. Another possible circumference adjustment is through a wide alligator clip that can be added onto flap to lengthen brace circumference. The user (or fitter) may also alter the height of the brace by pushing buttons on thigh shell and calf shell that engage with arms on the hinge to lengthen or shorten the frame by pulling the shells away from the hinge center or pushing the shells towards the hinge center. The sleeve has sufficient vertical elasticity to accommodate the different frame lengths. FIG.1Hshows the inner flat view of the orthopedic device shown inFIG.1G. The first strap112preferably extends from the seam136and relative to the first panel126. The seam136defines a profile with at least one curved segment172, and the first strap112is located along the curved segment. A second strap116preferably extends above the lower portion of the seam and the first strap112extends below the upper portion of the seam. A lower edge174of the second strap116may overlap the upper edge of the first strap112. A clearance may be defined between the first and second straps at certain locations176and the clearance is greatest in height furthest away from the seam. The second strap116may have a longer length than a length of the first strap112. The second panel preferably defines at least one flap104located at the second end. The at least one flap may include fastener material for engaging corresponding fastener material located at a second side of the first panel. For example, the at least one flap may comprise first104and second flaps106spaced apart by a gap so that a patella opening is formed in combination with the second side of the first panel. An exemplary usage scenario for some implementations of the flaps (straps)104,114,110,106depicted inFIG.1His now described. The combination of straps112,116and panel132serves to contain the soft tissue around the knee of the wearer and to hold the orthopedic device100on the leg of the wearer. Flap104may connect to the top portion of the second panel132and therefore constitutes the top strap (i.e., the strap positioned on the thigh of the wearer). Flap114may connect to the second strap116from the top. Flap110may connect to the first strap112which is the second from the bottom and flap106may connect to the bottom portion of the second panel132and therefore constitutes the bottom strap. Straps112and116are separate straps and flaps104and106may be connected to the same panel which come over straps112and116. One exemplary benefit of this disclosed configuration is that for suspension. Namely, strap112may be the most important of the straps for suspension and is the first one that is applied first in order to make sure that the brace stays on the leg well. FIG.1Ishows two wraps, where one wrap190is applied to a thigh shell192and the other wrap is applied to a calf shell194. Both wraps include two straps196,198,197,199respectively to make sure that the donning is easy and effective in tension for the user. This provides a very secure suspension as well as comfortable compression above and below the joint. Another benefit of this system is that the brace frame (FIGS.2A-2E) could contain height adjustment for a short, regular and tall patient. The Y strap shown could also be a simple (single) dynamic force strap without the additional Y strap component. A similar Y strap configuration may also be applied to the lower section of the dynamic offloading strap, without the thigh strap component or in conjunction with the thigh component. When both straps were to be used with the offloading straps, rotational control applied to both thigh and calf can be accomplished. The two additional straps would both anchor to the offloading straps close to knee center however would not have to be anchored at the same location, hence no double crossing in the popliteal would occur. This would allow for optimal placement of such straps without them having to cross in the popliteal which is a common issue for a so called double dynamic force strap brace. The lower strap section would then go through, for example, a D ring on the calf shell for tightening or adjustment by the patient similar to how the dynamic offloading strap is adjusted. FIGS.2A-2Eillustrate an exemplary hinge assembly200for use with, for example, the orthopedic device illustrated inFIGS.1A-1I3A-3B and4A-4B. The hinge assembly200includes an upper thigh plate202, a lower calve plate206that are each coupled to a hinge204. Mechanisms located on, for example, the upper thigh plate202and the lower calve plate206may enable the distance between the two plates202,206to be lengthened or shortened, depending upon the geometry of a wearer of the OA sleeve (and hinge assembly200). In some implementations, the upper thigh plate202will include two anchor locations208(e.g., D-rings), while the lower calve plate206will include a single anchor location208. The upper thigh plate202anchor locations208may be utilized for the dynamic force strap102,302and strap118,318. The lower calve plate206anchor location208may be utilized for the dynamic force strap102,302as well.FIG.2Eillustrates an exemplary exploded view for the hinge assembly200illustrating how the hinge assembly200is constructed. FIGS.3A and3Billustrate yet another wraparound sleeve configuration that includes, for example, four attachments. In some implementations, this sleeve configuration may be colloquially referred to as a soft OA brace. In the configuration illustrated inFIG.3A(an outer flat view), the user may start by applying two straps, one above the calf and one on the lower thigh. The patient may apply a wide panel that includes the bottom calf attachment306and the top thigh attachment304. These two straps304,306sit underneath the wide outer panel308. Prior to donning the brace, the user (or fitter) may use predetermined trim lines346,352shown in order to adjust the brace to the appropriate circumference size for both thigh and calf. Another circumference adjustment may be made through, for example, the application of one or more wide alligator clips that can be added onto flap to, for example, lengthen brace circumference. As is illustrated inFIG.3A, the circumference of a user's lower extremities would be positioned in the horizontal direction with the sleeve300illustrated as shown inFIG.3A. The upper panel308may be secured to the lower panel327via one or more seams372,374. The lower panel327also includes a first portion329that extends away from the upper panel308and a second portion331that also extends away from the upper panel308. The first portion329and the second portion331being separated from one other by a gap defined by a separation feature333. In the illustrated embodiment, the separation feature333comprises a curved edge, although it is appreciated that this separation feature can extend in a straight line across the gap, or may even take on other angular geometries. The user (or fitter) may also alter the height of the brace (200,FIGS.2A-2E) by, for example, pushing buttons on thigh shell and calf shell that engage with arms on the hinge to lengthen or shorten the frame by pulling the shells away from the hinge center or pushing the shells towards the hinge center. The sleeve300may have sufficient vertical (horizontal direction as depicted inFIG.3A) elasticity to accommodate the different frame lengths for the brace (200,FIGS.2A-2E).FIG.3Aalso illustrates two pockets384,380that are configured to accommodate the upper thigh plate (202,FIG.2B) and lower calve plate (206,FIG.2B), respectively. One of the pockets384may include two slots386,388to accommodate the D-rings (208,FIG.2B) shown on the upper thigh plate (202,FIG.2B), while the other pocket380may include a slot382to accommodate the D-ring (208,FIG.2B) shown on the lower calve plate (206,FIG.2B). These pockets380,384may be configured to attach to the lower panel327via the user of a variety of the means including, without limitation, Velcro®, zippers, buttons, clasps, or literally any other attachment means. By enabling the pockets380,384to be removably opened (or closed), the hinge assembly (200,FIGS.2A-2E) can be, for example, selectively removable from the sleeve300, thereby enabling the ability for the sleeve to be cleaned (e.g., with a washing machine, hand wash, or similar). FIG.3Bshows the inner flat view of the orthopedic device300shown inFIG.3A. The first strap312preferably extends from a first seam328that is located on the first panel326. Notably, the seam328is located away from the seam line(s) between the upper332and lower326panels. The first strap312also is narrower in width as the panel312runs from the seam328toward the flap (strap)310. The first strap312also runs generally parallel with the centerline351of the orthopedic device300. One exemplary benefit of this disclosed configuration is for suspension. Namely, strap312may be the most important of the straps for suspension and may be, for example, the first one of the straps that is applied in order to make sure that the brace stays on the leg well during donning. The seam328may define a profile with at least one curved segment, and the first strap312is secured along the curved segment of the seam328. A second strap316extends above its own unique seam328, as compared with the seam associated with the first strap312. Again, notably the seam328for the second strap316is also located away from the seam line(s) between the upper332and lower326panels. The second strap316also is slightly narrower in width as the panel316runs from the seam328toward the flap (strap)314. The second strap316also runs generally towards the centerline351of the orthopedic device300from the seam328towards the flap (strap)314. The second strap316may have a longer length than a length of the first strap312. Lying behind these first312and second straps316, is a second panel332. The second panel332preferably defines at least one flap304located on one end378of the orthopedic device. The portion of the panel332associated with the flap304also generally runs toward the centerline of the orthopedic device300. On the opposing end379of the device300, a second flap306may also be included which runs generally away from the centerline351of the orthopedic device300. Collectively, flaps304,306are both attached to a common panel332(see also panel308,FIG.3A); however, it is appreciated that they may be separated from one another in some implementations. For example, the two flaps304,306may be spaced apart by a gap so that a patella opening is formed in combination with the second side of the first panel. However, by sharing a common panel, it may assist a user in donning the device300by making placement easier as compared with an implementation that includes separate flaps304,306. The flaps304,306,310,314may include fastener material for engaging corresponding fastener material (e.g., Velcro®) located on the opposing side of the first panel326. An exemplary usage scenario for some implementations of the flaps (straps)304,314,310,306depicted inFIGS.3A-3Bis now described. The combination of straps312,316and panel332serves to contain the soft tissue around the knee of the wearer and to hold the orthopedic device300on the leg of the wearer. Flap304may connect to the top portion of the second panel332and therefore constitutes the top strap (i.e., the strap positioned on the thigh of the wearer). Flap314may connect to the second strap316from the top. Flap310may connect to the first strap312which is the second from the bottom and flap306may connect to the bottom portion of the second panel332and therefore constitutes the bottom strap. Straps312and316are separate straps and flaps304and306are connected to a separate panel for straps312and316. FIGS.3C and3Dillustrate the dynamic force strap302for use with, for example, the hinge assembly (200,FIGS.2A-2E). In particular,FIG.3Cillustrates the other side of the dynamic force strap shown inFIG.3D. They dynamic force strap302is configured to helically extend between, for example, upper and lower portions of the orthopedic device300. The second force strap318connects to a middle portion of the dynamic force strap302via, for example, a buckle or slide320, travels up the leg, opposite of the dynamic force strap102and connects to, for example, the upper thigh plate (202,FIG.2B), opposite of the dynamic force strap end358. The dynamic force strap302has first358and second ends360for securing to the upper thigh plate (202,FIG.2B) and lower calve plate (206,FIG.2B) of the hinge assembly (200,FIGS.2A-2E). The buckle or slide320enables the dynamic force strap302to be adjusted easily to a given user's anatomy. In some implementation, the top portion of the fabric illustrated inFIG.3Cmay be a woven fabric, while the top portion of the fabric illustrated inFIG.3Dmay be a knitted loop fabric. As a brief aside, a knit fabric is typically made from a single yarn that is looped continuously in order to produce a braided look to the fabric, while a woven fabric is made of multiple yarns that cross each other at, for example, right angles so as to produce a different look and feel. In other implementations, the knitted loop and woven fabric may be switched, or even replaced with a unitary construction (e.g., either knitted loop or woven fabric) in some implementations. These and other variants would be readily apparent to one of ordinary skill given the contents of the present disclosure. Referring now toFIGS.4A-4B, yet another configuration for an orthopedic device (e.g., an OA brace) is shown and described in detail. Specifically,FIG.4Aillustrates a thigh wrap400for the orthopedic device, whileFIG.4Billustrates a calve wrap450for the orthopedic device. Prior to donning the wraps400,450, the user (or fitter) may use the predetermined trim lines402,452shown in order to adjust the brace to the appropriate circumference size for both thigh and calf. Another circumference adjustment may be made through, for example, the application of one or more wide alligator clips that can be added onto flap to, for example, lengthen brace circumference.FIGS.4A-4Balso illustrates two pockets404,454that are configured to accommodate the upper thigh plate (202,FIG.2B) and lower calve plate (206,FIG.2B), respectively. One of the pockets404may include two slots406to accommodate the b-rings (208,FIG.2B) shown on the upper thigh plate (202,FIG.2B), while the other pocket454may include a slot456to accommodate the D-ring (208,FIG.2B) shown on the lower calve plate (206,FIG.2B). These pockets404,454may be configured to attach to the panel of the wrap via the user of a variety of the means including, without limitation, Velcro®, zippers, buttons, clasps, or literally any other attachment means. By enabling the pockets404,454to be removably opened (or closed), the hinge assembly (200,FIGS.2A-2E) can be, for example, selectively removable from the wraps400,450, thereby enabling the ability for the wraps to be cleaned (e.g., with a washing machine, hand wash, or similar). Wrap400includes to straps408,410which are configured to be attached to the other end412of the wrap400, while wrap450also includes two straps458,460which are configured to be attached to the other end462of wrap450. Collectively, these wraps are intended to be placed around the upper and lower leg of a user separately in a fashion similar to that shown in the embodiment ofFIG.1I. Where certain elements of these implementations can be partially or fully implemented using known components, only those portions of such known components that are necessary for an understanding of the present disclosure are described, and detailed descriptions of other portions of such known components are omitted so as not to obscure the disclosure. In the present specification, an implementation showing a singular component should not be considered limiting; rather, the disclosure is intended to encompass other implementations including a plurality of the same component, and vice-versa, unless explicitly stated otherwise herein. Further, the present disclosure encompasses present and future known equivalents to the components referred to herein by way of illustration. It will be recognized that while certain aspects of the technology are described in terms of a specific sequence of steps of a method, these descriptions are only illustrative of the broader methods of the disclosure, and may be modified as required by the particular application. Certain steps may be rendered unnecessary or optional under certain circumstances. Additionally, certain steps or functionality may be added to the disclosed implementations, or the order of performance of two or more steps permuted. All such variations are considered to be encompassed within the disclosure disclosed and claimed herein. While the above detailed description has shown, described, and pointed out novel features of the disclosure as applied to various implementations, it will be understood that various omissions, substitutions, and changes in the form and details of the device or process illustrated may be made by those skilled in the art without departing from the disclosure. The foregoing description is of the best mode presently contemplated of carrying out the principles of the disclosure. This description is in no way meant to be limiting, but rather should be taken as illustrative of the general principles of the technology. The scope of the disclosure should be determined with reference to the claims. | 32,561 |
11857449 | It will be appreciated by one skilled in the art that although a knee brace is shown in the Figures, the concepts of the present invention apply to any compression brace no matter where positioned on a patient. DETAILED DESCRIPTION OF THE INVENTION As used throughout this specification, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than a mandatory sense (i.e., meaning must), as more than one embodiment of the invention may be disclosed herein. Similarly, the words “include”, “including”, and “includes” mean including but not limited to. The phrases “at least one”, “one or more”, and “and/or” may be open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “one or more of A, B, and C”, and “A, B, and/or C” herein means all of the following possible combinations: A alone; or B alone; or C alone; or A and B together; or A and C together; or B and C together; or A, B and C together. Also, the disclosures of all patents, published patent applications, and non-patent literature cited within this document are incorporated herein in their entirety by reference. However, it is noted that citing herein of any patents, published patent applications, and non-patent literature is not an admission as to any of those references constituting prior art with respect to the disclosed apparatus. Furthermore, the described features, advantages, and characteristics of any particular embodiment disclosed herein, may be combined in any suitable manner with any of the other embodiments disclosed herein. Additionally, any approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative or qualitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term such as “about” is not to be limited to the precise value specified, and may include values that differ from the specified value in accordance with applicable case law. Also, in at least some instances, a numerical difference provided by the approximating language may correspond to the precision of an instrument that may be used for measuring the value. A numerical difference provided by the approximating language may also correspond to a manufacturing tolerance associated with production of the aspect/feature being quantified. Furthermore, a numerical difference provided by the approximating language may also correspond to an overall tolerance for the aspect/feature that may be derived from variations resulting from a stack up (i.e., the sum) of a multiplicity of such individual tolerances. Any use of a friction fit (i.e., an interface fit) between two mating parts described herein indicates that the opening (e.g., a hole) is smaller than the part received therein (e.g., a shaft), which may be a slight interference in one embodiment in the range of 0.0001 inches to 0.0003 inches, or an interference of 0.0003 inches to 0.0007 inches in another embodiment, or an interference of 0.0007 inches to 0.0010 inches in yet another embodiment, or a combination of such ranges. Other values for the interference may also be used in different configurations (see e.g., “Press Fit Engineering and Design Calculator,” available at: www.engineersedge.com/calculators/machine-design/press-fit/press-fit-calculator.htm). Any described use of a clearance fit indicates that the opening (e.g., a hole) is larger than the part received therein (e.g., a shaft), enabling the two parts to move (e.g. to slide and/or rotate) when assembled, where the gap between the opening and the part may depend upon the size of the part and the type of clearance fit (e.g., for a 0.1250 inch shaft diameter the opening may be 0.1285 inches for a close fit and may be 0.1360 inches for a free (running) fit; and for a 0.5000 inch diameter shaft size the opening may be 0.5156 inches for a close clearance fit and may be 0.5312 inches for a free clearance fit). Other clearance amounts may also be used. In accordance with at least one embodiment, a brace100as shown inFIG.1may broadly include a sleeve110formed of an elastic material, and may include one or more stiffening members that may be in the form of a spring. The elastic material used for the sleeve110may include, but is not limited to, lycra, rubber, latex, etc. The elastic material may comprise substantially an entire layer of the article, seeFIG.7, or it may comprise one or more regions of elasticity in the layer along with areas of a different elasticity, seeFIG.9. In a still further embodiment, there may be one or more strips of high compression material and regions of low compression material in the article, seeFIG.8. Preferably, in one embodiment, the strips of compression material do not have a free end. The strips of compression material may also be fan shaped wherein there is one end and each of the strips extend outwardly from that common end point. The free ends of the compression strips should be attached to another free end of a compression strip and not a material with less compression. This will help prevent the higher compression material from pulling the lower compression material and possibly ripping or tearing it. As seen inFIG.8the compressive strip201is comprised of a plurality of strips secured generally end to end to form a continuous strip that preferably has no free end. In a preferred embodiment the compression sleeve may have a plurality of layers. One layer, preferably the outer layer, may be made of a compression material. It will be appreciated that the compression layer may have a layer over it so it is not the outer surface. This may be a decorative material. This compression material may have areas of one amount of compression, as well as one or more areas of higher compressive forces. SeeFIG.8where the high compression material201has a greater compressive force than the remaining area202. By compression it meant a material that has a resting configuration that can be expanded through the use of a force to a larger size, and wherein the elastic material tries to return to its original configuration when the force is released. The compression material can be used in a variety of ways, including but not limited to, limiting the movability of a limb in one or more directions, provide support for weakened parts of the body or force areas of the body into a desired position, etc. The compression article may have one or more additional layers accompanying the compressive layer. These layers can be a body contact layer which may be made of any suitable material that aids in the user's comfort, for example. Other materials may be used to provide a wicking capability to draw moisture away from the skin or a material that has a coefficient of friction such that when it contacts the skin, the material renders it easy to position the limb or portion of the body. The inner layer may be made from any material depending on what properties are desired by the user or a medical practitioner. In a preferred embodiment there may also be a mesh material comprised of a TPE (Thermoplastic elastomer) or TPU (Thermoplastic polyurethane) as a layer. The mesh material due to its porosity provides a path for the heat or cold to reach the body contact layer and the body, as well. The TPE or TPU material can be the compression material or a separate layer. When TPE or TPU is present, it is preferably a separate layer and it is preferably in the form of a mesh layer. The mesh layer can be positioned between the compression layer and the body contact layer. As seen inFIG.12there can be a mesh material203that adds compressibility to selected areas of the compression layer by being positioned over the compression layer. The brace100may also include padding in key locations that may be made of any suitable material including, but not limited to, silicone or other cushioning material, which may be added therein using a suitable process such as a high frequency pressing process. The spring can be any resilient material that one or more portions thereof can be bent or deflated from its original position and wherein it returns to its original configuration. The elastic sleeve110may be formed to fit over the knee area of the wearer's leg, and may thus be generally hourglass shaped, having a narrow central region that may gradually widen toward each of the ends—i.e., towards the first end111and the second end112of the sleeve. Other shapes are used for other body locations as necessary. The elastic sleeve110may be formed to include a first stiffening member113and a second stiffening member114, each of which may be an elongated flat member (i.e., a leaf spring) that may be secured to the sleeve. In one embodiment the first stiffening member113and second stiffening member114may each be adhesive bonded to a side of the elastic sleeve110. In other embodiments the first stiffening member113and second stiffening member114may each secured to the side of the elastic sleeve110by being sewn to the side of the sleeve, by being sewn between an outer layer and an inner layer, or by having a cover material positioned over the stiffening member and being stitched to the side of the elastic sleeve. As seen inFIG.1, the first stiffening member113and second stiffening member114may be oriented to crisscross and form an X-shape. The first stiffening member113may be pivotally coupled to the second stiffening member114where the members cross, and in one embodiment may generally pivot with respect to each other according to movements of the wearer's upper leg portion (the lower thigh) and lower leg portion (the upper calf) at the knee joint. In another embodiment the first stiffening member113may be fixedly secured to the second stiffening member114to provide a reaction to assist the wearer who has bent down in standing back up, and assist in lifting themselves upward, and thus may store energy. The elastic sleeve110may be formed to include at least one pocket that may be sized and shaped to receive a correspondingly sized/shaped hot and/or cold pack therein, to apply heat and/or cooling therapy to the injured knee region. Such hot/cold packs are known in the art, as shown for example by the following U.S. Pat. No. 2,907,173 to Robbins; U.S. Pat. No. 3,175,558 to Caillouette; U.S. Pat. No. 3,342,324 to Piazze; U.S. Pat. No. 3,542,032 to Spencer; U.S. Pat. No. 3,804,077 to Williams; U.S. Pat. No. 4,462,224 to Dunshee; and U.S. Pat. No. 5,792,213 to Bowen. In addition, the following U.S. Patents disclose hot/cold packs that may be used herein, and which are configured for reuse, as they may be heated in a microwave or cooled by being placed in a refrigerator/freezer: U.S. Pat. No. 3,889,684 to Lebold; U.S. Pat. No. 4,462,224 to Dunshee; U.S. Pat. No. 4,700,706 to Munch; U.S. Pat. No. 5,190,033 to Johnson; and U.S. Pat. No. 5,843,145 to Brink. The pack does not have to be heated or cooled but can be room temperature. At this temperature the pack insertion increases the amount of compression or the area of the body where the pocket is. In a preferred embodiment the brace may have a slit in the outer surface of the compression material. This slit is the opening to a pocket formed in the sleeve for receiving the hot/cold pack. The pocket is preferably shaped to receive a correspondingly shaped heat or cold pack. The pocket and the heat or ice pack are preferably of similar shape. The heat or ice pack preferably has an angular end like a pointed tip that makes it easier to insert the pack into the pocket or pouch. A preferred shape is one with a pointed end that renders it easy to insert with a single hand.FIGS.9and10show examples of braces where different shaped pockets are present. These pockets would receive one or more correspondingly shaped packs. InFIG.9a circular area is shown for applying heat or cold. There could be a corresponding slit on the opposite side of the brace to receive an arcuate heat or cold pack corresponding to the region204shown inFIG.9.FIG.10shows another example of a compression brace where there is a pocket and a slit. The pocket may be a separate member in the structure. The pocket can also be an area in the article where thread or adhesive is applied to the article to form a pocket in the article. SeeFIG.10where the pocket205is formed by thread by sewing the outer compression layer to an adjacent layer. For example, a portion of the compression layer can be secured to a portion of the adjacent layer to form a pocket. The slit is preferably positioned in the compression material layer to avoid any section with high compression material in the brace. The area around the brace preferably has an area of reinforcement around the opening formed by the slit. SeeFIG.6. This reinforcement206can be a fabric or other suitable material that surrounds the slit opening. There may also be a flap or a button to close the flap to prevent the heat or cold pack from being removed unless desired. The slits reinforcement should prevent the fabric from around the slit from stretching so that the compression does not weaken over use. This is particularly advantageous when the stretching of the compression fabric is generally transverse to the length of the slit, i.e. the direction away from the long length of the slit. The slit is preferably positioned just above the area of the higher compression so that the pack can be placed under the higher compression material or under the compression material without ruining the compression. The ends of the slit preferably have a rivet or button over the end to prevent the slit from becoming longer and thereby tearing the compression fiber. The grommet, button or rivet, etc. may be made of any suitable material. The pouch portion extending from the slit preferably contacts the skin or body contact layer of the brace. In another embodiment the pouch has two layers. The outer layer is the compression material where the inner surface comprises one wall of the pouch. The other side of the pouch is the inside of the body contact layer in a two-layer structure. Alternatively, in a three-layer structure with a mesh outer compression layer, the compression layer and surface of the mesh layer are secured to form a pocket or pouch. The heat and cold can pass through the openings in the mesh toward the user. The body contact layer may be a fabric or other material that protects the body from damage due to the cold or heat. Many of the braces because of the body shape have a top end and bottom end. The ends will have a generally horizontal portion as a bottom or top surface, seeFIGS.9and12. Alternatively, the braces may have a length extending from the top edge to the bottom edge, seeFIG.9. The slit is preferably at an angle to one of the top or bottom edges of the brace as well as at an angle to an imaginary line extending perpendicular to at least one of the top or bottom edges of the brace, seeFIG.9. More specifically, the slit is positioned so that it is preferably not parallel to one of the top or bottom edges of the brace and not parallel or perpendicular to the imaginary line extending the length of the brace. The hot/cold pack utilized herein may also be formed to have a tab protruding from the end disposed nearest the opening into the pocket to assist in removal of the pack from the pocket due to the compression force trapping it therein as a result of the elasticity of the material used for the sleeve and pocket liner. The tab may also provide a convenient place to grasp the hot/cold pack after it has been heated in a microwave or cooled in a refrigerator/freezer. The hot/cold pack will be configured to stay at the designed temperature when applied to the wearer of the device for at least 12-15 minutes for cooling and for 15-20 minutes for application of heat, but which time may vary depending upon certain factors, such as the outside temperature, and the person's body temperature. The hot/cold packs may be stored in thermal isolation bags, which may also permit removal and subsequent usage in the pockets for use in intermittent hot/cold treatments for the wearer. The pocket(s) may be formed by creating an opening in the side of the elastic sleeve110and by securing (e.g., by stitching, gluing, or ultrasonic high frequency welding) a liner to the interior of the sleeve. The liner material for the pocket may also be an elastic material, so that the pocket (and thus the hot and/or cold pack received therein) may be pressed up against the body of the wearer by the sleeve. The presence of the hot and/or cold pack therein may also serve to increase tension to the surrounding area and force more of the hot/cold pack into contact with the body of the wearer, to provide greater surface area of contact, and thereby aid in spreading the effect of the hot/cold treatment. The opening in the side of the elastic sleeve110may be reinforced in any suitable manner. In one embodiment the sides of the opening in the elastic sleeve110may be reinforced by stitching. In another embodiment the sides of the opening in the elastic sleeve110may be reinforced by a grommet120that may be secured to the outside of the sleeve in any suitable manner. In yet another embodiment, one grommet120may be placed against the outside of the sleeve and one grommet120may be placed against the inside of the sleeve, over the opening, and the two grommets may be secured to each other (e.g., by adhesive bonding, stitching, using rivets, etc.), and thus be secured to the sleeve. The grommet120may be made of any suitable, material including, but not limited to, a metal, a thermoplastic rubber, a thermoplastic polyurethane, etc. The use of a grommet120on the outside, and/or the use of grommets on both the outside and inside may each serve to prevent the opening formed in the elastic sleeve material from expanding locally. A rivet121may be used at the ends of the slit, as shown inFIG.6. This arrangement permits placement of a hot/cold pack into the pocket from outside of the brace, and therefore conveniently permits its removal and replacement with another hot/cold pack at any time by the wearer. The elasticity of the pocket liner and of the sleeve may serve to keep the hot and/or cold pack from falling out. Alternatively or additionally, the elastic sleeve110may further include a closure apparatus to secure the opening into the pocket to positively retain the hot and/or cold pack therein. Such closure apparatus may be any suitable closure known in the art, including, but not limited to: buttons, snaps, hook and loop fastening materials (e.g., materials sold under the trade name “Velcro”), zippers, etc. The pockets and hot/cold packs may have any desired shape. Preferably, the pockets and corresponding packs have a shape formed to correspond to the desired area of the body for which the brace is designed, and may also be shaped/sized to accommodate use of the springs. For example, as shown inFIG.1, the elastic sleeve110may be formed to have a triangular shaped pocket that may extend into proximity to the X-shape of the first stiffening member113and second stiffening member114to form a generally triangular-shaped pocket. Also, the elastic sleeve110may be formed to have, for example, four such pockets-pockets116,117,118, and119(seeFIG.4), two of which pockets may be on the left side of the brace and two of which may be on the right side of the brace (i.e., to be positioned on the left side and the right side of the leg). The hot/cold packs may also be triangular-shaped, and as seen inFIG.3, a triangular-shaped hot/cold pack150A may be received within the pocket116, while a triangular-shaped hot/cold pack150B may be received within the pocket117. FIG.1shows the knee brace100after the triangular-shaped hot/cold pack150A has been received within the pocket116, and after the triangular-shaped hot/cold pack150B has been received within the pocket117. FIG.2shows the knee brace100after triangular-shaped hot/cold packs150A,150B,150C and150D have been respectively received within the pocket116,117,118, and119, and with the pocket cutaway to expose the packs. As noted above, in other embodiments the pockets may be formed in an elastic sleeve of a brace for other parts of the body (e.g., an ankle brace with horse shoe shaped hot/cold packs, a lower leg brace, knee brace, leg strap, full leg, % leg, hip, underwear, foot, back, waist, stomach, fingers, hand, wrist, forearm, elbow, full arm, shoulder, neck, top of head, short sleeve shirt, full sleeve shirt, shorts, full legged pants, etc.). Also, these braces may not require use of either the first stiffening member113or the second stiffening member114(or any stiffening member at all). The hot/cold packs that may be received in the pockets of any of those devices may provide for therapeutic effects (e.g., alleviating soreness and/or pain, reducing the effects of an existing injury, preventing a new injury, etc.). These inserts have been shown to reduce the effects of an injury by 50% to 90%, depending upon the location of use and the consistency of use. The pockets and stored hot/cold packs may be positioned to target muscle areas, tendons, and ligaments particularly where they attach to bone, and at other areas that are highly susceptible to injury. The shapes and size of the pocket or pockets may be specifically designed for the purpose of each of the above devices, which may receive correspondingly shaped hot/cold packs. While illustrative implementations of one or more embodiments of the disclosed apparatus are provided hereinabove, those skilled in the art and having the benefit of the present disclosure will appreciate that further embodiments may be implemented with various changes within the scope of the disclosed apparatus. Other modifications, substitutions, omissions and changes may be made in the design, size, materials used or proportions, operating conditions, assembly sequence, or arrangement or positioning of elements and members of the exemplary embodiments without departing from the spirit of this invention. Accordingly, the breadth and scope of the present disclosure should not be limited by any of the above-described example embodiments, but should be defined only in accordance with the following claims and their equivalents. | 22,524 |
11857450 | DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS A better understanding of the disclosure's different embodiments may be had from the following description read with the drawings in which like reference characters refer to like elements. While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are shown in the drawings and are described below. It should be understood, however, there is no intention to limit the disclosure to the specific embodiments disclosed, but on the contrary, the aim is to cover all modifications, alternative constructions, combinations, and equivalents falling within the spirit and scope of the disclosure. Numerical qualifiers (i.e., first, second, etc.) are used in the following discussion merely for explanatory purposes. They are not intended to limit their location or the number of segments or components of the embodiments. In these embodiments, the strap attachment is intended to be used in place of a standard D-ring conventionally used in orthopedic devices. A standard D-ring serves as a point of attachment from the strap to the frame of the orthopedic device to hold the brace to the user. It allows for adjustment of strap tension by pulling the strap through an opening formed by the D-ring. According to the embodiments, as shown inFIGS.3C and3D, the strap attachments can articulate to allow for strap articulation to accommodate for different anatomy. As seen inFIG.1, articulation of the strap attachment allows for the strap to contour to the user's thigh by angling downward. As illustrated inFIG.3A, the strap attachment can be articulated outward from the patient to allow for the user to easily slip the strap through the slot while minimizing the distance D the strap attachment extends from an edge18of the frame of the orthopedic device. This arrangement can be difficult on traditional D-rings as the plastic forming such D-rings can be stiff. FIG.2shows an embodiment of a strap attachment, and accommodations provided by a frame12of the orthopedic device. The strap attachment10includes a retainer or body24suspended from the frame12by a cable20. The cable20extends through retainer24with first and second segments20a,20bof the cable20extending from the retainer24to secure to the frame12. The retainer24is preferably arranged a variable distance D from an edge18of the frame, permitting adjustability, such as angular and distance, relative to the frame12, as discussed withFIGS.1,3A,3C, and3D. A connector48may securable to an end portion of each of the first and second segments20a,20b. The connector48may be arranged to engage the frame12to limit the extension of the segments20a,20bfrom the frame12.FIG.2depicts each end portion of the first and second segments20a,20b, including a connector48a,48b. In contrast,FIG.4Adiscloses a single connector60securing both ends of the first and second segments20a,20b, as in U.S. Patent Application Publication 2019/0374671. In either of the embodiments ofFIGS.2and4A, the first and second segments20a,20bmay move within a cavity36,37defined by a frame body32,33, to extend their distances individually X, Y from the frame edge18. In the embodiments, the connectors may permanently crimp ends of the cable or may be removable for further adjustment. The cavities shown may be accessible from inside the frame so the travel and length of the cable can be adjustable and field serviceable. The retainer24defines an inner surface26arranged proximate to an edge of a frame12. The inner surface26is adapted for wrapping a strap16thereabout. The retainer24also defines an outer surface28opposite the inner surface26. The outer surface preferably has rounded edges29a,29bleading to the inner surface26. The rounded edges29a,29bavoid the retainer24from catching on objects. In the illustrative example ofFIG.3A, a first segment17aof a strap16is adapted to wrap about the inner surface26, and a second segment17bextends past the first segment17ato secure to the first segment17apast the outer surface28. The strap16is biased about the inner surface26, with the rounded edges29a,29bextending outside of the strap16. The outer surface28may be arcuate to minimize sharp edges and facilitate application of the strap16on the retainer. The retainer24is preferably formed from plastic to reduce weight but is load bearing and preferably rigid to not yield when a strap is tensioned thereabout or therefrom. The retainer24is generally thicker and broader than a structural feature about which a conventional D-ring provides for wrapping a strap thereabout, particularly when the retainer24is considered combined with the cable20extending therethrough. The retainer24provides rigidity so a strap can be biased thereabout, whereas a cable would collapse. The retainer advantageously provides sufficient strength to anchor the strap on the user without jutting outwardly by an inconvenient amount. This minimizes the profile of the orthopedic device. According to variations, the retainer need not be molded, but can be provided as described in U.S. Patent Application Publication 2019/0374671. For example, the retainer may be formed as a metal tube, machined metal, or plastic part, or any other means of creating a flat surface for the strap to wrap around. While shown inFIG.2having two open ends, the cable20can alternatively be a continuous loop. The cable20may be formed from an elongate element such as a wire or a braided cable and may be formed from metal or polymeric material such as nylon. The cable may be replaced with a tubular member having a continuous structure formed or shaped as a loop to accommodate a tube or be provided with or without such a tube. As shown inFIG.2, the retainer24defines an internal channel30arranged for the cable20to extend therethrough. The internal channel30defines at least one section30a,30barranged to redirect the cable20from a first direction X, Y entering the retainer24to a different direction Z generally parallel with the inner surface26. In this manner, the cable20can extend continuously through the retainer24. The retainer24defines first and second apertures34a,34bthrough which the cable20extends into the internal channel30. In a variation of the embodiments, the cable can comprise two discrete segments that are not continuous with one another but individually attach at portions of the retainer; for example, each extending through a respective first and second aperture. Each cable segment has first and second terminal ends, with the first end secured to the frame and the second end secured to the retainer. From this variation, over two cable segments may secure the retainer to the frame. FIG.2shows the first and second segments20a,20bextending at their maximum, so the connectors48a,48bare both biased against portions of the frame within the cavity36. In this configuration, the distance D of the inner surface26of the retainer24is generally uniform relative to the frame edge18and is, therefore, parallel therewith. Such a configuration may be arranged as a default when a strap is uniformly pulled or tensioned from the frame. The distance or direction X, Y of the first and second segments20a,20bmay likewise be parallel and uniform. Generally, however, the internal channel30of the retainer24may be arranged so the cable20circulates through the internal channel30at about 180 degrees from entering a first aperture34aand exiting a second aperture34b. As shown inFIGS.3C and3D, the first and second segments20a,20bmay be extended at an acute angle A1or an oblique angle A2relative to the frame edge18, from a neutral position, as inFIG.3Awhen the inner surface26of the retainer24is arranged parallel to the frame edge18and spaced the distance D therefrom. FIG.3Bshows an embodiment of a strap16including a stopper90. The strap16may be adapted to extend through a slot (not shown) defined by the frame12. The slot (not shown) may be sized sufficiently large to permit passage of the strap16therethrough, and the stopper90may be sized larger than the slot (not shown) to prevent passage therethrough. The frame12may be arranged with at least one or first and second openings22a,22bthrough which the first and second segments20a,20bof the cable20extend. As shown inFIG.3A, the at least one opening22a,22bmay be configured with a taper and arranged for angular displacement of the first and second segment20a,20brelative to the edge18of the frame12. In a variation, the at least one opening22a,22bcan be oriented in any suitable direction. For example, the at least one opening22a,22bcan be formed to allow for the cable to exit the frame from the frame edge perpendicularly, or at diverging or converging orientations. The openings need not be the width of the cable, and may be flared toward the frame edge, as generally depicted inFIG.3A. Alternatively, the cable may extend from a single opening, such as one that flares toward the edge and separates the cable into diverging directions. Changing the position and directions of openings can changes how much articulation and strap clearance are allowed. In another variation, a diverter may be installed in the opening to regulate variability so it slidably secures on the cable to fit within the opening to fix a length of the cable that extends from the frame and/or reduce the angular adjustability of the cable relative to the frame edge. The opening can be arranged so that only a single cable segment extends from the frame to the retainer. In a variation, the frame may include means, such as a recess or channel into which ends of the cable may secure. For example, the frame may be devoid of the aforementioned cavity, but have attachment means located, such as recesses, along the edge of the frame for securing the cable generally externally along the frame. In another variation, ends of the cable may be secured by fasteners to the frame, either individually or by a central fastener. In these ways, it is unnecessary to form the frame with cavities. A connector also, as in U.S. Patent Application Publication 2013/0331751, published Dec. 12, 2013, can be used to which the cable is secured to the frame in a field serviceable manner with a strap tab and fastener. FIG.2shows the frame12with a body32defining a cavity36arranged for receiving the first and second connectors48a,48b. The body32forms at least one or first and second guide segments38a,38babout which the cable20extends. The first and second connectors48a,48bare adapted to bias against the at least one guide segment38a,38bto prevent the cable from coming loose from the frame and detaching the retainer. The frame body32and the at least one guide segment38a,38bform channels40a,40bsized to permit extension of the cable20and prevent extension or escape of the first and second connectors48a,48btherefrom. The cavity36may be arranged uniformly with the first and second guide segments38a,38barranged similarly, or each of the first and second guide segments38a,38bmay be arranged at angles and dimensions different from one another, forming differently sized channels relative to one another. A detent42may be provided and protrude from the frame body32toward the at least one guide segment38a,38bto define a first narrowed channel44more narrow than the channels40a,40b. The at least one guide segment38a,38bmay be cantilevered from the frame body32into the cavity36to form a second narrowed channel46more narrow than the at least one channel40a,40b. Various configurations may channel or guide the first and second segments20a,20bor the cable20generally within the frame, and narrowed sections may be provided to crimp or control movement of the cable20. FIG.4Aillustrates a variation of a cavity37of a frame body33having a generally uniform configuration, and adapted for the single connector60connecting first and second ends of the first and second cable segments20a,20b. FIG.4Billustrates another variation of a cavity62of a frame body35. The cavity62includes a central portion63adapted to receive at least one connector and first and second channels66a,66bextending to an outlet68a,68badapted for a cable to extend therethrough. The central portion63forms first and second stop surfaces64a,64barranged for preventing a connector from passing into the first and second channels66a,66b. FIG.5illustrates another embodiment of a strap attachment70. In this embodiment, the strap attachment70includes a cable76and an adjustable connector72. The adjustable connector72has at least one or first and second channels80,82through which the cable76extends. The second segment20adefines a portion78extending past the adjustable connector72. The cable76may be arranged for entering the adjustable connector72from outside the frame12so the first segment20aconnects to the adjustable connector72. In contrast, the second segment20bsecures to a connector48, as in aforementioned embodiments. The portion78extends from another side of the adjustable connector72so that the second segment20ais arranged for tying or securing a length86against the adjustable connector72. As a variation, the portion78may extend to a dial tensioning device, as in U.S. Patent Application Publication 2009/0287128, published on Nov. 19, 2009, and incorporated by reference. By the dial tensioning device, there is no tying of the length86, but it is captured by the dial tensioning device and the length of the cable76is regulated according to a desired distance of the retainer relative to the frame edge. The frame12defines a cavity88for receiving the adjustable connector72. The cavity88, may be formed along an inner side of the frame12so that a clinician can access the adjustable connector72. As in any other embodiments, strap attachments10,70may extend from opposed sides of a frame, sharing a cavity, as in the cavity88inFIG.5. In the depicted example, the orthopedic device may be provided with a strap attachment that is not further adjustable, and an adjustable strap attachment, or both the same. As in the depicted embodiment, the frame12provides at least one peg84extending in the cavity88upon which the strap attachment70is secured. It is to be understood that not necessarily all objects or advantages may be achieved under any particular embodiment of the disclosure. For example, those skilled in the art will recognize that the orthopedic device and strap attachment assembly may be embodied or carried out to achieve or optimize one advantage or group of advantages as taught without achieving other objects or advantages as taught or suggested herein. The skilled artisan will recognize the interchangeability of various disclosed features. Besides the variations described, other known equivalents for each feature can be mixed and matched by one of ordinary skill in this art to construct an orthopedic device and/or strap attachment under principles of the present disclosure. It will be understood by the skilled artisan that the features described may be adapted to other types of orthopedic devices or other devices used for carrying a strap. Hence this disclosure and the embodiments and variations are not limited to orthopedic devices but can be utilized in any suitable device. Although this disclosure describes certain exemplary embodiments and examples of an orthopedic device, it, therefore, will be understood by those skilled in the art that the present disclosure extends beyond the disclosed embodiments to other alternative embodiments and/or uses of the disclosure and obvious modifications and equivalents. It is intended that the scope of the present disclosure should not be limited by the disclosed embodiments described above, and may be extended to devices and other applications that may employ the features described. | 15,824 |
11857451 | BRIEF SUMMARY A posture training device and method is described herein. The posture training device allows an individual to assess and improve their posture to achieve a neutral spine. The device can be used independently, so it eliminates the need for a physical therapist or trainer to be present. Consequently, the device enables self-directed physical therapy and exercise. Unlike a wooden dowel, the posture training device is hands-free, making it suitable for a wide variety of activities that require the use of hands, including weightlifting, practicing yoga, working (e.g. typing), running, cycling, and swimming. Consequently, the posture training device allows posture training to be incorporated into a person's preferred activities or workday rather than requiring separate posture-only training sessions. The posture training device is shapable by hand to conform to a wide variety of body shapes and posture conditions. The device is compact and easy to store. The device is comfortable to wear for extended periods of time, such as during long workout sessions. The posture training device may be suitable for individuals suffering from poor posture conditions, such as sway back, lumbar lordosis, thoracic kyphosis, and forward head posture, who are seeking to improve their posture. The device may also be suitable for individuals with good posture who are seeking to maintain or improve their posture while performing their favorite activities. For example, the device may be suitable for endurance athletes who are seeking to maintain correct posture during extended exercise sessions as a way of reducing fatigue, reducing discomfort, and/or improving performance. The posture training device may include a chassis. The chassis may include a pliable body that is worn against a user's thoracic spine region. The device may include a first rod extending upward from the chassis and contacting the user's back of head region. The device may include a second rod extending downward from the chassis and contacting the user's sacrum region. Through physical contact provided by the pliable body, first rod, and second rod, the device may establish three regions of contact along a user's rear body. The pliable body may include an internal shapable member. Adjusting the shapable member may alter a rear surface contour of the pliable body to match a user's unique physical contour along their mid-back region. Adjusting the shapable member may adjust a relative angle between the first and second rods to further tailor the device to fit the user's unique physical contour. Consequently, regardless of whether the user has good or poor posture, the device can be adjusted to contact three regions along the user's rear body and serve as an effective posture training device. As the user's posture improves over time, the shapable member may be periodically adjusted to match the user's changing physical shape to encourage progressive posture improvement. DETAILED DESCRIPTION A shapable posture training device100is shown in the figures and described herein. The posture training device100is configured to contact a back of head region1, a mid-back region2, and a sacrum region3, thereby providing three regions of contact along a user's spine, as shown inFIGS.6and7. The posture training device100provides tactile feedback for postural alignment, thereby enabling the user to independently monitor and, if necessary, correct their posture to achieve a neutral spine position. The posture training device100can be worn, for example, during everyday activities or workout sessions, thereby allowing posture training to be incorporated into a user's daily routine. In addition to saving time and expense by avoiding sessions with a physical therapist, incorporating posture training into daily activities, such as biking, swimming, and yoga, may provide health and performance benefits that exceed those achievable with conventional methods. The posture training device100may include a chassis200. The chassis200may be worn against a user's thoracic spine (mid-back) region2during use, as shown inFIGS.6and7. The chassis200may include a pliable body275. The pliable body may have a top side286, a bottom side287, a left side288, a right side289, a horizontal midplane295, and a vertical midplane291, as shown inFIG.13A. The pliable body275may have a top portion298located between the horizontal midplane295and the top side286. The pliable body275may have bottom portion299located between the horizontal midplane295and the bottom side287. The pliable body275may have a middle portion279located proximate to the horizontal midplane295. The pliable body275may be made of, for example, ethylene-vinyl acetate (EVA) closed cell foam, chloroprene rubber (CR), styrene-butadiene rubber (SBR), or ethylene-propylene-diene-monomer (EPDM). These examples are not limiting. The pliable body275may have a rear surface280that fits comfortably against a user's mid-back region2. The chassis200may include a shapable member265. The shapable member265may be disposed within the pliable body275.FIG.12shows an exploded view of the chassis200and internal components, including the shapable member265.FIG.13Bshows a cross-sectional view of the chassis200and reveals positioning of the shapable member265within the chassis200. In some examples, the shapable member265may be a metal member (e.g. a metal strip, plate, or rod) that is capable of repeatedly bending and assuming new positions without breaking. In other examples, the shapable member265may be a polymer member that is capable of repeatedly bending and taking on new positions without breaking. The shapable member265may be capable of bending and assuming new positions hundreds or thousands of times over the lifecycle of the device, thereby allowing the user to reshape the device100every time it is worn without failure of the shapable member. The shapable member265may extend lengthwise within the chassis (e.g. from a top half of the chassis200to a bottom half of the chassis, as shown inFIG.13B). By bending the shapable member265, the chassis200may be transitioned from a flat configuration, as shown inFIGS.16-21, to a curved configuration, as shown inFIGS.24and25, that conforms to a user's mid-back region2. Each user may have a unique curvature along their mid-back to which the chassis200conforms to provide a proper fit. As a user's posture improves with training and exercise, the curvature of the chassis200may need to be manually adjusted to match changes in posture. The shapable member265allows the shape of the chassis200to be adjusted manually by hand to fit a wide variety of body shapes. By applying a bending force to the chassis200, the shapable member265within the chassis may be altered from flat to curved, resulting in the rear surface280of the chassis200transitioning from a flat surface to a contoured rear surface. As shown inFIG.14B, the posture training device100may include a first removable rod301. The posture training device100may include a second removable rod302. The first and second rods (301,302) may be separate rods that are removably insertable into respective rod receivers (235,240) in the chassis200. Having separate rods, instead of a single rod, may allow shorter rods to be used, which renders the posture training device100more compact when in a stowed configuration, as shown inFIG.4, and allows the device100to fit within a duffel bag or backpack. As shown inFIGS.5-7, when the chassis200is worn against the user's mid-back region, the first rod301may extend from the chassis200to a back surface of the user's head1, and the second rod302may extend from the chassis200to the user's sacrum region3, thereby establishing three regions of contact along the user's rear body. FIG.5Ashows an individual with good posture wearing the posture training device100.FIGS.5B-5Eshow four examples of individuals with poor posture wearing the posture training device100. Three contact regions are shown along the rear body of each individual and correspond to the three regions the device100contacts during use. The three regions are the back of head region1, thoracic spine region2, and sacrum region3. As shown inFIGS.5A-5E, the posture training device100may be adjusted to accommodate a wide variety of posture conditions. A relative rod angle A1is formed at an intersection between a first centerline310of the first rod301and a second centerline315of the second rod302, as shown inFIG.14A. For a user with good posture and a neutral spine, as shown inFIG.5A, the relative rod angle may be about 180 degrees. To meet the needs of certain poor posture conditions, the posture training device100may be adjustable to provide a relative rod angle less than 180 degrees (i.e. θ<180°), as shown inFIG.5E. Conversely, the posture training device100may be adjustable to provide a relative rod angle greater than 180° (i.e. θ>180°) to meet the needs of user's suffering from conditions such as lumbar lordosis, as shown inFIG.5C. In one example, the shapable member265may be bendable to provide relative rod angles A1ranging from about 135 degrees to about 225 degrees. In another example, the shapable member265may be bendable to provide relative rod angles A1ranging from about 145 degrees to about 215 degrees. In another example, the shapable member265may be bendable to provide relative rod angles A1ranging from about 155 degrees to about 205 degrees. In another example, the shapable member265may be bendable to provide relative rod angles A1ranging from about 165 degrees to about 195 degrees. FIG.14Bshows a cross-sectional view of the posture training device100having two rods. The first rod301may be inserted into a first opening205in the chassis200proximate to a top side of the chassis. The second rod302may be inserted into a second opening210proximate to the bottom side of the chassis200. The chassis200may include a first guide wall206that guides the first rod301into the first opening205. The first guide wall206may have a funnel shape. The first guide wall206may have a substantially parabolic shape with the first opening205located at or near a vertex of the parabolic shape. The chassis200may include a second guide wall211that guides the second rod302into the second opening210. The second guide wall211may have a funnel shape. The second guide wall211may have a substantially parabolic shape with the second opening210located at or near a vertex of the parabolic shape. The first opening205may include a first rod receiver235, as shown inFIGS.12and13B. The first rod receiver235may include a bore236to receive the first rod301. The second opening210may include a second rod receiver240, as shown inFIGS.12and13B. The second rod receiver240may include a second bore241to receive the second rod302. The first rod receiver235may include a first magnet255, as shown inFIGS.12and13B. The first magnet255may exert an attractive magnetic force on a ferrous end325of the first rod301that holds the first rod in place, as shown inFIG.14B. The second rod receiver240may include a second magnet260, as shown inFIGS.12and13B. The second magnet260may exert an attractive magnetic force on a ferrous end330of the second rod302that holds the first rod in place, as shown inFIG.14B. In one example, the ferrous ends may be steel screws threaded into respective ends of the rods. The rods (301,302) may be interchangeable and reversible in orientation. Accordingly, the first rod301may include a second ferrous end320, and the second rod302may include a second ferrous end335, as shown inFIG.14B. As shown inFIG.13B, the first rod receiver235may be located in a top portion298(e.g. top half) of the chassis200, and the second rod receiver240may be located in a bottom portion299(e.g. bottom half) of the chassis. The first rod receiver235may include a first slot237to receive a first end of the shapable member265, as shown inFIGS.12and13B. The second rod receiver240may include a second slot242to receive a second end of the shapable member265. Bending the shapable member265may result in intentional misalignment of a first bore centerline238of the first bore236and the second bore centerline243of the second bore241. As a result, and depending on the direction of the bend, an intersection of the first bore centerline238and the second bore centerline243may form a relative bore angle A2that is greater than 180 degrees, less than 180 degrees, or about 180 degrees as shown inFIG.13B. In one example, the shapable member265may be bendable to provide relative bore angles A2ranging from about 135 degrees to about 225 degrees. In another example, the shapable member265may be bendable to provide relative bore angles A2ranging from about 145 degrees to about 215 degrees. In another example, the shapable member265may be bendable to provide relative bore angles A2ranging from about 155 degrees to about 205 degrees. In another example, the shapable member265may be bendable to provide relative bore angles A2ranging from about 165 degrees to about 195 degrees. The pliable body275may include a first beam277extending lengthwise along a rear surface280of the pliable body, as shown inFIG.15. The first beam277may extend vertically from a top portion298of the pliable body to a middle portion279of the pliable body275. The first beam277may enhance the structural integrity of the pliable body275. The first beam277may cover the first rod receiver235with a pliable material and enhance comfort by providing a pliable covering over the rigid rod receiver. The pliable body275may include a second beam278extending lengthwise along a rear surface280of the pliable body, as shown inFIG.15. The second beam278may extend vertically from a bottom portion299of the pliable body to a middle portion279of the pliable body275. The second beam278may enhance the structural integrity of the pliable body275. The second beam278may cover the second rod receiver240with a pliable material and enhance user comfort by providing a pliable covering over the rigid rod receiver. The pliable body275may include one or more airflow features, such as one or more vents, louvers, or pockets to permit air exchange and prevent buildup of perspiration between the chassis200and the user's back.FIG.17shows a first rear pocket296and a second rear pocket297formed in the rear surface280of the pliable body275. The first rear pocket296may extend from a top portion298of the pliable body to a bottom portion299of the pliable body. The second rear pocket297may extend from a top portion298of the pliable body to a bottom portion299of the pliable body. In addition to improving airflow, the first and second pockets (296,297) may enhance bendability of the pliable body by reducing bending resistance created by the material of the pliable body. The pliable body275may include a rear channel276located between the first rod receiver235and the second rod receiver240, as shown inFIGS.13B and17. The rear channel276may allow the pliable body275to more easily bend to match a user's unique physical shape. The rear channel276may extend from the first rear pocket296to the second rear pocket297. The rear channel276may extend substantially horizontally across the rear surface280of the pliable body275. The rear channel276may permit bending of the pliable body275without interference between the first rod receiver235and the second rod receiver240. The rear channel276may permit bending of the pliable body275without interference between the first beam277and the second beam278. The rear channel276may be at least 0.25 inch wide. The rear channel276may be at least 0.5 inch wide. The rear channel276may be at least 0.75 inch wide. The rear channel may be at least 1.0 inch wide. As shown inFIG.13E, the chassis200may include a first rod storage slot245configured to receive and retain the first rod301. The first rod storage slot245may be formed in a front surface285of the pliable body275. The first rod storage slot245may retain the first rod301through a friction fit. The chassis200may include a second rod storage slot250configured to receive and retain the second rod302. The second rod storage slot250may be formed in the front surface285of the pliable body275. The second rod storage slot250may retain the second rod302through a friction fit. The pliable body275may include a plurality of strap slots configured to receive a wearable strap. A first strap slot281may be located between the horizontal midplane295and the top side286and between a vertical midplane291and a left side288, as show inFIG.13A. A second strap slot282may be located between the horizontal midplane295and the top side286and between the vertical midplane291and a right side289. A third strap slot283may be located between the horizontal midplane295and the bottom side287and between the vertical midplane291and the left side288. A fourth strap slot284may be located between the horizontal midplane295and the bottom side287and between the vertical midplane291and the right side289. The posture training device100may include a strap400. The strap400may secure the chassis200against the user's mid-back. The strap400may be a single strap or a plurality of straps. The strap400may include a first shoulder strap405, a second shoulder strap410, and a waist strap415, as shown inFIGS.1-3. The strap400may be woven through the strap slots (e.g.281,282,283,284) in the chassis200to form a first shoulder loop425, a second should loop430, and a waist loop435. The first shoulder loop425may wrap around the user's left shoulder. The second shoulder loop430may wrap around the user's right shoulder. The waist loop435may wrap around the user's waist. The waist loop435may include a fastener420, such as a buckle. The strap400may be adjustable in size. When stowing the device100, the strap400may be wrapped around the chassis275and rods (301,302), as shown inFIG.4. The strap may aid in securing the rods (301,302) in the rod storage slots (245,250). The elements and method steps described herein can be used in any combination whether explicitly described or not. All combinations of method steps as described herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made. As used herein, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. Numerical ranges as used herein are intended to include every number and subset of numbers contained within that range, whether specifically disclosed or not. Further, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of 1-10 should be construed as supporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth. All patents, patent publications, and peer-reviewed publications (i.e., “references”) cited herein are expressly incorporated by reference to the same extent as if each individual reference were specifically and individually indicated as being incorporated by reference. In case of conflict between the present disclosure and the incorporated references, the present disclosure controls. As used herein, term “connected to” can describe a first component directly connected to a second component or a first component indirectly connected to a second component by way of one or more intervening components. The methods and compositions of the present invention can comprise, consist of, or consist essentially of the essential elements and limitations described herein, as well as any additional or optional steps, components, or limitations described herein or otherwise useful in the art. It is understood that the invention is not confined to the particular construction and arrangement of parts herein illustrated and described, but embraces such modified forms thereof as come within the scope of the claims. The foregoing description has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the claims to the embodiments disclosed. Other modifications and variations may be possible in view of the above teachings. The embodiments were chosen and described to explain the principles of the invention and its practical application to enable others skilled in the art to best utilize the invention in various embodiments and various modifications as are suited to the particular use contemplated. It is intended that the claims be construed to include other alternative embodiments of the invention except insofar as limited by the prior art. | 20,753 |
11857452 | DETAILED DESCRIPTION OF THE INVENTION To facilitate a clear understanding of the present invention, illustrative examples are provided herein which describe certain aspects of the invention. However, it is to be appreciated that these illustrations are not meant to limit the scope of the invention and are provided herein to illustrate certain concepts associated with the invention. The entire description below is provided in the particular context of a patient restraint system for use in a hospital setting, and in particular a strap restraint system used with mentally handicapped patients in a clinical and protective hospital room. However, the invention of the present application is generally applicable to any other restraint systems in which any object requires secure restraint in one situation and an “invisible locked and secure presence” in a second situation. FIGS.1A-1Dshow the anti-ligature device of the present invention in four different views (respectively):FIG.1Aa top view,FIG.1Ba front view (fully-inserted, closed or first position),FIG.1Ca side view (not fully-inserted, exposed or second position), andFIG.1Danother front view (not fully-inserted, exposed or second position). As shown, anti-ligature device1includes a tub10, shown as a cylindrical enclosure. Tub10contains most of the other device components and is coupled to the other elements of the present invention. Tub10has outer surface9, extending a depth to12and having an external tub diameter14. Tub10includes a lip11at the top of the top. Lip11extends radially beyond tub outer surface9to a lip diameter13that is greater than the tub diameter14. Tub10includes an inner volume20that is defined by the tub inner surface19having an inner tub diameter15. Slot18is provided on tub10and extends through the entire tub, from inner to outer surface, so that a channel is formed within tub10. The channel provides for access between the exterior of tub10and the inner volume20. Preferably, slot18is geometrically configured in the shape of an “S,” a “Z” or a “C” as viewed from the tub side such that there are three portions of the slot—a first and a second (or top and bottom respectively) generally horizontal slot portions18′ and one, generally vertical, slot portion18″ conjoining the two horizontal slot portions. Tub10sits securely within a hole or mounting location3.FIG.2. Tub securing element25is coupled to a tub bottom portion16of tub10. Tub securing element25is secured to the environment within the mounting location. In one preferred embodiment, tub securing element is a threaded screw or bolt that is secured to the bottom portion16of tub10. In this arrangement, the bottom portion16of tub10may have a threaded nut encased as part of the tub structure for threadable engagement with the tub securing element25. The environment (hole) may itself have a hole or a depression in which some type of anchor7may be disposed. A double expansion anchor maybe be embedded when the mounting hole is concrete or other hard substance. A straight bolt and washer may also be used on wood surfaces and other solid objects that have access to the back side of the object. When the threaded screw or bolt is placed in the hole and engaged with the double expansion type anchor, an outer portion of the anchor expands to fill the embedded location in which it sits and the threaded bolt then pulls the inner portion of the double expansion anchor into a secure adherence position such that tub10then sits securely anchored in mounting location3. Mounting location3can be a wall, a floor or other solid object of some depth and/or securing capability such that tub10and tub securing element25may be used to anchor the tub in a somewhat permanent fashion within that solid element. Flat mounting surface5is necessarily a part of the solid object and mounting location3. The top surface of tub lip11is necessarily seated below the flat mounting surface5, or at a minimum is flush with flat mounting surface5when the tub10is fully inserted into mounting location3and secured with tub securing element25. This is important so that no portion of the tub10is accessible, bendable, pryable or otherwise capable of deformation or removal by the patient in the hospital room. In this regard, and in an ideal arrangement, the top surface of tub lip11is not only flush with flat mounting surface5, but lip diameter13of lip11is dimensioned to precisely fit within any indentation made within the mounting location to accommodate tub10and lip11so that a continuous and smooth surface is achieved when the tub10is fully inserted into mounting location3and secured with tub securing element25. Compressible element26is disposed within inner volume20and coupled to bottom portion16of tub10at a first end27. Compressible element26is coupled at a second end28to tub sealing element30. Tub sealing element30is dimensioned to fit within inner volume20of tub10. Compressible element26is compressed upon the insertion of tub sealing element30within inner volume20such that an upward force is applied to the tub sealing element30by the compressible element when the device is in the closed position and tub securing element30in its fully inserted position. InFIG.1B, the device is shown in the first position, with the tub sealing element30in a fully inserted (closed position). InFIG.1D, the device is shown in the second position, with the tub sealing element not fully-inserted (open position) and at least partially exposed to the environment. Tub sealing element30is generally comprised of two portions coupled together: an insertion portion40and top sealing portion32. Insertion portion40is coupled to the second end28of the compression element26at its bottom and to the top sealing portion32at a lower surface33thereof. As shown inFIGS.1A-1D, insertion portion40also has at least one dimension that has an outer diameter34that is slightly smaller than inner tub diameter15. In the embodiment illustrated inFIGS.1A-1D, insertion portion40is cylindrical as viewed from the top (FIG.1A) and has a generally rectangular solid form42as viewed from the front (FIGS.1B,1D). Insertion portion40has curved outer edge surfaces and a rectangular hole or slot46within the rectangular solid42. InFIG.1C, the side view of the rectangular solid comprising the insertion portion40is shown. InFIG.1B, a front view of the rectangular insertion portion is shown as fully inserted into inner volume20of tub10. As shown inFIG.1A, top sealing portion32is circular with a shallow depth33so as to comprise a shallow cylinder. Top sealing portion has an outer diameter that fits comfortably but snugly within inner lip diameter/outer tub diameter14when the tub sealing element is fully inserted into tub10. Top sealing portion32includes locking pins93on the outer periphery of the cylinder. Locking pins93may be solid non-compressible protrusions that extrude from the outer periphery of the top sealing portion32. One or more keyways90may be coupled to said locking pins may be included within or on the top of top sealing portion32. Keyways90are rotatable such that rotation in one direction retracts the locking pins within the top sealing portion and rotation in the other direction extends them out beyond the periphery of the outer diameter34of the top sealing portion32. Locking holes94are provided as indents on the inner tub surface19and are disposed at certain registered locations at the top portion of the tub10. When the device is in the final, first closed position, the locking pins93are aligned with the locking holes94and the keyway may be turned to extend the locking pins into the locking holes and secure the entire tub securing element in a locked relationship with tub10. Engagement pins43are included as part of the structure of the insertion portion40and are slidably inserted into holes in the profile edges of insertion portion40, preferably at a bottom portion thereof and slightly above the point at which the insertion portion is coupled to the second end28of compressible element26. Springs may be used behind the engagement pins43so that the pins are naturally pushed out and away from the body of the insertion portion40. When the top sealing portion32is fully inserted into tub10, and in the fully assembled device arrangement, the engagement pins are aligned with the first horizontal slot portion upon insertion of the tub sealing element. As the tub insertion element is first inserted into tub10, the pins43“pop out” when they engage with the top-most, first horizontal slot portion18′. Once assembled, and both engagement pins43(one on each of the two sides of insertion portion40) “pop out” and engage with slots18, the anti-ligature device is fully assembled. Once fully assembled, pins43remain engaged in slots18for the duration of the operational life of the anti-ligature device, traversing the slots from one horizontal portion, through the vertical portion and then through the other horizontal portion. Engagement pins43may also be “T-shaped” as viewed from the side of the pin (pin profile). In this arrangement, they are of sufficient diameter to be positioned in the slot18and securably screwed into insertion portion40of the tub securing element25as permanently affixed within tub10so as to create the final assembly. The anti-ligature is operable between the second position shown inFIG.1Dto the first position shown inFIG.1Bin the following manner. Transitioning the anti-ligature device is accomplished by pushing the tub sealing portion32down at the top surface35, against the upward force exerted by the compression element26. Simultaneous with the exertion of downward force, tub sealing element is rotated counter-clockwise (as viewed from the top) in relation to tub10so that engagement pins43travel along the upper horizontal slot portion18′ over to the joinder location of slot portion18with vertical slot portion18″. Continuing with the application of downward force, tub sealing element30is pushed into tub10and engagement pins43travel down along vertical slot portion18″ of slot18and to the joinder of vertical slot portion18″ with lower horizontal slot portion18′. To complete the transition from the second device position to the first device position, the tub sealing element is rotated by the force placed on top surface35again simultaneous with the exertion of downward force, in a counter-clockwise (as viewed from the top) in relation to tub10so that engagement pins43travel along the lower horizontal slot portion18′ over to the end of that horizontal slot portion. It should be appreciated that in both the first (closed) and second (exposed) device positions the compression element applies an upward force on tub sealing element30at all times. When fully compressed, and the device is fully disposed in closed device position, the engagement pins43are forced against a top edge of the lower horizontal slot portion18′. In this position, the compression element provides the greatest force on tub sealing element30. When fully exposed, and the device is fully disposed in the second device position, the engagement pins43are forced against a top edge of the upper horizontal slot portion18′. In this position, the compression element provides the least force on tub sealing element30. It should also be appreciated that the geometry of slot18can be any one of several shapes such that the above functions are accommodated. Thus an “S-shaped” or a “C-shaped slot” may be employed. In the case of a “C-shaped” slot the rotation direction of the tub sealing element would need to be reversed when transitioning between the two device positions. Most desirably, a “Z-shaped” slot is preferred so that the simultaneous application of force and rotation on the tub sealing element is more easily performed. Finally, registration notches21(FIG.4A) may be included at terminal and interstitial points along the travel path of engagement pins43within slot18such that the transition may be partially completed and “stored” mid-way, or may otherwise be securely terminated at the ends of the slots. In fact, in experimental use, the registration notches21at the ends of slot18proved to be the most secure and safe method of securing the tub sealing element30in final resting positions and preventing inadvertent rotation of the tub sealing element when in those positions. Is should be further be appreciated that different configurations and constructions of the tub and internal components may be achieved in accord with the teachings of the present invention. First, different tub geometries may be used. Square tubs, triangular tubs, truncated frustrum and other shapes of tubs are envisioned. Top portions of the top sealing portion may be maintained as round, and rotatably engageable within a round top hole in the top of an otherwise non-cylindrical tub. Different internal components and pin-hole or pin-slot arrangements may be used to accommodate variations to the basic geometric structures herein. The basic teachings provided herein are applicable, nonetheless. Further, the construction of the components may vary or be mixed and matched. The requisite parts may be cast metal, mild steel, with powder coating, stainless steel, high strength aluminum, molded plastic, 3D-printed material or combinations of any of the same, such that the objectives of the present invention are achieved. Also, different tub securing elements (hooks, clasps, hasps, rope, bolted platforms etc.) as well as different compression elements (pistons, hydraulics, deformable solids etc.) may be substituted so that the objectives of the invention herein are accomplished. FIG.2shows an exemplary environment in which the anti-ligature device of the present invention is used. Patient bed2is provided disposed on a floor of the environment. The anti-ligature devices are embedded in the floor or mounting locations3. In the hospital setting, the floor may be concrete and mounting holes3may be provided in the floor to a mounting depth4. The flat mounting surface5is the floor surface. Tub sealing element30extends above the floor surface in the opened position so that the restraint element slot46is exposed to the environment. Straps may then be threaded through the one or more exposed restraint element slots and across the bed2so as to restrain the patient thereto. A particularly preferred prototype of the anti-ligature device of the present invention has been invented and is described herein in detail with respect to the following figures.FIG.3shows prototype anti-ligature device101. In this embodiment, a mild steel construction having a powered coating is used for construction of the main structural pieces. When used in a floor and corrosion is of concern, a stainless steel construction may be desirable. In other applications high strength aluminum may be used as a fabrication material.FIG.3provides an oblique view of the device as fully assembled and displayed in the second (exposed, not fully-inserted) position. FIGS.4A-4Cshow, respectively, a front view, an oblique view, and a top view of the tub of the anti-ligature device according to one particularly preferred prototype embodiment of the present invention. Exemplary dimensions are included on the figures only as a reference as to the size of this embodiment (and are incorporated by reference to the FIGs. in the written portion of this specification in their entirety).FIG.4Ashows the tub110as it is inserted into mounting location (a hole in the floor)103. The mounting location103is formed so that an annular recessed portion106of the mounting location is formed at mounting surface105and at the outside the diameter of the main mounting hole. Lip111of tub110then sits in that recessed annular region. In this position, the top of the top surface of the lip is flush with the mounting surface105. Tub securing element125is shown as a threaded bolt that is secured to a bottom portion116of tub110. Tub110has a threaded hole122in the center of the bottom thereof. As mentioned above, the mounting location103includes a recessed additional hole at the center bottom in which a double expansion anchor107maybe embedded. The dimensions of the tub110and the mounting location are tightly controlled and coordinated with respect to one another, and in particular the tub exterior diameter114and the diameter of the mounting location are matched so that a tight insertion fit is achieved when the tub110is fully inserted into the mounting location. In practical application, the tub may be inserted into mounting location without the tub sealing element130and the tub securing element125may be screwed “through” the threaded hole provided at the bottom of the bottom tub portion116of tub110and straight on through to a double expansion anchor107beneath the tub110. Full insertion and tightening will then simultaneously expand and lock the double expansion anchor107to the mounting location103and secure tub110in place in that mounting location103. As shown inFIGS.4A and4B, four “zig-zag” or “Z-shaped” slots118are provided at the for ordinal positions of the tub, i.e. disposed evenly at 90 degrees from one another around the tub. Each slot118has two substantially horizontal portions118′ and one substantially vertical portion118″. As previously described, the engagement pins143attached to the tub sealing element engage in these slots to provide for slidable movement along the slots when the tub sealing element is transitioned from the first to the second positions and back again. FIG.5shows locking pins293, with springs95attached thereto and securing cap83. Locking pins293are shown in greater detail inFIGS.6A-6C. Securing cap83is shown in greater detail inFIGS.7A-7C. FIGS.6A-6Dshow, respectively, a bottom view, a side view, a front view and an oblique view of the locking pins293according to one particularly preferred prototype embodiment of the present invention. Exemplary dimensions are included on the figures only as a reference as to the size of this embodiment (and are incorporated by reference to the FIGs. in the written portion of this specification in their entirety). Locking pins293include head end pin portion213, pin stem215and ridge217on pin stem215. FIGS.7A-7Cshow, respectively, a bottom view, an oblique view and a side view the securing cap according to one particularly preferred prototype embodiment of the present invention. Exemplary dimensions are included on the figures only as a reference as to the size of this embodiment (and are incorporated by reference to the FIGs. in the written portion of this specification in their entirety). Securing cap83includes recessed annular region86, dowel turn stop84, and through holes85. FIGS.8A-8D, includingFIGS.8C′ and8D′, show, respectively, a side view, a top view a bottom view and three different oblique views of the keyway lock element290according to one particularly preferred prototype embodiment of the present invention. Exemplary dimensions are included on the figures only as a reference as to the size of this embodiment (and are incorporated by reference to the FIGs. in the written portion of this specification in their entirety). Keyway lock element290includes a head portion292having a flanged or chamfered edge291. The head portion292is coupled to key stem294and includes key holes296. The key stem294has an undulating edge profile295such that its edge swoops in an out with respect to a central axis297of said keyway lock element290. FIGS.9A-9Dshow, respectively, a top view, an oblique view, a side sectional view and a side view of the lock cup172according to one particularly preferred prototype embodiment of the present invention. Exemplary dimensions are included on the figures only as a reference as to the size of this embodiment (and are incorporated by reference to the FIGs. in the written portion of this specification in their entirety). Lock cup172is generally annular in shape. The annular lock cup172includes mounting holes174drilled vertically therethrough. Lock cup172has an inner annular ledge175disposed at the bottom of the annular lock cup172. The inner annular ledge175includes a locking pin seat176. Locking pin holes178are drilled laterally through the side of lock cup172from the locking pin seat176to the lateral exterior wall of the lock cup172. Securing pin holes179are included transverse to the locking pin holes178within the annular ring. Securing pin holes are179are preferably threaded and are drilled through to meet the locking pin holes178at a midpoint thereto. A threaded securing pin399is provided to be threadedly engaged in securing pin holes179so as to be able to contact locking pin holes178. The securing pin is inserted into securing pin hole179so as to prevent locking pins293from retracting too far back into lock cap172by “catching” the pins at ridge217. FIGS.10A-10Dillustrate a series of assembly drawings of the parts of the tub sealing element130in various stages of assembly according to one particularly preferred prototype embodiment of the present invention. InFIG.10A, a bottom view of each of the unassembled assembly components is shown. Mounting screws82are positioned for insertion through mounting holes85in securing cap83. Securing cap83is positioned for covering the bottom of lock cup172such that recessed annular region86rests against the downward facing inner annular ledge175of locking cap172. The diameter of securing cup83matches the diameter of the inner edge of central annular area of locking cup172. Keyway lock element290has keyway mounting holes299on the bottom of key stem294thereof for mateable coupling with mounting screws82when keyway lock element—turned upside-upside down—is inserted into the top of the annular ring (i.e. from the backside of lock cap172as shown inFIG.10A). InFIG.10B, a top view is shown of the upper restraint assembly169is shown including the following components: locking pins293and securing cap83. Locking pins293have the springs95inserted over the pin stem215and are inserted into the locking pin holes178. InFIG.10C, a bottom view is shown of the partially assembled tub sealing element130including the following components: locking pins293and keyway lock element290. Locking pins293have the springs95inserted over the pin stem215and are inserted into the locking pin holes178. Locking pin head ends213rest on the undulating edges of295of fully inserted keyway locking element290. It should be appreciated that the assembly ofFIG.10Comits the interposing interior restraint element onto the bottom of which is affixed the lock cup172and the top of which accommodates the keyway lock element290. It should also be noted that mounting holes174are accessed for assembly from the underside of the tub sealing element and through access holes in the bottom of the interior restraint element. InFIG.10D, a top view is shown of the partially assembled tub sealing element130as provided inFIG.10Cbut further including the securing cup83assembled thereto at the bottom surface. Again, the following components are included: locking pins293and keyway lock element290. Locking pins293have the springs95inserted over the pin stem215and are inserted into the locking pin holes178. Locking pin head ends rest on the undulating edges of295of fully inserted keyway lock element290. It should be appreciated that in one rotational position of the keyway lock element the undulating edges of key stem294exert force on the pin heads end213causing the locking pins293to be pushed through the locking holes294and out the sides of the annular region of the lock cup172. In this position, the springs95exert force on the key stem213and cause push back force into the annular ring. Dowel turn stop84provides for a stopping mechanism in the rotation of keyway lock element290so that the appropriate rotation of the keyway is provided to effect sufficient pin stem insertion without allowing the keyway lock element290from progressing past a maximal point of pin stem extension. Again, it should be appreciated that the assembly ofFIG.10Domits the interposing interior restraint element onto the bottom of which is affixed the lock cup172and the top of which accommodates the keyway lock element290. This has been omitted to show clearly the workings of the keyway lock element rotation and engagement of the locking pins. FIGS.11A-11Dshow, respectively, a top view, a bottom view, and a section view and a front view the interior restraint element160according to one particularly preferred prototype embodiment of the present invention. Exemplary dimensions are included on the figures only as a reference as to the size of this embodiment (and are incorporated by reference to the FIGs. in the written portion of this specification in their entirety). Interior restraint element160is generally cylindrical as shown in the top view ofFIG.11A. Top restraint disk162has a hole in the middle of the top161with a chamfered edge163on the hole edge. Restraint sidewalls164are coupled to the top restraint disk at opposite sides of the top restraint disk162. Only one restraint side wall is shown in the side view ofFIG.11Cwith the second being disposed directly behind the one being showing in that FIG. Bottom restraint disk166is coaxial with top restraint disk162and is of the same diameter and size. Along with the upper restraint assembly169(described below) restraint sidewalls164are coupled to the bottom restraint disk at opposite sides of the bottom restraint disk. Restraint disks162and166, coupled by restraint sidewalls provide for an open form cylindrical element (in combination with all other attached elements—one tub sealing element130) for insertion into tub110. FIG.11Dshows a full front profile of the interior restraint element160including the restraint element slot146. In a fully assembled tub sealing element, the lock cup172, securing cap183and locking pins93(together upper restraint assembly169) are all presented into the middle of interior restraint element160by insertion through slot146as shown inFIG.12. After insertion of the lock cup and associated parts, the components are assembled as follows. Four through holes167are provided on the bottom of bottom restraint disk166. These through holes are dimensionally arranged the same as the four mounting holes174on the bottom of lock cup172. The through holes167are provided to allow screwdriver/allen wrench access through the bottom restraint disk166and the restraint element slot146to the long mounting screws168shown inFIG.12. Using long mounting screws168, the upper restraint assembly169may be inserted into place and secured to the underside of the top restraint disk162of interior restraint element160. Is should be appreciated that for the locking pins93to work, the upper restraint assembly ideally orients the locking pins pointing out the side of the interior restraint perpendicular to the restraint element slot146, i.e. pointing straight out the sides as shown inFIG.11D. Finally, once the long mounting screws168have been fully inserted there is a small space in the screw holes268in the top restraint disk162. These small spaces may be sealed over with putty, glue or other composite material to prevent top-side access to the screw ends at the top surface of the top restraint disk, which sits exposed at the flush surface of the flat mounting surface5. Two through holes267are also provided on the bottom of bottom restraint disk166. These through holes are arranged so as to register with the two mounting holes85on securing cap83. The through holes267are provided to allow screwdriver/allen wrench access through the bottom restraint disk166and the restraint element slot146to the mounting screws82shown inFIG.10A. Using mounting screws82, the securing cap83may be inserted into place within the upper restraint assembly169, simultaneously with the insertion of the keyway locking element290into chamfered hole161and secured to the keyway locking element290at keyway mounting holes297. This assembly difficulty should be appreciated in that keyway locking element290is inserted into the top restraint disk162, while simultaneously inserting the upper restraint assembly169into the interior restraint element160and aligning the undulating edges295of key stem294such that proper registration of all parts is made upon assembly. Also shown in the sectional viewFIG.11Care two half sections of engagement pin receptacles243. Engagement pin receptacles are configured for receiving engagement pins143as shown inFIG.3. Again, these engagement pins are permanently attached to the tub sealing element130, and once the tub sealing element130is inserted into the tub110they are permanently disposed within slots118on tub110for slidable operation of the device as it transitions between the exposed and closed positions. FIG.12shows a partial assembly arrangement of the sealing element130the interior restraint element160having keyway locking element290inserted into chamfered hole161at the top surface thereof. Upper restraint assembly169is partially inserted into the restraint element slot146and long mounting screws168are positioned for securing the upper restraint assembly169to the interior restraint element160at the underside of top restraint disk162. Next, mounting screws82are positioned for securing the securing cap83to the keyway locking element290at keyway mounting holes299from the bottom as viewed inFIG.12. All mountings take place through access holes in the bottom restraint disk as previously described. FIG.13Ashow the spanner head key197used to rotate the keyway lock element290which throws the locking pins293, via the operation of the undulating edge on295on key stem294so as to lock and unlock the tub sealing element130to the tub110. In one particularly preferred embodiment, the locking pins293extrude out to the same tub holes/slot118/registration notches21that are used for the engagement pins143. Since locking only take place in the closed device position, the upper slot areas, particularly along the upper horizontal slot118′ are left vacant for use of the same by the locking pins293. Spanner head key197includes handle portion198and key pins199. Key pins199are inserted into key holes293as shown inFIG.13Bshowing the fully-assembled anti-ligature device101in the first position. Key holes293are shown at the top of keyway locking element290and rotated to engage the locking pins. In operation, the compressible element126provides sufficient force on the tub sealing element130such that the keyway lock element cannot easily be rotated without the spanner head key197. The terms “a” or “an,” as used herein, are defined as one or more than one. The term “another,” as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open transition). The term “coupled” or “operatively coupled,” as used herein, is defined as connected, although not necessarily directly and mechanically. While the invention has been disclosed in connection with the preferred embodiments shown and described in detail, various modifications and improvements thereon will become readily apparent to those skilled in the art. Accordingly, the spirit and scope of the present invention is not to be limited by the foregoing examples, but is to be understood in the broadest sense allowable by law. Although various embodiments, which incorporate the teachings of the present invention have been shown and described in detail herein, those skilled in the art can readily devise many other varied embodiments that still incorporate these teachings. | 31,724 |
11857453 | Before any embodiment of the invention is explained in detail, it is to be understood that the present invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings. The present invention is capable of other embodiments and of being practiced or being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. DETAILED DESCRIPTION The matters exemplified in this description are provided to assist in a comprehensive understanding of various exemplary embodiments disclosed with reference to the accompanying figures. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the exemplary embodiments described herein can be made without departing from the spirit and scope of the claimed invention. Descriptions of well-known functions and constructions are omitted for clarity and conciseness. Moreover, as used herein, the singular may be interpreted in the plural, and alternately, any term in the plural may be interpreted to be in the singular. In general, the present invention is directed to the systems and methods of an improved ostomy appliance. Specifically, the present invention is directed to ostomy faceplates that are specifically configured for interactions with NPWDs. The present invention sets forth an ostomy appliance and/or system that may include one or more of several features, including but not limited to the following: having a straight edge that may be aligned with a drape or other component of an NPWD; one or more channels for cutting drape material; one or more protrusions or rails for cutting drape material; a “D”-shaped ostomy appliance; a “D”-shaped flange for attaching an ostomy bag or pouch thereto; a tapered edge to facilitate overlapping by a drape material or other component of an NPWD; an ostomy appliance with an asymmetric and/or non-centered aperture for the stoma; an asymmetric ostomy bag or pouch configured to hang to the non-wounded side; attachment devices for an ostomy bag or pouch; and/or a breakaway or sump to reduce or prevent any stoma effluent from being drawn into the wound by an NPWD. In accordance with some embodiments (and as discussed in greater detail below), the design may comprise a straight edge as part of ostomy faceplate, a “D”-shaped flange and an asymmetric effluent bag that may not encroach towards the midline. There may be a channel in the faceplate so that an organized straight cut of the impermeable (or substantially impermeable, vapor permeable, etc.) negative pressure bandage may be made just prior to it becoming enmeshed with the effluent bag. The straighter end of the faceplate (closest to wound) may include a tapered end in order to facilitate an adequate seal with the negative pressure bandage. The ostomy appliance may also have an impermeable (or substantially impermeable, vapor permeable, etc.) bandage surrounding the faceplate that may be compatible with one or more types of NPWD. The bag of the ostomy appliance itself may also comprise a venting/sump system and/or snaps. More specifically, in accordance with some embodiments of the present invention, there may be a venting/sump system that may prevent the occasional complication of effluent being drawn into the wound by negative pressure, such as a break-away flap to prevent reversed flow. Additionally, in accordance with some embodiments, snaps may be included. For example, snaps (or other attachment devices, including but not limited mechanical attachment (hook-and-loop, zippers, latches, threaded connections, etc.), magnetic attachment, or any other type of suitable attachment) may be positioned to assist in securing the asymmetric bag to the faceplate. Positions of the snaps may vary. The male portion of the snap may be embedded in the faceplate and the female portion may be embedded on the bag, or vice versa. In accordance with some embodiments, other attachment devices may be embedded or attached to the faceplate and/or bag or may be attachable to a faceplate and/or bag so that other bags may be utilized. With reference toFIG.1, a prior art overlapping system100will be discussed. System100shows the use of an ostomy appliance110and a NPWD120. Note that the NPWD120overlaps a portion of the ostomy appliance110, due to the proximity between the stoma130and the wound131. The ostomy appliance110is substantially round and may be centered over and substantially concentric with the stoma130. The ostomy appliance may further include a round flange111for the attachment of a bag or pouch (not shown). The NPWD120may comprise a drape or dressing121that may be positioned over the wound120, and may include conduit or tubing122to a negative pressure device, such as a vacuum system. It can be seen from the prior art shown inFIG.1that when wounds are near or adjacent to an ostomy, there can be unintended interference between the ostomy appliance and the NPWD. With reference toFIG.2, an exemplary “D”-shaped ostomy appliance with “D”-shaped flange, in accordance with some embodiments of the present invention will now be discussed.FIG.2illustrates a “D”-shaped ostomy appliance210which may include a flange211for the attachment of a bag or pouch and may be located over a stoma231. The “D”-shaped ostomy appliance210may include a straight edge212, which may be positioned such that there is little or no interference with an NPWD220. The NPWD220may be positioned over a wound232and may comprise a drape material221with conduit or tubing222connected to a negative pressure device (not shown). It can be seen that the straight edge of the ostomy appliance permits both mechanisms of the NPWD and ostomy appliance to each be independently effective without interference from the other. It is also contemplated that the ostomy appliance may be “D”-shaped but may maintain a circular or substantially circular flange. With reference toFIG.3, an ostomy appliance310may include a straight edge312but may include a traditional and/or standard round flange311, which may be substantially centered over a stoma331. In this manner, standard ostomy bags or pouches may be used to attach to the flange311. Note that while the present invention uses terms such as “D”-shaped, this specific shape is not required. Rather, it is the straighter edge of the ostomy appliance that may be located adjacent or even abutting the NPWD that provides simultaneous use without unwanted or undesirable interference. Accordingly, the present invention should not be limited to this exact arrangement. It is further contemplated that the location of the ostomy appliance may not be centered upon a stoma. With reference toFIG.4an ostomy appliance410may include a flange411and a straight edge412. The straight edge412may be positioned proximate to an NPWD420, which may in turn comprise a drape421positioned over a wound432with conduit or tubing422connected to a negative pressure device (not shown). Because of proximity between the stoma431and wound432, the ostomy appliance410may be positioned as close to the stoma—and as far away from the wound—as possible. This may result in the stoma's being positioned in a nonconcentric location. Note that while this may not be ideal from a drainage perspective, once the wound adequately heals where an NPWD is unnecessary an ostomy faceplate may be positioned more centrally over the stoma. With reference toFIG.5, an exemplary ostomy faceplate510with a cut-out is shown. Ostomy faceplate510may again include a flange511for attachment to a bag or pouch. The ostomy faceplate510may further include two (2) straight edges512A,512B which may be used to position the faceplate510as close to drape material521for an NPWD520as possible. Again, the NPWD520may cover a wound532and may be attached to a negative pressure device (not shown) for generating negative pressure. Note that while the ostomy faceplate510is shown with a quarter removed, it is anticipated that various designs, arrangements, or configurations may be utilized to achieve close placement of the ostomy appliance to the NPWD or its associated drape or dressing. Also note that while the ostomy appliance510is shown with approximately one quarter removed, it is also anticipated that the appliance510may include one or more lines of weakness513, which may be used to remove portions of the faceplate. For example, the ostomy appliance510may be sold with a substantially circular or even rectangular shape but may include one or more lines of weakness513. Lines of weakness513may be used to remove portions of the ostomy appliance or faceplate. For example, a substantially circular ostomy faceplate may include at least two lines of weakness. Lines of weakness may be substantially perpendicular to each other such that portions of the faceplate may be removed. To maintain a consistent flange for bag or pouch attachment, the flange may be asymmetrical (such as the illustrated “D” shape) or may be offset to one or more sides of the faceplate. In this manner, portions of the faceplate may be removed to allow for close placement to an NPWD. In accordance with some embodiments of the present invention, an ostomy appliance or faceplate may include features to assist in cutting an NPWD drape or dressing—or indeed any proximate dressing. As discussed in greater detail below, such features may comprise a channel, one or more ridges or protrusions, joints or junctions to guide a cutting device, or other such alignment or guiding features. With reference toFIG.6an ostomy appliance610is illustrated. Note that while ostomy appliance610is illustrated as being “D”-shaped, it may take various shapes as discussed above. Ostomy appliance610may comprise a flange611, which is also illustrated as being “D”-shaped but may be in any other shape or configuration as discussed above. Adjacent or near the ostomy appliance610may be an NPWD621. Negative pressure wound device620may include a drape or dressing621, which may be attached a device that generates negative pressure, such as a vacuum (not shown). Ostomy appliance621may be positioned over or around stoma631, while the NPWD620may be positioned over or around wound632. Ostomy appliance610may further comprise a channel or groove613. Channel or groove613may be made in any number of ways, such as by an indent in the surface of the ostomy appliance610or by one or more ridges or protrusions. In this manner the drape or dressing used with an NPWD can be cut as close as possible to the ostomy appliance. As can be seen fromFIG.6, there may be some overlap where the drape or dressing621overlaps a portion of the ostomy appliance or faceplate610. In accordance with some embodiments of the present invention, an ostomy appliance or faceplate may include features to assist sealing of drapes or dressings used with an NPWD. For example—and as discussed in greater detail below—one or more sides of the ostomy appliance or faceplate may taper from its usual thickness to a lesser thickness, providing a more gradual transition between a drape or dressing and an ostomy appliance, and thereby assisting in obtaining and maintaining a proper seal of the drape or dressing. FIG.7illustrates a similar arrangement as shown inFIG.6above but illustrates the orientation of a channel in an ostomy appliance or faceplate710that is substantially square or rectangular. The ostomy appliance or faceplate710may include a flange711that may be round, “D”-shaped, square, or any other variation, and may further include a channel or guide713that may run substantially parallel or co-linear with edge712. Drape or dressing721may be configured over and/or around wound732, and (as discussed above) may overlap or abut a portion of the appliance or faceplate710. With reference toFIG.8, a cross section of an ostomy appliance800in accordance with some embodiments of the present invention will now be discussed. Ostomy appliance800may include a faceplate810, a hole or aperture820through which a stoma may protrude, a flange830(which may be in any size or shape sufficient to attach to an ostomy bag or pouch), a channel or groove840, and a taper portion850proximate to the channel or groove840. With reference toFIG.9, interaction between an ostomy appliance910and a drape or dressing960for an NPWD will now be discussed. As illustrated above, an ostomy appliance910may include a hole or aperture920through which a stoma may protrude, a flange930(which may be in any size or shape sufficient to attach to an ostomy bag or pouch), a channel or groove940, and a taper portion950proximate to the channel or groove940. A drape or dressing960used in conjunction with an NPWD may be positioned over a wound990and may have a portion970extend over the taper portion950of the ostomy appliance910. It can be seen that the drape or dressing960may extend up to channel or groove940. During installation the channel or groove940may provide guidance so that an organized straight cut of an impermeable (or substantially impermeable, vapor permeable, etc.) negative pressure bandage or drape may be made. It is contemplated that various other arrangements or interactions between an ostomy appliance and dressing or bandages for an NPWD may exist. For example, as illustrated inFIG.10, it is contemplated that an ostomy appliance faceplate1010may comprise an impermeable material (or substantially impermeable, vapor permeable, etc.) and may be integrally connected to, or part of, a drape or bandage1040for an NPWD. The faceplate portion1010of the integral device1000may include an opening or aperture1020for a stoma and a flange1030for the connection of a bag or pouch. In accordance with some embodiments, the faceplate portion1010may be comprised of one material, while the drape portion1040may be comprised of a second material. For example, the faceplate portion1010may be made of a rigid material, while the drape portion1040may be made of a flexible material, typically used for bandages or drapes. In accordance with some embodiments of the present invention, certain mechanisms, devices, or arrangements may be used to direct an ostomy bag or pouch to fall to a patient's side, away from a surgical (or other) wound. For example, as illustrated inFIG.11, an ostomy faceplate or appliance1110may be configured to provide a typical aperture for a stoma1120, but to have the flange for attachment of ostomy bags or pouches be positioned at an angle, such that while the flange lies in a single plane, one portion of the flange support1160is positioned further from the patient's skin (i.e., further in a Y axis), while another portion of the flange support1170is positioned closer to the patient's skin. With continued reference toFIG.11, a channel or groove1140may be positioned in the ostomy appliance1110to assist in cutting drape or other material associated with or used with an NPWD. Similarly, as discussed in greater detail above, the ostomy appliance1110may also comprise a tapered portion1150that may assist in creating a seal between drape material and the ostomy appliance1110. Note that in some alternatives the channel or groove1140may be omitted, as a surgeon may utilize the joint1170between the raised portion of the flange support1160and the other portions of the faceplate. With reference toFIG.12, the use of an angled ostomy appliance1210in conjunction with an ostomy bag or pouch1280is illustrated. Again, the ostomy appliance1210may include an opening or aperture1220for a stoma, a flange1230which may be positioned on an angle by resting on a first flange support portion1260that may be positioned further from a patient's skin than a second flange support1270. The ostomy appliance1210may further comprise a channel or groove1240and a tapered portion1250. During use, a drape or bandage1290of an NPWD may cover a wound1295and may extend up the tapered portion1250of the ostomy appliance. Note that while the above discussions with reference toFIGS.11and12have discussed a first and second flange support, such supports are not necessarily distinct from one another. In other words, the flange itself may lie in a single plane, said plane being configured on an angle compared with the patient's skin surface. In a cross-section view, this may result in seeing a first flange support portion and a second flange support portion. However, this may present a single surface lying on an angle with a smooth transition from one portion to the next. The above language is included not to limit the device to two such portions or their arrangement, but to illustrate that an ostomy bag or pouch may be persuaded to lie in a certain direction by angling the flange and bag support. With reference toFIG.13, interaction between an ostomy faceplate or appliance1310and a drape material1340for an NPWD will now be discussed. Again, ostomy faceplate1310may comprise an opening or aperture1320for a stoma and a flange1330for attachment of a bag or pouch. The flange may be of any shape, for example round, square, “D”-shaped, etc. The drape material1340may be positioned over a wound1350. To prevent pressure communication between the drape material1340and the ostomy appliance1310, a junction barrier1360may be utilized. Junction barrier1360may be comprised of an impermeable (or substantially impermeable, vapor permeable, etc.) material to prevent the negative pressure drawn by a negative pressure device (not shown) and applied under the drape material1340from drawing any effluent from the stoma, for example from around the flange1330(potentially due to a bag or pouch not being fully engaged, or a leaky seal therebetween), or from drawing effluent from under the ostomy faceplate1310. This junction barrier1360may be, for example, “T” shaped, and may comprise adhesive under the arms of the “T” such that the junction barrier may attach to one or both of the ostomy faceplate1310and the drape material1340. With reference toFIG.14, a top view of a quadrilateral shaped ostomy appliance1400will now be discussed. Ostomy appliance1400may comprise a faceplate1410that may include a flange1420and one or more tapered portions1430. Within flange1420(which may be of any shape, such as round or “D”-shaped), there may be various lines of weakness1440such that an aperture for a stoma may be positioned within the flange1430in the most desirable location (based on the required location of the stoma and the surgeon's preference). Similar toFIG.14,FIG.15illustrates an ostomy appliance1500that includes a flange1520and both tapered portions1530and a channel or groove1540that may be present on all edges of the faceplate1510. Again, within flange1520there may be various lines of weakness1550such that an aperture for a stoma may be positioned within the flange1530in any number of locations. With reference toFIG.16, a “D”-shaped ostomy appliance1600will now be discussed. Ostomy appliance1600may comprise a faceplate1610, a flange1620, an aperture for a stoma1630, a channel or groove1640, and/or a tapered portion1650, positioned along the straight edge of the “D” shape. Ostomy appliance1600may further comprise snaps, hooks, or other attachment devices1660in order to connect a bag or pouch to the ostomy appliance1600. Such attachment devices1660are illustrated at the seven o'clock, nine o'clock and eleven o'clock positions, but may be present at any location upon the faceplate1610. With reference toFIG.17, an ostomy appliance1700may comprise a faceplate1710, a flange1720, an aperture for a stoma1730, a tapered portion1740, and a cutting guide1750. In this embodiment, rather than a full channel or groove, a protruding rail1750may be used to guide a surgeon's cutting device (for example, a knife, scalpel, scissors or scissor blade, etc.) in order to make a straight cut along the edge of the ostomy appliance1700. For example, a surgeon may place the edge of a cutting device in the junction1760of the protruding rail and the tapered portion to guide the cutting device. Similar toFIG.17,FIG.18illustrates an ostomy appliance1800that may comprise a faceplate1810, a flange1820, an aperture for a stoma1830, and a tapered portion1840. In this embodiment, however, the tapered portion steps up to the main body of the ostomy faceplate1810at step1850. The junction1860between the tapered portion1840and the step1850may be used to guide a surgeon's cutting device. Note that in some embodiments, the thickness of the step1850may be comparable to the thickness of a drape used in an NPWD, so that upon installation there is a relatively smooth surface between the ostomy appliance and the drape. With reference toFIG.19, a different approach to placing an NPWD as close to an ostomy as possible is shown. Here, ostomy appliance1900may comprise faceplate1910, flange1920, and aperture for a stoma1930. Ostomy faceplate1910may comprise one or more portions1940that are removable, joined by lines of weakness. In this manner, portions1940A,1940B,1940C, etc., may be removed as necessary such that ostomy appliance1910may be placed as close as possible to an NPWD and/or its associated drape or bandage. FIGS.20and21show alternative embodiments to cutting guides.FIG.20illustrates a faceplate2010with combination of an extrusion2020and a channel, slot, or groove2030. In this manner, the depth of the channel2030may be maintained deep enough to guide a cutting device, while not threatening the rigidity of the faceplate2010.FIG.21illustrates an ostomy faceplate2110with a channel, slot, or groove2120formed between two protrusions2130. This may also permit the presence of a channel or groove on the faceplate2110without jeopardizing the structure or structural rigidity of the faceplate2110. Note in accordance with some embodiments of the present invention, the ostomy bags or pouches that mate with or connect to flanges of the present invention may have a corresponding shape or attachment mechanism. In other words, it is anticipated that a “D”-shaped flange on an ostomy appliance or faceplate may require an ostomy bag or pouch with a corresponding mating “D”-shaped attachment device. While the following discussion is exemplary, it is intended to provide background information into the installation and use of an improved ostomy appliance in conjunction with an NPWD. When a patient presents with both a wound and an ostomy, an ostomy appliance may first be installed over or around a stoma. When doing so, an ostomy appliance may have a preexisting aperture, or an aperture may be cut into the appliance. The ostomy appliance may be attached to the patient using adhesive typically attached to the bottom surface of an ostomy appliance. During installation of an NPWD, a drape or bandage may be placed over a wound and may be cut as close to the ostomy device as possible, for example by using a cutting guide disposed at the edge of the ostomy appliance. In accordance with some embodiments, the edge of the ostomy appliance may be tapered such that the drape or bandage may overlap a small portion of the ostomy appliance but may be configured to maintain an adequate or proper seal. It is contemplated that the ostomy appliance—or the portion of the ostomy appliance anticipated to be overlapped by a drape or bandage—may be made of a non-permeable material, a hydrocolloid film, a drape with an acrylic adhesive coating and a silicone layer, etc. It will be understood that the specific embodiments of the present invention shown and described herein are exemplary only. Numerous variations, changes, substitutions and equivalents will now occur to those skilled in the art without departing from the scope of the invention. Accordingly, it is intended that all subject matter described herein and shown in the accompanying drawings be regarded as illustrative only, and not in a limiting sense. | 24,049 |
11857454 | Before any embodiment of the invention is explained in detail, it is to be understood that the present invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings. The present invention is capable of other embodiments and of being practiced or being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. DETAILED DESCRIPTION The matters exemplified in this description are provided to assist in a comprehensive understanding of various exemplary embodiments disclosed with reference to the accompanying figures. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the exemplary embodiments described herein can be made without departing from the spirit and scope of the claimed invention. Descriptions of well-known functions and constructions are omitted for clarity and conciseness. Moreover, as used herein, the singular may be interpreted in the plural, and alternately, any term in the plural may be interpreted to be in the singular. The present invention sets forth an ostomy appliance and/or system that may include one or more of several features, including but not limited to the following: having a straight edge or substantially straight edge of a flange that may be aligned with a patient's or user's skin crease, roll, or fold. In accordance with some embodiments (and as discussed in greater detail below), the design may comprise a straight edge or substantially straight edge as part of an ostomy faceplate or appliance. The straight or substantially straight end of the faceplate or appliance may include a tapered end, may comprise different adhesive than the overall appliance or faceplate, and/or may be made from or comprised of a different material. The present document uses the term “flange,” which is intended to refer to a physical component that assists in the connection between a faceplate or appliance and a bag or pouch. Note that while the present invention generally illustrates faceplates and appliances as being separate from the bag or pouch, one-piece appliance-and-pouch devices are also contemplated. In such combined devices, there is still a flange that provides connection between the bag and the faceplate or appliance—though in combined devices the bag or pouch may not be removable. With reference toFIG.1, a substantially “D” shaped ostomy appliance is illustrated. The appliance inFIG.1comprises a material110that is generally attached to, or adhered to, a patient, and may comprise a flexible and comfortable material, such as flexible wound dressing (for example, DUODERM®—manufactured for ConvaTec). Flange120may comprise a more rigid (though still flexible and bendable) ring that may encircle an orifice130. During use, the orifice130may be aligned with a user's or patient's stoma. A bag or pouch may be attach to the flange120to receive effluent from the stoma. Note that the present invention provides a means to locate an ostomy faceplate or appliance close to user's skin creases, rolls, or folds. The general shape of the outside portion of the appliance can be of any variety, as at least one goal of the invention is to get as close to the crease, roll, or fold by positioning the straight or substantially straight edge of the flange proximate to the crease, roll, or fold. Accordingly, and with reference toFIG.2, the outer material210may be in any shape. Indeed, it is known that nurses, patients, and users often cut or trim this outer material to a desirable shape or size. However, round flanges on ostomies in the prior art prevent location of the appliance directly proximate to a crease, roll, or fold. FIG.2shows an appliance or faceplate with a substantially D-shaped flange220mounted on a square or rectangular material210. Again, an orifice230is positioned inside the flange220to receive a stoma. The present invention is intended to address a need in the art of different shaped ostomy appliances or faceplates to accommodate different body types and needs. For example, a user may have a centerline incision due to certain medical procedures (such as, but not limited to, emergency trauma surgery). The user may also have creases, rolls, or folds. To accommodate the centerline wound (and any negative pressure wound device that may be used to assist in closing and healing of the centerline incision) and a user's body type that may include creases, rolls, or folds, there may be more than one substantially straight edge to the flange on the ostomy appliance or faceplate. With reference toFIGS.3and4, a pie-piece shaped flange320,420may be mounted on a softer material310,410which may be of different shapes. The flange320,420, may again encircle an orifice330,430for receiving a stoma. Similar toFIGS.3and4,FIGS.5and6present an ostomy appliance with a substantially square or rectangular shaped flange520,620, mounted on a softer material510,610. Note that it is contemplated by the present invention that the orifice for the stoma may not be centrally located, but may be positioned asymmetrically within the flange. With reference toFIG.6, the orifice630is shown to be positioned in a corner of the flange620. A user may cut the orifice in the faceplate or appliance to position the orifice in a position necessary to receive a stoma, while aligning the straight or substantially straight edges of the flange with a user's creases, rolls, folds, incisions, wounds, etc. The overall shape of the flange can vary, provided that there is at least one straight or substantially straight edge. For example,FIG.7illustrates an ostomy appliance with a first material710, a flange720, and an orifice730, in which the flange720has several straight and a curved edge.FIG.8shows a triangular shaped appliance, comprising a triangular shaped material810and a triangular shaped flange820, including an orifice830. Note that while the present invention continually discusses straight or substantially straight edges to the flange, it is understood that some creases, rolls, or folds, may be in the shape of an arc. For example, a fold due to an enlarged abdomen may appear linear, but three-dimensionally may have a curve to it.FIG.9shows an oval-shaped ostomy appliance910with an oval-shaped flange920. Again, an orifice930is positioned within the flange920. FIG.10shows a rectangular shaped ostomy appliance1010and flange1020, with substantially parallel, substantially straight edges connected by rounded corners. Again, orifice1030is positioned within the flange1020. FIGS.11and12illustrate an ostomy appliance and flange that may have a more complex shape.FIGS.11and12illustrates an ostomy appliance1110,1210with a flange1120,1220within which is an orifice1130,1230. The overall shape of the flange1120,1220is substantially “T” shaped (though illustrated as an inverted “T”). FIGS.13-16illustrate the point that a “substantially straight edge” may include angle (such as inFIGS.13-15) or curves (such as inFIG.16). Each appliance includes a first material1310,1410,1510,1610, a flange1320,1420,1520,1620, and an orifice1330,1430,1530,1630. InFIG.13, the substantially straight edge of the flange1320may comprise multiple angled lines. InFIG.14, the substantially straight edge of the flange1420may comprise an angle extending away from the inside of the flange1420, while inFIG.15the substantially straight edge may comprise an angle extending toward the inside of the flange1520.FIG.16illustrates an appliance1610with a flange1630with a substantially straight edge comprising a series of curves or arcs. In other words, each embodiment of the ostomy appliance may comprise a flange that has an edge configured to be placed or disposed along an incision, roll, crease, or fold, thereby providing significant advantages over an ostomy appliance with a traditionally round flange. It will be understood that the specific embodiments of the present invention shown and described herein are exemplary only. Numerous variations, changes, substitutions and equivalents will now occur to those skilled in the art without departing from the scope of the invention. Accordingly, it is intended that all subject matter described herein and shown in the accompanying drawings be regarded as illustrative only, and not in a limiting sense. | 8,518 |
11857455 | DETAILED DESCRIPTION For the purpose of representing the principles of the disclosure and associated invention, reference will now be made to the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device and such further application of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art are included as part of the present disclosure. FIG.1shows the continuous, single piece article of a dual durometer polymeric material menstrual disc-shaped device (100) in the inverted “use configuration” comprised of a generally half spherical, thin, flexible, dome shaped catch (120) section that leads to and includes the uniform, continuous, circumferential 360-degree flexible hinge (140) which facilitates the continuous 360-degree continuous rim (160) shown in the dual durometer polymeric material menstrual disc-shaped device (100) use position encompassing the upper parts of the dome shaped catch (120) feature. FIG.2provides a cross-sectional view of the dual durometer polymeric material menstrual disc-shaped device (100) also shown in its inverted “use configuration”. This image more clearly illustrates the domed shaped catch (120) and uniform continuous circumferential 360-degree flexible hinge (140) both, produced from a second polymeric material of lower durometer hardness, attach to the 360-degree continuous rim (160), produced from a first higher durometer polymeric material. The attachment of the continuous 360-degree flexible hinge (140) and 360-degree continuous rim (160) occurs in the “two material bonding area” (117) on the inside diameter of 360-degree continuous rim (160) as shown in this inverted “use configuration”. Notably the “two material bonding area” (117) of the 360-degree flexible hinge (140), produced from the second lower durometer polymeric material, does not surround the 360-degree continuous rim (160), produced from the higher durometer hardness first polymeric material. The 360-degree flexible hinge (140) second polymeric material is overmolded onto the 360-degree continuous rim (160) forming a bond on the inside diameter of the 360-degree continuous rim (160). The dual durometer polymeric material menstrual disc-shaped device (100) is comprised of a first polymeric material that is often liquid silicone rubber of a Shore A of 45 or greater, and the second polymeric material often includes a liquid silicone rubber of a Shore A of or less. FIG.3offers an isometric top view of the dual durometer polymeric material menstrual disc-shaped device (100) in its inverted “use configuration” position more clearly revealing a top view of the continuous 360-degree flexible hinge (140) and 360-degree continuous rim (160). This image more clearly illustrates the domed shaped catch (120) and 360-degree flexible hinge (140) both produced from the second polymeric material attached to the circumferential 360-degree continuous rim (160), produced from the first polymeric material. The “two material bonding area” (117) is concealed by the circumferential 360-degree continuous rim (160) in this isometric top view. FIG.4is an isometric view of the dual durometer polymeric material menstrual disc-shaped device (100) in its elongated configuration. The thin flexible dome shaped catch (120) and the 360-degree flexible hinge (140), both produced from the second lower durometer polymeric material, connects to the much thicker 360-degree continuous rim (160), produced from the first higher durometer polymeric material when compared with the thinner flexible dome shaped catch (120). The “two material bonding area” (117) shown on the inside diameter of the 360-degree continuous rim (160), in this elongated configuration isometric view forms the connection and bond between the 360-degree continuous rim (160) and the 360-degree flexible hinge (140) and thinner flexible dome shaped catch (120). FIG.5offers a cross sectional view of the dual durometer polymeric material menstrual disc-shaped device (100) in its elongated configuration. The thin flexible dome shaped catch (120) and the 360-degree flexible hinge (140), both produced from the second polymeric material, connects to the much thicker 360-degree continuous rim (160), produced from the first polymeric material when compared with the thinner flexible dome shaped catch (120). More specifically the 360-degree continuous rim (160) is placed into a mold that creates the flexible dome shaped catch (120), 360-degree flexible hinge (140) by overmolding onto the 360-degree continuous rim (160) in the “two material bonding area” (117). The connection between the 360-degree flexible hinge (140) and 360-degree continuous rim (160) occurs in the “two material bonding area” (117) on the inside diameter of the 360-degree continuous rim (160) as shown in this elongated configuration. Notably the “two material bonding area” (117) of the 360-degree flexible hinge (140), produced from second polymeric material does not fully surround the 360-degree continuous rim (160). More specifically the second polymeric material creates both a flexible dome shaped catch (120) and the 360-degree flexible hinge (140) that partially travels up into the inside diameter portion of the 360-degree continuous rim (160) to create the “two material bonding area” (117). In this manner there is no need for full circumferential bonding to complete the overall dual durometer polymeric material menstrual disc-shaped device (100) design. The dual durometer polymeric material menstrual disc-shaped device (100) is comprised of a first polymeric material, that often utilizes liquid silicone rubber of a Shore A in a range from 45 to 75, and a second polymeric material with a liquid silicone rubber in a Shore A range of from 5 to 35. The disc-shaped menstrual cup device comprises at least three (3) major features offered in one complete, continuous menstruation disc-shaped device. These at least four features include; a catch, hinge, and a rim. These three featured elements are further described below: 1) The catch provided is a thin-walled, flexible, pliable section of the device that provides a comfortable, dome-shaped element which functions as a device to catch and store menstrual fluid. 2) The hinge connects with the catch to provide a “built-in” living hinge arrangement which allows the thin flexible catch to invert under the rim. The hinge provides an ability to manufacture the rim such that elongation of the menstrual disc design and applied configuration eliminates the possibility of troublesome undercuts to facilitate ease of manufacturing. The “living” hinge enables the catch to be inverted into a more conventional “use” or “usable” configuration. As the menstrual disc-shaped device is placed in an “inverted catch” or “in use configuration” or position, the menstrual disc-shaped device can be effectively positioned under the cervix. This “living” hinge also allows the user/menstruator to flip the catch back up, into the elongated configuration, for ease of cleaning, after removal and draining. This hinge feature enables the user to easily clean the menstrual disc-shaped device by allowing for exposure of all surfaces to running water and/or boiling water during washing cycles to assure proper sanitation. These washing cycles can be performed automatically in an automatic dishwasher. 3) The rim is optimized in order to provide the radial tear and tensile strength necessary so that the device can open easily and safely once the device is located beneath the cervix. The rim is designed to provide the necessary flexibility by ensuring proper flexural strength so that the device can be pinched by the user into a teardrop shape for easy vaginal insertion and location. This procedure is known as “folding”. The 360-degree rim and associated geometry offers a major advantage over conventional designs for ease of removal. Other menstrual disc-shaped devices rotate while in use. The menstrual disc-shaped device without a complete 360-degree rim and hinge which in the inverted use configuration creates a place for the user's finger to naturally grip under the rim in any rotation of the disc can be difficult to grip and extract. The “use configuration” provides a menstruation disc-shaped device that includes the catch in a “flipped” or inverted position that is directed toward the rim, allowing the menstrual disc-shaped device to be inserted for use and creates a place for the user's finger to naturally grip under the rim in any rotation of the disc for removal. FIGS.2and5depict an embodiment of the menstrual disc-shaped device with a rim produced from a firm first material bonded to a more flexible-higher elongation second material that comprises a 360-degree flexible hinge and catch elements. The high elongation hinge and catch aid the menstruator by making the rim easier to grip therefore making it easier to extract the menstrual disc-shaped device. More easily maneuverable and simultaneously minimizes user discomfort due to the firmer rim securing the device and the more flexible, invertible catch and hinge. The uniform continuous circumferential 360-degree flexible hinge provides the ability to easily invert the catch but also facilitates the user in positioning the device to their needs. By creating an enhanced gap between the rim and the hinge with a more flexible softer durometer catch the user has access to more easily provide proper positioning and or removal of the device. In an additional embodiment, alternate configurations of the rim can be manufactured to provide indentions, protrusions and/or “through-orifices” in order to allow the user to more easily grip the disc-shaped device for insertion, repositioning, or removal. Inverting the catch configures the disc to provide a flexible, softer part of the disc so that the disc can be positioned in a more proximate location to the cervical area. 4) Previous designs provided tethers attached on the outside of the rim, which greatly increased the chance of the tether irritating the menstruator. Menstruators are people that come in all shapes and sizes, with different cervix heights and preferred menstrual device or disc-like geometries. The dual durometer polymeric material menstrual disc-shaped device described herein can be modified for different diameters and catch configurations to meet the needs for different users. The most common method of manufacturing the menstrual disc-shaped device is by injection, transfer, or compression molding which enables the menstrual disc-shaped device to be molded in an elongated “wind-sock” shaped design followed by removal and subsequent inversion to create the final rim detail. Thermoplastics and Liquid Silicone Rubber (LSR) plastics are either organic or semi-organic (if inorganic fillers or inorganic monomers and polymers are used) materials that have (as their main attribute) relatively high tensile strength, elongation at break and tear strength due to their high molecular weights. Most engineers and manufacturers consider LSRs as thermosets in that they normally cannot be reused to make the same product. Alternatively, thermoplastics often allow the use of regrind during molding and extrusion operations. For the present disclosure the menstrual disc-shaped device is produced using one or more polymers that may include any of moldable thermosets, thermoplastics and/or elastomers. The list of possibilities includes thousands of variations of these polymers which includes polymer blends, composites, dual layered polymer systems, and also a large number of possible fillers to complete the product. Smooth surfaces and transitions of the menstrual disc-shaped device are required to minimize the potential for irritation, facilitate cleaning, and ease of manufacturability. The boiling water can be heated with one or more heating devices selected from the group consisting of ovens, stovetops, microwaves, wood-burning or other energy sourced stoves, infrared burners, sonic containers, and solar devices. In some cases, dishwashers and/or autoclaves can be used for cleaning and sanitizing purposes. Working Example FIGS.6and7demonstrate how the devices of the present disclosure are utilized in practice.FIG.6shows that both the menstrual cup (960) and dual durometer polymeric material menstrual disc-shaped device (100) collect menstrual fluids and can be worn for up to 12 hours, however their location and use varies slightly. As shown inFIG.6, the menstrual cup (960) is located/placed lower in the vaginal canal (950) usually within an inch of the opening of the vagina and away from the fornix (910) and cervix (930). The menstrual cup (960) does not tuck behind the pubic bone (940). It uses the muscular structure of the vaginal walls to create a seal and prevent leaks. FIG.7reveals the dual durometer polymeric material menstrual disc-shaped device (100) positioned higher up in the vaginal canal (950) in the fornix (910) and sits directly below the cervix (930). The dual durometer polymeric material menstrual disc-shaped device (100) is tucked behind the pubic bone (940) and uses the vaginal walls in the fornix (910) to create a seal. The dual durometer polymeric material menstrual disc-shaped device (100) differs from the menstrual cup (960) in that the user can use the dual durometer polymeric material menstrual disc-shaped device (100) during sexual intercourse to potentially block fluids from entering or exiting the uterus (920). As stated above,FIG.8illustrates one method of holding the menstrual disc shaped device folded in a teardrop shape prior to insertion, whileFIG.9illustrates the tear drop shape of the menstrual disc shaped device. FIG.8shows how the menstrual disc will be held in the hand (1120) while folded in the teardrop shape (1110). Here the dual durometer polymeric material menstrual disc-shaped device (100) is in the “pinched configuration”. The user would then insert their fingers with the folded pinched configuration disc (1110) into their vagina and continue to push it in as far as possible until it reaches the fornix (910) ofFIG.6andFIG.7and opens. The part of the rim that the user can reach with their finger gets tucked under the pubic bone (940) ofFIG.6andFIG.7. Once the dual durometer polymeric material menstrual disc-shaped device (100) ofFIG.7is tucked under the pubic bone (940), it is in the proper preferred location. FIG.9indicates what and how the dual durometer polymeric material menstrual disc-shaped devices (100) are folded into the teardrop shape (1110) prior to insertion. The pinched top of the menstrual discs (100) are folded and pinched into a teardrop shape (1110) that provides for the dual durometer polymeric material menstrual disc-shaped device (100) to achieve the smallest possible shape for easier and more comfortable insertion than has previously been possible. The teardrop shape for the menstrual discs folded in teardrop shape (1110) as shown differs from otherFIG.8shaped alternate possible shapes that created much larger, more uncomfortable, and sometimes impossible shapes that could be used for insertion into the vaginal canal. | 15,427 |
11857456 | DETAILED DESCRIPTION In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. Referring now toFIG.1A, the figure illustrates a computing device10connected via a network interface to a computer server30in an exemplary environment100. As will be further described herein the illustrated computing device10and computer server30may employ the computationally implemented methods, systems, and articles of manufacture in accordance with various embodiments. The computing device10and computer server30, in various embodiments, enable functions of the computing device10. Computing device10illustrated inFIG.1Acan be a tablet computer, in alternative embodiments, the computationally implemented methods, systems, and articles of manufacture in accordance with various embodiments may be embodied in other types of computer systems having other form factors including other types of portable computing devices such as, for example, mobile telephones, laptops, smartphones, e-readers, and so forth. Computing devices can include smartphones, client computers and the like as possible computing devices. As illustrated, the computing device10can include a display, such as a touchscreen as input/output of the computing device10. Computing device10can further include a keyboard, either as a touch input/output keyboard or as an attached keyboard. As further depicted, the computing device10may also be connected to a scanner16. In one embodiment, scanner16can be a scanning camera capable of creating a 3D image of teeth. Referring now toFIG.1B, computing device10is further illustrated with logic modules102, network interface104, user interface110, processors116and memory114. Logic modules102can be implemented using circuit components such as ASIC, logic modules102and other modules shown, may be implemented using a combination of specifically designed circuitry such as ASIC and one or more processors116(or other types of circuitry such as field programmable gate arrays or FPGAs) executing computer readable instructions152. For example, in some embodiments, at least one of the logic modules may be implemented using specially designed circuitry (e.g., ASIC) while a second logic module may be implemented using a processor116(or other types of programmable circuitry such as an FPGA) executing computer readable instructions152(e.g., software and/or firmware). System requirements could dictate a combination of software and firmware and circuitry to meet the embodiments herein, for example, logic modules could be designed to use the most efficient combination of software/hardware/firmware in order to quickly implement methods and systems within the scope of the present disclosure. In some embodiments, a Computer-Aided Design/Computer-Aided Manufacture (CAD/CAM) program operates to implement methods herein for forming a dental appliance from scanned images. For example, a CAD program can create data in a three-dimensional format and transmit the data to a manufacturing device, such as a 3D printer, milling machine, or injection mold creation device. Methods herein include using patient-oriented oral characteristic data to determine placement of button protrusions and vertical displacement automatically by categorizing a patient's sleep apnea needs according to soft tissue characteristics and dentition. Soft tissue as described herein refers to soft palate, gum line, uvula placement as well as hyoid tissue and the like in an oral cavity of a patient. In various embodiments, the memory114of the computing device10may comprise of one or more of mass storage device, read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), cache memory such as random access memory (RAM), flash memory, synchronous random access memory (SRAM), dynamic random access memory (DRAM), and/or other types of memory devices. In various embodiments, the one or more applications160stored in memory114may include, for example, an operating system162, a browser(s)163, and one or more productivity applications164such as a word processing application or an imaging application, scanning application and one or more communication applications166. Computing device10may also include access restricting module106. Access restricting module106of the computing device10can be configured to restrict access via the computing device10or preventing one or more actions by computing device10. Computing device10may also include appliance generation module108coupled to access restricting module106via a bus. Referring toFIG.2, appliance generation module108may be configured to determine that a first user20is an authorized user attempting to operate computing device10. Appliance generation module108can also be configured to determine an established authorized user based on network received data while computing device10is connected to a network connection50. In the case of appliance generation module108, existing in a cloud computing setting or computer server30, appliance generation module108may be configured to determine a network-based authorization for the first user when first logging into network50or cloud computing logging to computer server30. Appliance generation module108can be configured to receive inputs from a scanner16. In some embodiments, appliance generation module108is coupled to a milling device, a three-dimensional printer, or an injection mold creation device. Appliance generation module108can receive CAD/CAM data or other oral characteristic data and/or dentition data to enable creation of a dental appliance in accordance with one or more embodiments herein. Computer server30connecting via network50to the computing device10ofFIGS.1A and1Bcan establish and/or determine a vertical displacement and a forward mandibular position for treating sleep apnea. For example, scanner16and/or molds of a patient's teeth can be examined and used to determine the adjustment needed for treating sleep apnea. Upper and lower trays including button protrusions can be created from molds. For instance, a patient with malocclusion and sleep apnea will require a determination via scanner16or other method. Each patient, depending on the results of scanned teeth and soft tissue and patient feedback, may require a different placement of horizontal and vertical displacement for both treating sleep apnea. Vertical displacement can be by way of lower bite pads or by way of the thickness of a lower dental tray. In embodiments, the vertical displacement is part of the mold, milled appliance or 3D printed dental appliance. In one embodiment, the mold(s) enables pouring of an FDA approved material such as a thermoplastic material or nylon to form an upper and lower tray adapted to fit tightly but removably over upper and lower teeth such that the lower tray creates the forward mandibular position with respect to the upper tray when elastic material is releasably attached to the forward and the rearward portions of the opposite sides of the upper and lower trays, respectively, to enable the forward mandibular position of the lower tray with respect to the upper tray. Button protrusions on the lower dental tray and on the dental upper tray are arranged to enable elastic bands to attach thereto. In one embodiment, the button protrusions are included as part of the mold for injection molding, milled from a “puck” for the dental appliance trays, or directly manufactured during 3D printing. One embodiment includes determining a dimension and elasticity for one or more removably attachable elastic bands adapted to connect the upper and lower tray via protrusions on each of the upper and the lower trays such that the elastic bands create the forward mandibular position of the lower tray with respect to the upper tray. The elastic bands can include a plurality of pairs of elastic bands, each pair being of different length and/or elasticity. In one embodiment, the dental appliance is configured to be worn during sleep. Referring now toFIG.3, the dental appliance can include upper and lower trays that are manufactured using three-dimensional (3D) technologies such as 3D printing or 3D data collection via scanning or the like, that can be sent to a milling device300, as shown inFIG.3. The resulting dental appliance is shown inFIG.4. Referring now toFIG.4, the dental appliance400is shown including an upper tray410, lower tray420, upper button protrusion450, lower button protrusion460and bite pad470. Unlike other dental appliances that include button protrusions and lower bite pads, embodiments herein include bite pads that are not integral with the lower button protrusion but are directly manufactured as part of the dental tray. Direct manufacture, as used herein refers to forming a dental appliance homogeneously in that different parts, such as button protrusions and vertical displacement bite pads appropriate for a patient are manufactured at the same time as the dental trays themselves and incorporated into either a mold, a milled material or printed by a three-dimensional printer. The materials appropriate for a three-dimensional printer can be resin-type materials and materials described in U.S. Pat. No. 9,682,018 to Sadowsky et al., Jun. 20, 2017, “Denture Tooth and Material” which is hereby incorporated by reference in its entirety. As one of skill in the art will appreciate, materials appropriate for dental appliances must be FDA approved. Appropriate materials for resins is further described in Tanaka J, Hashimoto T., Stansbury J W, Antonucci J M, Suzuki K., “Polymer Properties of Resins Composed of UDMA an Methacrylates With the Carboxyl Group” Dental Material Journal 2001; 10:206-215, which incorporated by reference herein in its entirety. Three-dimensional printing, as referred to herein include, but is not limited to, stereolithography (SLA), micro-stereolithography (pSLA), DLP projection, 2PP (two photon polymerization), continuous liquid interface production and material jetting. In embodiments, three-dimensional printing includes a layer-by-layer printing with successive layers formed in discrete layers. For example, a surface with a build plate immersed in a reservoir of a formulation of a polymer/resin component can be exposed to light at wavelengths and intensity to activate a photoinitiator to cause photopolymerization. As one of skill in the art will appreciate, there are other methods of three-dimensional printing such as continuous liquid interphase printing, in which dental trays are built up from a reservoir of photopolymerizable resin. Continuous liquid interphase printing is described in U.S. Patent Publication Nos. 2015/0097315, 2015/0097316, and 2015/0102532, the disclosures of each of which are incorporated herein by reference in their entirety. In some embodiments, the dental appliance can be formed via injection molding. For example, two molds such as mold500illustrated inFIG.5can be used to the upper and lower dental trays. Referring now toFIG.6, a portion of a mold illustrating a negative of a bottom dental tray600is illustrated. Specifically, mold600includes negative teeth640, and negative button protrusions such as610and a negative for bite pads, such as620. Referring now toFIG.7, a positive mold for the bottom dental tray700is shown. Positive mold700includes button protrusions such as710, bite pad720and teeth740. Referring now toFIG.8, a similar mold toFIG.6is illustrated, showing a negative of an upper dental tray. As shown, negative mold800includes button protrusions810,812and negative teeth840. Referring toFIG.9, a positive mold900for the upper dental tray is shown, including button protrusions910,912and teeth940. Referring now toFIG.10, a milling process1000is shown including a solid material, or “puck”1010, milled for an upper dental tray made from an FDA approved material. In one or more embodiments, the material being milled can be an Ethylene Propylene Copolymer or a Polyoxymethlene Copolymer. In other embodiments, the material can be an thermoplastic olefin, thermoplastic polyolefin, or olefinic thermoplastic elastomer. As one of skill in the art will appreciate, different materials can be turned into “pucks” for milling. During the process, the button protrusions1010are milled as shown in1020. Next, as shown in1030, the upper dental tray of a dental appliance is milled from the puck. The bottom dental tray can be milled in a similar process. Thus, the dental appliance can be milled such that the button protrusions and/or the dental pads on the lower dental tray are part of one homogeneous dental tray by direct manufacturing independent of later gluing or cementing of the button protrusions and bite pads. Thus, as shown above, the upper and lower dental trays of a dental appliance can be directly manufactured using a milled process, injection molded process and/or 3D technology. Material appropriate for injection molding of dental appliances include thermoplastics, thermoplastic elastomers and the like. In one or Ethylene Propylene Copolymer or a Polyoxymethlene Copolymer. In other embodiments, the material can be an thermoplastic olefin, thermoplastic polyolefin, or olefinic thermoplastic elastomer Material appropriate for 3D printing technology include thermoset polymers such as light polymerizable liquid materials. In one or more embodiments, the material appropriate for 3D printing includes a crosslinked polymer, such as a polyurethane, a methacrylate or a copolymer. In some embodiments, 3D printing materials can include nylon materials. In one or more embodiments, the materials used for milling and/or injection molding can be provided by Myerson Tooth, Inc., including VisiClear™, and DuraFlex™, which are Ethylene Propylene Copolymers having the following properties as shown in Table 1: TABLE 1TestNominalPhysicalMethodValue UnitDensity-Specific GravityASTM D792.902 sp gr 23/23° C.(Method B)Melt Mass-Flow RateASTM D123840 g/10 min(MFR)MechanicalTensile Strength @ YieldASTM D6384060 psiTensile Elongation @ YldASTM D63812.00%Flexural Modulus (Procedure A)ASTM D7901% Secant: 145000psiImpactNotched Izod ImpactASTM D256.0899 ft lb/in(73° F.)ThermalDTUL @ 66psi-ASTM D648194° F.UnannealedOpticalHazeASTM D10036.00% In another embodiment, the milled or the injection molding material can be provided by DuraCetal™, also available from Myerson Tooth, Inc., which is a Polyoxymethlene Copolymer with the following properties shown in Table 2: TABLE 2TestPhysicalMethodNominal Value UnitSpecific GravityASTM D7921.41Melt Mass-Flow RateASTM D1238(MFR)MechanicalTensile StrengthASTM D6388800 psiTensile ElongationASTM D63860.00%Flexural ModulusASTM D790.38 psi ×106ImpactImpact Strength, Izod,ASTM D2561 ft-lb/innotched 1/8 in (3.18 mm) sectionThermalDeflectionASTM 648Temperature@ 264 psi(1.82 Mpa)DeflectionASTM D648315 fCTemperature@ 66psi(0.45 Mpa) Referring now toFIG.11, dental appliance1100is illustrated with an upper dental tray1102and lower dental tray1104with elastic bands connecting either side of the dental appliance. As shown, on a left side of the dental appliance, an elastic band1108is shown connecting button protrusion button1110and1120. The resulting dental appliance, from injection molding, milling, or 3D printing beneficially does not require added components other than elastic bands as shown inFIG.11because dental appliance is direct manufactured such that the button protrusions and mandibular bite pads do not have to be added later, but homogeneously included in molds, milled pucks or via a 3D generation machine. Prior to the direct manufacturing as disclosed herein, dental trays required different components such as button protrusions and bite pads to be added by gluing or the like or encased in a thermoforming (nonmilled) method. Because direct manufacturing requires placement of button protrusions and bite pads during manufacture of the dental appliance as a whole, the measurements for determining where the button protrusions and the bite pads for each patient are determined prior to the making of the homogeneous dental trays. Referring back toFIG.1A, scanner/camera16, in one embodiment, includes a determination of the necessary oral characteristic data, including dentition data, which can include teeth data and soft palate data, to determine proper placement of button protrusions and bite pads. In one or more embodiments, a method includes determining the amount of vertical component, or height of bite pads for the dental appliance as a function of the shape of the soft palate. In other embodiments, the vertical displacement is determined by the soft tissue of the patient, such as the hyoid shape. In one or more embodiments, a scanner and/or camera such as scanner/camera16detects shape of soft palate. The data is collected as oral characteristic data and provided to a processor which operates to classify the oral characteristics for fabrication of the homogeneous appliance. In one or more embodiments, there are three classifications for a soft palate: short, normal or long. Thus, in one or more embodiments, a method includes determining if the posterior edge of the soft palate is short. For example, if there is about 5 to 7 mm of space between the posterior edge of the soft palate to the posterior wall of the oral pharynx, the soft palate is determined to be short, and a dental appliance will need about 5 to 7 mm of vertical displacement. In some embodiments, to determine the vertical displacement, a scanner can measure the distance from the gingival-tooth crown juncture of the maxillary central to the gingival-tooth crown juncture of the mandibular central. If this distance is, for example, 20 mm and, thus, 7 mm of vertical is desired, in some embodiments, a vertical displacement can be determined such that the bite will have 7 mm of vertical displacement. In some embodiments, a method includes determining if the posterior edge of the soft palate is longer than a normal soft palate. If the soft palate is longer such that the posterior edge of the soft palate has 3 to 4 mm of space between it and the posterior wall of the oral pharynx, in some embodiments, a dental appliance can be made to provide 8 to 10 mm of vertical displacement to keep the soft palate from closing the airway when the patient in a supine position. If the soft palate is very long and webbed shaped with just 2 mm or less of space between the soft palate and the posterior wall of the oral pharynx, the appliance will likely require 11 to 14 mm of vertical. displacement. In one or more embodiments, a scanner determines whether a soft palate is short, long or normal and determines the placement of the uvula with respect to the palate.FIGS.12-17illustrate possible scanned illustrations of patient soft palates. Referring toFIGS.12and13, a profile of a patient's head1200and an open mouth of a patient1300are illustrated.FIG.12illustrates a short palate1210.FIG.13illustrates the same short palate1310from a front perspective. FIG.14illustrates profile1400and a normal palate1410of a patient.FIG.15illustrates an open mouth1500of a patient and a front perspective of a normal palate1510. FIG.16illustrates profile1600and a long palate1610of a patient.FIG.17illustrates an open mouth1700of a patient and a front perspective of a long palate1710. The determination of whether a palate is short, normal or long can be made by a dental professional through examination, or, in accordance with an embodiment, via scanner/camera16collecting data related to the patient. Determining the placement and size of the lower dental tray bite pads is a function of the length of the palate of a patient. Additionally, in some embodiments, maxillary button protrusions on an upper dental tray are placed on each incisal edge, in the embrasure between the right and left cuspids and first bicuspids. The placement of the mandibular button protrusions can be determined by determining a patient's range of motion. In some embodiments, a scanner detects maximal range of motion by measuring before and after extension of the lower jaw. For example, if the patient has only 5-7 mm of potential advancement, the buttons are placed 23 mm apart with the patient's teeth in centric. If the patient has 7-10 mm of potential advancement, the buttons are placed 25 mm apart, and if the patient has 10-17 mm of potential advancement, the buttons are placed 27 mm apart. In one or more embodiments, a method includes determining the location of the buttons on the mandibular arch by occluding the patient's models in centric and placing the center of the mandibular button 23, 25, or 27 mm from the center of the maxillary button. As described above, a scanner/camera takes images/scans of a patient's mouth to determine dentition data and soft tissue data, such as soft palate data and a computer system coupled to the scanner or processor incorporated into a scanner/camera determines the placement of the button protrusions and bite pads as described above. Referring now toFIG.18, an illustration of a dental appliance in accordance with embodiments herein is shown. More particularly, dental appliance1800includes an upper dental tray1802, a lower dental tray1804, four button protrusions1810,1820disposed on the upper dental tray1802, and button protrusions1830,1849disposed on the lower dental tray1804. Lower dental tray1804also is shown including vertical displacement bite pads1850and1860. In one embodiment, the dental appliance includes elastic bands1870and1880disposed on either side of the dental appliance to couple the upper dental tray1802to the lower dental tray1804. Also illustrated inFIG.18is a model1890which includes a patient's teeth. The model can be formed from a scan of a patient and 3D printed or from molds of a patient's teeth. In one or more embodiments, the dentition data includes gum line data to enable retention of the dental appliance for the patient. More specifically, an appliance can be better retained if the trays are designed to fit at the gum line. Thus, in some embodiments, a method includes determining a 3 millimeter distance below a tooth crown-gingival junction on the upper dental tray unless there is a protrusive axial inclination of the incisors. For protrusive axial inclinations of incisor patients, the upper dental tray is formed to reach one third to one half the way up on the anterior teeth. The lower dental tray is formed to reach 3 millimeters below a tooth crown-gingival juncture unless a patient's mandibular incisors also have a protrusive axial inclination. For protrusive axial inclination of mandibular incisor patients, the lower dental tray is formed to reach above the tooth crown-gingival area at the anterior incisors. The gum line data is provided to form the dental trays in 3D model prior to using either milling process or prior to use of mold. As described above, a dental appliance as shown inFIG.18is formed by, in one or more embodiments, a method including receiving oral characteristic data of a patient; processing the oral characteristic data in a server to determine dentition data, a vertical displacement and a forward mandibular position to enable the patient to breathe during sleep by opening an airway of the patient; and forming a dental appliance via direct manufacture using the dentition data, the vertical displacement and the forward mandibular position, the dental appliance including a lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray being homogeneous, the lower dental tray inclusive of a vertical displacement bite pad with the vertical displacement and a first pair of button protrusions, the upper dental tray inclusive of a second pair of button protrusions, the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two elastic bands are attached to connect the upper dental tray and the lower dental tray. In one or more embodiments, the dental appliance is formed by three-dimensional (3D) printing of one or more of a light polymerizable liquid thermoset crosslinked polymer, a polyurethane, a methacrylate or a copolymer. In one or more embodiments, the dental appliance is formed by three-dimensional (3D) printing of a polymerizable resin composition of a urethane monomer of urethane dimethacrylate (UDMA), an acidic monomer, and one or more hydrophobic monomers. In one or more embodiments, the dental appliance is milled or injection molded from one or more of an Ethylene Propylene Copolymer and a Polyoxymethlene Copolymer. In one or more embodiments, the dental appliance is injection molded using a thermoplastic olefin, thermoplastic polyolefin, or olefinic thermoplastic elastomer. In one or more embodiments receiving oral characteristic data of the patient includes scanning by a scanner or camera a mold of the teeth; and transmitting the oral characteristic data to a server. In one or more embodiments receiving oral characteristic data of a patient includes scanning by a scanner of an oral cavity of the patient; imaging the oral cavity to determine the dentition data, wherein the oral characteristic data includes dentition data as one or more images of teeth and a gum line of the patient and one or more images of a soft palate of the patient; and transmitting the oral characteristic to a server. In one or more embodiments the method includes determining via the oral characteristic data the vertical displacement as a function of a shape of the soft palate of the patient. In one or more embodiments the determining via the oral characteristic the vertical displacement as a function of the shape of the soft palate of the patient includes determining a vertical displacement of between 5 and 7 millimeters if the soft palate has between 5 to 7 millimeters of space between a posterior edge of the soft palate to a posterior wall of an oral pharynx of the patient. In one or more embodiments, the determining via the oral characteristic data the vertical displacement as a function of the shape of the soft palate of the patient includes processing the oral characteristic data to measure a distance from a gingival-tooth crown juncture of a maxillary central to a gingival-tooth crown juncture of a mandibular central. In one or more embodiments the determining via the oral characteristic data the vertical displacement as a function of the shape of the soft palate of the patient includes determining if a posterior edge of the soft palate is longer than a normal soft palate with between 3 and 5 millimeters of space between a posterior edge of the soft palate to a posterior wall of an oral pharynx of the patient; and providing the vertical displacement of between 8 and 10 millimeters. In one or more embodiments the determining via the oral characteristic data the vertical displacement as a function of the shape of the soft palate of the patient includes determining if a posterior edge of the soft palate is longer than a normal soft palate and webbed and wherein two millimeters or less of space exists between the soft palate and a posterior wall of an oral pharynx, providing at least 11 to 14 millimeters for the vertical displacement. In one or more embodiments the determining via the oral characteristic data the vertical displacement as a function of the shape of the soft palate of the patient includes determining whether the soft palate is one of short, normal, and long. In one or more embodiments the lower dental tray is inclusive of a first vertical displacement bite pad on a left side of the lower dental tray and a second vertical displacement bite pad on a right side of the lower dental tray wherein a height of each of the first and second vertical displacement bite pads is determined according to the oral characteristic data, the oral characteristic data providing soft tissue data of the patient indicative of airway function. In one or more embodiments the vertical displacement is provided by a thickness of the lower dental tray. Another embodiment is directed to a system including a processor and a non-transitory computer-readable storage medium storing instructions operative when executed on the processor to perform a method including receiving oral characteristic data of a patient; processing the oral characteristic data in a server to determine dentition data, a vertical displacement and a forward mandibular position to enable the patient to breathe during sleep by opening an airway of the patient; and forming a dental appliance via direct manufacture using the dentition data, the vertical displacement and the forward mandibular position, the dental appliance including a lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray being homogeneous, the lower dental tray inclusive of the vertical displacement and a first pair of button protrusions, the upper dental tray inclusive of a second pair of button protrusions, the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two elastic bands are attached to connect the upper dental tray and the lower dental tray. Another embodiment is directed to a method including receiving, by a server, one or more data sets associated with a patient; determining, by the server one or more positions for placement of button protrusions based on the received data sets from a scanner, the received data sets including at least a dentition pattern, a gum line measurement, a palate measurement of a soft palate shape of the patient and a uvula placement measurement with respect to the palate shape of the patient; communicating, by the server the one or more positions for placement of button protrusions and a vertical displacement, the communicating including assigning a value associated with each of the one or more positions for placement of button protrusions, each value representative of a distance between an upper tray button protrusion and a lower tray button protrusion for mandibular advancement; transmitting the value data to one or more of a three-dimensional printer, a milling apparatus and an injection molding apparatus; forming a dental appliance via direct manufacture using the value associated with each of the one or more positions for placement of button protrusions, the dental appliance including a lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray being homogeneous, the lower dental tray inclusive of the vertical displacement and a first pair of the button protrusions, the upper dental tray inclusive of a second pair of the button protrusions, the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two elastic bands are attached to connect the upper dental tray and the lower dental tray. In one or more embodiments, the dental appliance is formed by three-dimensional (3D) printing of one or more of a light polymerizable liquid thermoset crosslinked polymer, a polyurethane, a methacrylate and a copolymer. In one or more embodiments, the dental appliance is one or more of milled and injection molded using one or more of an Ethylene Propylene Copolymer and a Polyoxymethlene Copolymer. In one or more embodiments, the dental appliance is formed by three-dimensional (3D) printing of a polymerizable resin composition of a urethane monomer of urethane dimethacrylate (UDMA), an acidic monomer, and one or more hydrophobic monomers. In one or more embodiments, the dental appliance is injection molded using a thermoplastic olefin, thermoplastic polyolefin, or olefinic thermoplastic elastomer. In one or more embodiments, the vertical displacement is a function of the soft palate shape of the patient. In one or more embodiments, the vertical displacement is provided by one or more of a pair of bite pads on the lower dental tray or by a thickness of the lower dental tray. In one or more embodiments, the gum line determination identifies a maxillary tooth crown-gingival junction and a mandibular tooth crown-gingival junction, the upper dental tray is formed to reach about a three millimeter distance below the maxillary tooth crown-gingival junction on the upper dental tray, and the lower dental tray is formed to reach about three millimeters below the mandibular tooth crown-gingival junction. Another embodiment is directed to a system including a processor and a non-transitory computer-readable storage medium storing instructions operative when executed on the processor to perform a method including receiving, by a server, one or more data sets associated with a patient; determining, by the server one or more positions for placement of button protrusions based on the received data sets from a scanner, the received data sets including at least a dentition pattern, a palate measurement of a soft palate shape of the patient and a uvula placement measurement with respect to the palate shape of the patient; communicating, by the server the one or more positions for placement of button protrusions and a vertical displacement, the communicating including assigning a value associated with each of the one or more positions for placement of button protrusions, each value representative of a distance between an upper tray button protrusion and a lower tray button protrusion for mandibular advancement; transmitting the value data to one or more of a three-dimensional printer, a milling apparatus and an injection molding apparatus; forming a dental appliance via direct manufacture using the value associated with each of the one or more positions for placement of button protrusions, the dental appliance including a lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray being homogeneous, the lower dental tray inclusive of the vertical displacement and a first pair of the button protrusions, the upper dental tray inclusive of a second pair of the button protrusions, the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two elastic bands are attached to connect the upper dental tray and the lower dental tray. Those having skill in the art will recognize that the state of the art has progressed to the point where there is little distinction left between hardware and software implementations of aspects of systems; the use of hardware or software is generally (but not always, in that in certain contexts the choice between hardware and software can become significant) a design choice representing cost vs. efficiency tradeoffs. Those having skill in the art will appreciate that there are various vehicles by which processes and/or systems and/or other technologies described herein can be effected (e.g., hardware, software, and/or firmware in one or more machines or articles of manufacture), and that the preferred vehicle will vary with the context in which the processes and/or systems and/or other technologies are deployed. For example, if an implementer determines that speed and accuracy are paramount, the implementer may opt for a mainly hardware and/or firmware vehicle; alternatively, if flexibility is paramount, the implementer may opt for a mainly software implementation that is implemented in one or more machines or articles of manufacture; or, yet again alternatively, the implementer may opt for some combination of hardware, software, and/or firmware in one or more machines or articles of manufacture. Hence, there are several possible vehicles by which the processes and/or devices and/or other technologies described herein may be effected, none of which is inherently superior to the other in that any vehicle to be utilized is a choice dependent upon the context in which the vehicle will be deployed and the specific concerns (e.g., speed, flexibility, or predictability) of the implementer, any of which may vary. Those skilled in the art will recognize that optical aspects of implementations will typically employ optically-oriented hardware, software, and or firmware in one or more machines or articles of manufacture. The foregoing detailed description has set forth various embodiments of the devices and/or processes via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. In one embodiment, several portions of the subject matter described herein may be implemented via Application Specific Integrated Circuitry (ASICs), Field Programmable Gate Arrays (FPGAs), digital signal processors (DSPs), or other integrated formats. However, those skilled in the art will recognize that some aspects of the embodiments disclosed herein, in whole or in part, can be equivalently implemented in integrated circuitry, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the circuitry and/or writing the code for the software and or firmware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as a program product in a variety of forms, and that an illustrative embodiment of the subject matter described herein applies regardless of the particular type of signal bearing medium used to actually carry out the distribution. Examples of a signal bearing medium include, but are not limited to, the following: a recordable type medium such as a floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), a digital tape, a computer memory, etc.; and a transmission type medium such as a digital and/or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link, etc.). In a general sense, those skilled in the art will recognize that the various aspects described herein which can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or any combination thereof can be viewed as being composed of various types of “electrical circuitry.” Consequently, as used herein “electrical circuitry” includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes and/or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and/or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and/or electrical circuitry forming a communications device (e.g., a modem, communications switch, or optical-electrical equipment). Those having skill in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion or some combination thereof. Those having skill in the art will recognize that it is common within the art to describe devices and/or processes in the fashion set forth herein, and thereafter use engineering practices to integrate such described devices and/or processes into data processing systems. That is, at least a portion of the devices and/or processes described herein can be integrated into a data processing system via a reasonable amount of experimentation. Those having skill in the art will recognize that a typical data processing system generally includes one or more of a system unit housing, a video display device, a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors, computational entities such as operating systems, drivers, graphical user interfaces, and applications programs, one or more interaction devices, such as a touch pad or screen, and/or control systems including feedback loops and control motors (e.g., feedback for sensing position and/or velocity; control motors for moving and/or adjusting components and/or quantities). A typical data processing system may be implemented utilizing any suitable commercially available components, such as those typically found in data computing/communication and/or network computing/communication systems. While particular aspects of the present subject matter described herein have been shown and described, it will be apparent to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from the subject matter described herein and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of the subject matter described herein. Furthermore, it is to be understood that the invention is defined by the appended claims. | 42,371 |
11857457 | DETAILED DESCRIPTION OF THE EMBODIMENTS Objectives, structures, features, and advantages of the present disclosure are hereunder illustrated with specific embodiments, depicted with accompanying drawings, and described below. Referring toFIG.1throughFIG.22, a device for alleviating obstructive sleep apnea, which is provided in an embodiment of the present disclosure, essentially comprises a base1fitted and fixed to an user's head, an adjustment element3movable relative to the base1, a locking element2capable of limiting the movement of the adjustment element3, a resilient element4received in the adjustment element3, a suction member5operating in conjunction with the user's tongue T, and a negative pressure source6for providing a negative-pressure attractive force to the suction member5. Referring toFIG.1throughFIG.3, the base1comprises a mask-shaped mask portion11and a passage portion12protruding forward from the mask portion11. The mask portion11is arcuate in order to cover the user's face. A gap G is formed between the arcuate mask portion11and the negative pressure source6in the front-rear direction. The gap G opens outward in a direction perpendicular to the front-rear direction (as shown inFIG.26). The mask portion11has a pad13facing the user's face to increase the user's comfort while wearing the device. The pad13is made of a conventional, soft material, such as sponge and silicone. The mask portion11further has a plurality of ventilation pores111which are in communication with the gap G and the user's oral cavity. The ventilation pores111ensure that the mask portion11cannot hermetically seal the user's oral cavity. Referring toFIG.1,FIG.2andFIG.3, the base1further comprises a plurality of connection elements14and a plurality of fastening elements15. The connection elements14are disposed at four corners of the mask portion11, respectively. One end of each connection element14and one of the fastening elements15mesh with each other and thus are fixed to each other; hence, the connection elements14are connected to the mask portion11, and the connection elements14are rotatable relative to the mask portion11. The other end of each connection element14is connected to straps (not shown), fixing the base1to the user's head. Referring toFIG.3throughFIG.5, the passage portion12is cylindrical and extends in the front-rear direction, and it is hollow-cored to thereby receive the adjustment element3. The threaded inner surface of the passage portion12meshes with the threaded outer surface of the adjustment element3. The outer surface of the passage portion12dents inward to form a slot121. The slot121extends in the front-rear direction to thereby receive the locking element2. The front end of the slot121opens in a first direction, i.e., a radial direction of the passage portion12(i.e., upward and downward directions in this embodiment), so as to be in communication with the internal space of the passage portion12. The rear end of the slot121extends rearward to thereby penetrate the mask portion11. The middle part of the slot121is defined as a limiting segment1211for preventing complete separation of the locking element2from the passage portion12. The two lateral sidewalls of the limiting segment1211are oblique relative to the first direction and approach each other in the upward direction. In this embodiment, a second direction is defined as the left-right direction and is perpendicular to the first direction and the front-rear direction. In this embodiment, two positioning protruding portions122are protrudingly disposed on the outer surface of the passage portion12to operate in conjunction with the negative pressure source6during the assembly process. The two positioning protruding portions122are disposed on the left and right sides of the passage portion12. Referring toFIG.4andFIG.5, the locking element2enters the slot121from the front end of the passage portion12. The locking element2comprises a retaining portion21fixed to the base1and a resilient arm22for locking the adjustment element3. The retaining portion21is behind the locking element2. In this embodiment, the front end of the retaining portion21operates in conjunction with and interferes with two opposing sidewalls of the slot121, whereas the rear end of the retaining portion21comprises two snap-engagement arms211. Each snap-engagement arm211is resilient and is terminally provided with a snap-engagement bump2111which protrudes in a direction perpendicular to the front-rear direction. The snap-engagement arms211protrude rearward beyond the slot121. The snap-engagement bumps2111are snap-engaged with the rear surface (facing the user's face) of the mask portion11. The resilient arm22is connected to the front end of the retaining portion21. A locking portion221protrudes from the front end of the resilient arm22and protrudes in the first direction toward the interior of the passage portion12to consequently enter the passage portion12, so as to stop the displacement of the adjustment element3. The resilient arm22swings in its entirety in the first direction. In the first direction, the resilient arm22has a thin portion proximate to the locking portion221and a thick portion proximate to the retaining portion21(as shown inFIG.8). The thin portion of the resilient arm22can bend readily, such that the locking portion221can separate from the adjustment element3in the first direction to unlock the adjustment element3. Referring toFIG.6throughFIG.9, the resilient arm22has an unlocking-facilitating portion222which matches a driving element U. In this embodiment, the locking element2uses the driving element U to effectuate unlocking. The unlocking-facilitating portion222has an unlocking groove2221formed by denting the front end surface of the resilient arm22in a rearward direction. The driving element U comprises a body portion U0extending straightly, an unlocking portion U1bending downward from the front end of the body portion U0, and a pressing portion U2bending upward from the rear end of the body portion U0. The unlocking portion U1has an unlocking protruding portion U11which protrudes rearward and operates in conjunction with the unlocking-facilitating portion222. To unlock the locking element2with the driving element U, an operator (such as, patients, family members or medical personnel, etc.) mounts the driving element U on the unlocking-facilitating portion222from behind to cause the unlocking protruding portion U11to enter the unlocking groove2221, has the connection between the body portion U0and the pressing portion U2pressed against the outer surface of the passage portion12to function as a fulcrum, such that the pressing portion U2protrudes outward relative to the outer surface of the passage portion12, and presses the pressing portion U2to cause the driving element U to rotate about the fulcrum, causing the unlocking portion U1to bend upward and thereby driving the locking portion221to separate from the adjustment element3in the first direction. After the locking element2has been unlocked, the adjustment element3undergoes forward and rearward displacement relative to the base1. When the operator stops pressing the pressing portion U2, the resilient arm22relies on its own resilience to restore its initial position and drive the locking portion221into the slot121, thereby locking the adjustment element3anew. In another embodiment, the unlocking protruding portion U11is disposed on the unlocking-facilitating portion222, and the unlocking groove2221is disposed on the unlocking portion U1. Referring toFIG.10andFIG.11, there are shown cross-sectional views taken along the second direction at the limiting segment1211of the slot121when the locking element2is in an unlocked state. For description sake, the part of the locking element2proximate to the adjustment element3refers as a bottom, whereas the part distal to the adjustment element3refers as a top. The width of the top of the resilient arm22is less than the width of the top of the limiting segment1211, whereas the width of the bottom of the resilient arm22is greater than the width of the top of the limiting segment1211; hence, the resilient arm22cannot completely separate from the limiting segment1211of the slot121in the first direction, allowing the limiting segment1211to limit the position of the resilient arm22in the first direction, and allowing the least dimension of the limiting segment1211in the second direction to be less than the greatest dimension of the resilient arm22in the second direction, so as to limit the extent to which the resilient arm22bends and curves and thus mitigate the fatigue of the resilient arm22and extend the service life of the locking element2. Referring toFIG.4andFIG.5, the adjustment element3is received in the passage portion12to assume a hollow-cored cylindrical shape. In this embodiment, the adjustment element3comprises a cylinder31and a rear lid32. The outer surface of the cylinder31has outer thread which meshes with the inner thread of the passage portion12. Owing to the outer and inner threads, the adjustment element3is rotatable and thus capable of undergoing forward and rearward displacement along the passage portion12. Furthermore, owing to the outer and inner threads, the rear lid32is connected to the rear end of the cylinder31. The outer surface of the cylinder31dents inward to form a positioning slot311. The positioning slot311extends forward and rearward to receive the locking element2which has entered the passage portion12. After the positioning slot311has received the locking element2, the sidewall of the positioning slot311and the locking element2block each other, such that the adjustment element3is prevented from rotating along the threads and thus precluded from exiting and being admitted. Referring toFIG.8andFIG.9, the adjustment element3receives part of the resilient element4and part of the suction member5. A front blocking member33is disposed at the front end of the inside of the cylinder31to limit the forward displacement of the suction member5. A rear blocking member34is disposed in the rear lid32to prevent the resilient element4from protruding rearward beyond the adjustment element3. Referring toFIG.8andFIG.9, the resilient element4connects the adjustment element3and the suction member5, such that the suction member5and the adjustment element3move together forward and rearward. Owing to the user's tongue T, it is feasible for the suction member5to move forward and rearward relative to the adjustment element3. The resilient element4provides a resilient force (required for position restoration) to the suction member5movable relative to the adjustment element3, whereas the rear lid32and the cylinder31rotate relative to each other along the threads, such that the extent to which the resilient element4is compressed or extended can be adjusted, thereby adjusting the strength of the resilient force of the resilient element4. In this embodiment, the resilient element4is a spring which fits around the suction member5. The resilient element4has one end abutting against the suction member5and the other end abutting against the rear blocking member34. Referring toFIG.2andFIG.8, the suction member5comprises a tongue fixing portion51, a channel52connected to the tongue fixing portion51, and a connector53connected to the channel52. The tongue fixing portion51is pocket-shaped and encloses the front end of the user's tongue T. When the device is in operation, a negative pressure is transmitted to the tongue fixing portion51, and an attractive force is formed between the inner surface of the tongue fixing portion51and the user's tongue T, such that the user's tongue T is fixed to the tongue fixing portion51. The channel52extends into the adjustment element3to transmit the negative pressure to the tongue fixing portion51. The connector53is held at the front end of the adjustment element3by the front blocking member33and the resilient element4. Referring toFIG.12andFIG.13, there are shown schematic views of how the user's tongue T is fixed in place under a negative pressure by the tongue fixing portion51. The tongue fixing portion51is made of a soft material, such as silicone, and affixed to the surface of the user's tongue T to maintain the negative pressure. A thickened portion511is disposed on each of the upper and lower sides of the front end of the tongue fixing portion51. The thickened portions511work between the user's upper and lower teeth D. The thickened portions511are thicker than the remaining part of the tongue fixing portion51; hence, if the user's teeth D inadvertently abut against the thickened portions511, an occlusion force transmitted to the user's tongue T will be mitigated and spread. The thickened portions511each have an oblique surface5111which is smooth and faces the user's teeth D. The two oblique surfaces5111on the upper and lower sides of the tongue fixing portion51approach each other gradually in the forward direction. When the upper and lower teeth D inadvertently abut against the oblique surfaces5111, the tongue fixing portion51is compressed by the upper and lower teeth D and thus moved rearward, such that the user's teeth D slide forward across the oblique surfaces5111relative to the tongue fixing portion51until the tongue fixing portion51separates from the user's teeth D from behind. Referring toFIG.1,FIG.8andFIG.9, the negative pressure source6is in communication with the connector53via a catheter7, whereas the suction member5sucks on the user's tongue T under the negative pressure generated by the negative pressure source6. The connector53is in communication with the channel52and the catheter7. In this embodiment, the catheter7is U-shaped. Both the channel52and the catheter7are flexible hoses. The connector53comprises an axle portion531and two mouths532disposed at the front and rear ends of the axle portion531, respectively. The mouth532at the front end is inserted into the catheter7. The mouth532at the rear end is inserted into the channel52. A convex portion5321protrudes radially from the outer surface of each mouth532and surrounds the mouth532to widen the catheter7fitting around one mouth532and widen the channel52fitting around the other mouth532. The front and rear ends of the connector53each have a movable hermetic seal element533. The hermetic seal element533is disposed at the rim of the mouth532and has a narrowed portion5331which protrudes radially and inward. The narrowed portion5331abuts against the corresponding channel52or the catheter7, pressing the channel52or the catheter7tightly against the mouth532. One of the widened catheter7and the widened channel52is clamped radially by the corresponding convex portions5321and the hermetic seal elements533. In this embodiment, the hermetic seal elements533and the axle portion531are separately formed and connected by threads. In another embodiment, the hermetic seal elements533and the axle portion531are integrally formed, for example, the hermetic seal element533may be a snap, which can be opened by pressing. Referring toFIG.8andFIG.9, in this embodiment, the dimension of the hermetic seal elements533pressing against the channel52is less than the inner diameter of the resilient element4so as for the hermetic seal elements533to be received in the resilient element4. The hermetic seal element533pressing against the catheter7has an enlarged portion5332. The dimension of the enlarged portion5332is greater than the inner diameter of the resilient element4, such that the enlarged portion5332abuts against one end of the resilient element4to bear the resilient force exerted by the resilient element4, driving the suction member5to restore its initial position. The front end of the enlarged portion5332functions as a stopping portion5333which faces forward to abut against the front blocking member33and thereby limit the forward displacement of the tongue fixing portion51disposed at the rear end of the suction member5. Referring toFIG.8andFIG.9, in this embodiment, the connector53and the channel52are separately formed. In another embodiment, the connector53and the channel52are integrally formed. Referring toFIG.1andFIG.14, the negative pressure source6is mounted on the base1, such that the device for alleviating obstructive sleep apnea is a wearable device. The negative pressure source6is in communication with the channel52via the catheter7to provide a negative pressure to the tongue fixing portion51. The negative pressure source6is an electrical module which comprises multiple functional components. The functional components are enclosed by an external casing61. A through hole611is centrally disposed in the casing61and adapted to receive the passage portion12. An inlet612is disposed on the front side of the casing61to admit the catheter7into the casing61. An outlet613is disposed on the front side of the casing61to discharge gas. A accommodated depression614is disposed on the top side of the casing61to provide accommodated space to the user's nose. Referring toFIG.14throughFIG.19, two rails615are concavely disposed on the surface of the through hole611, and the two rails615are disposed on right and left sides of through hole611. The casing61comprises a front case61A and a rear case61B. A seam616between the front case61A and the rear case61B passes through the rails615. The rails615each comprise a guiding groove6151extending forward and rearward and crossing the seam616and a fixing recess6152connected to the guiding groove6151. An included angle is formed between the direction in which the guiding groove6151extends and the direction in which the fixing recess6152extends. In this embodiment, the guiding groove6151extends in the axial direction (i.e., the front-rear direction) of the through hole611. The fixing recess6152is perpendicular to the guiding groove6151and extends in the circumferential direction of the through hole611. To combine the passage portion12and the casing61, the operator moves the positioning protruding portion122along the guiding groove6151and then along the fixing recess6152before fixing the positioning protruding portion122to the fixing recess6152. In another embodiment, the fixing recess6152extends on the inner surface of the through hole611, and the included angle between the direction in which the guiding groove6151extends and the direction in which the fixing recess6152extends is not equal to 90 degrees. Referring toFIG.16throughFIG.19, in this embodiment, part of the fixing recess6152extends rearward and crosses the seam616to form a fixing segment6152A. The device further has an operating element8. In this embodiment, the operating element8is a resilient rubber ring disposed between the rear case61B and the mask portion11. An assembly process entails exerting an external force on the negative pressure source6to enable the negative pressure source6to move toward the mask portion11, such that the operating element8is compressed by the rear case61B and the mask portion11. After the positioning protruding portion122has entered the fixing recess6152, the external force is no longer exerted on the negative pressure source6and the base1, but the operating element8exerts resilient forces (acting in directions away from each other) on the rear case61B and the mask portion11, such that the positioning protruding portion122and the fixing recess6152move relative to each other in the front-rear direction until the positioning protruding portion122enters the fixing segment6152A. The rails615each further comprise an engaging member6153. The engaging member6153is disposed between the fixing segment6152A and the guiding groove6151. The operating element8keeps exerting a force in the front-rear direction, and the engaging member6153blocks the positioning protruding portion122in the circumferential direction of the through hole611; hence, the positioning protruding portion122is unable to reverse and retreat from the fixing recess6152, thereby fixing the negative pressure source6and the base1to each other. Referring toFIG.14andFIG.16, in this embodiment, the fixing segment6152A extends away from the guiding groove6151and crosses the seam616. In other words, the fixing recess6152is formed by fitting the front case61A and the rear case61B together. Both the fixing segment6152A and the engaging member6153are disposed on the rear case61B, whereas the remaining part of the fixing recess6152is disposed on the front case61A, so as to simplify the injection molding process required for forming the fixing recess6152. In another embodiment, the fixing segment6152A extends in the same direction as the guiding groove6151and crosses the seam616. Both the fixing segment6152A and the engaging member6153are disposed in the front case61A, whereas the remaining part of the fixing recess6152is disposed in the rear case61B. The positioning protruding portion122enters the fixing segment6152A and blocks the engaging member6153, so as to prevent the detachment of the positioning protruding portion122. The operating element8exerts a force under which the rear case61B and the mask portion11approach each other. The operating element8is, for example, a clamp. In another embodiment, the rails615are disposed on the outer surface of the passage portion12, and the positioning protruding portion122is disposed on the inner surface of the through hole611. In this embodiment, the casing61and the base1are separately manufactured and thereafter separably fitted together. In another embodiment, parts of the casing61, namely the front case61A and/or the rear case61B, can be integrally formed with the base1. Referring toFIG.20,FIG.21andFIG.22, the negative pressure source6essentially comprises a negative pressure pump62, a power source67for supplying power to the negative pressure pump62and the like, an electrical connector63for use in external connection, a negative pressure sensor64, a check valve65disposed between the negative pressure pump62and the negative pressure sensor64, and a controller68for receiving and sending a control signal. The negative pressure pump62can be a conventional, small-sized air extracting pump. As suggested by conventional wisdom, the negative pressure pump62in operation extracts gas in order to generate a negative pressure, and the target area for air extraction is located at the tongue fixing portion51. The extracted gas is delivered to the inside of the negative pressure source6via the channel52, the connector53, and the catheter7sequentially. Inside the negative pressure source6, the extracted gas is sensed with the negative pressure sensor64. The negative pressure sensor64is a conventional digital barometric pressure sensor. The negative pressure sensor64is in communication with the tongue fixing portion51and thereby can monitor the magnitude of the negative pressure at the tongue fixing portion51. Then, a measurement obtained by the negative pressure sensor64is sent to the controller68. If the measurement is less than a threshold, the controller68will increase the operating power of the negative pressure pump62; otherwise, the controller68will decrease the operating power of the negative pressure pump62. After being sensed with the negative pressure sensor64, the extracted gas passes through the check valve65. The check valve65is a conventional non-return ball valve dedicated to medical uses. The check valve65only permits the gas to flow unidirectionally from the tongue fixing portion51to the negative pressure pump62. Finally, the negative pressure pump62enables the extracted gas to be discharged from the negative pressure source6via the outlet613. In an ideal situation, even if the negative pressure pump62stops operating, a hermetically-sealed space required to maintain the negative pressure can be formed between the user's tongue T and the check valve65. Thus, the controller68causes the negative pressure pump62to stop operating and thus reduces power consumption as soon as the negative pressure sensor64detects that the negative pressure between the user's tongue T and the check valve65is sufficient to keep the user's tongue T and the tongue fixing portion51fixed to each other. In case of an insufficient negative pressure between the user's tongue T and the check valve65because of the muscular activity of the user's tongue T or for any other reasons, the controller68will restart the negative pressure pump62according to related measurements obtained by the negative pressure sensor64. Referring toFIG.20andFIG.21, in this embodiment, before the extracted gas passes through the check valve65, the negative pressure sensor64directly senses and measures the magnitude of the negative pressure at the tongue fixing portion51. Further, the check valve65shuts out the effect of the negative pressure pump62on the negative pressure sensor64. In this embodiment, the power source67is a built-in rechargeable battery, such as a lithium battery, disposed in the casing61and connected to the electrical connector63while being recharged. In order to reduce risks associated with the recharging process, the controller68instructs the negative pressure pump62to stop operating according to a signal which indicates that the power source67is being recharged during the recharging process carried out to the power source67. In other words, the device is not available for use to prevent users from using the device whenever the recharging process carried out to the power source67is underway. Referring toFIG.22, in this embodiment, an active noise-attenuating unit66is disposed, in an integrated manner, in the negative pressure source6. As shown in the diagram, the negative pressure source6is depicted by a square, because the constituent elements of the active noise-attenuating unit66are separately distributed inside the negative pressure source6. The diagram also shows the connective relationship between the negative pressure pump62and the controller68. The active noise-attenuating unit66receives power from the power source67and electrically connects to the controller68in order to send signals. The active noise-attenuating unit66attenuates noise generated as a result of the operation of the negative pressure pump62. The active noise-attenuating unit66comprises microphones for receiving sound waves of the noise, a noise-attenuating circuit, and speakers for generating reversed phase sound waves. The microphones, circuit and speakers are not shown in the diagram. The microphones are disposed in the vicinity of the negative pressure pump62to receive the noise sound waves from different angles. The microphones convert the received noise sound waves into corresponding noise signals. The noise-attenuating circuit comprises sub-circuits, such as an operator, register, rectifier, and amplifier. The operator generates actual reversed phase sound wave signals according to the received noise signals. The register has a built-in noise signal model for use by the negative pressure pump62. Before the operator receives the noise signals generated by the microphones, the register sends the built-in noise signal model to the operator, such that the operator generates predetermined reversed phase sound wave signals before generating actual opposite-phase sound wave signals. The speakers are disposed in the vicinity of the negative pressure pump62to send reversed phase sound waves at different angles. In response to the received reversed phase sound wave signals, actual or predetermined, the speakers generate reversed phase sound waves for offsetting the noises of the negative pressure source6. Since the generation of the predetermined reversed phase sound wave signals precedes the generation of the actual reversed phase sound wave signals, the predetermined reversed phase sound waves (i.e., first noise-attenuated sound waves) precede the actual reversed phase sound waves (i.e., second noise-attenuated sound waves). Furthermore, since the first noise-attenuated sound waves are not strictly out of phase with the actual noises, their superposition fails to completely offset the noises of the negative pressure source6but ends up with residual noise sound waves. The residual noise sound waves undergo superposition with actual noise sound waves and are received by the microphones to undergo the next instance of active noise-attenuation, so as to generate the second noise-attenuated sound waves. In this embodiment, the power supply to both the negative pressure pump62and the active noise-attenuating unit66is carried out by the power source67and controlled simultaneously by the controller68. The active noise-attenuating unit66and the negative pressure pump62are started simultaneously and shut down simultaneously according to a control signal from the controller68. Thus, it is only when the negative pressure pump62operates that the active noise-attenuating unit66is powered to function, so as to reduce power consumption of the active noise-attenuating unit66and extend endurance of the power source67. Referring toFIG.23throughFIG.25, a device for alleviating obstructive sleep apnea is provided according to the second embodiment of the present disclosure. In this embodiment, the locking element2is a screw. The outer surface of the passage portion12only has one positioning protruding portion122which radially protrudes. The positioning protruding portion122has a threaded hole which is in communication with the inside and outside of the passage portion12. The locking element2meshes with the threaded hole. The bottom of the screw of the locking element2functions as the locking portion221and enters the positioning slot311to fix the adjustment element3in place. In this embodiment, the locking element2is unlocked and locked with a common, appropriate screwdriver. Referring toFIG.23, the negative pressure pump62, the negative pressure sensor64, the check valve65and the power source67are received in the casing61. Referring toFIG.24andFIG.25, unlike the first embodiment, the second embodiment has the following distinguishing technical features. The adjustment element3does not have the rear lid. The adjustment element3comprises a front lid35disposed at the front end of the cylinder31. The front blocking member33is disposed on the front lid35to prevent the escape of the suction member5from the front opening of the adjustment element3. The rear blocking member34is disposed at the rear end of the cylinder31. In this embodiment, the front lid35is received at the front end of the adjustment element3by thread-based meshing. In another embodiment, the front lid35is connected to the inside or outside of the adjustment element3by any other means. According to the present disclosure, the device for alleviating obstructive sleep apnea has advantages as follows:(1) A user plays an active role in operating the adjustment element3, such that the suction member5undergoes relative displacement relative to the passage portion12together with the adjustment element3to thereby alter the course of pulling the user's tongue T, thereby minimizing the user's discomfort while the user is receiving therapy for obstructive sleep apnea.(2) The negative pressure source6is mounted on the base1, such that the device, including the negative pressure source6, can be worn on the user's head to thereby not only shorten the required length of the catheter7connecting the patient and the negative pressure source6but also prevent the catheter7from being pressed, entangled or stretched. Furthermore, with the catheter7being short, the resistance to the flow of the gas flowing through the catheter7decreases, such that the required operating power of the negative pressure source6and thus the noise and weight of the negative pressure source6can be minimized.(3) Since the course of the movement of the adjustment element3is fixed with the locking element2, the adjustment element3can be reused conveniently, so as to avoid the hassle of providing the adjustment element3repeatedly.(4) Before the extracted gas passes through the check valve65, the negative pressure sensor64directly senses and measures the magnitude of the negative pressure at the tongue fixing portion51. Further, the check valve65shuts out the effect of the negative pressure pump62on the negative pressure sensor64.(5) The active noise-attenuating unit66has a built-in noise signal model for use by the negative pressure pump62. Before receiving noise signals generated by the microphones, the register sends the built-in noise signal model to the operator. Thus, the operator generates predetermined reserved phase sound wave signals before generating actual reversed phase sound wave signals, so as to achieve preliminary noise attenuation and enhance user experience.(6) The power supply to both the negative pressure pump62and the active noise-attenuating unit66is carried out by the power source67and controlled simultaneously by the controller68. The active noise-attenuating unit66and the negative pressure pump62are started simultaneously and shut down simultaneously by the controller68according to measurements obtained by the negative pressure sensor64. Thus, it is only when the negative pressure pump62operates that the active noise-attenuating unit66is powered to function, so as to reduce power consumption of the active noise-attenuating unit66and extend endurance of the power source67.(7) The adjustment element3comprises the cylinder31and the rear lid32or comprises the cylinder31and the front lid35. The rear lid32and the front lid35connect to the cylinder31by thread-based meshing and move forward and rearward relative to the cylinder31; hence, the resilient element4has one end abutting against the cylinder31and the other end abutting against the rear lid32or the front lid35. The extent to which the resilient element4received in the adjustment element3is compressed or extended is adjusted through forward and rearward displacement of the rear lid32or the front lid35relative to the cylinder31, thereby adjusting the magnitude of the resilient force of the resilient element4. The present disclosure is disclosed above by preferred embodiments, but the preferred embodiments are not restrictive of the claims of the present disclosure. All equivalent technical changes made to the preferred embodiments in accordance with the accompanying drawings and specification of the present disclosure shall be deemed falling within the claims of the present disclosure. | 34,602 |
11857458 | DESCRIPTIVE KEY10freezable insert device15core assembly20rounded tip25flexible handle30loop35sidewall40non-toxic gel45vibrating applicator50power switch55charging port60holding stand65upright compartment70opening DESCRIPTION OF THE PREFERRED EMBODIMENTS The best mode for carrying out the invention is presented in terms of its preferred embodiment, herein depicted withinFIGS.1through5. However, the invention is not limited to the described embodiment, and a person skilled in the art will appreciate that many other embodiments of the invention are possible without deviating from the basic concept of the invention and that any such work around will also fall under scope of this invention. It is envisioned that other styles and configurations of the present invention can be easily incorporated into the teachings of the present invention, and only one (1) particular configuration shall be shown and described for purposes of clarity and disclosure and not by way of limitation of scope. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure, which is defined by the claims. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one (1) of the referenced items. 1. Detailed Description of the Figures Referring now toFIG.1, a front view of the freezable insert device10, according to the preferred embodiment of the present invention is disclosed. The freezable insert device10(herein also described as the “device”)10, provides a freezable insert particularly suited to be placed in a women's vagina to aid in the reduction of menopausal symptoms of hot flashes and other physical abnormalities. The device10provides for a freezable core assembly15that is generally tapered in design. The distal end of the core assembly15is provided with a rounded tip20which is inserted first into the vagina. The opposite or proximal end of the core assembly15is provided with a flexible handle25to aid in insertion and removal of the device10. A loop30is disposed on the distal end of the flexible handle25to facilitate gripping. It is also envisioned that a string25may be attached to the loop30to facilitate removal of the device10from the vagina. It is envisioned that the device10would be made available in multiple sizes to fit all sizes of users. The range of size measurements would vary between five to thirteen centimeters (5-13 cm) in length, and diameters that vary from one-and-a-half to three and a half centimeters (1.5-3.5 cm). Referring next toFIG.2, a top view of the device10, according to the preferred embodiment of the present invention is depicted. The top view of the device10discloses its circular nature. As expected, the flexible handle25and loop30remain visible. Referring now toFIG.3, a sectional view of the device10, as seen along a line I-I, as shown inFIG.2, according to the preferred embodiment of the present invention is shown. This view provides clarification on the interior construction of the core assembly15. A sidewall35of sufficient thickness to provide structural rigidity to the invention. The sidewall35also provides a sufficient thermal gradient to excessive temperatures (either too hot or too cold) from being transferred out of the core assembly15. It is envisioned that the sidewall35as well as other components of the device10such as the flexible handle25and the loop30would be made of medical grade plastic, silicone, latex, or similar material. The exact material of construction is not intended to be a limiting factor of the present invention. The interior of the core assembly15is filled with non-toxic gel40material including ingredients such as hydroxyethyl cellulose, polyacrylate, and/or vinyl-coated silica gel. The exact product materials as used in the non-toxic gel40are not intended to be a limiting factor of the present invention. While the present invention is intended to provide cooling capabilities by placing it in a standard refrigerator prior to use, it is also envisioned that the device10—could be warmed by placing it in a pot of warm water prior to usage as well. The non-toxic gel40will retain the applied temperature in a safe manner and release it in a controlled and steady state manner. The sidewall35is in direct contact with the freezable core assembly15and is disposed around the perimeter of the freezable core assembly15. Referring next toFIG.4, a front view of the device10, shown with a vibrating applicator45, according to the preferred embodiment of the present invention is disclosed. The vibrating applicator45attaches to the flexible handle25via friction fit. It is intended that the vibrating applicator45allows for easier insertion or application of the device10. The vibrating applicator45is envisioned to be a simple offset weight on a motor that is powered by in internal rechargeable battery in a simple series circuit with a power switch50. A charging port55is also provided to allow for recharging of the internal battery. It is envisioned that the vibrating applicator45may be used during the insertion or application process of the core assembly15only or may be left in place during the entire usage cycle of the device10. The removable nature of the vibrating applicator45allows it to be moved to different device10should more than one (1) cooling (or heating) treatment afforded by a single device10be required. Referring finally toFIG.5, a perspective view of the holding stand60, as used with the device10, according to the preferred embodiment of the present invention is depicted. The holding stand60holds up to six (6) devices10in individual upright compartments65, via upper openings70. The device10would simple be inserted in an upright manner while in a freezer compartment. The storage capabilities provided by the holding stand60aid in maintaining clean and sanitary conditions inside of a freezer as well as an organizational aid to allow for ease of access. It is envisioned that the holding stand60would be made of a plastic in a one-piece molding process. 2. Operation of the Preferred Embodiment The preferred embodiment of the present invention can be utilized by the common user in a simple and effortless manner with little or no training. It is envisioned that the device10would be constructed in general accordance withFIG.1throughFIG.5. The user would procure the device10from conventional procurement channels such as medical supply houses, discount stores, drug stores, mail order and internet supply houses and the like. Special attention would be paid to the overall size of the core assembly15with respect to the user so maximum comfort and cooling capabilities can be provided. After procurement and prior to utilization, the device10would be prepared in the following manner: the device10would be cleaned prior to initial use and in between each usage cycle; multiple device10would be placed in the upright compartments65of the holding stand60and stored in a conventional freezer until frozen; should warming capabilities be required, the device10would be placed in a pot of warm water for several minutes. At this point in time, the device10is ready for usage. During utilization of the device10, the following procedure would be initiated: the user would hold the device10by the flexible handle25and insert it into the vagina; cooling or warming action as afforded by prior placement in a freezer or warm water respectively is then imparted; said cooling action would reduce symptoms of hot flashes and other physical abnormalities during menopause or other obstetric and gynecological treatments where temperature and/or swelling in the vaginal area needs to be modified; should the temperature of the device10be modified such that it is no longer effective; the user may remove the first device10and replace with another. The user may also place the vibrating applicator45on the device10to aid in insertion. As aforementioned described, the vibrating applicator45may be used during the insertion or application process of the device10only or may be left in place during the entire usage cycle of the device10. After use of the device10, it is carefully cleaned, sanitized, and stored in the holding stand60until needed again at future time in a repeating and cyclical manner. The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. | 9,093 |
11857459 | DETAILED DESCRIPTION OF THE INVENTION While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed. The application of ultrasound to a surface of an eye may aid in delivery of drugs. A system may comprise an ultrasound-generating device that may be coupled to drug applicator. The ultrasound may aid in causing the drugs to penetrate to a target site within an intraocular space. The drug applicator may hold one or more drugs that may be delivered. The ultrasound will be delivered through the drug applicator to the eye. In some embodiments, the drug applicator may be separable from the device. The drug applicator may be formed from a material and have a design that may allow for low attenuation of the ultrasound delivered to the eye, while providing a comfortable connection with the eye. The drug applicator may be preloaded with a drug or a drug may be loaded in situ. FIG.1shows one embodiment of a system for ultrasound enhanced delivery of drugs. The system may comprise a delivery unit200, a signal generating unit300, and/or an input and control unit400. The delivery unit200, the generating unit300, and the input and control unit400may be operationally interconnected by communication links501,503,504. Communication links may comprise wired and wireless communications. Preferable communication mechanisms may include direct communication link, such as a WiFi, infrared, optical, radio, or Bluetooth communication link. Preferable communication links may also comprise wired communications, such as any kind of bus connection. The delivery unit200, the generating unit300, and the input and control unit400are preferably integrated together into a single housing and/or are optionally arranged into functional groups and integrated into a number of housings. A single housing may partially or completely enclose the delivery unit, the generating unit, and/or the input and control unit. A housing may or may not comprise one or more internal spaces within which the delivery unit, the generating unit and/or the input control unit may be provided. The delivery unit, the generating unit, and/or input control unit may or may not share one or more internal spaces. In some instances, the units may be separated from one another. The housing may or may be fluid tight (e.g., airtight, watertight). The housing may protect one or more components within from dust, particulates, light, or other external environmental conditions. Similarly, the housing may or may not prevent emissions (e.g., light) or substances from within the housing from leaving the housing. The delivery unit, the generating unit, and/or the input and control unit may share a common support. The common support may bear weight of the delivery unit, the generating unit, and/or the input and control unit. The common support may permit the delivery unit, the generating unit, and/or the input control unit to move together. The common support may maintain a fixed position between the delivery unit, the generating unit and/or the input control unit. The common support may or may not be a housing. Optionally, the delivery unit, the generating unit, and the input and control unit may be part of a housing that is formed as a handheld device. The various units may be integrated into various portions of the handheld device. The various units may or may not be removable or separable from the handheld device. In one example, the input and control unit400may be formed as a hand-held device comprising display and input means; the delivery unit200is preferably formed as a compact, optionally a hand-held, device that is configured to be ergonomically placed in front of the eye100and is further configured to touch the surface (e.g., scleral surface, corneal surface, limbus); and the signal generating unit300is preferably formed in a rugged housing, preferably having a rack compatible form factor. The various units may form a drug delivery device. For instance, the drug delivery device may comprise the delivery unit, the generating unit, and/or the input and control unit. The drug delivery device may comprise a housing. The drug delivery device may or may not comprise an entirety of a drug delivery unit or a portion of the drug delivery unit. The drug delivery device may or may not comprise a drug applicator. The drug delivery device may be reusable. A drug applicator may or may not be reusable. For instance, a drug applicator may be reusable when it is refilled with the same drug or a different drug. The drug applicator may be disposable. In some embodiments, the drug applicator may be a single-use disposable. The signal generating unit300, may comprise a controller302and a signal generator and/or amplifier301. The controller302may be operationally connected to the signal amplifier301. The signal generator and/or amplifier301are operationally connected with the ultrasound transducer202by communication link501. The signal generator and/or amplifier301and the controller302may be arranged in a common housing303of the signal generating unit300. The housing of the signal generating unit may be separate from a housing of a delivery unit200. Alternatively or in addition, the signal generating unit and the delivery unit may share a common housing. In an embodiment of the invention, the controller302may be configured to control the signal generator and/or amplifier301to generate the ultrasound signal. The controller may comprise one or more processors that may generate instructions that are sent to the signal generator and/or amplifier to generate the desired ultrasound signal. The controller may determine desired ultrasound characteristics as described in greater detail elsewhere herein. Additionally or optionally the signal generator and/or amplifier301is configured to amplify the ultrasound signal. The emitted ultrasound signal may have any desired characteristics. Examples of characteristics that may be controlled include wave form, frequency, and/or mechanical index. In one example, the emitted ultrasound may have a sine wave form and have a central frequency between 20 kHz and 100 kHz, more preferably at 40 kHz. Any other wave forms, frequencies, and/or mechanical indexes may be provided, as described elsewhere herein. In an embodiment of the invention, the emitted ultrasound signal may comprise pulsating waves with a duty cycle preferably ranging from 30% to 70% at a preferred pulse repetition rate between 1 Hz and 100 Hz. Various examples of emitted ultrasound signal profiles are provided in greater detail elsewhere herein. In an embodiment of the invention, the mechanical index of the emitted ultrasound signal is not exceeding 0.2 to avoid violent effects, e.g., cavitation effects, and/or tissue damages induced by the emitted ultrasound signal. In some embodiments, the mechanical index of the emitted ultrasound is about 0.2. In some embodiments, the mechanical index may be less than or equal to about 0.01, 0.05, 0.1, 0.12, 0.15, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23 0.25, 0.27, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 0.9. In some instances, the mechanical index may be greater than or equal to any of the values provided, or fall within a range between any two of the values provided. The mechanical index predicts the cavitation activities during the ultrasound application at a particular combination of frequency and intensity. The mechanical index is preferably controlled by a controlling the frequency and/or intensity of the emitted ultrasound signal. In an embodiment of the invention, the emitted ultrasound signal has a spatial average temporal average intensity of less than 4 W/cm2. It is preferred that the intensity is in the range between 0.005 W/cm2and 1 W/cm2. In some embodiments, the spatial average temporal average intensity may be less than or equal to about 0.001, 0.003, 0.005, 0.01, 0.03, 0.05, 0.07, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.6, 0.7, 0.8, 0.9, 0.95, 1, 2, 3, 4, or 5 W/cm2. The intensity may be greater than any of the values provided, or may fall within a range between any two of the values provided. The controller302, the signal generator and/or amplifier301, and the ultrasound transducer202may be collectively referred to as an ultrasound device. The display and control unit400may further comprise display and a user interactive device. The display and control unit400is operationally connected to the ultrasound device and the information sending and/or receiving unit203via communication links501,503,504. The communication links may comprise a cable and/or a wireless connection, or any other type of connection as described in greater detail elsewhere herein. The display and control unit may comprise a separate housing from the ultrasound device, or may share a common housing. In an embodiment of the invention, the display and control unit400may be implemented as an application on a tablet computer, a laptop computer, a desktop computer, a smart phone, or a personal digital assistant. Alternatively or in addition, the display and control unit400may be designed as a standalone device optionally comprising a battery. One or more portions of the drug delivery device may be powered by an on-board power source. For instance, a delivery unit, signal generating unit, and/or display and control unit may be powered by an on-board power source. The power source may comprise one or more batteries. For instance, the power source may comprise one or more primary cell batteries. The power source may comprise one or more rechargeable batteries. The power source may be used to power an ultrasound-generating device. The power source may be within a housing of a drug delivery device. The power source may or may not be removable or detachable from the drug delivery device. In some embodiments, a delivery unit200may comprise multiple portions that may be coupled to one another. For instance, the delivery unit may comprise a drug applicator and an ultrasound-generating device. In some embodiments, the ultrasound-generating device may be part of the drug delivery device. The drug applicator may or may not be part of the drug delivery device. In some embodiments, the drug applicator may be provided separately from the drug delivery device. The drug applicator may be coupled to the drug delivery device. In some embodiments, the drug applicator may be coupled to the drug delivery device in a separable and/or repeatable manner. Details of one embodiment of the delivery unit200are shown inFIG.2. The delivery unit200comprises a drug applicator201, an ultrasound-generating device, such as an ultrasound transducer202, and preferably an information sending and receiving unit203. The drug applicator201comprises at least one space800to hold the drug. The term ultrasound transducer202is including any hardware to produce an ultrasound signal. In an embodiment of the invention, the drug applicator201is formed from a low ultrasound attenuation material. The low ultrasound attenuation material can be at least one selected from the following list: epoxy resin, polyurethane rubber, polycarbonate, nylon 6-6, polyvinyl chloride, polyester, ultra-high molecular weight polyethylene, polypropylene, Teflon, polystyrene, neoprene rubber, polyvinyl alcohol, polydimethylsiloxane, silicone-containing rubber, silicon hydrogel, silicone rubber. Additionally or alternatively the drug applicator201can be formed from a silicon rubber doped with at least one of the following materials: nickel, silver, palladium, tungsten, gold, platinum, silicon oxide, titanium oxide, aluminum oxide, barium sulphate, iron oxide, zirconium dioxide, cerium oxide, bismuth oxide, ytterbium oxide, lutetium oxide, hafnium oxide. The drug applicator may be formed from or may comprise a low ultrasound attenuation material having an ultrasound attenuation less than or equal to about 20, 15, 12, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, or 0.1 dB/(MHz cm). The drug applicator may have an ultrasound attenuation greater than any of the values provided, or falling within a range between any two of the values provided. The low ultrasound attenuation may advantageously facilitate transport of ultrasound from the ultrasound-generating device to the drug applicator, and may eventually reach the target site. If the attenuation is too high, energy may be lost in the ultrasound transmission process, and acoustic output at the delivery site may be lower, which may impede the drug delivery process, or make the drug delivery process less effective. The drug applicator201may be configured to be coupled with a surface of an eye. In an embodiment of the invention, the drug applicator201is configured to be coupled to the scleral surface with a low ultrasound loss at a surface601bdirected towards the eye100. In some embodiments, the drug applicator may be configured to be coupled to a corneal surface. Any description herein of a scleral surface of the eye, may apply to any other portion of a surface of an eye, such as a corneal surface of the eye. In some embodiments, to enhance ultrasound coupling a substance may be applied to the surface601band/or the scleral surface of the eye100. The substance is filling an optional gap601abetween the drug applicator201and the scleral surface of the eye100. The substance can be, for example, an ultrasound coupling agent. The substance may have a gel or liquid form. An ultrasound coupling agent may have an acoustic impedance that is intermediate between a drug applicator and a surface of the eye (e.g., scleral surface, cornea surface, etc.). The acoustic impedance of the ultrasound coupling agent may fall between an acoustic impedance value of the drug applicator and an acoustic impedance value of the surface of the eye where the ultrasound coupling agent is configured to come into contact. In an embodiment of the invention, coupling of the drug applicator201to a surface of the eye, such as the scleral surface, can be improved by the design of the drug applicator201. The drug applicator201may be formed from an elastic material having a Young's modulus of less than 10 GPa. The drug applicator may be formed from an elastic material having a Young's modulus of less than or equal to 20 GPa, 15 GPa, 12 GPa, 10 GPa, 9 GPa, 8 GPa, 7 GPa, 6 GPa, 5 GPa, 4 GPa, 3 GPa, 2 GPa, 1.5 GPa, 1 GPa, 0.5 GPa, or 0.1 GPa. In some instances, the drug applicator may have a Young's modulus greater than any of the values provided, or falling between any two of the values provided. When the drug applicator201is made from a sufficiently elastic material, the drug applicator can be pressed against the eye100and, upon exerting a pressure, the drug applicator201will deform and adapt to the specific form of an individual eye100. The pressure can be evenly distributed on the scleral surface and the user experience is improved. In some embodiments, a pressure variation over the sclera surface where the drug applicator contacts the eye may be less than 5 MPa, 4 MPa, 3 MPa, 2 MPa, 1 MPa, 500 kPa, 300 kPa, 200 kPa, 100 kPa, 50 kPa, 30 kPa, 20 kPa, 15 kpa, 10 kPa, 7 kPa, 5 kPa, 3 kPa, 2 kPa, 1 kPa, 0.5 kPa, 0.1 kPz, 0.05 kPa, or 0.01 kPa. In addition, the gap601abetween the scleral surface and the drug applicator201is minimized and the ultrasound coupling is improved. In some embodiments, the drug applicator may directly contact the surface of the eye. The drug applicator may contact the surface of the eye without requiring an intermediary device or substance. In some embodiments, to enhance the contact between the drug applicator and the surface of the eye, the drug applicator may be shaped or formed to provide a large contact area with the surface of the eye. For instance, the drug applicator may be shaped or formed to have at least a 0.1 mm2, 0.5 mm2, 1 mm2, 1.5 mm2, 2 mm2, 3 mm2, 5 mm2, 7 mm2, 10 mm2, 15 mm2, 20 mm, 30 mm2, 40 mm2, 50 mm2, 75 mm2, 1 cm2, 1.5 cm2, 2 cm2, or 3 cm2area of contact between the drug applicator and a surface of the eye, such as the sclera of the eye. It is an advantage of the present invention over the prior art, that the delivery performance is not influenced by the stand-off distance d of the drug applicator201. Therefore, deformation of the drug applicator201is possible, without compromising the drug delivery performance. In an embodiment of the invention, the drug applicator201is configured to be mechanically coupled to the drug delivery system. In an embodiment, the drug applicator201is configured to be coupled to the ultrasound transducer202. The coupling may comprise a mechanical coupling and may hold the drug applicator201in a fixed position relative to the ultrasound transducer202, preferably in a fixed position at the ultrasound transducer202. The coupling may further comprise a low loss ultrasound coupling of the drug applicator201to the ultrasound transducer202. The low loss ultrasound coupling is preferably improved by using a substance at an interface602between the drug applicator201and the ultrasound transducer202. The substance is preferably an ultrasound coupling agent. The mechanical coupling preferably is a releasable mechanical coupling that is designed for coupling different drug applicators201to the ultrasound transducer202. The different drug applicators201preferably have a different size and/or a different form factor. Further examples of couplings between the drug applicator and the ultrasound transducer are provided in greater detail elsewhere herein. Any description herein of an ultrasound transducer202may apply to any type of ultrasound-generating device, and vice versa. The ultrasound transducer may be based on a design of flexural mode of vibration. A flexural transducer may advantageously produce a desired ultrasound frequency and/or intensity with a relatively low excitation voltage, low weight, and/or small size. In alternative embodiments, a stacked ceramic design of ultrasound transducer may be used. The ultrasound transducer may produce any frequency of ultrasound. For instance, the ultrasound transducer may produce a frequency of less than or equal to about 1 kHz, 5 kHz, 10 kHz, 20 kHz, 25 kHz, 30 kHz, 35 kHz, 37 kHz, 39 kHz, 40 kHz, 41 kHz, 43 kHz, 45 kHz, 50 kHz, 55 kHz, 60 kHz, 65 kHz, 70 kHz, 80 kHz, 90 kHz, 100 kHz, 120 kHz, 150 kHz, 200 kHz, 300 kHz, 400 kHz, 500 kHz, 600 kHz, 700 kHz, 800 kHz, 900 kHz, 1 MHz, 1.5 MHz, 2 MHz, 3 MHz, or 5 MHz. The ultrasound transducer may produce a frequency greater than any of the frequency values provided herein, or falling within a range between any two of the values provided herein. The ultrasound transducer may produce any ultrasound intensity. For instance, the ultrasound transducer may produce an intensity of less than or equal to about 0.001, 0.005, 0.01, 0.03, 0.05, 0.07, 0.1, 0.11, 0.12 0.13, 0.14, 0.15, 0.17, 0.2, 0.25, 0.3, 0.35, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.2, 1.5, 2, 2.5, 3, 5, or 10 W/cm2. The ultrasound transducer may produce an intensity greater than any of the intensity values provided herein, or falling within a range between any two of the values provided herein. In some embodiments, the ultrasound transducer may have an excitation voltage of less than about 0.1, 0.5, 1, 3, 5, 10, 15, 20, 22, 25, 27, 30, 33, 35, 40, 45, 50, 60, 70, 80, 90, 100, 120, 150, 200, 300, 500 VRMS. The excitation voltage may be less than any of these values while allowing the ultrasound transducer to operate at a frequency value as provided herein, or an intensity value as provided herein. In some embodiments, the excitation voltage may be greater than any of the values provided herein, or within a range falling between any two of the values provided herein. The ultrasound transducer may be of a low weight. For instance, the ultrasound transducer may weigh less than 1 g, 5 g, 10 g, 20 g, 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, 110 g, 120 g, 130 g, 150 g, 170 g, 200 g, 225 g, 250 g, 300 g, 350 g, 400 g, 500 g, 600 g, 700 g, 800 g, 1 kg, 2, kg, 3 kg, or 5 kg. The ultrasound may weigh less than any of these values while allowing the ultrasound transducer to operate a frequency value as provided herein, or an intensity value as provided herein. In some embodiments, the weight may be greater than any of the values provided herein, or within a range falling between any two of the values provided herein. The ultrasound transducer may be of a small size. For instance, the ultrasound transducer may have a maximum dimension (e.g., length, width, height, diagonal, or diameter) of less than 1 mm, 3 mm, 5 mm, 7 mm, 10 mm, 12 mm, 15 mm, 17 mm, 20 mm, 22 mm, 25 mm, 27 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 120 mm, 150 mm, 175 mm, 200 mm, 250 mm, or 300 mm. The ultrasound may have a maximum dimension less than any of these values while allowing the ultrasound transducer to operate a frequency value as provided herein, or an intensity value as provided herein. In some embodiments, the maximum dimension may be greater than any of the values provided herein, or within a range falling between any two of the values provided herein. In some embodiments, the ultrasound transducer may have a volume of less than 0.1 cm3, 0.5 cm3, 1 cm3, 1.5 cm3, 2 cm3, 2.5 cm3, 3 cm3, 4 cm3, 5 cm3, 6 cm3, 7 cm3, 8 cm3, 9 cm3, 10 cm, 12 cm3, 15 cm3, 17 cm3, 20 cm3, 25 cm3, 30 cm3, 35 cm3, 40 cm3, 50 cm3, 70 cm3, 100 cm3, 120 cm, 150 cm3, 200 cm3, 250 cm3, 300 cm3, 400 cm3, 500 cm3, 750 cm3, or 1000 cm3. The ultrasound may have volume less than any of these values while allowing the ultrasound transducer to operate a frequency value as provided herein, or an intensity value as provided herein. In some embodiments, the volume may be greater than any of the values provided herein, or within a range falling between any two of the values provided herein. Providing an ultrasound transducer with any of these characteristics may advantageously permit the ultrasound transducer to be used in medical applications for the eye and other soft tissue. The compact size and/or weight may allow the ultrasound transducer to be used on a portable drug delivery device. The ultrasound transducer may have any form factor. In some instances, the ultrasound transducer may have a form factor that may fit to a drug applicator. The ultrasound transducer may have a form factor that may allow the drug applicator to fit to the ultrasound transducer at an interface. An interface can be indirect contact with the drug applicator, or within a distance where the interface can be in contact with air, gas, water, gel, or other low ultrasound attenuation materials to prevent a reduction of the ultrasound. In some examples, the ultrasound transducer may have a triangle, square, round, ring shape, or other shape (such as those provided elsewhere herein) form factor at the interface. The interface of the ultrasound transducer can be formed of a single or multiple ultrasound transducers, which can be adjusted as necessary to achieve a desired shape. In some instances, the desired shape may include a circle or any other shape, as provided elsewhere herein. The desired shape may have an interior space. The interior space may be provided in the middle. The interior space may allow for combinations of the ultrasound transducer with additional features. For instance, the added features in the interior space could be coupled with the ultrasound transducer202at an interface202cinside the transducer to connect them to energy, control, or data transfer. Added features202c-ecan comprise an emitting device, such as a wavelength emitting device202csuch as an LED lamp, UV lamp, or light bulb, a wavelength recording device, such as a camera202dor microphone202e. Added features may be used in combination with a lens202f, which may adjust wavelengths. For instance, emitted wavelengths may be adjusted (e.g., focused, condensed, diffracted, filtered, reflected, split, etc.). Measured wavelengths can also be adjusted (e.g., magnified, focused, diffracted, filtered, reflected, split, etc.). The added features to the ultrasound transducer can be used for a variety of applications, such as causing chemical reactions such as UV cross-linking, and/or target site illumination plus video recording with a camera as described in greater detail elsewhere herein. This may allow a practitioner to examiner an eye prior to, during, and/or after treatment, for instance cornea crosslink (CXL) through UV light or VEGF drug delivery treating diabetic retinopathy or macular degenerations. In an embodiment of the invention, the information sending and/or receiving unit203is arranged and configured such that the information sending and/or receiving unit203can retrieve information about the drug applicator201and/or the drug when the drug applicator is coupled to the application head. In order to be able to identify the drug applicator201, the information sending and/or receiving unit203comprises reading means configured to read information related to the drug applicator201. The reading means preferably include a reader for a human- or machine-readable label and/or an RFID label. FIG.3shows an additional example of an embodiment of the delivery unit, in accordance with an embodiment of the invention. A delivery unit200may comprise a drug applicator201, and an ultrasound-generating device, such as an ultrasound transducer202, The delivery unit may also comprise an information sending and receiving unit203. The drug applicator201comprises at least one space800to hold the drug. The delivery unit may be configured to come into contact with an eye100. A surface601bof the drug delivery unit may be configured to face the eye and/or deliver ultrasound to the eye. The surface may optionally be configured to deliver drugs to the eye. A gap601amay or may not be provided between the eye-facing surface601bof the delivery unit and a surface of the eye, such as the sclera or cornea. The drug applicator201may or may not be removable from the ultrasound-generating device202. The drug applicator may have any type of shape for a desired application. In some embodiments, different drug applicators with different form factors may be swapped in and out. Different drug applicators with different characteristics (e.g., size, shape, material, elasticity, holding different drugs, attenuation properties) may be exchanged for one another. For example, a first drug applicator having a first set of characteristics may be coupled to the ultrasound-generating device. The first drug applicator may be removed. A second drug applicator having a second set of characteristics may be coupled to the ultrasound-generating device. The first set and second set of characteristics may be different from one another. The first set and second set of characteristics may or may not share one or more of the same characteristics. An information sending and/or receiving unit203may be operably coupled to the drug applicator and/or the ultrasound-generating device. The information sending and/or receiving unit may receive information about the drug applicator. The information sending and/or receiving unit may be able to sense, with aid of one or more sensors, when a drug applicator is coupled to the ultrasound-generating device and/or when a drug applicator is not coupled to the ultrasound-generating device. The presence and/or absence of a drug applicator may be detected. The information sending and/or receiving unit may be able to detect information about a drug applicator coupled to the ultrasound-generating device. The information may include type of drug applicator, one or more characteristics of the drug applicator, and/or an identifier or other information about the specific drug applicator (e.g., serial number, batch number, drug name, date of manufacture, etc.). The information sending and/or receiving unit may include a sensor that may capture information about a presence and/or absence of the drug applicator, or that may be able to collect information about the drug applicator (e.g., read a label of the drug applicator, measure a characteristic of the drug applicator, receive information emitted by the drug applicator). Examples of sensor types may include vision sensors (e.g., imaging devices capable of detecting visible, infrared, or ultraviolet light, such as cameras), proximity sensors (e.g., ultrasonic sensors, lidar, time-of-movement cameras), inertial sensors (e.g., accelerometers, gyroscopes, inertial measurement units (IMUs)), pressure sensors (e.g., barometers), audio sensors (e.g., microphones) or field sensors (e.g., magnetometers, electromagnetic sensors). Any suitable number and combination of sensors can be used, such as one, two, three, four, five, or more sensors. Optionally, the data can be received from sensors of different types (e.g., two, three, four, five, or more types). Sensors of different types may measure different types of signals or information (e.g., images, sounds, signals, position, proximity, pressure, etc.) and/or utilize different types of measurement techniques to obtain data. For instance, the sensors may include any suitable combination of active sensors (e.g., sensors that generate and measure energy from their own source) and passive sensors (e.g., sensors that detect available energy). In some embodiments, multiple types of sensors may be used to detect information regarding the drug applicator. In one example, an optical sensor may read a visual marker on-board the drug applicator. Examples of visual markers may include labels, words, numbers, characters, shapes, symbols, icons, barcodes, QR codes, a sequence of one or more flashing lights, or any other type of visual marker. In another example, the drug applicator may be an RFID reader that may read RFID information from the drug applicator. In another example, the drug applicator may comprise an infrared reader that may read infrared information being emitted by the drug applicator. In some embodiments, the information sending and/or receiving unit may comprise a communication unit that may receive information from a separate sensor or from the drug applicator. Additionally or alternatively to capturing information about the drug applicator, the information sending and/or receiving unit may capture information relating to the ultrasound-generating device. The information sending and/or receiving unit (and any sensors thereof) may be located in close proximity to the drug applicator and/or the ultrasound transducer. The information sending and/or receiving unit may aid in measurement and regulation of input cycle information. Information regarding a specific ultrasound cycle such as, but not limited to, single cycle time, cycle repetition, ultrasound intensity, ultrasound frequency and potential additional features may be sent from a signal generating unit300. Information may be sent to the ultrasound generating device202from a signal amplifier301through a communication link501. The information sending and/or receiving unit203may measure the ultrasound-generating device202output and send information back to the controller302which may back regulate the signal generator and/or amplifier301. Next to the general regulation of the ultrasound output and input, the information sending and/or receiving unit203can comprise a sensor, such as any sensor as previously described. For instance, one or more sensors may measure temperature, ultrasound frequency and/or intensity. Additional sensors and/or device may comprise a camera, electrode, tonometer, timer, scanning device, or lamp. The signal generator and/or amplifier301may receive signals from any of the sensors and/or devices. The signal generator and/or amplifier301may send information to the signal generating unit300and/or the display and control unit400, where parameters may be read and adjusted. The information sending and/or receiving unit may or may not comprise one or more processors on-board the unit. The information sending and/or receiving unit may or may not process information gathered by the sensors. The information sending and/or receiving unit may determine the presence or absence of a drug applicator and/or information about the drug applicator. The information sending and/or receiving unit may or may not send raw or formatted data to another portion of the drug delivery device to be processed. The information sending and/or receiving unit may be located anywhere on the drug delivery unit. In some embodiments, the information sending and/or receiving unit may be located on or near an ultrasound-generating device. The information sending and/or receiving unit may be located on or near an interface of the ultrasound-generating device configured to couple with the drug applicator. The information sending and/or receiving unit may be located on or at a side of the ultrasound-generating device configured to couple with the drug applicator. The information sending and/or receiving unit may be located on or in a surface of the ultrasound-generating device. An information sending and/or receiving unit may be embedded in the ultrasound-generating device. The information sending and/or receiving unit or a portion thereof may or may not be provided on the drug applicator. The information sending and/or receiving unit203may be operably coupled with a communication link502. The communication link may be a wired or wireless communication mechanism. The sending and/or receiving unit may send information about the drug applicator, which may include the presence or absence of the drug applicator, to another portion of the drug delivery device, via the communication the link. The information sending and/or receiving unit may or may not receive information via the communication link. In some embodiments, instructions may be sent to the information sending and/or receiving unit that may affect operation of the information sending and/or receiving unit. FIGS.4A to4Cshow schematic examples of a coupling701between a drug applicator201and an ultrasound-generating device202, in accordance with embodiments, of the invention. The drug applicator may be coupled to the ultrasound-generating device prior to operation of the drug delivery device. The coupling may be an interface between the drug applicator and ultrasound-generating device. For instance, the drug applicator may directly contact the ultrasound-generating device via the interface, which may be the coupling. In other instances, the coupling may be an intermediary component. The drug applicator may contact the ultrasound generating device via the intermediary component. The coupling may have any form or configuration between the ultrasound-generating device and the drug applicator. The schematics are provided to show a relationship between the ultrasound-generating device and the drug applicator, and coupling illustrated therein is not limited to the depictions provided. The ultrasound-generating device is operably coupled to the drug applicator via the coupling. FIG.4Ashows a schematic example of a coupling701between a drug applicator201and an ultrasound-generating device202. In some instances, the coupling may have a large surface area contact with the ultrasound-generating device and/or the drug applicator. For instance, the surface area contact may be maximized. For instance, the coupling may have a cross-sectional area greater than or equal to the cross-sectional area of the ultrasound-generating device, and/or the surface area of the drug applicator. The coupling may have a surface area that matches or is greater than the surface area of the ultrasound-generating device that comes into contact with the coupling, and/or the surface area of the drug applicator that comes into contact with the coupling. An increased surface area may allow the ultrasound signals from the ultrasound-generating device to be delivered to drug applicator in an increased manner. This may be desirable when less attenuation from the ultrasound-generating device to the drug applicator and/or the surface of the eye is desired. FIG.4Bshows an additional schematic example of a coupling701between a drug applicator201and an ultrasound-generating device202. In some instances, the coupling may have a smaller surface area contact with the ultrasound-generating device and/or the drug applicator. For instance, the surface area contact may be less than a total surface of the ultrasound-generating device and/or drug applicator. For instance, the coupling may have a cross-sectional area less than or equal to the cross-sectional area of the ultrasound-generating device, and/or the surface area of the drug applicator. The coupling may have a surface area that matches or is less than than the surface area of the ultrasound-generating device that comes into contact with the coupling, and/or the surface area of the drug applicator that comes into contact with the coupling. A decreased surface area may allow the ultrasound signals from the ultrasound-generating device to be delivered to drug applicator in a controlled manner. In some embodiments, the dimensions of the coupling mechanism may be selected to allow for a desired degree of ultrasound-attenuation. In some instances, the coupling mechanism may be selected to provide a desired form factor of the device. The desired form factor may depend on a design to permit the drug applicator to be attached or detached from the ultrasound-generating device in an easy and repeatable manner. FIG.4Cshows a schematic example of a coupling701between a drug applicator201and an ultrasound-generating device202. In some instances, the ultrasound-generating device may be coupled to a drug applicator by being inserted into a casing201dof the drug applicator. The coupling may be provided within the casing of the drug applicator. For instance, the surface area contact may or may not be maximized. In some embodiments, a drug applicator may be inserted into a casing of the ultrasound-generating device. The coupling may be provided within the casing of the ultrasound-generating device. The coupling may be formed of or may comprise a coupling medium. A coupling medium may be provided in an interface between the drug applicator and the ultrasound transducer. The coupling medium may be in a solid, liquid, suspension, and/or gel form. The coupling may be formed from a rigid, semi-rigid, or elastic material. The coupling medium may be formed from a low attenuation material. The coupling medium may have a thickness d. The thickness may be equal to a multiple of λ, where λ is a wavelength. The thickness may be a multiple of λ/4. The thickness may be an odd multiple of λ/4. An odd multiple may be an odd whole number (e.g., 1, 3, 5, 7, . . . ). This may improve or optimize impedance matching of the ultrasound-generating device (e.g., ultrasound transducer) and the drug applicator, thus allowing the ultrasound waves to transmit from the transducer to the target site. The wavelength λ, may be calculated by the following: λ=c/fr where c is the propagation speed in the coupling medium, and fris the resonance frequency. The propagation speed c may depend on the material type of the coupling medium. The propagation speed may depend on one or more physical characteristics of the coupling medium. For instance, the propagation speed may depend on elastic properties, density, or temperature of the coupling medium. Thus, the thickness of the coupling medium may be proportional to the wavelength. The thickness of the coupling medium may be directly proportional to the wavelength. The thickness of the coupling may be linearly proportional to the wavelength. The thickness of the coupling may be proportional (e.g., directly proportional, linearly proportional) to the propagation speed. The thickness may be proportional to the resonance frequency. The thickness may be inversely proportional to the resonance frequency. The thickness may be linearly inversely proportional to the resonance frequency. An interface between the drug applicator and the ultrasound-generating device may comprise a coupling medium having a thickness that is a multiple of a propagation speed of the coupling medium over the resonance frequency of the coupling medium. The coupling medium may have a thickness that is an odd multiple of a propagation speed of the coupling medium over four times a resonance frequency. In some embodiments, the stand-off distance between the drug applicator and the ultrasound-generating device may depend on the thickness as described. The stand-off distance between the drug applicator and the ultrasound-generating device may depend on a design of a casing of the drug applicator. Alternatively or in addition, the stand-off distance between the drug applicator and the ultrasound-generating device may depend on a design of a casing of the ultrasound-generating device. The stand-off distance may depend on a thickness of any component that may connect the drug applicator and the ultrasound-generating device. A coupling between the drug applicator and the ultrasound-generating device may occur by hand. Manual attachment and/or detachment may occur between the drug applicator and the ultrasound-generating device. The coupling may require use of two hands, or may be completed using only a single hand. A coupling between the drug applicator and the ultrasound-generating device may be effectuated without use of a tool. The coupling between the drug applicator and the ultrasound-generating device may comprise a simple release mechanism (e.g., quick-release mechanism). The simple release mechanism may comprise less than or equal to one, two, three, four, five, or six motions by hand. Examples of a single motion by hand may comprise a twist, pull, push, movement of a lever, depression of a button, a flip of a switch, or any other simple motions. Each of the motions may be in a single direction (e.g., axial direction, lateral direction, vertical direction, rotational direction, etc.). One or more, or all of the motions may be executed manually without use of a tool. The user may not need to exert any excessive force in performing any of the motions. Easy manual attachment and detachment between the drug applicator and ultrasound-generating device may permit the use of the disposable drug applicators by a drug delivery device. The various drug applicators can be swapped in and out as needed. The drug applicators can be easily attached for use with the drug delivery device, and then detached when the drug applicator is used and no longer needed. This may also advantageously allow for using different types of drug applicators with the same drug delivery device. FIGS.5A to5Bshow examples of how a drug applicator and an ultrasound-generating device may be coupled to one another. In one example, at least one of the drug applicator or the ultrasound-generating device may be at least partially inserted into the other. A drug applicator case ben at least partially inserted into the ultrasound-generating device, or vice versa. For instance, a drug applicator201may comprise a drug applicator case201d. The drug applicator may couple with the ultrasound-generating device202. The ultrasound-generating device may be at least partially inserted into the drug applicator case. The ultrasound-generating device may comprise one or more pins202g. The pins may protrude from an exterior surface of the ultrasound-generating device. The pins may be positioned so that they can click in a case lock201eof the drug applicator case201d. In some embodiments, the case lock may comprise one or more slots, cut-outs, grooves, or other mechanisms that may receive the pins. The case lock may have a shape that may allow the pins to lock into the case lock. The case lock may guide the pins along at least two different directions. The case lock may terminate at a circle or hook that may aid in keeping the ultrasound-generating device and the drug applicator together. Any description herein of pins may apply to any protruding portions that may be accepted into the case lock of the drug applicator case. In other embodiments, the reverse may be provided wherein the ultrasound-generating device may comprise one or more slots, cut-outs, grooves or other mechanisms that may receive protruding portions, such as pins, from the drug applicator case. In some embodiments, the pins from the drug applicator case may be formed on an interior surface of the drug applicator case, so they may form the case lock of the ultrasound generating device when the ultrasound generating device is inserted into the drug applicator case. In another example, an ultrasound-generating device202may comprise an ultrasound-generating device case. The ultrasound-generating device may couple with a drug applicator. The drug applicator may be at least partially inserted into the ultrasound-generating device case. The drug applicator may comprise one or more pins. The pins may protrude from an exterior surface of the drug applicator. The pins may be positioned so that they can click in a case lock of the ultrasound-generating device. In some embodiments, the case lock may comprise one or more slots, cut-outs, grooves, or other mechanisms that may receive the pins. The case lock may have a shape that may allow the pins to lock into the case lock. The case lock may guide the pins along at least two different directions. The case lock may terminate at a circle or hook that may aid in keeping the ultrasound-generating device and the drug applicator together. Any description herein of pins may apply to any protruding portions that may be accepted into the case lock of the ultrasound-generating device case. In other embodiments, the reverse may be provided wherein the drug applicator may comprise one or more slots, cut-outs, grooves or other mechanisms that may receive protruding portions, such as pins, from the ultrasound-generating device case. In some embodiments, the pins from the ultrasound-generating device case may be formed on an interior surface of the ultrasound-generating device case, so they may form the case lock of the drug applicator when the drug applicator is inserted into the ultrasound-generating device case. Alternatively or in addition, the interface of an ultrasound-generating device may comprise a first fastener configured to mate with a second fastener on-board the drug applicator. The first fastener and the second fastener may be configured to be screwed together. The ultrasound-generating device or the drug applicator may be screwed inside one another. In one example, the ultrasound-generating device or the drug applicator may be screwed inside the other through a case lock (e.g., of a drug applicator case or of an ultrasound-generating device case) and a pin (e.g., of an ultrasound-generating device or a drug applicator). The screwing together may permit direct or close contact between the drug applicator and the ultrasound-generating device. In some embodiments, the first fastener and the second fastener may be configured to snap together. Any interlocking mechanism or snap-fit mechanism may be employed to connect the ultrasound-generating device and the drug applicator. A case lock and/or pin may or may not be employed with the snapping mechanism. The mating between the first and second fasteners may or may not include a rotational component. The rotational component may include rotation about an axis extending along a length of the drug applicator and/or a length of the ultrasound-generating device. Axial rotation may occur about an axis extending through both the drug applicator and the ultrasound-generating device. In some embodiments, an additional interface602may have a direct contact between the drug applicator201and the ultrasound-generating device202, or may be filled with ultrasound-attenuation material such as, but not limited to, air, water, gel, and/or hydrogel to prevent any reduction of ultrasound intensity and to facilitate ultrasound transfer to the drug applicator. Improved ultrasound transfer to the drug applicator may result in improved ultrasound transfer to a delivery site100. A drug applicator and an ultrasound-generating device may snap together. In some embodiments, the drug applicator may snap onto the ultrasound-generating device or vice versa. They may snap together with aid of mechanical features. Various shapes may be provided that may aid in snapping together, such as interlocking or mating shapes. In some embodiments, magnets may aid in the coupling between the drug applicator and the ultrasound-generating device. In one example, a magnet may be placed on an ultrasound-generating device with a suitable metal or alloy on-board the drug applicator. Alternatively or in addition, a magnet may be placed on a drug applicator with a suitable metal or alloy on-board the ultrasound-generating device. This may allow the ultrasound-generating device and the drug applicator to be held together with aid of a magnetic force. This may be provided alternatively or in addition to any other connecting mechanism described elsewhere herein. This may be provided alternatively or in addition to any sorts of locks, screws, clips, or adhesives that may aid in coupling the drug applicator to the ultrasound-generating device. A variety of coupling mechanisms may be provided between a drug applicator and an ultrasound-generating device. As previously described, the mechanisms may allow for manual coupling and decoupling between the drug applicator and the ultrasound-generating device. The coupling may allow for repeatable coupling and decoupling between the drug applicator and the ultrasound-generating device. The coupling may allow for low ultrasound attenuation from the ultrasound-generating device to the drug applicator. The coupling may allow for low ultrasound attenuation from the ultrasound-generating device to a delivery site. Low ultrasound attenuation may have any values or characteristics, as described elsewhere herein. A drug applicator may be loaded with one or more drugs. The drug applicator may store the drugs in any manner within or on the drug applicator. For instance, drugs may be provided on a surface of the drug applicator. In some embodiments, an entirety of the surface of the drug applicator may be coated with the drugs. In some embodiments, only a portion of the surface of the drug applicator may be coated with the drugs. For instance, a portion of the surface of the drug applicator that is configured to come into contact with a surface of the eye may be coated with the drug. An interface601abetween a delivery site on the eye and the drug applicator can be filled with reagents or material that may improve drug delivery to the targeted site. This may occur by coating the drug and/or reagents on the surface of the drug applicator. Alternatively or in addition, the interface may be filled with the drug itself, for delivery to the delivery site on the eye. In some embodiments, the reagents or materials that may improve drug delivery to the target site may comprise microspheres, micelles, nanoparticles, proteins, molecules, or chemicals that may be adsorbed or absorbed on its surface. The reagents may comprise any reagents as described elsewhere herein. In another example, drugs may be incorporated into a porous material. For instance, the drugs may be soaked, encapsulated, adhered, or adsorbed on porous material. Examples of porous materials my include, but are not limited to, sponges, or polymer matrixes. Porous materials may have a porosity of at least 3%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 97%, or 99%. The porous materials may have a porosity less than any of the values provided, or falling within a range between any two of the values provided. The drugs may be provided within the pores of the porous materials. Drugs may be enclosed in a compartment within the drug applicator. The drugs may be completely enclosed within the compartment. A seal or cover may be removed to provide access to the drugs during use on a subject. In some embodiments, application of ultrasound may allow the drugs to pass through a wall or portion of the drug applicator to be delivered to a delivery site of on an eye of a subject. In some embodiments, the drugs may be provided within a compartment of the drug applicator that has an open or sealed end. The sealed end may be removed, ruptured, or pierced during use on a subject. A drug applicator may have a single type of drug loaded thereon. Alternatively, the drug applicator may have multiple types of drugs loaded thereon. The multiple types of drugs may be loaded into a common space. Alternatively the multiple types of drugs may be loaded into different spaces or chambers. The multiple types of drugs may be in fluidic communication with one another. Alternatively, the multiple types of drugs may be fluidically isolated from one another while loaded on the drug applicator. The multiple types of drugs may or may not be delivered to the same site of the eye upon use of the drug delivery device. Any description herein of the drugs may also apply to any reagents or materials that may aid in drug delivery. The reagents or materials that may aid in drug delivery may be stored with the drugs or may be stored separately from the drugs. FIGS.6A to6Dshow different embodiments of the drug applicator201in accordance with embodiments of the invention. The drug applicator may comprise an interior space800that may hold a drug to be delivered. The interior space may be a single continuous interior space. The interior space may have any geometric shape, such as a substantially spherical shape, cylindrical shape, conical shape, prismatic shape, or any other shape. Alternatively, the interior space may comprise multiple chambers or sections. The interior space may comprise multiple discontinuous interior spaces. In some embodiments, the interior space may comprise one or more pores or channels. The drug applicator may comprise one or more walls201aor solid sections that may partially or completely surround the interior space. The walls may be solid and non-porous. Alternatively, one or more portion of the walls may be porous. The walls may be impermeable to the drug contained within the interior space. Alternatively, one or more sections of the wall may be permeable to the drug contained within the interior space. In some embodiments, one or more sections of the walls may be permeable to the drug contained within the interior space under particular conditions (e.g., temperatures, light, applied ultrasound vibrations, or pressure). In some preferable embodiments, the drug held in the drug receiving space800may be sealed towards an exterior space, i.e. the ambient environment, to protect the drug from being polluted by any foreign substance or gas. The protection may be particularly desirable during production, transport, and/or storage of the drug applicator201or the system. Directly before use the seal may be broken to allow for the drug in the space800to be delivered. FIG.6Aillustrates an embodiment where the drug applicator201may be sealed on all surfaces. The space800for holding the drug inside the drug applicator201of this embodiment may be filled with a drug during the production process of the drug applicator201. The sealed drug applicator may be delivered and/or used with the drug delivery device. FIG.6Billustrates an embodiment where the drug applicator201is sealed on all surfaces and comprises a port structure201c. The port structure201cis configured to allow filling and/or refilling of this space800with a drug. The port structure may allow passage of the drug only when a filling device is inserted into the port. When the drug applicator is merely provided with the drug, the port structure may optionally not allow drug the leak out of the drug applicator. The port structure may reseal when the port structure is not in use. The port may allow the filling and/or refilling of the drug applicator at the manufacture stage, after delivery of the drug applicator, and/or immediately prior to use of the drug applicator. The drug may be delivered to the interior space while the drug applicator is attached to the drug delivery device, or while the drug applicator is separated from the drug delivery device. As illustrated inFIG.6C, the drug applicator201may optionally have at least one opening at a surface directed towards a surface of the eye (e.g., scleral surface, cornea surface). The opening may be provided at a surface opposite a surface that is configured to couple with the drug delivery device. In some embodiments, the drug receiving space800may be configured to be filled through at least one opening at the surface directed towards the scleral surface. The drug receiving space may be filled during production of the drug applicator, after delivery of the drug applicator, and/or immediately prior to use of the drug applicator. The drug may be delivered through the opening while the drug applicator is attached to the drug delivery device, or while the drug applicator is separated from the drug delivery device. FIG.6Dillustrates an embodiment where the drug applicator has at least one opening at a surface directed towards the eye surface and a port structure201c. The port structure201cis configured to allow filling and/or refilling of this space800with a drug. This may comprise any characteristics or may be used in any manner as described elsewhere herein. In these embodiments, one surface, preferably a surface directed towards the surface of the eye100, is preferably configured to have a removable cover (e.g., peel-off cover, snap-off cover, twist-off cover) and/or may be configured to be permeable for the drug held in this space800. In some embodiments, the surface may be impermeable for the drug under some conditions, but permeable to the drug under other conditions (e.g., certain temperatures, light ranges, ultrasound transmissions, with the addition of certain solutions). In an embodiment of the invention, the drug receiving space800is configured to receive a volume of a drug. The volume of the drug is preferably ranging from 10 μL to 1 mL. In some embodiments the volume of drug may be greater than 1 μL, 5 μL, 10 μL, 20 μL, 30 μL, 50 μL, 75 μL, 100 μL, 150 μL, 200 μL, 300 μL, 400 μL, 500 μL, 700 μL, 1 mL, 1.5 mL, 2 mL, 3 mL, or 5 mL. The volume of drug may be less than any of the values provided herein or may fall within a range between any two of the values provided herein. Additionally or optionally a further substance can be inserted into the drug receiving space800to improve the delivery of the drug and/or improve at least one chemical, physical and/or pharmaceutical property of the drug. Examples of such further substances may include, but are not limited to, deionized water, buffer solution (e.g., phosphate buffered saline), or surfactant (e.g., benzyl alcohol) which may dissolve hydrophobic drug molecules. In an embodiment of the port structure201c, the port structure is configured to be pierced by an injection needle, as illustrated inFIG.7A. The injection needle allows liquid communication between the drug receiving space800and a drug reservoir or container201fcoupled to the injection needle. The drug is preferably inserted from the drug reservoir or container into the drug receiving space800by applying a pressure. It is preferred that the port structure201cis self-sealing after the injection needle has been removed. FIG.7Bshows an example of another drug filling mechanism. The port structure201cmay be coupled to a drug conveyance mechanism, such as a tube201g. A flow control regulator201hmay be employed to control delivery of the drugs to or from the interior space800. The flow control regular may be a binary regulator which merely controls whether drug is permitted to flow or is not permitted to flow. The flow control regulator may control the amount/rate of drug that may flow. In some embodiments, drugs may be pumped to the interior space from a drug reservoir. Positive pressure from outside the reservoir may be used to ‘push’ the drugs into the interior space. In some instances, negative pressure from within the interior space may be used to ‘pull’ the drugs into the interior space. In some embodiments, both positive and negative pressure may be used to deliver the drugs into the interior space. These loading mechanism may be used for in situ loading. The in situ loading may occur by medical practitioners, or other users, manually. Examples of medical practitioners may include, but are not limited to, physicians, nurses, clinicians, or individuals employed by a hospital, clinic, or site that owns or operates the drug delivery devices. An individual using the device to administer to a subject may or may not have received training in the use of the device. An individual using the device may administer the device to other individuals, or may self-administer. An individual using the device may manually load the device in situ. The drug applicator may be loaded with the drug prior to using the drug. The drug applicator may be loaded with the drug prior to attaching the drug applicator to the drug delivery device, or while the drug applicator is attached to the drug delivery device. The drug applicator may be loaded with the drugs within 24 hours, 12 hours, 6 hours, 4 hours, 3 hours, 2 hours, 1 hour, 45 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, 3 minutes, 2 minutes, 1 minutes, 30 seconds, or 15 seconds of using the drug delivery device on a subject. The drug applicator may be loaded with the drugs while the subject is present, or while the subject is on-site. A subject may be a human subject or an animal subject. A subject may be a patient that is undergoing treatment through use of the device. A drug may be pre-loaded into the drug applicator during a manufacturing process. A benefit of loading a drug during the production in the open space of the drug applicator may be an optimized or increased volume or concentration within sterile conditions. An interface601bmay be sealed with a sealing material to prevent contamination of the drug prior to application. The sealing material may comprise a biocompatible film. The sealing material may be a plug or other type of cover. The drug applicator may be coupled to the drug delivery device prior to treatment of the subject. The sealed interface may be unsealed by hand or with aid of a removal device. In some embodiments, the seal may comprise a porous film or membrane, which may directly face the delivery site on the eye. The drug may penetrate through the film or membrane under particular conditions. For example, the drug may penetrate through the porous film or membrane upon application of the ultrasound. FIG.8shows a schematic of a drug applicator201configured to be applied to an eye100. The eye may comprise a target site for delivery of drugs. The target site may be on a surface of the eye or within an intraocular space of the eye. It may be desirable for the drugs to penetrate into the intraocular space of the eye, to be delivered to a target site. Delivery of drugs to the target site may aid in the treatment of eye. The target site may be at any depth within the eye. For instance, the target site may be at least 0 mm, 0.1 mm, 0.3 mm, 0.5 mm, 0.7 mm, 1 mm, 1.2 mm, 1.5 mm, 1.7 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.5 cm, 1.7 cm, 2 cm, 2.5 cm, or 3 cm within the eye. The target site may have a depth less than any of the values provided or within a range falling between any two of the values provided. The eye may comprise a delivery site that may be configured to come into initial contact with the drugs. The delivery site may be a site where the drug applicator comes into contact with the eye. The delivery site may be a site where the ultrasound is delivered to the eye. The delivery site may be provided on a surface of the eye. The delivery site may be on a sclera of the eye. The delivery site may be on a cornea of the eye. The delivery site may be on a front region of the eye on or surrounding the cornea. The delivery site may be a cornea surface, limbus, pars plana scleral surface, and/or posterior scleral surface. The delivery site may on a top region of the eye. The delivery site may on a lower region of the eye. The delivery site may on a right region or left region of the eye. The delivery site may be selected based on a target site for drug delivery. The delivery site may be selected based on the type of drug being administered. For example, for a first type of drug, a first delivery site may be selected, and for a second type of drug different from the first type of drug, a second delivery site different from the first delivery site may be selected. The delivery site may depend on a disease or eye condition being treated. For example, for a first disease or eye condition, a first delivery site may be selected, and for a second disease or eye condition different from the first disease or eye condition, a second delivery site different from the first delivery site may be selected. The systems and method provided herein may be used to deliver drugs to an eye. The systems and methods provided herein may be used to deliver drugs to a target site of the eye. The systems and methods provided herein may allow for transscleral and/or transcorneal delivery of drugs to a target site of the eye. This may be useful for the treatment of eye diseases or conditions, such as but not limited to, prophylaxis of central retinal vein occlusion, branch retinal vein occlusion, central serous retinopathy, cytomegalovirus retinitis, retinoblastoma, intraocular lymphoma, ocular melanoma, giant cell arteritis, histoplasmosis, ischemic optic neuropathy, macular pucker, macular telangiectasia, uveitis, choroidal neovascularization, age-related macular degeneration, diabetic retinopathy, glaucoma, retinitis pigmentosa, macular edema, macular degeneration, multirecurrent pterygia, ocular toxoplasmosis, proliferative vitreoretinopathy (PVR), Stevens-Johnson syndrome, ocular cicatricial pemphigoid, an ocular degenerative condition, a post-surgery condition, or any other disease or condition as provided elsewhere herein. This may be useful for treatment of eyes, even for relatively healthy eyes, such as delivery of vitamins or other substances beneficial for eyes. This may be useful for conducting diagnostics on the eye to deliver substances that may aid in imaging or measuring characteristics of the eye. A chosen target site and/or delivery site may depend on soft human or animal tissues. A subject, such as a human or animal subject, may have protective layers, such as an epidermis or dermis to protect the body from the environment. More soft tissue layers can be more easily penetrated or stimulated by directed ultrasound. Any of the applications provided herein for delivery to the eye may apply to other targets of a subject, such as, but not limited to, tongue, oral mucosa, nasal lining, vaginal tissue, anal tissue, or other portions of the subject's body. Indirectly accessible targets may include, but are not limited to, brain or muscles, bone, or other tissue. The drug applicator, as described elsewhere herein, may have any form factor. For example, the drug applicator may have a tip format, ring format, or any other format. In some embodiments, the drug applicator may have a substantially spherical form, semi-spherical form, cylindrical form, conical form, form of a conical frustum, toroidal form, ellipsoidal form, prismatic form, or any other form. The drug applicator may optionally have a concave surface that may fit an eyeball curvature. A surface of the drug applicator configured to come into contact with the eyeball may have a convex, flat, or concave shape. The drug applicator may be formed of a malleable material that may conform to fit an eyeball curvature. The drug applicator may be formed of a material that may conform to provide an increased surface area of contact between the drug applicator and the eyeball. The drug applicator may be configured to come into contact with any portion of the surface of the eye, such as a cornea surface, limbus, pars plana scleral surface, and/or posterior scleral surface. The drug applicator may or may not be configured to conform to a variety of curvatures of the eyes or features of the eye. The drug applicator may or may not be configured to conform to a variety of regions on the surface of the eye. The drug applicator may have any dimension. In one example, the drug applicator201may have an outer diameter201hor at least 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.5 cm, 1.7 cm, 2 cm, 2.2 cm, 2.5 cm, or 3 cm. The outer diameter may be less or equal to than any of the values provided or fall within a range between any two of the values provided herein. The drug applicator201may have an inner diameter201jor at least 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.5 cm, 1.7 cm, 2 cm, 2.2 cm, or 2.5 cm. The inner diameter may be less or equal to than any of the values provided or fall within a range between any two of the values provided herein. In one example, the drug applicator201may have an outer height201ior at least 0.5 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 1 cm, 1.2 cm, 1.5 cm, 1.7 cm, 2 cm, 2.2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 7 cm, 10 cm, 12 cm, 15 cm, 20 cm, 25 cm, or 30 cm. The outer height may be less or equal to than any of the values provided or fall within a range between any two of the values provided herein. In one example, the drug applicator201may have an inner height201kor at least 0.1 mm, 0.3 mm, 0.5 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 1 cm, 1.2 cm, 1.5 cm, 1.7 cm, 2 cm, 2.2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 7 cm, 10 cm, 12 cm, 15 cm, 20 cm, or 25 cm. The outer height may be less or equal to than any of the values provided or fall within a range between any two of the values provided herein. The dimensions of the drug applicator may be selected to hold a desired volume of the drug. The volume of drug within the various drug applicators may vary depending on a treatment plan that a drug applicator is used for. In some embodiments, the drug applicator may be configured to hold a volume of 100 μL to 5 mL. The drug applicator may be configured to hold any volume of drug, as described elsewhere herein. The dimensions of the drug applicator may depend on a desired delivery site on the eye. For example, depending on the delivery site, different dimensions or form factors of the drug applicator may be used to deliver the drugs. In one example, a drug applicator configured to deliver drugs to the cornea with an average diameter of 11 mm may result in a minimum applicator tip inside diameter of 12 mm and a radium 6 mm which may result in an inner height of 0.884 mm-44 mm to hold a volume of 100 μL-5 mL respectively. A drug applicator configured to deliver drugs to the sclera may have below a 12 mm inner diameter with similar chosen volumes for the space. A drug applicator configured to deliver drugs to the limbus may have a 1-2 mm inner diameter. In some embodiments, for stability and accuracy of targeting the delivery area, the minimum inner diameter would need to be at least 5 mm, which would result in an inner height of 5 mm-254.71 mm for a volume of 100 μL to 5 mL respectively. An interior space800of the drug applicator may determine the volume of the drug that may be held by the drug applicator. The interior space may be defined by an inner diameter and an inner height. The interior space may have a cylindrical shape. Alternatively, the interior space may have any other shape or configuration, (e.g., spherical, semi-spherical ellipsoidal, prismatic, conical, conical frustum, porous), as described elsewhere herein. FIG.9shows a perspective view of one embodiment of an application head205of the system. The application head may comprise a delivery unit200. The application head205may be configured to accommodate the ultrasound transducer202. Additionally and/or optionally the application head205is further configured to allow mechanical coupling and ultrasound coupling of the drug applicator201to the ultrasound transducer202. The outer appearance of the application head205may be defined by an external housing. The external housing may partially or completely enclose the ultrasound transducer. The external housing may or may not partially or completely enclose the drug applicator. In some embodiments, the drug applicator may be removable from the ultrasound transducer and may not be enclosed within the housing. The housing may be formed form a single piece. Alternatively, the housing may be formed from multiple pieces. For instance, the external housing may comprise a first housing part205aand a second housing part205b. In one example, the first housing part may be an upper housing part and a second housing part may be a lower housing part. The first and second housing parts, alone or in combination with additional housing parts, may enclose the ultrasound transducer. The housing may or may not enclose additional sections, such as a signal generating unit300and/or a display and/or input unit400. A drug delivery device may comprise the ultrasound transducer. The drug delivery device may comprise the housing. The drug delivery may or may not comprise the signal generating unit and/or the display and/or input unit. The drug delivery device may have a relatively compact size. In some embodiments, the drug delivery device may have a volume of less than or equal to about 1, 5, 10, 50, 75, 100, 150, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1250, 1500, 1750, 2000, 2250, 2500, 2750, 3000, 3250, 3500, 4000, 5000, 6000, or 7000 cm3. The drug delivery device may have a volume greater than or equal to any of the values provided herein or falling within a range between any two of the values provided herein. The housing of the drug delivery device may have a volume less than any of the values provided herein, greater than any of the values provided herein, or falling within a range between any two of the values provided herein. In some embodiments, the drug delivery and drug applicator may have a volume less than any of the values provided herein, greater than any of the values provided herein, or falling within a range between any two of the values provided herein, when the drug applicator is coupled to the drug delivery device. In some embodiments, the drug delivery device may have a maximum dimension of less than or equal to about 0.1 mm, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 3 mm, 4 mm 5 mm, 7 mm, 1 cm 1.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 12 cm, 15 cm, 17 cm, 20 cm, 22 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, 55 cm, 60 cm, or 70 cm. A maximum dimension may be a dimension of the device with the greatest length. A maximum dimension may be a length, width, height, diagonal, or diameter of the device. The drug delivery device may have a maximum dimension greater than or equal to any of the values provided herein or falling within a range between any two of the values provided herein. The housing of the drug delivery device may have a maximum dimension less than any of the values provided herein, greater than any of the values provided herein, or falling within a range between any two of the values provided herein. In some embodiments, the drug delivery and drug applicator may have a maximum dimension less than any of the values provided herein, greater than any of the values provided herein, or falling within a range between any two of the values provided herein, when the drug applicator is coupled to the drug delivery device. The drug delivery device may have a weight of less than or equal to about 0.1 g, 0.5 g, 1 g, 5 g, 10 g, 50 g, 75 g, 100 g, 150 g, 200 g, 250 g, 300 g, 350 g, 400 g, 450 g, 500 g, 600 g, 750 g, 1 kg, 2 kg, 3 kg, 4 kg, 5 kg, 6 kg, 7 kg, 8 kg, 9 kg, 10 kg, 11 kg, 12 kg, 13 kg, 15 kg, 20 kg, 25 kg, 30 kg, 35 kg, 40 kg, or 50 kg. The drug delivery device may have a weight greater than or equal to any of the values provided herein or falling within a range between any two of the values provided herein. The housing of the drug delivery device may have a weight less than any of the values provided herein, greater than any of the values provided herein, or falling within a range between any two of the values provided herein. In some embodiments, the drug delivery and drug applicator may have a weight less than any of the values provided herein, greater than any of the values provided herein, or falling within a range between any two of the values provided herein, when the drug applicator is coupled to the drug delivery device. The device may be sufficiently compact to be a handheld device. The device may be configured to be carried in a single human hand. The device may be configured to operate using a single human hand. The device may be carried or operated using two human hands. The device may comprise a gripping region configured to be gripped by a single human hand. The gripping region may optionally be contoured to be gripped by a human hand. The contouring may allow the various fingers of the human hand to be received on the grip. The contouring may allow the device to be held in an ergonomic manner while the device is used to administer ultrasound to a subject. The device may be configured to be a wearable device. The device may be worn on any portion of a subject's body. For instance, the device may be worn on a subject's head, face, neck, torso, arm, hands, legs, or feet. The device may be worn to at least partially cover one or more of the subject's eyes. The device may be supported on a subject's head. In some embodiments, the device may be supported with aid of at least a top portion of the head. In some embodiments, the device may be supported with aid of a forehead of the subject. The device may be supported with aid of one or more ears of the subject. For examples of wearable configurations are provided in greater detail elsewhere herein. FIG.10shows a perspective view of an embodiment of the system according to one aspect of the invention. The system may comprise an application head205, the drug applicator201, and additional housing and holding parts700a. The additional housing and holding parts preferably accommodate all components of the system. Alternatively, some components of the system are accommodated in the at least one further housing (not shown). A signal generating unit300may or may not be incorporated as part of the additional housing and holding parts. A display and/or input unit400may or may not be incorporated as part of the additional housing and holding parts. The drug applicator may or may not be removable from the application head. The application head may or may not be removable from the additional housing and holding parts. The application head may be coupled or decoupled from the additional housing and holding parts in a repeatable manner. The additional housing and holding parts700amay be configured to receive a patient's head. To receive a patient's head, preferably a chin-rest and/or forehead-rest are provided. In one embodiment of the invention the application head205is an attached to a flexible arm, allowing for an adjustment of the application head205and the drug applicator201relatively to the rest of the additional housing and holding parts700a. For example, a height of the application head205may be adjusted relative to the patient's eye when the patient's head is resting on the chin-rest and forehead-rest. The adjustment of the height of the application head may allow the accommodation of various facial features, sizes, and shapes. The application head may be adjusted to be brought to a desired position relative to an eye of the patient. The flexural arm may extend and/or retract to adjust the height of the application head. In some embodiments, the flexural arm may comprise one or more telescoping components that may allow for adjustment of length of the arm. The length of the flexural arm may be manually adjusted, or may be adjusted with aid of one or more actuator that may be capable of causing one or more sections of the arms to move relative to one another in response to a signal or command. The chin-rest and forehead-rest may allow a patient's eye to remain at a substantially static location, while the application head is brought to a desired position relative to the eye. The flexural arm may also optionally allow the application head to move laterally further and/or closer to the eye. The application head may be brought to a desired position relative to the eye to deliver the ultrasound and/or drugs. As previously described, the drug delivery device may have any form factor, such as a wearable form factor. The drug delivery device may be configured to worn on the head of the subject. The drug delivery device may be configured to cover at least a portion of a face of the subject. The drug delivery device may be configured to cover a single eye or both eyes of the subject. The drug delivery device may be configured to at least partially cover an eye of the subject. The drug delivery device may be configured at least partially wrap around the subject's head. In some embodiments, the drug delivery device may be supported with aid of a top of the subject's head. For instance, the drug delivery device may have the form of a hat or helmet. The hat or helmet may cover at least a portion of the top of the subject's head. A portion of the drug delivery device may extend down from the hat or helmet to cover the subject's eye or eyes. For instance, the portion extending down may have a form factor of a visor, goggles, or glasses. The drug delivery device may have the form factor of a visor, headband, or other object that may completely or partially encircle the subject's head without necessarily covering the top of the subject's head. One or more straps that may partially or completely circle the subject's head may be used to support the device on the subject's head. The drug delivery device may have the form factor of goggles or glasses. The drug delivery device may be at least partially supported by one or more ears of the subject. For instance, the drug delivery device may comprise portions that may extend past the subject's ears. The portions that extend past the subject's ears may include portions of glasses that may partially wrap behind the ear, or may include portions of goggles or headbands that may extend beyond the ear, or may include portions of hats or helmets that may extend beyond the ear. For instance, the drug delivery device may comprise a temple and/or ear piece that may extend to the ear and/or wrap behind the ear. The drug delivery device may have any form factor of any type of eyewear. The drug delivery device may comprise an eyewear frame comprising at least one extension configured to extend behind a subject's ear when the device is worn by the subject. FIG.11shows a perspective view of an embodiment of the system according to one aspect of the invention.FIG.12shows a perspective view of another embodiment of the system according to one aspect of the invention. The application head205and the system may be integrated into a device that resembles the outer appearance of a pair of glasses, or other type of eyewear or wearable device. Any description herein of glasses may apply to any other type of eyewear or wearable device. Directions such as front, left, and right are derived from directions during normal use of a glasses device. The application head205may be formed in a front portion of the glasses device. The drug applicator201may be attached to the application head205at a position in front of the left and/or right eye. Further housing and holding parts700bare preferably forming a frame and/or yokes of the glasses device. The housing and holding parts may or may not comprise a signal generating unit300and/or a display and/or input unit400. An application head may be supported by an eyewear frame. One or more ultrasound-generating devices may be supported by the eyewear frame. Each ultrasound-generating device may be configured to generate ultrasound that is delivered to a desired site of the eye when the device is worn by the subject. In some embodiments, a single ultrasound-generating device may be supported by the eyewear frame over a single eye. The ultrasound-generating device may be positioned on the eyewear frame to at least partially cover an eye when the device is worn by the subject. For example, the ultrasound-generating device may be configured to deliver ultrasound to the left eye only, or the right eye only. In some embodiments, the ultrasound-generating device may be affixed to the eyewear frame and may not move relative to the eyewear frame. In some embodiments, the ultrasound-generating device may be movable relative to the eyewear frame. For instance, the ultrasound-generating device may be configured to slide to the left or to the right, to cover a desired eye. For example, the ultrasound-generating device may be positioned over the left eye to deliver ultrasound to the left eye. When it is desirable to deliver ultrasound to the right eye, the ultrasound-generating device may be moved to be positioned over the right eye. The ultrasound generating device may be capable of moving along the eyewear frame without being removed or separated from the eyewear frame. Alternatively, the ultrasound generating device may be detached from the eyewear frame at a first position and reattached to the eyewear frame at a second position. In some embodiments, the positions relative to the left eye and/or right eye may be adjustable. This may be useful for accommodating different users with different face shapes and sizes. In some instances, the positions relative to the left and and/or right eye may be lockable. This may be advantageous when a repeat subject is wearing the device. The positions may be set for a particular subject, and whenever the subject undergoes a treatment session, the measurements may be fixed for that particular subject to place the ultrasound-generating device at the same position relative to the eye. Generation of the ultrasound may cause the delivery of at least one drug to a target site in the eye without damaging tissue of the eye. In some embodiments, an eyewear frame may support two ultrasound-generating devices, corresponding to each eye of the subject. In some embodiments, a single ultrasound-generating device may be used to deliver ultrasound to both eyes of the target. The ultrasound-generating device may generate ultrasound which may be conveyed via low attention materials to both eyes. In some embodiments, the ultrasound-generating device may be coupled to two drug applicators which may convey the ultrasound to both eyes. The ultrasound-generating device may or may not come into direct contact with the eye. In some embodiments, a drug applicator may be coupled to the ultrasound-generating device. The drug applicator may be supported by the eyewear frame. The drug applicator may be supported by a respective ultrasound-generating device. The drug applicator may come into contact with an eye. The drug applicator may be located to at least partially cover one or more eyes of the subject when the device is worn by the subject. The drug applicator may be coupled and/or decoupled from the ultrasound-generating device in a repeatable manner. If the ultrasound-generating device is movable or detachable from the eyewear frame, the drug applicator may be moved and/or detached with the ultrasound-generating device. In some embodiments, the drug applicators may be fixed to the eyewear frame while the ultrasound-generating devices may be detached or movable. In some embodiments, the drug applicators may be movable or detachable relative to the eyewear frame independent of the ultrasound-generating device. The drug applicators may be positioned relative to the eyewear frame to come into contact with a surface of the eye, or an eyelid of the eye. The ultrasound-generating device and/or drug applicators may move sideways along the frame of the eyewear. The ultrasound-generating device and/or drug applicator may move closer or further away from the surface of the eye (e.g., forwards and backwards). The drug applicator may be configured to deliver drugs to the surface of the eye. The drug applicator may be configured to deliver ultrasound from the ultrasound-generating device to the eye. Advantages of a wearable design may comprise improved usability, especially the improved user experience during the application process. The wearable design may also allow for easy alignment of the drug applicator and/or ultrasound to a desired site of the eye. In some embodiments, a subject may wear the device. Then the position of the drug applicator and/or ultrasound-generating device may be adjusted for the subject to allow delivery of ultrasound and/or drugs in a desired manner. The subject may wear the device for a duration of a treatment. In some embodiments, there may be treatment plans that call for the subject to wear the device at different times in the day or over the course of multiple days, weeks, or months. The components of the device, such as the ultrasound-generation device and/or drug applicator, may be readjusted every time the subject puts on the device. Alternatively, the previous positions for the components may remain for the eyewear and no adjustment or very little adjustment may be required when the subject puts on the eyewear again. FIG.13shows an example of a delivery unit comprising a light source, in accordance with embodiments of the invention. In some embodiments, it may be useful to apply light to drugs that are delivered to the eye to produce a desired effect. Examples of desired effects may include triggering a chemical reaction of the drug, such as cross-linking of the drug, altering the properties of the drug for improved penetration or desired effects of delivery. In some instances, after delivery of drug and the ultrasound to a desired site of the eye, a light may be provided to the desired site of the eye. In some instances, prior to, concurrently with, and/or subsequent to delivery of the drug to the desired site of the eye, the light may be provided. In some instances, prior to, concurrently with, and/or subsequent to delivery of the drug to the desired site of the eye, the light may be provided. The light may be provided from a source external to a drug delivery device. Alternatively, the light may be provided from the drug delivery device. In one example, an application head may comprise an on-board light source. A drug delivery device may comprise an ultrasound-generating device and a light source configured to generate light that is delivered to a desired site of the eye. The drug delivery device may be configured to couple with a drug applicator that may aid in delivery of the ultrasound to the desired site of the eye and permit light from the light source on-board the drug delivery device to be delivered to the desired site of the eye. The drug delivery device may comprise a housing. The light source may be provided within the housing. The ultrasound-generating device and the light source may be provided within a common housing. The housing may prevent light from the light source from escaping the device in an undesired manner. The light source may have a fixed position relative to the ultrasound-generating device. The light source may be coupled to the ultrasound-generating device. The ultrasound-generating device may comprise an interior space within which the light source resides. In one example, the ultrasound-generating device may have a geometric cross-section with a free space substantially in the middle which forms the interior space. For example, the ultrasound-generating device may have a circular cross-section with a free space at or near the center that forms the interior space. The light source may be provided within the free space and may directly shine light toward the drug applicator. The interior space or another portion of the drug delivery device may optionally comprise an optical element that may modify light emitted by the light source. Examples of an optical element may comprise a lens, filter, condenser, diffractor, prism, mirror, dichroic, beamsplitter, or any other type of optical element. The optical element may change a path of the light, focus the light, diffuse the light, split the light, reflect the light, filter out one or more wavelengths of the light, or modify the light in any other manner. The light source may be any type of light source. The light source may emit light anywhere along the electromagnetic spectrum. The light source may emit visible light, ultraviolet (UV) light, infrared light, microwaves, or any other type of light. In some embodiments, the light source may emit UV light. The light source may be a UV lamp emitting light along the UV-A wavelengths. In some embodiments, the light source may emit light at UV-B and/or UV-C wavelengths. The light source may emit light having wavelengths within the range of 10 nm to 400 nm. The light source may emit light having wavelengths between 315-400 nm. The light source may emit light having wavelengths less than 10, 30, 50, 100, 150, 200, 250, 280, 300, 315, 325, 350, 400, 450, or 500 nm. The light source may emit light having wavelengths greater than any of these values or falling within a range between any two of these values. The light source may comprise one or more LEDs. The light source may comprise one or more lasers. In one example, the drug delivery device and/or drug applicator may be used for UV (e.g., UV-A) treatment of a target site. The drug applicator201may comprise an inlet201afacing the gap601aand/or the ultrasound transducer202. The ultrasound transducer may be coupled to the light source (e.g., UV lamp)202c. The light source may be supported by a support structure202b. The light source and/or support structure may be within an interior space202aof the ultrasound-transducer. The light source may be partially or completely within the interior space. The light source may or may not protrude from the interior space. In some embodiments, the light source may completely protrude from the interior space. The emitted wavelengths from the light source may pass through the inlet201aof the drug applicator, whereby the drug applicator outer shell201bmay be potentially opaque and formed of or coated with material that may prevent the light from escaping through the drug applicator shell. For example, if the light from the light source comprises UV light, the drug applicator may comprise a shell that is formed of or coated with UV reflecting material to prevent any UV exposure to the outer environment. The only outlet for the UV light may be via the side facing the delivery site (e.g., the surface of the eye). In some embodiments, less than 20%, 10%, 5%, 3%, 2%, 1%, 0.5%, or 0.1% of the light emitted may escape through the housing of the ultrasound-generating device and/or the outer shell of the drug applicator. Thus, the drug applicator may comprise a first portion formed of an opaque material configured to at least partially define one space configured to hold the drug, and a second portion formed from a material that is at least partially transparent to light of a selected wavelength, configured to permit the light to pass from one side of the drug applicator to another side of the drug applicator. The space configured to hold the drug may be a single continuous space. The space configured to hold the drug may comprise multiple discontinuous spaces. The multiple discontinuous spaces may comprise pores. The first portion may be configured so that the light from the light source may not penetrate into the space to hold the drugs. This may be useful for preventing a reaction that may be initiated by the light source (e.g., cross-linking) until the drug is delivered to the desired site. The first portion may comprise a surface that is coated with a material that reflects light of selected wavelengths. For instance, if the light from the light source is a UV light, the coating may reflect UV light. The coating may be provided on an outer surface of the drug applicator. This may reduce any UV exposure to an outer environment. The coated may be provided on an inner surface of the drug applicator. This may reduce any UV exposure to the drugs within the space of the first portion. In some embodiments, the material that forms the first region may be reflective of the selective wavelengths (e.g., UV wavelengths). The first portion may comprise a target side that may be configured to contact a desired site of the eye. The target side may come into contact with an eyelid or a surface of the eye, such as the sclera, cornea, and/or limbus. In some embodiments, the target side may be formed from a soft, biocompatible material. The soft material may allow for comfortable contact with the eye, and/or increased surface area between the drug applicator and the eye, which may allow improved delivery of ultrasound to the eye. The target side may be configured to deliver reagents that may improve delivery of the drug to the target side. Further description of this is provided in greater detail elsewhere herein. In some embodiments, the first portion may be formed from an elastic material. The first portion may have any material property as described elsewhere herein for a drug applicator. The first portion may allow for soft comfortable contact with the eye without requiring a separate layer at the target side. The material for the entirety of the first portion may be the same, or a different material may be provided at the target side. The material provided at the target side may be softer than the rest of the material. In some embodiments, the material used by the first portion of the drug applicator may be formed from an opaque elastic material, such as polymers or silicone. The second portion of the drug applicator may be transparent to selected wavelengths of light. For instance, the second portion of the drug applicator may be transparent to at least a subset of the light emitted by the light source. In some instances, the second portion of the drug applicator may be transparent to an entirety of the wavelength range of light emitted by the light source. The second portion of the drug applicator may be transparent to UV light (e.g., UV-A light, UV-B light, and/or UV-C light). The second portion may be at least partially surrounded by the first portion. In some embodiments, the first portion may surround an interior space. The second portion may occupy a portion or an entirety of the interior space. In some embodiments, one or more drugs may be provided within the interior space, and the second portion may occupy a portion of the interior space to help contain the drugs. The second portion may comprise a solid, liquid, gel, and/or other type of material. The drugs held by the drug applicator may be any type of drug that may be delivered the eye. In some embodiments, the light source may be configured to initiate a reaction by the drug. For example, the light source may be configured to initiate cross-linking by the drug. In one example, the drug may be riboflavin. In some embodiments, collagen at the delivery site may be cross-linked using light from the light source. In one implementation, UV wavelengths can be generated via the light source at the ultrasound-generating device. The light may penetrate through the transparent applicator inlet201a, and the space800. The space may be used to hold drugs. The light may reach the delivery site100without scattering through the drug applicator outer shell201b. This may result in specific focused UV light for potential treatment of keratoconus treatment and/or LASIK/SMILE-related corneal ectasia. This may occur by cross-linking riboflavin or any other cross-linking agents at the delivery site, making it corneal cross-linking CXL. The combination of opaque and transparent material used by the drug applicator may be configured to allow UV illumination in selected areas and reduced overexposure of two other areas due to safety considerations. Drug applicators can have any form factor, such as those described elsewhere herein. For example, drug applicators may be, but are not limited to, round, cylindrical, conical, oval, triangle, square or rectangular. The drug applicator surface facing the gap601aand/or target site100can have the same shape or different shapes. They may have the same or different shapes relative to one another or the rest of the drug applicator. The target-facing surface may be coated with a biocompatible material which may be in contact with the target surface. The material can cover or close the space800of the drug applicator to prevent contamination of the drug. The material may also prevent spilling and loss during handling of the drug applicator. FIGS.14A to14Gshow examples of various configurations of a delivery unit or portion thereof. An ultrasound-generating device202may be provided. FIG.14Ashows an example of an ultrasound-generating device202. The ultrasound-generating device may comprise a transducer which may not require an interior space. FIG.14Bshows an example of an ultrasound-generating device202which may comprise an interface602configured to face a drug applicator. The interface may permit coupling between the ultrasound-generating device and the drug applicator. The interface may be provided on a side of the ultrasound-generating device that may be facing toward the eye. The ultrasound-generating device may comprise an interior space202a. FIG.14Cmay show a cross-section of the ultrasound-generating device202having an interior space202a. The ultrasound-generating device may have any cross-sectional shape. For example, the ultrasound-generating device may have a circular, elliptical, triangular, square, rectangular, trapezoidal, pentagonal, hexagonal, octagonal, or any other shaped cross-section. The interior space may have any cross-sectional shape. For instance, the interior space may have a circular, elliptical, triangular, square, rectangular, trapezoidal, pentagonal, hexagonal, octagonal, or any other shaped cross-section. The interior space may have any cross-sectional shape. The ultrasound-generating device and the interior space may be concentrically arranged. The ultrasound-generating device and the interior space may each comprise an axis extending through their respective lengths. The axes may pass through the center of their respective portions. The axes of each of these may be parallel to one another. The axes of each of these may directly overlay one another. In some embodiments, an emitter, such as a light source, may be provided within the interior space. Alternatively or in addition, a data collection device may be provided. The data collection device may comprise one or more sensors that may be capable of collecting data. For example, the data collection device may comprise one or more cameras, microphones, infrared detectors, UV detectors, lidar, or any other type of data collection device. FIG.14Eshows an example of a light source202cthat may be within the interior space202aof the ultrasound-generating device. The light source may be supported by a support structure202b. The support structure may provide connection of the light source to a power source, such as one more batteries provided elsewhere herein. In some instances, the support structure itself may comprise a power source, such as a battery, that may directly provide power to the light source. The ultrasound-generating device and the light source may or may not be powered by the same power source. They may be powered by different power sources. In some embodiments, the support structure may be formed of a high ultrasound attenuation material, which may reduce the influence of the ultrasound on the light source. In some embodiments, it may be desirable for the support structure to provide active or passive damping on ultrasound generated by the ultrasound-generating device. This may allow the light source to experience less or no ultrasound signals. Any description herein of a support structure for a light source may apply to a support structure for any other object, such as an emitting device or data collection device, provided within the interior space. FIG.14Gshows another example of a light source202cthat may be within the interior space202aof the ultrasound-generating device. The light source may be supported by a support structure. One or more optical elements202fmay be provided. The one or more optical elements may modify the light that has been emitted. Alternatively or in addition, one or more optical elements may be provided in the drug applicator. In some instances, one or more adjustment mechanisms202fmay be provided, which may be provided for an emission device or a data collection device. The adjustment mechanism may be an optical element or other type of adjustment mechanism. The adjustment mechanism may modify emission from a device within the interior space, or emissions from outside the interior space coming into the interior space. FIG.14Dshows an example of a data collection device, such as a camera202d. The camera may be supported on a support structure202b. The camera may be useful to image the delivery site. The camera may be used to capture still images or dynamic images. The camera may be a video camera that may be capable of capturing streamed images. The camera may be useful for collecting data about the delivery site and how the treatment is going. The transparent portion of the drug applicator may permit the camera to image the delivery site through the drug applicator. In some embodiments, the camera may be used in conjunction with the light source. The light source may be used to illuminate the region that is being imaged. In some embodiments, the light source may be to initiate a reaction by the drug, which may be imaged. FIG.14Fshows another example of a data collection device, such as a microphone202e. The microphone may be supported on a support structure202b. The microphone may be useful to collect acoustic data from the delivery site. In some embodiments, the microphone may be useful for collecting ultrasonic data. In some embodiments, the microphone may be used in conjunction with the light source. In some embodiments, one or more modules may be swapped in an out of the interior space of the ultrasound-generating device. For example, a light source may be swapped in and out with a different light source, or with a data collection device. A single module may fit within the interior space or multiple modules may fit within the interior space. For example, both a light source and a data collection device, or multiple types of data collection devices, may fit within the interior space. A drug applicator may be used to deliver drugs to a delivery site on the eye. The drug applicator may also be used to deliver ultrasound to the delivery site on the eye. Alternatively or in addition, a drug-holding overlay may be used to deliver drugs to a delivery site on the eye. The drug-holding overlay may be configured to contact a surface of the eye. The drug-holding overlay may be positioned on the surface of the eye and/or may at least partially adhere to the eye. The drug holding overlay may be configured to permit closure of the eye while the drug-holding overlay is applied to the surface. The drug holding overlay may have a low profile that may allow it to not protrude from the eye by more than 5 mm, 4 mm, 3 mm, 2.5 mm, 2 mm, 1.5 mm, 1.3 mm, 1.2 mm, 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.3 mm, 0.1 mm, 0.05 mm, or 0.01 mm. In some embodiments, the drug-holding overlay may be a contact lens, film, membrane, layer, or sheet. The drug holding overlay may be formed from a flexible material. The drug holding overlay may be malleable or may flex to conform to a shape of the surface of the eye. The drug holding overlay may have any shape. For instance, the drug holding overlay may have a substantially circular shape. The drug holding overlay may have an elliptical shape, rectangular shape, triangular shape, crescent shape, ring shape, or any other shape. The drug holding overlay may be substantially curved when in a natural state, similar to a curved surface of the eye. Alternatively, the drug holding overlay may be flat when in a natural state. The drug holding overlay may be formed of a porous material. The porous material may enable the drug holding overlay to hold at least one drug within the pores. The drug holding overlay may be formed of a hydrophilic, hydrophobic, amphiphilic, and/or sterile material. In some instances, the drug holding overlay may comprise a microcellular foam. In one example, the drug holding overlay may comprise a hydrophilic microcellular foam adjoined with a hydrophobic barrier film. The drug holding overlay may comprise a polymeric material, such as a polymeric film. The drug holding overlay may be formed from a low attenuation material. Any of the characteristics of the low attenuation material as described elsewhere herein may apply to the drug holding overlay. For example, the drug holding overlay may have an attenuation coefficient of less than 20, 15, 12, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, or 0.1 dB/(MHz cm). At least one drug may be encapsulated in the drug holding overlay. At least one drug may be adhered or applied on a surface of the drug-holding overlay. A method for delivery of at least one drug may comprise applying the drug-holding overlay to a surface of the eye. An ultrasound-generating device may be positioned relative to a desired site of the eye. Ultrasound may be generated with aid of the ultrasound-generating device, and ultrasound may be applied to the desired site. FIG.15shows an example of an application using a drug-holding overlay901on a surface of the eye100, in accordance with embodiments of the invention. An ultrasound-generating device1000may be positioned over an eyelid102of the eye. In some embodiments, the drug-holding overlay may be positioned on the surface of the eye beneath the eyelid. The drug-holding overlay may be positioned directly beneath the portion of the eyelid that is contacted by the ultrasound-generating device. Alternatively, the drug-holding overlay may be positioned beneath a different portion of the eyelid than the portion that is contacted by the ultrasound-generating device. The ultrasound-generating device may contact a portion of the eyelid when delivering ultrasound. The drug holding overlay may or may not be directly beneath the ultrasound-generating device when the ultrasound-generating device is contacting the eyelid. In some embodiments, the drug-holding overlay may be provided at a completely different portion of the eye. However, the ultrasound signals that may be provided to the eye may still aid in the delivery of drugs from the drug-holding overlay. The eye may be completely closed or partially closed when the ultrasound-generating device delivers ultrasound to the eyelid. Optionally, a drug applicator may be operably coupled to the ultrasound-generating device. The drug applicator may be positioned over the eyelid of the eye. The drug applicator may be formed of a low attenuation material that may permit the ultrasound to be transmitted to the eyelid. The drug-holding overlay may or may not be directly beneath the drug applicator. In some embodiments, the drug-holding overlay may be provided on a different region of the eye. FIGS.16A to16Bshow examples of additional applications using a drug-holding overlay901, in accordance with embodiments of the invention. An ultrasound-generating device1000may be positioned over the drug-holding overlay as shown inFIG.16A, or directly on a surface of the eye100while the drug holding overlay is at a different portion of the eye as shown inFIG.16B. In some embodiments, the drug-holding overlay may be positioned on any portion of the surface of the eye. For instance the drug-holding overlay may be positioned on a sclera, cornea, or limbus of the eye. The ultrasound-generating device may come into contact with the drug-holding overlay when delivering ultrasound. The drug holding overlay may be directly beneath the ultrasound-generating device when the ultrasound-generating device contacting the drug-holding overlay. The ultrasound-generating device may be positioned over a sclera of the eye, cornea of the eye, or limbus of the eye. The drug-holding overlay may be formed from a low attenuation material that may allow the ultrasound from the device to be conveyed to the surface of the eye. This may aid in delivery of the drugs from the drug-holding overlay to a target site of the eye. In some embodiments, the drug-holding overlay may be provided at a completely different portion of the eye. The ultrasound-generating device may come into direct contact with a surface of the eye. For instance, the ultrasound-generating device may come into direct contact with a sclera, cornea, or limbus of the eye. However, the ultrasound signals that may be provided to the eye may still aid in the delivery of drugs from the drug-holding overlay. The ultrasound-generating device may deliver ultrasound to a different portion of the surface of the eye than the portion of the eye upon which the drug overlay is provided. The ultrasound-generating device may deliver ultrasound to a different portion of the eye than a portion of the surface that receives the drugs. The eye may be open while the ultrasound-generating device is delivering the ultrasound. Optionally, a drug applicator may be operably coupled to the ultrasound-generating device. The drug applicator may be positioned over the drug-holding overlay in some embodiments. Alternatively, the drug applicator may directly contact the surface of the eye and the drug holding overlay may be at a different portion of the eye. The drug applicator may be formed of a low attenuation material that may permit the ultrasound to be transmitted to the drug holding overlay and/or the surface of the eye. The drug-holding overlay may or may not be directly beneath the drug applicator. In some embodiments, the drug-holding overlay may be provided on a different region of the eye from the applicator. In some embodiments, for particular treatment plans, it may be desirable to use the drug-holding overlay which is placed at a desired site of the eye. The drug-holding overlay may optionally be placed for an extended period of time, which may allow long-term delivery of the drugs. The application of ultrasound may provide enhanced delivery. The ultrasound delivery may be provided during the whole time the drug holding overlay is provided to the eye. Alternatively, the ultrasound-delivery may be provided for only a subset of the time that the drug holding overlay is provided to the eye. Alternatively or in addition, it may be desirable to use ultrasound to provide drainage from the eye, or from a drainage system around the eye. For example, it may be desirable to relieve increased intraocular pressure for certain conditions. In one instance, for treatment of diseases such as glaucoma, where there may be damage to a portion of the eye (e.g., optimal nerve of the eye) due to increased pressure that may result from a blockage of fluid draining from the eye, ultrasound may be applied to aid in drainage of the fluid from the eye. The ultrasound may be used in combination with drugs. For instance, for the treatment of the uveoscleral outflow or to decrease aqueous production, improved delivery of drugs to the target site may aid in the drainage of the fluid and relief from the pressure. Drugs, such as, but not limited to, prostaglandin analogs, beta blockers, adrenergic agents, miotics, carbon anhydrase inhibitors, or any other drugs as provided elsewhere herein, may be delivered to a desired site. Preferably, they may be delivered via a drug applicator to reduce loss of medication by tears, blinking or eye movement (e.g., compared to eye drops). Ultrasound may be applied which may aid in the delivery of these drugs. In some instances, these drugs may be provided via a drug-holding overlay. The ultrasound-stimulation may help to clear blocked drainage system, which may include an episcleral venous system, aqueous veins, canal of schlemm, and/or trabecular meshwork. Generation of ultrasound may permit draining of fluid from within the eye to reduce pressure within the eye. The draining of fluid may occur concurrently with delivery of one or more drugs. Draining of fluid may occur prior to delivery of one or more drugs. Draining of fluid may occur subsequent to the delivery of one or more drugs. In some embodiments, the ultrasound may operate at a desired frequency when draining fluid from within the eye. The desired frequency may have any value as provided elsewhere herein. In some instances, the desired frequency may be beneath 1 MHz. In some embodiments, the draining of the fluid may occur without causing any permanent damage to the eye. Optionally, the draining of the fluid may occur by disrupting the intracellular structure of the eye. In some instances, the draining of the eye may occur without increasing the temperature of the eye by a large amount. In some instances, the draining of the eye may occur without raising the temperature of the eye by more than 0.1 degree C., 0.5 degrees C., 1 degree C., 1.2 degrees C., 1.5 degrees C., 1.7 degrees C., 2 degrees C., 2.5 degrees C., 3 degrees C., 4 degrees C., 5 degrees C., 7 degrees C., or 10 degrees C. In some embodiments, the temperature of the eye does not exceed 33 degrees C., 34 degrees C., 35 degrees C., 36 degrees C., 37 degrees C., 38 degrees C., 39 degrees C., 40 degrees C., 41 degrees C., 42 degrees C., 43 degrees C., 44 degrees C., or 45 degrees C. The drainage of fluid may be useful during treatment of reducing intraocular pressure. For example, the drainage of fluid may be useful during glaucoma. In one example, ultrasound-mediated delivery of glaucoma drug may reach a trabecular meshwork and schlemm's canal. The ultrasound-mediated delivery of the glaucoma drug may occur via the limbus region. Alternatively, the drug may be delivered via other regions, such as the sclera or cornea. The delivery of drugs for treating glaucoma may occur concurrently with reducing aqueous production or increasing liquid outflow. The ultrasound could temporarily disrupt the trabecular meshwork, schlemm's canal and promote fluid outflow, thus reducing intraocular pressure. In some embodiments, high intensity ultrasound (e.g., 1 to 20 MHz) may be applied to reduce intraocular pressure. In some embodiments, the systems and methods provided herein may use lower intensity ultrasound, such as less than 1 MHz, 900 kHz, 800 kHz, 700 kHz, 600 kHz, 500 kHz, 400 kHz, 300 kHz, 250 kHz, 200 kHz, 150 kHz, 100 kHz, 80 kHz, 60 kHz, 50 kHz, 40 kHz, 30 kHz, or 20 kHz to reduce intraocular pressure. In other embodiments, low intensity ultrasound (e.g., with 2-4 W/cm2) may be provided. A drug delivery device may aid in the delivery of drugs and/or ultrasound to a desired site of the eye. This may allow drugs to be delivered to a target site of the eye, which may include a target site in an intraocular space of the eye. In some embodiments, depending on the drug to be delivered, or a treatment plan to be followed, different parameters may be provided for operation of an ultrasound-generating device of the drug delivery device. Instructions for operation of the ultrasound-generating device may be generated depending on the identity of the drug or a treatment plan for the eye. FIG.17shows an example of a process for generating instructions for operation of an ultrasound-generating device. A method of generating instructions for delivery of the drug may comprise obtaining a signal indicative of an identity of the at least one drug to be delivered or an identity of a treatment plan for the eye1701. The method may also comprise generating instructions operation of the ultrasound-generating device, based on the signal indicative of the identity of the drug or treatment plan1702. Ultrasound may be applied in accordance with the instructions, which may effect delivery of the drug1703. A signal indicative of an identity of the at least one drug to be delivered or an identity of a treatment plan for the eye may be obtained1701. The signal may be received at a drug delivery device, a display and/or input device, or a separate device. In some embodiments, the signal may be provided in response to a user input. The user input may be an input of an identity of the drug (e.g., a name of the drug, a selection of the drug from a plurality of drugs, a batch number or other identifier of the drug, a type of drug). The user input may be an input of an identity of a treatment plan for the eye. The identity of the treatment plan may comprise an identity of a disease or condition that is being treated for the eye (e.g., glaucoma, macular degeneration, diagnostic, vitamin delivery, prophylactics, or any other disease or condition as described elsewhere herein). The identity of a treatment plan may include a specific treatment plan identifier (e.g., name of plan, alphanumeric string identifying the plan, type of plan) which may or may not be unique for a particular subject or type of subject. A specific treatment plan for a subject may be generated with aid of a medical practitioner treating the subject. A specific treatment plan for the subject may be generated with aid of one or more processors based on certain inputs about the subject's conditions. In some embodiments, a user may be able to access settings for a disease/condition to be treated, ultrasound intensity, ultrasound frequency, cycle time, start, stop and/or timer. The user may be able to input or view patient information and/or a profile. For instance, the patient's name, medical records, disease/condition, stage of treatment, picture, may be accessed. In some instances, a user input may just be a patient identity, and the disease identity and/or treatment identity may be pulled from the patient's records. In some instances, the user input may just be the disease identity and/or treatment identity and the device or system may automatically generate operating parameters for the ultrasound-generating device. Alternatively, a user may manually adjust the operating parameters for the ultrasound-generating device, such as frequency, mechanical index, intensity, cycle time, cycle number, wait time, etc. The user input may be provided via a user interface. The user interface may be on-board the drug delivery device. For example, the user may directly input the identity of the drug and/or treatment plan directly into the drug delivery device. In another example, the user may interact with a display and/or input device which may be part of the drug delivery device or provided separately from the drug delivery device. In some instances, the display and/or input unit may communicate with the drug delivery device. The user input may be provided from any other external device. For example, the user may provide an input into a device, such as a computer, tablet, or smartphone, that may be in communication with the drug delivery device. In some embodiments, the signal indicative of the identity of the drug or identity of the treatment plan may be provided from one or more processors. The identity of the drug or identity of the treatment plan may be provided on a label of a drug applicator that may be coupled to the device. The drug applicator may be pre-loaded with at least one drug. The drug applicator may be coupled to the device in a removable fashion. When the drug applicator is coupled to the device, a sensor may be used to read the label of the drug applicator. Further details of reading the label from the drug applicator are provided in greater detail elsewhere herein. The label may provide information such as identity of the drug, volume of drug, identity of treatment plan, length of time for the treatment plan, specifics of the treatment plan, disease to be treated, identity of the subject, batch, time of manufacture, location of manufacture, manufacturer ID, expiration date, or other information relating to the drug applicator and/or drug. The information may be directly provided by the label, or the label may allow the drug delivery device to access a memory that may store the information. For example, if a treatment plan identifier is provided, the drug delivery device may access a memory storage on-board or off-board the device. The memory storage may have the additional information associated with the treatment plan identifier. In some embodiments, the drug applicator may ‘push’ information, such as the identity of the drug or treatment plan to the drug delivery device. For instance, the drug applicator may broadcast information, such as the identity of the drug or treatment plan, which may be read by a communication unit of the drug delivery device. One or more processors may be used to generate instructions for operation of the ultrasound-generating device based on the signal indicative of the identity of the drug or treatment plan1702. The processors may be on-board the drug delivery device. Alternatively, the processors may be off-board the drug delivery device. The processors may optionally be on-board a display and/or input device. The processors may be provided at a separate device. The processors may be provided as part of a cloud computing infrastructure. Generating instructions may comprise selecting instructions from a plurality of instruction options for various drugs or treatment plans. For example, a first set of instruction options may be provided for a first drug or treatment plan. A second set of instructions different from the first set of options may be provided for a second drug or treatment plan. A pre-set universe of sets of instructions may be provided. Based on which drug or treatment plan was identified, the appropriate set of instructions corresponding to the identified drug or treatment plan may be selected. In other instances, the instructions may be generated de novo and not selected from an existing pool of instructions. The instructions may be generated based on known parameters of the drugs and/or treatment plans. The instructions may be generated based on a subject's identity or characteristics of the subject. For example, if the subject is a 40 year old female, the instructions may be different from if the subject is a 60 year old male. If the subject has any known interactions with drugs, this may affect the instructions as well. For example, Person A may be more sensitive to drug A than Person B. The instructions may define operation of the ultrasound-generating device. This may include determining the frequency of the ultrasound, the mechanical index of the ultrasound, timing information for the ultrasound (e.g., a time duration TA of the ultrasound, a waiting period TW of the ultrasound, a number of duty cycles of the ultrasound, a length of the treatment plan of the ultrasound), a wave form of the ultrasound, and/or an intensity of the ultrasound. The ultrasound may be generated in accordance with the instructions1703. The generation of the ultrasound may effect delivery of drugs to the target site. In some embodiments, the ultrasound may be applied prior to, concurrently with, and/or subsequent to the drug applicator making contact with the eye. Further embodiments of the invention relate to integration of the system according to one aspect of the invention into existing treatment apparatuses for diseases of the eye. The system is preferably combined and/or integrated with other diagnostic and/or treatment devices. FIGS.18A to18Cshow examples of application of ultrasound in accordance with various treatment plans. FIG.18Ashows examples of ultrasound that may be applied in accordance with a treatment plan. The ultrasound may be delivered in pulses of on and off. The system may be operated in at least one application cycle. Each application cycle comprises at least one ultrasound emitting event with a time duration TA and a subsequent waiting period with a time duration TW. During the ultrasound emitting event the ultrasound device is operated and during the waiting period the ultrasound device is not operated. The drug applicator may be in contact with a surface of the eye such as a scleral surface, corneal surface, or limbus, for the complete duration of the at least one application cycle. Depending on the physical, chemical, and pharmaceutical properties of the drug different parameters for the application cycle are required. In one embodiment of the invention the system is configured to control at least one parameter, preferably a subset, selected from the following list: the time duration TA of the ultrasound emitting event, the time duration TW of the wait period after the ultrasound emitting event, the number of application cycles, the intensity of the ultrasound emitting event, the central frequency of the ultrasound emitting event, the mechanical index of the ultrasound emitting system, and in case of a pulsed ultrasound emitting event: the repetition rate of the ultrasound emitting event and the duty cycle of the ultrasound emitting event. Any number of application cycles may be provided. In some embodiments, a preset number of application cycles may be provided. In some instances, a preset duration for the application cycles to run may be provided. FIG.18Bshows an example of multiple application cycles that may be clustered together, in accordance with embodiments of the invention. The clusters of cycles may or may not be repeated. In some embodiments, a cluster may have a length of time TC. The length of the application cycles may collectively be about TE. The amount of time between the clusters may be a dormant period TD. The clusters may repeat any number of times. The clusters may repeat for a predetermined number of times, or during a preset duration. FIG.18Cshows an example of how parameters P may be varied over time t during a treatment plan. There may or may not be regular application cycles. In some embodiments, a series of application cycles with various characteristics may repeat, or may not repeat. For example, an amount of time that the ultrasound is ‘on’ T0may be fixed or may vary. A waiting period TWduring which the ultrasound is ‘off’ may be fixed or may vary. Similarly, a cluster length TEmay be fixed or may vary. Time between clusters TDmay be fixed or may vary. One or more parameters may be fixed for a particular application cycle. One or more parameters may be fixed for an entirety of a cluster. One or more parameters may be fixed for an entirety of a treatment plan. Alternatively, one or more parameters may be varied during a treatment plan. One or more parameters may be varied during a cluster. One or more parameters may be varied during an application cycle. Any parameter may be varied including, but not limited to, intensity of the ultrasound emitting event, the central frequency of the ultrasound emitting event, or the mechanical index of the ultrasound emitting system. For any of the times (e.g., TA, TW, TC, TD, TE), the amount of time may be on the order of microseconds, milliseconds, seconds, tens of seconds, minutes, or more. For instance, ultrasound may be generated for a time duration of less than or equal to about 0.001 s, 0.005 s, 0.01 s, 0.05 s, 0.1 s, 0.5 s, 1 s, 3 s, 5 s, 10 s, 15 s, 20 s, 30 s, 45 s, 60 s, 90 s, 120 s, 150 s, 180 s, 210 s, 240 s, 270 s, 300 s, 360 s, 420 s, 480 s, 540 s, 600 s, 1000 s, 2000 s, 3000 s, or 6000 s. Ultrasound may be generated for a time duration greater than any of the values provided herein or within a range falling between any two of the values provided herein. Similarly, a wait time may be provided for a time duration less than or equal to any time duration provided herein. A wait time may be greater than any time duration provided herein, or falling within a range between any time durations provided herein. Any other time associated with the ultrasound treatment profile (e.g., TC, TD, TE) may have a time duration less than, greater than, or falling between any two of the time durations provided herein. In some embodiments, an entire treatment plan may span on the order of seconds, minutes, hours, days, weeks, months, or years. A patient may receive ultrasound treatment at different points in time and may be re-acquainted with a drug delivery system as needed. For different drugs and/or treatment plans different ultrasound profiles may be provided over time. FIG.19shows an example of penetration of drugs to a target site within an intraocular space of the eye, in accordance with embodiments of the invention. An ultrasound-generating device202and drug applicator201may deliver drugs and ultrasound to an eye100. The ultrasound-generating device may advantageously permit penetration of drugs to a distance d within the eye. In some embodiments, it may be desirable to for the drug to penetrate to a posterior part of the eye. For example, for diseases such as diabetic retinopathy or macular degeneration, the drugs may be delivered to the posterior part of the eye. In some embodiments, the drugs may be corticosteroid or anti-VEGF drugs. Some of the drugs may include, but are not limited to triamicolone with trade names of aristocort, kencaort, or kenalog, or anti-VEGF with trade names of lucentis, eylea, or avastin. Through the ultrasound treatment as described herein, the drugs may be delivered to the back side of the eye, the retina. The concentration at which the drugs may be delivered may be the same, or at least 50%, 60%, 70%, 80%, 90%, 95%, 97%, or 99% of the drug concentrations provided with intravitreal injections without requiring such invasive techniques. The drug may be capable of penetrating to a depth d of at least 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.5 cm, 1 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm, or 0.1 cm. Such distance may be penetrated when the ultrasound is operating at any frequency value, such as less than or equal to 1 MHz, 900 kHz, 800 kHz, 700 kHz, 600 kHz, 500 kHz, 400 kHz, 300 kHz, 250 kHz, 200 kHz, 150 kHz, 120 kHz, 100 kHz, 90 kHz, 80 kHz, 70 kHz, 60 kHz, 50 kHz, 40 kHz, 30 kHz, 20 kHz, or 10 kHz. Such a distance may be penetrated when the ultrasound is operating at a frequency value greater than any of the values provided, or falling within a range between any two of the values provided. Such distance may be penetrated when the ultrasound is operating at any mechanical index, such as less than or equal to 0.01, 0.05, 0.1, 0.13, 0.15, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.6, 0.7, 0.8, 0.9. Such a distance may be penetrated when the ultrasound is operating at a mechanical index greater than any of the values provided, or falling within a range between any two of the values provided. Such distance may be penetrated when the ultrasound is operating at any intensity, such as less than or equal to 10, 9, 8, 7.5, 7, 6.5, 6, 5.5, 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1, 0.5, 0.1 W/cm2. Such a distance may be penetrated when the ultrasound is operating at a mechanical index greater than any of the values provided, or falling within a range between any two of the values provided. The drug may be capable of penetrating to any of the depths indicated within 600 seconds, 480 seconds, 420 seconds, 360 seconds, 300 seconds, 240 seconds, 180 seconds, 120 seconds, 90 seconds, 60 seconds, 30 seconds, 20 seconds, 15 seconds, 10 seconds, 5 seconds, 3 seconds, 2 seconds, 1 second, 0.5 seconds, or 0.1 seconds. The drug may be capable of penetrating to such depths within any of the indicated time values of the ultrasound being applied. The drug may be capable of penetrating to such depths within any of the indicated time values of the drug applicator making contact with a surface of the eye. The drug may be capable of penetrating to a maximum depth that the drug may travel within any of the time values provided. The drug may be configured to penetrate to a target site at any concentration. In some embodiments, the drug may delivered into the vitreous and the retina of the eye at any concentration. The drug may be delivered to a target site at a concentration of greater than or equal to 0.01, 0.05, 0.1, 0.3, 0.5, 0.7, 1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 2, 2.5, 3, 3.5, 4, 5, 7, 10, 12, 15, 17, 20, 25, 30, 35, 40, 50, 60, 70, 80, 100, 150, 200, 250, 300, 400, 500, 700, 1000, 1200, 1500, 2000, 2500, 3000, 3500, 4000, 5000, 7000, 10000 μg/mL. The drug may be delivered at a concentration less than any of the values provided or falling within a range between any two of the values provided. The drug may be capable of penetrating at any speed. The drug may be capable of being delivered at a speed of at least 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 150, 175, 200, 250, 300, 350, 400, 450, 500, 600, 700, 800, 900, 1000 μm2/s. The drugs that may be penetrating to such depths may be any type of molecule. The drugs may be penetrating to such depths under such ultrasound frequencies, intensities, or mechanical indexes. The drugs may be penetrating under any such concentrations or at any such speeds. The drugs may be penetrating to such depths within the time periods indicated. Such penetration may occur without damaging the eye tissue (e.g., sclera, retina, cornea, limbus). Such penetration may occur without damaging the eye tissue in a permanent manner. Such penetration may occur without increasing temperature of the eye by more than 0.1 degrees, 0.5 degrees, 1 degree, 1.5 degrees, 2 degrees, 2.5 degrees, 3 degrees, 3.5 degrees, 4 degrees, 5 degrees, 6 degrees, 7 degrees, 8 degrees, 9 degrees, or 10 degrees C., or any other temperature value provided elsewhere herein. Such penetration may occur without causing the temperature of the eye to rise beyond 33 degrees, 34 degrees, 35 degrees, 36 degrees, 37 degrees, 38 degrees, 39 degrees, 40 degrees, 41 degrees, 42 degrees, 43 degrees, 44 degrees, or 45 degrees C. The drug molecules may be small organic molecules, proteins, monoclonal antibodies, antibody fragments, or nanoparticles. Any size of molecule may be delivered to the target site. In some embodiments, the size of the molecules may be less than or equal to about 10 Da, 50 Da, 100 Da, 300 Da, 500 Da, 700 Da, 900 Da, 1 kDa, 2 kDa, 3 kDa, 5 kDa, 7 kDa, 10 kDa, 20 kDa, 30 kDa, 40 kDa, 50 kDa, 60 kDa, 70 kDa, 80 kDa, 90 kDa, 100 kDa, 120 kDa, 150 kDa, 170 kDa, 200 kDa, 220 kDa, 250 kDa, 280 kDa, 300 kDa, 350 kDa, 400 kDa, 450 kDa, 500 kDa, 600 kDa, 700 kDa, 800 kDa, 900 kDa, or 1 MDa. In some instances, the size of the molecules may be greater than any of the sizes provided herein. The size of the molecules may fall within a range between any two of the sizes provided herein. The size of the molecules comprising the drug to be delivered may be important for the parameters of the application cycle. For relatively small molecules, i.e., preferably having a size of less than 70 kDa, the drug delivery rate is primarily controlled by the duration of the ultrasound emission event TA. For relatively large molecules, i.e., preferably having a size of more than 70 kDa, the drug delivery rate is primarily controlled by the duration of the wait time TW after the ultrasound emission event. Since the optimal set of parameters of the application cycle varies for different drugs and/or different users, in it is preferred that the system comprises one or more processors for assisting the setting of parameters of the application cycle. The information sending and/or receiving unit203may be used to retrieve information about the drug from the drug applicator201. The display and input unit400may be provided to allow for changing of preset parameters. In an embodiment of the invention, the system is connected to a central database and the database manages information about optimal sets of parameters of the application cycle. The database may be provided on a cloud computing infrastructure. One or more drug delivery devices may be capable of communicating with the database. For instance, a drug delivery device may receive instructions about an optimal set of parameters for a particular treatment plan, drug, and/or patient. The drug delivery device may send information to the database about a drug, treatment plan and/or patient and the database may return the optimal set of parameters. Alternatively or additionally, optimal sets of parameters of the application cycle are stored on/in the drug applicator and are preferably retrieved by the information sending and/or receiving unit203. In some embodiments, the optimal sets of parameters on-board the drug delivery device. The optimal sets of parameters may be updated periodically or in response to an event from the central database. In an embodiment of the invention, the system comprises input means configured to manually set the parameters of the application cycle. The system according to one aspect of the invention is configured to carry out the method according other aspects of the invention. In the following aspects of preferred embodiments of the method for ultrasound enhanced delivery of drugs are described. The skilled person realizes that certain above described embodiments of the system relate to certain embodiments of the method described hereinafter. In an embodiment of the invention, the drug to be delivered is stored in the drug applicator201. Prior to the delivery operation the drug applicator201is coupled to the application head205. Prior to the coupling, a used drug applicator201is required to be removed. Prior or after the coupling the drug applicator201is prepared for the delivery operation. Preparing for the delivery operation preferably comprises removing a peel-off seal and/or removing a protective cover. In an alternative embodiment, the drug is stored in a container holding several doses of the drug. A drug applicator201is preferably permanently coupled to the application head202and/or a drug applicator201is coupled to the application head202. The drug applicator201is optionally cleaned prior to loading the drug into the drug applicator201. After the optional cleaning the drug is loaded into a drug receiving space800in the drug applicator201. The loading can be carried out while the drug applicator201is attached to the application head205or while the drug applicator201is not attached to the application head205. In an embodiment of the invention, after the drug applicator201has been prepared for the delivery operation the system is prepared for the delivery operation. In an alternative embodiment of the invention the system is prepared for the delivery operation prior to preparing the drug applicator201for the delivery operation. Preparing the system for the delivery operation preferably comprises setting the optimal set of parameters of the application cycle and/or adapting the parameters of the application cycle. Prior to setting and/or adapting the parameters of the application cycle information about the drug and/or information about the drug applicator201are preferably retrieved by the information sending and/or receiving unit203. In an embodiment of the invention, after the system and/or the drug applicator201have been prepared for the delivery process the system is positioned such that the drug applicator touches the scleral surface. In an alternative embodiment, the system is positioned prior to preparing the system and/or the drug applicator. Positioning the system preferably comprises applying an ultrasound transmission gel to an interface601bbetween the drug applicator201and the scleral surface. Positioning the system alternatively or additionally comprises pressing the drug applicator201against the scleral surface. In an embodiment of the invention, after the system has been positioned the at least one application cycle is performed. During the application cycle the drug applicator201is in permanent contact with the sclera surface. In an embodiment of the invention, during the at least one application cycle the temperature of the sclera surface is measured this measurement means. Measurement means preferably include a thermocouple and/or an infrared thermometer. It is preferred that the temperature of the scleral surface does not increase by more than 1° C. during the at least one application cycle. The system is preferably configured to control the ultrasound emission event to prevent excessive heating of the scleral tissue. In an embodiment of the invention, after the at least one application cycle and additional wait time is required for the drug to be delivered most efficiently. In an embodiment of the invention after the at least one application cycle the drug applicator201is removed from the scleral surface. Depending on the embodiment of the invention the drug applicator201is preferably configured to be reused at a later time or is configured to be a single use drug applicator201. Depending on the embodiment of the invention the drug applicator201is removed from the application head205after the at least one application cycle and/or remain on the application head205for later use. FIG.20shows effects of various mechanical indexes, in accordance with embodiments of the invention. For instance, different values for diffusivity (e.g., Dacoustic mixingof BSA) are provided for various mechanical indices. Such values are provided during 30 s 40 kHz ultrasound application N>=3. An error bar is provided that represents the standard deviation of the fitted diffusivity values. The highest degree of diffusivity may be provided for a mechanical index of 0.2. FIG.21shows how various frequencies affect intracellular junctions, in accordance with embodiments of the invention. For instance, using a 20 kHz ultrasound at a mechanical index=0.2 allows drug molecules (e.g., any type of molecules with any characteristics or parameters as provided elsewhere herein) to be delivered into the surface of the eye (e.g., the sclera, cornea, limbus) and/or suprachoroidal space, but not crossing the retina. The drug molecules may be delivered at any speed, such as any of the values described elsewhere herein, without damaging the eye tissue. Tight junction staining images are provided, which shows that at 20 kHz, the ultrasound does not disrupt the tight junctions of the retinal epithelium cells. At 40 kHz, ultrasound disrupted all the intercellular junctions. With the intercellular junctions intact, drug molecules cannot pass through the epithelial cell layer, and thus remain in the suprachoroidal space. FIG.22shows additional effects of various mechanical indexes, in accordance with embodiments of the invention. Concentration of BSA in a receiver chamber is shown for various mechanical indexes and frequencies. FIG.23shows further examples of effects of various mechanical indexes, in accordance with embodiments of the invention. At various mechanical indexes, different changes in BSA partition relative to control may be provided. In some embodiments, mechanical indexes of different cavitation regimes may be provided. For instance, lower mechanical index values may correspond to sable cavitation and higher mechanical indexes may correspond to transient cavitation. FIG.24shows examples of data pertaining to riboflavin delivery to a target site. For example, a riboflavin molecule may be delivered into a cornea by ultrasound. An ex vivo study was conducted of delivering small molecules into porcine corneal tissue. The small molecules used was riboflavin. The small molecules may have a molecular weight of about 376 g/mol or less. By using ultrasound at 40 kHz, at least 15 μg/mL of riboflavin was delivered into the deep corneal stromal tissue. An illustration is provided of riboflavin 1 mg/mL delivered into ex vivo pig corneas. The riboflavin concentration in μg/mL is shown for different circumstances, such as epithelium debrided (Epi-off) cornea with 30 minutes riboflavin contact, Epi-Off with 3 cycles of 90 seconds ultrasound+15 minutes breaks in between and Epi-Off with 3 cycles of 90 seconds ultrasound+5 minutes break in between. 0.1% Riboflavin solution, Peschke D was delivered in ex-vivo pig corneas. The 15 μg/mL safety threshold is exceeded by applying 3 cycles of 90 seconds ultrasound with 5 minute breaks in between. FIG.25shows another example of data pertaining to riboflavin delivery to a target site. This data shows the concentration of riboflavin molecules delivered into the cornea by ultrasound at indicated durations. The concentration of Riboflavin-5-Phosphate delivered into porcine corneas by ultrasound for 5 minutes or less reached the therapeutic threshold when compared with the concentration delivered via typical Dresden protocol (30 minutes instillation of riboflavin solution on the porcine cornea). Riboflavin-5-Phosphate (R5P), 1.5 mL, 0.1% solution was applied to a porcine eyeball, epi-off. The ultrasound parameters were 40 kHz, mechanical index 0.2. The cornea was in full contact with R5P over indicated time period. The cornea was excised and weighed. Extracted supernatant with R5P was used for fluorescent measurement. FIG.26shows an example of an experimental procedure implementing the systems and methods described herein. The procedure relates to an in vivo study of delivering small molecules into mice eyes for treatment of experimental autoimmune uveitis (EAU). The small molecules used were dexamethasone, with of a molecular weight of about 376 g/mol. For a given animal subject, the drug was delivered via intravitreal injection (10 μg in 1 μL balanced salt solution), to the left eye. For the right eye, the drug (10 μg in 1 μL balanced salt solution, repeat 3 times) was delivered by 40 kHz ultrasound. A timeline is illustrated of the experimental procedure. EAU mice were provided as described. The final n=2, as one mouse was dead on day 10 during the first treatment. The data for Mouse 1 and Mouse 2 were collected as detailed in greater detail below. On day 0, EAU induction occurred. Baseline imaging by confocal scanning laser ophthalmology (cSLO) and optical coherence tomography (OCT) occurred on day 0. On day 10, the drug was applied via ultrasound on the right eye. The drug was applied via intravitreal injection to the left eye. On day 13, imaging was conducted via cSLO and OCT. On days 13, 17, and 20, the drug was delivered to the right eye via ultrasound. On day 21, the mice were sacrificed for histology. Imaging was conducted by cSLO and OCT. FIG.27shows images of effects of the systems and methods described herein as illustrated by the experimental procedure. Images of the right eye and the left eye of Mouse 1, and the right eye and left eye of Mouse 2 are provided. The images are fundus photos, which may be taken via fundus fluorescein angiography (FFA). The images are provided for day 0, day 13, and day 21. Mouse 1 right eye shows no injury of retina and less infiltrated cells around the optic nerve head compared to the left eye. Mouse 2 right eye shows no injury of retina and less severe vasculitis compared to the left eye. This suggests that the application of the drug via the ultrasound results in less severe vasculitis and/or infiltrated cells around the nerve head compared to intravitreal injection. FIG.28shows further illustrations of the effects of the systems and methods. OCT sections are provided for the right eye and left eye of Mouse 1, and the right eye and left eye of Mouse 2. The images are provided for day 0, day 13, and day 21. The right eye of Mouse 1 shows less infiltrated cells around the optic nerve head compared to the left eye. The right eye of Mouse 2 shows less infiltrated cells around the optic nerve head compared to the left eye. This suggests that the application of the drug via the ultrasound results in less infiltrated cells around the optic nerve head compared with the intravitreal injection. FIG.29shows an illustration of a first mouse left eye from the experimental procedure. The FFA photo and OCT sections are illustrated, showing that the left eye of Mouse 1 has retina injury caused by intravitreal injection. The retinal change still existed at day 21 when the animal was sacrificed. FIG.30shows an illustration of a second mouse left eye from the experimental procedure. The FFA photo and OCT sections are illustrated, showing that the left eye of Mouse 2 has retina injury caused by intravitreal injection. The retinal change still existed at day 21 when the animal was sacrificed, although the regional damage at the injection site was reduced compared to Mouse 1, possibly due to improved technique. A drug delivery system or component thereof may be provided as a kit comprising instructions of use thereof. For instance, a kit comprising a drug delivery device may be provided with instructions of use thereof. A drug applicator may be provided together with the drug delivery device or may be provided separately. A kit comprising a drug applicator may be provided with instructions of use thereof. The kit may comprise information about drugs loaded onto the drug applicator. One or more settings for use of the drug delivery device for the particular drug and/or drug applicator may be provided in the instructions. In some embodiments, a drug delivery device may be reusable. A drug applicator may be coupled to the drug delivery device. The drug applicator may be reusable or may be disposable. Optionally, the drug applicator may be refilled or loaded with drugs. In some instances, the drug applicator may be disposable after a single use. Throughout this application the terms “drug”, “therapeutic agent”, and the more general term “molecules” are considered to be interchangeable and the respective use depends on the technical context. The use of one specific wording is not meant to limit the scope of the subject-matter protection is sought for. For example, a therapeutic agent may comprise a drug and/or a drug may comprise molecules. The term “drug”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound. In one embodiment of the invention the pharmaceutically active compound has a molecular weight up to 70 kDa and/or comprises antibodies, biologics conjugates, protein drug conjugates, corticosteroid drug conjugates, drug-encapsulated nanoparticles, drug-conjugated nanoparticles, protein drugs, biologics, corticosteroid drugs, nonsteroidal anti-inflammatory drugs, charged molecules, uncharged molecules, or a mixture of the above-mentioned pharmaceutically active compounds. In an alternative embodiment of the invention the pharmaceutically active compound has a molecular weight of more than 70 kDa and/or comprises antibodies, biologics conjugates, protein drug conjugates, corticosteroid drug conjugates, drug-encapsulated nanoparticles, drug-conjugated nanoparticles, protein drugs, biologics, corticosteroid drugs, nonsteroidal anti-inflammatory drugs, charged molecules, uncharged molecules, or a mixture of the above-mentioned pharmaceutically active compounds. In some instances, drugs may include any compounds or molecules that may be useful for treating a disease or condition of the eye, performing diagnostics, promoting health of the eye, or any other portion of the body. In some embodiments, examples of drugs may include but are not limited to: prostaglandin or analogs like latanoprost (Xalatan), bimatoprost (Lumigan) and travoprost (Travatan) which may increase uveoscleral outflow of aqueous humor; topical beta-adrenergic receptor antagonists such as timolol, levobunolol (Betagan), and betaxolol which may decrease aqueous humor production by the ciliary body; Alpha2-adrenergic agonists such as brimonidine (Alphagan) which may work by a dual mechanism, decreasing aqueous production and increasing uveo-scleral outflow; less-selective sympathomimetics like epinephrine and dipivefrin (Propine) which may increase outflow of aqueous humor through trabecular meshwork and possibly through uveoscleral outflow pathway; miotic agents (parasympathomimetics) like pilocarpine which work by contraction of the ciliary muscle, tightening the trabecular meshwork and allowing increased outflow of the aqueous humour; carbonic anhydrase inhibitors like dorzolamide (Trusopt), brinzolamide (Azopt), acetazolamide (Diamox) which may provide a reduction of aqueous humor production by inhibiting carbonic anhydrase in the ciliary body; betablockers; Bevacizumab (Avastin); Ranibizumab (Lucentis); Triamcinolone acetonide (Kenalog) (Triesence/Trivaris); Ganciclovir Intravitreal; Foscarnet Intravitreal; Cidofovir; Fomvirsen; Methotrexate; Vancomycin; Ceftazidime; Amikacin; Amphotericin B; Voriconazole; Dexamethasone; riboflavin; Nesvacumab or other monoclonal antibody that may target protein angiopoetin 2 (ANG2) or other proangiogenic cytokine; or Fovisa, Zimura or other aptamers which may bind with specificity and affinity to targets such as platelet-derived growth factor (PDGF). In an embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of central retinal vein occlusion, branch retinal vein occlusion, central serous retinopathy, cytomegalovirus retinitis, retinoblastoma, intraocular lymphoma, ocular melanoma, giant cell arteritis, histoplasmosis, ischemic optic neuropathy, macular pucker, macular telangiectasia, uveitis, choroidal neovascularization, age-related macular degeneration, diabetic retinopathy, glaucoma, retinitis pigmentosa, macular edema, cystoid macular edema, macular degeneration, multirecurrent pterygia, ocular toxoplasmosis, proliferative vitreoretinopathy (PVR), Stevens-Johnson syndrome, ocular cicatricial pemphigoid, endophthalmitis, an ocular degenerative condition, or a post-surgery condition which requires the delivery of a drug into an intrascleral space. The scope of protection of the invention is not limited to the examples given hereinabove. The invention is embodied in each novel characteristic and each combination of characteristics, which particularly includes every combination of any features which are stated in the claims, even if this feature or this combination of features is not explicitly stated in the claims or in the examples. While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. It is not intended that the invention be limited by the specific examples provided within the specification. While the invention has been described with reference to the aforementioned specification, the descriptions and illustrations of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Furthermore, it shall be understood that all aspects of the invention are not limited to the specific depictions, configurations or relative proportions set forth herein which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is therefore contemplated that the invention shall also cover any such alternatives, modifications, variations or equivalents. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby. | 161,307 |
11857460 | DETAILED DESCRIPTION Described here are systems and methods for accessing Schlemm's canal and for delivering a fluid composition therein and for tearing the trabecular meshwork to reduce intraocular pressure and thereby treat conditions of the eye. The fluids and certain components of the system, e.g., the slidable elongate member, may be used to provide a force for disrupting trabeculocanalicular tissues, which include the trabecular meshwork, juxtacanalicular tissue, Schlemm's canal, and the collector channels. As used herein, the term “disrupting” refers to the delivery of a volume of fluid or a system component that alters the tissue in a manner that improves flow through the trabeculocanalicular outflow pathway. Examples of tissue disruption include, but are not limited to, dilation of Schlemm's canal, dilation of collector channels, increasing the porosity of the trabecular meshwork, stretching the trabecular meshwork, forming microtears or perforations in juxtacanalicular tissue, removing septae from Schlemm's canal, cutting, tearing, or removal of trabeculocanalicular tissues, or a combination thereof. To better understand the systems and methods described here, it may be useful to explain some of the basic eye anatomy.FIG.1is a stylized depiction of a normal human eye. The anterior chamber (100) is shown as bounded on its anterior surface by the cornea (102). The cornea (102) is connected on its periphery to the sclera (104), which is a tough fibrous tissue forming the protective white shell of the eye. Trabecular meshwork (106) is located on the outer periphery of the anterior chamber (100). The trabecular meshwork (106) extends 360 degrees circumferentially around the anterior chamber (100). Located on the outer peripheral surface of the trabecular meshwork (106) is Schlemm's canal (108). Schlemm's canal (108) extends 360 degrees circumferentially around the meshwork (106). At the apex formed between the iris (110), meshwork (106), and sclera (104), is the anterior chamber angle (112). The systems are generally configured for single-handed manipulation and for control by a single operator, and include one or more features useful for easily accessing Schlemm's canal with minimal trauma. Once access to the canal has been obtained, the system may deliver a fluid composition and tear the trabecular meshwork. The lumen of the elongate member may be configured to deliver a fluid composition to the canal, and the body of the elongate member may be configured to cut or tear through the trabecular meshwork if the system is removed from the eye while the elongate member is within Schlemm's canal. It should be appreciated that in some instances the delivery systems described herein may be used only to deliver a fluid composition to Schlemm's canal (and not to tear the trabecular meshwork), or may be used only to tear the trabecular meshwork (and not to deliver a fluid composition). In some variations the methods described herein may comprise implanting a device completely or partially into Schlemm's canal in conjunction with delivering a fluid composition into the canal and/or tearing the trabecular meshwork. When a device is implanted into the canal, it will generally be configured to maintain the patency of Schlemm's canal without substantially interfering with transmural fluid flow across the canal. This may restore, enable, or enhance normal physiologic efflux of aqueous humor through the trabeculocanalicular tissues. Ocular implants such as those disclosed in U.S. Pat. No. 7,909,789, and such as those disclosed in U.S. Pat. No. 8,529,622, each of which is hereby incorporated by reference in its entirety, may be delivered. In some variations, the implants in U.S. Pat. No. 7,909,789 and U.S. Pat. No. 8,529,622 include a support having a least one fenestration that completely traverses a central core of Schlemm's canal without substantially interfering with transmural fluid flow or longitudinal fluid flow across or along the canal. The ocular device may also disrupt the juxtacanalicular trabecular meshwork or adjacent inner wall of Schlemm's canal. The ocular devices may also be coated with a drug useful for treating ocular hypertension, glaucoma, or pre-glaucoma, infection, or scarring, neovascularization, fibrosis, or inflammation postoperatively. The ocular device may also be formed to be solid, semi-solid, or bioabsorbable. I. SYSTEMS/DEVICES The systems described herein may be single-handed, single-operator controlled devices that generally include a universal handle having a grip portion and a housing that has an interior and a distal end. A cannula is typically coupled to and extends from the housing distal end. The cannula may include a proximal end and a distal curved portion, where the distal curved portion has a proximal end and a distal end, and a radius of curvature defined between the ends. In other variations, the cannula may be straight and may not comprise a distal curved portion. The cannula may also be configured to include a body; a distal tip having a bevel; and a lumen extending from the proximal end through the distal tip. The bevel may directly engage the distal end of the curved portion of the cannula (i.e., the bevel may directly engage the radius of curvature). The systems may also generally include a drive assembly partially contained within the housing comprising gears that translate rotational movement to linear movement. The system may also be configured to include a slidable elongate member comprising a lumen that is coaxially disposed within the cannula lumen. The system may also be configured to include a fluid assembly in the handle. Fluid compositions such as saline, viscoelastic fluids, including viscoelastic solutions, air, and gas may be delivered using the system. Suitable markings, colorings, or indicators may be included on any portion of the system to help identify the location or position of the distal end of the cannula and/or the slidable elongate member. In some instances, the systems described herein may be used to perform ab-interno trabeculotomy, ab-interno transluminal trabeculotomy, clear corneal trabeculotomy, clear corneal transluminal trabeculotomy, ab-interno canaloplasty, and/or clear corneal canaloplasty, and may be used to deliver a fluid composition into the anterior or posterior segment of the eye. An exemplary delivery system is depicted inFIG.2A. Delivery system (200) includes a universal handle (202) having a grip portion (204) and a housing (206). The housing (206) has a proximal end and a distal end. A cannula (208) is coupled to and extends from the housing's distal end. A drive assembly is substantially contained within the housing (206), which actuates movement of an elongate member (not shown) through rotation of one wheel (210) (two of which extend out of the housing (206) on opposite sides). The delivery system (200) may further comprise a lock (212) and a reservoir comprising a proximal opening (214). The delivery system (200) is described in more detail herein. The delivery systems described herein may in some variations be fully disposable. In other variations, a portion of the delivery system may be reusable (e.g., non-patient contact materials, such as the handle), while a portion of the delivery system may be disposable (e.g., patient-contact materials, such as the cannula and elongate member). In yet other variations, the delivery systems described herein may be fully reusable. Universal Handle The delivery systems described herein may include a universal handle capable of single-handed use. For example, the handle may be configured to be capable for use with the left or right hand, for use on the left or right eye, or in the clockwise or counterclockwise direction. That is, the handle may be configured such that the ability to use the delivery system is independent of which hand is used, which eye a procedure is performed on, or which direction around the canal a tool or fluid composition is delivered. For example, the delivery system may be used to deliver a fluid composition in a clockwise direction in an eye, and then with a simple flip of the handle (or by rotating the cannula itself 180 degrees in another variation) to a second orientation, may be used to deliver a fluid composition in the counterclockwise direction. However, it should be appreciated that in other variations, the delivery systems described herein may be configured to be used in a particular configuration (e.g., with a single side up, only in a clockwise direction, only in a counterclockwise direction, etc.). The handle generally includes a grip portion and a housing. The grip portion may be raised, depressed, or grooved in certain areas, or textured to improve hold of the handle by the user or to improve comfort of the user. The housing may include an interior portion and a distal end. The interior portion of the housing may contain a drive assembly and a positioning element (both further described below). In some variations, the distal end of the housing may include a fluid port that can provide fluids for irrigation of the operative field or to purge air from the system. The universal handle may be made from any suitable material, including without limitation, fluoropolymers; thermoplastics such as polyetheretherketone, polyethylene, polyethylene terephthalate, polyurethane, nylon, and the like; and silicone. In some variations, the housing or portions thereof may be made from transparent materials. Materials with suitable transparency are typically polymers such as acrylic copolymers, acrylonitrile butadiene styrene (ABS), polycarbonate, polystyrene, polyvinyl chloride (PVC), polyethylene terephthalate glycol (PETG), and styrene acrylonitrile (SAN). Acrylic copolymers that may be particular useful include, but are not limited to, polymethyl methacrylate (PMMA) copolymer and styrene methyl methacrylate (SMMA) copolymer (e.g., Zylar 631® acrylic copolymer). In variations in which the universal handle is reusable, the handle may be made from a material that can be sterilized (e.g., via autoclaving), such as a heat-resistant metal (e.g., stainless steel, aluminum, titanium). The length of the universal handle may generally be between about 1 inch (2.5 cm) to about 20 inches (50.8 cm). In some variations, the length of the universal handle may be between about 4 inches (10.2 cm) and 10 inches (25.4 cm). In some variations, the length of the universal handle is about 7 inches (17.8 cm). Cannula The cannula of the delivery system is typically coupled to and extends from the housing distal end, and is generally configured to provide easy and minimally traumatic access to Schlemm's canal using a minimally invasive ab-interno approach. The cannula may be fixedly attached to the distal end of the housing, or in other variations it may be rotatably attached to the distal end of the housing. In variations of the delivery systems where the handle is reusable and the cannula is disposable, the cannula may be removably attached to the distal end of the housing. Some variations of the cannula may include a proximal end and a distal curved portion, where the distal curved portion has a proximal end and a distal end, and a radius of curvature defined between the ends. However, it should be appreciated that in other variations the cannula may be straight and may not comprise a distal curved portion. The cannula may also be configured to include a body; a distal tip having a bevel and a sharpened piercing tip; and a lumen extending from the proximal end through the distal tip. When the cannula comprises a distal curved portion, the bevel may directly engage the distal end of the curved portion of the cannula (i.e., the bevel may directly engage the radius of curvature). In some variations, the sharpened piercing tip may comprise one or more angled surfaces, as is described in more detail below. The cannula may be made from any suitable material with sufficient stiffness to allow it to be advanced through the anterior chamber and into Schlemm's canal. For example, the cannula may be formed of a metal such as stainless steel, nickel, titanium, aluminum, or alloys thereof (e.g., Nitinol metal alloy), a polymer, or a composite. Exemplary polymers include without limitation, polycarbonate, polyetheretherketone (PEEK), polyethylene, polypropylene, polyimide, polyamide, polysulfone, polyether block amide (PEBAX), and fluoropolymers. In some instances, it may be advantageous to coat the cannula with a lubricious polymer to reduce friction between the ocular tissue and the cannula during the procedure. Lubricious polymers include, without limitation, polyvinyl alcohol, polyethylene glycol, polyvinyl pyrrolidone, fluorinated polymers (including polytetrafluoroethylene (PTFE or Teflon®)), and polyethylene oxide. In variations in which the cannula is reusable, the cannula may be made from a material that can be sterilized (e.g., via autoclaving), such as a heat-resistant metal (e.g., stainless steel, aluminum, titanium). The cannula generally has an outer diameter sized to gain access to the lumen of Schlemm's canal while minimally obstructing the surgeon's view. Accordingly, the outer diameter may range from about 50 microns to about 1000 microns. In some variations, the outer diameter may range from about 150 microns to about 800 microns. The cannula also has an inner diameter, which may range from about 50 microns to about 400 microns. The cannula may also be formed to have any suitable cross-sectional profile, e.g., circular, elliptical, triangular, square, rectangular, etc. The cannula may be configured to include multiple portions or parts. A cannula having a body, a distal curved portion having a proximal end and a distal end, a radius of curvature defined between the ends, and a bevel at the distal tip of the cannula that directly engages the distal end of the curved portion of the cannula may be particularly useful for accessing the lumen of Schlemm's canal. Here the body (straight portion of the cannula) may have a length ranging from about 5 mm to about 50 mm, about 10 mm to about 30 mm, or from about 14 mm to about 20 mm. In some variations, the body may have a length of about 18 mm. The distal curved portion of the cannula may be uniform in cross-sectional shape or it may taper closer to the distal end to facilitate entry into Schlemm's canal. The radius of curvature of the distal curved portion may be adapted to facilitate tangential entry, as well as precise and minimally traumatic entry into Schlemm's canal, and may range from about 1 mm to about 10 mm or from about 2 mm to about 5 mm. In one variation, the radius of curvature is about 2.5 mm. The cannula may also have an angular span suitable for facilitating entry into Schlemm's canal, and may range from about 70 degrees to about 170 degrees, or about 100 degrees to about 150 degrees. In one variation, the angular span is about 120 degrees. The size, shape, geometry, and the like, of the bevel at the distal end of the curved portion of the cannula may be beneficial in allowing easy and minimally traumatic access to Schlemm's canal. In this respect, and as described in further detail below, having a bevel that directly engages the radius of curvature of the distal end of the cannula may be particularly useful. In other variations, the cannula may include a short straight segment coupled to the distal end of the distal curved portion of the cannula (e.g., at the end of the radius of curvature). Here the bevel engages the straight segment and not the radius of curvature. The length of the straight segment may range from about 0.5 mm to about 5 mm. In some variations, the length of the straight segment ranges from about 0.5 mm to about 3 mm, or from about 0.5 mm to about 1 mm. The length of the straight segment may also be less than about 0.5 mm, e.g., it may be about 0.1 mm, about 0.2 mm, about 0.3 mm, or about 0.4 mm. In variations where the bevel directly engages the distal end of the curved portion of the cannula (i.e., the bevel directly engages the radius of curvature), the cannula lacks a straight segment (length of the straight segment is zero). It may also be useful to have a bevel that is sharp and short. Exemplary bevel angles may range from about 10 degrees to about 90 degrees. In some instances, the bevel angle may range from about 10 degrees to about 50 degrees. In one variation, the bevel angle is about 35 degrees, while in another variation the bevel is about 25 degrees. The bevel may also be oriented in any suitable direction. For example, the bevel may be oriented so that it opens up towards the surgeon, or it may be reversed to open away from the surgeon or in any plane in between. As is described in more detail below, in yet some variations, the cannula is configured to include one section that is sharp, and another section that is blunt (e.g., deburred). The dual surface configuration of such a cannula may be advantageous, since it may provide easier canal access by piercing the meshwork while also providing a gentle, dispersed force on the elongate member during elongate member retraction into the cannula to avoid cutting or breaking the elongate member due to retraction force. For example, as shown inFIG.4, the distal end of cannula (400) may have a sharpened piercing tip (402) and a smooth edge (404) that define portions of opening (406), through which a slidable elongate member (not shown) may be advanced and retracted. As is described in more detail with respect toFIGS.5,6A-6B, and7, the sharp tip (402) may be formed by compounding multiple bevels, and the smooth edge (404) may be created by smoothing or deburring inner and/or outer circumferential edges of the distal tip. Additionally, in some embodiments, the internal and/or external surfaces of the elongate member adjacent to the opening (406) may also be smoothed. Methods of making the cannula are described in more detail below. The cannula of an exemplary delivery system is shown in more detail inFIG.3. Here the cannula (300) comprises a proximal end (302) a distal curved portion (304), a body (314), and a distal tip (306). The distal curved portion (304) has a proximal end (308) and a distal end (310), and a radius of curvature (R) that is defined between the ends (308,310). The distal curved portion (304) also has an inner radius (320) defined by the surface of the cannula closest to the center of the radius of curvature (R), and an outer radius (322) defined by the surface of cannula further away from the center. A bevel (312) at the distal tip (306) directly engages the distal end of the curved portion of the cannula (310). In other words, the bevel (312) may be contiguous with the distal end of the curved portion of the cannula (310). As previously stated, this configuration of the distal curved portion (304) and bevel (312) may be beneficial or advantageous for allowing easy, atraumatic, and controlled access into Schlemm's canal. The angle of the bevel may also be important. In general, a short bevel may be beneficial. The bevel (312) may comprise an angle (A) between about 5 degrees and about 85 degrees. In some variations, the angle (A) may be about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, or 85 degrees. In some variations, the angle (A) may be between about 23 degrees and about 27 degrees. In the variation shown inFIG.3, the bevel angle (A) is about 25 degrees. FIG.5depicts a perspective view of a distal tip (502) of a cannula (500) comprising a bevel (514). The distal tip (502) may be cut or ground at an angle to create the bevel (514). As shown, the beveled distal tip (502) comprises a proximal end (508), a distal end (510), and an elongated opening (512) having an elliptical, rather than a circular, shape. The distal tip (502) may comprise an elliptical shaped lumen opening that is angled such that the top of the elliptical opening is closer to the proximal portion of the cannula than the bottom of the elliptical opening. Also shown inFIG.5are inner and outer circumferential edges (504,506). FIGS.6A and6Bdepict perspective and front views, respectively, of a variation of a distal tip (600) of a cannula comprising a bevel (602) and a sharpened piercing tip (614). As shown there, the distal tip (600) also comprises a proximal end (608), a distal end (610), inner and outer circumferential edges (604,606), and a lumen opening (612). The sharpened piercing tip (614) may comprise two angled surfaces (616) that converge to form a sharp point. The angled surfaces (616) may have any suitable angle that results in a sharpened piercing tip (614). For example, in some instances, the angle surfaces (616) may have an angle (B) relative to the longitudinal axis of the distal tip (600) of about 20, 25, 30, 35, 40, 45, or 50 degrees, between about 25 and about 50 degrees, or between about 37.5 and about 42.5 degrees. In some instances, the angle (B) may be about 40 degrees. Accordingly, in some variations, the angle between the two angled surfaces (616) may be between about 50 and about 100 degrees, and in some instances, the angle between the two angled surfaces (616) may be about 80 degrees. It should be appreciated that although the distal tip (600) is depicted with two angled surfaces, a distal tip with a single angled surface may also be used. Elongate Member The delivery systems described herein may comprise a slidable elongate member coaxially disposed within the cannula lumen. The elongate member may comprise a lumen and be configured to deliver a fluid composition. However, it should be appreciated that in other variations, the elongate member may not comprise a lumen and/or may not be configured to deliver a fluid composition. The elongate member may be coaxially disposed and slidable within the cannula lumen of the delivery systems described here. When the elongate member is in a retracted position relative to the cannula, the distal end of the elongate member may be located within (i.e., proximal to) the distal tip of the cannula. When the elongate member is in an extended position relative to the cannula, the distal end of the elongate member may be located outside of (i.e., distal to) the distal tip of the cannula. The length of extension of the elongate member beyond the distal tip of the cannula may correspond to the distance around Schlemm's canal that may be traversed by the elongate member (e.g., in order to disrupt Schlemm's canal and/or surrounding trabeculocanalicular tissues, and/or to deliver a fluid composition). When a variation of the delivery systems described herein is used to deliver a fluid composition, the length traversed by the elongate member may correspond to the length around Schlemm's canal to which the fluid composition is delivered. When a variation of the delivery systems described herein is used to tear or cut the trabecular meshwork, the length traversed by the elongate member may correspond to the length of trabecular meshwork that is cut or torn. In some variations, this length may be between about 1 mm and about 50 mm. In some of these variations, the length may be between about 10 mm and about 40 mm, between about 15 mm and about 25 mm, between about 16 mm and about 20 mm, between about 18 mm and about 20 mm, between about 19 mm and about 20 mm, between about 18 mm and about 22 mm, about 20 mm, between about 30 mm and about 50 mm, between about 35 mm and about 45 mm, between about 38 mm and about 40 mm, between about 39 mm and about 40 mm, or about 40 mm. The elongate member may be moved between extended and retracted positions using a drive assembly of the delivery system, described in more detail below. The elongate member may be sized so that it can be advanced through the cannula and into a portion of Schlemm's canal (e.g., 0 to 360 degrees of the canal). This size may in some instances allow it to disrupt trabeculocanalicular tissues, stent, and/or apply tension to the canal, and/or to deliver a fluid composition. The elongate member may be made from any suitable material that imparts the desired flexibility and pushability for introduction through the eye wall, accessing Schlemm's canal, and/or navigation through other ocular tissue structures. For example, the elongate member may comprise a polymer (e.g., nylon, polypropylene); a polymer reinforced with metal wire, braid or coil; composites of polymers and metal; or metals such as stainless steel, titanium, shape-memory alloy (e.g., Nitinol), or alloys thereof. In variations in which the elongate member is reusable, the elongate member may be made from a material that can be sterilized (e.g., via autoclaving), such as a heat resistant metal (e.g., stainless steel, aluminum, titanium). The elongate member may be straight with enough flexibility and pushability to navigate the ring-shaped Schlemm's canal or may be pre-shaped to about a 2-10 mm radius of curvature or about a 6 mm radius of curvature (i.e., the approximate radius of curvature of Schlemm's canal in an adult human) to more easily circumnavigate Schlemm's canal, partially or in its entirety. In some variations, the elongate member may be configured to be advanced over or along a guidewire. It may in some variations be desirable for the elongate member to have one or more features to improve visualization of the elongate member. For example, the elongate member may be colored (e.g., red, orange, yellow, green, blue, purple, etc.). Additionally or alternatively, visualization may be improved using an illuminated beacon, a fiber optic, side illuminating fiber optic, luminescence, fluorescence, or the like. For example, a fiber optic may travel along the body of the elongate member to deliver light to the distal tip of the elongate member, which may improve visualization of the distal tip of the elongate member as it is advanced or retracted about Schlemm's canal. In some variations the elongate member may be sized to be advanced atraumatically through Schlemm's canal. In other variations, the elongate member may be sized to have an outer diameter sufficient to disrupt Schlemm's canal and surrounding trabeculocanalicular tissues. The outer diameter may range from about 25 microns to about 1000 microns, from about 25 microns to about 500 microns, from about 50 microns to about 500 microns, from about 150 microns to about 500 microns, from about 200 microns to about 500 microns, from about 300 microns to about 500 microns, from about 200 microns to about 250 microns, from about 150 microns to about 200 microns, or from about 180 microns to about 300 microns. In some instances it may be beneficial for the elongate member to have an outer diameter of about 240 microns. In some variations, the distal end of the elongate member may be configured as a blunt bevel, an atraumatic tip, an enlarged atraumatic tip, or the like, to help the elongate member be advanced through Schlemm's canal. In some of these variations, the distal end may comprise a blunt parasol-shaped atraumatic tip. In other variations, a distal portion of the elongate member may optionally include a disruptive component, e.g., a notch, hook, barb, a rough surface, or combination thereof, to disrupt the juxtatrabecular portion of Schlemm's canal or juxtatrabecular meshwork. One or more projections emanating from the elongate member may further disrupt the juxtatrabecular portion of Schlemm's canal or juxtatrabecular meshwork and thus increase permeability of aqueous humor through the trabecular meshwork into Schlemm's canal. In some instances, the elongate member may also deliver energy to the trabeculocanalicular tissues (e.g., ultrasonic energy, radiofrequency energy (e.g., for electrocautery, electroablation), electromagnetic radiation, light energy (e.g., via a fiber optic)). The elongate member may comprise a lumen. For example, in one variation the elongate member may comprise a microcatheter (e.g., a nylon microcatheter). The elongate member may be configured to deliver a fluid composition. The fluid composition may travel through a lumen of the elongate member and may be delivered through an opening of the lumen. For example, as shown inFIG.2G, the elongate member (250) may be a flexible tube having a lumen in fluid communication with an opening at the distal tip (252). In some variations, the distal end of the elongate member may be configured or modified to aid delivery of the fluid composition into Schlemm's canal. For example, the distal end of the elongate member may comprise a cut out configured as a half tube. Additionally or alternatively to an opening at the distal tip, the elongate member may optionally comprise a plurality of openings through its wall that are spaced along the axial length of the elongate member. In this variation, the fluid composition may be delivered from the reservoir through the openings in the elongate member and into Schlemm's canal. This lateral ejection of fluid (e.g., a viscoelastic fluid) may in some instances enhance disruption of outflow tissues and enhance permeability to aqueous humor. It is understood that the openings can be of any suitable number, size and shape, and spaced along the axial length of the elongate member (including the distal tip) in any suitable manner. For example, the openings may be slots (802) (FIG.8A) or circles (804) (FIG.8B). Fluid compositions delivered using the elongate members (800,808) depicted inFIGS.8A-8Bmay partially flow out of the elongate member through the openings and partially out through the distal end of the elongate member. The distal end of the elongate member may also be configured as a half tube (806) (FIG.8C). Drive Assembly The delivery systems generally include a drive assembly. The drive assembly of the delivery system is generally configured to move an elongate member and/or deliver fluid composition into Schlemm's canal. The drive assembly may be at least partially contained within the housing and may include any suitable component or combination of components capable of providing the handle with universal functionality. The drive assembly may convert an external input (e.g., motion of a user's thumb or finger) into motion of one or more components of the delivery system. More specifically, the drive assembly may cause a slidable elongate member to be extended distally out of a cannula, and/or it may cause a slidable elongate member to be retracted proximally into a cannula. The drive assembly may also optionally cause a fluid composition to be delivered from a reservoir through the elongate member and/or cannula. Two or more of these effects (i.e., extension of the slidable elongate member, retraction of the slidable elongate member, and/or delivery of a fluid composition) may be actuated using the same actuation mechanism. This may allow for single-handed use of the delivery system. For example, if the actuation mechanism comprises a rotatable element (such as one or more wheels, as in variations described herein), rotating the rotatable element in a first direction may cause extension of the slidable elongate member, and rotating the rotatable element in a second direction may cause retraction of the slidable elongate member. When the delivery system is configured to deliver a fluid composition, rotating the rotatable element (e.g., in the second direction) may also cause delivery of a fluid composition. The delivery of the fluid composition may be simultaneous with movement (e.g., retraction) of the slidable elongate member. In some of these instances, the fluid composition may be delivered to the portion of Schlemm's canal in which the slidable elongate member is advanced; that is, the fluid composition may be delivered to the same angle and length of Schlemm's canal as the extension of the elongate member. When the fluid composition is simultaneous with retraction of the elongate member, fluid composition may take the place of the slidable elongate member as it is retracted and may dilate Schlemm's canal and/or the collector channels at that location in Schlemm's canal. Furthermore, the quantity of fluid delivered may be tied to the amount of movement of the elongate member; that is, a certain predetermined, fixed volume of fluid composition may be delivered via the elongate member (e.g., delivered out of the distal end of the elongate member) for a fixed amount of movement of the elongate member (e.g., a retraction distance) and for a fixed amount of rotation of the rotatable element. In some variations, the drive mechanism may be configured to allow the delivery system to be used only once—that is, the drive mechanism may prevent, for example, re-extension of the slidable elongate member after a predetermined amount of extension and/or retraction. In other variations the drive mechanism may be configured to allow the elongate member to be extended, retracted, re-extended, and re-retracted an unlimited amount. Exemplary mechanisms by which external input may be converted into motion of one or more components of the delivery system are described in more detail herein. In some variations, the drive assembly includes components that translate rotational motion into linear motion. For example, the drive assembly may include a linear gear and a pair of pinion gears. Each of the pinion gears may also be coupled to a rotatable component (e.g., a wheel). In some variations, such coupling may be accomplished with a pin that can be threaded through a central opening in the rotatable component and pinion gear, and a nut that secures the rotatable component and pinion gear in a manner so that rotation of the rotatable component also rotates the pinion gear and vice versa. In some variations, the wheels may be attached to the pinion gear by one of the following methods: 1) the wheels and pinion gears are molded as one part using plastic injection molding technology; 2) the wheels slide onto the pinion gear and are secured with adhesive; or 3) the wheels slide on the pinion gear and are mechanically fixed with a fastener or a “press fit,” where the wheels are forced onto the pinion gear and friction holds them secure. The wheels and pinion gears may rotate coaxially, in the same direction, and at the same angular rate. In some variations, the wheel may have markings or colorings to indicate degree of advancement or direction of advancement. One variation of the drive assembly comprises a linear gear, a pair of pinion gears, and at least one rotatable component coupled to each pinion gear. In other variations, the drive assembly includes a linear gear, a single pinion gear, and a single rotatable component coupled to the pinion gear. In variations with a pair of pinion gears, the pinion gears and associated wheel(s) may be disposed on either side of the linear gear. In some variations, the pinion gear(s) and linear gear may contact each other, i.e., the teeth of the pinion gears may directly engage corresponding teeth on the linear gear, and the wheels on one side of the linear gear may contact the wheels on the opposite side of the linear gear. In other variations, the pinion gear(s) and linear gear may be indirectly coupled, for example, via one or more idler gears. At least a portion of the wheel on a side of the linear gear may extend outside of the housing for a user to manipulate. The drive assembly may be manipulated with one hand when in a first configuration, and then manipulated with the same or the other hand when flipped over to a second configuration. A drive assembly having such flexible capability can be easily used by a surgeon who is right hand dominant or left hand dominant, and may also be used in a procedure in which the handle is flipped during a procedure such that the cannula is facing a first direction in a first portion of the procedure, and facing a second direction in a second portion of the procedure. In a further variation, the drive assembly may include one rotatable component on one side of the handle and the “universal” feature of the handle provided by a cannula that itself can rotate instead of flipping the handle. When the wheel(s) and pinion gear(s) rotate coaxially in the same direction, and when there is no idler gear or an even number of idler gears (e.g., two) between the pinion gear(s) and the linear gear, distal rotation of the portion of the wheel(s) extending out of the housing may result in proximal translation of the linear gear within the housing, and conversely, proximal rotation of the portion of the wheel(s) extending out of the housing may result in distal translation of the linear gear within the housing. When the wheel(s) and pinion gear(s) rotate coaxially in the same direction, and when there is an odd number of idler gears (e.g., one) between the pinion gear(s) and the linear gear within the housing, distal rotation of the portion of the wheel(s) extending out of the housing may result in distal movement of the linear gear within the housing, and conversely, proximal rotation of the portion of the wheel(s) extending out of the housing may result in proximal movement of the linear gear within the housing. A variation of a drive assembly is reflected in the delivery system (200) ofFIGS.2A-2I. The drive assembly may comprise a linear gear (e.g., a rack) (216), a pair of pinion gears (218) attached to the wheels (210), and a pair of idler gears (224). The pinion gears (218), idler gears (224), and linear gear (216) have teeth that engage each other to translate rotational motion (of the idler gears, pinion gears, and wheels) to linear motion (of the linear gear). More specifically, the linear gear (216) may comprise teeth on both a first side (220) and a second side (222), where the teeth on the first side engage the first idler gear (224), and the teeth on the second side engage the second idler gear (224). The rotation of each of the pinion gears (218), and in turn rotation of each idler gear (224) and the translation of the linear gear (216), is controlled by a rotatable component that can be manipulated by a user from outside the housing (206), shown in the figures as wheels (210). As shown, the wheels (210) may be integral with the pinion gears (218), such that they rotate coaxially and in the same direction. The pinion gears (218) are then coupled via teeth to idler gears (224) such that the wheels and pinion gears rotate together in the same direction, and the idler gears rotate in the opposite direction. Thus, distal rotation of the portion of the wheel (210) extending out of the housing (206) moves the linear gear (216) distally (and, as described in more detail herein, moves the elongate member toward an extended position), and proximal rotation of the portion of the wheel extending out of the housing moves the linear gear proximally (and, as described in more detail herein, moves the elongate member toward a retracted position). It should be appreciated that in other variations, the wheels (210) and linear gear (216) may be coupled such that distal rotation of the portion of the wheel extending out of the housing moves the linear gear (216) proximally, and proximal rotation of the portion of the wheel extending out of the housing moves the linear gear distally. That is, the wheels (210) may extend out of the housing (206) of the delivery system, such that the wheels may be rotated by a user to correspondingly rotate the pinion gears (218) and idler gears (224) and thus advance or retract the linear gear (216). The linear gear (216) may be slidable over the cannula (208), such that the cannula and wheels are fixed relative to each other and relative to the housing, while the linear gear translates relative to the housing. Because linear motion of the linear gear (216) may be generated by rotational motion of either of the two pinion gears (218) and idler gears (224), which may in turn be generated by rotating either of the wheels (210) extending from the housing (206), the delivery system (200) may be easily operated using a single hand with either the first side or the second side facing upwards, and thus the cannula (208) facing a first direction or a second direction. Put another way, although the variation shown has two wheels (210), rotation of only a single wheel (210) is required to translate the linear gear (216) (and in turn to extend or retract the elongate member). Rotation of a single wheel (210) will result in coordinated rotation of the second wheel. In other variations, the delivery system may comprise only a single wheel. The drive assembly may also comprise one or more features to stabilize the pinion gears or otherwise keep them in place. For example, in some variations the drive assembly may comprise wheel spacers configured to sit between axles of the pinion gears. In other variations, the rotational gears (i.e., pinion gears or idler gears) interfacing with the linear gear may be able to be disengaged from the linear gear by biasing their position off axis from the linear gear. This action de-couples the rotational gear teeth from the linear gear teeth to prevent linear gear movement with wheel rotation. The drive assembly may also be able to be locked to prevent rotation by engaging an intersecting pin or feature that prevents wheel rotation. Further variations of the drive assembly may not employ translation of rotational motion to linear motion. For example, a slide (e.g., a finger slide) on the handle may be fixed or detachably coupled to a gear within the housing of the handle (e.g., a linear gear as previously described). Here the drive assembly may be configured so that advancement or retraction of the slide causes advancement or retraction of an elongate member and/or delivery of a fluid composition into Schlemm's canal. In yet further variations, a button that can be pressed or squeezed may be employed instead of a slide, or a foot pedal may be employed to deliver a fluid composition and/or advance/retract an elongate member. Extending and Retracting the Elongate Member In some variations, a proximal end of the elongate member may be fixed relative to a portion of a drive assembly (e.g., the linear gear (216)), while the distal end may be slidably and coaxially disposed within the cannula lumen. The elongate member may in some instances be bonded to the drive assembly (e.g., via an adhesive) in order to leave the lumen of the elongate member unobstructed. The cannula, in turn, may be fixedly attached to the housing. In variations of the delivery systems in which the handle is reusable and the cannula and elongate member are disposable, a disposable assembly comprising the elongate member pre-loaded within the cannula may be attached to the reusable handle via any suitable mechanism, such as a threaded fastener or snap-in feature. When the portion of the drive assembly is moved proximally or distally within the housing, this may cause corresponding movement of the elongate member relative to the cannula. That is, movement of the portion of the drive assembly toward the cannula (i.e., toward the distal end of the housing) may cause the elongate member to move from a retracted position to an extended position, and movement of the portion of the drive assembly away from the cannula (e.g., toward the proximal end of the housing) may cause the elongate member to move from an extended position to a retracted position. An example of an elongate member (250) in an extended position is shown inFIGS.2F and2G. As shown inFIG.2F, the linear gear (216) may be in a distal position when the elongate member (250) is extended from cannula (208). Reservoir The systems may generally include a reservoir. The reservoir may contain various fluid compositions for delivery. Exemplary fluid compositions include saline and viscoelastic fluids. The viscoelastic fluids may comprise hyaluronic acid, chondroitin sulfate, cellulose, derivatives or mixtures thereof, or solutions thereof. In one variation, the viscoelastic fluid comprises sodium hyaluronate. In another variation, the viscoelastic composition may further include a drug. For example, the viscoelastic composition may include a drug suitable for treating glaucoma, reducing or lowering intraocular pressure, reducing inflammation, and/or preventing infection, fibrosis, scarring, clotting, thrombosis, bleeding, or neovascularization. Drugs such as antimetabolites, vasoconstrictors, anti-VEGF agents, steroids, heparin, anti-inflammatories, nonsteroidal anti-inflammatories (NSAIDs), other anticoagulants, fibrinolytic compounds, biologic agents, Rho kinase (ROCK) inhibitors, and agents for gene therapy, DNA, RNA, or stem cell-based approaches, may also be delivered in combination with the viscoelastic composition. Examples of glaucoma drugs include prostaglandins, beta blockers, miotics, alpha adrenergic agonists, or carbonic anhydrase inhibitors. Anti-inflammatory drugs such as NSAIDs, corticosteroids or other steroids may be used. For example, steroids such as prednisolone, prednisone, cortisone, cortisol, triamcinolone, or shorter acting steroids may be employed. Examples of antimetabolites include 5-fluoruracil or mitomycin C. Examples of drugs or antibodies that prevent neovascularization include bevacizumab, ranibizumab, and others. In still another variation, the system delivers the drug alone, without the viscoelastic composition. Saline solution may also be the fluid employed. In yet other variations, the system may be configured to deliver a gas, such as but not limited to air, an expansile gas (e.g., SF6, C3F8). In some variations, the reservoir may be at least partially defined by a fluid assembly and the housing, and the linear gear within the handle. The fluid assembly may be made from any suitable material previously mentioned for the cannula and the housing. The volume of fluid (in microliters) contained within the reservoir may range from about 2 μl to about 1000 μl, or from about 2 μl to about 500 μl. In some variations, the reservoir volume may range from about 50 μl to about 100 μl. The fluid composition may be preloaded in the reservoir or loaded into the reservoir prior to use of the system, e.g., at the start of an ocular procedure, so that the fluid can be delivered by a single device and by a single user. Again, this is in contrast to other systems that use forceps or other advancement tools to advance a fluid delivery catheter into Schlemm's canal and/or devices containing viscoelastic fluid that are separate or independent from a delivery catheter or catheter advancement tool, and which require connection to the delivery catheter or catheter advancement tool during a procedure by, e.g., an assistant, or by the hand of the surgeon while the delivery catheter or catheter advancement tool is held by another hand of the surgeon. For example, a loading component may be provided on the fluid assembly for transfer of a fluid composition into the reservoir. The loading component may have any suitable configuration that provides reversible securement of a fluid container, e.g., a syringe, cartridge, etc., to the system, and loading of a fluid composition into the reservoir. The loading component may be a luer fitting or include a one-way valve. For example, the exemplary delivery system (200) inFIGS.2A-2Icomprises a fluid assembly comprising a reservoir (226). In an exemplary method, a fluid composition may be loaded into the reservoir (226) though a proximal opening (214) via a proximal seal. The distal end of the reservoir may be formed by a plunger and a distal seal. The proximal opening (214) may comprise a mechanical seal. An example of a proximal seal is shown inFIG.9. The proximal seal (918) may be a mechanical seal located at the proximal end of the reservoir (956) and comprising a ball bearing (924) spring-biased against an o-ring or gasket (930) to seal closed the reservoir. A loading tool (926) (e.g., a nozzle) may be used to open the seal by pressing against the ball bearing (924) to move it proximally toward an open position. In other variations, the delivery system may comprise a luer fitting that allows a viscoelastic cartridge to be directly connected to the delivery system. While the proximal seal (918) is open, the fluid composition may be loaded into the reservoir. After loading of the fluid composition, the loading tool (926) may be removed, allowing the ball bearing (924) to return to its closed position. An o-ring or gasket (930) may sit between the ball bearing (924) and a spring (932), such that force from the spring presses the ball bearing into the gasket to form a seal between the ball bearing and gasket in the closed position. The loading tool (926) may be configured to fit into the proximal opening (958) to press against the ball bearing (924). The distally oriented force against the ball bearing (924) may move it distally into the open position, compressing the spring (932), and creating an opening between the ball bearing and the gasket (930), through which the fluid composition may flow. When the loading tool (926) is removed from the proximal opening (958), the spring (932) pushes the ball bearing (924) proximally back into the closed position. It should be appreciated that in other variations, the reservoir may comprise other types of seals allowing a fluid composition to be loaded into the reservoir. For example, the seal may comprise a membrane (e.g., a silicone membrane). A fluid composition may be loaded into the reservoir by puncturing the membrane with a needle (e.g., a 25 gauge needle). In yet other variations, the delivery systems described herein may be configured to receive a prefilled cartridge comprising a fluid composition. For example, the handle and fluid assembly may be configured such that a prefilled cartridge can be inserted into the fluid assembly. In order to load the reservoir, it may be desirable to at least temporarily secure the fluid assembly in place in order to allow application of distal force to the seal. In some variations, the delivery system may comprise a lock configured to hold the fluid assembly in place while a fluid composition is injected into the reservoir. However, it should be appreciated that in other variations the delivery system may not comprise a lock. In variations having a lock, it may be desirable for the lock to be removable from the delivery system (or to otherwise release the fluid assembly) in order to allow the fluid assembly to translate relative to the housing after the reservoir is loaded. Translation of the fluid assembly may allow for extension of the slidable elongate member and/or injection of the fluid composition during the procedure, as is described in more detail herein. In variations of the delivery systems having a lock, the lock may optionally additionally act as a cap to protect a distal opening to the reservoir. In these variations, the lock may comprise a first configuration in which it both holds the reservoir in place and covers the proximal opening to the reservoir, and a second configuration in which it holds the reservoir in place but allows the proximal opening to the reservoir to be accessed, such that the reservoir can be loaded with a fluid composition. In some instances, the lock may rotate from the first position to the second position. An exemplary lock (212) is shown in the delivery system (200). As shown inFIGS.2A-2B and2I, the lock (212) may comprise a pin (228) configured to fit into an opening in the handle of the delivery system. The lock (212) may have a shape configured to removably clip around the handle of the delivery system when the pin (228) is within the opening in the handle, allow the lock (212) to be securely fastened to the handle, while also allowing a user to remove it when desired. When the pin (228) is inserted into the opening in the handle, it may restrict movement of the reservoir (226) relative to the housing. This may, for example, allow a loading tool to apply force through the proximal opening to open the proximal seal of the reservoir (226), without the reservoir (226) sliding distally within the handle. Restricting movement of the reservoir (226) relative to the handle may prevent motion of the reservoir or other internal components of the delivery system before use (e.g., during transit). That is, when the pin (228) is inserted into the opening in the handle, it may also prevent rotation of the wheels, pinion gears, and idler gears, as well as translation of the linear gear. Once loading of the reservoir is complete, the lock (212) may be removed from the handle, thus removing the pin (228) from the opening in the handle, at which point the reservoir (226) may no longer be restricted by the lock from moving relative to the housing. Delivering a Fluid Composition The delivery systems described herein may be configured to deliver fluid to Schlemm's canal. The fluid may be delivered in a volume that provides sufficient force to disrupt Schlemm's canal and surrounding trabeculocanalicular tissues. Exemplary disruptive volumes may be about 1 μl, about 2 μl, about 3 μl, about 4 μl, about 5 μl, about 6 μl, about 7 μl, about 8 μl, about 9 μl, about 10 μl, about 11 μl, about 12 μl, about 13 μl, about 14 μl, about 15 μl, about 16 μl, about 17 μl, about 18 μl, about 19 μl, or about 20 μl. In some variations, the disruptive volume fluid may range from about 1 μl to about 50 μl, or from about 20 μl to about 50 μl. As mentioned above, an elongate member may be coaxially disposed within the cannula lumen. The elongate member may comprise a lumen. The lumen of the elongate member may be operatively connected to a reservoir for delivery of a fluid composition into Schlemm's canal. The elongate member generally has a proximal end, a distal end, and a wall that defines the lumen extending therethrough. However, in some instances, the delivery system lacks an elongate member conduit, and the fluid composition is delivered solely through the cannula. In other instances, two elongate members may be employed that each simultaneously advance through the canal in both clockwise and counterclockwise directions to more rapidly cannulate Schlemm's canal and deliver therapy. When the delivery systems are employed to deliver a fluid composition, the fluid composition may be preloaded in a reservoir of the system or loaded into the reservoir prior to use of the system. Some variations of the fluid assembly include a locking mechanism for preventing movement of the assembly within the handle, e.g., when the linear gear is being advanced or retracted. The locking mechanism may comprise a ratchet pawl, a combination of ratchet pawls or any other suitable mechanism that can be locked to prevent movement of the fluid assembly, and unlocked to allow movement of the fluid assembly. Referring back toFIGS.2A-2I, an exemplary delivery system (200) for delivering a fluid composition shown there may comprise a housing (206) and a cannula (208) extending from the distal end of the housing. A drive assembly (described in more detail above) may be located within the housing (206), as may be a fluid assembly (also described in more detail above). As described above, the drive assembly may comprise a linear gear (216) and a pair of pinion gears (218) each coupled to a wheel (210). The delivery system (200) may comprise a slidable elongate member (250). A proximal end of the elongate member (250) may be fixed relative to the linear gear (216), while the distal end of the elongate member (250) may be slidably and coaxially disposed within the lumen of the cannula (208). A reservoir (226) of the fluid assembly may be fluidly connected to a lumen of the elongate member (250). For example, a plunger (248), comprising a lumen may fluidly connect the reservoir (226) to the lumen of the elongate member (250). The proximal end of the plunger (248) may be located slidably within the reservoir (226), and the distal end of the plunger may be fixedly attached to the linear gear (216) of the drive assembly. The fluid assembly and the drive assembly may be connected via linkage (230). The linkage (230) may be configured to allow the fluid assembly and drive assembly to be moved as a unit, and may allow limited movement of the fluid assembly and drive assembly relative to each other. In some variations, the linkage (230) may allow different amounts of movement depending on the location of coupling with the drive assembly. The proximal end of the linkage (230) may be fixedly attached to the fluid assembly. The distal end of the linkage (230) may be coupled to the linear gear (216) of the drive assembly. The linear gear (216) may comprise a proximal portion (232) and a distal portion (234). In some variations, the proximal portion (232) may comprise teeth (236), and the distal portion (234) may comprise teeth (238). When the linkage (230) is coupled to the proximal portion (232) of the linear gear (216), the distal end of the linkage may be coupled via a one-way ratchet to the proximal portion of the linear gear of the drive assembly. The one-way ratchet connection may allow the distal end of the linkage (230) to move distally relative to the linear gear (216) but not proximally. More specifically, when the linkage (230) is coupled to the proximal portion (232) of the linear gear (216), the distal end of the linkage (230) may be able to be moved distally relative to and along a proximal portion of a track (240) in the proximal portion of the linear gear (216), but teeth (236) in the proximal portion of the track may resist proximal movement of the distal end of the linkage along the proximal portion of the track. The teeth (236) may be located on a surface perpendicular to the sides having teeth (220,222) configured to interface with the pinion gears (218). The surface having teeth (236) may also face inward toward track (240). In contrast, when the linkage (230) is coupled to the distal portion (234) of the linear gear (216) (i.e., when the linkage has been moved distally relative to the linear gear to reach the distal portion of the track (240)), the distal end of the linkage may be able to be moved both distally and proximally relative to the linear gear (216) along the distal portion of the track (240). The distal portion of the track may comprise teeth (238) that do not restrict the movement of the linkage (230) to a single direction along the distal portion of the track (240) (i.e., the linkage (230) may move proximally and distally within the track). The teeth (238) may allow for controlled movement of the linkage (230) relative to the linear gear (216) as the distal end of the linkage engages with each tooth, while still allowing the linkage to move both distally and proximally relative to the linear gear. The engagement of the distal end of the linkage (230) with the teeth (238) may provide haptic feedback to the user as the linkage is moved along the teeth. The engagement of the distal end of the linkage with the teeth (238) may also provide resistance to prevent fluid pressure from fluid within the reservoir from moving the plunger distally out of the reservoir (and in turn causing the linear gear and elongate member to move distally) when a user is not controlling or preventing the rotation of the wheel, after proximal movement of the linear gear and plunger. That is, after a user has rotated wheel (210) to generate proximal movement of the linear gear (216) and proximal movement of the plunger (248) within the reservoir (226), thereby causing fluid to be displaced from the reservoir for delivery through the plunger and elongate member (250), the user may release control of the wheel. When the user is not controlling or preventing rotation of the wheel (210), fluid pressure from fluid within the reservoir (226) may generate a force that could, without an opposing force, move the plunger (248) distally out of the reservoir, and in turn cause the linear gear (216) to move distally and the elongate member (250) to extend. The engagement between the teeth (238) and the distal end of the linkage (230) may provide an opposing force to resist this force generated by fluid within the reservoir (226). The opposing force on teeth (238) may stop the linear gear (216) from moving distally in response to the force generated by fluid within the reservoir (226), which in turn may prevent the plunger (248) from moving distally out of the reservoir and prevent the elongate member (250) from extending. The teeth (238) in the distal portion (234) of the linear gear (216) may each have a triangular shape having a sloped slide, such that as the linkage (230) translates in one direction relative to the teeth (238), the distal portion of the linkage (230) flexes in one dimension away from the teeth (238), and as the linkage translates in a second direction relative to the teeth (238), the distal portion of the linkage flexes in a second dimension away from the teeth. The teeth (238) may be smaller than teeth (236) to allow for proximal and distal motion of the linkage (230) relative to the linear gear (230) while still providing haptic feedback and resistance. The teeth (238) may have two different sloped surfaces to cause flexing of the distal portion of the linkage (230) in perpendicular directions depending on the direction of translation of the linkage relative to the linear gear (230). For example, when wheel (210) is rotated to cause proximal movement of the linear gear (216) relative to the linkage (230), the distal portion of the linkage may flex in a first direction in response to force from the teeth (238); when the wheel (210) is rotated in an opposite direction to cause distal movement of the linear gear (216) relative to the linkage (230), the distal portion of the linkage may flex in a second direction in response to force from the teeth (238); and the first and second directions of flexion may be perpendicular to each other. The engagement of the linkage (230) with one side of the teeth (238) may provide haptic feedback and stepwise load holding capabilities during distal movement of the linkage relative to the linear gear (216), while the engagement of the linkage (230) with the second side of the teeth (238) may provide haptic feedback and stepwise load holding capabilities and/or prevent distal spring-back of the linear gear (216) and spring-back extension of the elongate member (250) in response to fluid pressure generated by proximal movement of the linkage (in turn resulting in proximal movement of the plunger within the reservoir creating the fluid pressure), after a user is no longer controlling the movement of the drive assembly (e.g., releases contact on the wheel (210)). That is, when the wheel (210) is rotated to cause distal movement of the linear gear (216) relative to the linkage (230), and in turn extension of the elongate member (250), engagement between the distal portion of the linkage and one side of the teeth (238) (e.g., a distal side of the teeth) may provide haptic feedback. When the wheel (210) is rotated in an opposite direction to cause proximal movement of the linear gear (216) relative to the linkage (230), and in turn retraction of the elongate member (250), engagement between the distal portion of the linkage and another side of the teeth (238) (e.g., a proximal side of the teeth) may provide haptic feedback. Additionally, when a user releases contact on the wheel (210) or otherwise no longer controls the position or movement of the wheel after proximal movement of the linear gear (216) relative to the linkage (230), engagement between the distal portion of the linkage and the first side of the teeth (e.g., a distal side of the teeth) may prevent distal spring-back of the linear gear, and in turn spring-back extension of the elongate member, in response to force on the plunger from fluid within the fluid reservoir. In the variation shown, the distal portion of the linkage (230) has a u-shaped bend with a notch (254) configured to engage teeth (236) and teeth (238) when the distal portion of the linkage is coupled to the proximal (232) and distal (234) portions of the linear gear (216), respectively. When the distal portion of the linkage (230) is coupled to the proximal portion (232) of the linear gear (216), if the linear gear moves proximally relative to the linkage (230), the u-shaped bend allows connection point of the linkage (i.e., the notch (254)) to move away from the teeth (236) and into the space of the track (240) to allow proximal motion of the linear gear relative to the linkage. When the distal portion of the linkage (230) is coupled to the proximal portion (232) of the linear gear (216), the coupling between the connection point of the linkage (i.e., the notch (254)) and the teeth (236) prevents the linear gear (216) from moving distally relative to the linkage (230). That is, the coupling maintains the distance separating the proximal end of the linear gear (216) and the distal end of the reservoir (226). When the distal portion of the linkage (230) is coupled to the distal portion (234) of the linear gear (216), if the linear gear (216) moves proximally relative to the linkage (230), the u-shaped bend allows the connection point of the linkage (i.e., the notch (254)) to move away from the teeth (238) and into the space of the track (240) to allow proximal motion of the linear gear relative to the linkage. When the distal portion of the linkage (230) is coupled to the distal portion (234) of the linear gear (216), if the linear gear (216) moves distally relative to the linkage (230), the u-shaped bend allows the connection point of the linkage (i.e., the notch (254)) and a portion of the distal end of the linkage to deflect out of plane as it travels over a sloped surface of the teeth (238). In other variations, the distal portion of the track may not comprise teeth (e.g., may be smooth). When the distal end of the linkage (230) is within the proximal portion (232) of the linear gear, the fluid assembly and linear gear may be able to be brought closer together (via shortening of the portion of the linkage between the fluid assembly and the linear gear) when the linear gear is moved proximally and the elongate member is retracted, and the fluid assembly remains fixed relative to the housing; however, the distance between the linear gear and fluid assembly may be fixed when the linear gear is moved distally and the elongate member is extended. As such, when the linear gear is moved distally and the elongate member is extended, the fluid assembly may move distally. In contrast, as a result of the differences between the proximal and distal portions of the linear gear (216), when the distal end of the linkage (230) is within the distal portion (234) of the linear gear, the linear gear (216) may be able to be moved proximally and distally without the linkage (230) or fluid assembly moving; that is, the fluid assembly and linear gear may be able to be moved both closer and farther from each other. However, as described in more detail herein, the linear gear (216) may still provide resistance to relative movement of the linkage (230) when the distal end of the linkage is within the distal portion of the linear gear, but that resistance may be overcome by the user (e.g., by rotating the wheel (210)). Put another way, the relative movement of the linear gear (216) and linkage (230) (and, in turn, the relative movement of the linear gear and the fluid assembly fixedly attached to the linkage) may be more or less restricted depending on the relative locations of the linear gear and linkage. In a first configuration, the linkage's movement relative to the linear gear may be restricted, such that the linkage can move in one direction (e.g., distally) relative to the linear gear but not in the other direction (e.g., proximally). Thus, in the first configuration, the linear gear may be able to move toward the fluid assembly but not away from the fluid assembly. In the second configuration, the linkage's movement relative to the linear gear may not be restricted to one direction, i.e., the linkage may be able to move proximally and distally relative to the linear gear. Thus, the linear gear may be able to move toward and away from the fluid assembly. In the variation of delivery system (200), the transition between the first configuration and second configuration may be based on the amount of translation of the linkage relative to the linear gear. The linkage may initially be in the first configuration, before it has translated distally relative to the linear gear. Once the linkage has translated distally relative to the linear gear by a portion of the linear gear's length (e.g., half the length of the linear gear), the delivery system may change from the first configuration to the second configuration. It should be appreciated that in other variations, the linkage may be fixedly coupled to the linear gear and slidably coupled to the fluid assembly. In yet other variations, the linear gear and the fluid assembly may be connected via other mechanisms providing two configurations, wherein in a first configuration the linear gear is movable toward but not away from the fluid assembly, and in a second configuration the linear gear is movable toward and away from the fluid assembly. In these variations, the delivery system may switch from the first to the second configuration automatically or manually. Thus, the linear gear (216) and the fluid assembly may be movable relative to each other and may be movable within the housing (206). Movement of the linear gear (216) and fluid assembly relative to each other, as well as relative to the housing (206), may cause one or more effects, including extension and retraction of the slidable elongate member and/or delivery of a fluid composition. More specifically, because the proximal end of the plunger (248) may be located slidably within the reservoir (226), and the distal end of the plunger may be fixedly attached to the linear gear (216), movement of the linear gear toward the reservoir may cause proximal movement of the plunger within the reservoir. This may cause the length of the plunger (248) located within the reservoir (226) to increase. The portion of the plunger (248) within the reservoir (226) may displace fluid with the reservoir. The displaced fluid may move distally through the lumen of the plunger (248), through the lumen of the elongate member, and may be delivered out through a distal opening of the lumen of the elongate member. Additionally, as mentioned above, movement of the linear gear (216) relative to the housing (206) may cause the slidable elongate member (250) to extend or retract. The linear gear (216) may be moveable between proximal and distal positions via rotation of a wheel (210). Because the proximal end of the elongate member (250) may be fixed relative to the linear gear (216) and the distal end of the elongate member may be slidable within the lumen of the cannula (208), when the drive assembly is in a proximal position, the elongate member may correspondingly be in a retracted position relative to the cannula (208) (e.g., proximal to the distal tip of the cannula). When the drive assembly is in a distal position, the elongate member may correspondingly be in an extended position relative to the cannula (208). When the elongate member (250) is in the extended position, the distal end of the elongate member may extend out of the cannula (e.g., distal to the distal tip of the cannula). In one configuration, relative motion of the drive assembly (and its linear gear (216)), fluid assembly (and its reservoir (226)), and housing (206) may thus be used to extend the slidable elongate member (250) out of the cannula (208), and to retract the elongate member while simultaneously delivering fluid. In another configuration, relative motion of the drive assembly, fluid assembly, and housing (206) may be used to extend and retract the slidable elongate member (250) out of and into the cannula (206) without delivering fluid. For example, the delivery system (200) may start in a configuration where the reservoir (226) and linear gear (216) are separated by the full distance of the linkage (230), the reservoir (226) is located at the proximal end of the housing (206), and the slidable elongate member is in a retracted position within the cannula (208). This configuration is show inFIGS.2B-2E. One or both of the wheels (210) may be rotated in a first direction to advance the linear gear (216) distally within the housing (206). The linkage (230) may cause the reservoir (226) to move an equal distance distally within the housing (206), maintaining the spacing between the reservoir and the linear gear (216). The spacing may be maintained because in this configuration, the linear gear (216) can move proximally relative to the linkage (230) but not distally relative to it due to the teeth (236) in the track (240) on the proximal portion (232) of the linear gear, which couple with the distal end of the linkage (230). Thus, when the linear gear moves distally, the coupling between the linkage (230) and the linear gear (216) pulls the linkage and reservoir (226) distally within the housing (206). As the linear gear (216) advances, the elongate member (250) may move from the retracted position distally toward the extended position. This may cause the elongate member (250) to exit the distal opening of the cannula (208). The delivery device (200) may be configured such that moving the linear gear (216) to its distal-most position within the housing (206) results in the elongate member (250) moving to its fully extended, distal-most position relative to the cannula. When the linkage (230) and linear gear (216) are in the first configuration in which the linkage can move proximally but not distally relative to the linear gear, one or both wheels (210) may then be rotated in a second direction to retract the linear gear proximally within the housing (206). This may cause the slidable elongate member (250) to move from an extended position toward a retracted position. However, the fluid assembly and its reservoir (226) may not correspondingly move proximally within the housing (206). The housing (206) may comprise interior teeth (242) near the reservoir (226) configured to engage protrusions (244) fixed relative to the reservoir. For example, the protrusions (244) may be part of the proximal portion of the linkage (230) that is fixedly attached to the reservoir (226). The teeth (242) and protrusions (244) may allow the reservoir (226) to move distally within the housing (206) but not proximally within the housing. As such, when the linear gear (216) is retracted within the housing (206), the reservoir (226) may remain fixed relative to the housing. The linear gear (216) and reservoir (226) may therefore move closer together, with the linkage (230) moving distally along the track (240) in the linear gear to accommodate this movement. As the linear gear (216) and reservoir (226) move closer together, the plunger may displace fluid within the reservoir (226), as described in more detail above. The fluid may then travel through the lumen of the plunger and be delivered out through the lumen of the elongate member (250). When the linkage (230) and linear gear (216) are in the second configuration in which the linkage can move both proximally and distally relative to the linear gear, when one or both wheels (210) are rotated in a first direction to advance the linear gear (216) distally within the housing (206), the elongate member (250) may move distally toward the extended position. However, the linkage (230) and reservoir (226) may not move within the housing (206). Instead, the distal end of the linkage (230) may slide distally within the track (240) of the linear gear (216). This may cause the plunger to move distally out of the reservoir (226). In the second configuration, when one or both wheels (210) are rotated in the second direction to retract the linear gear (216) proximally within the housing (206), this may cause the slidable elongate member to move from an extended position toward a retracted position. The distal end of the linkage (230) may slide proximally within the track (240) of the linear gear (216). Although the proximal movement of the linkage (230) relative to the linear gear (216) may cause the plunger to move proximally into the reservoir (226), the plunger may not displace fluid within the reservoir (226), since it is returning to its position immediately prior to moving distally out of the reservoir. Thus, in both the first and second configurations, rotating one or more wheels (210) in a first direction, and correspondingly moving the linear gear (216) distally within the housing (206), may cause the slidable elongate member (250) to move toward an extended position. In both the first and second configurations, rotating one or more wheels (210) in an opposite, second direction, and correspondingly moving the linear gear (216) proximally within the housing (206), may cause the slidable elongate member (250) to move toward a retracted position. But rotating one or more wheels (210) in the second direction, and correspondingly moving the linear gear (216) proximally within the housing (206), may have different effects in the first and second configurations with respect to fluid delivery. In particular, in the first configuration, moving the linear gear (216) proximally within the housing (206) may cause fluid to be delivered out through the lumen of the elongate member during retraction of the elongate member. In contrast, in the second configuration, moving the linear gear (216) proximally within the housing (206) may cause the slidable elongate member to move toward a retracted position without any fluid being delivered. In the first configuration, as the elongate member is retracted, fluid may be delivered simultaneously out of the elongate member. The fluid may take the place of the elongate member as it is retracted, and as such, the fluid may be delivered to a trajectory that is the same as the trajectory along which the elongate member was advanced. A fixed, predetermined volume of fluid may be delivered for a given amount of retraction of the elongate member, due to displacement of the fluid in the reservoir by the plunger, and both the retraction of the elongate member and the delivery of a fluid composition may be effectuated by a single user motion (e.g., rotation of a wheel (210)). In some instances, full retraction of the elongate member may result in the delivery of between about 2 μl and about 9 μl of fluid. In some instances, full retraction of the elongate member may result in the delivery of between about 2 μl and 30 μl of fluid. In some of these instances, full retraction of the elongate member may result in the delivery of about 4.5 μl of fluid. In some of these instances, full retraction of the elongate member may result in the delivery of about 10 μl of fluid. As the elongate member is retracted, the delivery system (200) may produce audible and/or tactile clicks at increments. These clicks may, for example, be due to the ratcheting of the distal end of the linkage (230) distally relative to the linear gear (216). Each click may correspond to a fixed, predetermined volume of fluid, in some cases, between about 0.1 and about 1 μl. In some variations, the delivery system (200) may be configured to allow for a fixed cumulative amount of extension and/or retraction of the slidable elongate member while the system is in the first configuration. The fixed cumulative amount of extension/retraction may correspond, for example, to the full circumference of Schlemm's canal, two full circumferences of Schlemm's canal, or any desired distance. Exemplary fixed cumulative amounts may be, but are not limited to, about 39 mm to about 41 mm, about 38 mm to about 40 mm, about 35 mm to about 45 mm, about 78 mm to about 82 mm, about 76 mm to about 80 mm, or about 70 mm to about 90 mm. The delivery systems may additionally or alternatively be configured to allow for a fixed cumulative delivery of fluid (e.g., in some variations about 20 μl of fluid). For example, in one variation, the delivery system (200) may initially have the linear gear (216), elongate member, linkage (230), and reservoir (226) in their proximal-most locations within the housing (206). Rotation of a wheel (210) in a first direction may cause the linear gear (216) to move distally relative to the housing (206). This may cause the elongate member (250) to move distally out of the distal opening of the cannula (208) toward an extended position. In the first configuration the linkage (230) may be coupled via its distal end to the proximal portion (232) of the linear gear (216) having teeth (236) interfacing with the linkage (230), and thus, when the linear gear moves distally within the housing, the linkage may also move distally within the housing. Because the linkage (230) may be fixedly attached to the reservoir (226), the reservoir may also move distally within the housing. Rotation of a wheel (210) in a second, opposite direction may then cause the linear gear (216) to move proximally within the housing (206), but the linkage (230) and reservoir (226) may stay fixed relative to the housing, causing the distal end of the linkage to slide distally within the track (240) of the linear gear, and causing fluid to be delivered from the reservoir and out of the lumen of the elongate member (250). Repeated rotation of a wheel in the first and second directions (and thus repeated extension and retraction of the elongate member) may thus result in the distal end of the linkage (230) moving distally within the linear gear (216) with each cycle. After a particular cumulative amount of advancement and retraction of the elongate member (250), the distal end of the linkage (230) may reach the distal end of the proximal portion (232) of the linear gear (i.e., the distal end of teeth (236)). It should be appreciated that in some variations of the delivery system, this cumulative amount of advancement and retraction may be achieved in a single cycle of advancement and retraction. In other variations of the delivery system, this cumulative amount of advancement and retraction may only be achieved through at least two cycles of advancement and retraction (since the total translation of the linkage relative to the linear gear in a single cycle may be limited to the maximum advancement distance of the elongate member). In these variations, the total length of the proximal portion (232) of the linear gear (216) may be the same distance that the linear gear travels between its distal-most and proximal-most positions, and is the same distance that the elongate member extends from its retracted to extended position. For example, the total length of the proximal portion (232) of the linear gear (216) may be approximately 20 mm. As such, the delivery system (200) may be configured such that the elongate member may be advanced a first time approximately halfway around Schlemm's canal (i.e., 180 degrees, or approximately 19 mm to about 20 mm) in a first direction, which may be the maximum amount that the elongate member may be advanced without retraction. The elongate member may then be fully retracted (during which fluid may be delivered). After this first extension, the reservoir (226) of the fluid assembly may have moved half of its maximum distance toward its distal position, its distance to the linear gear (216) may have decreased by approximately half of its total possible decrease, and the distal end of the linkage (230) may be located at the halfway point of the linear gear (216)—that is, at the distal-most tooth (236) of the proximal portion (232) of the linear gear (216). The delivery system (200) may then be rotated about the handle, and the elongate member may be advanced a second time approximately halfway around Schlemm's canal in a second direction. The elongate member may then be retracted (during which fluid may be delivered). At the conclusion of the second extension, the reservoir (226) may be located at its distal-most position, its distance to the linear gear (216) may be at its minimum, and the distal end of the linkage (230) may be located at the distal-most position within the track (240) of the distal portion (234) of the linear gear (216). With the distal end of the linkage (230) in the distal portion (234) of the linear gear (216), the movement of the linear gear and elongate member may no longer be coupled to movement of the linkage or reservoir, and the elongate member may be repeatedly extended and retracted (without a cumulative limit) by repeated extension and retraction of the linear gear (216). The delivery systems may be further configured such that the elongate member disrupts the trabecular meshwork. In some variations, the elongate member may be configured such that advancement and/or retraction of the elongate member may disrupt the trabecular meshwork, and the elongate member may comprise one or more features to promote disruption of the trabecular meshwork upon advancement or retraction, such as disruptive components on the distal end of the elongate member, such as barbs, hooks, balloons, or the like. In other variations, the elongate member may be configured such that the body of the elongate member is configured to cut or tear the trabecular meshwork. For example, the delivery system may be configured such that the elongate member may be advanced out of the cannula and around Schlemm's canal; if the cannula is then removed from the eye without retracting the elongate member, the body of the elongate member may cut or tear the trabecular meshwork as the cannula is removed. The body of the elongate member may be configured to “unzip” the meshwork, cutting or tearing from a first location of the trabecular meshwork close to the cannula tip (i.e., at the proximal end of the elongate member) and continuing around the trabecular meshwork toward the distal end of the elongate member. The elongate member may be configured to apply a disruptive force to cut or tear the meshwork at one location of the meshwork at a time, sequentially around Schlemm's canal, rather than a disruptive force that simultaneously cuts or tears the meshwork throughout all of the trabecular meshwork being cut or torn. II. KITS The delivery systems described herein may be placed in specialized packaging. The packaging may be designed to protect the systems, and in particular, to protect the cannula. It may be desirable for the packaging to prevent contact between the distal tip of the cannula and any other object or surface. In order to do so, the packaging may comprise one or more elements configured to secure a delivery system to the packaging at one or more locations proximal to the distal tip of the cannula. Securing the delivery system at at least two locations proximal to the distal tip of the cannula may be desirable to limit the ability of the delivery system to pivot relative to the packaging. In one exemplary variation, the packaging may comprise a tray comprising a recess having a shape generally corresponding to the shape of the delivery system and comprising one or more pinch points configured to secure the delivery system at locations proximal to the cannula.FIG.10Ashows an exemplary tray (1004) for a delivery system (1000). Tray (1004) may comprise a recess (1006) configured to receive the delivery system. The tray (1004) may comprise first (1008) and second (1010) distal pinch points and first (1012) and second (1014) proximal pinch points configured to secure the delivery system within the recess (1006). When the delivery system is secured within the tray (1004), the cannula of the delivery system may be suspended such that the cannula is not in contact with the tray, and the pinch points may limit pivoting of the delivery system in a way that could cause the cannula to come into contact with the tray. The pinch points may be configured to safely secure the delivery system within the tray (1004), while also allowing a user to remove the delivery system from the tray in a controlled fashion. In variations in which the kits described here comprise additional components, the packaging may be designed to hold these additional components. For example,FIG.10Bshows an exemplary tray (1026) comprising a recess (1028) configured to hold a loading tool (1024) and a delivery system. As shown inFIG.10C, a tray (1040) may be configured to be sealed with a lid (1042) (e.g., heat sealed) and placed within a box (1044). The box (1044) may optionally further contain instructions for use (1046). The lid (1042) and/or box (1044) may optionally have labels (1048) affixed thereto. It should be appreciated that the packaging may have other configurations that protect the distal tip of the cannula. For example, in another variation, the packaging may comprise a stiff planar sheet to which the delivery system may be attached in an orientation such that the cannula is not in contact with the planar sheet. The delivery system may be attached (e.g., via ties or other materials wrapped around the housing) at two or more points along the housing in order to prevent movement of the delivery system relative to the planar sheet. It may be desirable to protect the cannula on at least two sides; for example, a portion of the planar sheet near the cannula may be bent around the cannula to protect the cannula on at least two sides, or a second stiff planar sheet may be attached to the delivery system opposite the first planar sheet. Some kits described herein may comprise multiple delivery systems. For example, a kit may comprise two delivery systems. In some variations, the kit may comprise two of the same system, such that, for example, the first delivery system may be used in a first eye of the patient and the second delivery system may be used in the second eye of the patient. Kits comprising multiple systems may be packaged in any suitable way, such as in a stacked configuration or side-by-side configuration. Some kits may comprise ocular implants in addition to one or more delivery systems as described herein. For example, a kit may comprise one or more devices configured to be implanted into Schlemm's canal, which may be generally configured to maintain the patency of Schlemm's canal without substantially interfering with transmural fluid flow across the canal. The kits may comprise one or more ocular implants such as, but not limited to, stents for placement in Schlemm's canal. In some variations, the ocular implants may be one or more of those disclosed in U.S. Pat. Ser. No. 7,909,789, which was previously incorporated by reference in its entirety, and U.S. Pat. Ser. No. 8,529,622, which was previously incorporated by reference in its entirety. III. METHODS Methods for treating conditions of the eye using the systems described above are also provided. In some variations, the methods of treating conditions of the eye comprise dilating Schlemm's canal and tearing the trabecular meshwork using a single delivery system. In some instances, treating conditions of the eye may result in increased aqueous humor drainage, reduced resistance to aqueous outflow, and/or reduced intraocular pressure. Some methods described herein may dilate Schlemm's canal, dilate the collector channels, and/or break any septae that may obstruct circumferential flow through Schlemm's canal. Dilation of Schlemm's canal may disrupt obstructed inner walls of the canal, stretch the trabecular meshwork, and/or increase the trabecular meshwork's porosity. This may improve the natural aqueous outflow pathway. The dilation may be performed by delivery of a fluid composition (e.g., a viscoelastic fluid as described herein). Some methods described here may comprise performing a trabeculotomy to cut trabecular meshwork. Some methods described here may comprise implanting an ocular device within Schlemm's canal. In some instances, the systems described herein may be used in performing ab-interno trabeculotomy, ab-interno transluminal trabeculotomy, clear corneal trabeculotomy, clear corneal transluminal trabeculotomy, ab-interno canaloplasty, and/or clear corneal canaloplasty. The methods are generally single-handed, single-operator controlled methods that are minimally invasive, e.g., they are tailored for an ab-interno procedure, which as previously mentioned, can be advantageous over the more invasive ab-externo approach. However, use of the ocular systems in an ab-externo method may be contemplated in some instances and thus, are not excluded here. The methods may be used to treat or prevent glaucoma, pre-glaucoma, or ocular hypertension. When treating glaucoma, the methods may also be used in conjunction with a cataract surgery (before or after) using the same incision during the same session or at another time. Some of the methods, described in more detail below, may comprise dilating Schlemm's canal and/or aqueous collector channels (e.g., with viscoelastic fluid) using the delivery systems described herein. The methods may also comprise tearing or cutting the trabecular meshwork of Schlemm's canal. These methods may be carried out separately, or they may be combined into a single procedure. For example, in some instances a portion (e.g., half) of Schlemm's canal may be dilated (using a fluid composition, for example), and the trabecular meshwork of the same or a different portion of Schlemm's canal may be torn or cut, within the same eye. As another example, all of Schlemm's canal may be dilated, and then all or a portion of the trabecular meshwork may subsequently be torn or cut. This may be desirable, for example, in order to both dilate the collector channels and tear or cut the trabecular meshwork. In some of these variations, dilation and tearing or cutting may be performed using a single delivery system, such as one described herein configured to deliver a fluid composition. For example, the elongate member of a delivery system configured to deliver a fluid composition may first be used to deliver a fluid composition to a portion of Schlemm's canal (e.g., about an 180 degree arc of the canal, about a 90 degree arc of the canal) as described herein, and subsequently to tear or cut the trabecular meshwork in the same portion of the canal as described herein. As another example, the elongate member of a delivery system configured to deliver a fluid composition may first be used to deliver a fluid composition to a portion of Schlemm's canal (e.g., about an 180 degree arc of the canal, about a 90 degree arc of the canal, etc.) and subsequently to tear or cut the trabecular meshwork in another portion of the canal (e.g., the other about-180 degree arc, another 90 degree arc, etc.). As yet another example, the elongate member of a delivery system configured to deliver a fluid composition may first be used to deliver fluid composition to all of Schlemm's canal (e.g., by delivering about 180 degrees of fluid composition in a first direction and then delivering about 180 degrees of fluid composition in a second direction), and then subsequently to tear or cut the full 360 degrees of trabecular meshwork (e.g., by tearing or cutting about 180 degrees of trabecular meshwork in a first direction and then tearing or cutting about 180 degrees of trabecular meshwork in a second direction). As yet another example, the elongate member of a delivery system configured to deliver a fluid composition may first be used to deliver fluid composition to all of Schlemm's canal in one step (i.e., by delivering about 360 degrees of fluid composition to Schlemm's canal in a single direction), and then subsequently to tear or cut the full 360 degrees of trabecular meshwork in a single step (i.e., by tearing or cutting about 360 degrees of trabecular meshwork in a single direction). In other variations, dilation and tearing or cutting may be performed using different delivery systems (e.g., the dilation may be performed using a delivery system configured to deliver a fluid composition, and the tearing or cutting may be performed using a delivery system not configured to deliver a fluid). As yet another example, in some instances dilation may be performed in one eye of a patient, while the trabecular meshwork may be torn or cut in the other eye of the patient. Procedures comprising dilating Schlemm's canal and/or tearing or cutting the trabecular meshwork may also be combined with procedures delivering an ocular device, either in the same eye or in a different eye of the same patient. For example, all or a portion of Schlemm's canal may be dilated, followed by insertion of an ocular device. As another example, a portion of the trabecular meshwork may be torn or cut, while an ocular implant may be delivered to another portion of Schlemm's canal. As yet another example, a portion of Schlemm's canal may be dilated, while an ocular implant may be delivered to another portion of Schlemm's canal. As yet another example, an ocular implant may be delivered to a portion of Schlemm's canal, and then Schlemm's canal may be subsequently dilated to improve the function of the ocular implant. Any suitable ocular device that maintains the patency of Schlemm's canal or improves outflow of aqueous humor may be implanted. For example, ocular devices that maintain the patency of Schlemm's canal without substantially interfering with fluid flow across, along, or out of the canal may be implanted. Such devices may comprise a support having at least one fenestration, as disclosed in U.S. Pat. No. 7,909,789, and U.S. Pat. No. 8,529,622, which were previously incorporated by reference in their entirety. Ocular devices that disrupt the juxtacanalicular trabecular meshwork or adjacent inner wall of Schlemm's canal may also be implanted. In addition to ocular devices made from metal or metal alloys, the use of sutures, modified sutures, modified polymers, polymeric filaments, or solid viscoelastic structures may be delivered. Fluid Composition Delivery Some methods described herein may comprise delivering fluid composition into the eye, such as into Schlemm's canal. The methods may generally include the steps of creating an incision in the ocular wall (e.g., the sclera or cornea) that provides access to the anterior chamber of the eye; advancing a cannula of the delivery system through the incision and at least partially across the anterior chamber to the trabecular meshwork; accessing Schlemm's canal with the cannula; and delivering the fluid composition into the canal using a elongate member slidable within the cannula lumen. The cannula may be configured to include a proximal end and a distal curved portion, where the distal curved portion has a proximal end, a distal end, and a radius of curvature defined between the ends. Here the cannula may also include a body and a distal tip having a bevel that directly engages the radius of curvature, e.g., it is contiguous with the radius of curvature. Further advantageous cannula features may also be included, which are described above. The method may also include the step of flushing the system with fluid (e.g., to remove air from the system) and/or the step of irrigating the operative field to clear away blood or otherwise improve visualization of the field. In some methods, an elongate member comprising a lumen may be advanced into Schlemm's canal and the fluid composition may be delivered via the elongate member. The elongate member and/or fluid delivery may dilate Schlemm's canal, and fluid delivery may additionally dilate the collector channels. The entire length of Schlemm's canal or a portion thereof may be dilated by the fluid. For example, at least 75%, at least 50%, at least 25%, at least 10% of the canal, or at least 1% of the canal may be dilated. The fluid compositions may also be delivered to treat various medical conditions of the eye, including but not limited to, glaucoma, pre-glaucoma, anterior or posterior segment neovascularization diseases, anterior or posterior segment inflammatory diseases, ocular hypertension, uveitis, age-related macular degeneration, diabetic retinopathy, genetic eye disorders, complications of cataract surgery, vascular occlusions, vascular disease, or inflammatory disease. The surgeon may first view the anterior chamber and trabecular meshwork (with underlying Schlemm's canal) using an operating microscope and a gonioscope or gonioprism. Using a 0.5 mm or greater corneal, limbal, or sclera incision, the surgeon may then gain access to the anterior chamber. A saline solution or viscoelastic composition may then be introduced into the anterior chamber to prevent its collapse. Here the saline solution or viscoelastic composition may be delivered through the delivery system cannula or by another mode, e.g., by infusion through an irrigating sleeve on the cannula. The surgeon, under direct microscopic visualization, may then advance the cannula of the delivery system through the incision towards the anterior chamber angle. When nearing the angle (and thus the trabecular meshwork), the surgeon may apply a gonioscope or gonioprism to the cornea to visualize the angle. The application of a viscous fluid (e.g., a viscoelastic composition as previously described) to the cornea and/or gonioscope or gonioprism may help to achieve good optical contact and negate total internal reflection thereby allowing visualization of the anterior chamber angle. As the surgeon visualizes the trabecular meshwork, the cannula may then be advanced so that the bevel of at the distal end of the curved distal portion of the cannula pierces the meshwork and is in communication with the lumen of Schlemm's canal. Next, a slidable elongate member coaxially disposed within the cannula lumen may be advanced into the canal under gonioscopic visualization. The elongate member may be advanced any suitable amount and direction about the canal. For example, the elongate member may be advanced between about 1 degree and about 360 degrees about the canal, between about 10 degrees and about 360 degrees about the canal, between about 150 and about 210 degrees about the canal, or any suitable distance, about 360 degrees about the canal, about 270 degrees about the canal, about 180 degrees about the canal, about 120 degrees about the canal, about 90 degrees about the canal, about 60 degrees about the canal, about 30 degrees about the canal, or about 5 degrees about the canal. In some variations, the elongate member may be advanced in two steps, e.g., first in a clockwise direction (e.g., about 180 degrees, about 90 degrees, etc.) and second in a counterclockwise direction (e.g., about 180 degrees, about 90 degrees, etc.) about the canal (e.g., to thereby achieve a 360 or 180 degree ab-interno viscocanalostomy or canaloplasty). In some variations, the elongate member may be advanced in one step (e.g., about 90 degrees in a clockwise direction, about 180 degrees in a clockwise direction, about 270 degrees in a clockwise direction, about 360 degrees in a clockwise direction, about 90 degrees in a counterclockwise direction, about 180 degrees in a counterclockwise direction, about 270 degrees in a counterclockwise direction, about 360 degrees in a counterclockwise direction) about the canal to thereby achieve a corresponding degree ab-interno viscocanalostomy or canaloplasty. Fluid may be injected upon advancement or retraction of the elongate member. Once the slidable elongate member has been positioned within the canal, a fluid composition, e.g., a viscoelastic solution, may be continuously or intermittently delivered through the lumen of the elongate member. The fluid composition may exit the lumen of the elongate member through its distal end (e.g., the through the distal tip), or through openings or fenestrations provided along its shaft, or a combination of both. The openings or fenestrations may be spaced along the axial length of the elongate member in any suitable manner, e.g., symmetrically or asymmetrically along its length. Other substances such as drugs, air, or gas may delivered be in the same manner if desired. In some variations, the slidable elongate member may be repositioned by retraction or repeated advancement and retraction. In some variations of the method, the same or different incision may be used, but the delivery system cannula is employed to access and dilate Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon may retract the slidable elongate member into the cannula and remove the delivery system from the eye. It should be appreciated that the cannulas described here may be specifically manufactured to comprise a dual-surface configuration at the distal tip (i.e., sharp and smooth surfaces), which may allow the elongate member to be advanced, repositioned, and/or retracted without severing it on the distal tip of the cannula. It should also be understood that these steps may be used alone or in combination with cataract surgery (in one sitting). Some of the delivery systems described herein may be configured such that the cumulative amount of advancement and/or retraction of the slidable elongate member is limited. For example, as described above, after the elongate member is advanced and retracted a particular cumulative distance (e.g., about 39 mm to about 40 mm each of advancement and retraction, corresponding to the approximate circumference of Schlemm's canal; or about 78 mm to about 80 mm each of advancement and retraction, corresponding to approximately twice the circumference of Schlemm's canal; or any other suitable distance), it may no longer be able to be advanced. This advancement and retraction may occur over multiple advancement-retraction cycles. For example, the elongate member may be advanced about 20 mm, then retracted by about 20 mm, then advanced by about 20 mm, then retracted by about 20 mm. When the cumulative distance is limited to about 40 mm, after these two cycles of advancement and retraction, the elongate member may no longer be able to be advanced. In other variations, the delivery systems may not limit the cumulative amount of advancement and/or retraction of the elongate member. In some variations of the ab-interno method, the fluid composition may be delivered simultaneously with retraction of the elongate member (i.e., the fluid compositions may be delivered in a manner where retraction of a system component allows advancement of the fluid out of the system cannula). It should be understood that the delivery systems may be configured so that the fluid compositions are delivered continuously, passively, automatically, or actively by the surgeon. The fluid compositions may also be delivered to the canal independent of the gear shaft movement with a pump or auxiliary plunger. In some variations, retraction of the elongate member may correspond to a fixed volume of fluid composition being delivered via the lumen of the elongate member. The fluid composition may be delivered via the distal opening of the lumen of the elongate member as it is retracted, and thus, the fluid may be evenly delivered throughout the portion of the canal through which the elongate member was advanced. The fluid compositions that may be delivered by the systems described herein include but are not limited to saline and viscoelastic fluids. The viscoelastic fluids may comprise hyaluronic acid, chondroitin sulfate, cellulose, derivatives or mixtures thereof, or solutions thereof. In one variation, the viscoelastic fluid comprises sodium hyaluronate. In another variation, the viscoelastic composition may further include a drug. For example, the viscoelastic composition may include a drug suitable for treating glaucoma, reducing or lowering intraocular pressure, reducing inflammation, fibrosis neovascularization or scarring, and/or preventing infection. For example, in some variations, the viscoelastic composition may include the therapeutic agents described herein, such as but not limited to Rho kinase (ROCK) inhibitors and agents for gene therapy, DNA, RNA, or stem cell-based approaches. The viscoelastic composition may also include agents that aid with visualization of the viscoelastic composition. For example, dyes such as but not limited to fluorescein, trypan blue, or indocyanine green may be included. In some variations, a fluorescent compound or bioluminescent compound is included in the viscoelastic composition to help with its visualization. In other variations, the system may deliver the drug alone, without the viscoelastic composition. In this case, the drug may be loaded onto or into a sustained release biodegradable polymer that elutes drug over a period of weeks, months, or years. It is also contemplated that air or a gas could be delivered with the systems, as described herein. Other variations of the ab-interno method include the use of an endoscope. Similar to the method described directly above, access to the anterior chamber is first made by incising the cornea, limbus, or sclera. Again, this may be done in combination with cataract surgery in one sitting, either before or after cataract surgery, or independently. The anterior chamber may be infused with saline solution or a viscoelastic composition may be placed in the anterior chamber to prevent its collapse. The saline or viscoelastic may be delivered as a separate step or it may be infused with the elongate member of the delivery system, an irrigating sleeve on the elongate member or cannula, or with a separate infusion cannula. The surgeon, under direct microscopic visualization, then advances the endoscope through the incision and towards the angle and trabecular meshwork. As the surgeon visualizes the trabecular meshwork via the endoscope or any associated display, the bevel of the cannula is advanced to pierce the meshwork. The elongate member is then advanced under endoscopic visualization. The elongate member may be advanced any suitable amount and direction about the canal. For example, the elongate member may be advanced between about 10 degrees to about 360 degrees about the canal, or it may be advanced in two steps, e.g., 180 degrees in a clockwise direction and 180 degrees in a counterclockwise direction about the canal (to thereby achieve a full 360 degree ab-interno viscocanalostomy). Once the elongate member has been positioned within the canal, a fluid composition, e.g., a viscoelastic fluid, may be continuously or intermittently delivered through the lumen of the elongate member. The fluid composition may exit the lumen of the elongate member through its distal end (e.g., the through the distal tip), or through openings or fenestrations provided along its shaft, or a combination of both. The openings or fenestrations may be spaced along the axial length of the elongate member in any suitable manner, e.g., symmetrically or asymmetrically along its length. Other substances such as drugs, air, or gas may be delivered in the same manner if desired. The elongate member may be repositioned by retraction or repeated advancement and retraction. In some variations of the method, the same or different incision may be used, but the delivery system cannula is employed to access and dilate Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon may retract the slidable elongate member into the cannula. In some variations the surgeon may then remove the delivery system from the eye; in other variations the surgeon may keep the delivery system within the eye and perform a trabeculotomy, as described in more detail herein. More generally, in methods described herein, exemplary volumes of viscoelastic fluid that may be delivered may in some instances be between about 1 μl and about 200 μl, or in some instances be between about 1 μl and about 100 μl. In some instances, sufficient volumes to provide a disruptive force may range from about 1 μl to about 50 μl, from about 1 μl to about 30 μl or from about 2 μl to about 16 μl. In one variation, a volume of about 4 μl is sufficient to disrupt Schlemm's canal and/or the surrounding tissues. In other variations, the volume of viscoelastic fluid sufficient to disrupt trabeculocanalicular tissues may be about 2 μl, about 3 μl, about 4 μl, about 5 μl, about 6 μl, about 7 μl, about 8 μl, about 9 μl, about 10 μl, about 11 μl, about 12 μl, about 13 μl, about 14 μl, about 15 μl, about 16 μl, about 17 μl, about 18 μl, about 19 μl, about 20 μl, about 25 μl, about 30 μl, about 35 μl, about 40 μl, about 45 μl, or about 50 μl. Tissue disruption may occur by viscodilating excessively and intentionally with at least about 1 μl, at least about 2 μl, at least about 3 μl, at least about 4 μl, at least about 5 μl, at least about 6 μl, at least about 7 μl, at least about 8 μl, at least about 9 μl, at least about 10 μl, at least about 11 μl, at least about 12 μl, at least about 13 μl, at least about 14 μl, at least about 15 μl, at least about 16 μl, at least about 17 μl, at least about 18 μl, at least about 19 μl, or at least about 20 μl of viscoelastic fluid per 360 degree arc of the canal. In some variations, at least about 20 μl, at least about 25 μl, at least about 30 μl, at least about 35 μl, at least about 40 μl, at least about 45 μl, or at least about 50 μl of viscoelastic fluid may be delivered. Depending on factors such as the type or severity of the condition being treated, the disruptive force may be generated to partially or completely destroy and/or remove the trabecular meshwork, and may be adjusted by varying the volume of viscoelastic fluid delivered. Additionally, the fluid compositions may be delivered to restore the tubular anatomy of Schlemm's canal, to clear obstructions within the canal, to disrupt juxtacanalicular trabecular meshwork or the inner wall of Schlemm's canal within the canal, or to expand the canal. Here the delivery systems may include wires, tubes, balloons, instruments that deliver energy to the tissues, and/or other features to help with these methods. It is contemplated that glaucoma may be treated using such systems with additional features. The surface of these systems may also be roughened or have projections to further disrupt the inner wall of Schlemm's canal and juxtacanalicular trabecular meshwork to enhance aqueous humor outflow or permeability. Additionally, it should be appreciated that the delivery systems described herein may be used to deliver the fluid compositions to the anterior chamber or anterior segment. The viscoelastic fluid may be delivered while advancing the elongate member of a single-handed, single-operator controlled device from Schlemm's canal in the clockwise direction, counterclockwise direction, or both, or during withdrawal of the elongate member from Schlemm's canal. As previously stated, the viscoelastic fluid may be delivered to disrupt Schlemm's canal and surrounding trabeculocanalicular tissues. For example, the delivered viscoelastic fluid may cause disruption by dilating Schlemm's canal, increasing the porosity of the trabecular meshwork, stretching the trabecular meshwork, forming microtears or perforations in juxtacanalicular tissue, removing septae from Schlemm's canal, dilating collector channels, or a combination thereof. The elongate member may be loaded with the viscoelastic fluid at the start of an ocular procedure so that the fluid can be delivered by a single device. This is in contrast to other systems that use forceps or other advancement tool to advance a fluid delivery catheter into Schlemm's canal and/or devices containing viscoelastic fluid that are separate or independent from a delivery catheter or catheter advancement tool, and which require connection to the delivery catheter or catheter advancement tool during a procedure by an assistant while the delivery catheter or catheter advancement tool is held by the surgeon. Trabeculotomy The methods described herein may comprise performing a trabeculotomy. The methods (as well as systems and devices) described herein, including the method for providing a disruptive force to trabeculocanalicular tissues, may be highly suitable for ab-interno trabeculotomy and goniotomy given that they avoid the use of electrocautery, and are capable of advancing elongate members over larger degrees of arc of Schlemm's canal. In some instances, disruptive tools may comprise disruptive components on their distal portions. Exemplary disruptive components include, without limitation, notches, hooks, barbs, balloons, or combinations thereof. In other instances, the disruptive tools may not comprise disruptive components on their distal portions, and indeed may have atraumatic blunt distal portions. Exemplary atraumatic distal portions include, without limitation, parasol or dome shaped distal portions. The outer diameter of the elongate member or tool may be variously sized for disruption of tissues, analogous to how fluid volumes may be varied to vary the level of disruption. For example, an elongate member or tool having an outer diameter ranging from about 50 to about 100 microns may be advanced through the canal to slightly dilate the canal and break or remove septae obstructing circumferential canalicular flow. An elongate member or tool having an outer diameter ranging from about 100 to 200 microns may be employed to perform the foregoing, and may also to begin to stretch the trabecular meshwork and juxtacanalicular tissues. An elongate member or tool having an outer diameter ranging from about 200 to about 300 microns may be able to perform the above, but may also create microtears in the trabecular meshwork and juxtacanalicular tissues, and may maximally dilate the collector channels. An elongate member or tool having an outer diameter ranging from about 300 to about 500 microns may maximally disrupt the tissues and may create tears or perforations all along the trabecular meshwork and juxtacanalicular tissues. The elongate member or tool may be advanced out from the tip of the cannula and into the canal about a 30 degree arc of the canal (e.g., advanced about 3 to 4 mm out of the cannula), advanced about a 60 degree arc of the canal (e.g., advanced about 6 to 8 mm out of the cannula), advanced about a 90 degree arc of the canal (e.g., advanced about 10 mm out of the cannula), advanced about a 120 arc of the canal (e.g., advanced about 15 mm out of the cannula), advanced about a 180 degree arc of the canal (e.g., advanced about 20 mm out of the cannula), or advanced about a full 360 degrees of the canal (e.g., advanced about 36 to 40 mm out of the cannula), for maximal intraocular pressure reduction. In some variations, the elongate member may have a non-uniform outer diameter. For example, the elongate member may have a tapered outer diameter, such that the outer diameter increases from the distal to proximal end. In some variations, the methods disclosed herein may include advancement of the elongate member between about a 5 degree arc of Schlemm's canal and about a 360 degree arc. In some variations, the methods may include advancement of the elongate member (or tool) about a 360 degree arc of Schlemm's canal, about a 270 degree arc of Schlemm's canal, about a 120 degree arc of Schlemm's canal, about a 180 degree arc of Schlemm's canal, or about a 90 degree arc of Schlemm's canal. In yet further variations, advancement of the elongate member (or a tool) may be about a 0 to 5 degree arc of Schlemm's canal, about a 30 degree arc of Schlemm's canal, or about a 60 degree arc of Schlemm's canal. Advancement may occur from a single access point in Schlemm's canal or from multiple access points in the canal. It may be beneficial to advance the elongate member in both clockwise and counterclockwise directions about a 180 degree arc of Schlemm's canal from a single access point in the canal. In other variations, the elongate member may be advanced in a single (clockwise or counterclockwise) direction about 360 degrees of Schlemm's canal from a single access point in the canal. Depending on factors such as the type or severity of the condition being treated, the disruptive force may be generated to partially or completely destroy and/or remove the trabecular meshwork, and may be adjusted by varying the tool configuration. In some methods, the trabecular meshwork may be disrupted during advancement of the slidable elongate member. Customizing a body segment of the elongate member proximal to the tip with one or more notches, barbs, or balloons that catch the meshwork as the distal tip is being guided and advanced along Schlemm's canal may also be used, thereby disrupting, partially tearing, fully tearing, and/or removing trabecular meshwork upon advancement. Additionally, an implant with edges specifically designed to cut the meshwork may be used. In yet other methods, the trabecular meshwork may be disrupted during retraction of the slidable elongate member. The methods for disrupting tissues may involve customizing the system (e.g., the elongate member, any catheters or wires, probe tips, etc.) to catch or grasp the meshwork upon retraction after advancement through the canal. This may be done using a wire with a bent tip, hook, notch, or barb on its end that is advanced through the lumen of the catheter that then snags the meshwork upon retraction, tearing it along its length or removing it altogether, or solely with a metal or polymer wire or suture (no catheter) whose tip (and/or body) is hooked, notched, or barbed in such a way that it can be advanced into Schlemm's canal without tearing the meshwork but snags the meshwork upon retraction, tearing the meshwork and/or removing it completely. The elongate member may be provided with a disruptive tool, e.g., a sharp-edged element, that can cut or tear the trabecular meshwork while being retracted into the cannula, which is held stationary. Exemplary sharp-edged elements may be a hook, wire, or any other suitable shape memory component that can extend from the cannula to tear, cut, or remove trabecular meshwork. Another method for disrupting tissues may include using oversized elongate members (e.g., having an outside diameter of 300-500 microns) to tear the meshwork upon delivery, or inflating or expanding the elongate member once it has been fully advanced into Schlemm's canal to stretch, disrupt, rupture, or fully tear the meshwork. For example, a catheter/elongate member, probe, or wire (with or without a lumen) whose tip is 200-250 microns in outer diameter, but having a shaft that begins to flare outwards after 3 clock hours of Schlemm's canal (i.e., at about the 5 or 10 mm mark on the catheter/elongate member) up to about 300, up to about 400, or up to about 500 microns, may be used, so that as the tip advances comfortably within Schlemm's canal, the enlarged shaft trails behind and ruptures the trabecular meshwork as it is advanced. In another method, cutting, destruction, removal, or the like of the trabecular meshwork may be accomplished by removing the cannula from the eye while leaving the elongate member in the canal, thereby tearing through the meshwork. For example, a cannula may be inserted into the anterior chamber and Schlemm's canal, and a tool (e.g., a slidable elongate member) may be advanced within the canal. The cannula may be removed from the anterior chamber without retracting the elongate member. This action by itself may tear the trabecular meshwork. As the cannula is removed from the anterior chamber, the elongate member may begin tearing the trabecular meshwork from the point at which the cannula was inserted into Schlemm's canal, and may continue tearing around the trabecular meshwork toward the distal end of the elongate member. The methods described here may be used to access the trabecular outflow system using a single clear corneal incision, and may allow for transluminal trabeculotomy of up to 360 degrees. The method may use a flexible elongate member that may be advanced and retracted using a single-handed disposable manual instrument. In one variation of the method, the cannula may be held securely against the angle while the flexible elongate member is advanced into Schlemm's canal. An exposed portion of one or more of the wheels may be rotated proximally to advance the flexible elongate member up to about 180 degrees around Schlemm's canal (about 20 mm of circumferential canal travel). For example, the elongate member may be advance about 90, 135, or 180 degrees. At this point, the flexible elongate member may in some instances be fully extended, and the wheel may no longer be able to be rotated. During this procedure, direct microscopic or gonioscopic visualization of the cannula tip may be maintained, and the anterior chamber may be maintained with viscoelastic or continuous balanced salt solution infusion. Once the flexible elongate member is advanced, the cannula may be removed from the eye through the incision without retracting the flexible elongate member. This may cause the body of the flexible elongate member to tear or cut through the trabecular meshwork. In some instances, it may be desirable to bias the distal tip of the cannula toward the trabecular meshwork being cut; this may in some instances help to prevent the flexible elongate member from slipping out of the canal during cannula removal. Exemplary Combined Method with Fluid Composition Delivery and Trabeculotomy Some of the methods described herein may comprise delivering fluid composition into the eye, such as into Schlemm's canal, and tearing or cutting the trabecular meshwork. For example, one variation of the methods described here may be carried out using the delivery system (200) ofFIGS.2A-2I. The method may allow for single-handed, manually operated delivery of fluid (e.g., viscoelastic fluid or gel) into Schlemm's canal via a slidable elongate member comprising a lumen (e.g., a microcatheter). The delivery of viscoelastic fluid may be metered, such that controlled, small amounts of viscoelastic can be delivered to the eye. The method may allow for catheterization and transluminal viscodilation of up to 360 degrees of Schlemm's canal, as well as trabeculotomy of up to 360 degrees of trabecular meshwork, using a single clear corneal incision for access. This method may, for example, reduce intraocular pressure in patients with glaucoma (e.g., open-angle glaucoma). A flow chart of the method is shown inFIGS.11A-11B. First, the delivery system (200) may be removed from its packaging. Next, the delivery system (200) may be loaded with viscoelastic fluid prior to the procedure. Suitable commercially available viscoelastics include but are not limited to Healon™, HealonGV™, Amvisc™, and PROVISC™. The commercially available viscoelastic cartridge may be attached externally to the delivery system via an exposed luer fitting at the proximal end of the housing (206). With the lock (212) attached to the housing (206), such that the pin (228) of the lock holds the reservoir (226) in place, the viscoelastic fluid may be injected from the viscoelastic cartridge into the reservoir (226) of the delivery system (200). It may be desirable to hold the delivery system (200) and viscoelastic cartridge upright during injection. The viscoelastic fluid may be injected until viscoelastic flow from the distal tip of the cannula (208) is visualized. The viscoelastic cartridge may then be removed from the delivery system. The lock (212) may then be removed from the delivery system (200) to release the reservoir (226). To place the delivery system (200) in the eye, the surgeon may first view the anterior chamber and trabecular meshwork (with underlying Schlemm's canal) using an operating microscope and a gonioscope or gonioprism. Using a 0.5 mm or greater corneal, limbal, or sclera incision, the surgeon may then gain access to the anterior chamber. It may be desirable for the incision to be at least about 1 mm wide. A saline solution or viscoelastic composition may then be introduced into the anterior chamber to prevent its collapse. The surgeon, under direct microscopic visualization, may then advance the cannula (208) of the delivery system (200) through the incision towards the anterior chamber angle. When nearing the angle (and thus the trabecular meshwork), the surgeon may apply a gonioscope or gonioprism to the cornea to visualize the angle. The application of a viscous fluid (e.g., a viscoelastic composition as previously described) to the cornea and/or gonioscope or gonioprism may help to achieve good optical contact and negate total internal reflection thereby allowing visualization of the anterior chamber angle. As the surgeon visualizes the trabecular meshwork, the cannula (208) may then be advanced so that the bevel of at the distal end of the curved distal portion of the cannula (208) pierces the meshwork and is in communication with the lumen of Schlemm's canal. The cannula (208) may be held securely against the angle while the elongate member is advanced into Schlemm's canal. To advance the elongate member into Schlemm's canal, a wheel (210) may be rotated in a first direction (e.g., by moving the exposed portion of the wheel distally) to advance the elongate member (250) up to about 180 degrees around Schlemm's canal (about 18 mm, about 19 mm, about 20 mm, about 18 mm to about 20 mm, or about 15 mm to about 25 mm of circumferential canal travel) in either a clockwise or counterclockwise direction. At this point, the elongate member (250) may be fully extended, and the wheel (210) may no longer be able to be rotated in the first direction. During this procedure, direct microscopic or gonioscopic visualization of the cannula tip may be maintained, and the anterior chamber may be maintained with viscoelastic or continuous balanced salt solution infusion. A wheel (210) may then be rotated in a second, opposite direction (e.g., by moving the exposed portion of the wheel proximally) to retract the elongate member (250). As the elongate member (250) is retracted, a specific predetermined volume of viscoelastic may be steadily delivered out of the lumen of the elongate member in a metered fashion, which may cause transluminal viscodilation of Schlemm's canal and/or collector channels. In some variations, full retraction of the elongate member (250) results in the delivery of between about 2 μl and about 9 μl of viscoelastic fluid (e.g., about 4.5 μl of viscoelastic fluid). In other variations, full retraction of the elongate member (250) results in the delivery of between about 5 μl and about 15 μl of viscoelastic fluid (e.g., about 10 μl of viscoelastic fluid). The wheel (210) may be configured to be incrementally rotated with audible and/or tactile clicks at incremental rotation; in some cases, between about 0.1 and about 1 μl of viscoelastic fluid may be delivered with each click. As illustrated inFIGS.12A-12C, the delivery of viscoelastic (1200) to Schlemm's canal (1202) and collector channels (1204) during retraction of the elongate member (250) into the cannula (208) may result in the angle and length of delivery of viscoelastic to Schlemm's canal corresponding to the angle and length of the elongate member into the canal (e.g., up to about 180 degrees, and about 18 mm, about 19 mm, about 20 mm, about 18 mm to about 20 mm, or about 15 mm to about 25 mm of circumferential length). In some instances, viscoelastic may be used to tamponade any blood reflux back into the anterior chamber. It should be appreciated that in other variations, the elongate member (250) may be advanced up to about 360 degrees around Schlemm's canal in either a clockwise or counterclockwise direction, and retraction of the elongate member may result in delivery of viscoelastic to the full length of Schlemm's canal. Viscoelastic may then be delivered to the other half of Schlemm's canal. The tip of the cannula (208) may be removed from Schlemm's canal and the delivery system (200) may be flipped, such that the cannula (208) is rotated 180 degrees to face the opposite direction. In some instances, the delivery system (200) may be flipped in the anterior chamber, without removing the cannula (208) from the eye. In other instances, the delivery system (200) may be removed from the eye, flipped, and reinserted into the incision. The tip of the cannula (208) may then be reinserted into Schlemm's canal via the same incision in the trabecular meshwork, and advancement and retraction of the elongate member (250) and delivery of viscoelastic fluid as described above may be repeated to viscodilate another portion of the canal (e.g., the remaining 180 degrees of Schlemm's canal), with the advancement of the elongate member in an opposite direction (i.e., counterclockwise if the first advancement was clockwise, or clockwise if the first advancement was counterclockwise). A procedure delivering viscoelastic fluid around 360 degrees of Schlemm's canal may deliver between about 4 μl and about 18 μl of viscoelastic fluid in total to the eye (e.g., about 9 μl of viscoelastic fluid), or between about 10 μl and 30 μl of viscoelastic fluid in total to the eye (e.g., about 20 μl of viscoelastic fluid). The elongate member (250) may then be used to perform a transluminal trabeculotomy of up to 360 degrees. The cannula (208) may be held securely against the angle while the elongate member (250) is advanced into Schlemm's canal. In some variations, this advancement may be performed after viscoelastic fluid delivery without moving the tip of the cannula (208); that is, the elongate member (250) may be advanced in the same direction around Schlemm's canal as where fluid was delivered immediately prior. In other variations, the elongate member (250) may be advanced in the opposite direction. In these variations, the tip of the cannula (208) may be removed from Schlemm's canal and the delivery system (200) may be flipped, such that the cannula (208) is rotated 180 degrees to face the opposite direction. In some instances, the delivery system (200) may be flipped in the anterior chamber, without removing the cannula (208) from the eye. In other instances, the delivery system (200) may be removed from the eye, flipped, and reinserted into the incision. The tip of the cannula (208) may then be reinserted into Schlemm's canal via the same incision in the trabecular meshwork. To advance the elongate member (250) into Schlemm's canal, a wheel (210) may be rotated in the first direction (e.g., by moving the exposed portion of the wheel distally) to advance the elongate member up to about 180 degrees around Schlemm's canal (about 18 mm, about 19 mm, about 20 mm, about 18 mm to about 20 mm, or about 15 mm to about 25 mm of circumferential canal travel). At this point, the elongate member (250) may be fully extended, and the wheel (210) may no longer be able to be rotated in the first direction. During this procedure, direct microscopic or gonioscopic visualization of the cannula tip may be maintained, and the anterior chamber may be maintained with viscoelastic or continuous balanced salt solution infusion. Once the elongate member is advanced, the cannula (208) may be removed from the eye through the incision without retracting the elongate member (250), as shown inFIGS.13A-13C. This may cause the elongate member (250) to tear or cut through the trabecular meshwork (1304). In some instances, it may be desirable to bias the distal tip of the cannula (208) toward the trabecular meshwork being cut; this may in some instances help to prevent the elongate member (250) from slipping out of the canal during cannula removal. Removal of the cannula (208) without retraction of the elongate member (250) may cause the elongate member to transmit the force from removing the cannula (208) into a force that tears or cuts the trabecular meshwork (1304). Removal of the cannula (208) thus results in an “unzipping” effect to tear or cut the trabecular meshwork (1304). That is, the trabecular meshwork (1304) is torn by the body of the elongate member (250) from its proximal to distal end. First, force on the trabecular meshwork (1304) from the proximal end of the body of the elongate member (250) causes the trabecular meshwork to tear near the insertion point of the cannula (208). As the cannula (208) continues to be withdrawn from the eye, the body of the elongate member (250) continues to tear through the trabecular meshwork (1304), toward the distal tip of the elongate member. It should be noted that this method causes the trabecular meshwork to be progressively torn from a first location (the proximal end of the extended elongate member, near the insertion point of the cannula) to a second location (the distal end of the extended elongate member), as opposed to being cut or torn simultaneously along the distance from the first location to the second location. Furthermore, it should be noted that in this method each portion of the trabecular meshwork is not torn by a single feature of the elongate member (e.g., a distal end of the elongate member upon advancement or retraction); rather, each portion of the trabecular meshwork is torn by the portion of the elongate member adjacent to it after the elongate member has been advanced. It should be appreciated that in other variations, the elongate member may be advanced up to about 360 degrees around Schlemm's canal in either a clockwise or counterclockwise direction, and removal of the cannula may result in the tearing or cutting of approximately 360 degrees of the trabecular meshwork. After the delivery system is fully removed from the eye, the elongate member (250) may be retracted back into the cannula by rotating a wheel (210) in the second direction (e.g., by moving the exposed portion of the wheel distally). During this retraction of the elongate member, no fluid may flow out of the distal end of the elongate member. Once the elongate member (250) is fully retracted into the cannula (216), the delivery system (200) may be flipped, such that the tip of the cannula (208) is rotated 180 degrees to face the opposite direction. The cannula tip may then be advanced into the anterior chamber through the corneal or scleral incision, and the distal tip may be advanced into the same entry into Schlemm's canal. The method described above may then be repeated on the second half of Schlemm's canal to cut through the trabecular meshwork. In some instances, viscoelastic may be used to tamponade any blood reflux back into the anterior chamber. At the end of the procedure, the anterior chamber may be irrigated (e.g., with balanced salt solution) through the corneal wound (either manually or automated). A balanced salt solution or viscoelastic may be used to reform the anterior chamber as needed to achieve physiologic pressure and further tamponade any blood reflux from the collector channels back into the anterior chamber. If necessary, a suture may be used to seal the corneal or scleral incision. Postoperatively, an antibiotic or antiseptic, mydriatic agent, or a miotic agent, may be used as appropriate. For example, a miotic eye drop may be used for weeks or months to help prevent synechiae formation and angle closure. Thus, it should be appreciated that the delivery system (200) may be configured to perform a procedure involving a first portion comprising delivering a viscoelastic fluid to dilate Schlemm's canal and/or the collector channels, and a second portion comprising cutting or tearing the trabecular meshwork. In some variations, the entire procedure may be performed using a single corneal incision and a single access point in Schlemm's canal. In some variations, delivering the viscoelastic fluid may comprise two steps (delivering the viscoelastic fluid to a first length of Schlemm's canal and delivering the viscoelastic fluid to a second length of Schlemm's canal); and cutting or tearing the trabecular meshwork may comprise two steps (cutting or tearing a first length of the trabecular meshwork and cutting or tearing a second length of Schlemm's canal). In other variations, delivering the viscoelastic may comprise one step, and cutting or tearing the trabecular meshwork may comprise one step. The delivery system (200) may be configured such that it switches from a first configuration in which it delivers fluid upon elongate member retraction to a second configuration in which it does not deliver fluid upon elongate member retraction. In some variations, the switch may occur automatically after the delivery system (200) has undergone a predetermined cumulative amount of elongate member retraction. For example, the delivery device (200) may be configured such that it switches from the first configuration to the second configuration after a cumulative amount of elongate member retraction equal to the full circumference of Schlemm's canal (e.g., between about 38 mm and about 40 mm). In other variations, the switch may be carried out manually by the operator. It should be appreciated that the viscoelastic fluid may be delivered to and the trabecular meshwork torn in the same length of the canal (including all of the canal), or viscoelastic fluid may be delivered to and the trabecular meshwork torn in different lengths of the canal. It should also be appreciated that the viscoelastic fluid delivery may comprise one, two, three, four, or more steps, and/or tearing the trabecular meshwork may comprise one, two, three, four, or more steps. In one variation, the method may comprise dilating 360 degrees of Schlemm's canal; and tearing the trabecular meshwork of 360 degrees of Schlemm's canal. In one variation, the method may comprise dilating 180 degrees of Schlemm's canal; dilating the other 180 degrees of Schlemm's canal; tearing the trabecular meshwork of 180 degrees of Schlemm's canal; and tearing the trabecular meshwork of the other 180 degrees of Schlemm's canal. In another variation, the method may comprise dilating 90 degrees of Schlemm's canal; dilating another 90 degrees of Schlemm's canal; tearing the trabecular meshwork of 90 degrees of Schlemm's canal; and tearing the trabecular meshwork of another 90 degrees of Schlemm's canal. The dilated 180 degrees may entirely overlap with the torn 180 degrees; it may not overlap at all; or it may partially overlap. In another variation, the method may comprise dilating 180 degrees of Schlemm's canal; dilating the other 180 degrees of Schlemm's canal; tearing the trabecular meshwork of 90 degrees of Schlemm's canal; and tearing the trabecular meshwork of another 90 degrees of Schlemm's canal. In another variation, the method may comprise dilating 90 degrees of Schlemm's canal; dilating another 90 degrees of Schlemm's canal; tearing the trabecular meshwork of 180 degrees of Schlemm's canal; and tearing the trabecular meshwork of the other 180 degrees of Schlemm's canal. Ab-Externo Approach In other variations, the methods may comprise accessing Schlemm's canal through an ab-externo approach. An ab-externo approach to delivering a fluid composition and/or performing a trabeculotomy may include additional or slightly different steps. For example, the creation of tissue flaps, suturing, etc., may be part of the ab-externo method. In general, the ab-externo method may include the following steps. First, under microscopic visualization, conjunctiva may be incised, a scleral flap may be created, and tissue may be dissected to identify the ostia into Schlemm's canal. The anterior chamber may be separately infused with saline or may have a viscoelastic composition placed in it to prevent collapse of the anterior chamber angle. The operation may be done as a standalone procedure or in combination with cataract surgery in one sitting. It may also be done before the cataract surgery portion or after it. Using a delivery system described herein, the cannula may be advanced into Schlemm's canal and a elongate member coaxially disposed within the cannula lumen may be advanced into the canal under gonioscopic visualization. Once the elongate member has been positioned within the canal, a fluid composition, e.g., a viscoelastic fluid, may be continuously or intermittently delivered through the elongate member. The fluid composition may exit the lumen of the elongate member through its distal end (e.g., the through the distal tip), or through openings or fenestrations provided along its shaft, or a combination of both. The openings or fenestrations may be spaced along the axial length of the elongate member in any suitable manner, e.g., symmetrically or asymmetrically along its length. Other substances such as drugs, air, or gas may be delivered in the same manner if desired. The elongate member may be repositioned by retraction or repeated advancement and retraction. In some variations, the delivery system may further be used to perform a trabeculotomy as described herein. The delivery system may then be removed from the eye. The configurations of the delivery systems described here may be advantageous in many different respects. In one aspect, the delivery system may be capable of being used in an ab-interno method of delivering a fluid composition into the canal. In another aspect, the delivery system may be capable of being used in an ab-interno method of performing a trabeculotomy with an elongate member. In another aspect, the delivery system cannula may be configured to allow easy and atraumatic access to Schlemm's canal. Furthermore, the delivery system may be configured in a manner that gives the surgeon greater freedom of use, all in a single instrument. For example, the handle of the system may be configured so that it can be used with either side up (i.e., by flipping over the handle or rotating the cannula). Thus, the delivery system may be designed to be used in a clockwise or counterclockwise direction with either hand and in either eye. For example, the delivery system may be capable of being used with the right or left hand to access Schlemm's canal in a counterclockwise fashion, or used with the right left hand to access the canal in a counterclockwise fashion, in either eye. Thus, access to the canal from all four quadrants of the eye can be achieved. In yet a further respect, the delivery system comprises single-handed, single-operator controlled devices configured to provide a force sufficient to disrupt Schlemm's canal and surrounding tissues to improve flow through the trabeculocanalicular outflow pathway. The systems generally combine access cannulas, delivery elongate members, elongate member advancement mechanisms, and viscoelastic fluids into a single device so that one person or one hand can advance the elongate member or deliver the fluid. Methods of Manufacturing the Cannula As mentioned above, the cannulas described here may be configured to both pierce the trabecular meshwork or other tissue, and reversibly deliver the elongate member without cutting, breaking, or otherwise damaging the elongate member. In order to accomplish this dual purpose, the cannulas may be manufactured to comprise distal ends with both sharp and dull or blunt portions. Generally, methods of manufacturing the cannulas described here may comprise creating a bevel at a distal tip of the cannula, sharpening the distal end of the distal tip to create a sharpened piercing tip, smoothing a portion of the distal tip of the cannula, and bending a portion of the cannula along a longitudinal axis of the cannula. In some variations, methods may also comprise acquiring a cannula of an appropriate working length, roughening an outer surface of the cannula, applying a protective covering to a portion of the distal tip, polishing a portion of the cannula, and cleaning the cannula. FIG.7depicts an exemplary method of manufacturing a cannula for use with the devices, systems, and methods described here. As shown there, a method of manufacturing the cannula (700) may comprise acquiring a cannula of an appropriate working length (702), roughening an outer surface of the cannula (704), creating a bevel at a distal tip of the cannula (706), sharpening the distal tip of the cannula (708), applying a protective covering to a portion of the distal tip of the cannula (710), smoothing a portion of the distal tip of the cannula (712), bending the cannula (714), polishing the cannula (716), and cleaning the cannula (1418). It should be appreciated that while the method steps inFIG.7are depicted in a particular order, many of the steps may be completed in a different order, and some of the steps may be optional all together, as is discussed in more detail below. To begin the process, a cannula of a suitable working length may be acquired (702). The cannulas may be purchased pre-cut to a desired working length, or the raw material used to create the cannulas, for example, stainless steel hypodermic tubing, may be purchased in bulk quantities and cut to the appropriate length during the cannula manufacturing process. The cannulas may be examined for damage or other visual defects upon acquisition and throughout the manufacturing process. In some variations, the working length (i.e., a length suitable for handling the cannula during manufacturing) may correspond to the final desired length of the cannula. In other variations, for ease of manufacturing for example, the working length may be longer than the desired length, and the cannula may be cut or shortened to the final desired length at any point during the manufacturing process (e.g., by cutting the proximal end of the cannula), including as the last step of the process. Exemplary working lengths include, but are not limited to, between about 50 mm and about 70 mm, between about 40 mm and about 90 mm, and more specifically, about 60 mm. The proximal end of the cannula may be cut, treated, and/or finished at any time during the manufacturing process. In some instances, the proximal end of the cannula may be square cut (i.e., cut substantially perpendicular to the longitudinal axis of the cannula). The edges of the proximal end may be smoothed or rounded using any suitable method, for example, by media blasting. This smoothing of the proximal end of the cannula may prevent cutting, tearing, or otherwise damaging the elongate member. For example, smoothing the proximal end may remove any sharp edges or jagged surfaces therefrom, and may remove any debris or deposits remaining in the proximal end of the lumen from the cutting process. The proximal end of the cannula may be inspected after smoothing, and if sharp or serrated edges remain, the proximal end may be further smoothed. In some variations, an outer surface of the cannula may optionally be roughened (704) or texturized, which may assist in adhering the cannula to the handle. For example, in some instances, a proximal or central portion of an outer surface of the cannula may be abrasively blasted to create a textured or rough surface to which adhesive may be applied. Abrasively blasting an outer surface of the cannula may increase the surface area of the abrasively blasted portions, which may provide for better adhesion between the handle and the cannula. As described above, the distal end of the cannula may be beveled. The bevel may be created (706) by cutting or grinding the distal end of the cannula at an angle relative to the longitudinal axis of the cannula. More specifically, the bevel may be installed such that it traverses and is transverse to the lumen of the cannula. As described above,FIG.3depicts a side view of a cannula (300) comprising a bevel (312) at its distal tip (306). The bevel (312) may comprise an angle (A) between about 5 degrees and about 85 degrees. As mentioned above, the angle (A) may be important to properly puncture the trabecular meshwork and access Schlemm's canal without damaging other surrounding tissue, and/or to adequately visualize advancement and retraction of the elongate member. In some variations, the angle (A) may be about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, or 85 degrees. In some variations, the angle (A) may be between about 23 degrees and about 27 degrees. In some of these variations, the angle (A) may be about 25 degrees. As described above,FIG.5depicts a perspective view of a distal tip (502) of a cannula (500) after a bevel has been created. As shown, the beveled distal tip (502) now comprises a proximal end (508) and a distal end (510). Additionally, creating the bevel at the distal tip (502) may elongate the opening (512) at the distal tip (502) creating an elliptical, rather than circular, shaped opening. Thus, beveling the distal tip (502) may yield an elliptical shaped lumen opening that is angled such that the top of the elliptical opening is closer to the proximal portion of the cannula than the bottom of the elliptical opening. Also shown inFIG.20are inner and outer circumferential edges (504,506). Although installing the bevel may create sharp edges, and in some instances, a sharp distal tip, it may be desirable to further sharpen a portion of the distal tip of the cannula to achieve easier access into Schlemm's canal with higher precision. Accordingly, in some instances, after the bevel has been created, the distal tip may be further sharpened (708) to create a sharpened piercing tip that may further assist in piercing the trabecular meshwork. The distal tip may be sharpened using any suitable means, for example, by grinding or otherwise removing a portion of the external surface and/or a portion of the outer circumferential edge of the distal end of the distal tip of the cannula. To minimize unwanted sharp edges that may damage the elongate member, it may be desirable to maintain as much of the wall thickness at the distal tip as possible, and to ensure that the thickness of the wall is uniform. It may also be beneficial to prevent cannula material or other sharpening byproducts from forming, building-up, adhering to, or otherwise being deposited on an internal surface of the cannula in the lumen. Such materials may become debris create raised or sharp surfaces or edges that may cut or damage the elongate member when the delivery system is in use. As described above,FIGS.6A and6Bdepict perspective and front views, respectively, of a variation of a distal tip (600) of a cannula comprising both a bevel (602) and a sharpened piercing tip (614). The distal tip (600) also comprises a proximal end (608), a distal end (610), inner and outer circumferential edges (604,606), and a lumen opening (612). The sharpened piercing tip (614) may be created by grinding the distal end (610) of the distal tip (600), thereby creating two angled surfaces (616) that converge to form a sharp point. The angled surfaces (616) may be formed at any suitable angle that results in a sharpened piercing tip (614). For example, in some instances, the angle surfaces (616) may have an angle (B) relative to the longitudinal axis of the distal tip (600) of about 20, 25, 30, 35, 40, 45, or 50 degrees, between about 25 and about 50 degrees, or between about 37.5 and about 42.5 degrees. Accordingly, in some variations, the angle between the two angled surfaces (616) may be between about 50 and about 100 degrees. It should be appreciated that although the distal tip (600) is depicted with two angled surfaces, a distal tip with a single angled surface may also be used. Turning back toFIG.7, the method for manufacturing the cannula (700) may further comprise smoothing a portion of the distal tip (712) of the cannula. In variations in which the distal tip of the cannula is sharpened, as described above with respect toFIGS.6A and6B, the method may further comprise applying a protective covering (710) over the sharpened portion of the distal tip, for example, the distal end of the sharpened piercing tip (614) and/or the angled surfaces (616), prior to smoothing the distal tip (712). In variations in which the distal tip is not sharpened after it is beveled, it may still be desirable to apply a protective covering over the distal end of the distal tip (as described with respect toFIG.5above). Applying a protective covering may help to maintain the sharp edge(s) during smoothing. As mentioned above, the distal tip of the cannula may be configured to both pierce tissue, and to deliver a elongate member. The elongate member itself may be susceptible to being pierced, cut, severed, or otherwise damaged by the cannula. In order to protect the elongate member, it may be important to smooth or deburr the surfaces and/or edges of the distal tip of the cannula that the elongate member may contact. For example, referring again toFIGS.6A and6B, in some variations, a portion of the inner and/or outer circumferential edges (604,606), the surface between the edges (618), and/or the internal and/or external surfaces of the cannula adjacent to the opening (612), may be smoothed. This may even out and/or dull these edges and surfaces. For example, it may be desirable to smooth a portion of the inner circumferential edge (604) at the proximal or distal end (608,610) of the distal tip (600), or to smooth the entire inner circumferential edge. In some instances, a portion of the outer circumferential edge (606) may also be smoothed while maintaining the sharp edges of the distal tip (e.g., the sharpened piercing tip). For example, a portion of the outer circumferential edge (606) may be smoothed at the proximal end (608) of the distal tip (600), or the entire outer circumferential edge (606), up to the angled surfaces (616) may be smoothed. Additionally, it may be desirable to smooth or deburr the surface between the edges (618) and/or the internal or external surface of the cannula adjacent to the opening (612) at the proximal end (608) or distal end (610) of the distal tip (600), or circumferentially around the opening (612). Portions of the distal tip (600) of the cannula may be deburred, smoothed, evened, rounded, dulled, or the like, using any suitable mechanism. For example, smoothing portions of the distal tip of the cannula may comprise mechanical and/or manual deburring, abrasive or soda media blasting, sanding, grinding, wire brushing, laser ablating, polishing (e.g., electropolishing), a combination thereof, or the like. Turning back toFIG.7, the method of manufacturing a cannula (700) may further comprise bending a distal potion of the cannula (714) to form the distal curved portion described above. Bending the catheter may properly orient the distal tip such that it may atraumatically puncture the trabecular meshwork. Referring back toFIG.3, in some variations, the distal portion of the cannula may be bent such that the sharpened piercing tip is located along the outer radius (322) of the curved cannula. In some instances, the distal portion of the cannula may be bent to an angle between about 100 and about 125 degrees, about 115 and about 125 degrees, or to about 118 degrees relative to an external surface of a proximal portion of the cannula. The distal portion of the cannula may be bent using any suitable mechanical or manual bending process. It may be important to select a bending process that does not alter the cross-sectional size and shape of the cannula during the bending process. Additionally, it should be appreciated that the cannula may be bent at any point in the manufacturing process, and bending need not occur after the distal tip of the cannula is smoothed, as depicted in the method (700) inFIG.7. The method of manufacturing a cannula (700) may optionally comprise polishing (716) all or a portion of the cannula, for example, the distal tip of the cannula. In variations in which the cannula is polished, polishing the cannula (716) may remove debris, markings, indentations, grooves, or the like, left on the surfaces of the cannula. These markings may be remnants from any part of the manufacturing process, and specifically may be from creating the bevel at the distal tip of the cannula (706), sharpening the distal tip of the cannula (708), and/or smoothing a portion of the distal tip of the cannula (712). Polishing the cannula (716) may be especially useful in variations in which smoothing a portion of the distal tip of the cannula (712) comprises a process that generally leaves debris or markings behind, for example, laser ablation. Polishing the cannula (716) may be completed using any suitable method, for example, electropolishing, staged media blasting using media with increasing grain size, or the like. If desired, the cannula may be cleaned (718) prior to its installation into the delivery systems described here. For example, in some variations, the cannula may be passivated to remove iron oxide or other contaminants. In some instances, the cannula may be passivated using an acid like, for example, nitric oxide. In other variations, the cannula may be cleaned using cleansers, ultrasonic baths, or any other suitable cleaning process. The cannula and/or the assembled delivery system may be sterilized, for example, using gamma irradiation. The gamma irradiation dose range may be, for example, between 25-40 kGy. Other irradiation energies may be used for sterilization, for example e-beam irradiation. Alternative sterilization methods include gas sterilization, for example ethylene oxide gas sterilization. In variations in which all or a portion of the systems are reusable, as described herein, these portions may be sterilized and reused. For example, in variations in which the handle is reusable and the cannula and elongate member are disposable, after use the used cannula and elongate member may be removed, the handle sterilized, and a new cannula and elongate member attached to the sterile handle. While the inventive devices, systems, kits, and methods have been described in some detail by way of illustration, such illustration is for purposes of clarity of understanding only. It will be readily apparent to those of ordinary skill in the art in light of the teachings herein that certain changes and modifications may be made thereto without departing from the spirit and scope of the appended claims. | 163,159 |
11857461 | LIST OF REFERENCE NUMERALS 1the device/system2reservoir balloon3exit port4protective sleeve5flexible ‘under-wire’ or bracing structure6endcap7port8plug/flow limiting rod9plug peak10tube11lumen of the tube12secondary tube13egress track/tube14endcap opening of the egress track/tube15lacrimal sac opening of the egress egress track/tube16guide-wire17guide-wire central open lumen18secondary guide-wire19insertion catheter20medication/fluid composition with an active ingredient DETAILED DESCRIPTION OF THE INVENTION In order to eye treat infection, inflammation of the eye, glaucoma and other ocular diseases or disorders, drugs are often required to be administered to the eye. A conventional method of drug delivery is by topical drop application to the eye's surface. Topical eye drops, though effective, can be inefficient. As one example, when an eye drop is instilled in an eye, it often overfills the conjunctival sac (i.e., the pocket between the eye and the lids) causing a substantial portion of the drop to be lost due to overflow of the lid margin and spillage onto the cheek. In addition, a large portion of the drop remaining on the ocular surface can be washed away into and through a lacrimal canaliculus, thereby diluting the concentration of the drug before it can treat the eye. Moreover, topically applied drugs often have a peak ocular effect for about two hours post-application, after which additional applications of the drugs should be, but are often not, administered to maintain the desired drug therapeutic benefit. To compound ocular management difficulty, patients often do not use their eye drops as prescribed. This poor compliance can be due to, for example, an initial stinging or burning sensation caused by the eye drop and experience by a patient. Instilling eye drops in one's own eye can be difficult, in part because of the normal reflex to protect the eye. Therefore, one or more drops may miss the eye. Older patients may have additional problems instilling drops due to arthritis, unsteadiness, and decreased vision. Pediatric and psychiatric populations pose difficulties as well. Conditions of dry eye have been treated by blocking the tear flow from the eye into and through the lacrimal canaliculus. This has involved closing the canalicular canal by stitching the punctal opening shut or by using electrical or laser cauterization to seal the punctal opening. Although such procedures can provide the desired result of blocking tear flow to treat a dry eye, they are unfortunately not reversible without reconstructive surgery. In a field different from ocular management, control of respiration-related (e.g., allergies) diseases or disorders often requires repetitive manual digestion or other intake of a medication, and as such, can be ineffective due to a lack of patient compliance or non-localized drug delivery. Therapeutic Devices There have a variety of therapeutic devices designed to address eye and lacrimal system related conditions. Primary amongst them are lacrimal punctal plugs. There are several devices, which have useful features, yet do not have the advantages of the current invention. In one reference, Sim, S. et al. “Composite Lacrimal Insert and Related Methods,” United States Patent Application 20100034870 application Ser. No. 12/432,553, filed Apr. 29, 2009 [5], discloses a removable, drug-releasing lacrimal implant owned by QLT. The plug is implanted into a lacrimal punctum of a subject. Such a punctal plug comprise to a drug core that erodes with delivery to the tear film, dependent on tear movement to dissolution of the drug core. The drug core is sedentary and the tears are required to flow in and out of the reservoir for drug distribution. The reference does not describe an extended plug connected to a reservoir located in the lacrimal sac of the current invention. In another reference, Hubbell, J. A. et al. “Photopolymerizable Biodegradable Hydrogels as Tissue Contacting Materials and Controlled-Release Carriers,” U.S. Pat. No. 5,410,016 filed Mar. 1, 1993 [6], discloses a biodegradable PEG based system also used for punctal plug delivery owned by Ocular Therapeutix. The reference does not describe an extended plug connected to a reservoir located in the lacrimal sac of the current invention. In another reference, Rodstrom, T. R. et al. “Punctal Plugs and Methods of Delivering Therapeutic Agents,” United States Patent Application 20080181930 filed Jan. 30, 2008 [7], discloses another punctal plug drug delivery system with a matrix of a silicone and an ophthalmic drug with a parylene polymer coating on a portion of the outer surface. The method of drug delivery is passive utilizing the dissolution of the drug into the tear film of the eye. The plug and an extended portion, but lacks the reservoir of the current invention. In another reference, Borgia, M. J. et al. “Punctal Plugs for the Delivery of Active Agents,” United States Patent Application 20070298075 filed Jun. 7, 2007 [8], discloses another example of punctal plugs with slow release drug delivery. The reference does not describe reservoir of the current invention. In another reference, Brubaker, M. J. et al. “Sustained Release Drug Delivery Devices,” WIPO Patent Application WO/2002/056863 Application PCT/US2001/048804, filed Jul. 25, 2002 [9], discloses another plug device for distribution of a medication. The reference does not describe an extended plug connected to a reservoir located in the lacrimal sac of the current invention. In another reference, Rapacki, A. R. et al. “Lacrimal Implants and Related Methods,” United States Patent Application US 2010-0274204 A1 filed Feb. 23, 2010 [10], discloses another lacrimal drug delivery device which is an extended version of a punctal plug, with an additional anchoring arm that extends down the lacrimal duct when inserted. The reference describes the use of “balloons” as structural elements to position the device, not as drug containing reservoirs. The reference does not describe a reservoir located in the lacrimal sac of the current invention. In another reference, Cohan, B. E. “Opthalmic Insert and Method for Sustained Release of Medication to the Eye,” European Patent EP1891942B1 Application EP1178779A1, filed Apr. 7, 2000 [11], discloses an apparatus for intubation of lacrimal duct (lacrimal drainage pathway) for treatment of lacrimal duct obstruction. Additionally, the internal portion of the device may act as a reservoir of medication that may be released through a pore on the device in a controlled manner based upon a specific geometry of the device. This controlled rate is still based upon tear dissolution of the medication and penetration of the reservoir by the tear film. The reference does not describe a balloon reservoir or a reservoir located in the lacrimal sac of the current invention. In another reference, Murube, J. et al. (2003) Subcutaneous Abdominal Artificial Tears Pump-Reservoir for Severe Dry Eyes,Orbit22(1), 29 [12], discloses a study of an implanted pump-reservoir unit placed under the subcutaneous tissue of the abdomen for providing artificial tears to the ocular surface in patients with severe dry eye. While this system does provide for a reservoir, the system uses an electrical pump and the reservoir's location is far from the lacrimal sac. The reference does not describe a balloon reservoir or a reservoir located in the lacrimal sac of the current invention. Another reference, U.S. patent application Ser. No. 11/641,903 by Freilich [13] has many limitations that make it unusable including, but not limited to: 1. The faceplate is the site of control for resistance of outflow. This would not work in practical terms. In order to be flow limiting, one would need a larger (longer) barrier to flow as in the current device as noted above. The prior art is very vague regarding what is driving the flow. In a system where there is active pressure pushing the fluid out, the resistance is dependent on the pressure drop in the system. The lower the pressure drop then the lower the resistance needed etc. Practically speaking both long “low” resistance plugs and short “high” resistance plugs could work. Both approaches have benefits. Firstly, the long low resistances plug may not be dependent on the driving pressure of the balloon. This could be good if the rate of flow through the plug has another driver out of the balloon (capillary etc). Second, a short high resistance plug is potentially driven with simple pressure drop over a resistance. Length of resistance is an important factor in flow resistance but equally important is the pressure drop (if pressure driven flow) and the diffusion rate (pressure independent flow). Freilich [13] does not differentiate between these two types of pressure. The current invention contemplates both a long lower resistance plug and a small high resistance plug as alternatives, or in one embodiment in combination. 2. The Freilich device includes an expandable reservoir connected to a tube and then connected to the flow limiting plate. The tube as described in the Freilich application will not allow for reliable implantation and reliable flow. This is a critical difference from the current invention. The current invention device comprises more than simply a tube connecting the reservoir to the faceplate. In one embodiment, the present invention device will require the plug (in one embodiment silicone hydrogel) to extend from the reservoir all the way (or most of the way) to the endcap, which may be a faceplate. Therefore, the current invention will not simply have a tube connecting the reservoir to the endcap . . . it will be a flow limiting plug or rod. This will also allow the hydrogel to act as a wick from the balloon to the tear surface and will also prevent any kinking post implantation. It should also be noted that the Freilich application [13] states “As a result of the structure of device300, there is provided an open channel or passageway that extends from the opening202of collarette200, through the entire length of the stent310” This is the focus of the Freilich device. The current invention bypasses this limitation as noted above. 3. Freilich teaches a collertte that resides against the punctum and the eye. The current invention device will have a hydrogel plug that resides substantially behind the border of the endcap (domes out) so that it is in contact directly with the ocular surface and allows exchange of drug directly to the tear film. As such, the mechanism of delivery of the current invention consists of both a movement of the drug from the balloon to the endcap, but also an osmolar drive of drug from the hydrogel to the tears. There is significant discussion in Freilich [13] about holes and openings that allow for medication communication with the eye while using holes will not work consistently. The current invention bypasses that with the above description. 4. The Freilich patent discusses and expandable reservoir [13]. It does not teach a balloon like mechanism like (U.S. Pat. No. 6,196,993 to Cohan et al [14]). The current invention teaches a balloon like reservoir that acts as a low-pressure force (Freilich discloses a pump like mechanism “expandable pouch is filled with medication and the medication is thereafter permitted to flow naturally (e.g., through capillary action), through digital pressure applied by the patient to the nasal lacrimal sac, and or with assistance of a miniature pump.” Further, the Freilich patent does not describe pressure driven flow from the balloon, but specifies a “pumping mechanism.” The current invention balloon reservoir is elastic so that the driving force of fluid is minimal. 5. The method that Freilich [13] employs filling the device does not appear to have practical application as using a syringe with soft tip to reach in and then go half way out before filling will lead to bubbles forming in the balloon. The current invention contemplates a method of filling from the bottom up is key. Bubbles can be excluded. Having bubbles in this system will cause poor reliability and even failure of flow. DETAILED DESCRIPTION OF AN EXEMPLARY EMBODIMENT The current invention involves an implanted medical device designed as a lacrimal system for drug delivery. In one embodiment, the invention comprises a “plunger” type device with a silicone hydrogel plug8. The device1may include a reservoir balloon2coupled to a tube10that extends through the lacrimal duct to the punctum. The tube10may include an endcap6or faceplate that abuts against the punctum and prevents the tube10from retracting into the lacrimal duct. A guide-wire16may be provided for insertion of the device1. In one embodiment, the device1is advanced into the lacrimal system using an insertion catheter19. Once the device1is inserted, the reservoir balloon2may be filled with a fluid20and retraction of a silicone hydrogel8or similar material from the device1to plug up the lumen11of the tube10that leads to an endcap6and thus control egress of fluid20to the tear film. In one embodiment, the device1enables a method for filling the reservoir balloon2from the bottom up and then leaving the plug8behind. The plug8may reside significantly within the tube10of the device rather than entirely within the endcap6. The length of the plug8may be used to control delivery since anything at just the endcap6would be open to trauma and will leave little room for complexity. In one embodiment, the plug8spans the distance from just beyond the endcap6to the reservoir balloon2. In one embodiment, the plug8may occupy anywhere between 1/32 to the full distance between the endcap6and the reservoir balloon2. In one embodiment, the tube10comprises medical grade silicone. In one embodiment, the device1does not have a tube10, but rather only comprises a plug8spanning the distance between the endcap6to the reservoir balloon2. In one embodiment, the length of the plug8may vary. In one embodiment, the plug8length may vary from an endcap6, such as a faceplate, all the way to the reservoir balloon2and anywhere in between. In some embodiments, the plug8is generally flush with the endcap6. In some embodiments, the plug8extends distally past the endcap6from approximately 1-200 microns to comprise a plug peak9. The endcap6may be integrally connected to the tube10. In other embodiments, the endcap6is coupled to the tube10by an adhesive or one or more fasteners. In some embodiments, the endcap6may have a diameter of 1-2.5 mm. It may be oval with the long dimension at 2 mm and the short dimension at 1 mm. It may be circular or oval or square. The height of the endcap6may range from 20 microns to 300 microns. In some embodiments, the endcap6may taper at the end from 300 μm at the apex to 10 microns at the edges. The flow-limiting plug8may protrude past the apex of the endcap6by 1 μm to 50 μm to comprise a plug peak9. In some embodiments, the protruding portion of the plug may be displaced from the apex of the endcap6towards one of the edges of the endcap6to enhance contact with the tear film. In one embodiment, the plug8is a silicone hydrogel plug. In one embodiment, the plug8is a non-silicone hydrogel plug. In one embodiment, the plug material may be selected from the group comprising nano-spheres, microspheres, filter membranes, porous membranes, porous materials such as foams and solid materials such as polymers with textured outer surfaces that will allow fluid to flow around etc. In one embodiment, the plug8comprises materials with grooves. In one embodiment, said grooves are flow limiting tortuous paths for flow. In one embodiment, plug8provides an occluding mechanism. In one embodiment, the plug8may be colorless or may be blue, red, or yellow. In one embodiment, the plug8contains fluorophores to provide for a distinction from surrounding materials and tissues. In one embodiment, the silicone hydrogel plug8may also contain materials that allow it to fluoresce after exposure to a specific wavelength of light. In one embodiment, the plug8spans the distance from just beyond the endcap6to the reservoir balloon2. In one embodiment, the plug8may occupy anywhere between 1/32 to the full distance between the endcap6and the reservoir balloon2. In one embodiment, the tube10comprises medical grade silicone. In one embodiment, the device1does not have a tube10, but rather only comprises a plug8spanning the distance between the endcap6to the reservoir balloon2. In one embodiment, the plug8comprises a flow limiting rod. Device Implantation To be effectively placed in the lacrimal system and properly deliver therapeutic agents to the tear film of the eye, the device may be deliverable by tracking through the tortuous and narrow anatomy. To do this, the dimensions have to be very small and in an uninflated state (e.g., <1 mm in diameter). In one embodiment, the invention further comprises a delivery system that includes a guide-wire16combined with an inflation device. In one embodiment, the invention further comprises an insertion catheter19. In one embodiment, said guide-wire16comprises a central open lumen17. In one embodiment, said central open lumen17is flexible. In one embodiment, said central open lumen17allows injection of fluid distal directly into the balloon reservoir2. In another embodiment, the delivery system is enhanced by internal characteristics of the device. In one embodiment, the device comprises a secondary guide-wire18that extends the external length of said device. In one embodiment, the device further comprises a stiff but flexible ‘under-wire’ that gives the reservoir balloon2bracing structure5. In one embodiment, no secondary guide-wire18is needed to travel the length since there is a stiff but flexible ‘under-wire’ that gives the device some push-ability. In this embodiment, the inflation device connects proximal to the endcap. The device may be inserted using an insertion catheter as shown inFIG.10-FIG.15.FIG.10shows the device1advanced into the punctum.FIG.11shows the device1advanced into the lacrimal sac through the lower lacrimal duct.FIG.12shows the device1reservoir balloon2inflated in the lacrimal sac. The device1reservoir balloon2is inflated through the lumen of either the guide-wire16or the device lumen11.FIG.13shows the flow-limiting plug8retracted from the distal end of the device1.FIG.14shows the insertion catheter19and guide-wire16fully retracted leaving the flow-limiting plug8in place.FIG.15shows a version of the device wherein the insertion catheter19and guide-wire16fully retracted leaving the flow-limiting plug8in place, wherein the plug8occupies the entire length between the endcap6and the reservoir balloon2. The lacrimal drug delivery system of the current invention may be inflatable while in situ and be able to contain the proper amount of drug. To do this and maintain the initial low profile size the balloon reservoir may expand from its uninflated state to fill with enough drug to provide the continual delivery that is contained. In one embodiment, expansion of said balloon reservoir is at least 500%. In one embodiment, such the volume of said inflated balloon reservoir is at least 100 micro liters. In one embodiment, said balloon reservoir comprises silicone. Silicone is especially good for this application since it has high elongation inflation with very low pressures. Initial testing showed peak inflation pressures less that 6 psi (see e.g.,FIG.9). It is an important consideration, when compared to the slow flow rates that is needed, providing balloon pressure comprises the driving force. The lower the driving pressure, the easier it may be to create the resistance provided by the plug needed to reach that flow rate. In one embodiment, the invention relates to a method of treatment, comprising: a) providing: i) a subject comprising a punctum, lacrimal ducts, and a lacrimal sac, ii) a lacrimal system drug delivery device, comprising: A) a reservoir balloon having an exit port, wherein said reservoir balloon is capable of insertion inside said lacrimal sac, B) a tube comprising at least one lumen fluidly coupled to said exit port, wherein said tube extends from said elastic reservoir through at least one of the lacrimal ducts, C) an endcap comprising a port fluidly coupled to the terminal end of said tube wherein said endcap interfaces with said punctum in contact with the tear film of the eye, and D) a plug, wherein the plug resides within the lumen of said tube of the device, and b) inserting said drug delivery device into said lacrimal system; c) filling said reservoir balloon with composition with at least one active ingredient; and d) administering said composition to said subject using said lacrimal system drug delivery device. In one embodiment, said device further comprises a guide-wire attached to said plug. In one embodiment, said composition with at least one active ingredient further comprises a therapeutic agent. In one embodiment, filling comprises introduction of said composition with at least one active ingredient through said tube. In one embodiment, step c) further comprises removal of said guide-wire attached to said plug, wherein said plug obtains a final position within the lumen of said device up until the endcap of said device. In one embodiment, said device further comprises at least one egress track connecting said endcap to outside of said reservoir balloon. In one embodiment, said egress track is designed to allow tears to flow from the ocular surface into the lacrimal sac and beyond. In one embodiment, said plug regulates the flow of said composition from said device. In one embodiment, said plug positioning within said lumen regulates the flow of said composition from said device. In one embodiment, the plug spans the distance from just beyond the endcap to the reservoir balloon. In one embodiment, the plug may occupy anywhere between 1/32 to the full distance between the endcap and the reservoir balloon. In one embodiment, the tube comprises medical grade silicone. In one embodiment, the device does not have a tube, but rather only comprises a plug spanning the distance between the endcap to the reservoir balloon. In one embodiment, the plug comprises a flow-limiting rod. In one embodiment, said guide-wire comprises a central open lumen. In one embodiment, said guide-wire is occupies a lumen of said device for delivery of said device into position. In one embodiment, said central open lumen is flexible. In one embodiment, said central open lumen allows injection of fluid distal directly into the balloon reservoir. In another embodiment, the delivery system is enhanced by internal characteristics of the device. In one embodiment, the device comprises a secondary guide-wire18extends the external length of said device. In one embodiment, the device further comprises a stiff but flexible ‘under-wire’ that gives the reservoir balloon bracing structure. In one embodiment, the inflation device connects proximal to the endcap. In one embodiment, the reservoir balloon is substantially elastic. In one embodiment, the reservoir balloon is semi-elastic. In one embodiment, the reservoir balloon is substantially nonelastic. In some embodiments, the device comprises a protective sleeve be placed over said reservoir balloon. In one embodiment, said sleeve protects against leaks entering the nasal duct or other tissue compartments. In one embodiment, said device contains fluorescent material or coloring to allow for detection and position confirmation by the user (physician or patient). In one embodiment, the method further comprises filling said reservoir balloon with a therapeutic agent or medication. In one embodiment, said reservoir balloon is implanted within the sinuses surrounding the eye. In one embodiment, the punctal portion or endcap allows for filling the reservoir balloon with medication, but the reservoir balloon sits in a sinus and allows for delivery of drug through the plug to the tear film of the eye. In one embodiment, expansion of said balloon reservoir is at least 500%. In one embodiment, expansion of said balloon reservoir is at least 700%. In one embodiment, such the volume of said inflated balloon reservoir is at least 100 micro liters. There are not many types of balloons that could do this. In one embodiment, said balloon reservoir comprises silicone. In one embodiment, said reservoir balloon enables anatomical fixation. In one embodiment, fixation is achieved by the balloon inflating beyond the diameter of the proximal common canaliculus thus preventing it from extruding back into the proximal lacrimal outflow system. In one embodiment, said anatomical fixation is a device retention feature. In one embodiment, said plug regulates the flow of said composition from said device. In one embodiment, said plug positioning within said lumen regulates the flow of said composition from said device. In one embodiment, said active ingredient consists of artificial tears, glaucoma drops, anti-inflammatory agents, nonsteroidal agents, antibiotics, biologics, proteins, aptamers, nucleic acids, cytokines, plasma, sympahtomemetics, parasympathomemetics, prostaglandin analogues, beta blockers, alpha-agonists, and anti-VEGF agents. In one embodiment, the flow of said fluid out of said device is controlled by adjustment of said plug by an operator (patient or physician) to decrease flow at given times of the day when treatment might not be needed (while sleeping for example). In one embodiment, the reservoir balloon will deliver fluid+/−active ingredients to the ocular surface at a fixed rate between 0.1 micro liters and 30.0 micro liters per day for a minimum of one week. In another embodiment, the delivery is achieved for a minimum of 60 days. In one embodiment, the tube has multiple lumens such that the hydrogel, guide-wire or inflation lumens are all each separate lumens. In the preferred embodiment, all three (the hydrogel plug, the guide wire, and the reservoir balloon inflation lumen) utilize the same lumen. In one embodiment, the hydrogel/plug material is delivered through the inflation lumen. In one embodiment, the plug is tethered to the bottom (distal part) of the reservoir balloon so that expansion of the balloon is limited in the long access and drives expansion of the balloon to the sides instead. Once the device is delivered and filled, the balloon reservoir delivers the fluid containing the therapeutic agent at a slow rate. There are several viable ways to affect therapeutic agent delivery. First, for pressure driven flow, the lower the pressure drop the lower the resistance needs to be to create the right flow rate. A second method, ignores the pressure completely. The methods to drive flow in these cases includes a wicking or transport phenomena that occurs in fluid filled hydrogels or some types of membrane filters. The benefits to these approaches are that the pressure in the balloon is no longer a variable in the flow rate, which leads to constant drug delivery if the pressure changes during deflation. In one embodiment, the plug provides a fluid hydrogel to facilitate the delivery of the therapeutic agent from the reservoir balloon through the lumen to the endcap of the device and beyond to the tear film of the eye. Referring toFIG.2andFIG.8, in one embodiment, the reservoir balloon2is implanted within the sinuses surrounding the eye. In one embodiment, the punctal endcap6or distal endcap6allows for filling the reservoir balloon2with medication wherein the plug8is removed. In one embodiment, the reservoir balloon2sits in a sinus and allows for delivery of drug through the connected tube10through said plug8from said reservoir balloon2. In one embodiment, the punctal portion is implanted through the caruncle or through the conjunctiva (similar to implantation of a jones tube) and allow for the reservoir balloon2through the plug8to deliver drug directly to the tear film of the eye. The device with associated reservoir balloon2can be implanted so that the distal endcap6has the plug8with the plug peak9extended from the port7of the endcap6is proximate to the tear film abutting the upper or lower punctum and the opposite end is composed of a reservoir balloon2(positioned in the lacrimal sac) that can be filled with an active ingredient, such as a drug or other therapeutic solution. Once filled, the active ingredient will be “wicked” from the reservoir balloon2from the exit port3through the connected tube10with lumen11and through the plug8to the distal opening port7in the endcap6, which is proximate to the tear film. In one embodiment, said plug8comprises a flow-limiting rod. The drug may then enter the tear film and be absorbed by eye tissues to treat various ocular diseases. The device may or may not also connect to the nasal cavity through the termination of the tear duct system. The device may contain one or more egress tracks13connecting the endcap6to the lacrimal sac to allow for tear drainage away from the eye towards the natural lacrimal outflow system. In one embodiment, the endcap contains at least one additional port that connects at least one egress track13towards the reservoir balloon end of the device. In one embodiment, said egress track13terminates externally from said reservoir balloon2to enable drainage from the tear film of the eye to the lacrimal sac and beyond. The egress of drug20from the reservoir balloon2of the device may be entirely dependent on the nature of and positioning of the plug8. In one embodiment, no active pumps are needed. In some embodiments, drugs20are delivered long term to the ocular surface in a regular and consistent manner. Other devices that deliver drug to the tear film using a punctal plug or lacrimal plug do so by a drug core that degrades after contact with the tear film. While not limiting the current invention, one method of insertion of the device1would be to introduce the collapsed device on the punctal side in an insertion method similar to the introduction of a Crawford tube. In one embodiment, the collapsed device is introduced into the lacrimal system with an insertion catheter19. The collapsed reservoir balloon2of the device is envisioned to fit through the punctum and canaliculus wherein the reservoir balloon2of the device would reside in the lacrimal sac allowing for expansion when filled with a therapeutic agent. In one embodiment, a lubricant is coupled with the system to allow for smoother atraumatic insertion. In one embodiment, the device further comprises a guide-wire16to enable delivery of said device into the lacrimal system. In the embodiment, the device contains a further tube10from the reservoir2allowing access to the reservoir2from the nasolacrimal duct for flushing and refilling. In one embodiment, a further tube could be accessed through various means including, but not limited to a small clip upon the tube, a groove in groove lock system, a kiss lock/coin purse system of closure, or complete closure or crimping of the end of the tube. While not limiting the device, it is envisioned that the device would conform the standard anatomical size variations. In one embodiment, the device could be used for subjects of various sizes and age ranges. In one embodiment, the device may not be appropriate in certain subjects, including, but not limited to subjects with trauma to the nasolacrimal system, subjects with chronic nasal inflammation, or dacryocystitis. Dacryocystitis is an inflammation of the nasolacrimal sac, frequently caused by nasolacrimal duct obstruction or infection. In one embodiment, the device functions and serves for at least two months or greater than sixty days. In the particular cases of treating dye eye or glaucoma, the device therapy would last at least two months. In the case of post-surgical treatment of conditions, such as cataracts, would involve treatment ranging of two to six week, possibly longer. As discussed above, the present invention provides compositions, methods and devices relating to a lacrimal, eye, sinuses and/or periocular tissues system implant devices, which greatly increase their ability to deliver therapeutic agents consistently with a simple straightforward design and in larger quantities than is currently available. In one aspect, the present invention provides for the combination of various therapeutic agents and lacrimal, eye, sinuses and/or periocular tissues system implant for use in medical intervention, continuing medical therapy, and/or cosmetic or reconstructive surgery. In one aspect, the present invention is a lacrimal, eye, sinuses and/or periocular tissues system therapeutic agent delivery device for use in medical intervention, continuing medical therapy, and/or cosmetic or reconstructive surgery. In some examples, an antimicrobial coating can be disposed on, or impregnated in, at least a portion of the outer surface of the implant body to further prevent microbial growth on the implant body. In an example, the antimicrobial coating can include an agent selected from the group comprising 2-bromo-2-nitropropane-1,3-diol, 5-bromo-5-nitro-1,3-dioxane, 7-ethyl bicyclooxazolidine, benzalkonium chloride, benzethonium chloride, benzoic acid, benzyl alcohol, boric acid, bronopol, cetylpyridinium chloride, chlorhexidine digluconate, chloroacetamide, chlorobutanol, chloromethyl isothiazolinone and methyl isothiazoline, dimethoxane, dimethyl oxazolidine, dimethyl hydroxymethyl pyrazole, chloroxylenol, dehydroacetic acid, diazolidinyl urea, dichlorobenzyl alcohol, DMDM hydantoin, ethyl alcohol, formaldehyde, glutaraldehyde, hexachlorophene, hexetidine, hexamethylenetramine, imidazolidinyl urea, iodopropynyl butylcarbamate, isothiazolinones, methenammonium chloride, methyldibromo glutaronitrile, MDM hydantoin, minocycline, ortho phenylphenol, p-chloro-m-cresol, parabens (butylparaben, ethylparaben, methylparaben), phenethyl alcohol, phenoxyethanol, piroctane olamine, polyaminopropyl biguanide, polymethoxy bicyclic oxazolidine, polyoxymethylene, polyquaternium-42, potassium benzoate, potassium sorbate, propionic acid, quaternium-15, rifampin, salicylic acid, selenium disulfide, sodium borate, sodium iodate, sodium hydroxymethylglycinate, sodium propionate, sodium pyrithione, sorbic acid, thimerosal, triclosan, triclocarban, undecylenic acid, zinc phenosulfonate, and zinc pyrithione. In an example, the antimicrobial coating can include a material selected from the group comprising silver lactate, silver phosphate, silver citrate, silver acetate, silver benzoate, silver chloride, silver iodide, silver iodate, silver nitrate, silver sulfadiazine, silver palmitate or one or more mixtures thereof. In an example, the antimicrobial coating can include at least one of an antibiotic or an antiseptic. For instance, the antimicrobial coating can include a temporary anesthetic lasting, on average, between a few hours and a day. In still other examples, the antimicrobial coating can include a drug use to treat an underlying disease, such as a bolus for immediate effect. A therapeutic agent (or simply “agent”) can comprise, among other things, a drug made from one or any combination of the following or their equivalents, derivatives or analogs, including, anti-glaucoma medications, (e.g. adrenergic agonists, adrenergic antagonists (beta blockers), carbonic anhydrase inhibitors (CAIs, systemic and topical), parasympathomimetics, prostaglandins and hypotensive lipids, and combinations thereof), antimicrobial agent (e.g., antibiotic, antiviral, antiparacytic, antifungal, etc.), a corticosteroid or other anti-inflammatory (e.g., an NSAID or other analgesic and pain management compounds), a decongestant (e.g., vasoconstrictor), an agent that prevents of modifies an allergic response (e.g., an antihistamine, cytokine inhibitor, leucotriene inhibitor, IgE inhibitor, immunomodulator), a mast cell stabilizer, cycloplegic, mydriatic or the like. Example available agents include, but are not limited to, thrombin inhibitors; antithrombogenic agents; thrombolytic agents; fibrinolytic agents; vasospasm inhibitors; vasodilators; antihypertensive agents; antimicrobial agents, such as antibiotics (such as tetracycline, chlortetracycline, bacitracin, neomycin, polymyxin, gramicidin, cephalexin, oxytetracycline, chloramphenicol, rifampicin, ciprofloxacin, tobramycin, gentamycin, erythromycin, penicillin, sulfonamides, sulfadiazine, sulfacetamide, sulfamethizole, sulfisoxazole, nitrofurazone, sodium propionate), antifungals (such as amphotericin B and miconazole), and antivirals (such as idoxuridine trifluorothymidine, acyclovir, gancyclovir, interferon); inhibitors of surface glycoprotein receptors; antiplatelet agents; antimitotics; microtubule inhibitors; anti-secretory agents; active inhibitors; remodeling inhibitors; antisense nucleotides; anti-metabolites; antiproliferatives (including antiangiogenesis agents); anticancer chemotherapeutic agents; anti-inflammatories (such as hydrocortisone, hydrocortisone acetate, dexamethasone 21-phosphate, fluocinolone, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, betamethasone, triamcinolone, triamcinolone acetonide); non steroidal anti-inflammatories (NSAIDs) (such as salicylate, indomethacin, ibuprofen, diclofenac, flurbiprofen, piroxicam indomethacin, ibuprofen, naxopren, piroxicam and nabumetone). Examples of such anti-inflammatory steroids contemplated for use with the present lacrimal implants, include triamcinolone acetonide (generic name) and corticosteroids that include, for example, triamcinolone, dexamethasone, fluocinolone, cortisone, prednisolone, flumetholone, and derivatives thereof); antiallergenics (such as sodium chromoglycate, antazoline, methapyriline, chlorpheniramine, cetrizine, pyrilamine, prophenpyridamine); anti proliferative agents (such as 1,3-cis retinoic acid, 5-fluorouracil, taxol, rapamycin, mitomycin C and cisplatin); decongestants (such as phenylephrine, naphazoline, tetrahydrazoline); miotics and anti-cholinesterase (such as pilocarpine, salicylate, carbachol, acetylcholine chloride, physostigmine, eserine, diisopropyl fluorophosphate, phospholine iodine, demecarium bromide); antineoplastics (such as carmustine, cisplatin, fluorouracil; immunological drugs (such as vaccines and immune stimulants); hormonal agents (such as estrogens, estradiol, progestational, progesterone, insulin, calcitonin, parathyroid hormone, peptide and vasopressin hypothalamus releasing factor); immunosuppressive agents, growth hormone antagonists, growth factors (such as epidermal growth factor, fibroblast growth factor, platelet derived growth factor, transforming growth factor beta, somatotrapin, fibronectin); inhibitors of angiogenesis (such as angiostatin, anecortave acetate, thrombospondin, anti-VEGF antibody); dopamine agonists; radiotherapeutic agents; peptides; proteins; enzymes; extracellular matrix; components; ACE inhibitors; free radical scavengers; chelators; antioxidants; anti polymerases; photodynamic therapy agents; gene therapy agents; and other therapeutic agents such as prostaglandins, antiprostaglandins, prostaglandin precursors, including antiglaucoma drugs including beta-blockers such as Timolol, betaxolol, levobunolol, atenolol, and prostaglandin analogues such as bimatoprost, travoprost, latanoprost etc; carbonic anhydrase inhibitors such as acetazolamide, dorzolamide, brinzolamide, methazolamide, dichlorphenamide, diamox; and neuroprotectants such as lubezole, nimodipine and related compounds; and parasympathomimetrics such as pilocarpine, carbachol, physostigmine and the like. Additional agents that can be used with the present lacrimal implants include, but are not limited to, drugs that have been approved under Section 505 of the United States Federal Food, Drug, and Cosmetic Act or under the Public Health Service Act. The present lacrimal implants can also be used with drugs listed in the FDA Orange Book that has or records the same date as, earlier date than, or later date than, the filing date of this patent document. For example, these drugs can include but are not limited to, among others, dorzolamide, olopatadine, travoprost, bimatoprost, cyclosporin, brimonidine, moxifloxacin, tobramycin, brinzolamide, aciclovir timolol maleate, ketorolac tromethamine, prednisolone acetate, sodium hyaluronate, nepafenac, bromfenac, diclofenac, flurbiprofen, suprofenac, binoxan, patanol, dexamethasone/tobramycin combination, moxifloxacin, or acyclovir. Examples of diseases or disorders that can be treated with above-listed agents include, but are not limited to, glaucoma, pre- and post-surgical ocular treatments, dry eye, anti-eye allergy, anti-infective, post-surgical inflammation or pain, or respiration-related disorders, such as allergies In some examples, the therapeutic agent can include a lubricant or a surfactant, for example a lubricant to treat dry eye. In other examples, the therapeutic agent can include an absorbent capable of absorbing tear from an eye. Although the form of the therapeutic agent is envisioned to be a fluid20with a flow-limited release through an exit port3connected to the reservoir2, is also possible that the drug supply can comprise one or more biocompatible materials capable of providing a sustained release of the one or more agents. For example, a biodegradable matrix, a porous drug supply, or liquid drugs supply. A matrix that includes the agents can be formed from either biodegradable or non-biodegradable polymers. In some examples, a non-biodegradable drug supply can include, but are not limited to, silicone, acrylates, polyethylenes, polyurethane, polyurethane, hydrogel, polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, polymer foam, silicone rubber, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonate urethane, polyurethane, polyimides, stainless steel, nickel-titanium alloy (e.g., Nitinol), titanium, stainless steel, cobalt-chrome alloy (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.). In some examples, a biodegradable drug supply can comprise one or more biodegradable polymers, such as protein, hydrogel, polyglycolic acid (PGA), polylactic acid (PLA), poly(L-lactic acid) (PLLA), poly(L-glycolic acid) (PLGA), polyglycolide, poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, polyorthoesters, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(alpha-hydroxy acid) and combinations thereof. In some examples, the drug supply can comprise a hydrogel polymer. Any drug supply matrix must be capable of compression-controlled release through the previously described port. Thus, specific compositions and methods of lacrimal system for drug delivery have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently continued. REFERENCES 1. Fleisher, D. et al. (1996) “Improved Oral Drug Delivery: Solubility Limitations Overcome by the Use of Prodrugs,”Adv. Drug Delivery Rev.19(2), 115-130.2. Smith, C. D. et al. (1994) “A Sensitive Assay for Taxol and Other Microtubule-Stabilizing Agents,”Cancer Lett.79(2), 213-219.3. Mooberry, S. L. et al. (1995) “Tubercidin Stabilizes Microtubules against Vinblastine-Induced Depolymerization, a Taxol-Like Effect,”Cancer Lett.96(2), 261-266.4. Ro, A. J. et al. (2012) “Morphological and Degradation Studies of Sirolimus-Containing Poly(Lactide-Co-Glycolide) Discs,”Journal of Biomedical Materials Research Part B: Applied Biomaterials100B(3), 767-777.5. Sim, S. et al. “Composite Lacrimal Insert and Related Methods,” United States Patent Application Publication Number US 2010-0034870 A1, application Ser. No. 12/432,553, filed Apr. 29, 2009. (published Feb. 11, 2010).6. Hubbell, J. A. et al. “Photopolymerizable Biodegradable Hydrogels as Tissue Contacting Materials and Controlled-Release Carriers,” U.S. Pat. No. 5,410,016, application Ser. No. 08/022,687, filed Mar. 1, 1993. (issued Apr. 25, 1995).7. Rodstrom, T. R. et al. “Punctal Plugs and Methods of Delivering Therapeutic Agents,” United States Patent Application Publication Number US 2008-0181930 A1, application Ser. No. 12/022,520, filed Jan. 30, 2008. (published Jul. 31, 2008).8. Borgia, M. J. et al. “Punctal Plugs for the Delivery of Active Agents,” United States Patent Application Publication Number US 2007-0298075 A1, application Ser. No. 11/759,327, filed Jun. 7, 2007. (published Dec. 27, 2007).9. Brubaker, M. J. et al. “Sustained Release Drug Delivery Devices,” WIPO PCT Patent Publication Number WO/2002/056863, Application PCT/US2001/048804, filed Jul. 25, 2002. (published Dec. 17, 2001).10. Rapacki, A. R. et al. “Lacrimal Implants and Related Methods,” United States Patent Application Publication Number US 2010-0274204 A1, application Ser. No. 12/710,855, filed Feb. 23, 2010. (published Oct. 28, 2010).11. Cohan, B. E. “Opthalmic Insert and Method for Sustained Release of Medication to the Eye,” European Patent EP1891942B1, Application EP1178779A1, filed Apr. 7, 2000. (issued Mar. 3, 2010).12. Murube, J. et al. (2003) “Subcutaneous Abdominal Artificial Tears Pump-Reservoir for Severe Dry Eyes,”Orbit22(1), 29.13. Freilich, D. “Ophthalmic Insert,” United States Patent Application Publication Number US 2008-0086101 A1, application Ser. No. 11/641,903, filed Dec. 20, 2006. (published Apr. 10, 2008).14. Cohan, B. E. and Diamond, H. “Ophthalmic Insert and Method for Sustained Release of Medication to the Eye,” U.S. Pat. No. 6,196,993, application Ser. No. 09/294,720, filed Apr. 19, 1999. (issued Mar. 6, 2001). | 47,237 |
11857462 | DETAILED DESCRIPTION In the following description, various embodiments of the present invention will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the embodiments. It will also, however, be apparent to one skilled in the art that the present invention can be practiced without the specific details. Furthermore, well-known features may be omitted or simplified in order not to obscure the embodiment being described. Systems for imaging and/or treating an eye of a patient are provided. In many embodiments, a free-floating mechanism provides a variable optical path by which a portion of an electromagnetic beam reflected from a focal point disposed within the eye is directed to a path length insensitive imaging assembly, such as a confocal detection assembly. In many embodiments, the free-floating mechanism is configured to accommodate movement of the patient while maintaining alignment between an electromagnetic radiation beam and the patient. The electromagnetic radiation beam can be configured for imaging the eye, can be configured for treating the eye, and can be configured for imaging and treating the eye. Referring now to the drawings in which like numbers reference similar elements,FIG.1schematically illustrates a laser surgery system10, in accordance with many embodiments. The laser surgery system10includes a laser assembly12, a confocal detection assembly14, a free-floating mechanism16, a scanning assembly18, an objective lens assembly20, and a patient interface device22. The patient interface device22is configured to interface with a patient24. The patient interface device22is supported by the objective lens assembly20. The objective lens assembly20is supported by the scanning assembly18. The scanning assembly18is supported by the free-floating mechanism16. The free-floating mechanism16has a portion having a fixed position and orientation relative to the laser assembly12and the confocal detection assembly14. In many embodiments, the patient interface device22is configured to interface with an eye of the patient24. For example, the patient interface device22can be configured to be vacuum coupled to an eye of the patient24such as described in co-pending U.S. Provisional Patent Application Ser. No. 61/721,693, entitled “Liquid Optical Interface for Laser Eye Surgery System”, filed Nov. 2, 2012. The laser surgery system10can further optionally include a base assembly26that can be fixed in place or repositionable. For example, the base assembly26can be supported by a support linkage that is configured to allow selective repositioning of the base assembly26relative to a patient and secure the base assembly26in a selected fixed position relative to the patient. Such a support linkage can be supported in any suitable manner such as, for example, by a fixed support base or by a movable cart that can be repositioned to a suitable location adjacent to a patient. In many embodiments, the support linkage includes setup joints with each setup joint being configured to permit selective articulation of the setup joint and can be selectively locked to prevent inadvertent articulation of the setup joint, thereby securing the base assembly26in a selected fixed position relative to the patient when the setup joints are locked. In many embodiments, the laser assembly12is configured to emit an electromagnetic radiation beam28. The beam28can include a series of laser pulses of any suitable energy level, duration, and repetition rate. In many embodiments, the laser assembly12incorporates femtosecond (FS) laser technology. By using femtosecond laser technology, a short duration (e.g., approximately 10−13seconds in duration) laser pulse (with energy level in the micro joule range) can be delivered to a tightly focused point to disrupt tissue, thereby substantially lowering the energy level required to image and/or modify an intraocular target as compared to laser pulses having longer durations. The laser assembly12can produce laser pulses having a wavelength suitable to treat and/or image tissue. For example, the laser assembly12can be configured to emit an electromagnetic radiation beam28such as emitted by any of the laser surgery systems described in copending U.S. Provisional Patent Application Ser. No. 61/722,048, entitled “Laser Eye Surgery System”, filed Nov. 2, 2012; and U.S. patent application Ser. No. 12/987,069, entitled “Method and System For Modifying Eye Tissue and Intraocular Lenses”, filed Jan. 7, 2011. For example, the laser assembly12can produce laser pulses having a wavelength from 1020 nm to 1050 nm. For example, the laser assembly12can have a diode-pumped solid-state configuration with a1030(+/−5) nm center wavelength. As another example, the laser assembly12can produce laser pulses having a wavelength 320 nm to 430 nm. For example, the laser assembly12can include an Nd:YAG laser source operating at the 3rd harmonic wavelength (355 nm) and producing pulses having 50 pico second to 15 nano second pulse duration. Depending on the spot size, typical pulse energies used can be in the nano joule to micro joule range. The laser assembly12can also include two or more lasers of any suitable configuration. The laser assembly12can include control and conditioning components. For example, such control components can include components such as a beam attenuator to control the energy of the laser pulse and the average power of the pulse train, a fixed aperture to control the cross-sectional spatial extent of the beam containing the laser pulses, one or more power monitors to monitor the flux and repetition rate of the beam train and therefore the energy of the laser pulses, and a shutter to allow/block transmission of the laser pulses. Such conditioning components can include an adjustable zoom assembly and a fixed optical relay to transfer the laser pulses over a distance while accommodating laser pulse beam positional and/or directional variability, thereby providing increased tolerance for component variation. In many embodiments, the laser assembly12and the confocal detection assembly14have fixed positions relative to the base assembly26. The beam28emitted by the laser assembly12propagates along a fixed optical path through the confocal detection assembly14to the free-floating mechanism16. The beam28propagates through the free-floating mechanism16along a variable optical path30, which delivers the beam28to the scanning assembly18. In many embodiments, the beam28emitted by the laser assembly12is collimated so that the beam28is not impacted by patient movement induced changes in the length of the optical path between the laser assembly12and the scanner16. The scanning assembly18is operable to scan the beam28(e.g., via controlled variable deflection of the beam28) in at least one dimension. In many embodiments, the scanning assembly18is operable to scan the beam28in two dimensions transverse to the direction of propagation of the beam28and is further operable to scan the location of a focal point of the beam28in the direction of propagation of the beam28. The scanned beam is emitted from the scanning assembly18to propagate through the objective lens assembly20, through the interface device22, and to the patient24. The free-floating mechanism16is configured to accommodate a range of movement of the patient24relative to the laser assembly12and the confocal detection assembly14in one or more directions while maintaining alignment of the beam28emitted by the scanning assembly18with the patient24. For example, in many embodiments, the free-floating mechanism16is configured to accommodate a range movement of the patient24in any direction defined by any combination of unit orthogonal directions (X, Y, and Z). The free-floating mechanism16supports the scanning assembly18and provides the variable optical path30, which changes in response to movement of the patient24. Because the patient interface device22is interfaced with the patient24, movement of the patient24results in corresponding movement of the patient interface device22, the objective lens assembly20, and the scanning assembly18. The free-floating mechanism16can include, for example, any suitable combination of a linkage that accommodates relative movement between the scanning assembly18and, for example, the confocal detection assembly24, and optical components suitably tied to the linkage so as to form the variable optical path30. A portion of the electromagnetic radiation beam28that is reflected by eye tissue at the focal point propagates back to the confocal detection assembly14. Specifically, a reflected portion of the electromagnetic radiation beam28travels back through the patient interface device22, back through the objective lens assembly20, back through (and de-scanned by) the scanning assembly18, back through the free-floating mechanism16(along the variable optical path30), and to the confocal detection assembly14. In many embodiments, the reflected portion of the electromagnetic radiation beam that travels back to the confocal detection assembly14is directed to be incident upon a sensor that generates an intensity signal indicative of intensity of the incident portion of the electromagnetic radiation beam. The intensity signal, coupled with associated scanning of the focal point within the eye, can be processed in conjunction with the parameters of the scanning to, for example, image/locate structures of the eye, such as the anterior surface of the cornea, the posterior surface of the cornea, the iris, the anterior surface of the lens capsule, and the posterior surface of the lens capsule. In many embodiments, the amount of the reflected electromagnetic radiation beam that travels to the confocal detection assembly14is substantially independent of expected variations in the length of the variable optical path30due to patient movement, thereby enabling the ability to ignore patient movements when processing the intensity signal to image/locate structures of the eye. FIG.2schematically illustrates details of an embodiment of the laser surgery system10. Specifically, example configurations are schematically illustrated for the laser assembly12, the confocal detection assembly14, and the scanning assembly18. As shown in the illustrated embodiment, the laser assembly12can include an ultrafast (UF) laser32(e.g., a femtosecond laser), alignment mirrors34,36, a beam expander38, a one-half wave plate40, a polarizer and beam dump device42, output pickoffs and monitors44, and a system-controlled shutter46. The electromagnetic radiation beam28output by the laser32is deflected by the alignment mirrors34,36. In many embodiments, the alignment mirrors34,36are adjustable in position and/or orientation so as to provide the ability to align the beam28with the downstream optical path through the downstream optical components. Next, the beam28passes through the beam expander38, which increases the diameter of the beam28. Next, the expanded beam28passes through the one-half wave plate40before passing through the polarizer. The beam exiting the laser is linearly polarized. The one-half wave plate40can rotate this polarization. The amount of light passing through the polarizer depends on the angle of the rotation of the linear polarization. Therefore, the one-half wave plate40with the polarizer acts as an attenuator of the beam28. The light rejected from this attenuation is directed into the beam dump. Next, the attenuated beam28passes through the output pickoffs and monitors44and then through the system-controlled shutter46. By locating the system-controlled shutter46downstream of the output pickoffs and monitors44, the power of the beam28can be checked before opening the system-controlled shutter46. As shown in the illustrated embodiment, the confocal detection assembly14can include a polarization-sensitive device such as a polarized or unpolarized beam splitter48, a filter50, a focusing lens51, a pinhole aperture52, and a detection sensor54. A one-quarter wave plate56is disposed downstream of the polarized beam splitter48. The beam28as received from the laser assembly12is polarized so as to pass through the polarized beam splitter48. Next, the beam28passes through the one-quarter wave plate56, thereby rotating the polarization axis of the beam28. A quarter rotation is a presently preferred rotation amount. After reflecting from the focal point in the eye, the returning reflected portion of the beam28passes back through the one-quarter wave plate56, thereby further rotating the polarization axis of the returning reflected portion of the beam28. Ideally, after passing back through the one-quarter wave plate56, the returning reflected portion of the beam has experienced a total polarization rotation of 90 degrees so that the reflected light from the eye is fully reflected by the polarized beam splitter48. The birefringence of the cornea can also be taken into account if, for example, the imaged structure is the lens. In such a case, the plate56can be adjusted/configured so that the double pass of the plate56as well as the double pass of the cornea sum up to a polarization rotation of 90 degrees. Because the birefringence of the cornea may be different form patient to patient, the configuration/adjustment of the plate56can be done dynamically so as to optimize the signal returning to the detection sensor54. Accordingly, the returning reflected portion of the beam28is now polarized to be at least partially reflected by the polarized beam splitter48so as to be directed through the filter50, through the lens51, and to the pinhole aperture52. The filter50can be configured to block wavelengths other than the wavelengths of interest. The pinhole aperture52is configured to block any returning reflected portion of the beam28reflected from locations other than the focal point from reaching the detection sensor54. Because the amount of returning reflected portion of the beam28that reaches the detection sensor54depends upon the nature of the tissue at the focal point of the beam28, the signal generated by the detection sensor54can be processed in combination with data regarding the associated locations of the focal point so as to generate image/location data for structures of the eye. As shown in the illustrated embodiment, the scanning assembly18can include a z-scan device58and a xy-scan device60. The z-scan device58is operable to vary a convergence/divergence angle of the beam28and thereby change a location of the focal point in the direction of propagation of the beam28. For example, the z-scan device58can include one or more lenses that are controllably movable in the direction of propagation of the beam28to vary a convergence/divergence angle of the beam28. The xy-scan device60is operable to deflect the beam28in two dimensions transverse to the direction of propagation of the beam28. For example, the xy-scan device60can include one or more mirrors that are controllably deflectable to scan the beam28in two dimensions transverse to the direction of propagation of the beam28. Accordingly, the combination of the z-scan device58and the xy-scan device60can be operated to controllably scan the focal point in three dimensions, for example, within the eye of the patient. As shown in the illustrated embodiment, a camera62and associated video illumination64can be integrated with the scanning assembly18. The camera62and the beam28share a common optical path through the objective lens assembly20to the eye. A video dichroic66is used to combine/separate the beam28with/from the illumination wavelengths used by the camera. For example, the beam28can have a wavelength of about 355 nm and the video illumination64can be configured to emit illumination having wavelengths greater than 450 nm. Accordingly, the video dichroic66can be configured to reflect the 355 nm wavelength while transmitting wavelengths greater than 450 nm. FIG.3Ashows an example embodiment of the free-floating mechanism16(shown supporting a scanning assembly18, an objective lens assembly20, and a patient interface device22) to illustrate a suitable linkage that accommodates relative movement between the scanning assembly18and the confocal detection assembly14. Optical components are coupled with associated links of the linkage so as to form the variable optical path30. The free-floating mechanism16includes a first support assembly72, a second support assembly74, and a base assembly76. The eye interface device22is coupled with and supported by the objective lens assembly20. The objective lens assembly20is coupled with and supported by the scanning assembly18. The combination of the interface device22, the objective lens assembly20, and the scanning assembly18form a unit that moves in unison in response to movement of the patient. The first support assembly72includes a first end frame78, a second end frame80, and transverse rods82,84, which extend between and couple to the end frames78,80. The transverse rods82,84are oriented parallel to a first direction86. The scanning assembly18is supported by the transverse rods82,84and slides along the rods82,84in response to patient movement parallel to the first direction86. The transverse rods82,84form part of a linear bearing accommodating patient movement parallel to the first direction86. The second support assembly74includes a first end frame88, an intermediate frame90, transverse rods92,94, a second end frame96, and vertical rods98,100. The transverse rods92,94extend between and couple to the first end frame88and to the intermediate frame90. The transverse rods92,94are oriented parallel to a second direction102, which is at least transverse to and can be orthogonal to the first direction86. Each of the first and second directions86,102can be horizontal. The first support assembly72is supported by the transverse rods92,94and slides along the rods92,94in response to patient movement parallel to the second direction102. The transverse rods92,94form part of a linear bearing accommodating patient movement parallel to the second direction102. The vertical rods98,100extend between and couple to the intermediate frame90and to the second end frame96. The vertical rods98,100are oriented parallel to a third direction104, which is at least transverse to each of first and second directions86,102, and can be orthogonal to at least one of the first and second directions86,102. The vertical rods98,100form part of a linear bearing accommodating relative movement between the second support assembly74and the base assembly76parallel to the third direction104, thereby accommodating patient movement parallel to the third direction104. First, second, and third reflectors106,108,110(e.g., mirrors) are supported by the free-floating mechanism16and configured to reflect the electromagnetic radiation beam28to propagate along the variable optical path30. The first reflector106is mounted to the first support assembly72(to the first end frame78in the illustrated embodiment). The second reflector108is mounted to the second support assembly74(to the intermediate frame90in the illustrated embodiment). The third reflector110is mounted to the base assembly76. In operation, the beam28emitted by the laser assembly is deflected by the third reflector110so as to propagate parallel to the third direction104and be incident upon the second reflector108. The second reflector108deflects the beam28so as to propagate parallel to the second direction102and be incident upon the first reflector106. The first reflector106deflects the beam28so as to propagate parallel to the first direction86and into the scanning assembly18, which then controllably scans and outputs the scanned beam through the objective lens assembly20and the eye interface device22. By propagating the beam28parallel to the third direction104from the third reflector110to the second reflector108, the length of the corresponding portion of the variable optical path30can be varied so as to accommodate relative movement of the patient relative to the third direction104. By propagating the beam28parallel to the second direction102from the second reflector108to the first reflector106, the length of the corresponding portion of the variable optical path30can be varied so as to accommodate relative movement of the patient relative to the second direction102. By propagating the beam28parallel to the first direction86from the first reflector106to the scanning assembly18, the length of the corresponding portion of the variable optical path30can be varied so as to accommodate relative movement of the patient relative to the first direction86. In the illustrated embodiment, the free-floating mechanism16further includes a first solenoid brake assembly112, a second solenoid brake assembly114, and a third solenoid brake assembly116. The solenoid brake assemblies112,114,116are operable to selectively prevent inadvertent articulation of the free-floating mechanism16during initial positioning of the laser surgery system10relative to a patient's eye. Inadvertent articulation of the free-floating mechanism16may occur, for example, when the laser surgery system10is initially repositioned to be in a suitable position relative to the patient. For example, in the absence of any mechanism for preventing inadvertent articulation of the free-floating mechanism16, movement of the laser surgery system10may induce inadvertent articulation of the free-floating mechanism16, especially when a user induces movement of the laser surgery system10through contact with, for example, the objective lens assembly20to move the objective lens assembly20into a suitable location relative to the patient. When the laser surgery system10is supported by a support linkage mechanism that includes setup joints, preventing inadvertent articulation of the free-floating mechanism16can be used to ensure that the initial positioning of the laser surgery system occurs via articulation of the setup joints instead of via articulation of the free-floating mechanism16. The first solenoid brake assembly112is configured to selectively prevent inadvertent movement between the scanning assembly18and the first support assembly72. Engagement of the first solenoid brake assembly112prevents movement of the scanning assembly18along the transverse rods82,84, thereby preventing relative movement between the scanning assembly18and the first support assembly72parallel to the first direction86. When the first solenoid brake assembly112is not engaged, the scanning assembly18is free to slide along the transverse rods82,84, thereby permitting relative movement between the scanning assembly18and the first support assembly72parallel to the first direction86. In many embodiments, the free-floating mechanism16includes a detent mechanism and/or an indicator that is configured to permit engagement of the first solenoid brake assembly112when the scanning assembly18is centered relative to its range of travel along the transverse rods82,84, thereby ensuring equal range of travel of the scanning assembly18in both directions parallel to the first direction86when the first solenoid brake assembly112is disengaged following positioning of the objective lens assembly20relative to the patient. The second solenoid brake assembly114is configured to selectively prevent inadvertent movement between the first support assembly72and the second support assembly74. Engagement of the second solenoid brake assembly114prevents movement of the first support assembly72along the transverse rods92,94, thereby preventing relative movement between the first support assembly72and the second support assembly74parallel to the second direction102. When the second solenoid brake assembly114is not engaged, the first support assembly72is free to slide along the transverse rods92,94, thereby permitting relative movement between the first support assembly72and the second support assembly74parallel to the second direction102. In many embodiments, the free-floating mechanism16includes a detent mechanism and/or an indicator that is configured to permit engagement of the second solenoid brake assembly114when the first support assembly72is centered relative to its range of travel along the transverse rods92,94, thereby ensuring equal range of travel of the first support assembly72in both directions parallel to the second direction102when the second solenoid brake assembly114is disengaged following positioning of the objective lens assembly20relative to the patient. The third solenoid brake assembly116is configured to selectively prevent inadvertent movement between the second support assembly74and the base assembly76. Engagement of the third solenoid brake assembly116prevents movement of the base assembly76along the vertical rods98,100, thereby preventing relative movement between the second support assembly74and the base assembly76parallel to the third direction104. When the third solenoid brake assembly116is not engaged, the base assembly76is free to slide along the vertical rods98,100, thereby permitting relative movement between the second support assembly74and the base assembly76parallel to the third direction104. In many embodiments, the free-floating mechanism16includes a detent mechanism and/or an indicator that is configured to permit engagement of the third solenoid brake assembly116when the base assembly76is centered relative to its range of travel along the vertical rods98,100, thereby ensuring equal range of travel of the base assembly72in both directions parallel to the third direction102when the third solenoid brake assembly116is disengaged following positioning of the objective lens assembly20relative to the patient. In an optional embodiment, the third reflector110is omitted and the incoming beam28is directed to propagate parallel to the third direction104so as to be incident on the second reflector108. Each of the reflectors106,108,110can be adjustable in position and/or in orientation and thereby can be adjusted to align the corresponding portions of the variable optical path30with the first, second, and third directions86,102,104, respectively. Accordingly, the use of the third reflector110can provide the ability to align the portion of the variable optical path30between the third reflector110and the second reflector108so as to be parallel to the third direction104and thereby compensate for relative positional and/or orientation variability between the laser assembly12and the free-floating mechanism16. In the illustrated embodiment of the free-floating mechanism16, the first and second directions86,102can be horizontal and the third direction104can be vertical. The free-floating mechanism16can also include a counter-balance mechanism configured to inhibit gravity-induced movement of the eye interface device22and/or transfer of gravity-induced force to an eye via the eye interface device22. For example, a counter-balance mechanism can be employed to apply a counter-balancing vertical force to the second assembly74, thereby inhibiting or even preventing gravity-induced relative movement between the second assembly74and the base assembly76and/or transfer of gravity-induced force to an eye via the eye interface device22. Other suitable variations of the free-floating mechanism16are possible. For example, the scanning assembly18can be slidably supported relative to a first support assembly via a vertically-oriented linear bearing. The first support assembly can be slidably supported relative to a second support assembly via a first horizontally-oriented linear bearing. The second support assembly can be slidably supported relative to a base assembly via a second horizontally-oriented linear bearing that is oriented transverse (e.g., perpendicular) to the first horizontally-oriented linear bearing. In such a configuration, a counter-balancing mechanism can be used to apply a counter-balancing force to the scanning assembly18, thereby inhibiting or even preventing gravity-induced movement of the scanning assembly18and the eye interface device22and/or transfer of gravity-induced force to an eye coupled with the eye interface device22. The free-floating mechanism16can also incorporate one or more sensors configured to monitor relative position (1) between the scanning assembly18and the first support assembly72, (2) between the first support assembly72and the second support assembly74, and/or (3) between the second support assembly74and the base assembly76. FIG.3Bschematically illustrates relative movements that can be used in the free-floating mechanism16that can be used to accommodate patient movement, in accordance with many embodiments. The free-floating mechanism16includes the first reflector106, the second reflector108, and the third reflector110. In many embodiments, the free-floating mechanism16includes a linkage assembly (not shown) that is configured to permit certain relative movement between the scanner18and the first reflector106, between the first reflector106and the second reflector108, and between the second reflector108and the third reflector110so as to consistently direct the electromagnetic radiation beam28to the scanner18while accommodating three-dimensional relative movement between the patient interface device22and the laser assembly generating the electromagnetic radiation beam28. For example, similar to the embodiment of the free-floating mechanism16illustrated inFIG.3A, a free-floating mechanism16can be configured such that the scanner18is supported by a first support assembly such that the scanner is free to translate relative to the first support assembly parallel to the first direction86, thereby maintaining the location and orientation of the beam28between the first reflector106and the scanner18. Likewise, the first support assembly can be supported by a second support assembly such that the first support assembly is free to translate relative to the second support assembly parallel to a second direction102, thereby maintaining the location and orientation of the beam28between the second reflector108and the first reflector106. And the second support assembly can be supported by a base assembly such that the second support assembly is free to translate relative to the base assembly parallel to a third direction104, thereby maintaining the location and orientation of the beam28between the third reflector110and the second reflector108. The free-floating mechanism16can also employ one or more relative rotations so as to maintain the location and orientation of path segments of the beam28. For example, the scanner18can be supported by a first support assembly such that the scanner is free to undergo a rotation118relative to the first support assembly about an axis coincident with the path segment of the beam28between the first reflector106and the scanner18, thereby maintaining the location and orientation of the beam28between the first reflector106and the scanner18. Likewise, the first support assembly can be supported by a second support assembly such that the first support assembly is free to undergo a rotation120relative to the second support assembly about an axis coincident with the path segment of the beam28between the second reflector108and the first reflector106, thereby maintaining the location and orientation of the beam28between the second reflector108and the first reflector106. And the second support assembly can be supported by a base assembly such that the second support assembly is free to undergo a rotation122relative to the base assembly about an axis coincident with the path segment of the beam28between the third reflector110and the second reflector108, thereby maintaining the location and orientation of the beam28between the third reflector110and the second reflector108. The free-floating mechanism16can also employ any suitable combination of relative translations and relative rotations so as to maintain the location and orientation of path segments of the beam28. For example, with respect to the configuration illustrated inFIG.3B, the free-floating mechanism16can employ relative translation parallel to the second direction102, relative translation parallel to the third direction104, and relative rotation122, thereby allowing three-dimensional movement of the patient interface22relative to the laser assembly used to generate the beam28, and thereby accommodating patient movement. FIG.4is a simplified block diagram of acts of a method200, in accordance with many embodiments, of imaging an eye while accommodating patient movement. Any suitable device, assembly, and/or system, such as described herein, can be used to practice the method200. The method200includes using a beam source to generate an electromagnetic radiation beam (act202). The method200includes propagating the electromagnetic radiation beam from the beam source to a scanner along a variable optical path having an optical path length that changes in response to movement of the eye (act204). The method200includes focusing the electromagnetic radiation beam to a focal point at a location within the eye (act206). The method200includes using the scanner to scan the focal point to different locations within the eye (act208). The method200includes propagating a portion of the electromagnetic radiation beam reflected from the focal point location back along the variable optical path to a sensor (act210). The method200includes using the sensor to generate an intensity signal indicative of the intensity of a portion of the electromagnetic radiation beam reflected from the focal point location and propagated to the sensor (act212). FIGS.5,6and7are simplified block diagrams of optional acts that can be accomplished as part of the method200. For example, the method200can include using a first support assembly to support the scanner so as to accommodate relative movement between the scanner and the first support assembly so as to accommodate movement of the eye (act214). The method200can include using a second support assembly to support the first support assembly so as to accommodate relative movement between the first support assembly and the second support assembly so as to accommodate movement of the eye (act216). The method200can include using the first support assembly to support a first reflector configured to reflect the electromagnetic radiation beam so as to propagate to the scanner along a portion of the variable optical path (act218). The method200can include using a base assembly to support the second support assembly so as to accommodate relative movement between the second support assembly and the base assembly so as to accommodate movement of the eye (act220). The method200can include using the second support assembly to support a second reflector configured to reflect the electromagnetic radiation beam to propagate along a portion of the variable optical path so as to be incident on the first reflector (act222). The method200can include using the sensor to generate the intensity signal comprises passing a reflected portion of the electromagnetic radiation beam through an aperture to block portions of the electromagnetic radiation beam reflected from locations other than the focal point location (act224). The method200can include passing the electromagnetic radiation beam through a polarization-sensitive device (act226). The method200can include modifying polarization of at least one of the electromagnetic radiation beam and a portion of the electromagnetic radiation beam reflected from the focal point location (act228). The method200can include using the polarization-sensitive device to reflect a portion of the electromagnetic radiation beam reflected from the focal point location so as to be incident upon the sensor (act230). FIG.8schematically illustrates a laser surgery system300, in accordance with many embodiments. The laser surgery system300includes the laser assembly12, the confocal detection assembly14, the free-floating mechanism16, the scanning assembly18, the objective lens assembly20, the patient interface22, communication paths302, control electronics304, control panel/graphical user interface (GUI)306, and user interface devices308. The control electronics304includes processor310, which includes memory312. The patient interface22is configured to interface with a patient24. The control electronics304is operatively coupled via the communication paths302with the laser assembly12, the confocal detection assembly14, the free-floating mechanism16, the scanning assembly18, the control panel/GUI306, and the user interface devices308. The free-floating mechanism16can be configured as illustrated inFIG.3to include, for example, the first reflector106, the second reflector108, and the third reflector110. Accordingly, the free-floating mechanism16can be configured to accommodate movement of the patient24relative to the laser assembly12and the confocal detection assembly14in any direction resulting from any combination of three orthogonal unit directions. The scanning assembly18can include a z-scan device and a xy-scan device. The laser surgery system300can be configured to focus the electromagnetic radiation beam28to a focal point that is scanned in three dimensions. The z-scan device can be operable to vary the location of the focal point in the direction of propagation of the beam28. The xy-scan device can be operable to scan the location of the focal point in two dimensions transverse to the direction of propagation of the beam28. Accordingly, the combination of the z-scan device and the xy-scan device can be operated to controllably scan the focal point of the beam in three dimensions, including within a tissue of the patient24such as within an eye tissue of the patient24. As illustrated above and described with respect toFIG.3, the scanning assembly18is supported by the free-floating mechanism16, which accommodates patient movement induced movement of the scanning assembly18relative to the laser assembly12and the confocal detection assembly14in three dimensions. The patient interface22is coupled to the patient24such that the patient interface22, the objective lens assembly20, and the scanning assembly18move in conjunction with the patient24. For example, in many embodiments, the patient interface22employs a suction ring that is vacuum attached to an eye of the patient24. The suction ring can be coupled with the patient interface22, for example, using vacuum to secure the suction ring to the patient interface22. The control electronics304controls the operation of and/or can receive input from the laser assembly12, the confocal detection assembly14, the free-floating assembly16, the scanning assembly18, the patient interface22, the control panel/GUI306, and the user interface devices308via the communication paths302. The communication paths302can be implemented in any suitable configuration, including any suitable shared or dedicated communication paths between the control electronics304and the respective system components. The control electronics304can include any suitable components, such as one or more processor, one or more field-programmable gate array (FPGA), and one or more memory storage devices. In many embodiments, the control electronics304controls the control panel/GUI306to provide for pre-procedure planning according to user specified treatment parameters as well as to provide user control over the laser eye surgery procedure. The control electronics304can include a processor/controller310that is used to perform calculations related to system operation and provide control signals to the various system elements. A computer readable medium312is coupled to the processor310in order to store data used by the processor and other system elements. The processor310interacts with the other components of the system as described more fully throughout the present specification. In an embodiment, the memory312can include a look up table that can be utilized to control one or more components of the laser system surgery system300. The processor310can be a general purpose microprocessor configured to execute instructions and data, such as a Pentium processor manufactured by the Intel Corporation of Santa Clara, California. It can also be an Application Specific Integrated Circuit (ASIC) that embodies at least part of the instructions for performing the method in accordance with the embodiments of the present disclosure in software, firmware and/or hardware. As an example, such processors include dedicated circuitry, ASICs, combinatorial logic, other programmable processors, combinations thereof, and the like. The memory312can be local or distributed as appropriate to the particular application. Memory312can include a number of memories including a main random access memory (RAM) for storage of instructions and data during program execution and a read only memory (ROM) in which fixed instructions are stored. Thus, the memory312provides persistent (non-volatile) storage for program and data files, and may include a hard disk drive, flash memory, a floppy disk drive along with associated removable media, a Compact Disk Read Only Memory (CD-ROM) drive, an optical drive, removable media cartridges, and other like storage media. The user interface devices308can include any suitable user input device suitable to provide user input to the control electronics304. For example, the user interface devices308can include devices such as, for example, a touch-screen display/input device, a keyboard, a footswitch, a keypad, a patient interface radio frequency identification (RFID) reader, an emergency stop button, and a key switch. System Calibration The laser surgery system10can be calibrated to relate locations in a treatment space with pixels in the camera62and with control parameters used to control the scanning assembly18such that the focal point of the electromagnetic radiation beam can be accurately positioned within the intraocular target. Such calibration can be accomplished at any suitable time, for example, prior to using the laser surgery system10to treat a patient's eye. FIG.9is a top view diagram of a calibration plate402that can be used to calibrate the laser surgery system10. In many embodiments, the calibration plate402is a thin plate having an array of target features, for example, through holes404therein. In alternate embodiments, the calibration plate402is a thin plate having a field of small dots as the target features. While any suitable arrangement of the target features can be used, the calibration plate402ofFIG.9has an orthogonal array of through holes404. Any suitable number of the target features can be included in the calibration plate402. For example, the illustrated embodiment has 29 rows and 29 columns of the through holes404, with three through holes at each of the four corners of the calibration plate402being omitted from the orthogonal array of through holes404. In many embodiments, each of the through holes404is sized small enough to block a suitable portion of an electromagnetic radiation beam when the focal point of the electromagnetic radiation beam is not located at the through hole. For example, each of the through holes404can have a diameter slightly greater than the diameter of the focal point of the electromagnetic radiation beam so as to not block any of the electromagnetic radiation beam when the focal point is positioned at one of the through holes404. In the embodiment shown, the through holes404have a diameter of 5 μm, which is sized to be used in conjunction with a focal point diameter of 1 μm. FIG.10schematically illustrates using the calibration plate402to calibrate the camera62of the laser surgery system10. The calibration plate402is supported at a known fixed location relative to the objective lens assembly20. In many embodiments, the objective lens assembly20is configured for telecentric scanning of the electromagnetic radiation beam and the calibration plate402is supported to be perpendicular to the direction of propagation of the electromagnetic radiation beam. The calibration plate402is disposed between the objective lens assembly20and a light source406. The light source406is used to illuminate the calibration plate402. A portion of the illumination light from the light source406passes through each of the through holes404, thereby producing an illuminated location within the field of view of the camera62at each of the through holes404. A light beam408from each of the through holes404passes through the objective lens assembly20, through the video dichroic66, an into the camera62. In many embodiments, the camera62includes a sensor having an orthogonal array of pixels (e.g., in x and y directions where the corresponding z direction is in the direction of propagation of the electromagnetic radiation beam). In many embodiments, X and Y pixel values for each of the light beams408is used in conjunction with the known locations of the through holes404relative to the objective lens assembly20to determine the relationship between the camera X and Y pixel values and locations in the treatment space for dimensions transverse to the propagation direction of the electromagnetic radiation beam. FIG.11schematically illustrates using the calibration plate402to calibrate the scanning assembly18. The calibration plate402is supported at a known fixed location relative to the objective lens assembly20. In many embodiments, the objective lens assembly20is configured for telecentric scanning of the electromagnetic radiation beam and the calibration plate402is supported to be perpendicular to the direction of propagation of the electromagnetic radiation beam. The calibration plate402is disposed between the objective lens assembly20and a detector410. The detector410is configured to generate a signal indicative of how much of the electromagnetic radiation beam is incident thereon, thereby being indirectly indicative of how much of the electromagnetic radiation beam is blocked by the calibration plate402. For example, when the focal point of the electromagnetic radiation beam is positioned at one of the through holes404(as illustrated for the focal point disposed on the right side of the detection plate402inFIG.11), a maximum amount of the electromagnetic radiation beam passes through the through hole and is incident on the detector410. In contrast, when the focal point of the electromagnetic radiation beam is not positioned at one of the through holes404(as illustrated for the focal point disposed above the left side of the detection plate402inFIG.11), a portion of the electromagnetic radiation beam is blocked from reaching the detector410. Control parameters for the z-scan device58and the xy-scan device60are varied to locate the focal point of the electromagnetic radiation beam at each of a suitable set of the through holes, thereby providing data used to determine the relationship between the control parameters for the scanning assembly18and the resulting location of the focal point of the electromagnetic radiation beam. The z-scan device58is operable to vary a convergence/divergence angle of the electromagnetic radiation beam, thereby being operable to control the distance of the focal point from the objective lens in the direction of propagation of the electromagnetic radiation beam. The xy-scan device60is operable to vary a direction of the electromagnetic radiation beam in two dimensions, thereby providing the ability to move the focal point in two dimensions transverse to the direction of propagation of the electromagnetic radiation beam. A suitable existing search algorithm can be employed to vary the control parameters for the z-scan device58and the xy-scan device60so as to reposition the focal point to be located at each of a suitable set of the through holes404. In many embodiments where the objective lens assembly20is configured to telecentrically scan the electromagnetic radiation beam, the resulting control parameter data for the scanning assembly18can be used to calibrate the scanning assembly18relative to directions transverse to the direction of propagation of the electromagnetic radiation beam (e.g., x and y directions transverse to a z direction of propagation of the electromagnetic radiation beam). FIG.12schematically illustrates using a fluorescent material block412to calibrate the scanning assembly18. The fluorescent material block412is made of a suitable fluorescent material that emits light in response to absorbing electromagnetic radiation. The fluorescent material block412is supported at a fixed location relative to the objective lens assembly20. With the focal point of the electromagnetic radiation beam disposed within the block412, the camera62is used to observe the location of the resulting fluorescent emission in the block412. The observed location of the resulting fluorescent emission can be used in conjunction with calibration data for the camera62to determine x and y coordinates of the associated focal point in the treatment space. Suitable variation in the location of the focal point within the fluorescent material block412and associated position data for the resulting fluorescent emissions generated via the camera62can be used to calibrate the control parameters for the scanning assembly18. For example, in embodiments where the objective lens assembly20is configured to telecentrically scan the focal point, the corresponding positional data for the resulting fluorescent emissions can be used to generate calibrated control parameters for the xy-scan device60for positioning the focal point transverse to the direction of propagation of the electromagnetic radiation beam. FIG.13schematically illustrates the use of a reflective member414to calibrate the scanning assembly18. The reflective member414is supported at a suitable plurality of known fixed distances relative to the objective lens assembly20. In many embodiments, the objective lens assembly20is configured for telecentric scanning of the electromagnetic radiation beam and the reflective member414is supported to be perpendicular to the direction of propagation of the electromagnetic radiation beam. The reflective member414reflects the electromagnetic radiation beam back through the objective lens assembly20, back through the scanning assembly18, back through the free-floating mechanism16, and back to the confocal detection assembly14. For a particular distance between the objective lens assembly20and the reflective member414, the z-scan device58can be operated to vary the distance of the focal point from objective lens assembly. Alternatively, for a particular setting of the z-scan device resulting in a particular distance of the focal point from the objective lens assembly, the distance between the objective lens assembly20and the reflective member414can be varied. As illustrated inFIG.14, a resulting signal416produced by the detection sensor54of the confocal detection assembly14varies in intensity with variation in the distance between the focal point and the reflective member414. The intensity of the signal416generated by the detection sensor54is maximized when the focal point is located at the surface of the reflective member414, thereby maximizing the amount of reflected light that passes through the pinhole aperture52to reach the detection sensor54. By determining the values of the control parameter for the z-scan device58corresponding to a suitable plurality of distances between the reflective member414and the objective lens assembly20, suitable calibration parameters can be generated for use in controlling the z-scan device58to control the location of the focal point in the treatment space in the direction of propagation of the electromagnetic radiation beam. Focal Point Scan Control The laser surgery system10can be configured to image and/or modify an intraocular target by scanning the focal point of the electromagnetic radiation beam in a particular area. For example, referring now toFIG.15andFIG.16, the laser surgery system10can be used to incise an anterior capsulotomy and/or a posterior capsulotomy in the anterior portion of a lens capsule418. The focal point of the electromagnetic radiation beam can be scanned to form an anterior capsulotomy closed incision boundary surface420that transects the anterior portion of the lens capsule418. Likewise, the focal point of the electromagnetic radiation beam can be scanned to form a posterior capsulotomy closed incision boundary surface430that transects the posterior portion of the lens capsule418. The anterior and/or posterior closed incision boundary surfaces420,430can be designated using any suitable approach. For example, a plan view of the patient's eye can be obtained using the camera62. A capsulotomy incision designator422can be located and shown superimposed on the plan view of the patient's eye to illustrate the size, location, and shape of a planned capsulotomy relative to the patient's eye. The capsulotomy incision designator422can be manually defined by an operator of the laser surgery system10and/or the laser surgery system10can be configured to generate an initial capsulotomy incision designator422for operator verification and/or modification. The anterior capsulotomy closed incision boundary surface420can be defined on a projection of the capsulotomy incision designator422such that the anterior capsulotomy closed incision boundary surface420transects the anterior portion of the lens capsule418at all locations around the anterior capsulotomy incision boundary surface420for all expected variations in the location of the anterior portion of the lens capsule418relative to the projection of the capsulotomy incision designator422. For example, a curve corresponding to the capsulotomy incision designator422can be projected to define an intersection with a minimum depth mathematical surface model (e.g., a spherical surface) defining a minimum expected depth configuration for the anterior portion of the lens capsule418with the resulting intersection being an anterior capsulotomy upper closed curve424that defines an upper boundary for the anterior capsulotomy closed incision boundary surface420. Likewise, the curve corresponding to the capsulotomy incision designator422can be projected to define an intersection with a maximum depth mathematical surface model (e.g., a spherical surface) defining a maximum expected depth configuration for the anterior portion of the lens capsule418with the resulting intersection being an anterior capsulotomy lower closed curve426that defines a lower boundary for the anterior capsulotomy closed incision boundary surface420. Alternatively, the focal point can be scanned using a low imaging-only power level (e.g., a power level sufficient to provide for imaging of the intraocular target via processing of the signal generated by the detection sensor54of the confocal detection assembly14without modifying the intraocular target) along the projection of the capsulotomy incision designator422while varying the depth of the focal point to determine the depth of the anterior lens capsule at a sufficient number of locations around the projection of the cap sulotomy incision designator422. For example,FIG.18illustrates variation of intensity of the signal generated by the detection sensor54with variation in depth of the focal point with the maximum peak in intensity corresponding to the depth of the anterior portion of the lens capsule418. The measured depths of the anterior lens capsule can then be used to determine suitable anterior capsulotomy upper and lower boundary curves424,426of the anterior capsulotomy closed incision boundary surface420. In a similar fashion, the posterior capsulotomy closed incision boundary surface430can be defined on a projection of the capsulotomy incision designator422such that the posterior capsulotomy closed incision boundary surface430transects the posterior portion of the lens capsule418at all locations around the posterior capsulotomy incision boundary surface430for all expected variations in the location of the posterior portion of the lens capsule418relative to the projection of the capsulotomy incision designator422. For example, the curve corresponding to the capsulotomy incision designator422can be projected to define an intersection with a minimum depth mathematical surface model (e.g., a spherical surface) defining a minimum expected depth configuration for the posterior portion of the lens capsule418with the resulting intersection being a posterior capsulotomy upper closed curve434that defines an upper boundary for the posterior capsulotomy closed incision boundary surface430. Likewise, the curve corresponding to the capsulotomy incision designator422can be projected to define an intersection with a maximum depth mathematical surface model (e.g., a spherical surface) defining a maximum expected depth configuration for the posterior portion of the lens capsule418with the resulting intersection being a posterior capsulotomy lower closed curve436that defines a lower boundary for the posterior capsulotomy closed incision boundary surface430. Alternatively, the focal point can be scanned using a low imaging-only power level (e.g., a power level sufficient to provide for imaging of the intraocular target via processing of the signal generated by the detection sensor54of the confocal detection assembly14without modifying the intraocular target) along the projection of the capsulotomy incision designator422while varying the depth of the focal point to determine the depth of the posterior lens capsule at a sufficient number of locations around the projection of the capsulotomy incision designator422. The measured depths of the posterior lens capsule can then be used to determine suitable posterior capsulotomy upper and lower boundary curves434,436of the posterior capsulotomy closed incision boundary surface430. While any suitable projection of the capsulotomy incision designator422can be used to define the anterior and/or posterior capsulotomy incision boundary surfaces420,430, in many embodiments an inverted cone shaped projection of the capsulotomy incision designator422is employed so as to maintain a suitable safety margin distance between the electromagnetic radiation beam, which converges to the focal point while propagating from the objective lens assembly20to the focal point, and the edge of the iris. Accordingly, in many embodiments, the posterior capsulotomy has a smaller diameter than a corresponding anterior capsulotomy for a given capsulotomy incision designator422, for example, as illustrated. The laser surgery system10can be used to form any suitably shaped capsulotomy. For example, while the anterior and posterior capsulotomies in the illustrated embodiments are circular, any other suitable shape, including but not limited to, elliptical, rectangular, and polygonal can be formed. And the anterior and/or posterior capsulotomy can be shaped to accommodate any correspondingly suitably shaped IOL. Concurrent Imaging and Adaptive Tissue Treatment The laser surgery system10can be configured to generate image data concurrent with tissue treatment. For example, the focal point of the electromagnetic radiation beam can have an intensity sufficient to modify an intraocular target (e.g., eye tissue, an IOL) with a resulting portion of the electromagnetic radiation beam reflected from the focal point back to the detection sensor54of confocal detection assembly14used to generate a signal that is processed to generate image data corresponding to the focal point location. By scanning the focal point in a pattern that crosses a boundary of an intraocular target, the detection sensor54can be used to concurrently generate a signal that can be processed to identify the location of the crossed boundary. For example,FIG.18illustrates variation of intensity of the signal generated by the detection sensor54with variation in depth of the focal point with the maximum peak in intensity corresponding to the depth of the anterior portion of the lens capsule418. The location of the crossed boundary can be used to control subsequent scanning of the focal point so as to reduce the amount of tissue that is treated. For example, when incising an anterior capsulotomy in the lens capsule, the focal point can be scanned in a scan pattern that is at least in part based on the location of the anterior portion of the lens capsule as determined by processing the signal from the detection sensor54generated during a previous scan pattern. FIG.17is a simplified block diagram of acts of a method500for adaptively scanning the focal point of the electronic radiation beam relative to a boundary of an intraocular target, in accordance with many embodiments. The method500can be accomplished, for example, using any suitable system including any suitable laser surgery system described herein such as the laser surgery system10. The method500includes scanning a focal point of the electromagnetic radiation beam in a first scan pattern so as to cross a boundary of an intraocular target (act502). In many embodiments, the scan pattern moves the focal point transverse to and/or parallel to the direction of propagation of the electromagnetic radiation beam. The intraocular target having the crossed boundary can be any suitable intraocular target including, for example, the anterior lens capsule, the posterior lens capsule, the crystalline lens, the cornea, the iris, an intraocular lens, and the limbus. Where a plurality of scan patterns is applied to create an incision surface (e.g., the closed incision boundary surface420shown inFIGS.15and16), the scan patterns can be configured such that the electromagnetic radiation beam propagates to the focal point through unmodified eye tissue and/or IOL material. For example, the scan patterns can be configured and accomplished such that modification occurs in a generally deeper to shallower manner. The method500further includes generating a signal indicative of the intensity of a portion of the electromagnetic radiation beam reflected from the focal point during the scanning of the focal point in the first scan pattern (act504). For example, because the first scan pattern crosses the boundary of the intraocular target, the signal generated by the detection sensor (e.g., such as the signal illustrated inFIG.18) and focal point position data for the first scan pattern can be processed to determine the location of the crossed boundary (act506) by, for example, identifying a signal variation consistent with the applicable boundary. Having determined the location of where the first scan pattern crossed the boundary of the intraocular target, the focal point can be scanned in a second scan pattern that is configured at least in part based on the location where the first scan pattern crossed the boundary of the intraocular target (act508). For example, the second scan pattern can be configured to only extend beyond an estimated location of where the second scan pattern will cross the boundary of the intraocular target by predetermined amounts selected to account for possible variations in the estimated location of where the second scan pattern will cross the boundary in view of knowing where the first scan pattern crossed the boundary of the intraocular target. In many embodiments, the second scan pattern will be immediately adjacent to if not overlapped with the first scan pattern, thereby reducing the possible variation between the measured location where the first scan pattern crossed the boundary and the estimated location where the second scan pattern will cross the boundary. In many embodiments in which an incision surface is created, a series of subsequent scan patterns can be accomplished in which the location where one or more previous scan patterns crossed the boundary of the intraocular lens can be used to configured at least one of the subsequent scan patterns to, for example, minimize the tissue and/or material modified and/or increase the accuracy with regard to which tissue and/or material is modified. FIG.19schematically illustrates repeated use of a location where a scan pattern for the focal point crossed a boundary of an intraocular target to configure a subsequent scan pattern. WhileFIG.19employs scan patterns having variation in the location of the focal point relative to the z-dimension (i.e., parallel to the direction of propagation of the electromagnetic radiation beam), the concept illustrated can be adapted to apply to any suitable scan pattern having, for example, variation in the location of the focal point relative to directions transverse to as well as transverse to and parallel to the direction of propagation of the electromagnetic radiation beam (e.g., x-direction variation, y-direction variation, and/or z-direction variation). An initial scan pattern510can be configured so as to extend between two locations512,514that are selected so that the initial scan pattern510crosses a boundary516for an intraocular target for all expected variations in the location of the boundary516. By processing the signal generated by the detection sensor54during the initial scan pattern510along with focal point location data for the initial scan pattern510, a location518where the initial scan pattern510crossed the boundary516can be identified. A second scan pattern520can then be configured at least in part based on the location518. For example, end locations522,524for the second scan pattern520can be selected based on the location518so as to, for example, substantially minimize the length of the second scan pattern so as to minimize the amount of tissue and/or material treated. By processing the signal generated by the detection sensor54during the second scan pattern520along with focal point location data for the second scan pattern520, a location526where the second scan pattern520crossed the boundary516can be identified. Any suitable subsequent scan pattern can be configured in a similar fashion. For example, by processing the signal generated by the detection sensor during a scan pattern530along with focal point location data for the scan pattern530, a location532where the scan pattern530crossed the boundary516can be identified. End points542,544for a subsequent scan pattern540can be selected based on the location532so as to, for example, substantially minimize the length of the scan pattern540so as to minimize the amount of tissue and/or material treated. Accordingly, a series of scan patterns can be adaptively configured and applied using boundary location data for the intraocular target generated from one or more previous scan patterns. FIG.20illustrates a series of scan patterns550that can be used to incise a surface that transects a boundary552of an intraocular target. In the illustrated embodiment, the scan patterns550are adaptively configured using boundary location data generated from one or more previous scan patterns of the series of scan patterns550, such as described above with respect toFIG.19and method500. Accordingly, the series of scan patterns550can be configured to generally extend beyond both sides of the boundary552by substantially uniform distances and thereby follow the general shape of the boundary552. FIGS.21and22illustrate scanning directions554,556that can be used to incise the series of scan patterns550. While any suitable scanning directions can be used, the illustrated directions554,556can be used to avoid having the electromagnetic radiation beam propagate through previously treated tissue/material prior to reaching the focal point. Corneal Incisions The laser surgery system10can be configured to create different types of corneal incisions including, for example, one or more arcuate (e.g., relaxation) incisions, one or more cataract surgery primary access incisions, and/or one or more cataract surgery secondary (sideport) incisions. Each of these types of corneal incisions can be made in one or more different configurations. FIGS.23through25illustrate aspects of arcuate incisions of a cornea that can be formed by the laser surgery system10, in accordance with many embodiments.FIG.23shows an en face view of arcuate incisions within the optical zone of the cornea that can be formed using the laser surgery system10. The optical zone can user-adjustable within, for example, the range of 2 mm-11 mm. For asymmetric arcuate incisions, the optical zone can be independently adjustable for each incision. Arc length can be user-adjustable within, for example, the range of 10°-120°. FIG.24shows a cross-sectional view of an arcuate incision in the cornea that can be formed using the laser surgery system10and that penetrates the cornea anterior surface and has an uncut posterior portion.FIG.25shows a cross-sectional view of an arcuate intrastromal incision in the cornea that can be formed using the laser surgery system10. The arcuate intrastromal incision has an uncut anterior portion and an uncut posterior portion. Side cut angle can user-adjustable within, for example, the range of 30°-150°. Uncut posterior and anterior portions can be user-adjustable within, for example, the range of 100 μm-250 μm or 20%-50% of the cornea thickness. Cornea thickness can be measured at the projected intersection of the incision with the cornea anterior/posterior measured at 90° to anterior/posterior cornea surface regardless of what side cut angle is chosen. FIG.26shows an en face view of a primary cataract incision in the cornea that can be formed using the laser surgery system10. The primary cataract incision provides access to surgical tools used to, for example, remove a fragmented crystalline lens nucleus and insert an IOL.FIG.27shows a cross-sectional view of a primary cataract incision of the cornea that can be formed using the laser surgery system10. Limbus offset can be user-adjustable within, for example, the range of 0.0 mm-5.0 mm. Width can be user-adjustable within, for example, the range 0.2 mm-6.5 mm. Length can be user-adjustable within, for example, the range of 0.5 mm-3.0 mm. Side Cut Angle can be user-adjustable within, for example, the range of 30°-150°. Plane depth can be user-adjustable within, for example, the range of 125 μm-375 μm or 25%-75% of the cornea thickness. Length can be defined as the en face view distance between the projected incision intersection with the cornea anterior and the cornea posterior.FIG.28shows a cross-sectional view of a primary cataract incision that includes an uncut anterior portion.FIG.29shows a cross-sectional view of a primary cataract incision that includes an uncut posterior portion.FIG.30shows a cross-sectional view of a primary cataract incision that includes an uncut central length. AndFIG.31shows a cross-sectional view of a primary cataract incision that includes no uncut portion. Side Cut Angle can be user-adjustable within, for example, the range of 30°-150°. Uncut central length can be user-adjustable within, for example, the range of 25 μm-1000 μm. FIG.32shows an en face view of a sideport cataract incision in the cornea that can be formed using the laser surgery system10. The sideport cataract incision provides access for surgical tools used, for example, to assist in the removal of a fragmented crystalline lens.FIG.33shows a cross-sectional view of a sideport cataract incision of the cornea that has an uncut posterior portion and can be formed using the laser surgery system10. Limbus offset can be user-adjustable within, for example, the range of 0.0 mm-5.0 mm. Width can be user-adjustable within, for example, the range 0.2 mm-6.5 mm. Length can be user-adjustable within, for example, the range of 0.5 mm-3.0 mm.FIG.34shows a cross-sectional view of a sideport cataract incision that includes an uncut anterior portion.FIG.35shows a cross-sectional view of a sideport cataract incision that includes an uncut central length. AndFIG.36shows a cross-sectional view of a sideport cataract incision that includes no uncut portion. Side Cut Angle can be user-adjustable within, for example, the range of 30°-150°. Uncut central length can be user-adjustable within, for example, the range of 100 μm-250 μm or 20%-50% of the cornea thickness. Cornea thickness can be measured at the projected intersection location of the incision with the cornea anterior/posterior measured at 90° to the anterior/posterior cornea surface regardless of what side cut angle is chosen. Real-Time Monitoring Based Intensity Control The laser surgery system10can be configured to use real-time monitoring to control the intensity of the electromagnetic radiation beam. The real-time monitoring can include, for example, monitoring of the signal generated by the detection sensor54of the confocal imaging assembly14and/or monitoring a sensor (e.g., a microphone) configured to detect specific target structures or the occurrence of a cavitation event. FIG.37is a simplified block diagram of acts of a method600for controlling the intensity of an electromagnetic radiation beam used to modify an intraocular target (e.g., tissue, IOL). The method600can be accomplished, for example, using any suitable system including any suitable laser surgery system described herein such as the laser surgery system10. The method600includes comparing a signal indicative of the intensity of a portion of an electromagnetic radiation beam reflected from a focal point to an operative range for modifying an intraocular tissue without generation of plasma and associated cavitation event (act602). The signal can be generated, for example, by the detection sensor54of the laser surgery system10. If the comparison indicates that the intensity of the electromagnetic beam is outside of the operative range (10 micro joules for example), the intensity of the electromagnetic radiation beam is adjusted to be within the operative range (act604). FIG.38is a simplified block diagram of acts of a method610for controlling the intensity of an electromagnetic radiation beam used to modify an intraocular target (e.g., tissue, IOL). The method610can be accomplished, for example, using any suitable system including any suitable laser surgery system described herein such as the laser surgery system10. The method610includes monitoring an intraocular target for an occurrence of a cavitation event generated by the electromagnetic radiation beam used to modify the intraocular target (act612). For example, the signal generated by the detection sensor54of the laser surgery system10can be monitored for the occurrence of a cavitation event in the intraocular target. This would lead to an increased confocal signal reflection from the eye that may indicate an over treatment. In such a case, the laser pulse energy can be automatically reduced by the control electronics304. The laser surgery system10can also incorporate a sensor (e.g., a microphone) configured to detect the occurrence of a cavitation event in the intraocular target. If an occurrence of a cavitation event in the intraocular target is detected, the intensity of the electromagnetic radiation beam is reduced (act614). Posterior Capsulotomy Through an IOL In some instances, the posterior portion of a lens capsule of a patient's eye may become at least partially opaque subsequent to the installation of an intraocular lens (IOL). In such instances, it may be preferable to perform a posterior capsulotomy through the IOL to avoid removal of the IOL. In many embodiments, the laser surgery system10can be configured to perform a posterior capsulotomy through an IOL. For example, the laser surgery system10using an electromagnetic radiation beam having a wavelength between 320 nm to 430 nm can be used to perform a posterior capsulotomy through an IOL made from a material sufficiently transmissive of the wavelength used. While any suitable electromagnetic radiation beam of any suitable wavelength can be used, a wavelength between 320 nm to 430 nm can be used to maximize scattering of the electromagnetic radiation beam by the vitreous so as to minimize possible damage to the retina. FIG.39illustrates an IOL620positioned in a lens capsule622and an adjacent portion of the anterior hyaloid surface624of the vitreous626. To avoid damage to the anterior hyaloids surface624so as to avoid compromising containment of the vitreous626, the anterior hyaloid surface624can be separated and displaced relative to the posterior portion of the lens capsule622using any suitable approach. For example, a suitable fluid can be injected into the eye forward of the anterior hyaloid surface so as to separate the anterior hyaloid surface from the posterior portion of the lens capsule622.FIG.40illustrates the adjacent portion of the anterior hyaloid surface624displaced relative to the IOL624and a closed boundary incision surface628transecting the posterior portion of the lens capsule622. The closed boundary incision surface628can be formed using any suitable system or method, including those described herein such as the laser surgery system10. For example, the closed boundary incision surface628can be formed using concurrent imaging and adaptive tissue treatment as described herein so as to reduce the extent by which the closed boundary incision surface extends on one or both sides of the posterior portion of the lens capsule622so as to reduce the probability of damaging the anterior hyaloid surface624and/or the IOL620. Refractive Correction Via Laser-Induced Modification of Refractive Index of an IOL As described herein, the laser surgery system10can be used to modify eye tissue (e.g., corneal tissue) without generating plasma and associated cavitation event. The laser eye surgery system10can also be used to modify an IOL in situ without generating plasma and associated cavitation event.FIG.41illustrates an IOL630that has been modified by using the laser eye surgery system10to induce a plurality of small localized modification632. In many embodiments, the small localized modifications632are accomplished so as to change the refractive index of the IOL material within the small localized modifications632. Such localized modification of refractive index can be used to controllably configure the refractive index profile of the IOL630so as to impose a desired refractive correction without removal of the IOL630from the patient's eye. Suitable IOL targets include acrylic IOLs or in general all materials that have at least some transmission of the laser wavelength to enable the modification. Other IOL materials are feasible as long as suitable transmission is provided. Modification of the refractive index may be in the order of about 10%, so in the case of acrylic with an index of refraction of 1.4914 it may be modified to have an index of refraction of about 1.6405 or to about 1.3423. Lens Fragmentation The laser surgery system10can be configured incise a crystalline lens. For example, the electromagnetic radiation beam28generated by the laser assembly12can have a wavelength that is suitably transmissible by the crystalline lens, such as, for example, a wavelength between 800 nanometers and 1100 nanometers. FIG.42shows a capsulotomy incision designator422and a fragmentation boundary designator640, in accordance with many embodiments, overlaid on a plan view of an eye that shows the location of the limbus642and the pupil644. In many embodiments, each of the capsulotomy incision designator422and the fragmentation boundary designator640is positioned and sized to maintain at least a minimum suitable safe working distance from the pupil644to avoid having the electromagnetic radiation beam28be incident on the pupil644to avoid associated damage of the pupil644. Accordingly, the fragmentation boundary designator640can be used in conjunction with the pupil644to determine a corresponding iris safety margin distance. FIG.43shows a cross-sectional diagram of an eye that illustrates a lens fragmentation volume646defined to maintain an anterior safety margin distance648from the anterior portion of the lens capsule418, an iris safety margin distance650from the pupil644, and a posterior safety margin distance652from the posterior portion of the lens capsule418. As described herein, the laser surgery system10can be used to identify the location of a boundary of an intraocular target, and can be configured to identify a suitable set of locations on the anterior and posterior lens capsule. For example, the focal point can be scanned using a low imaging-only power level (e.g., a power level sufficient to locate a suitable set of locations on the anterior and posterior portions of the lens capsule418via processing of the signal generated by the detection sensor54of the confocal detection assembly14without modifying eye tissue) along a suitable path selected to cross the anterior and/or posterior portion of the lens capsule418to locate positions on the lens capsule418at a sufficient number of locations to support definition of the lens fragmentation volume646. Referring now toFIG.44, in many embodiments, the laser surgery system10is configured to create a pattern of intersecting incisions654within the lens fragmentation volume646so as to fragment the lens within the lens fragmentation volume646into discrete fragments configured (e.g., sized, shaped) for subsequent removal from the lens capsule418. While any suitable lens fragmentation parameters can be employed, example lens fragmentation parameters, including fragmentation patterns, cut dimensions for lens segmentation and softening, laser settings, and applicable safety margins, are illustrated inFIG.45and provided in Tables 1 and 2. TABLE 1User-adjustable Lens Fragmentation ParametersFeatureDefaultRangeStep SizeUnitsDiameter*3.0-10.00.5mmHorizontal Spot Spacing105-252.5μmVertical Spot Spacing4010-10010μmPulse Energy, Anterior**81-100.5μJPulse Energy, Posterior**101-100.5μJSeg-Soft Spacing500100-1500100μmGrid Spacing500100-2000100μm* Default diameter is defined by available pupil diameter - 2*safety margin.**Pulse energy to vary stepwise (linear) from posterior to anterior, if different TABLE 2Lens Fragmentation Safety MarginsFeatureDefaultRangeStep SizeUnitsIris500N/AN/AμmAnterior ***500200-1000100μmPosterior ***500500-1000100μm*** Safety margins follow lens surface contours. Corneal Flaps In many embodiments, the laser surgery system10is configured to incise corneal flaps. Referring now toFIG.46throughFIG.49, a corneal flap660prepared in accordance with many embodiments is shown. The flap660can be prepared in any suitable sequence. For example, the flap600can be prepared by first using the laser surgery system10to laser incise a posterior surface662for the flap660. The posterior surface662can have any suitable configuration. For example, the posterior surface662can have a perimeter that is a curved line centered approximately on the optical axis663of the eye24and extending through an arc of about two hundred and seventy degrees. With the posterior surface662established, the laser surgery system10can be used to form an incision extending from the anterior surface664of the cornea24to the perimeter of the posterior surface662to establish an edge666for the flap660. Once the edge666is incised, the flap30can be raised to expose a bed of stromal tissue668. After exposure, the bed of stromal tissue668can be, for example, photoablated using an excimer laser (not shown). After photoablation with the excimer laser, the flap660can be repositioned over the bed of stromal tissue668and allowed to heal. The result is a reshaped cornea24. Intra-Stromal Corneal Incisions In many embodiments, the laser surgery system10is configured to create intra-stromal corneal incisions that can, for example, be used to correct refractive errors. For example,FIG.50is a cross-sectional view of a cornea illustrating an incised volume670that is separated from surrounding intra-stromal tissue of the cornea by enclosing incision surfaces created by the laser surgery system10. The illustrated incised volume670is axially-symmetric about the optical axis of the eye. The laser surgery system10can be used to form an access incision672of suitable configuration to allow removal of the incised volume670. Removal of the incised volume670results in reshaping of the cornea so as to modify the refractive properties of the cornea. One or more incised volumes of any suitable configuration can be incised and removed to reshape the cornea so as to modify the refractive properties of the cornea. For example, the incised volume670illustrated inFIG.50is configured to modify the refractive properties of the cornea to correct myopia. As another example,FIG.51illustrates an annularly-shaped incised volume674that can be laser incised by the laser surgery system10and then removed to reshape the cornea to correct hyperopia. The illustrated incised volume674is axially-symmetric about the optical axis of the eye. One or more additional incisions can be laser formed by the laser surgery system10to divide the incised volume670,674into suitably sized portions to facilitate their removal. While the illustrated incised volumes670,674are both axially-symmetric and configured to correct myopia and hyperopia, respectively, any other suitably configured incised volume(s) can be incised so as to effect a desired reshaping of the cornea corresponding to a desired refractive modification of the cornea. Corneal Inlay Pockets Referring now toFIG.52andFIG.53, which show a cross-sectional view and a plan view of a cornea, respectively, the laser surgery system10can be configured to create an intra-stromal pocket680in a cornea. The intra-stromal pocket680is configured to accommodate an inserted intra-stromal inlay. The intra-stromal pocket680is defined by one or more intra-stromal incision surfaces682,684that are laser incised by the laser surgery system10. For example, the intra-stromal pocket680can be defined by a single incision surface682(e.g., a circular planar intra-stromal incision) configured to accommodate and position an inserted intra-stromal inlay. The intra-stromal pocket680can also be defined by incising a volume and removing the incised volume to leave a three-dimensional intra-stromal pocket configured to accommodate and position an inserted intra-stromal inlay. For example, the intra-stromal pocket680can be defined by incising a volume bounded by the illustrated incision surfaces682,684, both of which are axially-symmetrically shaped relative to the visual axis of the eye. The laser surgery system10can be used to create an access incision686that extends from the intra-stromal pocket680insertion to the anterior surface of the cornea. The combination of the intra-stromal pocket680and the access incision686has an intra-stromal perimeter688and an exposed perimeter690disposed on the anterior surface of the cornea. An intra-stromal inlay can then be inserted into the intra-stromal pocket680through the access incision686without the creation of a full corneal flap. The intra-stromal pocket680can be formed so as to accommodate and position and/or orient any suitable intra-stromal inlay. For example, the intra-stromal pocket680can have a circular perimeter and be configured to accommodate and position a correspondingly sized circular disk-shaped intra-stromal inlay. As another example, the intra-stromal pocket680can have a non-circular perimeter of any suitable shape (e.g., ellipse, rectangular, polygonal) and be configured to accommodate, position, and orient a correspondingly sized and shaped intra-stromal inlay, thereby controlling the angular orientation of the inserted intra-stromal inlay relative to the optical axis of the eye. Such control of angular orientation of the inserted intra-stromal inlay can be used to, for example, treat astigmatism. An example of an intra-stromal inlay for which the laser assembly10can create a corresponding intra-stromal pocket680includes an opaque circular micro-disc with a small opening in the center, for example, the KAMRA™ inlay. DSEK/DMEK/DALK and PK Incisions The laser surgery system10can be configured to create corneal surgical incisions such as Descemet's Stripping Endothelial Keratoplasty (DSEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), Deep Anterior Lamellar Keratoplasty (DALK), and/or Penetrating Keratoplastic (PK). DSEK, DMEK, DALK, and PK corneal incisions are used to treat corneal diseases in which one or more portions of the cornea are dysfunctional and are surgically removed and exchanged. Because the laser surgery system10is operable to form precise corneal incisions, better clinical results and better patient satisfaction may result with regard to DSEK, DMEK, DALK, and/or PK corneal incisions as compared to less precise approaches. Enhanced Patient Clearance Referring now toFIG.54, in many embodiments of the laser surgery system10, the scanning assembly18and the objective lens assembly20are configured to provide a clearance700(e.g., between 100 and 250 millimeters in many embodiments with the illustrated clearance being approximately 175 millimeters) between the scanning assembly18and the patient24without using a lens relay. The clearance700is achieved by utilizing an optical design that is constrained by target physical size parameters while being configured to create precise incisions within a desired scan volume without using a lens relay. The clearance700is desirable for both the physician and the patient. For the physician, adequate clearance enhances visibility of the patient during the patient docking process, and provides room for the physician to grasp the objective lens assembly20directly for easy manipulation of the position of the objective lens assembly20relative to the patient. For the patient, the clearance700may help reduce the possibility of excessive patient movement that may arise due to patient anxiety stemming from a claustrophobic reaction to the proximity of the scanning assembly18. Significant design parameters relative to the configuration of the scanning assembly18and the objective lens assembly20include the desired scan volume (e.g., desired cut radius at each of various depths within the patient's eye), the strehl ratio (laser focused spot quality), telecentricity, desired patient clearance, number of optical elements (lenses), and not utilizing a lens relay. By balancing these parameters, a patient clearance of approximately 175 millimeters and objective lens housing of approximately 60 millimeters in diameter were achieved. An important aspect to achieving an efficient configuration for objective lens assembly20without the use of a lens relay is the use of a small number of high optical power negative and positive lenses. In the illustrated embodiment, the objective lens assembly20does not utilize a lens relay, which would require a larger number of lenses and create a patient clearance far in excess of that required to provide adequate access for the physician and of that required to adequately reduce patient discomfort due to a claustrophobic reaction to the proximity of the instrument. In contrast,FIG.55illustrates an objective lens assembly704that utilizes a lens relay (as evidenced by beam cross-over locations706,708) and has a clearance710of approximately 340 mm, which exceeds the clearance700of between 100 and 250 mm and is thus significantly beyond a presently preferred range of clearances for this application. In many embodiments, the scanning assembly18is also configured to minimize the diameter of the objective lens housing. For example, in many embodiments, the scanning assembly18includes an xy-scan device60, which is operable to deflect the beam28in two dimensions transverse to the direction of propagation of the beam28. In many embodiments, the xy-scan device60includes a single deflectable mirror that is controllably deflectable to scan the beam28in two dimensions transverse to the direction of propagation of the beam28. By using a single mirror as opposed to two or more mirrors, the diameter of the objective lens housing can be reduced due to the ability to avoid additional transverse displacement of the beam28associated with the use of two or more scanning mirrors. Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims. The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby. | 95,364 |
11857463 | DETAILED DESCRIPTION The present disclosure provides for the delivery of photodisruptive fluence levels of visible or infrared photons to the precise point of the target tissue of the eye by direct or fiberoptic delivery systems without impinging upon the overlying or surrounding tissue or upon the tissue at the region of beam entry into the eye for the purpose of effecting removal of select tissue in precise shapes and depths. Ultrashort laser pulses are directed into the eye either through the cornea or ab internally via fibers to enable laser radiation, including visible and infrared radiation, under gonioscopic control or through fiberoptic elements, including fiber lasers, thereby effecting precisely controlled photodisruptive removal of such target tissue of the corneo scleral angle. Such tissue may include TM, juxtacanalicular TM, and portions of Schlemm's canal, collector channels, aqueous veins and sclera. Preferably, a laser with pulse duration in the range from 20 fs to 300 ps is used, although it is to be recognized that even shorter pulse durations may be used. The laser uses an optical coupling to affect controlled photodisruption of the target. A coupling system employs a goniolens or an ab interno fiberoptic that precisely targets the outflow obstructing tissues to effect removal of the outflow obstruction. Such targeting may include localization of Schlemm's canal, detected optically or otherwise, such as by OCT (optical coherence tomography) or photoaccoustic spectroscopy. The optical system may also include features to enhance visualization of Schlemm's canal by controlling localized and diffuse pressure gradients, for example by creating relative hypotomy to induce blood reflux into Schlemm's canal. Means of coupling the globe of the eye optically to the laser beam delivery system may be included to enable the exquisite precision of the photodisruptive laser. Such systems include goniolens flange systems, including coupling capabilities such as suction, with diameters in the range of IO to 25 mm, fluidic chambers both to control intraocular pressure (“IOP”) and to maintain corneal clarity and shape. To enable optical pathways, such as planar surface to enable precision targeting, suction means for similar purposes which, in addition, exquisitely control light energy delivery registration to the target tissues. In the case of the fiber laser, the fiber may have multiple channels to control intraocular pressure, to enable visualization and optical coupling to Schlemm's canal. Preferably, the procedure for creating openings in the trabecular meshwork comprises: (1) imaging the target tissue, (2) locking a pattern to the image, (3) creating the pattern and controlling the depth of laser penetration, and (4) maintaining IOP to enable visualization of Schlemm's canal and concurrently controlling egress of blood to prevent optical decoupling of light obstruction for subsequent laser delivery to target tissue. Several 20 to 200 μm partial depth openings may be created concurrently without complete penetration to prevent blood reflux or other optical pathway obscuring elements after which Schlemm's canal inner wall penetration is effected to all sites concurrently. IOP is altered to affect this optical pathway, which is lowered to allow targeting of Schlemm's canal then elevated to prevent blood reflux. Gonioscopic an fiberoptic delivery systems for laser surgery in the eye wherein thermal and/or radiation damage to the eye is minimized are disclosed. In connection with glaucoma treatment, laser energy is applied gonioscopicay transcorneal or directed through the fiberoptic element. When gonioscopic, the deflecting mirror may be stationary or may have elements to adjust the mirror within the goniolens delivery system both to precisely target the subject tissue and to precisely direct femtosecond laser energy to these tissues. Such a mirror may be mechanically controllable to effect scanning. The gonioscope is coupled to the eye by various means, including prongs, clips, suction, viscoelastic, aqueous solution and inflatable balloons. The laser delivery system is also coupled both to the goniolens and via the goniolens to the target cornea-scleral angle tissues. The optical delivery is stabilized through precise control of the goniolens and goniolens mirror position and control of the femtosecond laser energy delivered to the target tissue by sensors which detect precise laser tissue interactions as they occur. The systems may include image stabilization to enable precise laser coupling to the docked goniolens device which includes a mirroring/light deflecting system to enable viewing and treating the cameo scleral angle structure at the laser delivery system, at the goniolens or fiber or both. In one embodiment a goniolens is applied to the cornea and a laser beam is focused on the target tissue. In another embodiment, a fiberoptic handpiece is passed through an incision in the eye where it is stabilized and secured to the globe and the laser beam is focused on the target tissue. In one goniolens configuration, a multidimensional mobile reflective surface (e.g., a Mylar balloon) is moved (horizontally, vertical and in depth) by inflation or deflation. This system can include fluidics to control temperature within the lens system. This configuration also may include concurrent illuminating beams and treatment beams with image capture for pixel to pixel image matching to control precise targeting when coupled to a mobile or curved target. In another goniolens configuration DLP (Digital Light Processing) optical semiconductors or equivalent are used to control the gonioscopic delivery. In yet another configuration, the system is capable of detecting cardiac cycle pulsation and the filling and emptying causing choroid translation of outflow structures by optical or ultrasound techniques, coupling the detection system to the optical delivery system to enable precise photo disruption of target tissue by means of a combination or individually: (a) mechanically controlled mirror, (b) piezoelectric controlled mirror, (c) DLP optical semiconductor, (d) surface reflecting fluid balloons (e.g. Mylar) included at the laser and/or within a gonioscopic delivery system. The goniolens air/surface optics are either plano or concave or convex. The mirror/light reflecting element optics are either plano, concave, convex, complex curved or in a segmented mirror array. Light altering materials include variable optical density fluid lair filled balloons, glass, plastic or metal shaped to enable photodisruption to occur at target regions which are both beyond the critical angle to the corneal surface and are curved, residing on the inner surface of a globe. The laser beam emitted from the laser source may be parallel, convergent or divergent and it is altered by the lens mirror system to enable all forms of emitted beams to focus with a suprathreshold photodisruptive fluence at the target tissue. In one configuration, the goniolens includes a pressure detection means to compensate for cardiac cycle translation of the entire globe/orbit structures/choroid and intraocular structures including detection of choroidal filling and emptying from cardiac cycle events, which may include pressure detectors in the goniolens or goniolens flange and software in the laser delivery system to compensate for this target translation to enable precise target photodisruption on the moving target. A concentric ring system may be used to enable (1) registration either through suction or through a retaining mechanical device (prongs, corkscrew) (2) IOP control (3) ocular pulsation detection. A bladder/balloon system may be used to control optical surfaces, including cornea and any internal mirroring surfaces to enable an emitter to best couple to the target tissue. In coupling the cornea, the cornea may be compressed (e.g. flattened) or the goniolens corneal surface may be curved and coupled to the corneal surface by optically neutral fluidic means, liquids and gels. In the case of a direct (e.g. non mirror) goniolens delivery system the direct goniolens is retained in a holding device coupled to an optic delivery system with mirror external to the goniolens. Such external mirroring enables the laser source and viewing optics to be inclined at angles from 10° to 170°, often 60° to 120° and most often 80° to 110° in relation to the target tissue. In the moving eye/goniolens complex the laser fires only when the target is optically captured and stabilized. These optical coupling mechanisms enable precise photodisruption at the target tissue in space and in depth. In the case of an ab interno fiber, the optical delivery is stabilized through precise control of the fiber position and control of the femtosecond laser energy delivered from the fiber tip by sensors which detect precise fiber tip position and alignment to the target tissue. The photodisruptive radiation is directed to the target tissues, namely corneoscleral angle structures comprising trabecular meshwork, juxtacanalicular trabecular meshwork, components of Schlemm's canal, and in some cases adjacent cornea, sclera, and iris structures to create fluid passageways between the anterior chamber of the eye and Schlemm's canal or alternatively the suprascleral/subTenon space or alternatively the suprachoroidal space. Photodisruptive laser energy is targeted to gonioscleral angle structures for the purpose of removing tissue which impedes aqueous outflow or to redirect outflow. Openings are created by patterns of adjacent photodisruption regions in this tissue. The patterns consist of various shapes in size ranging from surface dimensions of 20 to 200 microns and depth adequate to penetrate the inner wall of Schlemm's canal. Patterning enables openings to be created individually, sequentially or several concurrently. In one iteration, when concurrently, the depth is controlled at each opening to allow the creation of craters without entering SC until all craters are at a depth after which minimal additional tissue removal would enter SC thus enabling the optical pathway in the anterior chamber to remain clear. Only at this time would SC be perforated at each crater concurrently to minimize optical pathway obscuration by blood reflux from SC. In other iterations, in which the IOP is regulated to prevent blood reflux from SC, other patterning options are used, to create individual openings or several concurrent openings in from 1 to 12 clock hours of the angle. Surgical trauma to the outer wall of Schlemm's canal, or in the case of full thickness penetration to the overlying conjunctival and Tenon's tissue, all extremely subject to scarring, is thereby minimized. This is in contrast to current procedures which result in more scarring of sensitive ocular structures and therefore more rapid failure of procedures whose purpose is to control TOP. By minimizing trauma while creating an aqueous humor egress route, the present invention minimizes healing and increases longevity of improved outflow at the site of filtration. The present invention enables a significantly greater opportunity for success, including the ability to titrate the amount of photodisruptive energy necessary to result in a measured lowering of intraocular pressure. Referring toFIG.6, an overview of a method of operating a fiber-optic laser delivery system for treatment of glaucoma or other eye conditions follows:FIG.6is a side sectional view of the interior anatomy of a human eye showing fiber-optic probe23in relation to an embodiment of a method of treating glaucoma. After applying local and/or peri retrobular anesthesia, a small self-sealing incision14can be created in the cornea15with a surgical blade or femtosecond laser or other device. The anterior chamber can be further stabilized with a viscoelastic agent. Fiber optic probe23can then be positioned and advanced in the incision.14into the anterior chamber7to target the trabecular meshwork immediately or ab interno or a distal end of fiber-optic probe23contacts or is substantially adjacent to the target tissue for removal. Fiber optic probe23may be manually directed or held rigid in relation to the ocular structures via anchoring to the globe, sclera17or cornea15through devices which may include prongs56which also may hold in place a pressure regulating system55and an ocular pulse sensing system54. Laser energy is delivered from the distal end of fiber-optic probe23targeting the trabecular meshwork across the anterior chamber or in contact or adjacent to the tissues sufficient to cause photodisruption. Tissues to be removed include the trabecular meshwork9, the juxtacanalicular trabecular meshwork13and an inner wall of Schlemm's canal11. Fiber-optic probe23delivered photodisruptive energy creates an aperture in the proximal inner wall of Schlemm's canal11but does not perforate the distal outer wall. In some embodiments, additional apertures can be created in the trabecular meshwork and the target tissue following reposition of the probe. Thus by removing outflow obstructing tissues, the resultant aperture or apertures are effective to restore relatively normal rates of drainage of aqueous humor. Referring toFIGS.3-5, an overview of a method of surgical gonioscopic delivery systems for the treatment of glaucoma or other eye conditions follows:FIG.3shows an optical delivery system consisting of an indirect goniolens50attached to the sclera17mechanically or by prongs56or suction, with an internal mirror52. The mirror may be individual or segmented and fixed or mobile to enable scanning for both viewing and for treatment targeting. In the condition of a mobile mirror/mirror surface, the mirror52can be controlled mechanically or pneumatically or with a Mylar type surface reflecting balloon. The mirror can be plano, concave, convex and singular or in a segmented array. A beam51of pulsed radiation is generated by a femtosecond laser and delivered into the eye by the delivery system, including the goniolens50. The beam51is reflected by a mirror52which may be controlled by a servo system53connected to a controller58to focus scanning photodisruptive energy onto the curved surface of the target tissue. The optics enable bidirectional use, one direction is used to treat the target tissue, the other direction is used to view and/or sense the x, y, z coordinates of the targeted tissue to enable precise treatment and removal of the target regions. The beam51has a set of pulse parameter ranges specifically selected to photodisrupt targeted tissue of the trabecular meshwork, while minimizing damage to surrounding tissue. Thus, the beam has a wavelength between 0.4 and 2.5 microns. The exact wavelength used for a particular subject depends on tradeoffs between strong absorption by the meshwork and transmission of preceding ocular structures and aqueous humor.FIG.4shows an indirect goniolens50attached to the cornea15mechanically56or by suction with an internal mirror52.FIG.5shows a direct goniolens attached to the sclera17by suction57or mechanically with a mirror system52external to the goniolens. The pulse duration of the laser beam is chosen to have a high probability of photodisrupting material of the corneoscleral angle outflow tissues. There is an inverse relationship between the laser pulse duration and the energy required in each pulse to generate optical breakdown. The pulse duration is selected to be shorter than the thermal relaxation of the target so that only the targeted material is heated, and the surrounding tissue is unaffected. Thus, the pulse duration is between 20 fs and 300 ps. The pulse rate is between 1 and 500 KHz. The pulse energy is chosen to facilitate photodisruption and minimize the shockwave effect of the laser light. A typical value for the pulse energy is between 300 to 1500 nJ. The spot diameter is chosen such that sufficient laser energy density is provided to facilitate photodisruption of the trabecular meshwork tissue. The spot size is between 1 to 10 microns. The goniolens50is anchored either on the sclera17or the cornea15by a suction ring57or prongs56. The anchoring system is attached to a pressure regulating system55and an ocular pulse sensing system54. The anchoring system is either concentric57or segmented56. Scanning the spot in the x, y, and z direction effects patterns for tissue removal. FIG.7shows the target tissue to be photodisrupted in a perspective view70and in a cross-sectional view71. In this case a single site is demonstrated but understood is duplication of this site over several regions individually or concurrently. Alternatively, the TM may be approached ab externo via the semi-transparent sclera using high numerical aperture optics and a fundamental wavelength that allows deep penetration through the sclera. This produces targeted ablation of the deep corneo scleral angle structures, specifically targeting TM, JCTM and portions of Schlemm's Canal. In this instance the coupling lens could be planar or curved. All coupling lenses, goniolenses and fibers require focusing devices at the laser which couple optically to the lenses, goniolenses and fibers to effect appropriate fluences at the target tissue to effect micro ablations and thereby tissue removal. Preferably, the procedure for ultrashort laser pulse trabeculostomy comprises the steps that follow.1. Prepare patient for femto laser trabeculostomy procedure.2. Prepare femto laser which has been pretested on a model of trabecular meshwork for accuracy and fluence at the target tissue.3. Align gonio lens with optical alignment system of laser visualization system to target planned trabecular meshwork tissue sites and lock the target into the system for treatment.4. In the case where the gonio lens mirror is not stationary, but mobile, assure the tracking system is engaged to control all optical surfaces.5. Secure the gonio lens onto the eye. This may be pneumatic or physical engagement to control all movement and enable tracking system to engage and apply energy only when target is precisely focused for appropriate delivery of laser energy to the target sites. If mobile, laser will only engage when precise target alignment assures exact tissue targeting in x, y and z loci.6. Anchor the gonio lens either on the cornea or the sclera either by prongs or a suction ring.7. Attach anchoring system to a pressure regulating system and an ocular pulse sensing system.8. In the ease where cardiac cyclic translation of target is monitored and controlled, engage this system to enable precise depth targeting.9. Couple end of optical pathway to a fem to second laser.10. Locate Schlemm's canal with the gonioscope.11. The goniolens mirror may be curved to allow targeting of curved trabecular meshwork.12. Focus laser beam on target tissue.13. Photodisrupt target tissue until crater forms adjacent to Schlemm's canal.14. Repeat step 14. up to 10 times in a pattern, for example, from 5 o'clock to 1 o'clock.15. The patterns consist of various shapes in size ranging from surface dimensions of 20 to 200 microns and depth adequate to penetrate the inner wall of Schlemm's canal.16. Using the laser, concurrently extend craters so they become ostia into Schlemm's canal.17. Detach gonioscope.18. In the case where femto laser energy is delivered fiberoptically within the eye, all above apply. In addition, following paracentesis and stabilization of the anterior chamber with aqueous and/or viscoelastic agents, the fiberoptic delivery system is placed into the anterior chamber and imaging of all relevant structures is performed to assure targeting to planned sites. The fiber and fiber position maintaining devices are engaged and enabled, manually and/or automatically. The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, to exclude equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims that follow. | 20,284 |
11857464 | InFIG.1, a flow diagram is shown of an embodiment of a method of producing a pair of goggles. In the embodiment ofFIG.1, it is shown that inputs are provided to a processing unit1. The inputs may comprise a plurality of 2D-images100of the face of a user and information regarding the dimension101of the face of the user in the 2D-images at least in the area around the eyes of the user. Based on said inputs, the processing unit1is adapted to produce 3D-data102defining the contour of the face of the user and defining the dimension101of the face of the user at least in the area around the eyes of the user. Alternatively, 3D-data102defining the contour of the face of the user and defining the dimension101of the face of the user at least in the area around the eyes of the user may be provided directly to the processing unit1. The 3D-data102may comprise a 3D-image and information regarding the dimension of the 3D-image. The 3D-data102or 3D-image may e.g. be detected by use of a 3D-camera such as a range camera or a stereo camera. The 2D-images100and/or the 3D-data102may be produced/detected by the user e.g. by use of the camera function in the user's smartphone. The production and/or collection and/or transmittal to the processing unit1of the 2D-images100and/or the 3D-data102may be carried out by use of a specially developed application program (app) installed on the user's smartphone or tablet. The contacting surface103, which defines the surface on the face of the user intended to contact the goggles, when the user is wearing the goggles, is determined based on the 3D-data102. Data regarding the contacting surface103may be defined automatically by the processing unit1based on pre-defined contact areas104. Alternatively, the processing unit1may be provided with information regarding contact areas104on the face of the user, where the contacting surface103should at least be located, and the processing unit1may model the location of the contacting surface103based on this information. The contact areas (facial points) may be identified by use of vectors. Thus, contact areas may be determined based on vectors at points at the eye inner and eye outer corner, and vectors defining the structure change of the face at points going from those locations and away from the eye in a horizontal direction, as well as vectors defining the structure changes of the face at points going from the middle of the eye and a certain distance away from the eye in a vertical direction. The contact areas may be determined this way by vectors not just at a few locations around the eyes, but may be determined at several locations around the eyes so that an optimal contacting surface is obtained. Thus, as an example, the vertical location of the goggles may be determined (calculated) from vectors at points starting from the middle of the eye and moving upwards/downwards in the vertical direction. When the vectors reach a predefined angle relative to the face of the user (pointing away from the face), a contacting area on which part of the goggles is to touch the face of the user is located. The horizontal location of the goggles may be determined by use of vectors at points starting from the eye inner corner and going towards and up the nose. When the vectors reach a predefined angle relative to the face of the user, a contacting area on which part of the goggles is to touch the face of the user is located. This technique of determining contact areas may be used at several locations around the eyes so that an optimal contacting surface may be determined and an optimal pair of goggles for the user is produced. As written above, the contacting surface may also be determined based on only one contact area and a contacting surface of a predefined shape. In this case, the contact area may be determined from vectors at points starting from e.g. the eye inner corner and going towards and up the nose. When the vectors reach a predefined angle relative to the face of the user, a contacting area on which part of the goggles is to touch the face of the user is located. The optimal contacting surface may be arranged in the vicinity of the edges of the skull of the user, which edges define the eye sockets. Thus, if the position of the contacting surface is altered only slightly (e.g. 2 mm), the contacting surface is possibly not positioned optimally anymore, which may result in that water enters the eyes of the user. Based on inter alia the provided 3D-data102and said contact areas104, the processing unit1may model structure-data105, which can be used for designing at least the part of said goggles106, which is adapted to contact the face of the user, i.e. for designing a user contacting part reproducing the contour and dimension of the face of the user at the contacting surface103. An input of the structure-data105may be provided to a production unit2adapted to receive said input of structure-data105and to produce at least the part of said goggles106(the user contacting part), which is adapted to contact the face of the user, when the user uses/wears the goggles. The production unit2may also produce the entire goggles (e.g. the user contacting structure, or the user contacting structure and goggle frame) so that there is no need for assembling the goggle frame and the user contacting part after their production. An app installed e.g. on the user's smart phone may control the production and/or collection and/or transmittal of the 2D-images100and/or the 3D-data102, however may also carry out the analysis of the 3D-data102and provide the structure-data105. An input of structure-data105can then be provided to the processing unit1or directly to the production unit2. The production unit2should be adapted to produce at least part of said goggles106based on said structure-data104or to produce a form to produce at least said part based on said structure-data104. The production unit2may use one of various techniques such as printing or casting said goggles, or grinding/cutting out said goggles from a base material, etc, automatically or manually. The base material may form at least the part of the goggles, which is adapted to contact the face of the user and may initially be oversized, but during the production be cut such that the goggles fits directly to the skin of the user. The size of the separation length (e.g. how much of the base material has to be cut off) may inter alia depend on the contour of the face of the user and on how large the root of the nose is. The applicant has found that the production unit2may advantageously be a 3D-printing unit such as a 3D-printer, which is a well-established and tested means for printing a 3D-element with a complicated structure in a fast and precise manner. Today, various types of 3D-printers are commercially available several of which may be applied in the present method depending on inter alia the required material of the part of said goggles to be produced. InFIG.2, an exploded view of a pair of user-customised goggles3is seen in perspective from the back. The user-customised goggles3may comprise a goggle frame4and a user contacting structure, which may comprise a first5and a second user contacting structure6. However, it is foreseen that the goggle frame4and the first5and second user contacting structures6may be produced as one unit. The goggle frame4ofFIG.2may comprise a first7and a second glass or lens frame8comprising a first9and second opening10adapted to accommodate the glasses11or lenses11of said goggles3, through which the user can see, when wearing the goggles3. Each of said first7and second glass or lens frame8may comprise an inner surface7′,8′, respectively. The first7and second glass or lens frame8may be connected by a connection piece12. The goggle frame4may further comprise a first13and a second side bar14, each comprising an aperture15configured for connecting to an elastic or flexible strap for securing said goggles3to the face of the user. Each of the first7and a second glass or lens frame8of the goggle frame4may comprise a groove16,17. The first5and second user contacting structure6may comprise a first18,19and a second surface20,21, respectively. Said first18,19and second surfaces20,21may be separated by an outer22,22′ and inner surface23,23′, respectively, of the first5and second user contacting structures6. Said outer22,22′ and inner surfaces23,23′ may be parallel and/or not parallel. Said first18,19and second surfaces20,21may be separated by a separation length (i.e. a width of said outer22,22′ and/or inner surfaces23,23′, respectively), which may vary depending on the location on said user contacting structures5,6. Thus, the width/thickness of the user contacting structure5,6relative to their central axes A,A′ may vary. The first surfaces18,19of said user contacting structures5,6may each comprise a user contacting part24,25adapted to contact the face of the user, where the user contacting part24,25reproduces the contour and dimension of the face of the user at the contacting surface on the face of the user. Thus, the shape and the size of said user contacting part24of said first user contacting structure5may be different from said user contacting part25of said second user contacting structure6, and the shape and size of said user contacting parts24,25may each vary from user to user, as the contour of the face varies from user to user. Said user contacting parts24,25may comprise a membrane comprising a flexible material arranged at said first surfaces18,19to contact the skin of the face of the user, when the user wears the goggles. The membrane ensures a comfortable and sealing fit between the face of the user and said goggles. The second surfaces20,21of said user contacting structures5,6may each comprise a ridge26,27adapted to engage with the grooves16,17of the first7and second glass or lens frames8of the goggle frame4so that a solid and leak free connection is provided between the user contacting structures5,6and the goggle frame4. Other types of engagement means such as broken grooves/ridges, protrusions/recesses, adhesives, etc. are foreseen within the present application. The first5and second user contacting structures6may each comprise an inner opening28,29through which the user can see, when wearing the goggles3. InFIG.2, an examples is shown of the first5and second user contacting structures6prior to the shaping the first surfaces18,19of the first5and second user contacting structures6(referred to as5′ and6′, respectively). InFIG.3, an exploded view of a pair of user-customised goggles3is seen in perspective from the front. For similar features as shown in the previous Figs., similar reference numbers have been used. InFIG.3, the goggle frame4is shown to comprise said glasses11or lenses11of said goggles3, where said glasses11or lenses11of the goggles3may be transparent, so that the user may see through the said glasses11or lenses11, when wearing said goggles3. InFIG.3, it is shown that the second surfaces20,21of the first5and second user contacting structures6may each comprise the ridge26,27adapted to engage with the grooves16,17(not shown) of the first7and second glass or lens frames8of the goggle frame4. Thereby, a solid and leak free connection is provided. The engagement may include a sealant, such as a flexible gasket, arranged between said ridges26,27and said grooves16,17, and/or the engagement may include an adhesive, such as a glue or paste, arranged between said ridges26,27and said grooves16,17. InFIG.4, an exploded view of a pair of user-customised goggles3is seen from above. For similar features as shown in the previous Figs., similar reference numbers have been used. The first18,19and second surfaces20,21of the first5and second user contacting structures6are shown to be separated by inter alia said outer surfaces22,22′ defined by a separation length30,31, respectively, which as shown may vary across said outer surfaces22,22′ of said first5and second user contacting structures6, and which may depend on the contour of the face of the user on the contacting surface on the face of the user surrounding the eyes of the user. It is seen that said first surfaces18,19of the first5and second user contacting structures6may have a varying gradient and a varying course relative to said inner23,23′ and outer surfaces22,22′ (and the central axes A,A′) of the first5and second user contacting structures6, as said first surfaces18,19(and said user contacting parts24,25) reproduces the contour of the face of the user. InFIG.5, an exploded view of a pair of user-customised goggles3is seen from the side. For similar features as shown in the previous Figs., similar reference numbers have been used. The height32of said first5and/or second user contacting structure6may be similar or different from the height33of the goggle frame4depending inter alia on the chosen contacting surface on the face of the user and on the type of goggle, e.g. swimming goggles or diving goggles. InFIG.6, a pair of assembled user-customised goggles3is seen from above. For similar features as shown in the previous Figs., similar reference numbers have been used. It is shown that the first5and/or second user contacting structures6may protrude at least partly out from a back side34,34′ of said goggles3so that at least the user contacting parts24,25of the first surfaces18,19of said user contacting structures5,6is adapted to contact the face of the user, when the user wears said goggles3. Alternatively, only said first surfaces18,19protrude from the back side34,34′ of said goggles3so that the goggle frame4encircles the outer surfaces22,22′ of said user contacting structures5,6. The goggle frame4and the user contacting structures5,6may be produced as one unit so that no following assembly is required. InFIG.7, a pair of assembled user-customised goggles3is seen in perspective. For similar features as shown in the previous Figs., similar reference numbers have been used. | 14,049 |
11857465 | DETAILED DESCRIPTION The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. It will, however, be apparent to those skilled in the art that these concepts may be practiced without these specific details. In some instances, well known structures and components are shown in block diagram form in order to avoid obscuring such concepts. According to some health organizations, one concept of infection control is to prevent or stop the spread of infections in the healthcare setting. Separating or isolating infectious organisms from a clean environment by utilizing a physical barrier limits the spread of the infectious organism. Several aspects of an air isolation apparatus or box will now be presented with reference to various apparatuses and methods. These apparatuses and methods will be described in the following detailed description and illustrated in the accompanying drawings by various blocks, modules, components, steps, processes, etc. (collectively referred to as “elements”). While the methods may be described in an ordered series of steps, it will be apparent to those skilled in the art that the methods may be practiced in any operative order and each step may be practiced in various forms that are apparent to those skilled in the art. Air isolation apparatus, isolation apparatus, box, intubation box, isolation system, system, or simply apparatus may be used interchangeably in the disclosure. In some examples, patient isolation apparatus/structure/box/system may be used interchangeably with Air isolation apparatus. In some instances, these terms may refer to the entire system including the structure, and accessories such as an intravenous (IV) pole, filtration system, etc. In other instances, the terms may simply refer to the structure itself not including any or all of the accessories. Some exemplary measurements may be provided throughout the specification by way of example and not of limitation. When a numerical value and/or measurement is provided, it is understood that the dimensions may be smaller or larger according to preference or design requirements. A portable collapsible air isolation apparatus may be versatile, yet provide a portable protective barrier enclosure designed to prevent an operator of the apparatus and their equipment from exposure to pathogenic biological airborne particulates, such as SARS-CoV-2, an infectious respiratory virus. In some embodiments, the apparatus may provide a non-permeable physical barrier that effectively separates infectious aerosolized droplet particles from the surrounding environment, by containing the patient's infectious droplets within its micro-environment. An operator may be used interchangeably with health care provider. Health care provider may include, without limitation, practitioners, including physicians, physician assistants, pharmacists, dentists, nurse practitioners, nurses, respiratory therapists, paramedics, emergency medical technicians, physical therapists, technologists, dental assistants, or any other practitioners or allied health professionals, etc. that have a role in using a device for human use. “Operator” may be one or more of any combination of health care practitioners. This medical device may be a transparent physical barrier designed to cover a patient's head and upper body that incorporates access ports, sealed by Federal Drug Administration (FDA)-grade silicone rubber, to allow for isolated patient access through which the operator's hands may be passed to perform medical procedures. Due to its mobile capability, the protective barrier enclosure may be utilized by first responders upon the initial point of contact with a confirmed infectious, or suspected to be infectious, patient. By isolating a patient from the initial point of contact, the risks of spreading deadly diseases such as SARS-CoV-2, through aerosolization and fomite transfer may be significantly reduced. Those skilled in the art will recognize that the description provided herein is by way of example and of limitation. In other embodiments, the air isolation apparatus may be used with robots or remote-controlled robotic systems. In yet other embodiments, the air isolation apparatus may be used in mixed environments with a mixture of human attendants (operators) and machinery or robotic systems. For example, robotic systems may provide for routine or pre-programmed procedures on a patient through the air isolation apparatus, while humans may provide specialized procedures (either before or after the robotic assistances). In some embodiments, the apparatus may provide an additional layer of barrier protection in addition to personal protective equipment (PPE) against airborne particles or droplets expelled from patients or the attending healthcare provider. In this manner, the apparatus may provide protection to one or both of the healthcare provider and the patient. While the apparatus may provide for significant protection, in some instances, the apparatus may not be intended to replace the need for PPE or room/equipment sanitation and disinfection procedures. Because the apparatus is portable and collapsible, the apparatus may be removed if to avoid impeding an operator's ability to care for a patient or impeding the operator's ability to perform a medical procedure on the patient. The patient may be under direct observation and receive supplemental oxygen via portable or wall-mounted medical air during use of the apparatus. The design of the apparatus may provide fast and speedy deployment based on the foldable configuration that allows the apparatus to be deployed in a few easy steps. As well, the apparatus may be folded up when the operator is finished with use of the apparatus. Fast deployment provides significant benefits to both the patient who can receive immediate care, while also provide benefits to the operators who will be protected from possible pathogens from the patient. Another benefit of the design may include safety in deploying the apparatus and safety in usage of the apparatus. The apparatus may also be designed with the features of portability and versatility. In one embodiment a gurney attachment system may be provided for enhancing the functions of the apparatus. In some embodiments, the gurney attachment system may be a proprietary system design to be suitably used with the apparatus. The gurney attachment system may include two components of an anchor and a brace. Together, the anchor and brace allow the apparatus to be quickly attached to most gurneys and hospitals beds, and to be safely used during transport of a patient, decreasing chances of injury to the patient or operator. The brace may also prevent the apparatus from sliding forward and down when the head of the gurney or bed is elevated to Fowler's position (e.g., a standard patient position where the patient may be seated at any angle including 45-60 degrees), allowing the patient to sit upright and breathe more comfortably. In one aspect, the apparatus may be configured as a proprietary multi-purpose apparatus with ample interior space for working with the patient. The apparatus may be configured to contain the spread of infectious aerosolized droplets within a small footprint, while still allowing ample room for an operator to freely maneuver medical instruments inside of the apparatus. In another aspect, the apparatus may be configured to provide safe access to a patient without physical restrictions. The wide main access panel may allow the operator to have unrestricted access to the patient including the patient's cephalic region, providing the operator with sufficient range-of-motion to render various life-saving medical procedures or treatments without the typical constraints associated with an intubation box. In some embodiments, the apparatus may include a self-sustaining filtration system that allows the apparatus to be used for any duration including long durations. For example, by supplying a 3M® HEPA filtration system, the apparatus may be able to sustain its own negative-pressure micro-environment, without the need of an external source of suction (e.g., a hospital suction line), for up to eight hours or more as a patient is being transported. In some embodiments, the filtration system may be powered (e.g., battery or electricity powered) using any number of filter elements; in other embodiments, the filtration system may be a passive (non-powered) system. A storage box found on the operator side (e.g., the side used by an operator to serve the patient) of the unit may allow for convenient access and protection of all the mechanical filtration components, as well as an IV Pole. The apparatus provides many benefits including early isolation. Isolating a patient with infectious or potentially infectious aerosolized droplets and other pathogens from the first point of contact in the field may significantly reduce the risk of inadvertently spreading a deadly respiratory disease, such as SARS-CoV-2. Another benefit may include durability of the embodiments. The apparatus may be comprised of lightweight and durable aluminum, which provides a structural framework for the flexible and highly impact resistant polycarbonate panels that may compose the apparatus. One or more panels may form a frame of the apparatus. One skilled in the art will recognize that materials may vary based on design or user preference. While some embodiments show rigid panels and structures, the disclosure is not so limited. In some examples, non-rigid structures and materials may be used where suitable based on user preference or design. In other embodiments, the materials may be selected from any variety of metals, woods, plastics, polymers, ceramics, glass, hybrids, etc. Non-rigid materials may be used where suitable, with such materials including fabrics/textiles (whether natural or synthetic), foams, etc. Another benefit of the embodiments may include providing access to various points of the patient. For example, the apparatus may include holes or openings at any of the surfaces including the top, side, rear (facing from the open side). For example, the apparatus may be equipped with various access points (e.g., main access panel, auxiliary access panel and semi-circular arm port) which may allow first responders and operator to safely, properly, and effectively render the vital care a respiratory-compromised patient may require. The apparatus may enable a patient-focused perspective. For example, multiple respiratory treatment modalities may be utilized. By allowing operator and first-responders to safely perform aerosol generating procedures (AGP) such as intubation, emergency continuous positive airway pressure (CPAP), bi-level positive airway pressure (Bi-PAP), high flow nasal canula (HFNC), and nebulized breathing treatments out in the field, a patient's chances of survival may be significantly increased due to the earlier onset of medical care received. As well, the apparatus provides the ability to render necessary life-saving treatments/procedures earlier on during the course of infection that may significantly increase a patient's chances of survival. Yet another benefit of the apparatus may be lowering costs by keeping healthcare employees safe, preventing the spread of germs and pathogens, decreasing costs on cleaning supplies, and potentially decreasing staff call-outs. In the various embodiments, some features of the apparatus may include a foldable design, with an apparatus that may fold down to a height of five inch or less; other embodiments may fold to a taller height based on design or preference. Another feature may include a collapsible design, with the apparatus being able to be collapsed in as few as ten seconds or less; other embodiments with increased features or based on design or preference may fold in greater than ten seconds. Yet another feature may include fast and speedy assembly, with the physical barrier that may be quickly assembled in ten seconds or less; other embodiments with increased features or based on design or preference may be assembled in greater than ten seconds. Some embodiments may include generous interior dimensions providing ample room for an operator to comfortably perform necessary procedures/treatments without the typical constraints of other embodiments. Yet another feature may include fast and speedy full apparatus assembly, including assembly of the entire system which may include the apparatus, motor with filter (e.g., a 3M® motor with HEPA filter), and clear drape which may together be assembled in at little as one and a half minutes or less; other embodiments with increased features or based on design or preference may be assembled in greater than one and a half minute. While the disclosure includes a motor in some embodiments, those skilled in the art will recognize that any variety of mechanisms to provide negative pressure may be used, including the motors, other electro-magnetic systems, induction systems, fans, blower motors, or any other mechanical or hydraulic type system, etc. Another feature may include a portable design including preset mounts which may be in place with attachment elements (such as carabiners) for a shoulder strap, as well as a conveniently placed carry handle. Another feature may include a stackable design, wherein when multiple apparatuses are stored together, they may be stacked on top of each other, and the central safety catch of the apparatus on top (of each corresponding pair of apparatuses) will interconnect through a slit that is located at the top of the corresponding bottom apparatus. Another feature may include a versatile design including an apparatus able to be deployed and safely operated on any standard gurney or hospital bed with (e.g., any size including from two inch to six inch mattress thickness) without interfering with the transport and maneuvering of the gurney or hospital bed. Another feature may include being self-contained and self-sustaining, with the apparatus supplying its own intravenous (IV) pole (e.g., to hang IV fluid bags), as well as a 3M® motor, HEPA filters, and a battery (which may include an intrinsically safe battery with up to eight hours or more of battery life). Another feature may include a re-usable design with any or all components being re-usable between patients after proper disinfection; in some embodiments the drape (e.g., a clear plastic drape, fabric, etc.) may be a one-time use item. In some embodiments the reusable components may be disinfected with a variety of cleaners including hydrogen peroxide, soap, water, bleach (including in diluted form), as well as Sani-Cloth®. The apparatus may include panels with transparent or see-through material such as plastics, polycarbonates, glass, etc., which may be durable and highly impact resistant. In some embodiment, the apparatus may use panels having a thickness of up to ⅛″ or 1/16″ or greater. The apparatus may be hinged (e.g., using piano or spring hinges) at the base and/or other edges. When the apparatus is assembled, the edges may be sealed (e.g., with polycarbonate channels) to ensure that the infectious aerosolized droplets do not escape to the surrounding environment. Alignment of the panels may be achieved through various means including using any combination of tabs, neodymium magnets, velcro, latches, etc. to keep the center panels properly aligned over the bilateral side panels while also maintaining its shape. The apparatus may be disinfected with a variety of cleaners including: hydrogen peroxide, soap & water, bleach (e.g., 10:1 dilution), and Sani-Cloth®. Some embodiments may include unique custom designs including magnet channels and methods of attachment. There may be custom stainless steel magnet channels (in some examples there may be eight such channels) that are designed to hold and channel both the north and south poles of an N52 neodymium bar magnet in one direction, towards a stainless-steel strike plate. All stainless-steel parts may be passivated for extra corrosion resistance. In some embodiments, there may be two magnet channels that are located towards the base of the apparatus, with one attached to the frame via the square aluminum tubes located on each side. The two corresponding strike plates for these magnets may be attached to the outside of each of the side panels. These magnets may serve to maintain the stability of the side panels as well as aid with keeping them erect and aligned when the apparatus is being setup and assembled. In some embodiments, there may be two magnet channels that are located on the vertical backing plate with its corresponding strike plates located towards the base of the front panel. There may be two corresponding strike plates located on the back of the rear panel. These two magnet channels may have a dual purpose, which may be to maintain the stability of the front panel during assembly and use, as well as attaching to the rear panel when the apparatus is collapsed for storage to keep the apparatus from unintentionally opening. There may be four magnets located at the bottom side of the apparatus, which serve to maintain the swing arms in position. They aid with keeping the swing arms in place when flipped forward to stay in position and maintain the protection of the edge of the polycarbonate apparatus that extends out. When the swing arms are flipped backward, and the apparatus is installed on a gurney or hospital bed, the magnets keep them stored in place. These magnets may also be replaced with spring hinges that are loaded to close (or biased/tensions to close). The lid of the box may also be held by two small magnets, or two spring hinges loaded to close (or biased/tensions to close). There may be four magnet channels that may be strategically placed on the top of both side panels, with one towards the operator side and one towards the patient's side, per panel. These four magnet channels may be held in place on the polycarbonate panels via two roll pins that penetrate the layers of material (e.g., three layers), which may consist of two layers of the stainless-steel channel and the polycarbonate panel sandwiched in between, firmly holding them in place. Four strike plates which may have a similar design with the roll pins for attachment, may be located on the far lateral sides of the lid/center panels and correspond to the location of the magnet channels. This system may keep the center panels properly aligned over the bilateral side panels and maintain the apparatus's shape and rigidity throughout use. These magnets may prevent the lid from slipping and collapsing down towards the patient during use or transport. In some embodiments, the apparatus may include a cover or drape over some or all the structure. In some embodiments, the cover(s) may be designed to be draped over the top of the apparatus via the rear panel, tucked over areas of the patient's body (e.g., including the caudal region), around the shoulders and arms, and then non-permanently locked inside two tension locks found on both sides of the apparatus. The drape may create a seal around the patient's upper body, containing any infectious aerosolized droplets that may escape, and complements the apparatus structure and filtration system in creating a negative pressure micro-environment. For example, the filtration system may create negative pressure (i.e., the pressure inside of the apparatus is lower than the pressure outside) within the apparatus so that germs do not escape the inside into the outside environment. In some embodiments, the seal around the patient's thoracoabdominal region may not be air tight, which allows a sufficient influx of ambient air to enter and move towards the apparatus as the filter motor and filter draw contaminated air out of the apparatus, filtering it in the process. The drapes may allow operators and first responders to safely perform cardiopulmonary resuscitation (CPR), while still being protected from the patient's infectious or potentially infectious aerosolized droplets that are being compressed out upon exhalation while they are performing chest compressions. The base may be made up of a lightweight frame material such as aluminum with certain components made up of stainless steel, such as the IV pole and IV pole base, as well as the mechanism that attaches the proprietary anchor and brace system. In some embodiments, the base may maintain the structure and rigidity of the apparatus when it is fully assembled. The base may be the unifying structure which allows the apparatus to be safely adapted for use on gurneys and hospital beds via its attachment to the anchor, brace, and accessory components. The accessory components may include any or all of the components other than the main structure; in some embodiments, the accessories may include the IV pole, motor, filtration system, drapes, etc. The configuration may also provide protection and easy transport of the collapsed polycarbonate panels, filtration system, and accessory components. In some embodiments, the apparatus may include an IV pole, as well as a filter motor (e.g., a 3M® filter motor), HEPA filters, and an intrinsic battery (e.g., one lasting up to 8 hours or more). This configuration may allow the negative pressure micro-environment to be maintained throughout the transportation of a patient on a gurney/hospital bed, without the need of an external source of suction (such as a hospital's suction line). FIG.1is the apparatus100as viewed from the patient's side102with the operator's side left panel104towards the far left end. For reference, when viewed from the operator's perspective104, the panel130is the “right” panel, and panel140is the “left” panel. The apparatus may include three access points, with the one access panel (e.g., a main access panel) (at the back from the patient's perspective102or front from the operator's perspective103) of the apparatus100having the largest opening; in some embodiments the main access panel (obscured inFIG.1). The auxiliary access panel132may measure 6″ wide×8″ tall and may be custom installed depending on provider preference on the left and/or the right side panel130,140. This auxiliary access panel132may permit an operator/assistant to quickly and safely introduce necessary equipment that the operator may require, such as a stylet, bougee, laryngoscope, endotracheal tube, emergency CPAP device, bag-valve mask (BVM), or to provide assistance. Another opening, arm port134, (which may also be called the third access point) may be a semi-circular arm port5″ in diameter, which allows an operator/assistant to safely insert their arm into the apparatus100to continue with life-saving bag-valve mask (BVM) compressions without completely breaking the seal formed by the clear plastic drape. The main and auxiliary access panels132may be designed to self-close and may be kept sealed in place by an attachment mechanism including magnets, Velcro, latches, snap fastener, etc. Both panels132and the arm port134may be lined by Food & Drug Administration (FDA) grade silicone rubber which may have cutouts to accommodate the operator's arms. The silicone rubber templates may be held in place by a polycarbonate frame, which may be attached via thumbs screws, allowing them to be quickly replaced as needed. While the embodiment ofFIG.1shows rubber flaps in the openings auxiliary access panel132, arm port134, those skilled in the art will recognize that various suitable designs may be used based on preference and requirements. For example, in some embodiments, the openings auxiliary access panel132, arm port134may be coupled to long gloves (e.g., also used in glove boxes) such that there are no air gaps or holes. Yet other embodiments are possible using other elastic or flexible materials. The panel130may include an access port138to install a motor (not shown) that may be used for filtering air and/or to create a negative pressure within the apparatus100. Such port may be called a suction port. In some examples, such as illustrated inFIG.1, the access port138may be a circular port lined with a rubber grommet to install the motor. The motor may draw air out of the space within the apparatus100. In some embodiments, the motor may be a 3M® HEPA filter motor. In some embodiments, the motor may be fixed and/or permanently attached to a panel130,140with air gaps minimized using sealing material. In some embodiments, the opposite side140(right side from patient's perspective102) may be similarly designed and a mirror image of the left side130, including an auxiliary access port and/or arm port. In some embodiments, the oppose side140may or may not include the motor port138. The left130and right140sides may include any combination of the access ports based on user preference and design. For example, in some embodiments on the left panel130includes access ports; in other embodiments, only the right panel140includes access ports. In yet other examples, there may be one access port on one side and two access ports on the other side. Any number and type of ports may be present on either panel130,140. In some embodiments, the panel155may have two bilateral corners156a-b(e.g., at 45 degrees) located at the top left and top right of the panel155. This design may prevent the sharp corners from tearing into the drape (e.g., clear plastic drape not shown) that is installed on the apparatus100. It may also allow the drape to be easily folded upon itself along the edge, forming a “buffer-zone” that contributes to the seal of the apparatus100. As illustrated inFIG.2, there may be two semi-circular cutouts157a-bat the midline of the rear panel. The cutouts may allow the operator to easily reach through the rear panel160to collapse the apparatus. Some embodiments may include the protective shield122. When the apparatus100is collapsed and not in use, the L-shaped protective shield122may be flipped forward into position (as shown inFIG.1) to protect the underside of the apparatus100and its flex panel deflectors. Before the apparatus100is fully deployed and attached to a gurney or hospital bed, this protective shield may be released and pulled back towards the operator before use. This shield122may be swung back towards the operator, and the base120is placed on top of a gurney or hospital bed. The shield122may serve a secondary function by helping to stabilize any left and right swaying movement of the apparatus that may occur while on the gurney or hospital bed. FIG.2is a view of the exemplary collapsible apparatus100as viewed from the operator's perspective. The panel160may be called the “rear” panel if seen from the patient's perspective or the “front” panel if seen from the operator's perspective. As described above, on either one of the side panels130,140may be included an auxiliary access panel, semi-circular arm port, and a two-inch access port lined by a rubber grommet, for placement of a motor and filter. The panel that does not contain the auxiliary access panel, semi-circular arm port, and two-inch access port, may have a six-inch fiberglass reinforced rubber silicone handle232attached to it, e.g., via two barrel bolts. The handle232may be placed towards the operator and in the lower half of the panel140. The handle232may provide for ergonomic accessibility when lifting the panel upwards to assemble. Some embodiments may include an IV pole210. The IV pole210may be made out of metals or other solid materials including stainless steel (e.g., 304 stainless steel) providing for high corrosion resistance. The IV pole210may be attached to the storage box220through a uniquely designed hook and slot system that allows the IV pole210to be secured safely when not in use as well as when it is erected vertically with an IV bag attached (not shown). The specially designed hook and slot system may prevent the IV pole210from coming apart from the component storage box220while the apparatus is being transported. The apparatus100may utilize the weight of the attached base of the apparatus and gravity to keep the hook stabilized in the slot, unless it is manually lifted up and pushed forward out of the horizontal slot, sliding it out of the adjacent opening. Once the IV pole210clears the slot, it may be rotated 90 degrees to the right, and the reverse operation may be performed. The same hook on the IV pole210may be slipped forward through the vertical slot located about an inch away, then the IV pole210may be allowed to slide down the angle of the slot, into an adjacent slot on the right. The adjacent slot may prevent the hook from being pushed back out of the slot, unless the entire IV pole210is lifted up and slid to the left against the angled slot and out of the first slot. Once the IV pole210is in the vertical position and ready to be used, the lid222of the storage box220is closed, and contains another slot that wraps around the IV pole210itself. The slot in the lid further prevents the IV pole210from swinging/swaying while the gurney is in motion, and in the back of an ambulance. The slot in the lid222prevents any initial motion that could aid with the unwanted slipping of the hook up and out of the secured position. In addition to the slots that secure the IV pole210in place, there may also be a stainless-steel base attached at the bottom of the IV pole210, which may act as a counterbalance, and aid with securing the IV pole210by preventing it from getting unintentionally knocked upwards during transport over bumps. The embodiment may prevent unwanted and unintentional movement of the IV pole210while it is in the functioning, vertical position, as well as in the stored, horizontal position. In some embodiment, the top of the IV pole210may have an L-shaped, 90-degree angle hook211that IV bags can be placed on. The IV pole210and IV hook211may be made of standard sized ⅜″ diameter stainless steel rods, which may be highly corrosion resistant. The IV hook211diameter may be universal, allowing for the attachment of any standard medical IV bag. Those skilled in the art will readily recognize that any of a variety of mechanisms may be used to secure the IV bag or to provide hydration to the patient. In some embodiments where the IV bag or hydration is not necessary, the IV pole210may be omitted for configurations of the apparatus100, or the IV pole210may be folded away in cases where the IV pole210is included in the configuration of the apparatus100. In some embodiments, the IV pole210may be an integrated and/or permanently attached component of the apparatus100with a folding mechanism that easily folds out of the way and folds into the extended configuration. In some embodiments, the IV hook211may accommodate a liter bag of IV fluids, while other embodiments may accommodate more than one bag of smaller volume medications/fluid bags. Shown onFIG.2are knobs or handles240a-bfor adjusting the mounting system of the apparatus100. A gurney/bed attachment mechanism250is also shown. The attachment mechanism250is used to secure the apparatus100to the gurney and/or bed. Those skilled in the art will recognize that other attachment mechanisms are possible as dictated by user preference or design. In other embodiments, the knob/handle204a-bmay be larger or smaller, round or other shape to cater to different users. An operator may attend to a patient from an access port162(e.g., a main access port) that includes multiple hand openings on the panel160. In some embodiments, this access port162may measure 18″ wide×6″ tall. This opening162may allow the operator to have unrestricted access to the patient's cephalic region, providing the operator with ample room to perform various life-saving procedures without many typical constraints. The access port162may be designed to self-close and may be kept sealed in place by an attachment mechanism including magnets, Velcro, latches, snap fastener, etc. The access port162may be lined by FDA grade silicone rubber which may have cutouts to accommodate the operator's arms. The silicone rubber templates may be held in place by a polycarbonate frame, which may be attached via thumbs screws, allowing them to be quickly replaced as needed. As with the auxiliary ports134(FIG.1), in some embodiments, the access port162may be coupled to long gloves (e.g., also used in glove boxes) such that there are no air gaps or holes. Yet other embodiments are possible using other elastic or flexible materials. FIG.3is side view of the exemplary apparatus100, according to an embodiment of the disclosure. The apparatus100may include bilateral flex panel deflectors310located on both sides of the apparatus100(opposite side of apparatus100may include similar deflector). The flex panel deflectors310may be attached to the apparatus100by hinges and allow for the comfortable accommodation of patients with wider shoulders. The flex panel deflectors310may aid in preventing free-floating aerosolized droplet particles from traveling out the sides of the apparatus100. The flex panel deflectors310may be lined with rubber silicone to aid with gripping drapery that may be placed over the apparatus100including in the area of the deflectors310. At the bottom of both flex panels may be ⅞″ wide cutouts312(opposite side of apparatus100may include similar cutout) that are 2.2″ long, and angled (e.g., around 47 degrees), towards the operator side. These cutouts312on both sides may allow for the safe passthrough of corrugated ventilation tubing (used when a patient is placed on a ventilator), oxygen tubing, IV lines, suction tubing, digital endoscope wires, and any other tubes/wires that may be used for the patient. These slots312may be angled (e.g., at around 47 degrees) to facilitate any emergency that could arise, requiring the entire apparatus100unit to be pulled backwards and away from the patient, at a slight (e.g., around 15 degree) angle. The angle may facilitate the tubes and wires to be dropped down and out of the way as the apparatus100is being pulled backward, preventing them from getting snagged on the apparatus100, which could cause them to be pulled out from the patient, causing injury. In the example ofFIG.3, the side panel130is shown with a motor320attached to the access port (138ofFIG.1). The motor may include a hose or tubing extending from the motor for coupling to other hoses or tubing (not shown) to expel air from the apparatus100. The IV pole210is shown installed to hang an IV bag in this configuration. Some embodiments may include a multi-purpose bracket330 Loosening the mounting system knobs240′ on both sides may allow the loop slides241to freely slide up and down and rotate about the knobs240′. It will be appreciated by those skilled in the art that the mounting system and loop slides may be implemented in any manner suitable for the embodiments. Some embodiments may include a bilateral shoulder strap mount points340, which may be attachment points located on both sides of the apparatus for carabiner attachments to a shoulder strap. FIGS.4A-Care a bottom view (FIG.4A) of the exemplary apparatus100, a side illustration (FIG.4B) of the brace410, and an illustration (FIG.4C) showing rotation of the brace, according to an embodiment of the disclosure. As seen from the bottom, the apparatus100includes the protective shield122(in the extended configuration). The protective shield122may serve another purpose of bracing the apparatus100against a gurney. The shield122may be called a brace122. When the shield122is folded back, the shield122together with the coupling plate410combine to capture the frame421of the gurney424(a small section of a gurney is shown for illustrative purposes). The shield122pushes from the right side (as viewed fromFIG.4) while the coupling plate410pushes from the left side to capture the gurney frame421. In some embodiments the coupling plate410may be called an anchor410. The coupling plate410′ may include a plate component412and a lower bracket component414. The knob240, loop slide, anchor410, and brace122may form the gurney attachment system (e.g., proprietary in some embodiments). The anchor410and brace122together may allow the apparatus100to attach non-permanently to the gurney424or hospital bed422, mattress, padding, etc. (a small section of bedding is shown for illustrative purposes) without the use of a clamp or hook. The configuration may allow the apparatus100and base to be completely and immediately pulled away from the gurney424and patient in the event of an emergency. This may be achieved by having the operator grasp the L-shaped handles found on apparatus100. The anchor plate410may prevent the apparatus100from shifting back and forth, wobbling up and down, and swaying left to right while it is fully assembled on the gurney424. The anchor410may be wedged in between the mattress422that the patient lies on, and the frame of the hospital bed or gurney424. This may be a safety feature that prevents unintentional movement of the apparatus100while it is fully deployed with the patient inside the apparatus100. The brace122in conjunction with the anchor410may encase the top portion of the gurney424or hospital bed's422structural frame (towards the side of the patient's head), preventing the apparatus100from being unintentionally flipped backward and off of the patient while it is in use. There may be two red thumb screws located on the cross tube that connects the anchor122and brace410to the base that may be tightened once the apparatus100is fully assembled on the gurney424, to prevent the tube from freely spinning. Tightening of these two red thumb screws as well as the two knobs that are on both sides of the base may keep the base and apparatus100sturdily attached to the gurney424or hospital bed422while it is in transport. The brace122may function like a hook and prevent the apparatus from sliding forward and down when the head of the gurney424or bed422is elevated to Fowler's position, allowing the patient to sit upright and breathe more comfortably. The brace122may also assist with providing lateral stability by decreasing the amount of side-to-side rocking that may occur due to shifting of the patient's weight during transport, especially with the head of the gurney424or bed422elevated to Fowler's position. Together, the anchor410and brace122may allow the apparatus100to be quickly attached to most gurneys424and hospital beds422and to be safely used during transport of a patient, decreasing chances of injury to the patient, first responder, or operator. FIG.4Cshows the movement/rotation of the brace122′ to capture the frame421of the gurney. The brace in the first position122′ is extended/rotated to the far right. When the brace122″ is folded in the second position122″, it rotates towards the anchor410. In the third position122′″, the brace122″′ rotates to capture the frame421of the gurney.FIG.4Cshows the gurney frame421sandwiched between the brace122′″ and the plate element412of the anchor410. In the event of an emergency and immediate access to the patient is required, the apparatus100may be quickly pulled backwards and away from the patient/gurney424(e.g., at about a 15-degree angle), via the two L-shaped handles located on either side of the apparatus100, thus allowing unrestricted access to the patient within seconds. This may be accomplished because the anchor plate410sits in between the gurney424or hospital mattress422and the frame of the bed/gurney, utilizing the weight of the patient's upper torso and head, to apply downward pressure on the anchor410, sandwiching it between the mattress422and frame421. The anchor plate410may also be lined with rubber silicone on the edge, to provide extra friction, preventing it from sliding around during transport. This unique safety design of the anchor410and brace122together, allow for the security and stability of the apparatus100on the gurney424, while also prioritizing the patient's safety in the event of an emergency. FIGS.5A-Dare views and illustrations showing steps to collapse the apparatus100, according to an embodiment of the disclosure, withFIG.5Ashowing is a side view of the exemplary apparatus100,FIG.5Bshowing a front view (from patient's perspective) of the exemplary apparatus100′,FIG.5Cshowing an illustration of steps4-6, andFIG.5Dshowing a representation of the segments in the collapsed configuration. The panels of the apparatus100are hinged at various points of the panels. Some of the panels may be completely separate from other panels. For example, the top panel (e.g.,150ofFIG.1) is not connected or hinged to the side panels and may be completely separated—“C” or “U” grooves and magnets may be used to couple these panels together. In the sample ofFIG.5A, the panels are hinged at the edges of the dotted line representations; for example, segment502A is hinged at the bottom and top of the dotted line representation. Segments502B,502C have multiple hinges anywhere the dotted line representation creates an angle. As illustrated, any of the panels may include multiple segments that are hinged together. In the first step ofFIG.5A, the top502B/502C and back502A (which may form one contiguous piece) may be pulled up and rotated counterclockwise as illustrated by the ‘Step1’ arrow. The same step1is illustrated inFIG.5Bshowing the top/back panels being pulled up and away from the two side panels. The top/back panels may be mated to the side panels using various latching or alignment elements. For example, the panels may be joined together with any combination of tabs, neodymium magnets, velcro, latches, etc.; these various mating elements may need to be detached first before folding the panels out of the way so that each step may require multiple sub-steps. For example, in the embodiment ofFIG.5A, the top panel may have ‘U’ or ‘C’ shaped groove pieces to grab onto the thin edge of the side panels and the panels may include corresponding magnets to firmly mate together so that minor movement does not separate the panels. In such an example, step1may include detaching the magnets, pulling the panels away from the grooves and then pulling the top/back panel away from the side panels. In step2and step3, the side panels are folded in and down into the base. The side panels are not hinged or permanently connected to the top/back panel (e.g.,502A,502B,502C) so they may move freely and independently of the top/back panel. Each side panel may be hinged at the bottom/base of the respective panel so in step2the right panel may be rotated counter-clockwise to fold the panel down towards the base; in step3the left panel may be rotated clockwise to fold the panel down towards the base. The steps may be reversed as suitable based on user preference and design. For example, step2may include the left side being folded down before folding down the right side down as step3. Moving toFIG.5C, the top and back panels may have multiple hinges. The hinge elements may be connected in any suitable fashion based on user preference and design. In the example ofFIG.5C, at step4the back panel502A′ is folded down (clockwise) and then at step5the top panel segment502B′ (which may include multiple hinged pieces) is rotated counter-clockwise to fold flat against the back panel502A′. At step6, the front/rear piece502C′ is folded clockwise to lay flat against502B′.FIG.5Dis a representation of the panels folded and collapsed; the representation is exaggerated for illustrative purposes. Folding the apparatus100out (e.g., deploying the apparatus100for use with a patient) may be the reverse process from step6to step1. For example, the apparatus100may being with the panels folded as represented inFIG.5Dand the operator (or any other person/machine capable of handling the apparatus100) unfolding from step to step1. WhileFIGS.5A-Dshow one exemplary embodiment, those skilled in the art will readily recognize that various implementations may be possible. For example, the panels and components may be hinged at any suitable points; alternatively, or additionally, the panels and components may use mechanisms other than hinges to allow the panels and component to articular and move or fold relative to the apparatus100. Any or all edges may be hinged or unhinged based on user preference and design. FIG.6is perspective view of the exemplary apparatus in a collapse state, according to an embodiment of the disclosure. The apparatus100inFIG.6is shown with the operator side104towards the bottom right of the figure and the patent side102shown toward the top left of the figure. The protective shield122is shown deployed in the example ofFIG.6. FIG.7is front view (from the patient's perspective) of the exemplary apparatus as used by an operator and patient of the apparatus, according to an embodiment of the disclosure.FIG.7omits various features for simplicity and to avoid obscuring parts of the figure—some omitted features include various accessories including filters and motors, drapery over the patient. The patient710may be lying on a gurney or hospital bed (not shown) while receiving care from an operator720. The various ports of the apparatus provide easy access for the operator and any assistants to access the patient. WhileFIG.7shows one configuration, the disclosure is not so limited. For example, as discussed above, the access ports may take any configuration including embodiments with integrated gloves on the access ports. When the patient710is centered and positioned comfortably on a surface, e.g., a gurney, stretcher, operating room (OR) table, the operator720opens the apparatus100and carefully aligns it above the patient710while ensuring complete coverage of the patient's710head. There are two safety hooks located bilaterally on the operator720side of the apparatus, providing a gap (e.g., 1½″×⅜″) for the operator720to secure the apparatus100down to the surface (e.g., gurney/stretcher) using the “rope” of their choice. In some embodiments, bungee cord may be used. The safety hooks hold the apparatus100down to the surface (e.g., gurney/stretcher) in the event of sudden jarring or accidental tipping of the surface (e.g., gurney or stretcher). The use of the safety hooks is required for use in the transportation setting due to the smaller stretcher width (e.g., 24″) and the greater risk of tipping the apparatus100over during the transportation process. Once the apparatus100is properly positioned, an assistant may place clear vinyl drape (e.g., 96″×36″) over the patient's710thoracic/abdominal region while aligning the marked alignment elements (not shown) of the apparatus with the target corners on both sides of the front lid of the apparatus100. The operator720must ensure that the drape is centered and wraps completely over the top of the lid in order to form a “pseudo” seal, by creating a physical obstacle for ascending aerosolized droplets. The assistant then hands the left corner of the drape to the operator720, where the operator720pulls the drape taut and slides it in between the gap of the protruding L-shaped tension lock and the mattress of the surface (e.g., gurney/stretcher), creating the tension for the 2-part locking system. The action is followed through by pulling the drape thru a ⅛″ gap located on the medial side of the left L-shaped handle. This system creates sufficient tension to lock the drape in place, while the apparatus100is in use. The same steps may be repeated for the right side. Some embodiments may provide for ample interior room. The interior dimensions of the apparatus may be configured to provide the ample space; in some examples the apparatus may measure up to 21.44″×21.88″×21.63″ (1×w×h) or larger, which may provide ample room for an operator to freely maneuver medical instruments inside, such as a bougee or stylet without issue. Some embodiments may include bilateral tension locks/handles. There may be two L-shaped handles strategically located on both sides of the base. These may be lined with closed cell silicone foam on the inside/edges, allowing the operator to easily slide in and secure the drape. After the drape is folded over the top of the rear panel and folded upon itself over the corners of the rear panel, the remaining length of the drape may be pulled taut and slid in between the silicone foam on both sides. This tightly secures the drape by pinching it between the two layers of closed cell silicone foam, utilizing these bilateral tension points as anchors and the corners of the rear panel as the fulcrum. By using tension to secure the position of the drape, instead of adhesives, buttons, clamping, etc., this allows for additional safety for the patient in the event of an emergency. If only the drape needed to be removed for immediate access to the patient, the drape may be quickly pulled up and forward from the top center section, right above the rear panel. The weight of the apparatus would resist the force of the drape being pulled away and the drape would slide out from between the silicone foam. By not securing the drape using adhesives, clamps, buttons, etc., the drape won't snag on the apparatus as it is being pulled away, which could jar the patient during the process. Additionally, the anchor and brace would also act as a secondary safety net, ensuring that the entire unit does not get lifted up when the drape is removed, potentially injuring the patient. The placement of the handles may allow the operator to properly adjust the positioning of the apparatus once it is placed on the gurney, as well as allow the operator to quickly pull the apparatus back and away from the patient and gurney, in the event of any emergency. They may also allow for easy transporting/relocating of the apparatus while it is fully assembled. Some embodiments may include bilateral safety mounts. Found towards the patient side, and on both sides of the base may be two gurney mounts which hug the gurney mattress from both sides, keeping the apparatus aligned with the mattress and preventing the apparatus from sliding left to right (side to side) during transport or if the apparatus is accidentally jarred during use. These mounts are lined with silicone rubber to provide additional friction against the cloth material on the mattress, decreasing any unwanted movement of the unit. Some embodiments may include bilateral locks. The mechanism that attaches the anchor and brace system to the base is adjusted and locked by bilateral handles which ensure that the distance between the bottom of the base and the anchor plate remain the same at all times. Adjusting the bilateral locks may allow the operator to compensate for the different thicknesses found in a variety of gurney/hospital bed mattresses that the apparatus may be installed on. This adjustment may allow the apparatus to be installed on a wide variety of mattresses in the outpatient and inpatient setting. Most standard gurneys may have a two-inch-thick mattress, while most hospital beds may have a six inch thick mattress, both of which may easily be accommodated. The embodiments are flexible and may accommodate gurneys, beds, and other body support systems of any size according to preference and design requirements. Some embodiments may include a central safety catch, including a 2″×8″×⅛″ aluminum lip that may extend downward from the base's frame and catch onto the head of the mattress. This may prevent the apparatus from moving forward when the head of the gurney or hospital bed is elevated, allowing the patient to sit upright and breathe more comfortably while maintaining enclosure integrity. Some embodiments may include a storage box at the front of the base. The storage box may include specifically designed mounts for storage of a motor, battery, filters, and IV pole. The apparatus may have specifically designed slots that anchor the IV pole in a stored position, when not in use, as well as slots for an upright mount of the IV pole when the apparatus is fully deployed and an IV bag is attached. The lid of the box may have a 3/16″ deep by 8″ wide slot towards the rear, which may allow for two collapsed apparatuses to be stacked on top of each other securely. The slot accommodates the central safety catch (discussed above) that protrudes downward from another apparatus, securely keeping the two collapsed apparatuses together, preventing them from slipping off of one another when stored away on a shelf. Some embodiments may include a handle, including a 6″ wide handle, located on the operator side of the apparatus, at the bottom of the front of the storage box, allowing for easy carrying of the apparatus when it is fully collapsed. The handle may be attached to the frame of the entire unit, giving the user a sturdy and well-balanced position to hold the apparatus from. In some embodiments, clear vinyl drape may be used as cover for the apparatus. In other embodiments, painters cover may be used in the event that the original drape is damaged or dirty. Once the clear drape is secured in place, the operator of the apparatus may proceed to intubate the patient if that is the next step. The front panel of the apparatus has a horizontal flip up access door (e.g., measuring 6″×18″ to provide suitable access) and when opened fully (e.g., 180 deg), can be held open by making contact with the magnet above it (e.g., 3″ in some embodiments). This rectangular access door allows the physician/paramedic to reach their arm inside the apparatus and comfortably intubate the patient while protected behind the clear acrylic. The access door (e.g., 6″×18″) has two layers of clear vinyl on the inside of the apparatus. The first layer is precut with two horizontal cross-shaped patterns, measuring, e.g., 6″ apart. The second layer of vinyl measures, e.g., 11″×20″ and acts as a secondary barrier to help reduce the amount of aerosolized droplet particles that may travel/escape through the two arm openings in the first layer of clear vinyl, that is being used by the physician/paramedic during the procedure. The wide horizontal opening allows for much improved lateral mobility of the physician's or paramedic's forearms during the intubation or extubation procedure. With every physician and paramedic unique and different, the horizontal opening enables the operator to more naturally and comfortably perform the intubation procedure, leading to a safer, and more successful outcome. The ease of use that comes with the increased lateral mobility provides the physician with increased maneuverability of their tools, and increased range of motion (ROM) in their forearms and wrists. The smaller top panel is angled at, e.g., 26 degrees to reduce the amount of glare from light directly above, increasing the operator's visual field. The angled panel also serves to promote air circulation within the apparatus, towards the suction vent located at the top of the back panel, by decreasing the amount of stagnant air that accumulates in the corners of the apparatus. The larger top panel is a flat surface measuring, e.g., 11″×22″ that doubles as a workspace area, if items need to be placed there for upcoming use. There is a 2″ acrylic lip that extends perpendicularly on the end of both of the side panels. This lip is 2″ extension beyond the “soft” width, that is one piece and bent 90 deg, thermoformed. This 2″ lip functions as an aerosol deflector and prevents the free-flow movement of any infectious aerosolized particles from escaping the containment field, which is the area contained within the apparatus and clear vinyl drape. The 2″ lip physically prevents the accidental spread of infectious aerosolized droplets from travelling freely between the two side panels of the apparatus. The 2″ lips that extend also serve as the front stabilizers of the apparatus, by creating a wider base footprint on the gurney and increasing the safety and security of the apparatus. The back panel may be angled, e.g., at 45 degrees to increase the volume of air exposed to the suction port when in use. The suction port is directed towards the general area of the patient's mouth and nose, to increase the chances of sucking up and filtering the expelled respiratory droplets. To accommodate multiple patient sizes, the left and right panels in the “soft” width region may flex outward to accommodate patients with wider shoulders. The hinges on these panels may be spring loaded and return the panel back to its original position when the apparatus is removed. The apparatus may be compatible with most standard gurneys/stretchers 24″ and above, owing to its compact, yet versatile size. The apparatus may fold down to a height of only, e.g., 5½″, allowing it to be easily transported or stored away until needed. Due to its compact size, the apparatus may be taken into the field and setup by paramedics and emergency medical technician (EMTs) after they make the initial contact with the potentially infected patient. When the patient is transported from the ambulance into the emergency department (ED), the apparatus contains and isolates the patients' airborne respiratory droplets, thereby minimizing the risk of exposure to numerous healthcare professionals. Once the patient is admitted, the apparatus can be swapped out to the one the hospital uses, if they have their own, or the paramedics can set up an exchange plan with their local hospitals, to further minimize exposure during transfer of the apparatus. In some embodiments, the self-contained apparatus may collapse to a height of only, e.g., 5½″ and expands to a height of approximate 22″ when in use. The apparatus may maintain a base footprint of about 23″×23″. When multiple apparatuses are stored in their collapsed state, the apparatuses may interlock when folded and stacked upon one another, allowing for better organization. The triangular shaped base corners of the apparatus may aid with the overall stability of the structure of the apparatus, while also creating a bottom cover for the trimmed corners of the stretchers/gurneys, which would otherwise be left open. The baseboard corners in the apparatus may allow the apparatus and the patient to be closer to the operator of the apparatus, leading to an improved field of vision of the patient's airways. This also allows the operator to maintain better ergonomics, reducing neck and back strain from reaching forward and hunched over. Some embodiments may include two safety catches located at the bottom of the front of the operator panel designed to prevent the apparatus from sliding down the gurney/stretcher mattress when the head of the gurney/stretcher is elevated. The safety catch may also accommodate gurneys/ambulance cots with mattress head widths narrower than 8″, allowing the narrower mattresses to slide in between the safety catches, preventing the apparatus from sliding down into the patient when the head of the gurney/stretcher is elevated. FIG.8is an exemplary flow diagram illustrating methods for assembling the exemplary portable collapsible air isolation apparatus. The apparatus may be the apparatus100ofFIG.1. The method may be performed by an operator, an assistant, or any person capable of handling the apparatus. In some embodiments, an automated attendant, a machine, a robot, etc. may perform any or all of the steps ofFIG.8. The person or automated entity performing the steps may be called the “assembler.” The method may include, at step810providing a collapsible box structure. The collapsible box structure may be the apparatus100ofFIG.1. In some examples, the structure may be partially assembled with all hinges installed such that only folding/folding and minor steps such as aligning mating points are needed. In some examples, the structure may be provided in any unassembled form including completely unassembled (hinges not screwed, no items fastened, etc.) as a kit. In the examples where the structure is partially or entirely unassembled (e.g., provided as a kit), the assembler may perform additional steps (e.g., screwing in attachments/accessories, joining various elements, etc.). In some examples, the structure may have been previously used and folded for storage. The method may include, at step820folding out the structure to assemble the structure for use with a patient. Step820may be represented by the reverse process ofFIGS.5D-Awith the structure beginning in the folded state (e.g.,FIG.6andFIG.5D) and proceeding backwards from step6to step1. The method may include, at step830determining whether accessories are needed for the apparatus100. Some of the accessories may include drapery, a motor, filter, IV pole (for hanging an IV bag), etc. If any accessories are needed, the method may proceed to step840. If no accessories are needed, the method may proceed to step850. The method may include, at step840, attaching accessories to the apparatus100. Some of the accessories may include drapery, a motor, filter, IV pole (for hanging an IV bag), etc. In the case of the IV pole, some embodiments of the IV pole may be attached as illustrated inFIG.2, e.g., by using the hook and slot system. Drapery may be placed on apparatus100to cover any or all portions of the apparatus100including over the patient areas. The method may include, at step850, deploying the structure. Deployment may include using the structure in any of the suitable medical or other settings including on a gurney, hospital, other medical facility, etc. In the case of use on a gurney, the structure may be secured onto the gurney, e.g., as provided inFIGS.4A-Cand the associated description. A patient may be placed inside the structure, e.g., as provided inFIG.7and the associated description. In some embodiments, optional steps during or after step850may include providing a patient for the structure, and positioning or placing the patient within the structure. FIG.9is another exemplary flow diagram illustrating methods for disassembling the exemplary portable collapsible air isolation apparatus. The apparatus may be the apparatus100ofFIG.1. The method may be performed by an operator, an assistant, or any person capable of handling the apparatus. In some embodiments, an automated attendant, a machine, a robot, etc. may perform any or all of the steps ofFIG.9. The person or automated entity performing the steps may be called the “disassembler.” The method may include, at step910providing an assembled collapsible box structure. The collapsible box structure may be the apparatus100ofFIG.1. In some examples, the assembled structure may have been deployed, e.g., for use with a patient undergoing medical treatment. In some examples, assembled structure may have been deployed, e.g., for use with a gurney or medical bed, etc. In some embodiments, optional steps during or before step910may include removing a patient from the structure, and/or detaching the structure from frame(s) such as a gurney, bed, mattress, etc. The method may include, at step920the method may determine whether the structure has accessories. If the structure has accessories, the method may proceed to step930. If the structure does not have accessories, the method may proceed to step940. The method may include, at step930, detaching accessories from the structure. Some of the accessories may include drapery, a motor, filter, IV pole (for hanging an IV bag), etc. In the case of the IV pole, some embodiments of the IV pole may be detached as illustrated inFIG.2, e.g., by using the hook and slot system. Drapery may be removed from the structure that was used to cover any or all portions of the structure including over the patient areas. The method may include, at step940collapsing or folding down the structure to disassemble the structure, e.g., for storage, transportation, to reduce the footprint, etc. Step940may be represented by the process ofFIGS.5A-Dwith the structure beginning in the deployed state (e.g.,FIG.5A) and proceeding from step1to step6. In some embodiments, step940may include using a protective shield (e.g.,122ofFIG.1); for example, the L-shaped protective shield may be flipped forward into position (as shown inFIG.1) to protect the underside of the structure and its flex panel deflectors. In some embodiments, optional steps (e.g., during or after step940) may include stacking the structures together, e.g., for storage, transportation, or to conserve space, etc. It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Further, some steps may be combined or omitted. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented. FIG.10is an alternative embodiment 1000 ofFIG.1showing a perspective view of an exemplary portable collapsible air isolation apparatus for treatment of patients with respiratory symptoms, according to an embodiment of the disclosure. FIG.11is an alternative embodiment ofFIG.2showing a view of the exemplary apparatus as viewed from the operator's perspective, according to an embodiment of the disclosure.FIG.12is an alternative embodiment 1200 ofFIG.3showing a side view of the exemplary apparatus, according to an embodiment of the disclosure.FIG.13Ais an alternative embodiment ofFIG.4Ashowing a bottom view of the exemplary apparatus, according to an embodiment of the disclosure. FIG.14is an alternative embodiment ofFIG.4Cshowing another side profile illustration showing rotation of the brace component, according to an embodiment of the disclosure.FIG.15shows a side view of the apparatus including the Bianca Box1500.FIG.16shows a side view of the apparatus including the Bianca Box1500in another configuration.FIG.17shows another view of the apparatus including the Bianca Box. InFIGS.10-14, similar components are labeled with the same numbers as those found inFIGS.1-4C. The descriptions of the same numbers are omitted for brevity. The apparatus which may be called a BIANCA Box may be comprised of (7) polycarbonate panels which are assembled to construct the isolation & containment structure with accompanying plastic drape. The base which may be called a BIANCA Base may include an aluminum base frame (with corresponding 3M® storage box) which provides rigidity and structural support for the attached BIANCA Box. BIANCA Box and Base together may be called the BIANCA Box unit. The BIANCA Anchor plate (anchor plate)1301may be a flat metal plate that is wedged in between the gurney or hospital bed mattress and its corresponding frame. The BIANCA brace (brace)1302may be an L-shaped metal plate with minimum inside height of one and a half inches, that interlocks with the BIANCA Anchor to be welded together. The BIANCA Box may include the BIANCA Anchor and Brace1301,1302. In the above embodiments ofFIGS.10-14, the apparatus may include a fastening system or a mounting system. This system may be called a Universal Gurney Fastening System (UGFS). The UGFS may be is comprised of:1. BIANCA Anchor plate2. BIANCA Brace3. Center safety catch (backing plate extension from BIANCA Base that interlocks with the BIANCA Anchor)4. (2) Safety skid plates (attached to BIANCA Base)5. Tubular pivoting crossbar with two locking thumb screws6. (2) Slotted adjustable tension plates7. (2) Locking Tension knobs The Universal Gurney Fastening System (UGFS) may be designed to attach and stabilize the BIANCA Box or any other apparatus, in some embodiments non-permanently, and in some embodiments without a closed loop fastening style, to a gurney (e.g. stretcher, hospital bed, surgical bed, ambulance cot, or similar 4 wheeled device with a mattress and frame) with or without the presence of a patient being transported. The UGFS may be primarily composed of two main components, the BIANCA Anchor and the BIANCA Brace. Together, they allow the entire BIANCA Box unit to be quickly and securely attached to any ambulance cot, gurney, stretcher, surgical bed, or hospital bed, with a 2″-6″ (length of adjustable tension bars can be modified according to different thickness requirements) mattress height. This unique system may allow for safe use of the BIANCA Box unit in multiple situations including, during emergency medical transport in the back of an ambulance, helicopter, plane, or boat, during maneuvering of a hospital bed/gurney, and while the bed is stationary. It keeps the BIANCA Box unit stable and prevents it from falling over during vehicle maneuvers, as well as during transport of a patient into and out of the ambulance or any other mode of transportation such as a plane, helicopter, or boat. The UGFS prevents the BIANCA Box unit or other apparatus from sliding forward and down when the head of the bed/gurney is elevated to fowler's position (45-60 degrees), which is the optimum position for a patient in respiratory distress. This position decreases the weight exerted on a patient's lungs thereby promoting efficient oxygenation through improved chest expansion. Fowler's position permits a patient in respiratory distress to breathe easier and more comfortably. In the event of an emergency and immediate access to the patient is required, the entire BIANCA Box unit can be quickly pulled backwards and away from the patient and gurney at approximately a 10-15-degree angle, without difficulty or having to unlock, unhook, or unlatch any fasteners. This action is performed via the two handles located on either side of the BIANCA Box unit and allows unrestricted access to the patient within (2) seconds. This proprietary fastening system attaches to all types of ambulance cots (including FERNO®& Stryker®), gurneys, stretchers, and hospital beds. In summary, the UGFS allows the BIANCA Box or other attached apparatus, to be safely operated during transport with or without a patient, decreasing chances of injury to the patient, operator, first responder, or healthcare provider. The UGFS also increases structural support for the attached BIANCA Base or other apparatus by providing additional rigidity to the frame which decreases the effect of torsional forces exerted upon it. This additional rigidity in the BIANCA Base translates to increased structural support to the flexible and highly impact resistant polycarbonate panels that comprise the BIANCA Box. The UGFS can also be used in non-mobile applications, such as a stationary bed, or any place where stability and quick access are required. The length of the slotted adjustable tension plates can be increased or decreased as necessary to accommodate various thickness requirements. The size of the UGFS can be scaled to accommodate smaller or larger applications, including mobile or non-mobile. The UGFS may also be applied vertically with modifications. The BIANCA Anchor and Brace1300may be attached to the BIANCA Base as a universal gurney fastening system, comprising of two main components, the BIANCA Anchor and Brace. Together, the BIANCA Anchor and Brace allow the BIANCA Box unit to be quickly and non-permanently (without the use of a clamp, latch, lock, hook, cable, or any other semi-permanent/permanent fastening mechanism) attached to most gurneys and hospital beds, allowing it to be safely used during transport of a patient, which decreases chances of injury to the patient, first responder, and healthcare provider. Its design allows the BIANCA Box and Base to be completely and immediately pulled away from the gurney and patient in the event of an emergency. This is achieved by having the operator grasp the L-Shaped handles found on both sides of the BIANCA Box unit. The BIANCA Anchor and Brace are two separate pieces that are designed to interlock and be welded permanently together. The BIANCA Anchor is quickly installed by wedging the anchor plate underneath the gurney or hospital bed mattress at the top towards where the patient head will be located, while the BIANCA Brace captures the frame of the gurney or hospital bed underneath. In the event of an emergency and immediate access to the patient is required, the BIANCA box can be quickly pulled backwards and away from the patient/gurney at about a 15-degree angle, via the two L-shaped handles located on either side, thus allowing unrestricted access to the patient within two seconds. This is accomplished because the anchor plate sits in between the gurney or hospital mattress and the frame of the bed/gurney, utilizing the weight of the patient's upper body to apply downward pressure on the Anchor, sandwiching it between the mattress and frame. Therefore, when the anchor plate and brace is pulled backwards and away from the top of the gurney/hospital bed, it is free to slide out without having to loosen any fastener or connections. This unique safety design of the BIANCA Anchor and Brace together, allow for the security and stability of the BIANCA Box unit on the gurney, while also prioritizing the patient's safety in the event of an emergency. The BIANCA Anchor and Brace are directly attached to the tubular pivoting crossbar (with two locking thumb screws) that is fixed to two slotted adjustable tension plates (one found per side). The slots in these adjustable tension plates correspond with the threads of two locking tension knobs, found on each side of the BIANCA Base. Tightening of these locking tension knobs, ultimately affixes the BIANCA Anchor and Brace to the BIANCA Base. The BIANCA Anchor1301may include an anchor plate as an aluminum plate (could be titanium or stainless steel in the future for increased strength, durability, and reduction in weight) that is specifically designed to slide in between the mattress and metal frame of a gurney, ambulance cot, or hospital bed. Because it is attached to the BIANCA Box above, it is subjected to left and right twisting motions which could cause deformity to its shape. The shape of the anchor plate is designed to withstand torsional forces from all directions to keep it straight and aligned flat in between the mattress and its frame. It has a rounded shape at the end which allows it to be wedged like a plate, in between the mattress and frame. Some ambulance cots have shoulder straps that anchor at the top of where the shoulders are normally located (when the patient is laying flat) into the frame beneath it. This causes an issue for a large plate to be inserted without interfering with the safety points/anchors where the shoulder straps attach. The BIANCA Anchor plate solves this issue with its rounded design and tapered sides, allowing the plate to be inserted in between the shoulder straps without affecting the safety harness that secures the patient to the frame of ambulance cot during transport. The size and location of the BIANCA Anchor plate is designed to directly correspond with the patient's head and shoulder region on the top side of the mattress. This design utilizes the upper body weight of the patient to keep the BIANCA Box unit stable. The patient's weight keeps the mattress down, which keeps the BIANCA Anchor plate flat and flush with the mattress and ambulance cot frame. The anchor plate prevents the BIANCA Box unit from shifting back and forth, wobbling up and down, and swaying left to right while it is fully assembled on the gurney or hospital bed. The BIANCA Anchor is wedged in between the mattress that the patient lays on, and the frame of the hospital bed or gurney. The downforce exerted by the weight of the patient's upper body is translated to the mattress, which keeps the anchor plate flat and flush with the gurney or hospital bed frame. With the anchor plate flat, the tubular pivoting crossbar and all attached components including the BIANCA Base and BIANCA Box are also maintained flat and flush with the gurney or hospital bed frame. Furthermore, the anchor plate has a slot in the center that interlocks with the center safety catch, which is an extension from the center backing plate of the BIANCA Base. Once interlocked, and the patient is strapped down, and the two locking thumb screws are tightened, the BIANCA Box unit cannot be rotated backwards due to the BIANCA Anchor and Brace capturing the gurney or hospital bed frame. The interlocking of these two pieces prevents the entire unit from flipping backwards and off the gurney or hospital bed preventing any possible injury or harm to the operators or patient. This safety feature prevents unintentional movement of the box while it is fully deployed with the patient inside the BIANCA Box. The outer edge of the BIANCA Anchor is lined with high-temperature silicone rubber for edge protection and add friction between the mattress above and metal frame below it, which decreases sliding around during transport. The BIANCA Brace1302used in conjunction with the anchor plate encases the top portion of the gurney or hospital bed's structural frame (towards the side of the patient's head), preventing the box from being unintentionally flipped backwards and off the patient while it is in use. It prevents the BIANCA Box unit from shifting weight left or right because it encompasses the frame of the gurney or hospital bed. The BIANCA Brace also assists with providing lateral stability by decreasing the amount of side-to-side rocking that may occur due to shifting of the patient's weight during transport, especially with the head of the gurney or bed elevated to Fowler's position. The BIANCA Anchor and Brace are fixed to the tubular pivoting crossbar in the center. The BIANCA Brace begins as a flat sheet of metal that is designed to be bent at a 90-degree angle, creating an L-shape with a minimum inner height of one and a half inches. This new L-shaped brace is interlocked and welded to the BIANCA Anchor. Once these two pieces are permanently interlocked together, a C-Channel is formed. This C-Channel will have a minimum gap of 1.5″ to accommodate a variety of gurney or hospital metal bed frames. The C-Channel effectively wraps around 75% of the square or tubular metal frame of the gurney or hospital bed, limiting its mobility and the directions that it can move in. The C-Channel effectively only allows movement in one direction, which when mounted at the head of the gurney/bed is backwards towards the operator of the BIANCA Box unit. The brace functions like a hook and prevents the BIANCA Box unit from sliding forward and down when the head of the gurney or hospital bed is elevated to fowler's position, which allows the patient to sit upright and breathe more comfortably. The center safety catch1303(backing plate extension from BIANCA Base that interlocks with the BIANCA Anchor) may be an aluminum lip that extends downward from the BIANCA Base's backing plate and catches the head of the mattress. This prevents the box from moving forward when the head of the gurney or hospital bed is elevated to fowler's position, allowing the patient to sit upright and breathe more comfortably while maintaining enclosure integrity. The center safety catch also interlocks with a slot in the BIANCA Anchor, preventing the entire BIANCA Box unit from rotating backwards off of the gurney or hospital bed. The (2) Safety skid plates1304(attached to BIANCA Base) may be found towards the patient side, and on both sides of the BIANCA Base are two gurney skid plates which hug the gurney mattress from both sides, keeping the box aligned with the mattress and preventing the box from sliding left to right (side to side) during transport or if the box is accidentally jarred during use. These mounts are lined with silicone rubber to provide additional friction against the cloth-like/textured material of the mattress, decreasing any unwanted movement of the unit. The tubular pivoting crossbar1305with two (2) locking thumb screws (see below) is described next. The tubular pivoting crossbar is made up of a smaller diameter, stainless steel, inner tube with a marginally larger diameter, aluminum, outer tube which encases the inner tube like a sheath with approximately a small air gap in between the two tubes. The stainless steel inner tube is permanently affixed to the stainless steel, slotted adjustable tension plates on both ends, while the aluminum outer tube is permanently affixed to the backside of the aluminum BIANCA Anchor and Brace in the center. The small air gap in between the two tubes allows the outer tube to freely pivot 360 degrees around the inner tube, unobstructed. The stainless steel, slotted adjustable tension plates are attached to the BIANCA Base via the locking tension knobs which travel through their slots and ultimately threaded into the nuts located in inferior support of the BIANCA Base. The purpose of this pivoting mechanism is to allow the operator of the BIANCA Box unit to easily maneuver and slide the attached BIANCA Anchor plate in between the gurney or hospital bed mattress and its frame. Only the outer aluminum tube has two evenly spaced holes with a diameter that corresponds with the threaded inner diameter of two nuts that have been welded on the outside. Two locking thumbscrews are threaded through these nuts and when tightened down, the outer aluminum tube no longer pivots freely around the inner tube and is locked in place until loosened. Unlocking of these locking thumbscrews, allows the BIANCA Anchor and Brace to be freely maneuvered to accommodate differences between various ambulance cots, gurneys, or hospital bed manufacturers. The (2) Locking thumb screws1305ais described next. Two red thumb screws located on the tubular pivoting crossbar that connects the BIANCA Anchor and Brace to the BIANCA Base. These need to be tightened once the box is fully assembled on the gurney, to prevent the outer tube from unwanted pivoting around the inner tube while the BIANCA Box unit is in use. Tightening of these two red thumb screws as well as the two locking tension knobs that are on both sides of the BIANCA Base, keeps the base and box sturdily attached to the gurney or hospital bed while it is in transport. The (2) Slotted adjustable tension plates1306is described next. Two slotted stainless steel plates are fixed to the tubular pivoting crossbar, with one on each side. The slots in the center of the plate run almost the entire length of the plate and its width corresponds with the thread thickness of the locking tension knobs. The length of the slot allows the BIANCA Anchor and Brace to accommodate various mattress heights. To accommodate a thicker mattress, the entire anchor and brace unit can be slid downward, widening the gap between the anchor plate and the bottom of the BIANCA Base. If a thinner mattress is utilized, then the entire anchor and brace can be slid upward, narrowing the gap between the anchor plate and the bottom of the BIANCA Base. This mechanism attaches the BIANCA Anchor and Brace system to the BIANCA Base and allows the operator to adjust the UGFS to accommodate varying mattress thicknesses. Once the desired mattress thickness is adjusted for, the system is locked in place by tightening the two locking tension knobs, on either side of the BIANCA Base. This ensures that the distance between the bottom of the BIANCA Base and the BIANCA Anchor plate remains exactly where they need to at all times, so that the BIANCA Box does not lift away from the BIANCA Anchor and Brace if the gurney goes over a bump, or the ambulance it is being transported in, goes over a bump in the road. Adjusting locking tension knobs allows the operator to compensate for the different thicknesses found on a wide variety of gurney/hospital bed mattresses that the BIANCA Box can be installed on. Most standard gurneys have a 2″ thick mattress, while most hospital beds have a 5-6″ thick mattress, both of which can easily be accommodated. The (2) Locking tension knobs1307are described next. Two studded tension knobs, one on each side of the BIANCA Base, are passed through the slot in the adjustable tension plates and are threaded into nuts located on the inferior support of the BIANCA Base. The location of these nuts are aligned at specific points so that when the locking tension knobs are tightened, the following occur: the BIANCA Anchor interlocks with the Center safety catch and together the BIANCA Anchor and Brace lie flush with the gurney or hospital mattress and its metal frame. These two locking tension knobs must be engaged prior to operation of the BIANCA Box or movement of the gurney or hospital bed, in order to ensure that the BIANCA Box unit is properly secured to the frame of the gurney or hospital bed. These locking tension knobs are not required to be loosened prior to emergency removal of the BIANCA Box unit. The knobs can also be handles, star grips, knurled grips, or any type of component that provides leverage. In some embodiments, the UGFS may permit:1. Quick attachment to gurneys, stretchers, hospital beds, and ambulance cots with various mattress heights ranging from 2-6″2. Safe operation while maneuvering the ambulance cot, gurney/stretcher, or hospital bed during patient transport3. Immediate patient access in the event of an emergency without having to unhook, unlock, unclamp, unlatch any fasteners or use of any other permanent/semi-permanent fastening mechanism. The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.” | 87,223 |
11857466 | DETAILED DESCRIPTION The various embodiments will be described in detail with reference to the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. References made to particular examples and implementations are for illustrative purposes, and are not intended to limit the scope of the invention or the claims. Embodiments include a table system for use with an imaging device, such as a diagnostic medical imaging device. As shown inFIGS.1-6, a table system100according to various embodiments may include a base portion101configured to support the table system100over a support surface (e.g., a floor102), a patient support103which includes a platform105sized and shaped to support a patient in a standing position and a bed107sized and shaped to support the patient in a lying position, and a linkage portion109coupled between the base portion101and the patient support103that is pivotable with respect to both the base portion101and the patient support103. A first drive mechanism may be located in the linkage portion109and may drive the pivoting of the linkage portion109with respect to the patient support103. A second drive mechanism may also be located in the linkage portion109and may drive the pivoting of the linkage portion109with respect to the base portion101. In embodiments, the patient support103may be positioned in a vertical position (as shown inFIGS.1,5and6) in which the platform105is substantially parallel to the support surface (e.g., floor102) and a horizontal position (as shown inFIGS.3and4) in which the bed107is substantially parallel to the support surface (e.g., floor102). As used herein, the term “substantially parallel” means±15° from an exactly parallel position. The patient support103may be positioned at any arbitrary angle between a horizontal and vertical configuration. As shown inFIG.2, for example, the patient support103may be tilted at a 45° angle between a vertical and horizontal position. In embodiments, the patient support103may stably support the full weight of a human body and may support greater than 200 kg, such as up to about 800 kg, over the full range of pivoting motions of the patient support103and linkage portion109. The patient support103may include an elongated first portion111having a surface forming the bed107which may support a patient in a lying or inclined position and a second portion113having a surface forming the platform105which may support a patient in a weight-bearing standing or inclined position. The first portion111may have a length dimension that is preferably greater than the average height of an adult human, such as between 2-3 meters (e.g., about 2.5 meters). The second portion113may extend substantially perpendicular to the first portion111at a first end115of the first portion111. As used herein, the term “substantially perpendicular” means±15° from an exactly perpendicular position. The second portion113may have a length dimension that is less than the length dimension of the first portion111. In embodiments, the length dimension of the second portion113may be between 20-50 cm (e.g., about 35 cm), and may be greater than the average foot length of an adult human to enable a patient to comfortably stand on the platform105. The width of the first and second portions111,113may be greater than the average width of an adult human (e.g., average shoulder width in the case of the first portion111and/or average stance width in the case of the second portion113) and may be at least about 40 cm. The width of the first and/or second portions111,113may be less than a bore diameter of a medical imaging device (e.g., an x-ray CT scanner or MRI device), such as less than about 120 cm, and may be between about 50 and 80 cm. The bed107of the first portion111may be concavely curved, as is most clearly visible inFIG.5. The distal end117of the first portion111may have a curved edge, as shown for example, inFIG.1. The platform105of the second portion113may also have a similar curved edge. The rounded and/or curved surfaces of the patient support103may help to minimize beam attenuation by the patient support103during an imaging scan. As shown inFIGS.1-6, the patient support103may include a pair of bracket members119that may extend away from a rear surface121of the second portion113of the patient support103(i.e., opposite the platform105, as shown inFIGS.2-4). The bracket members119may be connected to the linkage portion109along an axis a to enable the patient support103to pivot with respect to the linkage portion109, as described in further detail below. The patient support103may be made of one or more suitable high-strength materials. In preferred embodiments, the patient support103may be made of a radiolucent (i.e., x-ray transparent) material, such as carbon fiber. In one embodiment, the patient support103may comprise a single piece of carbon fiber that may form at least the bed107and the platform105. The carbon fiber element may form a rigid outer shell that may contain a suitable lightweight and radiolucent filler material, such as a foam. The patient support103may include additional structural reinforcing elements (e.g., plates, rods, brackets, etc.) that may or may not be radiolucent. For example, the patient support103may include one or more metal (e.g., aluminum, steel, etc.) support plates which may be secured to a carbon fiber patient support structure using fasteners. In embodiments in which the patient support103includes structural reinforcing elements made from a non-radiolucent material, such as aluminum, the non-radiolucent material may preferably be located so as not to interfere with an imaging scan of a patient on the patient support103. For example, in the embodiment ofFIGS.1-6, an aluminum support frame may be confined to the brackets119, at or near to the rear surface121of the second portion113and/or adjacent to the first end115of the first portion111. This may enable a patient standing on the platform105to be scanned over the entire length of the body including through the feet without interference (i.e., image artifacts) from non-radiolucent reinforcing element(s). The base portion101of the table system100may include a pair of parallel bracket members201. The bracket members201may be fixed to the floor or other stable support surface using fasteners, such as bolts. The bracket members201of the base portion101may be made of a suitable high-strength structural material, such as aluminum or steel. The bracket members201may have an angled upper surface203as shown inFIGS.2-6. The angled upper surface203of the bracket members201may be complementary to an angled surface123of the bracket members119of the patient support103, as shown inFIG.1. The bracket members201of the base portion101may be connected to the linkage portion109along an axis a′ to enable the linkage portion109to pivot with respect to the base portion101as described in further detail below. The linkage portion109may include a flat first major surface301and a flat second major surface303that extends parallel to the first surface301. The bracket members201of the base portion101and the bracket members119of the patient support103may connect to the linkage portion109via opposing first and second side walls305,307of the linkage portion109. A first rotary drive shaft309(seeFIG.6) may extend through one or both side walls305,307of the linkage portion109and connect to at least one bracket member119of the patient support103. At least one rotary bearing within the linkage portion109may enable the first rotary drive shaft to rotate with respect to the linkage portion109to pivot the patient support103with respect to the linkage portion109about axis a. A second rotary drive shaft311(seeFIG.6) may extend through one or both side walls305,307of the linkage portion109and connect to at least one bracket member201of the base portion101. At least one rotary bearing within the linkage portion109may enable the linkage portion109to rotate with respect to the second rotary drive shaft311to cause the linkage portion109to pivot with respect to the base portion101about axis a′. The linkage portion109may be made from durable, high-strength material(s) to provide a high degree of structural integrity and to prevent the components within the linkage portion109from being damaged. In one embodiment, as shown inFIG.6, the linkage portion109may include a rigid support frame313made from a suitable high-strength metal material, such as aluminum or steel. The support frame313may include a support plate315extending adjacent and parallel to the first major surface301of the linkage portion109. A similar support plate may extend adjacent and parallel to the second major surface303of the linkage portion109. First and second drive systems317,319for driving the rotation of the linkage portion109with respect to the patient support103and base portion101may be located at least partially between the two support plates315. As shown inFIG.6, one or more block members321for supporting rotary bearing(s)323for a rotary drive shaft311may be secured between the support plates315. A similar configuration may also be located on the opposite side of the linkage portion109to support the other rotary drive shaft309. The linkage portion109may include an outer shell325enclosing an interior housing327that may contain the support frame313, rotary bearings313, rotary drive shafts309,311and drive systems317,319.FIG.6illustrates the linkage portion109with the outer shell325partially removed. The outer shell325may define the first and second major surfaces301,303and sidewalls305,307,308and310of the linkage portion109. As shown, for example, inFIG.2, the third and fourth sidewalls308and310of the linkage portion109may have a rounded contour to enable the linkage portion109to pivot with respect to the ground and the patient support103with minimal clearance. In embodiments, the outer shell325may be made from a plastic or carbon fiber material. FIG.6illustrates the drive systems317,319for driving the rotation of the rotary drive shafts309,311relative to the linkage portion109. In embodiments, the drive systems317,319may have a mirrored configuration where two drive systems are rotated 180° within the interior housing327of the linkage portion109. For example, a first drive system317for driving the rotation of the first rotary drive shaft309may include a first motor329between the support plates315that may be geared in to a first drive chain331that meshes with a first sprocket wheel333coupled to the first rotary drive shaft309. Thus, the first motor329may drive the rotation of the first rotary drive shaft309and the pivoting of the patient support103with respect to the linkage portion109. A second drive system319coupled to the second rotary drive shaft311may include a second motor between the support plates315(not visible inFIG.6) that may be geared in to a second drive chain335that meshes with a second sprocket wheel337coupled to the second rotary drive shaft311. The second sprocket wheel337and the second rotary drive shaft311may be fixed to the base portion101of the table system100(e.g., between bracket members201). The second motor may drive the second drive chain335around the second sprocket wheel337, causing the linkage portion109to rotate on the rotary bearing(s) and pivot with respect to the base portion101. Rotary encoders may be provided on one or more of the motor, gears or rotary bearings of each of the drive systems317,319for indicating the relative rotational positions of the base portion101, linkage portion109and patient support103. As shown inFIG.1, in some embodiments, the entire table system100may be rotated and/or translated along at least one direction. For example, the base portion101of the system100may be mounted to a platform400on a rotating bearing to enable the table system100to be rotated in the direction of arrow401. The rotating platform400may be mounted to a rail system402to enable the table system100to translate in at least one direction, such as along the direction of arrows403and/or arrows405. The rotation and translation motion of the table system100may enable a patient to be loaded onto the patient support103when the table system100in a first position and orientation and then moved to a second position and/or orientation to perform an imaging scan. For example, the table system100may be rotated such that the patient support103is oriented in line with a patient imaging axis of an imaging device (such as an x-ray CT scanner). Where the imaging device has a fixed bore, the entire table system100with the patient supported thereon may be translated into the bore. It is noted that the relative rotational positions of the base portion101, linkage portion109and patient support103may remain fixed during the scan such that the torque forces experienced along the length of the patient support103remains constant, even when the table system100translates into the imaging bore. Thus, there may be no dynamic sagging of the patient support103during an imaging scan. It will be understood that in some embodiments, the table system100may be fixed to a floor or other support surface102and may not rotate and/or translate as illustrated inFIG.1. A control system500(e.g., a processor and memory) may be operatively coupled to the table system100, as schematically illustrated inFIG.6. The control system500may be located partially or completely within the table system100(e.g., within the linkage portion109) and/or within one or more separate components, such as a workstation, an imaging system or a mobile cart. The control system500may receive position feedback data (e.g., rotary encoder data) from the table system100and may send control signals to the motor(s) of the table system100to cause the motors to drive one or both of the rotary drive shafts309,311and pivot the linkage portion109and/or the patient support103into a desired configuration. The linkage portion109and/or the patient support103may be pivoted to one or more pre-set configurations of the table system100(e.g., stored in the memory of the control system500) and/or the configuration may be controllably adjusted by a user using a suitable user input device501(e.g., buttons, joystick, computer keyboard and/or mouse, touchscreen display, etc.). Various pivot motions and operating modes of a table system100according to an embodiment are now described with reference toFIGS.1-5. In embodiments, the table system100may be used to support a patient while performing a variety of imaging scans of the patient using an imaging system. The imaging system may be an x-ray computed tomography (CT) imaging system. Examples of x-ray CT imaging devices that may be used according to various embodiments are described in, for example, U.S. Pat. No. 8,118,488, U.S. Patent Application Publication No. 2014/0139215, U.S. Patent Application Publication No. 2014/0003572, U.S. Patent Application Publication No. 2014/0265182, U.S. Patent Application Publication No. 2014/0275953, U.S. Provisional Patent Application No. 62/425,746 and U.S. application Ser. No. 15/130,258, the entire contents of all of which are incorporated herein by reference. It will be understood that these embodiments are provided as illustrative, non-limiting examples of imaging systems suitable for use with a table system100according to various embodiments, and that an embodiment table system100may utilize various types of medical imaging devices. For example, alternatively or in addition to an x-ray CT device, a table system100of the various embodiments may be used with an x-ray fluoroscopic imaging device, a magnetic resonance (MR) imaging device, a positron emission tomography (PET) imaging device, a single-photon emission computed tomography (SPECT), an ultrasound imaging device, etc. In one non-limiting embodiment, the table system100may be used to obtain diagnostic images of a patient in a standing or weight-bearing position. A patient may stand on the platform105of the patient support103, optionally with their body leaning or resting against the bed107. A gantry of an imaging system may be moved such that the patient and patient support103are positioned within the bore of the gantry, such as by lowering the gantry over the patient and patient support103(or alternatively, raising the patient and patient support103into the bore of the gantry). An example of a system for performing an x-ray CT imaging scan of a patient in a weight-bearing position is described in U.S. Patent Application Publication No. 2014/0139215, which was previously incorporated by reference. In some embodiments, the table system100may be used to move a patient between a lying position (i.e., where the patient support103extends in a generally horizontal direction with the patient supported primarily by bed107) and a standing or weight-bearing position (i.e., where the patient support103extends in a generally vertical direction with the patient supported primarily by platform105). In embodiments, a patient may be first loaded onto the patient support103in a lying position. The feet of the patient may be adjacent to the platform105. An optional restraint (e.g., one or more Velcro® straps) may be utilized to secure the patient to the patient support103. The patient support103along with the patient may then be tilted up into a standing or weight-bearing position. Alternately, the patient may be loaded onto the patient support103in a standing position (e.g., the patient may step up onto the platform105) and the patient support103along with the patient may be tilted down into a lying position. FIG.1illustrates the table system100in a first configuration. In this configuration, the linkage portion109lies flat and parallel to the support surface102(e.g., the floor). The bracket members201of the base portion101and the bracket members119of the patient support103are adjacent to the first and second side walls305,307(seeFIGS.2-3) of the linkage portion109. The second portion113of the patient support103may extend over and parallel to the first major surface301of the linkage portion109. The first portion111of the patient support103may extend vertically upward from and perpendicular to the first major surface301of the linkage portion109. The configuration ofFIG.1may provide a relatively small footprint with the base portion101, linkage portion109and patient support103folded over one another in a compact manner. FIG.2illustrates the pivoting motion of the patient support103with respect to the linkage portion109in the direction of arrow600. InFIG.2, the patient support103is tilted about 45° with respect to the linkage portion109. In embodiments, the patient support103may pivot with respect to the linkage portion109over a range of at least about 90°, and preferably at least 180° such as up to about 270°. FIG.3illustrates the pivoting motion of the linkage portion109with respect to the base portion101in the direction of arrow601. As shown inFIG.3, the linkage portion109is pivoted about axis a′ by 90° such that the first and second major surfaces301,303of the linkage portion109extend in a vertical direction and are oriented perpendicular to the support surface102(e.g., floor). In the configuration ofFIG.3, the patient support103is pivoted 180° relative to the configuration ofFIG.1, such that the second portion113of the patient support103is now offset from and parallel to the second major surface303of the linkage portion109. The first portion111of the patient support103extends in a horizontal direction perpendicular to the second major surface303of the linkage portion109. FIG.4shows another configuration in which the linkage portion109has been pivoted 180° from the configuration ofFIG.1such that the first major surface301of the linkage portion109now lies horizontal against the support surface102(e.g., the floor) and the second major surface303of the linkage portion109faces vertically upwards. In this configuration, the patient support103has been pivoted 270° relative to the configuration ofFIG.1, such that the second portion113of the patient support103extends vertically upward from and perpendicular to the second major surface303of the linkage portion109, and the first portion111of the patient support103extends in a horizontal direction over and parallel to the second major surface303of the linkage portion109. An advantage of the configuration ofFIG.4is that it may facilitate easy loading and unloading of a patient to and from the patient support103. In many cases, it can be challenging for a patient to get onto or be placed onto a conventional table for an imaging device. Often, particularly in the case of sick or infirm patients, this may require lifting patient from a gurney up onto a dedicated radiology table, which can be problematic for the medical staff. A table system100according to various embodiments may be lowered such as shown inFIG.4so that the bed107on which the patient is supported may be at a comfortable height for loading and unloading of the patient. For example, the bed107may be at a height of no more than about 50 cm, such as between 30 and 40 cm from the floor. This may allow a patient to easily climb onto or be lowered down onto the bed107, which may be easier for both the patient and the medical staff members. The patient support103may then be raised from the lowered position ofFIG.4to a height suitable for an imaging scan (e.g., such that the patient support103may be positioned within the bore of an imaging device). In embodiments, the patient support103may be raised to raise the bed107to a height of one meter or more from the floor.FIG.3shows the patient support103raised to a maximum height for performing a scan of a patient supported in a horizontal lying position on the bed107. The patient support103may be raised to any height between the lowered position inFIG.4and the raised position ofFIG.3by controlling the relative pivoting motions of the base portion101, linkage portion109and patient support103. A control system500of the table system100(seeFIG.6) may coordinate the pivoting motions so that bed107stays generally horizontal as the patient support103is raised and lowered. The bed107may also be moved to an inclined position at any arbitrary angle (e.g., ±30° from the horizontal position shown inFIGS.3and4). In embodiments, this may enable the patient to be supported in Trendelenburg and/or reverse Trendelenburg positions. FIG.5illustrates the table system100in a configuration suitable for imaging a patient in a standing or weight-bearing position. In embodiments, the patient support103may be pivoted upwards by a pre-determined angle (e.g., 90°) from the lowered position shown inFIG.4to the position shown inFIG.5. In the configuration ofFIG.5, the patient support103is supported in a cantilevered manner from the linkage portion109by the bracket members119. The patient may be supported in a standing position on the platform105, which is parallel to the support surface102(e.g., floor). The patient support103may be pivoted to any arbitrary angle with respect to the linkage portion109, such as an angle between 0-90° from the surface303of the linkage portion109so that the weight of the patient may be partially supported by the platform105and partially supported by the bed107. An imaging gantry of an imaging device (e.g., x-ray CT scanner) may scan the entire length of the patient without interference from either the linkage portion109or the base portion101of the table system100. Various examples of diagnostic imaging applications that may be performed on a human or animal patient in a weight-bearing position using the present table system100include, without limitation: Imaging the bones of a foot. The three-dimensional relationships of the bones in the foot in a flatfoot deformity are difficult to assess with standard radiographs. CT scans demonstrate these relationships but are typically made in a non-weightbearing mode. The use of a weightbearing CT or other imaging apparatus may be useful in imaging the feet in patients with severe flexible pesplanus deformities and to better define the anatomical changes that occur. Imaging of a limb (e.g. leg). Weight-bearing (CT) bilateral long leg hip to ankle examination and non-weight bearing cross-sectional imaging (CT) of the affected limb may be performed on the hip, knee and ankle, for example, and may be useful for determining variations in angulation and alignment accuracy for diagnosis and/or surgical planning. Imaging of a spine. Weight bearing scanning (e.g., CT scanning) may be useful for improvements in the accurate diagnosis of degenerative spinal disorders by scanning a patient in the “real life” standing position. By scanning in the standing position, the spinal disc and facet joint compresses, which may enable more specific and precise diagnosis of degenerative spine disorders. Imaging of a joint (e.g., knee). Weight bearing scanning (e.g., CT scanning) of the knee may enable more specific and precise diagnosis of the patella-femoral kinematics and may also be useful in surgical planning. Angiography. Weight bearing angiography (e.g., CT angiography) may enable more accurate diagnosis, and may be used, for example, to examine the pulmonary arteries in the lungs to rule out pulmonary embolism, a serious but treatable condition. Weight bearing angiography may also be used to visualize blood flow in the renal arteries (those supplying the kidneys) in patients with high blood pressure and those suspected of having kidney disorders. Narrowing (stenosis) of a renal artery is a cause of high blood pressure (hypertension) in some patients and can be corrected. A special computerized method of viewing the images makes renal CT angiography a very accurate examination. This is also done in prospective kidney donors. Weight bearing angiography may also be used to identify aneurysms in the aorta or in other major blood vessels. Aneurysms are diseased areas of a weakened blood vessel wall that bulges out—like a bulge in a tire. Aneurysms are life-threatening because they can rupture. Weight bearing angiography may also be used to identify dissection in the aorta or its major branches. Dissection means that the layers of the artery wall peel away from each other—like the layers of an onion. Dissection can cause pain and can be life-threatening. Weight bearing angiography may also be used to identify a small aneurysm or arteriovenous malformation inside the brain that can be life-threatening. Weight bearing angiography may also be used to detect atherosclerotic disease that has narrowed the arteries to the legs. A table system100such as shown and described may also be used to support a patient for interventional radiology procedures and external beam radiation (e.g., LINAC) treatment procedures. The foregoing method descriptions are provided merely as illustrative examples and are not intended to require or imply that the steps of the various embodiments must be performed in the order presented. As will be appreciated by one of skill in the art the order of steps in the foregoing embodiments may be performed in any order. Words such as “thereafter,” “then,” “next,” etc. are not necessarily intended to limit the order of the steps; these words may be used to guide the reader through the description of the methods. Further, any reference to claim elements in the singular, for example, using the articles “a,” “an” or “the” is not to be construed as limiting the element to the singular. The preceding description of the disclosed aspects is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects without departing from the scope of the invention. Thus, the present invention is not intended to be limited to the aspects shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein. | 28,249 |
11857467 | DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A tabletop sagittal adjustment device is generally indicated by the numeral10inFIGS.1-8. The adjustment device10can be integrated with a surgical table12, and the adjustment device10can be manipulated during surgery to adjust the position of a patient P thereon. In doing so, the adjustment device10can be used to alter the position of the patient P before and during surgery to, for example, manipulate the spine of the patient. To illustrate, the adjustment device10can be used to facilitate changing of the spinal alignment of the patient P. Furthermore, for example, altering the position of the patient can be used to accommodate different surgical pathways to the spine of the patient P. Thus, before and during surgery, the adjustment device10can be used to position the patient P in a first position, and then the adjustment device10can be used to reposition the patient P in a different position via manipulation of the adjustment device10. The adjustment device10includes a first patient support portion14and a second patient support portion15positioned on top of a base plate18of the surgical table12. The first and second patient support portions14and15are provided over an upper surface20of the base plate18, and the base plate18and the upper surface20thereof are spaced apart from the ground by a base portion22thereof. The upper surface20can be spaced from the ground at a height to accommodate performance of surgery on the patient P. The first and second support portions14and15can have various shapes to accommodate positioning portions of the body of the patient P thereon. As depicted inFIGS.1-8, for example, the first and second support portions14and15are generally rectangular, and include upper surfaces16and17, respectively, for supporting the patient P thereon. The patient P, as depicted inFIGS.2-5, is positioned on the upper surfaces16and17of the first and second patient support portions14and15, respectively, in a lateral position. As discussed below, the first and second patient support portions14and15are supported by and moveable over the upper surface20of the base plate18. Thus, using the first and second support portions14and15, the patient P can be positioned and repositioned before and during surgery. In doing so, the patient P can be positioned in various lateral positions to, for example, manipulate the spine of the patient P and/or adjust the surgical pathways to the patient's spine. To illustrate,FIGS.2and3shows the patient P in a lateral position with the patient's legs straightened to facilitate lordosis in the patient's spine,FIG.4shows the patient P in a lateral position manipulated to apply kyphosis to the patient's lumbar spine, andFIG.5shows the patient P in a lateral position manipulated to apply additional lordosis to the patient's lumbar spine. A handle24can be attached to one of first and second patient support portions14and15to facilitate movement of at least one of the first and second patient support portions14and15. As depicted inFIGS.1-8, for example, the handle24is attached to the first support portion14. As discussed below, the handle24serves as a lever arm facilitating repositioning of at least the first support portion14. Additionally, lower surfaces26and27of the first and second support portions14and15can be provided with omnidirectional movement mechanisms. For example, the lower surfaces26and27can include omnidirectional casters or rollers (not shown) that afford movement of the first and second support portions14and15in any direction on the upper surface20of the base plate18. As discussed above, the first and second support portions14and15are supported by and moveable over the upper surface20of the base plate18. Furthermore, at least one of the first and second support portions14and15can be moveably attached to the base plate18. For example, as depicted inFIGS.6-8, the first support portion14and the second support portion15are pivotally attached to the base plate18by pins30and32, respectively. The pins30and32are received through holes in the first and second support portions14and15, and removably inserted into holes34and36provided in the base plate18. By pinning the first and second support portions14and15to the base plate18, the first and second support portions14and15can pivot about the pins30and32, respectively, to afford the movement depicted inFIGS.1-8. The holes34and36are sized to afford constrained movement of the pins30and32relative thereto, and thus, provide fixed pivot points for the first and second support portions14and15, and the handle24can be used in pivoting the first support portion14, as depicted inFIGS.7and8. Furthermore, the first and second support portions14and15can be unpinned from the base plate18to facilitate unconstrained movement thereof on the upper surface20. FIGS.9-11depict another embodiment of the surgical table generally referenced by the numeral12′. The surgical table12′ also includes first and second support portions14and15of the adjustment device10, and the first and second support portions14and15, as depicted inFIGS.9-11, are pinned to the base plate18using larger holes40and42. The holes40and42can be formed in the base plate18or a second base plate44positioned between the base plate18and the first and second support portions14and15. The second base plate18can also be used with the surgical tables12and12″. The holes40and42are sized to receive and afford semi-constrained movement of the pins30and32relative thereto, and thus, provide variable pivot points for the first and second support portions14and15. Again, the handle24can be used in pivoting the first support portion14, as depicted inFIGS.10and11, and the first and second support portions14and15can be unpinned from the base plate18to facilitate unconstrained movement thereof on the upper surface20. FIGS.12-14depict another embodiment of the surgical table generally referenced by the numeral12″. The surgical table12″ also includes first and second support portions14and15of the adjustment device, and the first and second support portions14and15, as depicted inFIGS.12-14, are pinned to the base plate18using a channel46. The channel46is sized to receive and afford semi-constrained movement of the pins30and32relative thereto, and thus, provide variable pivot points for the first and second support portions14and15. Again, the handle24can be used in pivoting the first support portion14, as depicted inFIGS.13and14, and the first and second support portions14and15can be unpinned from the base plate18to facilitate unconstrained movement thereof on the upper surface20. Additionally, in each of the embodiments of the surgical table12,12′, and12″, the first and second support portions14and15can be provided with locking mechanisms for restraining movement of the first and second support portions14and15after positions therefor have been selected. Furthermore, the upper surfaces16and17of the first and second support portions14and15of each of the embodiments of the surgical table12,12′, and12″ can provided with cushioning to provide relatively soft surfaces for supporting the patient P. For example, the cushioning can be integrated with the upper surfaces16and17, and/or the first and second support portions14and15can be provided with attachment points to which removable cushioning can be attached. Either way, each of the embodiments of the surgical tables12,12′, and12″ can be provided with relatively soft surfaces for supporting the patient P thereon. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims. | 7,893 |
11857468 | DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION With reference to the details ofFIGS.3-11, a funerary capsule C for viewing and transporting dead bodies to cremation sites according to the invention comprises:a casket1for containing the body, provided with a side wall2and a lid3liftable by rotation on respective hinges4,5relative to the remaining stationary portion of said casket1;a bag (not illustrated) for containing the body, which can be placed in said casket1, provided with handles and closing ties;handles6, which can be extracted laterally from the base7of said casket1;legs8for resting on the ground, which can be folded and housed under the base7of said casket. The casket1, the side wall2and the lid3of the capsule C are made of synthetic materials of known and suitable type, adapted to be subjected to sanitation processes that ensure the hygiene of the capsule C and allow its reuse without health risks for the funeral operators. The casket1and the side wall2of the capsule C are made of opaque synthetic materials, while the lid3of the capsule C is made of transparent synthetic materials, adapted to allow viewing of the body contained therein. For religions that do not allow viewing of the body, said lid3is instead made of opaque material. The bag for containing the body, the related handles and the related closing ties, are made of natural fibers, suitable to be incinerated during cremation of the body. Naturally, bag must be understood as any enclosure made of fabric, such as a veil, shroud, etc., used in different countries around the world according to religious or civil customs. Moreover, the closing ties can comprise closing means of Velcro® or zip fastener type. The hinges4for lifting the side wall2of the capsule C are advantageously of pivot type: said hinges4are two and are provided symmetrically at the two end points of the casket1, so as to facilitate the upward rotation of the side wall2and allow easy and direct access to the bag containing the body. The body can be extracted from the capsule C by simply being pulled horizontally, without requiring lifting or particular precautionary measures. Advantageously, said hinges4are of the type with adjustable friction. The hinge5for lifting the lid3of the capsule C is preferably of rectilinear type. Said legs8for resting the coffin on the ground are provided with hinges (not illustrated) adapted to allow the rotation thereof between a position of use resting on the ground (FIG.11) and an idle position folded under said base7(FIGS.3-10). In more complex possible variants of embodiment (not illustrated), the funerary capsule C can also comprise:a system for cooling the body, housed in the base of the casket1;a system for lighting the body, arranged in the upper profile of the casket1and/or of the related liftable side wall2. The use of a funerary capsule C for viewing and transporting dead bodies, for example to cremation sites or sites of worship (such as mosques in the case of Muslims), according to the invention, can be summarized as described below. The dead body is laid out inside the appropriate bag for containing it and with it inserted into the casket1of the funerary capsule C, supported by appropriate legs8for resting on the ground. The movement of the body is facilitated by the handles arranged on the bag, while its insertion into the casket1of the funerary capsule C is facilitated by temporarily lifting the related side wall2and the related closing lid3on the respective rotation hinges4,5. After the body has been inserted into the casket1of the funerary capsule C, and after having re-opened the bag containing it, the related side wall2and the related lid3are returned to the initial lowered position, in this case determining closing thereof and arrangement (with the legs8folded under the casket1) for transporting the body to the viewing site (mortuary, place in which the funeral is to be held, etc.) or cremation site chosen. The movement of the funerary capsule C is facilitated by the extractable handles6, arranged on the base7of the casket1for containing the body. At the viewing site, the dead body will be visible through the transparent lid3of the casket1of the funerary capsule C, while the bag will perform the function of lining for covering and/or decorating the casket1of the funerary capsule C. At the cremation site, the dead body will be extracted from the casket1of the funerary capsule C after being closed inside the bag again and loaded with the bag into the crematory used for its incineration. Extraction of the body from the casket1of the funerary capsule C is facilitated by the handles provided on the bag and by temporary lifting of the related side wall2and of the related closing lid3on the respective rotation hinges4,5, while closing of the bag is enabled by appropriate ties arranged thereon. Only the bag for containing the body, the related handles, and the related closing ties will be incinerated during cremation of the body, thereby allowing a reduction in atmospheric pollution produced by cremation services, mainly due to the energy consumption and atmospheric emissions deriving from the incineration of coffins for traditional cremations. After having performed its service, the funerary capsule will instead be subjected to sanitation treatments, which will allow it to be reused, in this way allowing a reduction in the operating costs of the cremation services, mainly determined by the single use of coffins for traditional cremations. In more complex possible variants of embodiment (not illustrated), the funerary capsule C can also comprise a system for cooling the body, arranged in the base7of the casket1, or a system for lighting the body, arranged in the upper profile of the casket1and/or of the related liftable side wall2. | 5,855 |
11857469 | DESCRIPTION OF EXAMPLE EMBODIMENTS With reference toFIGS.1and2, it is possible to note that a device for transporting a coffin is composed of a supporting frame approximately covered by the coffin. Advantageously, the device according to the present invention comprises a plurality of sliding shelves1,2, each of such sliding shelves1,2being designed to increase the extension of the supporting frame with respect to the area covered by the coffin. With reference toFIGS.1,3and7, it is possible to note that each of the sliding shelves1is connected to the supporting frame through a hinge11to be able to rotate inside and outside. In the same way, each of the sliding shelves2is connected to the supporting frame through a linear guide to be able to slide inside and outside (as shown, for example, inFIG.10). Each of the sliding shelves1,2, comprises a concavity1ato enable the interaction with the shoulder of an operator. Each of the sliding shelves1,2comprises at10least one portion of a layer of deformable material, not shown, to improve the distribution of the load on an operator. With reference toFIGS.1and from3to6, it is possible to note that the supporting frame comprises a plurality of transverse rods3approximately along the width direction of the coffin, to support each of the sliding shelves1,2. Each of the transverse rods3is equipped with a clamp4in order to fasten and lock the coffin. The clamp4comprises a sliding rod41with a lever42for a quick locking. The end of such sliding rod41is shaped as an hook or anyway of another type of catching element, which can adhere with safety to the surface of the coffin The supporting frame comprises at least one longitudinal rod5connected to the plurality of transverse rods3through mechanical interface means with permanent locking systems or quick locking/unlocking systems (as shown, for example, inFIG.6). Such at least one longitudinal rod5is equipped with handles6of a removable type or permanently fastened, and with a locking system comprising the clamp4to fasten and lock the coffin longitudinally. The device can be completely detachable from the coffin once having ended its use. The device for transporting a coffin comprises transverse rods equipped with clamps to fasten and lock the coffin. Each of such clamps comprises a sliding rod with a lever for their quick locking. The end of such sliding rod can be shaped as a hook or anyway of another type of catching element, which can adhere with safety to the surface of the coffin. A variation provides that the sliding rod41is connected to the transverse rod3through a recall spring (not shown). The longitudinal rod is connected to the plurality of transverse rods through mechanical interface means with permanent locking systems or quick locking/unlocking systems, such as screws with a projecting shaped head, shown inFIG.6. Both the transverse rods and the handles are applied to the longitudinal rod, making them slide till a suitable and more comfortable position for an operator. It is possible to increase the number of the operator stations by simply adding or removing a transverse rod and a pair of handles sliding along the longitudinal axis. Alternatively, the ends of the longitudinal rod can house a locking system equipped with a holding hook to block head and feet of the coffin. In this way, the device is fastened to the coffin not only transversally, but also longitudinally, allowing oscillations in pitch and roll safety when handling the coffin, for example along a staircase of a building or of a religious place. The device of the invention is made with mechanical elements and parts of a commercial type. For example, it is possible to use the following bill of industrial materials:Handles with plate/Offset, UHFNEAG125-S;Recess width 6 mm/plane aluminum profiles, HFSQN4-1070-1500;Recess width 10 mm/plane aluminum profiles/1 recess, HFSPURE8-1830-400;profiles/Rectangular tubes, HFHQ4080-2-450;Push-Pull, MC07-15. | 3,989 |
11857470 | DETAILED DESCRIPTION The present patent application specification and drawings provide multiple embodiments of a vehicle, such as a wheelchair, and suspension that enhances the ability of the vehicle to traverse obstacles and/or improve the ride quality of the wheelchair. The illustrated embodiments of the vehicles are wheelchairs, but the concepts of the illustrated embodiments are equally applicable to other types of vehicles. Generally, the wheelchairs each include a frame, a seat supported by the frame, a pair of drive assemblies, a pair of front anti-tip wheels, and at least one rear anti-tip wheel. In one embodiment, the front anti-tip wheels are connected to the frame, such that positions of axles of the front anti-tip wheels are fixed relative to the frame. In this embodiment, the drive assemblies are moveable with respect to the frame and optionally with respect to one another. In another embodiment, a linkage couples a front anti-tip wheel to a rear anti-tip wheel such that movement of the front anti-tip wheel causes movement of the corresponding rear anti-tip wheel and/or vice versa. For example, the linkage may couple the front anti-tip wheel to the rear anti-tip wheel such that upward movement of the front anti-tip wheel relative to the frame causes upward movement of the rear anti-tip wheel relative to the frame. Similarly, the linkage may couple the front anti-tip wheel to the rear anti-tip wheel such that downward movement of the front anti-tip wheel relative to the frame causes downward movement of the rear anti-tip wheel relative to the frame. In this application, the term “frame” refers to any component or combination of components that are configured for coupling, mounting, attaching, or affixing of a drive assembly and at least one anti-tip wheel. In this application, the terms “couple,” “mount,” attach,” “affix,” “fix,” etc. are to be interpreted to include direct and indirect, through intermediate “coupling,” “mounting,” attaching,” “affixing,” “fixing,” etc. For example, a component that is “fixed” to the frame may be directly connected to the frame or the component may be connected to the frame by one or more intermediate components that prevent relative movement of the component with respect to the frame. FIGS.1and2illustrate a first embodiment of a wheelchair100. The wheelchair100includes a frame102, a seat103supported by the frame, first and second drive assemblies104,105(seeFIG.2), first and second suspension assemblies106,107(seeFIG.2), first and second front anti-tip wheels120,121(seeFIG.2) and at least one rear anti-tip wheel108. The seat103is shown schematically inFIGS.1and2and is omitted in the illustrations of many of the embodiments to indicate that any type of seat can be used. Also, seat103may face in either direction (i.e. toward the “front” anti-tip wheels120as shown or toward the rear anti-tip wheels108) in any of the embodiments disclosed in this application. As such, the illustrated embodiments may be configured as front wheel drive wheelchairs or rear wheel drive wheelchairs. In addition, the wheelchair100may be configured as a mid-wheel drive wheelchair. Any of the drive and suspension arrangements disclosed in this application may be used on front wheel drive wheelchairs, rear wheel drive wheelchairs, or mid wheel drive wheelchairs. The direction of forward travel may be in the direction indicated by arrow50or in direction indicated by arrow51. In the illustrated embodiments, the wheelchair may include two separate drive assemblies. However, in other embodiments a single drive motor may drive both drive wheels. In the illustrated embodiments, each drive assembly104,105may be coupled to the frame by a corresponding suspension assembly106,107, such that each drive assembly is moveable relative to the frame102, and such that the drive assemblies are moveable relative to one another. In another embodiment, the drive assemblies are moveable with respect to the frame, but are fixed or linked to one another. The suspension assemblies106,107can take a wide variety of different forms, several non-limiting examples of which are disclosed in detail below. The suspension assembly106,107can be any arrangement that allows the drive assemblies106,107to move upward and/or downward relative to the frame. In this application, the terms “up”, “upward”, “down”, “downward”, “above” and “below” and any other directional terms refer to the relative positions of the components when all of the wheels of the wheelchair are on a flat, level surface, such as support surface119illustrated inFIG.1. In the embodiment illustrated byFIGS.1and2, each drive assembly104,105includes a drive motor130and a drive wheel132. The drive motor130may comprise a motor/gear box combination, a brushless, gearless motor, or any other known arrangement for driving the drive wheel132. The drive motor130drives the drive wheel132about the axis of rotation112. The at least one rear anti-tip wheel108may take a wide variety of different forms. For example, there may be one, two, or any number of rear anti-tip wheels. Each rear anti-tip wheel108may be a wheel of a caster assembly170which is rotatable about a substantially vertical axis171with the wheel108being rotatable about a substantially horizontal axis174. Alternatively, the wheel108may be mounted for rotation only about a substantially horizontal axis174(i.e. there is no rotational connection at171). In this alternative embodiment, the wheel108would typically, but not necessarily, be off the ground. In the illustrated embodiment, two rear anti-tip wheels108are disposed rearward of the drive wheels132. The rear anti-tip wheels may be disposed on the ground or spaced apart from a horizontal support surface when the wheelchair is at rest in a normal operating position on the horizontal support surface. The rear anti-tip wheels may include integral suspension elements, such as resilient spokes. In the example illustrated byFIGS.1and2, two caster assemblies170include anti-tip wheels108that are disposed on the horizontal support surface119when the wheelchair is in a normal operating position. In the example illustrated byFIGS.1and2, the suspension assemblies106,107are mirror images of one another. As such, only suspension assembly106is described in detail. In the illustrated embodiments, the suspension assemblies106,107are independently moveable relative to one another. However, the suspension assemblies106,107can be linked together, such that they move in unison, such that one assembly causes movement of the other assembly, or movement of one assembly is limited based on the position of the other assembly. The illustrated suspension assembly106includes a pivot arm134and a biasing member172. The pivot arm134is pivotally coupled to the frame102at a pivot axis110. The illustrated drive assembly104is fixed to the pivot arm134. However, the drive assembly104may be otherwise coupled to the pivot arm, such that movement of the pivot arm134causes movement of the drive assembly104relative to the frame102. The pivot arm134may take a wide variety of different forms. For example, the pivot arm134may be any member that is pivotable with respect to the frame102to move the drive assembly104upward and downward with respect to the frame. The illustrated pivot arm134includes a forward link180and a caster assembly170, which includes a rearward link182. In the embodiment illustrated byFIGS.1and2, the drive assembly102is fixed to the forward link180and a rearward link182that supports the rear anti-tip wheel. The rear anti-tip wheel108may be coupled to the rearward link182in any manner where movement of the pivot arm134causes movement of the rear anti-tip wheel108. The forward link180and the rearward link182of the pivot arm134may be fixed relative to one another as indicated schematically by brace member184. It should be understood that no actual brace member184is required. Rather, the schematic brace member merely indicates any fixed connection between the forward link180and the rearward link182or that the links are integrally formed. Alternatively, the forward link180and the rearward link182may be independent members that are pivotable about a common pivot axis or pivotable about two separate pivot axes (SeeFIGS.4A and4B). When the forward link180and the rearward link182are not fixed together, they may optionally be coupled together by an extendable link186(SeeFIGS.20A,20B, and20C), which would replace the fixed brace member. The axis110can be positioned at a wide variety of different locations with respect to the frame102. For example, the pivot axis110can be positioned at any position on the frame or below the frame using with one or more brackets, etc. In the embodiment illustrated byFIGS.1and2, the drive assembly pivot axis110of the drive assembly104is below an axis of rotation112of a drive axle114of the drive assembly104. The pivot arm134may be a substantially rigid member that is connected to the motor drive130and the rear anti-tip wheel108. In one embodiment, the pivot arm134is flexible or one or more portions of the pivot arm are flexible to provide inherent shock absorbing properties in the pivot arm. The pivot arm134may be made from a wide variety of materials, including, but not limited to, metals and plastics. The biasing member172can take a wide variety of different forms. Any spring device, devices or assembly can be used as the biasing member. The biasing member may be a single spring, a bi-directional spring, or multiple spring elements. The biasing member may include a shock absorbing component, for example, the biasing member may be a shock absorber2006with a spring return (SeeFIG.20C). In the example illustrated byFIGS.1and2, a spring mount190is fixed to the frame102. The biasing member172is disposed between the spring mount190and the pivot arm134. The biasing member172illustrated byFIG.1is a compression spring that biases the rearward link182downward relative to the frame102as indicated by arrow192. An optional stop194may be fixed to the frame to limit downward movement of the rearward link182with respect to the frame. In one embodiment, the biasing member is not fixed to the mount190or the pivot arm134. In another embodiment, the biasing member is connected to one or both of the mount190and the pivot arm134. In the embodiment illustrated byFIGS.1and2, the downward biasing of the rearward link182causes upward biasing of the forward link180.FIGS.1,1A,1B and1Cillustrate that the biasing member172can be an extension spring or a compression spring positioned at a variety of different locations to provide the upward drive assembly/downward rearward link182biasing. For example, inFIG.1Athe biasing member172is an extension spring positioned below the rearward link182. InFIG.1B, the biasing member172is an extension spring positioned above the forward link180. InFIG.1C, the biasing member172is a compression spring positioned below the forward link180. In another embodiment, the biasing member172is configured to bias the forward link180downward and rearward link182upward. This can be accomplished in a variety of different ways. For example, in the examples illustrated byFIGS.1and1C, the biasing member172can be changed from a compression spring to an extension spring and, in the examples illustrated byFIGS.1A and1B, the biasing member172can be changed from an extension spring to a compression spring. In another embodiment, the biasing member172is configured to bias the pivot arm134to a home position, such as the position relative to the frame illustrated byFIG.1. Biasing to a home position can be accomplished in a variety of different ways. For example, a bidirectional spring can be coupled to the pivot arm and/or any one or more of the spring arrangements that bias the rear link182downward can be used with any one or more of the spring arrangements that bias the forward link180downward. In an exemplary embodiment, the biasing member is configured such that the drive wheel132and the rear anti-tip wheel108engage the horizontal support surface119when the wheelchair is at rest on the horizontal support surface. The first and second front anti-tip wheels120,121may take a wide variety of different forms. For example, the wheels120,121may be wheels of caster assemblies (see for example, rear caster assemblies170) or the wheels may be mounted for rotation only about a substantially horizontal axis173, as in the embodiment illustrated byFIG.1. In the illustrated embodiment, the first and second front anti-tip wheels120,121are located forward of the drive wheels132. The front anti-tip wheels120,121may be disposed on the horizontal support surface119or spaced apart from the horizontal support surface119when the wheelchair is at rest or in a normal operating position, as in the embodiment illustrated byFIG.1. In one exemplary embodiment, the front anti-tip wheels120,121may include integral suspension elements, such as resilient spokes. The first and second front anti-tip wheels120,121are supported by first and second arms191that are coupled to the frame102. However, any number of arms and front anti-tip wheels may be included. In the example illustrated byFIGS.1and2, the arms191are fixedly connected to the frame. However, in other embodiments, the arms191may be suspended from the frame such that the arms are moveable with respect to the frame. For example, the arms191may be pivotally connected to the frame (See for example arm1790inFIG.16C) and/or coupled to the frame for translational movement relative to the frame (See for example coupling806inFIG.8A). The first and second arms191may take a wide variety of different forms. The arms191may be rigid or substantially rigid. In one embodiment, the arms191are flexible to provide inherent shock absorbing properties in the arm. The arms191may be made from a wide variety of materials, including, but not limited to, metals and plastics. In the example illustrated byFIGS.1and2, the arms191are rigid. An axle that defines the axis of rotation173of each of the front anti-tip wheels120,121is connected to each of the arms. As such, the front anti-tip wheels120,121are connected to the arms191such that positions of axes of rotation173of the front anti-tip wheels with respect to the frame102are fixed. In the example illustrated byFIGS.1and2, the front anti-tip idler wheels120,121are spaced apart from the horizontal support surface119when the wheelchair is at rest or in the normal operating position on the horizontal support surface119. FIGS.3A-3Hillustrate a more specific embodiment of the wheelchair100illustrated byFIGS.1and2. It should be understood that the present application is not limited to the more specific embodiment illustrated byFIGS.3A-3H.FIG.3Aillustrates the wheelchair100at rest in the normal operating position on the horizontal support surface119.FIG.3Billustrates the wheelchair ofFIG.3Awith the drive wheel132schematically illustrated to more clearly illustrate the suspension106.FIGS.1D and3D-3Gillustrate operation of the wheelchair100. More specifically, these views are elevational views that illustrate embodiments of the wheelchair100traversing over an obstacle300by ascending the obstacle. Referring toFIGS.1D and3D, the drive wheels132bring the front anti-tip wheels120,121into engagement with the obstacle300. The drive wheels132force the anti-tip wheels120,121up and onto the obstacle. The drive wheels132remain on the ground and the upward movement (indicated by arrow302) of the front anti-tip wheels120,121causes the frame102to rotate (indicated by arrow304) about the pivot axis110of the suspensions106,107. The rotation304of the frame102relative to the pivot axis causes compression (indicated by arrows306) of the biasing member172. As a result, additional downward force is applied to the rear anti-tip wheel108. Referring toFIG.3E, the drive wheels132continue to drive the wheelchair100forward. The drive wheels132engage and climb over the obstacle300. As the drive wheels132move up and over the obstacle, the biasing member172forces the rear anti-tip wheel108down. Referring toFIG.3F, the drive wheels132move the wheelchair100further forward on the obstacle300. The rear anti-tip wheels108engage the obstacle300. The biasing member172cushions the impact between the rear anti-tip wheels108and the obstacle. The drive wheels132continue to drive the wheelchair100forward and pull the rear anti-tip wheels108up onto the obstacle300. Referring toFIG.3G, a variety of situations can cause forward tipping of a wheelchair. For example, traveling down a hill, decelerating rapidly, and driving off of an obstacle, such as a curb can cause forward tipping. In the example illustrated byFIG.3F, the front anti-tip wheels120,121engage the support surface119to prevent excessive forward tipping. FIGS.4A and4Billustrate another embodiment of a wheelchair400. The wheelchair400has separate forward and rearward links180,182. Referring toFIG.4B, as in all of the embodiments described herein, the wheelchair400may include any number of rear anti-tip wheels. For example,FIG.4Billustrates that the wheelchair400may include a single center anti-tip wheel (shown in phantom), first and second rear anti-tip wheels (shown in solid lines), or three rear anti-tip wheels (all of the illustrated anti-tip wheels). The forward link180is pivotally connected to the frame102at a pivot axis410and the rearward link182is pivotally connected to the frame at a pivot axis411. The pivot axes410,411may be positioned at any location with respect to the frame102, including locations near or below the frame. The pivot axis410may be forward or rearward of the axis of rotation112of the drive wheel. The pivot axis410may be coincident with the pivot axis411. The separate links180,182allow for independent movement of the drive assembly104relative to the rear anti-tip wheel108. Separate biasing members472,473bias the links180,182downward relative to the frame as indicated by arrows420,422respectively. An optional motion transfer link402may be coupled to the forward and rearward links180,182to control relative motion therebetween. The motion transfer link402can take a wide variety of different forms. For example, the link may be rigid, flexible, or extendible in length. Any link or arrangement that transfers at least some portion of motion in at least one direction of the forward link180to the rearward link182and/or vice versa can be used as a motion transfer link402. Examples include, but are not limited to springs, struts, shock absorbers, rigid links, flexible links, belts, wires, cam arrangements, gear trains, any combination of these, etc. FIG.5illustrates the wheelchair400traversing over an obstacle300. The drive wheels132bring the front anti-tip wheels120into engagement with the obstacle300. The drive wheels132force the anti-tip wheels120up and onto the obstacle. The rear anti-tip wheels are biased against the ground by the biasing member473and the drive wheels132are biased against the ground by the biasing member472. Upward movement (indicated by arrow502) of the front anti-tip wheels120causes the frame102to cant. The canting of the frame102may cause some relaxation of the biasing member472and/or some compression of the biasing member473. The drive wheels132continue to drive the wheelchair400forward, and the drive wheels climb over the obstacle300. The drive wheels132move the wheelchair400further forward to pull the rear anti-tip wheels over the obstacle300. FIGS.6A and6Billustrate another embodiment of a wheelchair600. The wheelchair600has a pivot arm134and one or more rear anti-tip wheels108are connected to the frame102by a fixed arm602. The drive assembly104is connected to the pivot arm134. The pivot arm134is pivotally connected to the frame102at a pivot axis610. The pivot axis610may be positioned at any location with respect to the frame102, including locations near or below the frame. The pivot axis610may be forward or rearward of the axis of rotation112of the drive wheel. The biasing member172biases the pivot arm134downward relative to the frame as indicated by arrow618. FIG.7illustrates the wheelchair600traversing over an obstacle300. The drive wheels132bring the front anti-tip wheels120into engagement with the obstacle300. The drive wheels132force the anti-tip wheels120up and onto the obstacle. The drive wheels132are biased against the ground by the biasing member172. Upward movement (indicated by arrow702) of the front anti-tip wheels120causes the frame102to pivot about the pivot axis610(indicated by arrow704). The pivoting of the frame102may cause some relaxation of the biasing member172depending on the arrangement of the biasing member. The drive wheels132continue to drive the wheelchair600forward, and the drive wheels climb over the obstacle300. The drive wheels132move the wheelchair600further forward to pull the rear anti-tip wheels108over the obstacle300. FIGS.8A and8Billustrate another embodiment of a wheelchair800. In the exemplary embodiment illustrated byFIGS.8A and8B, the wheelchair includes track suspension assemblies806,807(seeFIG.8B). The suspension assemblies806,807are mirror images of one another. As such, only suspension assembly806is described in detail. The suspension assembly806may be any arrangement that defines a path of travel of the drive assembly104with respect to the frame102. For example, the suspension assembly806may include at least one track808, at least one follower810, and at least one biasing member172, such as a spring or other similar device. The illustrated suspension assembly806includes two tracks808and two followers810, but any number of tracks and followers can be used. The illustrated followers810are attached to the drive assembly104and the tracks808are attached to the frame102. Alternatively, the followers810could be attached to the frame102with the tracks808attached to the drive assembly104. Further, the drive assembly104and/or frame102may be otherwise coupled to the tracks808and followers810. In the illustrated embodiment, the followers810are slideably disposed in the tracks808such that the tracks808define the path of relative movement of the drive assembly104relative to the frame102. The illustrated tracks808are linear and define a path of travel that extends in a generally vertical direction. However, the tracks can be configured to define a path of travel having any shape, extending in any direction, including arcuate shapes. The path of travel can have one or more straight and/or curved portions. Further, an arrangement may be included to rotate the drive assembly104relative to the frame102as the drive assembly104moves along the path of travel. The biasing member172can take a wide variety of different forms, as described above. In the example illustrated byFIGS.8A and8B, the biasing member172is disposed in the track808between an end812of the track and the follower810. This arrangement biases the drive assembly104downward relative to the frame102. However, the biasing member172can be arranged in any manner to provide a biasing force between the drive assembly104and the frame102. The biasing member172may be connected directly to the frame102and the drive assembly104or through one or more intermediate members. An optional stop894, such as the end surface of the track, may be fixed to the frame to limit downward movement of the drive assembly104with respect to the frame. In an exemplary embodiment, the biasing member172causes the drive wheel132to engage the horizontal support surface119when the wheelchair is at rest on the horizontal support surface. In the example illustrated byFIGS.8A and8B, the wheelchair800has a rearward link882that supports the rear anti-tip wheel108. The rearward link882is optionally pivotally connected to the frame at a pivot axis811. The pivot axis811may be positioned at any location with respect to the frame102, including locations near or below the frame. The separate link882allow for independent movement of the drive assembly104relative to the rear anti-tip wheel108. A separate biasing member873biases the link882downward relative to the frame102as indicated by arrow820. FIG.9illustrates the wheelchair800traversing over an obstacle300. The drive wheels132bring the front anti-tip wheels120into engagement with the obstacle300. The drive wheels132force the anti-tip wheels120up and onto the obstacle. The rear anti-tip wheels108are biased against the ground by the biasing member873and the drive wheels132are biased against the ground by the biasing member172. Upward movement (indicated by arrow802) of the front anti-tip wheels120causes the frame102to cant. The canting of the frame102may cause some relaxation of the biasing member172and some compression of the biasing member873. The drive wheels132continue to drive the wheelchair800forward, and the drive wheels climb over the obstacle300. The drive wheels132move the wheelchair800further forward to pull the rear anti-tip wheels over the obstacle300. FIGS.10A and10Billustrate another embodiment of a wheelchair1000. The wheelchair1000is similar to the wheelchair800, with the exception that the movement of the rear anti-tip wheels108relative to the frame102is at least partially linked to movement of the drive assembly104relative to the frame. This coupling can be accomplished in a wide variety of different ways. In the example illustrated byFIG.10A, the relative movement of the drive assembly104relative to the rear anti-tip wheels108is restricted by another track and follower arrangement1002. However, any arrangement can be used. Any link or arrangement that transfers at least some portion of motion in at least one direction of the drive assembly104to the rear anti-tip wheel108can be used. The illustrated track and follower arrangement1002includes at least one track1008, at least one follower1010, and at least one coupling member1012. The illustrated follower1010is attached or coupled to the pivot link882and the track1008is attached to the frame102. Alternatively, the follower1010could be attached to the frame102with the track1008attached to the pivot link882. In the illustrated embodiment, the follower1010is slideably disposed in the track1008. The illustrated track1008is linear and defines a path of travel that extends in a generally vertical direction. However, the tracks can be configured to define a path of travel having any shape, extending in any direction, including arcuate shapes. The path of travel can have one or more straight and/or curved portions. In the illustrated embodiment, the coupling member1012couples the follower1010to the drive assembly104. As a result, the position of the rear anti-tip wheel108is at least partially dependent on the position of the drive assembly104. The coupling member1012can take a wide variety of different forms. Any arrangement of transferring at least some portion of movement of the drive assembly104to the follower can be used. In the illustrated embodiment, the follower1012is an extension of the link882that is engaged by the drive assembly104when the drive assembly moves upward relative to the frame102. This upward movement of the follower1010relative to the frame translates into downward movement of the rear anti-tip wheel relative to the frame102in the embodiment illustrated byFIG.10A. The wheelchair1000will traverse obstacles in generally the same manner as the wheelchair800, except the movement of the rear anti-tip wheel108relative to the frame is somewhat dependent on the position of the drive assembly104relative to the frame. FIGS.11A and11Billustrate another embodiment of a wheelchair1100. The wheelchair1100is similar to the wheelchair1000, except the rear anti-tip wheel108is connected to the frame102by a fixed arm1102.FIG.12illustrates the wheelchair1100traversing over an obstacle300. The drive wheels132bring the front anti-tip wheels120into engagement with the obstacle300. The drive wheels132force the anti-tip wheels120up and onto the obstacle. The drive wheels132are biased against the ground by the biasing member172. Upward movement (indicated by arrow1102) of the front anti-tip wheels120causes the frame102to cant. The canting of the frame102may cause some relaxation of the biasing member172depending on the arrangement of the biasing member. The drive wheels132continue to drive the wheelchair1100forward, and the drive wheels climb over the obstacle300. The drive wheels132move the wheelchair1100further forward to pull the rear anti-tip wheels108over the obstacle300. FIGS.13A and13Billustrate another embodiment of a wheelchair1300. The wheelchair1300is similar to the wheelchair800, except the rear anti-tip wheels108are each coupled to the frame102by a track suspension assembly1306. The suspension assembly1306may be any arrangement that defines a path of travel of the rear anti-tip wheel with respect to the frame. For example, the suspension assembly1306may include at least one track1308, at least one follower1310, and at least one biasing member173, such as a spring. The illustrated suspension assembly1306includes two tracks1308and two followers1310, but any number of tracks and followers can be used. The illustrated followers1310are attached to an arm1350that carries the rear anti-tip wheel108and the tracks1308are attached to the frame102. Alternatively, the followers1310could be attached to the frame102with the tracks1308attached to the rear anti-tip wheel. Further, the rear anti-tip wheels108and/or the frame102may be otherwise coupled to the tracks1308and followers1310. In the illustrated embodiment, the followers1310are slideably disposed in the tracks1308such that the tracks808define the path of relative movement of the rear anti-tip wheels108with respect to the frame102. The illustrated tracks808are linear and define a path of travel that extends in a generally vertical direction. However, the tracks can be configured to define a path of travel having any shape, extending in any direction. The path of travel can have one or more straight and/or curved portions. Further, the arm1350can be pivoted or rotated relative to the frame as the arm1350and connected anti-tip wheel108moves along the path of travel. The biasing member173can take a wide variety of different forms as described above. In the example illustrated byFIGS.13A and13B, the biasing member173is disposed in the track1308between an end1312of the track and the follower1310. This arrangement biases the anti-tip wheel108downward relative to the frame102. However, the biasing member173can be arranged in any manner to provide a biasing force between the rear anti-tip wheel108and the frame102. The biasing member173may be connected directly to the frame102and the anti-tip wheel108or through one or more intermediate members. A stop1394, such as the end surface of the track, may be fixed to the frame to limit downward movement of the rear anti-tip wheel108with respect to the frame. In an exemplary embodiment, the biasing member173causes the rear anti-tip wheel108to engage the horizontal support surface119when the wheelchair is at rest on the horizontal support surface. Referring toFIG.13A, an optional motion transfer link1352(not shown inFIG.13B) may be coupled to the drive assembly104and the rear anti-tip wheel108to control relative motion therebetween. The motion transfer link1352can take a wide variety of different forms. For example, the link may be rigid, flexible, or extendible in length. Any link1352or arrangement that transfers at least some portion of motion in at least one direction of the drive assembly104to the rear anti-tip wheel108can be used. FIGS.14A and14Billustrate another embodiment of a wheelchair1400. The wheelchair1400is similar to the wheelchair1300, except the track suspension assemblies806are replaced with the pivot arm180and biasing member172arrangement shown inFIGS.4A and4B. An optional motion transfer link1452(not shown inFIG.14B) may be coupled to the drive assembly104and the rear anti-tip wheel108to control relative motion therebetween. The motion transfer link1452can take a wide variety of different forms and can be coupled to the suspension assemblies in a wide variety of different ways, including, but not limited to, pivot connections, etc. For example, the link may be rigid, flexible, or extendible in length. Any link1452or arrangement that transfers at least some portion of motion in at least one direction of the drive assembly104to the rear anti-tip wheel108can be used. FIG.15is a schematic view illustrating drive wheels132suspended to sides1500of the frame102. In one embodiment, one or more wheels that are suspended from the frame, such as drive wheels132, front anti-tip wheels120,121(not shown inFIG.15) and/or rear anti-tip wheels108(not shown inFIG.15), are suspended such that upward and downward movement of the wheel does not result in significant fore and aft movement of the suspended wheel. This can be accomplished in a variety of different ways. For example, the track and follower arrangements disclosed above may be configured to have this effect. InFIG.15, drive wheels132are coupled to the frame102by a pivot arm1502. A pivot axis1504of the pivot arm1502is perpendicular or substantially perpendicular to an axis of rotation112of the drive wheel (which is generally perpendicular to the sides1500of the frame). As a result, when the pivot arm1502pivots upward or downward, the drive wheel132does not move substantially fore or aft with respect to the frame102. Any of the suspensions of wheels relative to the frame disclosed in this application can be replaced with this type of suspension. FIGS.16and17illustrate another embodiment of a wheelchair1700. The wheelchair1700includes a frame102, a seat103supported by the frame, first and second drive assemblies104,105, first and second suspension assemblies1706,1707, first and second front anti-tip wheels120,121, and a pair of rear anti-tip wheels108. Each drive assembly104,105is coupled to the frame102. In the embodiment illustrated byFIGS.16and17, the drive assemblies are fixed to the frame102. However, the drive assemblies104,105can alternatively be coupled to the frame in a manner that allows relative movement between the drive assemblies and the frame102. For example, the drive assemblies104,105can be coupled to the frame102using any of the suspension assemblies disclosed in this application. In the example illustrated byFIGS.16and17, the suspension assemblies1706,1707are mirror images of one another. As such, only suspension assembly1706is described in detail. In the exemplary embodiment, a front anti-tip wheel120is positioned forward of the drive wheels122and the rear anti-tip wheel108is positioned rearward of the drive wheels. The suspension1706includes a linkage1709and a biasing member172. The linkage1709couples the front anti-tip wheel120to the rear anti-tip wheel108such that movement of the front anti-tip wheel relative to the frame102is transferred to the rear anti-tip wheel108and/or vice versa. The linkage1709may take a wide variety of different forms. Any arrangement that transfers motion of the front anti-tip wheel120relative to the frame102to the rear anti-tip wheel108can be employed. In the exemplary embodiment illustrated byFIGS.16and17, the linkage1709couples the front anti-tip wheel120to the rear anti-tip wheel108such that upward movement of the front anti-tip wheel120relative to the frame102causes upward movement of the rear anti-tip wheel108relative to the frame and/or vice versa. A wide variety of different linkages or arrangements may couple the front anti-tip wheel120and the rear anti-tip wheel108such that upward movement of the front anti-tip wheel120relative to the frame102causes upward movement of the rear anti-tip wheel108relative to the frame and/or vice versa. The illustrated linkage1709is but one example of the many different arrangements that may be used. The linkage1709includes a front anti-tip pivot arm1790, a rear anti-tip pivot arm1734, and a connecting link1711. The front anti-tip pivot arm1790is pivotally connected to the frame102at a pivot axis1713. A forward portion1735of the front anti-tip pivot arm1790extends forward from the pivot axis1713and a rearward portion1737of the front anti-tip pivot arm1790extends rearward from the pivot axis1713. The rear anti-tip pivot arm1734is pivotally coupled to the frame102at a pivot axis1710. A forward portion1780of the rear anti-tip pivot arm1734extends forward from the pivot axis1710and a rearward portion1782of the rear anti-tip pivot arm1734extends rearward from the pivot axis. The pivot axis1713and the pivot axis1710can be positioned at a wide variety of different locations. For example, the pivot axis1713and the pivot axis1710can be positioned at any position on the frame and/or positions below the frame by one or more brackets. In the embodiment illustrated byFIG.16, the pivot axis1713is forward and below the axis of rotation112of the drive wheel132. In the embodiment illustrated byFIG.16Cand the embodiment illustrated byFIG.19, the pivot axis1713is aligned with the axis of rotation112of the drive wheel. In another embodiment, the pivot axis is positioned below the axis of rotation173of the front anti-tip wheel. In the embodiments illustrated byFIGS.16and19B, the pivot axis1710is positioned forward of a midplane1750(i.e. a plane located at a position half way between the front and the back of the frame). The illustrated pivot axis1710is located at or near a bottom of the frame. Nevertheless, pivot axis1710can also be positioned very near or even at or behind the mid-plane1750. The pivot arms1734,1790may be substantially rigid members or may be flexible to provide inherent shock absorbing properties in the pivot arm. The pivot arms1734,1790may be made from a wide variety of materials, including, but not limited to, metals and plastics. The connecting link1711couples the front anti-tip pivot arm1790to the rear anti-tip pivot arm1734. The connecting link may take a variety of different forms and may be coupled to the pivot arms1734,1790in a wide variety of different ways. The connecting link1711may have any configuration that transfers motion between the front anti-tip pivot arm1790and the rear anti-tip pivot arm1734. In the example illustrated byFIG.17, the connecting link1711is a rigid member that is pivotally connected to the front anti-tip pivot arm1790at a pivot axis1792and that is pivotally connected to the rear anti-tip pivot arm at a pivot axis1794. The connecting link could also be flexible, or extendible in length and can be coupled to the pivot arms in any manner. The biasing member172can take a wide variety of different forms. Any spring device, devices, or assembly can be used as the biasing member. The biasing member may be a single spring, a bi-directional spring, or multiple spring elements. The biasing member may include a shock absorbing component, for example, the biasing member may be a shock absorber with a spring return2006(SeeFIG.20C). In the example illustrated byFIGS.16and17, the biasing member172is disposed between a mount1790that is fixed to the frame and the pivot arm1734. The biasing member172illustrated byFIG.16is a compression spring that biases the rear anti-tip arm1734downward as indicated by arrow1762. A stop194may be fixed to the frame to limit downward movement of the pivot arm1734with respect to the frame. In the embodiment illustrated byFIGS.16and17, the downward biasing of the rear pivot arm1734causes downward biasing of the forward anti-tip arm1790through the connecting link1711as indicated by arrow1764. FIGS.16A-16Cillustrate that the biasing member172can be an extension spring or a compression spring positioned at a variety of different locations to provide the downward front and rear pivot arms1790,1734biasing. For example, inFIG.16Athe biasing member172is an extension spring positioned below the rear anti-tip arm1734. InFIG.16Bthe biasing member172is an extension spring positioned above the front anti-tip arm1790. InFIG.16C, the biasing member172is a compression spring positioned above the front anti-tip arm1790. In another embodiment, the biasing member172is configured to bias the front and rear anti-tip arms1790,1734upward. This can be accomplished in a variety of different ways. For example, in the examples illustrated byFIGS.16and16C, the biasing member172can be changed from a compression spring to an extension spring and in the examples illustrated byFIGS.16A and16B, the biasing member172can be changed from an extension spring to a compression spring. In another embodiment, the biasing member172is configured to bias the pivot arm134to a home position, such as the position relative to the frame illustrated byFIG.16. Biasing to a home position can be accomplished in a variety of different ways. For example, a bidirectional spring can be coupled to the linkage1709and/or any one or more of the spring arrangements that bias the pivot arms downward can be used with any one or more of the spring arrangements that bias the pivot arms upward. In an exemplary embodiment, whether the biasing member172biases the arms upward, downward, or to a home position, the biasing member causes the rear anti-tip wheel108to engage the horizontal support surface119and the front anti-tip wheel to be spaced apart from the horizontal support surface when the wheelchair is at rest on the horizontal support surface. In another embodiment, the front anti-tip wheel120engages the horizontal support surface119when the wheelchair is at rest on the horizontal support surface. The front anti-tip wheel120is connected to the forward end1735of the front anti-tip arm1790and the rear anti-tip wheel is connected to the rearward end1782of the rear anti-tip arm1734. As noted above, the first and second front anti-tip wheels120,121and the rear anti-tip wheels108may take a wide variety of different forms. In the embodiment illustrated byFIGS.16and17, the front anti-tip wheels120,121are mounted for rotation only about a substantially horizontal axis173and the rear anti-tip wheels108are wheels of caster assemblies170. FIGS.19A-19Fillustrate a more specific embodiment of the wheelchair1700illustrated byFIGS.16and17. It should be understood that the present application is not limited to the more specific embodiment illustrated byFIGS.19A-19D.FIG.19Aillustrates the wheelchair1700at rest in the normal operating position on the horizontal support surface119.FIG.19Billustrates the wheelchair ofFIG.19Awith the drive wheel132shown schematically to more clearly illustrate the suspension1706. FIGS.18and19C-19Eillustrate operation of the wheelchair1700to traverse over an obstacle300. Referring toFIGS.18and19C, the drive wheels132bring the front anti-tip wheels120into engagement with the obstacle300. The drive wheels132force the anti-tip wheels120,121up and onto the obstacle. This cause the anti-tip wheels120to move upward with respect to the frame102, which, in turn, causes the anti-tip wheels108to move upward relative to the frame102. In the embodiments illustrated byFIGS.18and19C, the linkage1709transfers the upward movement of the front anti-tip wheel120to the rear anti-tip wheel108against the biasing force of the biasing member172. When anti-tip wheel120moves upward, the front anti-tip pivot arm1790rotates about the pivot axis1713as indicated by arrow1910. In the embodiment illustrated byFIG.19C, the pivot axis1713is coincident with the axis of rotation112of the drive wheel132, but could be positioned at any location. The rotation of the front anti-tip pivot arm1790forces the connecting link1711downward as indicated by arrow1912. The downward movement of the connecting link1711causes the rear anti-tip pivot arm1734to rotate about the pivot axis1710as indicated by arrow1914. The rearward portion1782of the rear anti-tip pivot arm1734moves relatively upward with respect to the frame against the biasing force of the biasing member172as indicated by arrow1916. The drive wheels132and the rear anti-tip wheels108remain on the ground and the upward movement (indicated by arrow302) of the front anti-tip wheels120may cause the frame102to cant. Referring toFIG.19D, the drive wheels132continue to drive the wheelchair1700forward. The drive wheels132engage and climb over the obstacle300. Referring toFIG.19E, the drive wheels132move the wheelchair1700further forward on the obstacle300. The rear anti-tip wheels108engage the obstacle300. The biasing member172cushions the impact between the rear anti-tip wheels108and the obstacle. The drive wheels132continue to drive the wheelchair1700forward and pull the rear anti-tip wheels108up onto the obstacle300. Referring toFIG.19F, a variety of situations can cause forward tipping of a wheelchair. For example, traveling down a hill, decelerating rapidly, and driving off of an obstacle, such as a curb can cause forward tipping. In the example illustrated byFIG.19F, the front anti-tip wheels120engage the support surface to prevent excessive forward tipping. When the front anti-tip wheels120,121engage the support surface119, the biasing member172is compressed by the linkage1709to cushion the impact with the support surface. In one exemplary embodiment, the amount of force applied by the biasing member172, and/or the position of the pivot axis1713can be adjusted or selected to control the amount of resistance to forward tip provided by the front anti-tip pivot arm1790. For example, the resistance to forward tip can be increased for a heavy user by increasing a spring constant of the biasing member and/or shortening the distance between the pivot axis1713and the front anti-tip wheel120. The spring constant of the biasing member can be decreased and/or the distance between the pivot axis1713and the front anti-tip wheel120can be increased to provide smoother curb climbing for a lighter user that may need less resistance to forward tip. FIGS.23and24illustrate another embodiment of a wheelchair2300. The wheelchair2300includes a frame102, first and second drive assemblies104,105, first and second suspension assemblies2306,2307, first and second front anti-tip wheels120,121, and one or more rear anti-tip wheels108. Each drive assembly104,105is coupled to the frame102. In the embodiment illustrated byFIGS.23and24, the drive assemblies are fixed to the frame102. However, the drive assemblies104,105can alternatively be coupled to the frame in a manner that allows relative movement between the drive assemblies and the frame102. For example, the drive assemblies104,105can be coupled to the frame102using any of the suspension assemblies disclosed in this application or any other suspension arrangement. In the example illustrated byFIGS.23and24, the suspension assemblies2306,2307are mirror images of one another. As such, only suspension assembly2306is described in detail. In the exemplary embodiment, a front anti-tip wheel120is positioned forward of the drive wheels122and the rear anti-tip wheel108is positioned rearward of the drive wheels. The suspension2306includes a linkage2309and a biasing member172. The linkage2309couples the front anti-tip wheel120to the rear anti-tip wheel108such that movement of the front anti-tip wheel relative to the frame102is transferred to the rear anti-tip wheel108and/or vice versa. The linkage2309may take a wide variety of different forms. Any arrangement that transfers motion of the front anti-tip wheel120relative to the frame102to the rear anti-tip wheel108and/or vice versa can be employed. In the exemplary embodiment illustrated byFIGS.23and24, the linkage2309couples the front anti-tip wheel120to the rear anti-tip wheel108such that upward movement of the front anti-tip wheel120relative to the frame102causes upward movement of the rear anti-tip wheel108relative to the frame and vice versa. A wide variety of different linkages or arrangements may couple the front anti-tip wheel120and the rear anti-tip wheel108such that upward movement of the front anti-tip wheel120relative to the frame102causes upward movement of the rear anti-tip wheel108relative to the frame and/or vice versa. The illustrated linkage2309is but one example of the many different arrangements that may be used. The linkage2309includes a front anti-tip pivot arm2390, a rear anti-tip pivot arm2334, and a connecting link2311. The front anti-tip pivot arm2390is pivotally connected to the frame102at a pivot axis2313. A first portion2335of the front anti-tip pivot arm2390extends forward from the pivot axis2313and a second portion2337of the front anti-tip pivot arm2390extends upward from the first portion2335. The rear anti-tip pivot arm2334is pivotally coupled to the frame102at a pivot axis2310. A forward portion2380of the rear anti-tip pivot arm2334extends forward from the pivot axis2310and a rearward portion2382of the rear anti-tip pivot arm2334extends rearward from the pivot axis. The pivot axis2313and the pivot axis2310can be positioned at a wide variety of different locations. For example, the pivot axis2313and the pivot axis2310can be positioned at any position on the frame and/or positions below the frame by one or more brackets. In the embodiment illustrated byFIG.23, the pivot axis2313is forward and below the axis of rotation112of the drive wheel132. In the embodiment illustrated byFIG.23, the pivot axis2310is positioned forward of a midplane2350(i.e. a plane located at a position half way between the front and the back of the frame). The illustrated pivot axis2310is located at or near a bottom of the frame. Nevertheless, pivot axis2310can also be positioned very near or even at or behind the mid-plane2350. The pivot arms2334,2390may be substantially rigid members or may be flexible to provide inherent shock absorbing properties in the pivot arm. The pivot arms2334,2390may be made from a wide variety of materials, including, but not limited to, metals and plastics. The connecting link2311couples the front anti-tip pivot arm2390to the rear anti-tip pivot arm2334. The connecting link may take a variety of different forms and may be coupled to the pivot arms2334,2390in a wide variety of different ways. The connecting link2311may have any configuration that transfers motion between the front anti-tip pivot arm2390and the rear anti-tip pivot arm2334. In the example illustrated byFIG.23, the connecting link2311is a rigid member that is pivotally connected to the front anti-tip pivot arm2390at a pivot axis2392and that is pivotally connected to the rear anti-tip pivot arm at a pivot axis2394. The connecting link could also be flexible, or extendible in length and can be coupled to the pivot arms in any manner. The biasing member172can take a wide variety of different forms. Any spring device, devices, or assembly can be used as the biasing member. The biasing member may be a single spring, a bi-directional spring, or multiple spring elements. The biasing member may include a shock absorbing component, for example, the biasing member may be a shock absorber with a spring return2006(SeeFIG.20C). In the example illustrated byFIG.23, the biasing member172is connected (optionally pivotally connected) between a first mount2391that is connected to the frame102and a second mount2393that is connected to the front pivot arm2390. The biasing member172illustrated byFIG.23is a compression spring that biases the front anti-tip arm2390downward as indicated by arrow2364. A stop194may be fixed to the frame to limit downward movement of the pivot arm2334and/or the pivot arm2390with respect to the frame. In the embodiment illustrated byFIG.23, the downward biasing of the front pivot arm2390causes downward biasing of the rear anti-tip arm2334through the connecting link2311as indicated by arrow2362. The embodiment illustrated byFIG.23Ais similar to the embodiment illustrated byFIG.23, except, the biasing member172is connected (optionally pivotally connected) between a first mount2391A that is connected to the frame102and a second mount2393A that is connected to the rear pivot arm2334(instead of the front pivot arm2390). In the embodiment illustrated byFIG.23A, the downward biasing of the rear pivot arm2334causes downward biasing of the front anti-tip arm2390through the connecting link2311as indicated by arrow2364. The biasing member172can be an extension spring, a compression spring, or any type of extendible or retractable device or member positioned at a variety of different locations to provide the downward front and rear pivot arms2390,2334biasing. In another embodiment, the biasing member172is configured to bias the front and rear anti-tip arms2390,2334upward. This can be accomplished in a variety of different ways. For example, the biasing member172can be changed to apply force in the direction opposite the direction indicated by arrow2364. In the embodiment illustrated byFIG.23, the front and rear anti-tip wheels120,108are biased into contact with the support surface. However, the front and rear anti-tip wheels120,108can be biased to any home position. For example, the front anti-tip wheel120or the rear anti-tip wheel108can be biased to a home position that is above the support surface. Biasing to a home position can be accomplished in a variety of different ways. For example, a bidirectional spring can be coupled to the linkage2309and/or any one or more spring arrangements that bias the pivot arms downward can be used with any one or more spring arrangements that bias the pivot arms upward. In an exemplary embodiment, whether the biasing member172biases the arms upward, downward, or to a home position, the biasing member causes the front anti-tip wheel120and the rear anti-tip wheel108to engage the horizontal support surface119when the wheelchair is at rest on the horizontal support surface. In another embodiment, the front anti-tip wheel120is spaced apart from the horizontal support surface119when the wheelchair is at rest on the horizontal support surface. The front anti-tip wheel120is a wheel of a caster assembly. The illustrated front anti-tip wheel is rotatable about a caster axis175. The illustrated front anti-tip wheel is connected to the forward end2335of the front anti-tip arm2390and the rear anti-tip wheel is connected to the rearward end2382of the rear anti-tip arm2334. As noted above, the first and second front anti-tip wheels120,121and the rear anti-tip wheels108may take a wide variety of different forms. In the embodiment illustrated byFIG.23, the front anti-tip wheels120,121and the rear anti-tip wheels108are wheels of caster assemblies. FIGS.26A and26Billustrate a more specific embodiment of the wheelchair2300illustrated byFIGS.23and24. It should be understood that the present application is not limited to the more specific embodiment illustrated byFIGS.26A and26B.FIG.26Aillustrates the wheelchair2300at rest in the normal operating position on the horizontal support surface119.FIG.26Billustrates the wheelchair ofFIG.26Awith the drive wheel132removed to more clearly illustrate the suspension2306. FIGS.25and25Aillustrate operation of the exemplary embodiments of the wheelchair2300to traverse over an obstacle300. The drive wheels132bring the front anti-tip wheels120into engagement with the obstacle300. The drive wheels132force the anti-tip wheels120,121up and onto the obstacle. This cause the anti-tip wheels120to move upward with respect to the frame102, which, in turn, causes the anti-tip wheels108to move upward relative to the frame102. The linkage2309transfers the upward movement of the front anti-tip wheel120to the rear anti-tip wheel108against the biasing force of the biasing member172. The biasing member172is compressed as indicated by arrows2500inFIG.25and arrows2500A inFIG.25A. When anti-tip wheel120moves upward, the front anti-tip pivot arm2390rotates about the pivot axis2313as indicated by arrow2410. The rotation of the front anti-tip pivot arm2390forces the connecting link2311downward as indicated by arrow2412. The downward movement of the connecting link2311causes the rear anti-tip pivot arm2334to rotate about the pivot axis2310as indicated by arrow2414. The rearward portion2382of the rear anti-tip pivot arm2334moves relatively upward with respect to the frame against the biasing force of the biasing member172as indicated by arrow2416. The drive wheels132and the rear anti-tip wheels108remain on the ground and the upward movement (indicated by arrow302) of the front anti-tip wheels120may cause the frame102to cant. The drive wheels132continue to drive the wheelchair2300forward. The drive wheels132engage and climb over the obstacle300. The drive wheels132move the wheelchair2300further forward on the obstacle300. The rear anti-tip wheels108engage the obstacle300. The biasing member172, through the linkage2309in theFIG.23embodiment (or directly in theFIG.23Aembodiment), cushions the impact between the rear anti-tip wheels108and the obstacle. The drive wheels132continue to drive the wheelchair2300forward and pull the rear anti-tip wheels108up onto the obstacle300. A variety of situations can cause forward tipping of a wheelchair. The front anti-tip wheels120are configured to engage the support surface to prevent excessive forward tipping. When the front anti-tip wheels120,121engage the support surface119, the biasing member172is compressed by the linkage2309to cushion the impact with the support surface. In one exemplary embodiment, the amount of force applied by the biasing member172, and/or the position of the pivot axis2313can be adjusted or selected to control the amount of resistance to forward tip provided by the front anti-tip pivot arm2390. For example, the resistance to forward tip can be increased for a heavy user by increasing a spring constant of the biasing member and/or shortening the distance between the pivot axis2313and the front anti-tip wheel120. The spring constant of the biasing member can be decreased and/or the distance between the pivot axis2313and the front anti-tip wheel120can be increased to provide smoother curb climbing for a lighter user that may need less resistance to forward tip. In the embodiments disclosed above, the motion of one or more wheels with respect to the frame may be linked to the motion of one or more other wheels with respect to the frame. The wheels may be linked in a wide variety of different ways. For example, one or more rigid links may couple the relative motion of one or more wheels relative to the frame to one or more other wheels with respect to the frame or a variable length link may couple the relative motion of one or more wheels to one or more other wheels.FIGS.20A,20B, and20Cillustrate examples of variable length links.FIG.20Aillustrates a shock absorber2002,FIG.20Billustrates a spring2004, andFIG.20Cillustrates a shock absorber with a spring return2006. In these examples, the variable length links are pivotally connected to pivot arms, but the variable length links could be coupled to the wheels in any manner. A wide variety of other variable length links may also be used. In one exemplary embodiment, one or more of the anti-tip wheels120,121,108of the wheelchair are replaced with an anti-tip structure that is not a wheel. Such an arrangement may be particularly useful applications where the corresponding wheel is normally off the ground. For example, the front anti-tip wheels102,121in the embodiments disclosed above may be replaced with an anti-tip structure that is not a wheel. However, an anti-tip structure that is not a wheel may be used in any wheelchair configuration. Anti-tip wheels may be replaced with a wide variety of different anti-tip structures. For example, any structure capable of engaging an obstacle (for example, a curb), and sliding or otherwise moving over the obstacle can be used. Examples of anti-tip structures that can be used in place of a wheel include, but are not limited to, members with inclined surfaces (such as inclined skis), continuous tracks (such as those used on tanks), cylinders having a spiral flange (such as those used on screw propelled vehicles), rotatable geometric shapes (such as triangles, squares, etc), and the like. FIGS.21A and21Billustrate embodiments where the anti-tip structure is a ski2100. The illustrated ski2100has arched contact surfaces2102, but can have any shape and may be flat.FIGS.22A and22Billustrate embodiments where the anti-tip structures are continuous tracks2200. The tracks2200include belts2202disposed around rollers2204, such that the belts are moveable around the rollers. The anti-tip structures may be mounted to the wheelchair in any orientation with respect to the wheelchair. In the embodiments illustrated byFIGS.21A,21B,22A, and22B, bottom or contact surfaces2102,2202of the anti-tip structures are inclined upward, away from a support arm2104that connects or couples the anti-tip structure to the frame. This upward inclination facilitates movement of the anti-tip structure over the obstacle. The anti-tip structures2100,2200can be mounted or coupled to the support arm2104in a variety of different ways. In the embodiments illustrated byFIGS.21A and22A, the anti-tip structures2100,2200are fixed to the support arm2104. In the embodiments illustrated byFIGS.21B and22B, the anti-tip structures2100,2200are moveably coupled to the support arm2104. The anti-tip structures2100,2200can be moveably coupled to the support arm2104in a variety of different ways. Any arrangement that allows the anti-tip structure2100,2200to move with respect to the support arm2104can be used. In the illustrated examples, the anti-tip structures2100,2200are pivotally connected to the support arm2104. An optional biasing member2150, such as a spring, biases the anti-tip structure2100,2200forward as indicated by arrow2152. The biasing member2150cushions impact between the anti-tip structure2100,2200. While various inventive aspects, concepts and features of the inventions may be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present inventions. Still further, while various alternative embodiments as to the various aspects, concepts and features of the inventions—such as alternative materials, structures, configurations, methods, devices and components, alternatives as to form, fit and function, and so on—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts or features into additional embodiments and uses within the scope of the present inventions even if such embodiments are not expressly disclosed herein. Additionally, even though some features, concepts or aspects of the inventions may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present disclosure, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of an invention, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified as such or as part of a specific invention, the inventions instead being set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. While the present invention has been illustrated by the description of embodiments thereof, and while the embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. For example, pivotal connections can be made of any number of structures including bearing assemblies, pins, nuts and bolts, and frictionless sleeve assemblies. Additionally, springs or shock absorbers can be added between pivoting and non-pivoting components to limit, dampen, or somewhat resist the pivotal motions of these components. Therefore, the invention, in its broader aspects, is not limited to the specific details, the representative apparatus, and illustrative examples shown and described. Accordingly, departures can be made from such details without departing from the spirit or scope of the applicant's general inventive concept. | 65,452 |
11857471 | DETAILED DESCRIPTION Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. While the present disclosure illustrates an adjustable seat cushion assembly10that is configured for use with a chair, and more specifically a wheelchair, it should be appreciated that the adjustable seat cushion assembly10is not limited for use with a wheelchair. The adjustable seat cushion assembly10can be used with any suitable chair or support device suitable to support a person while sitting. Accordingly, as used herein, the term “chair” can include, but is not limited to, a wheelchair, an armchair, a rocking chair, a car seat, a swivel chair, an office chair, a recliner, a director's chair, a high chair, a sofa, a backed stool, and/or any clinical/medical chair such as a surgical chair, dental chair, chiropractic chair or massage chair. Accordingly, the adjustable seat cushion assembly10can be positioned on (or connected to or mounted on) any such suitable chair, and then adjusted to provide suitable support for a person that is sitting in the chair. Referring now to the figures,FIGS.1-9illustrate an example of an embodiment of the adjustable seat cushion assembly10. The adjustable seat cushion assembly10is configured to be positioned on (or mounted to) a suitable chair, such as a wheelchair (not shown). The adjustable seat cushion assembly10is configured to selectively support a user through a first support material (e.g., foam) and a second support material (e.g., air) to improve positional stability, reduce pressure related injury, and allow a user to offload their ischial tuberosity (or “sit bones”). With reference now toFIG.1, the adjustable seat cushion assembly10is shown without a cover. The adjustable seat cushion assembly10includes a base14and an adjustable air pad assembly18. An airflow control assembly22is in fluid communication with the adjustable air pad assembly18. The adjustable seat cushion assembly10shown inFIG.1can be positioned within (or covered by) the cover (not shown). The cover is configured to contact the body of a user. The cover can be made of any material suitable for user contact, such as nylon, SPANDEX, a blend thereof, or any other suitable material (or combination of materials) that reduces the risk of user skin irritation, skin or soft tissue breakdown, sores, and/or any category or stage of pressure related injury. The cover is also configured to be removable in order to facilitate cleaning, laundering, or replacement. With reference now toFIG.2, the base14is shown with the air pad assembly18and airflow control assembly22removed. The base14includes a front end26opposite a back end30. A leg support36is positioned towards the front end26. As shown inFIGS.2-3, the leg support36defines a pair of recessed leg troughs40a,40b. The leg support36and associated leg troughs40a,40bare contoured to support a thigh area of each leg. With reference toFIGS.2and4, the base14defines a raised back ledge44(also referred to as a cantle44). The back ledge44is positioned towards the back end30of the base14. The back ledge44includes a central channel48. Referring toFIGS.2and5, the base14includes a recessed support portion52(also referred to as a pelvic support portion52) positioned between the leg support36and the back ledge44. The recessed support portion52defines a pelvic well56(or a well56). The support portion52is recessed relative to (or below) the leg support36. As shown inFIG.5, a first thickness T1of the base14at the leg support36is greater than a second thickness T2of the base14at the recessed support portion52. The first thickness T1and the second thickness T2are both measured from a bottom surface60to a user contact surface64of the base14. With reference back toFIG.2, the support portion52is sloped from each respective side68a,68bof the base14, the leg support36, and the back ledge44toward the pelvic well56. The slope is an increasing depth (or increasing recess) such that the pelvic well56defines the deepest recess into the base14. The pelvic well56also defines an aperture72that extends entirely through the base14. With reference toFIG.6, the bottom surface60of the base14includes a recessed channel76. The recessed channel76extends from a valve access end80(or a first end80) to the aperture72. A secondary channel84extends from the recessed channel76to an air nozzle access end88. As shown inFIGS.3and6, the valve access end80is positioned in the front end26of the base14. The air nozzle access end88is positioned at a corner of the base14between the front end26and a second side68b. It should be appreciated that one or both of the valve access end80and/or the air nozzle access end88can be positioned at any location in the base14suitable to provide user access to a valve and/or an air nozzle. For example, the valve access end80and/or the air nozzle access end88can be positioned in the front end26, the back end30, a first side68a, the second side68b, or a corner (or transition) between the front end26and a side68a,68b, or the back end30and a side68a,68b. The base14can be constructed of a first material. In the illustrated embodiment, the base14is formed of a firm foam material as the first material. In other embodiments, the base14can be constructed of multiple plies of material. For example, the base14can have a first layer of firm, dense support foam. A second layer of cushioning (or softer or less firm) foam can be positioned onto the first layer in targeted areas that contact a user, such as the leg support36. In yet other embodiments, the base14can be constructed of any material suitable for providing support to a user while sitting. The first material is provided to support a portion of a user. With reference now toFIGS.1,7, and8, the adjustable air pad assembly18is configured to be positioned in the support portion52of the base14. The adjustable air pad assembly18includes a first air support member92and a separate, second air support member96(shown inFIGS.1and7). The first air support member92and the second air support member96are both removable from the support portion52to provide selective, customized support for a user. The air pad assembly18provides air as a second material to support a portion of a user. With specific reference toFIG.7, the first air support member92defines two separate air bladders (not shown). Each air bladder has a plurality of air cells100,100a. The first air support member92has an axis of symmetry104that separates a first side support108(also referred to as a right side support108or a first support108) and a second side support112(also referred to as a left side support112or a second support112). As such, the first side support108and the second side support112are symmetrical. The first side support108defines a first air bladder (or first air chamber or first internal air chamber) (not shown) that includes a plurality of air cells100,100a(or a first plurality of air cells100,100a). The first plurality of air cells100,100ain the first side support108are in fluid communication with each other (or are fluidly interconnected). The second side support112defines a second air bladder (or second air chamber or second internal air chamber) (not shown) that includes a plurality of air cells100,100a(or second plurality of air cells100,100a). The second plurality of air cells100,100ain the second side support112are in fluid communication with each other (or are fluidly interconnected). The first and second air bladders are separate and not directly fluidly connected to each other. As such, air cannot directly flow between the first and second air bladders. Accordingly, the first and second side supports108,112are separate and not directly fluidly connected to each other. Air in the first side support108cannot directly flow into the second side support112, and air in the second side support112cannot directly flow into the first side support108. Thus, air in one of the side supports108,112does not migrate to the other side support112,108as a user moves, providing a more stable support platform. Each side support108,112is also configured for separate, selective adjustment of an inflation level. The inflation level is a desired quantity of air within the associated air bladder. The desired inflation level can be achieved by either inflation or deflation of the air bladder in response to the quantity of air within the air bladder. When positioned in the support portion52, the first air support member92partially surrounds the pelvic well56. More specifically, the first air support member92extends between the first side68aand the pelvic well56, extends between the back ledge44and the pelvic well56, and extends between the second side68band the pelvic well56. As such, the first air support member92has a generally U-shape (or horseshoe shape). However, the first air support member92does not cover (or overlap) the pelvic well56. With reference toFIGS.7-8, the air cells100aof the first air support member92that are positioned proximate (or adjacent) to the leg support36have a cross-sectional shape that is distinct from the remaining air cells100. As illustrated inFIG.8, the air cells100ahave an overhang (or undercut) cross-sectional shape. Stated another way, a first portion116of each air cell100athat contacts a user has a greater length than a second portion120of each air cell100athat is connected to the first air support member92. A sloped portion124extends between the first portion116and the second portion120. When the first air support member92is positioned on the support portion52, the air cells100aare positioned adjacent the leg support36. A transitional edge128between the leg support36and the recessed support portion52is positioned near the sloped portion124of the air cells100a. Thus, the first portion116of each air cell100aextends over the transitional edge128. This reduces potential the risk of skin irritation, abrasion, or other skin or soft tissue breakdown caused by contact with the transitional edge128. In the illustrated embodiment, the air cells100aare aligned in a row extending from the first side68ato the second side68bof the base14. In other embodiments, the air cells100acan be arranged from the first side68ato the second side68bof the base14in a random pattern, in a laterally offset pattern, an alternating pattern, or any other suitable pattern to provide suitable support for a user. In the illustrated embodiment, the cross-sectional shape of the air cells100aare different than the air cells100. The air cells100,100acan be configured to inflate/deflate, function, and otherwise operate in a similar fashion. With reference back toFIG.7, the second air support member96is removably positioned within (or received by) the pelvic well56. The second air support member96defines a third support. The third support defines a third air bladder (or third air chamber or third internal air chamber) (not shown). Stated another way, the second air support member96defines the third air bladder. The third air bladder includes a plurality of air cells100(or a third plurality of air cells100). The third air bladder is configured for selective adjustment of the inflation level, separate from the first and second air bladders. In the illustrated embodiment, the first air support member92and the second air support member96are each formed of neoprene. In other examples of embodiments, the support members92,96can be formed of any material for transferring air, storing air, and providing support for a user while sitting. Referring now toFIGS.1and9, the airflow control assembly22is in fluid communication with the adjustable air pad assembly18. More specifically, the airflow control assembly22is in fluid communication with the first air support member92and the second air support member96. The airflow control assembly22is configured to facilitate selective inflation and/or deflation of each of the first air bladder and associated first plurality of air cells100,100a, the second air bladder and associated second plurality of air cells100,100a, and the third air bladder and associated third plurality of air cells100. With reference toFIG.9, the air flow control assembly22includes a valve132(also referred to as a control valve132). A first conduit136(also referred to as an air supply conduit136or a first air conduit136) is in fluid communication with (or fluidly connected to) the valve132. A plurality of conduits fluidly connect the valve132to the adjustable air pad assembly18, and more specifically to each of the air bladders of the first air support member92and the second air support member96. With reference toFIGS.7and9, a second conduit140(also referred to as a first bladder supply conduit140or a second air conduit140) is in fluid communication with (or fluidly connects) the valve132and the first side support108. A third conduit144(also referred to as a second bladder supply conduit144or a third air conduit144) is in fluid communication with (or fluidly connects) the valve132and the second side support112. Accordingly, a plurality of conduits140,144fluidly connect the valve132and the first air support member92. A fourth conduit148(also referred to as a third bladder supply conduit148or a fourth air conduit148) is in fluid communication with (or fluidly connects) the valve132and the second air support member96. With reference back toFIG.7, each of the conduits140,144,148are configured to removably couple (or selectively couple) to a supply valve152(or a valve stem152) associated with each air bladder of the first and second air support members92,96. In other embodiments, each of the conduits140,144,148can be coupled to the respective first and second air support members92,96by a non-removal connection. With reference back toFIG.9, each of the conduits140,144,148includes a fluid coupling156to selectively connect and disconnect the conduit140,144,148to the valve132. For example, the fluid coupling156can be a quick disconnect coupling, such as an in-line male coupling that selectively engages an in-line female coupling. An example of a suitable quick disconnect coupling includes a fluid quick coupling manufactured by LinkTech Couplings, a division of Nordson Corporation, which has a corporate headquarters in Westlake, Ohio. In other embodiments, the fluid coupling156can be any suitable coupling that facilitates a selective (or detachable) fluid connection between the valve132and each conduit140,144,148can be used. The valve132includes an internal slide (not shown) coupled to opposing knobs160. The slide is configured to laterally slide within a valve housing164. By laterally moving the internal slide relative to the valve housing164in a first direction, the valve132selectively fluidly connects the conduits140,144,148to the air supply conduit136. Moving the internal slide relative to the valve housing164laterally in a second, opposite direction fluidly disconnects the conduits140,144,148and the air supply conduit136. An example valve132is the ISOFLO valve sold by Roho, Inc., a division of Permobil AB, which has a corporate headquarters in Timrå, Sweden. The valve is also disclosed in U.S. Pat. No. 6,564,410, the contents of which are incorporated by reference in its entirety. In other embodiments, the valve132can be any suitable valve that provides a selective fluid connection between conduit136and conduits140,144,148to facilitate inflation and/or deflation of the first and second air support members92,96. An air valve168(or inflation/deflation valve168) is coupled to the first conduit136at an end opposite the connection to the valve132. The air valve168includes a valve cap172. The valve cap172is rotatably connected to the air valve168to facilitate opening and closing of the air valve168. For example, rotation of the valve cap172in a first direction facilitates opening of the air valve168, while rotation of the valve cap172in a second direction, opposite the first direction, facilitate closing of the air valve168. The air valve168is configured to engage an air pump (not shown). The air pump can be a hand pump, a manual pump, a motorized pump, or any other suitable pump that is configured to supply air to the adjustable air pad assembly18. The air flow control assembly22is mounted (or coupled) to the base14, and more specifically the bottom surface60of the base14. This allows the air flow control assembly22and the associated components to be concealed, limiting exposure to potential damage and/or unintentional adjustment of the adjustable air pad assembly18. The valve132is mounted in the valve access end80of the recessed channel76. The valve132is mounted by a mounting assembly176. The mounting assembly176includes a plurality of loops that surround the valve housing164. The loops are fastened to the base14by one or more fasteners (e.g., a screw, a bolt, etc.). The valve132extends outward from the valve access end80such that it is exposed (or partially exposed) to provide user access to the valve132. The first conduit136is positioned in (or received by) the secondary channel84. The secondary channel84can be suitably sized to form a friction fit with the first conduit136to selectively retain the first conduit136in the secondary channel84. A portion of the first conduit136extends through the air nozzle access end88to provide user access to the air valve168. The conduits140,144,148are positioned in the recessed channel76, extending from the valve132through the aperture72. The conduits140,144,148then extend through the aperture72and into the conduits pelvic well56, where the conduits140,144,148connect to the respective first and/or second air support members92,96. In operation, the air pad assembly18is configured to be selectively inflated and/or deflated to provide customized support for a user. To inflate the air pad assembly18, the air pump is coupled to the air valve168, and the valve cap172is actuated (rotated) into an open configuration. The valve132is similarly actuated into an open configuration, for example by sliding the internal slide laterally relative to the valve housing164in a first direction to create a fluid connection between the first conduit136and the conduits140,144,148. The pump can then supply air through the first conduit136and to the valve132, where air is distributed to the second conduit140, the third conduit144, and the fourth conduit148. Air travels through the conduits140,144,148to the respective first, second, and third air bladders of the first and second air support members92,96. This inflates the plurality of air cells100,100aassociated with the first side support108and the second side support112, and the air cells100of the second air support member96. Once the air pad assembly18is suitably inflated, the valve cap172is actuated (rotated) into a closed configuration. The valve132can also be actuated into a closed configuration, for example by sliding the internal slide laterally relative to the valve housing164in a second direction, opposite the first direction to terminate (or block) the fluid connection between the first conduit136and the conduits140,144,148. The air pump can be removed (or disengaged) from the air valve168. After an initial inflation of the air pad assembly18, selective adjustment of the inflation level of the first and second air support members92,96can occur. For example, the valve cap172can be actuated into the closed configuration. With the valve132remaining in an open configuration, a user can engage the air pad assembly18, and more specifically can engage the first side support108and the second side support112, and the air cells100of the second air support member96. This can facilitate a redistribution of air within the air pad assembly18. For example, air can then travel from the first side support108to the valve132through the second conduit140. This air can then be redistributed from the valve132to the second side support112(through the third conduit144) and/or to the second air support member96(through the fourth conduit148). As another example, air can travel from the second side support112to the valve132through the third conduit144. This air can then be redistributed from the valve132to the first side support108(though the second conduit140) and/or to the second air support member96(through the fourth conduit148). As another example, air can travel from the second air support member to the valve132through the fourth conduit148. This air can then be redistributed from the valve132to the first side support108(though the second conduit140) and/or to the second air support member96(through the fourth conduit148). It should be appreciated that if the air pad assembly18is overinflated (or it is desired to reduce the total amount of air within the air pad assembly18), the valve cap172can be actuated into the open configuration to deflate the air pad assembly18to a desired inflation level. If the air pad assembly18is underinflated (or it is desired to increase the total amount of air within the air pad assembly18), the valve cap172can be actuated into the open configuration and air can be introduced into the air pad assembly18by the air pump to reach a desired inflation level. Once the desired inflation level is achieved (either by deflation or inflation), the valve cap172can be actuated into the closed configuration. Once the desired inflation level of the air pad assembly18, and the first side support108, the second side support112, and the air cells100of the second air support member96is achieved, the valve132can be actuated into a closed configuration to maintain the selected inflation level of the first side support108, the second side support112, and the air cells100of the second air support member96. To deflate the air pad assembly18, the valve cap172of the air valve168is actuated (rotated) into the open configuration. The valve132is similarly actuated into an open configuration, for example by sliding the internal slide laterally relative to the valve housing164in a first direction to create a fluid connection between the first conduit136and the conduits140,144,148. With a user contacting the air pad assembly18(e.g., sitting on the air pad assembly18), air travels through from the respective first, second, and third air bladders of the first and second air support members92,96, through the conduits140,144,148, through the valve132, and out through the first conduit136, where the air is discharged through the air valve168. Once the user is properly positioned on the air pad assembly18, and a desired (or suitable) inflation level is achieved, the valve cap172is actuated (rotated) into a closed configuration. The valve132can also be actuated into the closed configuration, for example by sliding the internal slide laterally relative to the valve housing164in a second direction, opposite the first direction to terminate (or block) the fluid connection between the first conduit136and the conduits140,144,148. One or more aspects of the adjustable seat cushion assembly10for a chair provides certain advantages. For example, the adjustable seat cushion assembly10provides two materials (or support materials) for improved user support while sitting. The first material being a foam material and the second material being air. The first material is firmer than the second material. As such the first material (foam) is provided to support a leg region of a user, while a combination of the first material (foam) and the second material (air) is provided to support a pelvic region of a user. The second material (air) is advantageously adjustable and customizable to provide selective support for a user. The adjustability and customization of support occurs while the user is engaged with the adjustable seat cushion assembly10(e.g., sitting on the adjustable seat cushion assembly10). Accordingly, adjustment and customization of the air pad assembly18occurs with minimal disruption to the user (i.e., the user does not need to be removed from the seat cushion assembly10during adjustment or customization of the air pad assembly18). The combination of the first material (foam) and the second material (air), along with the unique recessed support portion52and pelvic well56, reduces an immersion depth of a user into the adjustable air pad assembly18that is needed to provide full contact and support to the pelvic region of the user. In a seat cushion assembly that utilizes only air, a user generally needs to immerse into the seat cushion between approximately two inches and three inches for the seat cushion to fully contact the user. Full contact is necessary to provide adequate support for the user. The recessed support portion52and associated pelvic well56formed of the first material (foam), along with the second material (air) of the overlaying adjustable air pad assembly18achieves full contact with the user at a reduced immersion depth. For example, a user need only immerse approximately one inch into the adjustable air pad assembly18, and more specifically into the first air support member92and/or second air support member96, to achieve full user contact. The reduced immersion depth allows the adjustable air pad assembly18to utilize shorter (or less tall) air cells100,100a. In addition, the air pad assembly18includes a plurality of separate air zones to provide selective support for a user. The first air support member92defines two separate air support zones that are symmetrically arranged. A first air zone (or first air support zone) corresponds to the first side support108(and associated first air bladder and plurality of air cells100,100a). A second air zone (or second air support zone) corresponds to the second side support112(and associated second air bladder and plurality of air cells100,100a). In addition, the second air support member96defines a third air zone (or a third air support zone). The three air zones are independent, and can be separately adjusted and/or customized. In addition, as a user moves on the seat cushion assembly10, air from the three air zones does not move to any other air zone. As such, the three separate air zones improve positional stability. Further, the air pad assembly18can be further customized by removing one of the first air support member92or the second air support member96. In the illustrated embodiment (or a first configuration), the adjustable seat cushion assembly10includes both of the first air support member92and the second air support member96. However, in certain situations, it may be desirable for a user not to use one of the first air support member92or the second air support member96. Accordingly, the first air support member92or the second air support member96can be selectively removed from the adjustable seat cushion assembly10. In one embodiment (or a second configuration), the first air support member92can be removed by disengaging the fluid coupling156positioned in the first and second conduits140,144. The first air support member92can then be removed (or disengaged) from the base14. The remaining second air support member96can be adjusted or customized to provide suitable support for a user in combination with the base14. In another embodiment (or a third configuration), shown inFIG.10, the second air support member96can be removed by disengaging the fluid coupling156positioned in the third conduit148. The second air support member96can then be removed (or disengaged) from the base14. The remaining first air support member92can be adjusted or customized to provide suitable support for a user in combination with the base14. This configuration allows a user to float their ischial tuberosity bones over the pelvic well56. In addition, the combination base14and air pad assembly18can provide improved support to reduce pressure related injuries and allow a user to offload their ischial tuberosity (or “sit bones”). The defined recessed leg troughs40a,40bformed of a foam material provides comfort and support for a user's leg region. The recessed support portion52and associated pelvic well56covered by the adjustable first and second air support members92,96create a stable support platform for the pelvic region of the user, while also facilitating a user to offload their ischial tuberosity (or “sit bones”). The air pad assembly18also includes a two-part deflation protection system for reducing a risk of unintentional or accidental deflation of the air pad assembly18. For example, in response to the valve132being in the closed configuration, but the valve cap172being in an open configuration, the valve132prevents deflation of the first side support108, the second side support112, and the air cells100of the second air support member96. As such, in situations where the valve cap172is accidentally or unintentionally placed into the open configuration, the valve132, when in the closed configuration, can block air flow and associated deflation of the air pad assembly18. Additional features and advantages of the invention are set forth in the disclosure and the following claims. | 29,475 |
11857472 | An exemplary embodiment of the present disclosure will be described below with reference to the drawings. The embodiment described below is an example of the present disclosure and the present disclosure is not limited to the following embodiment except for the essential structure thereof. DETAILED DESCRIPTION As illustrated inFIG.1, a wheelchair11according to an exemplary embodiment can be fixed to a side sill7, which is the vehicle body member of a vehicle1and forms a door opening3on the side surface of the vehicle1when a seat back portion13bof a wheelchair seat13is tilted backward of the wheelchair11. The side sill7is a substantially tubular strength member extending in a front-rear direction X of the vehicle1. Specifically, the vehicle1in theFIG.1includes a vehicle body2having the door opening3, a front door4that covers the door opening3, and a vehicle seat6provided inside the vehicle body2. The vehicle1includes vehicle body members that form at least parts of the door opening3of the vehicle1. Specifically, the vehicle1in theFIG.1has, as the vehicle body members that form the door opening3, the side sill7that extends in the front-rear direction X of the vehicle1and forms the lower edge of the door opening3, and pillars and an upper rail that are the other vehicle body members and extend upward from the front end and the rear end of the side sill7. In addition, as illustrated inFIG.1andFIGS.6and7, in the vehicle1according to an exemplary embodiment, the upper surface of a part of the side sill7inside the vehicle is covered with an interior trim9, which is an interior member. The interior trim9is fixed to the upper surface of the side sill7by adhesive or the like. As illustrated inFIG.1andFIGS.6and7, the interior trim9is provided with a pair of engaged holes9aas engaged portions that can be engaged with a pair of push-along handle portions13cthat can also be used as engaging portions provided in the wheelchair11. The distance between the pair of engaged holes9ais set so that the pair of push-along handle portions13cof the wheelchair11described above can be engaged with the pair of engaged holes9a. As illustrated inFIGS.2and3, the wheelchair11includes the wheelchair seat13(the seat according to the present disclosure), a body frame14, and a plurality of wheels, that is, a pair of rear wheels15and a pair of front wheels16. The wheelchair seat13includes a seating portion13aon which the wheelchair user can sit, the seat back portion13bwith which the back of the user makes contact, a pair of support bars13ethat support both sides of the seat back portion13b, and the pair of push-along handle portions13cthat can be gripped, from behind the wheelchair11, by an assistant or the like who pushes the wheelchair11(generic term for a person who pushes the wheelchair11from behind, such as an assistant or a caregiver). In an exemplary embodiment, the push-along handle portions13cconstitute the engaging portions by which the wheelchair11can be fixed to the vehicle1. As illustrated inFIGS.4and5, the inclination angle of the seat back portion13bwith respect to the seating portion13acan be changed. Specifically, the seat back portion13bis attached rotatably between the standing position (seeFIGS.2and3) at which the seat back portion13bstands orthogonally to the seating portion13aand the reclining position (FIGS.4and5) at which the seat back portion13bis tilted backward of the seating portion13a. More specifically, the seat back portion13bis attached swingably in the vertical direction about the rotation support portion13das the rotation center at the rear end of the seating portion13a. Although the wheelchair seat13is detachably attached above the body frame14, the wheelchair seat13may be fixed to the body frame14. Furthermore, as illustrated inFIGS.2and3, the body frame14has a structure capable of supporting the wheelchair seat13and specifically includes a pair of main frames17disposed on the left and right sides of the wheelchair11separately, a pair of sub-frames18attached to the pair of main frames, a crossbar19connecting the pair of main frames17to each other, a pair of footrests21, and a pair of footrest arms22. The pair of rear wheels15is rotatably attached to the pair of main frames17, respectively. The main frames17according to an exemplary embodiment are L-shaped members as illustrated inFIGS.2and3and can support the seating portion13aof the wheelchair seat13from below and both sides in the width direction of the wheelchair11. The pair of main frames17and the seating portion13aare detachably connected to each other by a known connection method, such as fitting a convex portion provided in one of them to a concave portion provided in the other of them. The pair of sub-frames18is provided so as to extend downward of the main frames17and forward of the rear wheels15from the main frames17. The pair of front wheels16is rotatably attached to the front end portions of the pair of sub-frames18. Each of the rear wheels15illustrated inFIG.2includes a spoke wheel15amade of metal or hard resin (such as FRP) and a tire15bmade of rubber or soft resin. The spoke wheel15aincludes a rim15cthat is annular in side view, a hub15drotatably supported by the main frame17, and a plurality of (three inFIGS.2and3) spokes15ethat extend radially from the hub15dand are connected to the inner peripheral surface of the rim15c. In contrast, each of the front wheels16includes a caster and the like, can swing around a shaft extending in the vertical direction with respect to the end portion of the sub-frame18, and can change the turning direction. The pair of footrests21are the portions on which the feet of the wheelchair user are placed. The pair of footrests21is attached to positions above the front wheels16of the pair of sub-frames18via the pair of footrest arms22. The pair of push-along handle portions13chas the structure in which the seat back portion13bcan be fixed to the side sill7by engaging the push-along handle portions13cwith the side sill7, which is the vehicle body member that forms the door opening3of the vehicle1, when the seat back portion13bis tilted backward of the wheelchair11. Specifically, the push-along handle portions13cproject backward of the seat back portion13bfrom the upper ends of the pair of support bars13esupporting both sides of the seat back portion13b. In the wheelchair11according to the exemplary embodiment configured as described above, the wheelchair11can be easily fixed to the vehicle1by simply tilting the seat back portion13bbackward of the wheelchair11as illustrated inFIGS.6and7. Specifically, the wheelchair11is disposed at a position at which the back surface of the seat back portion13bfaces the door opening3of the vehicle1, and the seat back portion13bis tilted backward of the wheelchair11. At this time, the pair of push-along handle portions13ccan be fixed to the side sill7via the interior trim9by engaging the pair of push-along handle portions13cwith the pair of engaged holes9aformed in the interior trim9that covers the vehicle side upper surface of the side sill7on the side surface of the vehicle1. This can fix the wheelchair11to the vehicle1. In this state, the wheelchair user can move to the vehicle seat6by hand or the like through the seat back portion13b. The push-along handle portions13cmay be engaged with the edge portion on the vehicle inner side of the interior trim9or the side sill7without being engaged with the pair of engaged holes9a. (Characteristics of the Exemplary Embodiment) (1) The wheelchair11according to an exemplary embodiment includes the seating portion13aon which the user of the wheelchair11sits, the body frame14that supports the seating portion13a, and the wheels (the pair of rear wheels15and the pair of front wheels16) rotatably supported on the left and right sides of the body frame14, and the seat back portion13bcapable of changing the inclination angle with respect to the seating portion13a, in which the push-along handle portions13care provided as the engaging portions for fixing the seat back portion13bto the vehicle body member. When the seat back portion13bis tilted backward of the wheelchair11as illustrated inFIGS.4and5, the push-along handle portions13cenable the seat back portion13bto be fixed to the side sill7via the interior trim9as the vehicle body member that forms the door opening3of the vehicle1as illustrated inFIG.7. According to this structure, when the seat back portion13bis tilted backward of the wheelchair11, the push-along handle portions13cas the engaging portions are engaged with the side sill7, which is the vehicle body member forming the door opening3of the vehicle1, and the seat back portion13bcan be fixed to the side sill7. Accordingly, since the wheelchair11and the vehicle1are directly connected to each other without intervention of another member, the wheelchair can be stably fixed to the vehicle1when the wheelchair user gets on and off the vehicle1. In this state, the wheelchair user can easily move from the seat back portion13bto the seat6of the vehicle1by hand or the like. In addition, since the wheelchair11according to an exemplary embodiment has the push-along handle portions13cas the engaging portions, the getting-on-and-off assist mechanism including the transfer board does not need to be provided in the vehicle1unlike the prior art described in patent document 1, there is an advantage that the space in the vehicle is not reduced. (2) In the wheelchair11according to an exemplary embodiment, the engaging portions are configured by the push-along handle portions13c, provided behind the seat back portion13b, that can be gripped by the assistant pushing the wheelchair11. According to this structure, the engaging portions are configured by the pair of push-along handle portions13cprovided behind the seat back portion13b. Accordingly, the seat back portion13bcan be easily fixed to the side sill7by simply connecting the push-along handle portions13cto the engaged holes9aof the interior trim9fixed to the side sill7as the vehicle body member that forms the door opening3of the vehicle1when the seat back portion13bis tilted backward of the wheelchair11. Moreover, since the push-along handle portions13cnot only have the original function of the push-along handle portions13cthrough which the assistant or the like pushes the wheelchair11by hand, but also serve as the engaging portions for fixing the wheelchair11to the vehicle1, an increase in the number of components of the wheelchair can be reduced. In addition, the pair of push-along handle portions13cis used as the engaging portions in an exemplary embodiment. Accordingly, the seat back portion13bof the wheelchair11can be more stably fixed to the side sill7by the pair of push-along handle portions13cdisposed apart from each other. (3) In the wheelchair11according to an exemplary embodiment, the push-along handle portions13cproject backward of the seat back portion13band can be engaged with the engaged portions (the engaged holes9aof the interior trim9fixed to the side sill7in an exemplary embodiment) formed in the vehicle body member when the seat back portion13bis tilted backward of the wheelchair11. According to this structure, since the push-along handle portions13care engaged with the engaged holes9aof the interior trim9as the engaged portions formed in the vehicle body member when the seat back portion13bis tilted backward of the wheelchair11, the wheelchair11can be stably fixed to the vehicle1. Accordingly, the wheelchair user can easily transfer from the wheelchair11to the vehicle seat6. Moreover, after transferring to the vehicle seat6, the state in which the wheelchair11is fixed to the vehicle1can be easily released by removing the push-along handle portions13cfrom the engaged holes9a. (4) In the wheelchair11according to an exemplary embodiment, the push-along handle portions13c, which are the engaging portions, can be engaged with the side sill7, which forms the lower edge of the door opening3formed on the side surface of the vehicle1. According to this structure, by engaging the push-along handle portions13cwith the side sill7, which is the strength member forming the lower edge of the door opening3on the side surface of the vehicle1, to fix the seat back portion13bto the side sill7, the wheelchair11can be securely fixed to the vehicle body2at a position as close as possible to the vehicle seat6of the vehicle1. As a result, the wheelchair user can easily transfer from the wheelchair11to the vehicle seat6of the vehicle1. (Modifications) (A) Although the engaging portions engaged with the vehicle body member are configured by the push-along handle portions13cthat project backward of the seat back portion13bin an exemplary embodiment described above, the engaging portions may further include holding portions23as illustrated inFIGS.8and9in a modification of the present disclosure. The holding portions23are disposed apart from the push-along handle portions13cand can hold the vehicle body member such as the side sill7together with the push-along handle portions13c. For example, the holding portions23include elastically deformable hooks having hooked tips. The holding portions23can be elastically deformed in the vertical direction (the direction in which the distance from the push-along handle portions13cchanges). The other structure of the wheelchair11is the same as the structure of the wheelchair11according to the exemplary embodiment illustrated inFIGS.1to5. In the wheelchair according to the modification illustrated inFIGS.8and9, the push-along handle portions13ccan be engaged with the pair of engaged holes9a(that is, the pair of engaged holes9aof the interior trim9fixed to the upper surface of the side sill7) that are the engaged portion of the vehicle member that forms the door opening3of the vehicle1when the seat back portion13bis tilted backward of the wheelchair11, and the side sill7(particularly, an upper flange portion7aof the side sill7), which is the vehicle body member, can be held by the push-along handle portions13cand the holding portions23. This can securely fix the wheelchair11to the side sill7, which is the vehicle body member. (B) Although the push-along handle portions13care engaged with the pair of engaged holes9aof the interior trim9fixed to the upper surface of the side sill7in the exemplary embodiment described above, the present disclosure is not limited to this example. In a modification of the present disclosure, the push-along handle portions13cmay be engaged with concave portions or convex portions (such as flange portions) formed on the side sill7and, in this case, the push-along handle portions13ccan be fixed directly to the side sill7without intervention of the interior trim9, thereby achieving a simpler structure of the vehicle1and a stronger fixation between the wheelchair11and vehicle1. (C) Although the engaging portions are configured by the push-along handle portions13cin the exemplary embodiment described above, the present disclosure is not limited to this example. The engaging portions of the present disclosure are the engaging portions provided in the seat back portion13band only need to have the structure in which the seat back portion13bcan be fixed to the vehicle body member such as the side sill7that forms the door opening3of the vehicle1when the seat back portion13bis tilted backward of the wheelchair11. Accordingly, a dedicated member may be provided as the engaging portion separately from the push-along handle portions13c. (D) In the present disclosure, the door opening of the vehicle1is not limited to the door opening3on the side surface of the vehicle1and may be a rear gate that opens in the rear portion of the vehicle1. Even in this case, the wheelchair11can be fixed to the periphery of the rear gate that opens in the rear portion of the vehicle1by the push-along handle portions13c, which are the engaging portions. (E) Although the push-along handle portions13care used as an example of the engaging portions in the present disclosure, the present disclosure is not limited to this example. As another example of the engaging portion, one of a latch mechanism used for a locking mechanism for a vehicle door and an engaged portion such as a striker engaged with the latch mechanism may be attached to the rear side of the seat back portion13bof the wheelchair11. In this case, the other of the latch mechanism and the engaged portion only needs to be attached to the vehicle body member. (F) Although the wheelchair11is fixed to the side sill7at the lower edge of the door opening3in the exemplary embodiment described above, the present disclosure is not limited to this example and the wheelchair11may be fixed to another vehicle body member (such as, for example, the front door4) around the door opening3. ADVANTAGE OF THE DISCLOSURE In the wheelchairs according to the aspects described above, the wheelchairs can be stably fixed to the vehicle when the wheelchair user gets on and off the vehicle. DESCRIPTION OF REFERENCE SIGNS AND NUMERALS 1: vehicle2: vehicle body3: door opening6: vehicle seat7: side sill (vehicle body member)9: interior trim9a: engaged hole (engaged portion)11: wheelchair13: wheelchair seat (seat)13a: seating portion13b: seat back portion13c: push-along handle portion (engaging portion)14: body frame15: rear wheel16: front wheel23: holding portion | 17,499 |
11857473 | DETAILED DESCRIPTION The seat features of the present teachings are discussed in detail herein in relation to a mobility device and other applications. However, various types of applications may take advantage of the seat features of the present teachings. Referring now toFIG.1, seat assembly40000can be removably positioned upon a wheelchair base, for example, by use of the connecting features located on seatpan mounting bracket30001. To provide comfort and security to the user, seat assembly40000can include first configuration footrest40017, seat cushion30002, backrest cushion30017, and armrest cushions30046. First configuration footrest40017can be mounted to height-adjustable first configuration bottom post40021and first configuration top post40019. Seatpan mounting bracket30001can include tie down30069that can be used to secure the wheelchair and seat to, for example, an automobile seat belt. Seatpan mounting bracket30001can be coupled with rear tube holder bracket30011that can be coupled with first configuration top back frame bracket40011. First configuration top back frame bracket40011can couple the seat back with attendant handle50001. Referring now toFIG.1A, seatpan mounting bracket30001can be coupled with rear tube holder bracket30011by fold hinge bracket30010. The folding of backrest shell30019onto seat cushion30002can be enabled by applying pressure to fold handle30014engaging springs on guide pins. In some configurations, the angle of backrest shell30019, and therefore backrest cushion30017(FIG.1), can be adjusted by rotating backrest angle adjust knob40049. In some configurations, the angle of backrest shell30019can be fixed and backrest angle adjust knob40049can be omitted. Adjustment of the height of armrest structures30043, and therefore armrest cushions30046, can be enabled by a combination of vertical back frame canes30013(FIG.2A) (one for each armrest structure30043) and armrest mount brackets30040(one for each armrest structure30043). Referring now toFIGS.1B-1F, second configuration seat assembly40000-1can include, but is not limited to including, user controller attachment bracket30226that can securely attach user controller22006to armrest bracket30043. User controller22006can include any desired shape, size, and functionality, and can be commercially available or custom-built. A joystick and/or toggles can be included. User controller22006can be operably coupled with a power base (not shown) by any desired means, including, but not limited to, by cable22128, that can be routed so as not to interfere with the movement of seat assembly40000-1. User controller attachment bracket30226can be operably coupled with either of armrest brackets30043or elsewhere as desired. Second configuration seat assembly40000-1can include footrest30064that can rotate towards second configuration lower footrest post30062when not in use. Second configuration lower footrest post30062can be positionally adjusted with respect to seat bracket30001to raise or lower second configuration footrest30064. Second configuration lower footrest post30062can be attached, by any suitable means such as, for example, but not limited to, screws, bolts, hook-and-eye, and magnets, to second configuration upper footrest post30061according to the desired position of footrest30064. Armrest structure30043(FIGS.1E and1F) can be rotated towards the backrest for user convenience and for streamlined transporting of the seat. Referring now primarily toFIGS.2A-2E, the seat, backrest, and arms of second configuration seat assembly40000-1can by operably coupled by second configuration top back frame bracket30012, rear tube holder bracket30011, and second configuration armrest mount bracket30040. Second configuration armrest mount bracket30040can surround vertical back frame cane30013that can include a first end and a second end. The first end of vertical back frame cane30013can engage rear tube holder bracket30011, and the second end of vertical back frame cane30013can engage second configuration top back frame bracket30012. Vertical back frame cane30013can be secured between top back frame bracket30012and rear tube holder bracket30011by bolt40000-10. Bushings40014-3can surround second configuration armrest mount bracket30040as it slides up and down along vertical back frame cane30013. Second configuration armrest mount bracket30040can enable both adjustment of the height of the armrest and the rotation of the armrest towards the backrest. Height adjustment of armrest structure30043can be accomplished by a push button action of armrest height adjustment button30045by the user. Armrest narrow flanged bushing40014-2, armrest wide flanged bushing40014-1, and armrest nut with hole30044can operably couple armrest structure30043with armrest mount bracket30040and armrest height adjustment button30045through, for example, but not limited to, a threaded coupling. Armrest mount bracket30040can operably couple armrest structure30043with vertical back frame cane30013that can operably couple armrest structure30043with rear tube holder bracket30011and second configuration top back frame bracket30012. Within armrest mount bracket30040are components that can enable height adjustment of armrest structure30043. The components can include, but are not limited to including, button transition rod40011-1that can operably couple armrest height adjustment button30045with button slide30042. Button transition rod40011-1can achieve aligned coupling with button slide30042through its placement in button slide cavity40061-3(FIG.7I). Button slide30042can control the release of the current position of armrest structure30043by positionally interacting with male lock pin30041-1. Male lock pin30041-1and female lock pin30041-2can cooperatively engage with vertical back frame cane30013to establish the height of the armrest. Button slide30042can respond to a depression of button30045by disengaging male/female lock pins30041-1/2from vertical back frame cane30013to allow second configuration armrest mount bracket30040to slide along vertical back frame cane30013. When armrest height adjust button30045is depressed, button slide30042is depressed, moving button slide lock position40061-1(FIG.7I) and releasing the lock on armrest structure30043enabled by the contact between button slide lock position40061-1(FIG.7I) and male lock pin30041-1. As button slide30042is depressed, button slide open position40061-3(FIG.7I) can become aligned with male lock pin30041-1, and can enable male lock pin30041-1and female lock pin30041-1to retreat from back frame cane cavity40025-2(FIG.7J), releasing the lock on the position of armrest structure30043and allowing armrest mount bracket30040to slide in channel40025-1(FIG.7J). Armrest mount bracket30040can be provide a low-friction sliding surface between vertical back frame cane30013and armrest mount bracket30040. Spring arm mechanism40017can enable the return of button30045to engaged position with respect to button slide30042, male lock pin30041-1, and female lock pin30041-1. In some configurations, adjustment screw40025-3(FIG.7K) can be used to bolt armrest structure30043to vertical back frame cane30013. Referring now toFIGS.2F-2G, second configuration armrest30048can be operably coupled with armrest mount bracket30040(FIG.2A) in the same way as has been described herein. Second configuration armrest30048can include second configuration armrest structure30043-1, armrest shell30047, and second configuration armrest cushion30046-1. Second configuration armrest structure30043-1can include curvature30043-1C that can enable positional accommodation during use of second configuration armrest30048. Second configuration armrest structure30043-1can include a support structure that can taper with respect to curvature30043-1C, relatively smaller support structure30043-1D being associated with armrest shell interface30043-1E, and relatively larger support structure30043-1G being associated with area30043-1K between armrest shell interface30043-1E and armrest mount bracket interface30043-1J. The support structure can provide stable resistance to pressure placed upon armrest shell interface30043-1E. The support structure can be continuous or discontinuous, and can be constructed of the same or different material from armrest shell interface30043-1E. Second configuration armrest structure30043-1can include rotation stops30043-1H that can maintain the rotation of second configuration armrest30048within a preselected number of degrees. Armrest shell30047can be situated between second configuration armrest structure30043-1and second configuration armrest cushion30046-1. Armrest shell30047can include structure interface30047-1that can be operably coupled to second configuration armrest structure30043-1and second configuration armrest cushion30046-1, and can include cushion interface30047-2that can be operably coupled to second configuration armrest cushion30046-1. Armrest shell30047can decouple the geometry of second configuration armrest structure30043-1from the geometry of second configuration armrest cushion30046-1by providing a mounting platform for second configuration armrest cushion30046-1. Thus the geometry of second configuration armrest structure30043-1can remain fixed while the geometry of second configuration armrest cushion30046-1can vary based on user preference and need. Armrest cushion30046-1can include, for example, relatively narrower edge30043-1B that can cooperatively, with relatively wider edge30043-1A, accommodate arm comfort while maintaining space for the torso in the seat assembly. Armrest cushion30046-1can thus be contoured to accommodate the arm's geometry, and can be attached to armrest shell30047by any suitable fastening means such as, for example, but not limited to, glue, magnets, screws, bolts, and hook-and-eye fasteners. Armrest shell30047can be attached to second configuration armrest structure30043-1by any suitable means as well. Referring now toFIGS.3A,3B, and4A, seatpan bracket30001can operably couple footrest30064with rear tube holder bracket30011. Seatpan bracket30001can include mounting points for at least one vehicle tie down30069, fold hinge bracket30010, and footrest mount bracket30060(FIG.3B). Fold hinge bracket30010can enable secure mounting of rear tube holder bracket30011that can enable folding of the backrest towards seatpan bracket30001when fold handle30014is shifted. Seatpan bracket30001can include seatpan alignment cavities30001-2(FIG.4A) and30001-1(FIG.4A) that can matingly align seatpan bracket30001with seat shell30000(FIG.4I). Seatpan wings30001-3(FIG.4A) can enable operable coupling of seatpan bracket30001with a seat mounting device (not shown) such as, for example, but not limited to, a powerbase for a motorized wheelchair. Referring now toFIGS.4B-4F, the backrest can be locked in place, and also can be released and folded towards the seat cushion. When the backrest is folded forward, the armrests can be rotated towards the backrest to enable compact storage. The junction between armrest structure30043(FIG.4B) and second configuration armrest mount bracket30040(FIG.4B) can enable smooth rotation of armrest structure30043(FIG.4B). Fold hinge bracket30010can include bottom hinge knuckles30010A (FIG.4C) mounted to hinge leaf30010B (FIG.4C). Rear tube holder bracket30011can include top hinge knuckles30011A (FIG.4C) that can operably couple with bottom hinge knuckles30010A (FIG.4C) and surround hinge pin30020(FIG.4C). When fold handle30014(FIG.4C) is lifted, at least one spring pin40010, engaged within spring pin cylinder40017(FIG.4C), can release at least one retention hook30015, protruding from retention hook cavity30015B (FIG.4C), and can enable at least one retention hook30015to disengage from at least one retention hook rest30015A (FIG.4C). At least one retention hook30015can engage with cavity30011B (FIG.4C). It is then possible to rotate rear tube holder bracket30011, operably coupled with the backrest, towards seat bracket30001. The backrest can be lifted back into an operational position, rotating rear tube holder bracket30011away from seat bracket30001. At a pre-selected point in the rotation, at least one retention hook30015(FIG.4C) can engage with at least one retention hook rest30015A (FIG.4C), locking the backrest in place. Referring now toFIG.4G, rear tube holder bracket30011can be shaped to accommodate a seat cushion, in particular, rear tube holder bracket30011can include a curvature angle30011E that can be varied, during manufacture, depending upon the shape of the seat cushion. Rear tube holder bracket30011can include fastening cavity30011D that can accommodate bolt40000-10(FIG.2A), and cane cavity30011C that can accommodate vertical back frame cane30013(FIG.2A). Referring now toFIG.4H-4M, seat shell30000can be mounted atop seat bracket30001(FIG.4A). Seat shell30000can provide an interface between seat cushion30002(FIG.4K) and seatpan mounting bracket30001(FIG.4A). Seat shell30000can be contoured to retain seat cushion30002(FIG.4K) while, at the same time, providing edges, such as chamfered or beveled edges, that can enable comfortable seating. For example, seat shell30000can include at least one seat shell side rest40079-1(FIG.4I) that can retard lateral motion of seat cushion30002(FIG.4K). Seat shell30000can include seat shell bottom40079-2(FIG.4I) that can include seat alignment first feature40079-10(FIG.4J) and seat alignment feature second feature40079-11(FIG.4J) described herein. Seat shell30000can include at least one seat magnet40079-3(FIG.4I) that can enable operable coupling between seat shell30000and seat cushion30002(FIG.4K). Seat shell30000can be constructed of multiple parts or can be a single piece. In some configurations, seat shell30000can include seat shell front right40079-6(FIG.4J), seat shell front left40079-7(FIG.4J), seat shell rear right40079-8(FIG.4J), and seat shell rear left40079-9(FIG.4J) that can be joined together by, for example, at least one seat shell bolt40079-4(FIG.4J) and/or at least one seat shell pin40079-5(FIG.4J). When the parts of seat shell30000are joined, at least one seat shell rib40079-12(FIG.4I) can be formed. Referring now toFIG.4N, seat cushion30002can rest upon seat shell30000(FIG.4I), and can be operably coupled with seat shell30000(FIG.4I) through the coupling of fastening means such as, for example, but not limited to, at least one seat magnet40079-3(FIG.4I) with at least one seat cushion magnet40013-1on seat cushion shell interface40013-3. Seat shell ribs40079-12(FIG.4J) can be accommodated by seat cushion troughs40013-2. Seat cushion30002can include user seat surface40013-4that can, in some configurations, include padding for comfort. Seat cushion30002can include any type and amount of padding and any type of upholstery. Referring now toFIG.5, optional attendant handle50001can be retracted to reduce its height, and can be set to a specific height to accommodate the attendant. In particular, handle grasp50001-2can be depressed. The depression can reduce the length of handle post top50001-1by sliding it into handle post bottom50001-3. Handle interface50001-6can include pivot bolt cavity50001-4that can rest upon backrest pivot shaft40011-5(FIG.3B), the combination of which can enable snap placement of attendant handle50001with respect to backrest shell30019. Attendant handle50001can include knob shaft accommodation50001-5that can provide space for threaded knob shaft40011-1(FIG.3A). Attendant handle50001can enable an attendant to assist a user in, for example, but not limited to, climbing stairs. Referring now toFIGS.6A-6F, backrest shell30019can include knob interface bracket40023-1(FIG.6B) that can accommodate angle adjustment knob40049(FIG.6C), if it is present, through an operable coupling enabled by connecting screw cavity40023-2(FIG.6B). Backrest shell30019can include multiple parts or can be manufactured as a single piece. In some configurations, backrest shell30019can include mirrored image backrest shell right40023-4(FIG.6B) and backrest shell left40023-5(FIG.6B) that can be joined at backrest shell ribs40023-6(FIG.6B). Backrest shell right40023-4(FIG.6B) and backrest shell left40023-5(FIG.6B) can include at least one backrest magnet40023-3(FIG.6B) that can accommodate attachment of backrest cushion30017(FIG.6F). Attachment means to couple backrest shell30019with backrest cushion30017(FIG.6F) can include, but are not limited to including, backrest magnets40023-3(FIG.6B) that can be attached to backrest shell30019by any kind of fasteners including, but not limited to screws, bolts, hook-and-eye fasteners, and glue. Backrest shell30019can include at least one backrest spacer40023-7(FIG.6B) that can provide for positioning of additional cushioning. At least one backrest spacer40023-7(FIG.6B) can include recess30019C (FIG.6C) that can accommodate means to attach various pieces of backrest shell30019together. Referring now toFIGS.6G-6I, first configuration top back frame bracket40011(FIG.6G) can provide recesses for mounting backrest angle adjust knob40049(FIG.6H), if present. Angle adjust knob40049(FIG.6H) can be operably coupled with threaded knob shaft40011-1(FIG.6H) that can include a cavity to accommodate bracket knob connecting screw40011-8(FIG.6G). Backrest angle adjust knob40049(FIG.6H) can cause the angle of backrest shell30019(FIG.6E) (and therefore backrest cushion30017(FIG.6F)) to change during travel along threaded knob shaft40011-1(FIG.6H) by threaded footrest insert40011-2(FIG.6H) and retaining ring40011-4(FIG.6H). Retaining ring40011-4(FIG.6H) can include, but is not limited to including, an axially or radially assembled ring, an inverted ring, a beveled ring, and a spiral ring. Bracket knob connecting screw40011-8(FIG.6G) can operably couple backrest shell30019(FIG.6B) with backrest angle adjust knob40049(FIG.6H) through knob interface bracket40023-1(FIG.6B) to enable positional adjustment of backrest shell30019(FIG.6B) by rotating backrest angle adjust knob40049. Backrest angle adjust knob40049(FIG.6H) can be operably coupled with connecting pin40011-10(FIG.6G). When backrest angle adjust knob40049(FIG.6H) is rotated, pressure is placed upon connecting pin40011-10(FIG.6G) which can cause rotation of backrest shell30019(FIG.6B). First configuration top back frame bracket40011(FIG.6G) can provide recesses for backrest pivot shaft40011-5(FIG.6C) that can be held in place by, for example, but not limited to, pivot shaft bolts40011-7(FIG.6H) and recessed bolthead washers40011-6(FIG.6H). Referring now primarily toFIG.6F, backrest cushion structure30017can include contoured backrest cushion40003-2on a first side of backrest cushion structure30017. Contoured backrest cushion40003-2can be sized and padded to interface with a specific user. Backrest cushion structure30017can include backrest shell interface40003-3that can interface with backrest shell30019. Backrest shell interface40003-3can include recessed features that can include at least one backrest cushion magnet40003-1that can operably couple with at least one backrest shell magnet40023-3(FIG.2B) to enable removable coupling between backrest shell30019(FIG.6B) and backrest cushion structure30017. The recessed features can accommodate backrest spacers40023-7(FIG.2B). Referring now toFIGS.6J-6L, second configuration top back frame bracket30012can include backrest rotation pin30018that can be held in place by rotation pin bolt40002(FIG.6K) and rotation pin bushing30085(FIG.6K). Second configuration top back frame bracket30012can include at least one spacer40020that can maintain the distance between backrest shell30019(FIG.6F) and top back frame bracket30012. Top back frame bracket30012can include curvature angle30012D (FIG.6J) that can be varied, during manufacture, according to the shape of the backrest. Any shape of the backrest can be accommodated by modifying curvature angle30012D (FIG.6J) of top back frame bracket30012. Top back frame bracket30012can operably couple with vertical back frame cane30013(FIG.2A) at cane cavity30012C (FIG.6J). Second configuration top back frame bracket30012can operably couple with backrest shell30019by means of backrest rotation pin30018that can simultaneously pass through backrest pin cavities30019A/30019B (FIG.6L) and top bracket pin cavities30012A/30012B (FIG.6L). Referring now toFIG.7A, first configuration armrest mount bracket40053can include contoured rests40053-4that can surround and admit female lock pin30041-2(FIG.2A). Adjustment screw cavity40053-5can accommodate adjustment screw40025-3(FIG.7L). At least one armrest wing40053-3can enable alignment of first configuration armrest mount bracket40053with armrest structure30043(FIG.1). Recesses40053-1can operably couple armrest nut with hole30044. Referring now toFIGS.7B-7D, armrest structure30043(FIG.7B) can operably couple with first configuration armrest mount bracket40053(FIG.7B), that can slide along vertical back frame cane30013(FIG.7B). Armrest structure30043(FIG.7C) can also operably couple with second configuration armrest mount bracket30040(FIG.7C). Referring now toFIGS.7E-7H, second configuration armrest mount bracket30040can include rectangular alignment tabs30040-4that can surround and admit female lock pin30041-2(FIG.2A) at recess30040-5(FIG.7H) and can rest in cane cavity40025-1(FIG.7J). Alignment tabs30040-4can maintain the position of vertical back frame cane30013(FIG.7D) within second configuration armrest mount bracket30040. At least one armrest wing30040-2can enable alignment of second configuration armrest mount bracket30040with armrest structure30043(FIG.1). Adjustment screw cavity30040-3can accommodate adjustment screw40025-3(FIG.7K). Vertical back frame cane30013(FIG.2A) can rest within mount bracket cavity30040-1(FIG.7H). Positional maintenance pins (not shown) can rest in pin cavities40025-4(FIG.7J) to maintain the position of second configuration vertical back frame cane30013(FIG.7D) between second configuration top back frame bracket30012(FIG.2A) and rear tube holder bracket30011(FIG.2A). Referring now toFIGS.8A and8B, second configuration footrest30064, second configuration lower footrest post30062, and second configuration upper footrest post30061can combine to provide a footrest structure for seat assembly40000-1. The height of footrest30064can be adjusted by raising and lowering second configuration lower footrest post30062. The height can be secured by engaging a fastening means such as, for example, but not limited to, at least one screw40054coupling fastening cavities of second configuration upper footrest post30061and second configuration lower footrest post30062. The angle of footrest30064can be adjusted by turning screw30064D (FIG.8B) either counterclockwise or clockwise, depending on the desired angle with respect to second configuration lower footrest post30061. Referring now toFIG.8C, in some configurations, the orientation of first configuration upper footrest post40019and first configuration lower footrest post40021can be adjusted forwards and backwards relative to the direction of motion and seat cushion30002. In some configurations, the position of first configuration footrest40017can be adjusted forwards and backwards to accommodate the comfort needs of the user. First configuration lower footrest post40021can telescope into first configuration upper footrest post40019to enable adjustment of the length of the footrest structure. In some configurations, the relative positions of first configuration lower footrest post40021and first configuration upper footrest post40019can be maintained by fastening means such as, for example, but not limited to, screws, bolts, hook-and-eye fasteners, and glue. Referring now toFIGS.8D-8E, footrest mount bracket40029can operably couple the footrest structure with seat pan mounting bracket30001(FIG.4A). Upper footrest spacer40043(FIG.8E), legrest flanged bushing40037(FIG.8E), recessed bolthead washer40039(FIG.8E), legrest swing bolt40226(FIG.8E), and footrest o-ring40045(FIG.8E) can, in combination, enable limited forward-backward movement of upper footrest post40019. The forward position of the footrest structure can be maintained by spring plunger40027. Lower footrest spacer40033(FIG.8E), footrest swing bolt40237(FIG.8E), footrest washer40031(FIG.8E), and footrest nut40238(FIG.8E) can, in combination, enable folding of first configuration footrest40017towards lower footrest post40021. First configuration footrest40017can accommodate both feet, and can be constructed as a single item or in parts. The foot-facing surface of first configuration footrest40017can include non-slip features40017-1and rear stop40017-2. Referring now toFIGS.8F-8I, second configuration footrest30064can be operably coupled with second configuration lower footrest post30062, which can cooperatively engage with second configuration upper footrest post30061to raise and lower footrest30064. The height of footrest30064can be fixed by engaging a fastener into adjustment cavity30062A when the desired height is attained. Height adjustment can be tooled or tooless, depending upon, for example, the type of fastener used. Second configuration upper footrest post30061can be operably coupled with seat bracket30001(FIG.1), by means of footrest bracket30060, and can include limited backward rotation in response to pressure exerted upon footrest30064. Bumper30063, constructed of a compliant material, can buffer the effect of the pressure. Joints in the seat assembly can be reinforced by a combination of recessed bushing30085(FIG.8H), for example, and bolt40002(FIG.8H). Bolt40002(FIG.8H) can be inserted into the recess of recessed bushing30085(FIG.8H) and engaged therein. Any subsequent stress on the joint can be met by both the strength of bolt40002(FIG.8H) itself in addition to the strength of recessed bushing30085(FIG.8H). Further, the head of bolt40002(FIG.8H) can reside within the recess of recessed bushing30085(FIG.8H), maintaining a flush appearance. Other joints in the seat assembly can be constructed in a similar manner. In some configurations, footrest first rib pattern30064C can differ from footrest second rib patter30064E. In some configurations, footrest first rib pattern30064C can accommodate manufacturing and cost requirements, while footrest second rib pattern30064E can accommodate user slip protection. Referring now toFIGS.9A-9C, a seating assembly110can offer a plurality of automated or user-operable features to facilitate expedient performance of routine tasks by user of seating assembly110, specifically when seating assembly110is provided on a wheelchair or any other mobility device. Seating assembly110can be further constructed to suit pre-determined requirements of individuals with physical constraints. These physical constraints can range from injuries or issues related to the lower body organs, spinal cord issues or neurological issues damaging communication of brain with other parts of the body. It should be noted that the use of the seating assembly110cannot be limited to individuals with above discussed apprehensions only and can be used by any individual irrespective of any physical constraints. Further, seating assembly110can be used by individuals of varying ages and body types. Most features of the seating assembly110can be adjustable and/or can be removably attached based on user preferences. Continuing to refer toFIGS.9A-9C, seating assembly110can be employed with a mobility device such that seating assembly110can engage a user controller120that can operate features of a mobility device/wheelchair and seating assembly110. User controller (UC)120can also comprise structural features such as but not limited to, mounts, coupling junctions, etc., to engage with seating assembly110and subsequently with a mobility device (not shown). Structural features as discussed above and others, (not shown) can enable mounting of UC120with seating assembly110and/or with another component of mobility device/wheelchair. Positioning of UC120, with respect to seat assembly110, can be governed by degree of comfort with which user of seating assembly110can reach and operate UC120. In some configurations, UC120can be mounted to seating assembly110through user control mount125. Continuing to refer toFIGS.9A-9C, UC mount125can be constructed to have substantially ambidextrous parts, enabling cost-effective manufacture of UC mount125. UC mount125can be manufactured based on user preference. Armrests133A and133B (FIG.12A) can be engaged with the remainder of seating assembly110through corresponding armrest supports135A and135B. Each armrest support135A,135B can comprise a first region that can attach respective armrest support135A and135B to a frame (not shown) of seating assembly110and a second region configured to receive at least one arm cushion thereupon. Arm cushion131A can be committed to armrest133A and arm cushion131B can be dedicated to armrest133B (FIG.12A). Referring toFIGS.9B and9C, second regions of armrest supports135A and135B can further comprise corresponding base surfaces137A (FIG.9B) that can face away from arm cushions131A and131B. These base surfaces137A (FIG.9C) can provide receiving platforms to engage UC mount125, the UC tilt mechanism. A coupling assembly140(FIG.10A) can moveably attach UC mount125with the armrest base surfaces137A. In some configurations, a plurality of coupling assemblies140(FIG.10A) can be used to engage UC mount125with at least one of armrests133A and/or133B. Coupling assemblies140(FIG.10A) can operate jointly or discretely from one another for achieving engagement. Moveably coupling UC mount125with armrest base surface137A can allow UC120to be placed in more than one position, alternating towards vertical position155A and towards horizontal position155B. Each of the optional positions can allow the user to conveniently operate UC120and consequently operate the mobility device/wheelchair that can be operably coupled with seating assembly110. Provision of optional positions for UC120can allow user to align with respect to a piece of furniture without being obstructed by a rigid position of UC120. For example, the user of a mobility device such as a wheelchair with seating assembly110can sit against a table or desk maintaining or adjusting the distance between the wheelchair and the table without any obstruction from or damage to UC120. Referring now toFIGS.9B-9C, locking apparatus143on UC mount125can allow UC120to be held in first position150(FIG.9B) when a locking mechanism is deployed. In unlocked condition, UC mount125can be transitioned and held into second position153(FIG.9C). Seat assembly110can include first position150(FIG.9B) in which user control mount125is locked, and second position153(FIG.9C) in which user control mount125is unlocked. In unlocked condition, the user of seating assembly110can adjust UC120into a preferred position by shifting UC mount125away from armrest133A. Second position153(FIG.9C) can be variable. In first position150(FIG.9B) or when user mount125is operably coupled with armrest support135A, UC mount125can be generally parallel to armrest133A. While in second position153(FIG.9C), UC mount125can form an angle with respect to armrest133A, causing displacement of UC120. Referring now toFIG.10A, coupling assembly140can operate in conjunction with locking mechanism143to engage UC mount125(FIG.9B) with armrest133A, and can enable UC mount125(FIG.9B) to reversibly displace from first position150(FIG.9B) to a second position153(FIG.9C). Locking mechanism143can optionally comprise receptacle147(FIG.10B) and lever145. Receptacle147(FIG.10B) can engage with base surface137A of armrest133A, and can jointly operate with lever145to engage shaft121(FIG.9C) of UC mount125with base surface137A. In a locked position, UC mount shaft121(FIG.9C) can be operably coupled with base surface137A such that a coupling segment of lever145can link with a complementing coupling part in receptacle147(FIG.10B) and trap shaft121(FIG.9C) there between. Receptacle147(FIG.10B) can comprise primary receptacle147A (FIG.10B) and secondary receptacle147B (FIG.10B). Primary receptacle147A (FIG.10B), which can roughly match the cylindrical shape of telescoping tube121A, can serve as a trench to receive, and provide lateral restraint for, shaft121(FIG.9C) of UC mount125when it is in first position/locked position150(FIG.9B). Lever145can be operably engaged with shaft121(FIG.9C) and can comprise bar segment144(FIG.9B) that can serve as a coupling segment, and can be trapped into secondary receptacle147B (FIG.10B) when UC mount125is in a locked position. The user can trap or release bar segment144(FIG.9B) from secondary receptacle147B (FIG.10B) by operating lever145(FIG.10B) that can include a paddle configured to be operated by a user. While in first position150(FIG.9B) or locked position, lever145can be angled with respect to shaft121(FIG.9C) of mount125, such that bar segment144(FIG.9B) is confined in secondary receptacle147B (FIG.10B). In second position153(FIG.9C), lever145can form a renewed angle with respect to shaft121(FIG.9C), releasing bar segment144(FIG.9B) from secondary receptacle147B (FIG.9C). The coupling can allow a user to unlock and displace UC120(FIG.9B) at a desirable angle with respect to armrest133A (FIG.10A). In some configurations, shaft121(FIG.9C) can include a telescopic conduit such that a user can alter the length of shaft121(FIG.9C) as per the length of the user's arm. In some configurations, telescoping conduit can be secured without tools, for example, but not limited to, securing with wing nuts and/or thumb screws. In some configurations, shaft121(FIG.9C) can include a multi-part component. In some configurations, shaft121(FIG.9C) can include a single, continuous elongation. In some configurations, shaft121can include a filler such as, for example, a textured tape. Referring now specifically toFIGS.10A and10B, coupling assembly140can engage at least one end of UC mount125with armrest133A. A pivoting assembly160and bracket161can form coupling assembly140such that bracket161can enable engagement between base137A and pivoting assembly160. Bracket161can be rigidly fastened with base surface137A and pivoting assembly160engages therewith such that rotary portion (not shown) can pivot away and towards base surface137A. Bracket161can further comprise cylindrical protrusion that can serve as roller162(FIG.11D) around which pivoting assembly160can be operatively housed. Pivoting assembly160can engage with bracket161by receiving roller162(FIG.11D) into a roller space163. Coupling and frictional interaction between roller162(FIG.11D) and remaining components of pivoting assembly160have been discussed in greater detail in later part of this specification. Bracket161can be affixed to base137A through fastening agents such as, but not limited to, screws, bolts, pins, etc., fastening components such as those enlisted above and others. Similar fastening agents can be employed for receptacle147(FIG.10B) and lever145of locking mechanism143. A user control bed123can be a part of UC mount125such that bed123can permanently couple with shaft121. User control125can be held on the UC bed123through fastening components such as, but not limited to, screws and bolts affixed therewith. A base (not shown) of the user control120and/or UC bed123can provide a plurality of fastening junctions that can allow a user to orient UC120as required. Displacement of UC mount shaft121can cause subsequent displacement of UC bed123and hence UC120. Referring now toFIG.11A, UC mount125can comprise a shaft121operably coupled with UC bed123on the distal end of shaft121, and pivoting assembly140on the proximal end of shaft121. Fasteners127can operably couple UC120(FIG.9A) with UC mount bed123. Any kind and shape of user controller with fastening points the approximate locates of fasteners127can be attached to UC mount bed123. Shaft121can include a multi-part component. Shaft121of can include first tube121A and a second tube121B. Second tube121B can at least partially nest inside first tube121A and can cooperatively, with first tube121A, provide a telescopic elongation to adjust the combined length of shaft121. In some configurations, first tube121A can possess a diameter larger than the diameter of second tube121B to achieve nesting and telescopic length adjustment. Shaft segments121A and121B can provide a roll degree of freedom therewith, providing additional positioning options to user. Shaft segment121A can comprise a longitudinal incision122to receive shaft segment121B of varying diameters. Incision122can further allow first shaft segment121A to acceptably deform when a second shaft segment121B is received therein. In some configurations, shaft121can include rigid or incompressible spacer121C to ensure compact fitting between first shaft segment121A and second shaft segment121B. In some configurations, shaft121can include no spacer or can be a single-piece, continuous device. When UC mount125is in position150(FIG.9B), bumpers (not shown) formed by a cavity within receptacle147, extending into the cylindrical cutout of second lever segment144B can press against first shaft segment121A, creating a compression that can inhibit possible unwanted mechanical movement. Continuing to refer toFIG.11A, shaft121and shaft segments121A,121B, and121C can jointly define track124in shaft121. Track124can house cables or power and data cords (not shown) between UC120(FIG.12A) and a mobility device. First aperture124A, disposed on a distal end of shaft121can serve an entry gate for receiving cables or cords from UC120(FIG.12A) that can be attached to UC mount bed123. Cables and cords can extend along track124and can exit from a second aperture124B, that can be disposed on proximal end of shaft121. Apertures124A and124B can further facilitate swapping of cable unions, as required. Exiting cables and cords can be engaged with hanger141that can be optionally integrated with coupling assembly140. The layout for receiving cables can enable cable management related to the mobility device. Continuing to refer toFIG.11A, incision122on first shaft segment121can be pinched by constricting blocks146A and146B. Blocks146A and146B can be optionally disposed on either sides of incision122and can be constricted together through fastening features such as, but not limited to screws, pins, and bolts. In some configurations, blocks146A,146B can be welded onto shaft segment121A as a single block. Shaft segment121A can be slitted to provide incision122and uniformly divided blocks146A and146B on either sides of incision122. At least one of divided blocks146A and/or146B can further comprise an attachment means to engage lever145therewith. Divided blocks146A,146B and lever145can together, at least partly, form locking mechanism143(FIG.12A). Lever145can serve as user operated portion of locking mechanism143(FIG.12A) and receptacle147(FIG.9C) can jointly achieve locking and releasing of shaft121. Continuing to refer toFIG.11A, lever145can comprise two segments. First lever segment144A can jointly operate with receptacle147(FIG.9C) to trap and release shaft121. In some configurations, first lever segment144A can include a bar that can be held in primary receptacle147A (FIG.9C). Second lever segment144B (FIG.9C) can serve to attach lever145with at least one of divided blocks146A and/or146B to primarily engage lever145with shaft121. In some configurations, the engagement can optionally include a hinge connection to allow desirable operation of lever145. In some configurations, swiveling motion of lever145can be achieved by force application from a user operation on lever145, and can engage or release first lever segment144A with primary receptacle147A (FIG.9C), causing shaft121to be engaged or disengaged from secondary receptacle147B (FIG.9C) of receptacle147(FIG.9C). The swivel motion can be spring-loaded. Referring now toFIGS.11B-11D, pivoting assembly140(FIG.11B) can be optionally positioned at the proximal end of shaft121, allowing operable engagement between UC mount120(FIG.9A) and base137A (FIG.9C) belonging to one of armrests133A or133B (FIG.12A). Bracket161can rigidly engage with armrest base137A (FIG.9C) and can further couple with a housing165therewith. Bracket161can be integrated with roller162(FIG.11D) such that roller162(FIG.11D) can receive other components of rotary structure169. In some configurations, bracket161and roller162(FIG.11D) can be a single, continuous component. Rotary structure169can receive roller162(FIG.11D) in a roller space163(FIG.11D). At least one bearing and/or bushing such as but not limited to, flanged bushing168(FIG.11D) can be employed to provide a thrust bearing between bracket161and rotary structure169. In some configurations, flanged bushing168(FIG.11D) can be replaced by or supplemented with any other component/s that can enable avoidance of contact between similar materials of bracket161and rotary structure169. Flanged bushing168(FIG.11D) can serve as a radial bearing in rotary structure169(FIG.11D) for roller162(FIG.11D). The radial compression between the surfaces of roller space163(FIG.11D), flanged bushing168(FIG.11D) and roller162(FIG.11D) can largely govern required friction to allow pivoting motion of pivoting assembly160(FIG.10A). Referring toFIG.11D, in company with receiving roller162, rotary structure169can also operably engage with housing165. Rotary structure169can be composed of a cylindrical portion disposed in between a radial projection166and an elongated portion170. Projection166can partially oscillate in pocket164(FIG.11C) of housing165such that its oscillation can transition into a pivoting motion of rotary structure169and consequently pivot elongation170. At least a part of the periphery of housing165can serve as hard-stops for regulating oscillatory motion of projection166. In some configurations, hard stop elements can be provided in housing165and, in some configurations, hard stop elements can be distinct from the body of housing165. In some configurations, housing165can limit travel to 30°. In some configurations, housing165can be manufactured by machining or printing. In some configurations, pocket164(FIG.11C) of housing165can comprise one or more shim structures that can be removably retained therein. As a result, a variable hard stop can be provided for oscillatory motion of projection166. Altering the motion of projection166can impact the angular adjustment of UC mount120(FIG.9A) with respect to shaft121(FIG.11A). Shaft121(FIG.11A) can couple with pivoting assembly140(FIG.11B) by at least partially retaining elongation170in track124of hollow shaft121(FIG.11A). Continuing to refer toFIG.11D, a plurality of washers or like components such as but not limited to, compression springs, can be employed in rotary structure169to provide axial pre-load between rotary structure169and bracket161through flanged bushing168. The pre-load can create additional friction. In some configurations, bushing173A, flat washer173B and Belleville washer173C, held together by, for example, shoulder bolt173D can achieve the pre-load. The number and type of washers and/or bushings can be varied based on the extent of pre-load desired. End cap167can be affixed to rotary structure169to enclose rotary components. Materials and dimensions of the sub-components of rotary structure169can be determined based on a desired friction there between such that UC mount125(FIG.11A) can be pivoted with a desired force application and can halt at a desirable second position153(FIG.9C). Additional fastening elements can be employed to ensure a uniform pivoting of most sub-components of rotary structure169. In some configurations, rotary structure169can be a solid piece, without roller pocket163and/or roller162. Referring now toFIG.12A, third configuration seating assembly110can comprise headrest113that can be disposed on backrest130. Headrest113can be engaged with backrest130through discrete attachments114that can be completely dedicated to this coupling. Attachment114can allow user to alter position of headrest113with respect to backrest130. As a result, users of varying heights can adjust headrest113as per personal convenience. In some configurations, rails109(FIG.9A) can serve as pairing means for accepting headrest113with backrest130. In some configurations, headrest113can be rigidly fastened to rails109(FIG.9A) or can be adjustably fastened to rails109(FIG.9A). In case of an adjustable attachment between headrest113and rails109(FIG.9A), a user can alter the position of headrest113with respect to backrest130and the desired height of attendant handle115. A plurality of attachment mechanisms can be employed for adjustably engaging headrest113with rails109(FIG.9A). At least one attachment mechanism can cause headrest113to slide along length of rails109(FIG.9A). Headrest113can further be composed of cushion113A and base113B. Attachments114and/or rails109(FIG.9A) can be partially or completely captured between cushion113A and base113B to ensure the attachments and/or rails109(FIG.9A) do not interfere when a user's head rests on headrest113. In some configurations, headrest113can be removably attached with attachment114and/or rails109(FIG.9A). As a result, user can enjoy an option of using seating assembly110without headrest113, when desired. Referring now toFIGS.12B-12C, attendant handle115can be housed in backrest130. Handle115can serve as an auxiliary feature to maneuver seating assembly110(FIG.12A) by an individual other than user of seat assembly110(FIG.12A). Handle115is also referred to as an attendant handle since it can be used by an attendant assisting a user of seat assembly110(FIG.12A) during occasions that demand additional and/or external support to supplement movement capability of a wheelchair or mobility device containing seating assembly110(FIG.12A). In some configurations, an attendant can use handle115when a user of seat assembly110(FIG.12A) is climbing stairs in a wheelchair or any mobility device that can contain seat assembly110(FIG.12A). In some configurations, when a user is operating a wheelchair or mobility device over a terrain that offers a higher friction against wheels of the wheelchair or mobility device, handle115can be used. Attendant handle, such as, but not limited to, attendant handle115can serve as a convenient gripping and force bearing component to maneuver a wheelchair or mobility device on which seat assembly110(FIG.12A) may be affixed. Continuing to refer toFIGS.12B-12C, handle rails109can moveably engage attendant handle115with backrest130. Handle115can travel away from and towards backrest130through handle rails109. The travelling motion of handle rails109can occur along the length of rail slots or pathways109A and109B that can nest in backrest130. An attendant can adjust the length of attendant handle115, as per preference and/or required by any circumstances. Backrest130can further comprise a front surface130A (FIG.13A) and an opposing back surface130B. Front surface130A (FIG.13A) can provide a mounting surface for cushion surface180that can cover or partially cover front surface130A (FIG.13A). A plurality of engagement methods can be employed to attach cushion surface180to front surface130A (FIG.13A). In some configurations, cushion surface180can be coupled with front surface130A (FIG.13A) through a fastener such as, but not limited to, a screw or a bolt. In some configurations, cushion surface180can be coupled with front surface130A (FIG.13A) through VELCRO® strips provided on the opposing side of cushion surface180that can mate with corresponding VELCRO® strips disposed on front surface130A (FIG.13A). The engagement methods can allow a user of seat assembly110(FIG.12A) to conveniently switch cushion surface180as per preference. Referring toFIG.12C, back surface130B of backrest130can comprise latch200to operate attendant handle115. Latch200can further comprise flange205that can participate in operating and locking the mechanism, optionally disposed in the interior of front surface130A (FIG.13A) of backrest130(FIG.12A). Raised supports202, in conjunction with frame portion210, can retain latch200against back surface130B of backrest130. Raised supports202can be integral with back surface130B and can provide a first pair of apertures212A (FIG.13D). In some configurations, raised supports202can be molded with back surface130B during manufacture. In some configurations, raised supports202can be welded to backrest130(FIG.12A). Raised supports202, latch200and frame210can provide coupling features that can further mutually align to engage latch200there between. Referring now toFIG.13A, front surface130A can include a plurality of cover layers that can enclose an attendant handle operating assembly190. Casing191can be integrated with or attached to backrest130(FIG.12A), and can house attendant handle operating assembly190. In some configurations, backrest130(FIG.12A) can be molded with casing191and a plurality of subframes193can be provided therein. The plurality of subframes193can receive corresponding components that can make up attendant handle operating assembly190. Securing layers181,182and183can be positioned between attendant handle operating assembly casing191and cushion surface180. Layers181,182,183can ensure a reliable covering of attendant handle operating mechanism190such that mechanism190can function without external intervention that can obstruct operating of assembly190. A combination of cover layers181,182and183can further serve as an upholstery or padding to receive cushion surface180. A plurality of combinations can be used to cover operating assembly190and a plurality of permutations and combinations of these layers can serve as upholstery for cushioning surface. The combinations can include, but are not limited to, a varying number of cover layers, varying material/s for cover layer and similar alternations. Additionally, cover layers181,182,183can be fastened using a number of fasteners such as, but not limited to, screws, bolts, and pins. Cover layers can be positioned such that fasteners or engaging agents do not interfere with handle operating assembly190. In some configurations, casing191can be embossed into inner face185, allowing components of assembly190to be nested therein. Platforms or surfaces185A and185B can receive cover layers181can assist in further partially providing upholstery for layers182and183and cushion surface180. A desirable spaced enclosure can be formed through casing191and cover layers181,182,183, that can retain operating assembly190, and can allow unobstructed functioning of components of operating assembly190. Continuing to refer toFIG.13A, covering layers181,182and183of present teachings can be a single-part or a multi-part component. A first or immediate covering layer181that can face operating assembly190, can optionally be a two or more-piece component such that each component piece engages with an area of inner face185of backrest130(FIG.12A). In some configurations, the engagement can occur at an area other than the area occupied by attendant handle operating assembly190. In some configurations, inner surface185can be divided into two regions. First region185A can be occupied by attendant handle operating mechanism assembly190, and second region185B can partially or completely accept cover layers181,182and183to engage with surface185. Region185A can be centrally located on surface185, and region185B can be positioned peripherally and can engage layers182and183therewith. Each piece of first layer181can mate to entirely cover casing191. Covering layers such as, but not limited to, cover layers181and183, can affix thereupon to provide a secure cover for casing191. A plurality of fastening agents such as, but not limited to, screws, bolts, and pins, can be used to combine covering layers181,182and183. Referring now toFIG.13B, inner face185of backrest130can comprise an optionally embossed or pressed case191that can house attendant handle operating mechanism190. A plurality of subframes193can be provided in case191. The plurality of subframes193can serve as receptacles for moving parts that can jointly retain, lock, release and allow rails109along substantially vertical pathways or slots109A and109B. Subframes193can also serve as receptacles and/or fastening junctions for moving components housed therein. One purpose of these moving components can be to trap and release rails109by operation of latch200(FIG.12B). Attendant handle operating assembly190can comprise at least one focal point311that can serve as an engagement junction for most moving components of assembly190. Adjustable joint312can optionally engage a second engagement point of moving components of assembly190such that adjustable joint312can be restricted to travel at variable hard stop330. In some configurations, operating assembly190can comprise a plurality of beams or bars that can mate at focal point311. Continuing to refer toFIG.13B, case191can comprise pathways109A and109B for rails109of attendant handle115. Rails109can be inserted through a plurality of aligned apertures in backrest130(FIG.12A) to receive and retain rails109. Subframes193can further define edges250and251along each pathway109A and109B. Edges250and251can be sized and shaped to at least partially rim received rails109. Edges250and251can serve at alignment junctions to ensure that rails109do not derail pathways109A and109B. Attachment features in the form of cuffs110A and110B can be held by edges250and/or251. Cuffs110A and110B can be retained in edges250and/or251and can subsequently receive rails109therein. In some configurations, cuffs110A and110B can serve as bushings to provide a smooth sliding surface for rails109. Traps331A and331B can retain cuffs110A and110B to enable positioning of rails109. Edges250and251can be dimensioned to receive rails109along with retaining members110A,110B and traps331A,331B and any other retaining members, such as, but not limited to, bushings and washers. Following alignment in pathways109A and109B, the disposition of moving components of operating assembly190can enable capturing and releasing rails109in pathways109A and109B. Referring now toFIG.13C, stoppers322,324can commit to each of rails109(FIG.13B). Stoppers322,324can couple with displaceable components of operating assembly190(FIG.13B) such that operation of these components can cause stoppers322,324to halt and maintain rails109at a desirable junction in corresponding pathways109A and109B (FIG.13B). In some configurations, bumpers323,325can couple with stoppers322,324and can compress against rails109to halt and maintain rails109in their halted position. It should be noted that bumpers323,325(FIG.13C) can be sized in varying geometries such that chosen geometry can suffice to engage with stopper322on one end, and compress against rails109(FIG.13B) on another. A plurality of similar or dissimilar sized bumpers323,325can be employed with stoppers322and324. For achieving a locked position, displacing components of operating assembly190(FIG.13B) can thrust stoppers322towards rails109(FIG.13B) and for releasing or in an unlocked position, stoppers322,324can be retracted away from rails109(FIG.13B). In some configurations, a compression spring (not shown) can be held between stoppers322and324such that on being retracted from rails109(FIG.13B), stoppers322and324can be maintained at a known distance there between. Variable hard stop330(FIG.13B) can be disposed at a junction in case191(FIG.13B) such that displaceable components of assembly190(FIG.13B) can be refrained from travelling beyond hard stop330(FIG.13B). Geometry of hard stop330(FIG.13B) can be constructed to allow variable positioning of hard stop330(FIG.13B). Continuing to refer primarily toFIG.13C, displaceable components of operating assembly190(FIG.13B) can comprise central beam315with at least two engagement points315A and315B. First side beam317and second side beam319can be operably coupled with central beam315at focal point311(FIG.13B) by fastener312and accompanying nut, whose ends are protected by end caps335A/335B. Each set of side beam/s317and319can comprise at least two sets of corresponding engagement points each,317A,317B and319A and319B. At least one of engagement points belonging to each side beam317and319can couple with first engagement point315A of central beam315and can optionally unite at focal point311. First set of side beams317can extend substantially perpendicular to central beam315and can further engage with at least one of stoppers322through engagement point317B, for example. Second set of side beams319can engage with central beam315at focal point311and can extend generally perpendicular to central beam315. The engagement can be achieved through engagement point319B or engagement point319A, for example, and can couple second set of side beam/s319with second stopper324. Continuing to refer primarily toFIG.13C, at least one stopper322,324can commit to one of rails109A (FIG.13B) and/or109B (FIG.13B). First set of side beams317can engage with first stopper322through second engagement point317B of first set of side beams317. Second stopper324can engage with second set of side beams319through engagement points319A. Each stopper322,324can further comprise coupling surfaces342and344, respectively. Coupling surfaces342and344can receive and retain engagement points317B and319A, respectively. Fastening of side beams317,319with respective stoppers322,324can be achieved through fastening agents such as, but not limited to, screws, bolts, and pins. Stoppers322and324can engage with casing and/or enclosure191(FIG.13B) through fasteners at coupling junctions352and354of stoppers322and324. Fastening of stoppers322and324with casing or enclosure191(FIG.13B) can enable stoppers322and324to retain a desired degree of movement for when handle operating assembly190(FIG.13B) transitions from a locked position to an unlocked position and vice versa. In some configurations, stopper322and/or324can retain a freedom of pivoting around coupling junctions352and354. Referring primarily toFIG.13D, pre-determined disposition of moving components of operating assembly190(FIG.13B) can contribute in achieving locking and unlocking of rails109(FIG.13B) through operating assembly190(FIG.13B). Bridging orifice207can allow flange205to pass there through and receive a fastening agent such as, but not limited to, shoulder screw (not shown) which can further couple with engagement points of central beam315(FIG.13C) and side beams317,319. Fastener312(FIG.13C) can engage with flange205across bridging orifice207and can receive second set of side beam319(FIG.13C), central beam315(FIG.13C) and first set of side beam317(FIG.13C) such that raising and lowering of focal pin313(FIG.13B) can subsequently raise and lower engagement assembly of side beams317,319(FIG.13C) and central beam315. Above discussed engagement can further trap central beam315(FIG.13B) between first set of side beam/s317and second set of side beam/s319(FIG.13B). Continuing to refer toFIG.13D, back surface130B of backrest130(FIG.12A) can retain latch200. Attachment of latch200can be achieved by engaging bar214through first set of apertures212A that can exist on raised features202on backrest130(FIG.12A), second set of apertures or latch apertures212B, and third set of apertures212C. The engagement can enable latch200to retain a rotary motion around bar214. User-generated rotation of latch200can generate a linear force allowing flange205to travel along the length of bridging orifice207, and can enable linear motion of flexible pin313(FIG.13B) that can enable a user to actuate assembly190(FIG.13B). Referring now toFIG.14A, latch200can be held in a locked positon300or unlocked position310(FIG.14C). In locked position300, latch200can enable attendant handle operating mechanism190(FIG.14B) to trap attendant handle115such that an application of force for adjusting the length of handle115cannot displace attendant handle115(FIG.14A) from the position in which it is stationed. In unlocked position310(FIG.14C), attendant handle operating assembly190(FIG.14B) can allow attendant handle115to be adjusted in terms of its protruding height by applying a desired force on handle115. Latch200in a locked position (FIGS.14A and14B) can be compared with latch200in an unlocked position (FIGS.14C and14D). Flange205can serve as an interface or force transfer agent between latch200and handle operating assembly190(FIG.14B). Continuing to refer toFIG.14A, a plurality of geometries and designs can be given to latch200. In some configurations, latch200can include a gripping or pushing surface that the user can contact for operating latch200. In some configurations, latch200can include handle portion200A and rotatable portion200B. In locked position, handle portion200A can be pushed away form backrest surface130B (FIG.14B) causing a partial rotation of rotatable portion200B. Flange205can extend from rotatable portion200B such that rotational displacement of latch200can displace flange205through bridging orifice207. Displacement of flange205towards frame portion210, as seen on back surface130B of backrest130(FIG.13B), can enable displacement of adjustable joint312such that engaged central beam315(FIG.14B) can also be displaced away from frame portion210and can further cause focal point311(FIG.14B) to shift. Referring now toFIG.14B, shifting of focal point311, in locking positon300(FIG.14A) can cause side beams317,319to extend substantially perpendicular to central beam315. Side beams317,319can exert a thrust on stoppers322and324, causing them to displace towards rails109(FIG.14A) of handle115(FIG.14A). Bumpers323,325can compress against corresponding rails109(FIG.14A) and cease rails109(FIG.14A) from travelling along pathways109A,109B (FIG.12B). Referring now toFIGS.14C and14D, to enable rails109(FIG.14C) to adjustably travel along respective pathways109A,109B (FIG.12B), handle operating mechanism190(FIG.14D) can release rails109(FIG.14C) by rotatably displacing latch200(FIG.14C) into an unlocked position. In the unlocked position, handle portion200A (FIG.14C) of latch200(FIG.14C) can appear to be lifted away from back surface130B (FIG.14D). As a result, flange205can be displaced toward frame portion210(FIG.14C) along the length of bridging orifice207(FIG.14C), and can result in displacement of adjustable joint312(FIG.14D). Variable hard stop330(FIG.14D) can be positioned in casing191(FIG.14D) of inner face185A (FIG.13A) of backrest130(FIG.12A), can serve as a hard stop for flexible point312(FIG.14D), and can restrict rotation of latch200(FIG.14C). Central beam315(FIG.14D) can operably couple adjustable joint312(FIG.14D) with focal point311(FIG.14D), and can enable displacement of focal point311(FIG.14D) towards frame portion210(FIG.14C). Shifting of focal point311(FIG.14D) can cause side beams317,319(FIG.14D) to displace from their substantially perpendicular position with respect to central beam315(FIG.14D). Displaced side beams317,319(FIG.14D) can retract stoppers324,322(FIG.14D) from pathways109A,109B (FIG.12B). The retraction can result in loosening contact between stopper bumpers323,325(FIG.14D) and respective rails109(FIG.14C). As a result, rails109(FIG.14C) can freely travel along length of travel ways109A,109B (FIG.12B). A user can choose an appropriate length of handle115(FIG.14C) extending of out backrest130(FIG.12A) and can retain the chosen length when transitioning into locked position300(FIG.14B) by operating latch200(FIG.14C). While the present teachings have been described in terms of specific configurations, it is to be understood that they are not limited to these disclosed configurations. Many modifications and other configurations will come to mind to those skilled in the art to which this pertains, and which are intended to be and are covered by both this disclosure and the appended claims. It is intended that the scope of the present teachings should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings. | 64,615 |
11857474 | DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS While the invention will be described in connection with one or more preferred embodiments, it will be understood that it is not intended to limit the invention to those embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims. Turning now toFIGS.1-21, it is seen that a preferred embodiment of a bed10of the present invention is illustrated. The bed10has a top11, a bottom12, a first end13, a second end14, a first side15and a second side16. The bed has a deck20that is connected to a main frame30. The deck20has two ends21and22. The deck can be any suitable deck that can be flat or articulating. The present invention not limited to any particular deck configuration. Preferably, two end lift assemblies50and350are provided to raise and lower the bed10between low and high positions. The main frame30is perhaps best illustrated inFIGS.13and14. The main frame has a cross rail31, a cross rail32, a side rail33and a side rail34. Cross rails31and32are preferably parallel to each other. Side rails33and34are preferably parallel to each other. Two actuator mounts35and36are also provided. The first end lift assembly50and the second end lift assembly350preferably have the same components. In this regard, the first end lift assembly50will be discussed in detail and it will be understood that the second end lift assembly350will preferably be similar or the same. The first end lift assembly50has a wheel frame60a wheel assembly90, a support frame100, a load transfer assembly140and an actuator260. Each of these components will be described below. The wheel frame60has a first side leg70and a second side leg80. The first side leg70has a first end71and a second end72. The first end71is preferably movably and pivotally coupled with side rail33of the main frame30. The second side leg80also has a first end81and a second end82. The first end81is preferably movably and pivotally coupled with side rail34of the main frame30. The second ends72and82are preferably pivotally connected to the wheel assembly90. The wheel assembly can be any suitable wheel assembly and is not limited to an assembly as illustrated in the drawings. Side legs70and80preferably act in unison with respect to each other. The support frame100has two arms110and120, and a crossbar130interconnecting the arms. Arm110has a first end111and a second end112. Arm120has a first end121and a second end122. The crossbar130is connected to the arms110and120at a position between the respective ends. The crossbar130has a first end131and a second end132. A first set of tabs135is near end131and a second set of tabs136is near end132. It is appreciated that while two tabs are shown at each end, that this aspect of the invention could have only one tab on each end without departing from the broad aspects of the present invention. The support frame100is pivotally connected to the main frame30. The support frame100is also pivotally connected to the wheel frame60. The load transfer assembly140has a pivot arm150, a pivot arm170, a cross member190, a cam arm200, a follower220, a cam arm230and a follower250. Looking atFIGS.19and20, it is seen that the pivot arm150preferably has a first plate151and a second plate152. While two parallel plates are illustrated, it is appreciated that a single plate may alternatively be used without departing from the broad aspects of the present invention. Further, the plates act in unison. In this regard, they will be described as part of a single pivot arm. The pivot arm150has an end155with a pivot hole156there through. The pivot arm150has an opposite or second end160with an ear161or other protrusion extending therefrom. A hole165is through the pivot arm150and is located between the ends155and160. Pivot arm170preferably has a first plate171and a second plate172. While two parallel plates are illustrated, it is appreciated that a single plate may alternatively be used without departing from the broad aspects of the present invention. Further, the plates act in unison. In this regard, they will be described as part of a single pivot arm. The pivot arm170has an end175with a pivot hole176there through. The pivot arm170has an opposite or second end180with an ear181or other protrusion extending therefrom. A hole185is through the pivot arm170and is located between the ends175and180. The first pivot arm150and second pivot arm170are joined with a cross member190. The cross member190has slots to stationarily receive the ears161and181of the pivot arms. In this regard, both pivot arms150and170, and the cross member act as a single rigid component. The cross member190has tabs191extending therefrom on an opposite side as where the pivot arms connect to the cross member. It is appreciated that while two tabs191are preferred, that a single tab may alternatively be used without departing from the broad aspects of the present invention. The pivot arms150and170are preferably generally C-shaped. The general shape is preferably defined by the center of holes165and185being offset from a line extending generally between respective ends of the pivot arms. The first end155of pivot arm150is pivotally connected to tab135of the crossbar130. The first end175of pivot arm170is pivotally connected to tab136of the crossbar130. These two pivotal connections have the same pivot axis and define a fulcrum axis of a fulcrum. The cross member190is movable in an orbital path about the fulcrum axis. Looking now toFIGS.13-16, it is seen that the cam arm200is preferably made of a single plate201. Yet, it is appreciated that multiple plates, acting in unison, could alternatively be used without departing from the broad aspects of the present invention. The cam arm200has a top205and a bottom206, a first end210and a second end211. A slot215is through the cam arm200and is generally oriented between the ends210and211. The slot215is preferably nonlinear to achieve one result of the present invention although it could be linear if a different configuration was desired. The slot has an upper surface, which is a cam surface216, and a lower surface. The cam arm200is preferably stationarily connected to the main frame30. It preferably lies in a cam arm axis that this preferably parallel with a side rail longitudinal axis of side rail33. The follower220preferably operably couples the pivot arm150and the cam arm200. The follower220is preferably a roller. It is appreciated that the follower could alternatively be a glide or other low friction structure without departing from the broad aspects of the present invention. The follower220is received within hole165of the pivot arm and is also received within the slot215or the cam arm200. The follower moves within the slot215as the pivot arm150pivots about the support frame crossbar130. It is appreciated that in the preferred embodiment, the two plates151and152of the pivot arm are on opposite sides of a single cam arm plate201, resulting in a clevis with the follower acting as a clevis pin. It is understood that all that is required is a single pivot arm plate supporting a follower in a fixed position, and a single cam arm plate. The cam arm230is preferably made of a single plate231. Yet, it is appreciated that multiple plates, acting in unison, could alternatively be used without departing from the broad aspects of the present invention. The cam arm230has a top235and a bottom236, a first end240and a second end241. A slot245is through the cam arm230and is generally oriented between the ends240and241. The slot245is preferably nonlinear to achieve one result of the present invention although it could be linear if a different configuration was desired. The slot has an upper surface, which is a cam surface246, and a lower surface. The cam arm230is preferably stationarily connected to the main frame30. It preferably lies in a cam arm axis that this preferably parallel with a side rail longitudinal axis of side rail34. The follower250preferably operably couples the pivot arm170and the cam arm230. The follower250is preferably a roller. It is appreciated that the follower could alternatively be a glide or other low friction structure without departing from the broad aspects of the present invention. The follower250is received within hole185of the pivot arm and is also received within the slot245or the cam arm230. The follower moves within the slot245as the pivot arm170pivots about the support frame crossbar130. It is appreciated that in the preferred embodiment, the two plates171and172of the pivot arm are on opposite sides of a single cam arm plate231, resulting in a clevis with the follower acting as a clevis pin. It is understood that all that is required is a single pivot arm plate supporting a follower in a fixed position, and a single cam arm plate. The actuator260has two ends261and262, respectively. End261is preferably attached to actuator mount35. It is appreciated that while the actuator260is illustrated as being connected to the main frame30, that the present invention is not limited to having the actuator be mounted to the main frame. In this regard, the actuator260could be mounted to a different structure without departing from the broad aspects of the present invention. The second end262of the actuator is preferably connected to the cross member tabs191. Extension of the actuator60causes the pivot arms150and170to rotate about the fulcrum. The generally C-shaped arms allow the arms to clear the support frame while rotating. Also, the actuator260passes below the support frame while clearing the support frame. The follower220is at a first end of the slot215when the bed is in the low position and moves to the opposite end of the slot when the bed is in the high position. Similarly, the follower250is at a first end of the slot245when the bed is in the low position and moves to the opposite end of the slot when the bed is in the high position. The followers220and250act against the cam surfaces216and246to raise the bed. It is appreciated that the lower slot surfaces constrain the followers from disengaging the cam surfaces in an event where there was an exterior vertical load on the bed (for example if someone was lifting the end of the bed). A load curve of the actuator260is determined by a few factors including the slot profile, where the actuator effectively couples to the pivot arms (orbital path) and wherein the followers are supported by the pivot arms (orbital path). The locations of the last two variables are selected in a manner that allows for a relatively horizontally oriented slot in the cam arm. This is advantageous as the cam, acting mostly vertically, is able to support loads in a more rigid fashion, by creating less deflection within the components of the transfer assembly. A second end lift assembly350is similar to the first end lift assembly50. It has a wheel frame360, a wheel assembly370, a support frame380, a load transfer assembly390and an actuator410. The lift assemblies can be used for opposite ends of the bed. In this regard, one can be used for the head section and the other can be used for the foot section of the bed10. As described above, the bed10has multiple actuators. The amount of current that each actuator draws corresponds to the amount of force needed to lift the load on that portion of the bed. Looking now atFIG.21, a load curve achieved by the present invention is illustrated. The electronics in the bed are designed to allow the maximum current draw setting for each actuator to be set at a desired threshold, so that the controls will shut down if/when that threshold of current draw is exceeded. If the bed is either overloaded or restricted from elevating, the excessive current draw will cause the electronics to shut down, helping to prevent mechanical damage from occurring. By establishing a substantially flat load curve for the Hi-Lo mechanism of the bed, the threshold cut off can be set with the least amount of overload being exerted on the bed. Turning now toFIGS.22-28, it is seen that an alternative preferred embodiment of a bed510of the present invention is illustrated. The bed510has a top, a bottom, a first end513, a second end514, a first side and a second side. The bed has a deck520that is connected to a main frame530. The deck520has two ends521and522. The deck can be any suitable deck that can be flat or articulating. The present invention not limited to any particular deck configuration. Preferably, two end lift assemblies550and850are provided to raise and lower the bed510between low and high positions. The main frame530has two cross rails and two side rails. Cross rails are preferably parallel to each other. Side rails are preferably parallel to each other. Two actuator mounts35and36are also provided. The first end lift assembly550and the second end lift assembly850preferably have the same components. In this regard, the first end lift assembly550will be discussed in detail and it will be understood that the second end lift assembly850will preferably be similar or the same. The first end lift assembly550has a wheel frame560a wheel assembly590, a support frame600, a load transfer assembly640and an actuator260. Each of these components will be described below. The wheel frame560has a first side leg570and a second side leg580. The first side leg570has a first end and a second end. The first end is preferably movably and pivotally coupled with a side rail of the main frame530. The second side leg580also has a first end and a second end. The first end is preferably movably and pivotally coupled with a side rail of the main frame530. The second ends are preferably pivotally connected to the wheel assembly590. The wheel assembly can be any suitable wheel assembly and is not limited to an assembly as illustrated in the drawings. Side legs570and580preferably act in unison with respect to each other. The support frame600has two arms610and620, and a crossbar630interconnecting the arms. Arm610has a first end and a second end. Arm620has a first end and a second end. The crossbar630is connected to the arms610and620at a position between the respective ends. The crossbar630has a first end and a second end. The cross bar630has tabs636. It is appreciated that while two tabs are shown, that this aspect of the invention could have only one tab without departing from the broad aspects of the present invention. The support frame600is pivotally connected to the main frame530. The support frame630is also pivotally connected to the wheel frame560. The load transfer assembly640has a pivot arm650, a cam arm670, and a follower690. The pivot arm650preferably has a first plate651and a second plate652. While two parallel plates are illustrated, it is appreciated that a single plate may alternatively be used without departing from the broad aspects of the present invention. Further, the plates act in unison. In this regard, they will be described as part of a single pivot arm. The pivot arm650has an end655with a pivot hole656there through. The pivot arm650has an opposite or second end660with a pivot hole661therethrough. A hole665is through the pivot arm650and is located between the ends655and660. The pivot arm650is preferably generally C-shaped, as seen inFIGS.27-28. The general shape is preferably defined by the center of holes665being offset from a line extending generally between pivot hole656and pivot hole661. The first end655of pivot arm650is pivotally connected to tab636of the crossbar630. This pivot axis defines a fulcrum axis of a fulcrum. Pivot hole661pivots in an orbital path with respect to the fulcrum axis. This connection can be offset from a center of the crossbar630. This can be done to accommodate the actuators of both lift assemblies550and850. Cam arm670is preferably made of two plates671and672. Yet, it is appreciated that a single plate could alternatively be used without departing from the broad aspects of the present invention. The cam arm670has a top680and a bottom682, a first end682and a second end683. A slot685is through the cam arm670and is generally oriented between the ends682and683. The slot685is preferably nonlinear to achieve one result of the present invention although it could be linear if a different configuration was desired. The slot has an upper surface, which is a cam surface686, and a lower surface. The cam arm670is preferably stationarily connected to the main frame530. It preferably lies in a cam arm axis that this preferably parallel with a side rail longitudinal axis of side rail. The follower690preferably operably couples the pivot arm650and the cam arm670. The follower690is preferably a roller. It is appreciated that the follower could alternatively be a glide or other low friction structure without departing from the broad aspects of the present invention. The follower690is received within hole665of the pivot arm and is also received within the slot685or the cam arm670. The follower moves within the slot685as the pivot arm650pivots about the support frame crossbar530. It is appreciated that in the preferred embodiment, the two plates151and152of the pivot arm are on opposite sides of a cam arm plates671and672. Yet, it is understood that all that is required is a single pivot arm plate supporting a follower in a fixed position, and a single cam arm plate. The actuator700has two ends701and702, respectively. End701is preferably attached to actuator mount of the main frame530. It is appreciated that while the actuator700is illustrated as being connected to the main frame530, that the present invention is not limited to having the actuator be mounted to the main frame. In this regard, the actuator700could be mounted to a different structure without departing from the broad aspects of the present invention. The second end702of the actuator is preferably connected to the pivot arm650as hole661. Extension of the actuator700causes the pivot arm650to rotate about the fulcrum. The generally C-shaped arm allow the arms to clear the support frame while rotating. Also, the actuator700passes below the support frame while clearing the support frame. The follower690is at a first end of the slot685when the bed is in the low position and moves to the opposite end of the slot when the bed is in the high position. The follower690acts against the cam surface686to raise the bed. It is appreciated that the lower slot surface constrains the follower from disengaging the cam surface in an event where there was an exterior vertical load on the bed (for example if someone was lifting the end of the bed). A second end lift assembly850is similar to the first end lift assembly550. It has a wheel frame860, a wheel assembly870, a support frame880, a load transfer assembly890and an actuator910. The lift assemblies can be used for opposite ends of the bed. In this regard, one can be used for the head section and the other can be used for the foot section of the bed530. Thus, it is apparent that there has been provided, in accordance with the invention, a bed with a raiseable mattress frame by actuators operating with a controlled load curve that fully satisfies the objects, aims and advantages as set forth above. While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications, and variations as fall within the spirit and broad scope of the appended claims. | 19,764 |
11857475 | DESCRIPTIVE KEY 100detachable commode 200commode storage bracket 202bracket frame 204slide 210commode 220seat 222pail aperture 223lid 230leg 232upper leg section 234lower leg section 236spring-loaded button 238height adjustment aperture 240seat back 241seat back slot 250handle 251handle slot 260pail 262top aperture 264lip 900bed 902head of bed 904foot of bed 1. Description of the Invention The present invention is directed to a detachable commode (herein described as the “invention”)100. The invention100may comprise a commode storage bracket200, a commode210, and a pail260. The commode storage bracket200may be coupled to the underside of the bed frame of a bed900, having a head of bed902and a foot of bed904. The commode210may be stored under the bed900supported by the commode storage bracket200. The commode210may be removed from the commode storage bracket200when needed. The commode210may hold the pail260such that the commode210may be operable as a toilet. The commode210may be adapted for a patient to sit on a seat220of the commode210and while urinating and/or defecating into the pail260. As non-limiting examples, the bed900may be a hospital bed and the commode storage bracket200may be added onto the bed900or may be built into the bed900. In a preferred embodiment, the commode storage bracket200is located adjacent to the foot of bed904. The commode storage bracket200may comprise a bracket frame202that couples to the underside of the frame of the bed900. In some embodiments, the commode storage bracket200may be added to the frame of the bed900using mounting hardware. As used herein, mounting hardware may refer to mechanical devices that are used to attach one object to another, including devices whose only purpose is to improve aesthetics. As non-limiting examples, the mounting hardware may comprise screws, nuts, bolts, washers, rivets, crossbars, hooks, collars, nipples, cams, standoffs, knobs, caps, plates, rails, lips, brackets, or any combination thereof In some embodiments, the commode storage bracket200may be built into the frame of the bed900as an integral part of the frame of the bed900. The commode storage bracket200may comprise a pair of slides204which may be located at the bottom of the commode storage bracket200and which may be oriented to point towards the center of the commode storage bracket200such that the commode210may rest on and between the pair of slides204when not in use. As a non-limiting example, the pair of slides204may be a pair of L-channels. The commode210may be a piece of furniture that may be operable as a toilet. The commode210may comprise the seat220, a plurality of legs230, a seat back240, and one (1) or more handles250. The commode210may be operable to support the pail260. The commode210may be adapted for the patient to sit upon while using the commode210. The seat220may be a horizontally-oriented surface comprising a pail aperture222. The seat220may be adapted to support the weight of the patient. The pail aperture222may be located at the center of the seat220. The pail aperture222may be operable to support the pail260. The shape of the pail aperture222may match the footprint of the uppermost edge of the pail260. A lip264on the top of the pail260may prevent the pail260from passing entirely through the pail aperture222. A lid223is hingedly attached to the seat220, directly rearward of the pail aperture222, for selective covering thereof The plurality of legs230may elevate the seat220above the floor. As non-limiting examples, the plurality of legs230may comprise four (4) individual leg assemblies230that may be hingedly coupled to the underside of the seat220at each corner of the seat220or they may comprise two (2) U-shaped legs that may be hingedly coupled to the underside of the seat220at opposing ends of the seat220. The plurality of legs230may pivot up to a position that is parallel to the seat220for storing the commode210and may pivot down to a position substantially perpendicular to the seat220for use. The plurality of legs230may be adapted to lock in the up position such that the plurality of legs230remain up while the commode210is stored beneath the bed900. The plurality of legs230may be adapted to lock in the down position such that the commode210is stable and safe for the patient to sit upon. The plurality of legs230may be adapted to be unlocked by a caregiver before pivoting between the up position and the down position. In some embodiments, the height of the seat220may be adjusted by varying the length of the plurality of legs230. An individual leg selected from the plurality of legs230may comprise one (1) or more height adjustment mechanisms. As a non-limiting example, an individual height adjustment mechanism may comprise an upper leg section232with a plurality of height adjustment apertures238and a lower leg section234with a spring-loaded button236where the upper leg section232is a larger diameter than the lower leg section234such that the lower leg section234may slide into and out of the upper leg section232. The spring-loaded button236may engage one (1) of the plurality of height adjustment apertures238to retain the individual leg at a specific height. The spring-loaded button236may be adapted to be pressed by the caregiver to disengage from the plurality of height adjustment apertures238such that the lower leg section234may slide to change the length of the individual leg. The spring-loaded button236may re-engage one of the plurality of height adjustment apertures238when the spring-loaded button236aligns with one of the plurality of height adjustment apertures238. The seat back240may be coupled to the top surface of the seat220behind the lid223. The seat back240may be adapted to prevent the patient from sliding off the rear of the seat220. The height of the seat back240may be selected to fit within the space available between the top surface of the seat220and the bottom of the bed frame. A seatbelt is capable of securing around a portion of a user and may be attachable to the seat back240. The seat back240is secured within a seat back slot241of the seat220and is vertically movably adjustable therein. This vertical adjustment may be necessary in order to store the commode210under the bed900. The one (1) or more handles250may be fixedly coupled to the top surface of the seat220on one (1) or both sides of the pail aperture222. The one (1) or more handles250may be adapted for the patient to grasp for support. The height of the one (1) or more handles250may be selected to fit within the space available between the top surface of the seat220and the bottom of the bed frame. Each handle250is secured within a handle slot251of the seat220and is vertically movably adjustable therein. This vertical adjustment may be necessary in order to store the commode210under the bed900. In some embodiments, the seat back240and/or the one (1) or more handles250may pivot to a position that is parallel to the top surface of the seat220such that a taller seatback may be used without interfering with under-the-bed storage of the commode210. The pail260may be an open top container for holding urine and excrement. As a non-limiting example, the pail260may be emptied, cleaned, and stored in a patient bathroom when not in use. The pail260may be lowered into the pail aperture222on the commode210for use. The pail260may comprise a top aperture262through which the pail260may be filled and emptied. The pail260may comprise the lip264surrounding the top aperture262to prevent the pail260from passing through the pail aperture222of the seat220. In use, the commode210may be stored beneath the bed900in the commode storage bracket200. The pail260may be stored in a clean state in the patient bathroom. When a patient with ambulatory limitations indicates that they must use a toilet, the caregiver may retrieve the pail260from the patient bathroom and bring the pail260to the side of the bed900. The caregiver may slide the commode210from under the bed900and pivot the plurality of legs230downward. If necessary, the height of the seat220may be adjusted using the one (1) or more height adjustment mechanisms on the plurality of legs230. The commode210may be extracted from the commode storage bracket200and placed free-standing next to the bed900. The pail260may be lowered into the pail aperture222on the seat220. The caregiver may assist the patient in swinging the patient's legs over the side of the bed900and standing in front of the commode210. The patient may turn and sit on the commode210to urinate and/or defecate. After cleaning, the patient may stand, turn, and sit on the bed900. The caregiver may assist the patient in lifting the patient's legs onto the bed900. The pail260may be removed from the commode210, carried to the patient bathroom, emptied, and cleaned. The commode210may be returned to the commode storage bracket200where the plurality of legs230may be pivoted up and the commode storage bracket200may slide into place beneath the bed900. The availability of the commode210within the bed900addresses issues of timely access to a toilet, cross-contamination between patients when toilets are shared, and effective use of space within a patient room. The exact specifications, materials used, and method of use of the invention100may vary upon manufacturing. The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. | 10,007 |
11857476 | DETAILED DESCRIPTION OF THE INVENTION FIGS.1through4illustrate an intensive use furniture component shown as a first and second embodiment of a bed20. Referring to aFIGS.1and3, the bed20is rectangular having a top surface22, a pair of end side walls24and a front and rear side walls26. The bed20has an attachment means27formed in the end, rear and front walls24,26. The attachment means may comprise a plurality off fastener pockets32disposed in spaced relation on the end surfaces and front and rear surfaces for receiving fasteners (not shown) therein for extending through the shell to attach the bed20to the floor F (FIG.5). The top surface22has a ridge33surrounding the support portion35forming a recessed pocket on the top of the bed. The ridge and support surface form a recessed pocket as a means for locating a mattress (not shown) as well as containing the seepage of bodily or other undesirable fluids within the ridge33. Each of the surfaces may have a contoured or smooth non-penetrable outer shell for resisting penetration by fluids. A cover25may be placed over the fastener pockets32to protect the fasteners from the user and to prevent fluid from seeping into the pockets or contraband being placed in the fastener pocket32. Referring toFIGS.2and4, the intensive use bed20is shown in a bottom perspective view. The intensive use bed20has a bottom surface34forming the mounting surface for attaching the bed to a floor F (FIG.5). The bottom surface is formed comprising a plurality of openings36forming a honeycomb structure38to improve strength and reduce the weight of the bed20. A bottom plate39may be plastic welded or adhesively attached over the bottom surface34to cover the openings36to increase strength and to prevent contraband or fluid from residing in the openings, for example if the bed is not attached to the floor. The honeycomb structure38comprises a plurality of end support beams40extending between the end walls24. The honeycomb structure38further comprises the plurality of edge support beams42extending between the front walls26and the rear walls forming a plurality of chambers43(FIG.6) enclosed in the shell of the bed and open recesses36opening to the bottom surface34. As illustrated inFIGS.1to4, the outer walls24,26may have contoured ridges37formed in the surface to provide ridges for support of the walls and improve the aesthetic appearance of the bed. The fastener pockets32formed in the outer walls24,26are generally scalloped shaped. A fastener hole40is formed in the fastener pocket32to accommodate a fastener such as a bolt or the like being inserted into the mounting location and attached to the floor under the bed. The fastener pockets32of the bed also accept tie down buckles45for use in psychiatric applications. Referring toFIGS.3and4, the bed20illustrated as a second embodiment has a pair of storage openings28opening into the front surface29. The storage surface29has a gently sloped storage cavity floor27to prevent fluid collection and ease spray cleaning and drying. Referring toFIGS.5and8, the fastener pocket32is shown having a contoured surface45extending to a bolt hole40formed from through the mounting surface, shown as mounting flange46. The mounting flange46is formed in each of the fastener pockets32having a top side39in the fastener pocket32adjacent the contoured surface and a bottom side41on the bottom surface34. The fastener hole40extends from the top side39to the bottom side41and is adapted to receive a fastener such as a bolt extending through the mounting flange for attachment to a structure such as the floor F. A metallic or plastic insert50may be inserted in fastener hole44to provide additional support for the mounting flange46to prevent crushing the flange when the bolt is tightened. As illustrated inFIG.5, contoured cover49aand inFIG.8, flat cover49bare used to hide the bolt to prevent tampering. The cover49a,49bis attached by plastic welding or adhesive51, forming a slightly recessed surface with respect to the walls24,26. Referring toFIGS.6and7the contoured cover49ahas a shape for being received in fastener pocket32as shown inFIG.5. Referring toFIGS.9and10, the contoured cover49bhas a generally planar shape having a contoured outer edge to fit into and cover the fastener pocket32as illustrated inFIG.8. Continuing to refer toFIGS.5and8, foam52is injected into the generally hollow chambers of the honeycomb structure of the bed20. A caulk channel or groove54is shown intermediate the outer edge56of the bottom surface34and the fastener hole40. The caulk channel54extends around the entire perimeter of the lower surface. The caulk channel54is preferably semicircular in cross sectional shape and preferably has a radius of between 0.07 inches and 0.25 inches. Referring toFIGS.11-14, an alternate embodiment of an intensive use furniture component is illustrated as an intensive use nightstand60. The intensive use nightstand60has a top surface62, a pair of side surfaces64and a front surface68. Front surface68is shown having two openings70for holding items such as books. Or clothes. Nightstand60has rounded corners72and a smooth outer surface on the top62and sides64. The nightstand60may have a mounting surface on the base78and/or the back surface79. The nightstand is shown having a plurality of fastener holes76formed in the base78. Referring toFIG.13, a section view of the nightstand60is illustrated showing two openings70and a generally horizontal lower surface80and fastener holes76extending from the lower opening70through the base78. An insert may be molded into fastener holes76to prevent crushing the base78when fasteners are tightened. Referring toFIG.14, a caulk channel77is illustrated on lower surface81of base78and the back surface79. Caulk channel77extends around the entire perimeter of base78and spaced from the outer edge of the base78, to sealingly attach the nightstand to the floor in conjunction with fasteners (not shown) extending through fastener holes76. The caulk channel77is preferably formed intermediate the fastener holes76and the outside perimeter of the base78. Alternately, the nightstand may be adapted having a mounting surface on the back surface79for attachment to a wall W. Referring toFIG.14, a detailed view taken from view14ofFIG.6is illustrated showing a caulk channel82on the vertical rear surface79. The caulk channel82extends around the entire perimeter of the vertical rear surface79for sealingly attaching the nightstand62adjacent wall W. The nightstand60has gently sloped storage cavities73to prevent fluid collection and ease spray cleaning and drying. Referring toFIGS.15and16, a third embodiment of an intensive use furniture component is illustrated as a wall shelf90. Wall shelf90is illustrated as a three-shelf92wall shelf, however additional configurations may also be manufactured having more or fewer shelves92. The wall shelf90as a top94, a bottom96and two sides98. Each shelf92extends between the two sides98and is defined by the opening between adjacent shelves. The wall shelf90is preferably formed by rotational molding forming a hollow outer core97that is filled with structural foam100. A mounting flange99is formed around the perimeter of the wall shelf90having a plurality of spaced fastener holes95for accepting threaded fasteners to attach wall shelf90to a wall. Referring toFIG.16, a section view of the wall shelf ofFIG.8is illustrated having shelves92defining openings106. The wall shelf90ofFIGS.15and16is generally mounted vertically having a longer vertical length and shorter horizontal width. Top94and bottom96are formed having non-horizontal surfaces to prevent items from being placed on top of the wall shelf90or to resist climbing thereon by the users. A flat rear surface108forms a mounting surface adapted to mount against a wall W by fasteners extending through the fastener holes94. The shelves92are gently sloped and form storage cavities to prevent fluid collection and ease spray cleaning and drying. A caulk channel110is formed on the mounting flange99for accepting a bead of caulk (not shown) to sealingly attach the wall shelf to the wall W and eliminate any gaps between the wall shelf and the wall. Referring toFIGS.17-19an additional embodiment of an intensive use furniture component is shown as a desk120. The desk120has an upper surface122having rounded corners and a pair of support legs124and a rear support panel126. The support legs have a mounting surface121on the bottom for attaching to the floor F, the mounting surface having a perimeter surrounding bolt holes125. A plurality of fastener openings128are shown formed in the lower portion of the support legs124having the bolt holes extending through the mounting surface to the floor with the head of the bolt adapted to be recessed in the fastener opening128. As illustrated inFIGS.18and19, the desk120may be rotationally molded forming a hollow shell having a core130which may be filled with foam132such as polyurethane. The upper surface122comprises a separately manufactured hard writing surface constructed from one of a high pressure laminate, thermo laminate, wood, plastic sheet or other planar material which may be separately manufactured and attached to the support legs124. It is anticipated the support legs may further comprise a caulk groove on the top mounting surface123attached to the upper surface122to provide a contraband barrier between the legs and the writing surface. The writing surface may also be integrally molded with the legs124. Referring toFIGS.17and18, the fastener openings128are generally scallop shaped openings in the support legs124. The fastener openings128provide a recessed mounting for fasteners extending through fastener hole134. Referring toFIG.12, the support legs124are preferably formed by a molding process to create a hollow shell130which may be filled with the structural foam132. A caulk channel138is formed on the lower surface140on each support leg on24. The caulk channel extends around the perimeter of the floor surface140of the support leg. The caulk channel is adapted to receive the bead of caulk for sealing and attaching the desk120to the floor. As discussed with respect to the bed20above, the fastener openings may be closed with covers to conceal the bolts B (FIG.6). Referring toFIGS.20-24, an alternative embodiment of an intensive use furniture component is shown as a footstool150. The footstool150has a mounting flange152surrounding a foot support154having a top surface156. Footstool150is secured to a floor surface158by fasteners159extending through each of a plurality of fastener holes156formed in the base. A foam fill hole157is formed in the bottom155to provide access for blowing in or inserting foam in the footstool hollow shell. As illustrated inFIG.20, the footstool150has a bottom158and a hollow interior cavity160. The footstool150may be formed by rotational molding or similar process to form a substantially hollow shell164that may be filled with foam166(FIG.15) for support and sound deadening. A central cavity162extending from the bottom158reduces the amount of material used for forming the footstool150. Bottom158may also comprise a plurality of support ridges172adding structural integrity to the mounting flange on52. The support ridges172extend from the central cavity162to a position adjacent caulk channel174. Fastener holes156are formed in a circumferential position with respect to the bottom158. Caulk channel174is formed in the bottom158intermediate the fastener holes158and the outer perimeter176. Referring toFIGS.23and24, foam166is used to support the hollow shell164. The caulk channel174is disposed on the bottom158adjacent the outer perimeter176for receiving a bead of caulk178for sealingly attaching the footstool152to a floor surface F. The support ridges172are molded into the bottom158to provide structural support for the base. Referring toFIGS.25to34, an alternate embodiment of an intensive use furniture component is illustrated as a wardrobe190comprising cabinet191having a top192, sides194, a base196, a back panel197and an optional, at least one door198attached to the cabinet191. The wardrobe190is adapted for mounting to a floor surface or an adjacent wall surface of both. The wardrobe190has a plurality of fastener openings200formed on the top192for receiving fasteners to attach to an adjacent wall W. An integrally molded sloped top surface193is used to prevent storage and concealment of contraband and further resist climbing. The sloped surfaced could be a separate piece and attached during manufacturing or installation by fasteners or adhesive as is well known n the art of fastening plastic components together. The hinged door illustrated inFIG.25, preferably uses a piano style hinge202to create the strongest and most secure attachment to the wardrobe190as illustrated inFIGS.25,26and28-33. The door may also be reversible as a left or right hinge depending on the installation requirements. A tambour door option may also be considered unique in the field. The door can be molded the same as the other components in the product line or may be different such as HPL (high pressure laminate) laminate, thermoformed laminate, MDF or wood. The door is positioned to allow for complete 270 degree opening around the piano hinge as necessary to prevent overstressing the hinges as shown inFIG.34. Metal inserts204(FIGS.25,26and28) are used throughout the product to attach the hinges to increase attachment strength and security. A locking means206may be included through integrated or separate latch features. Referring toFIGS.26and28, the clothes hanging feature210is molded as an integral J-bar212feature to prevent a traditional bar being used as a ligature support. The geometry of the J-bar212is preferred to be integrated into the part, but may be a separate piece fastened into the cabinet191. A removable piece could be used as a weapon in these intended environments. The cabinet191has recessed pockets214at the upper portion having internal j-bar212on the lower front surface for securely supporting the hook of a standard clothes hanger. The upper portion of the wardrobe190is filled to resist hiding contraband or other material above the j-bar212. A hanger recess216is formed between the j-bar212and the back218of the cabinet191to accommodate the hanger. Fastener holes220are formed in the back218and extend through the back panel197which is adapted to be a mounting surface for attachment to a wall W. Contraband barrier203is formed in back panel197as shown inFIG.33. Fasteners224are extending from inside the cabinet through the back panel to the wall W. Additional fasteners224are disposed in fastener pockets226on the top of the cabinet191as illustrated inFIG.34. As discussed above, covers may be used to conceal the fasteners and close the fastener pockets226. A lower shelf230is formed in the cabinet191forming a storage opening228between the shelf230and the base196. Referring toFIGS.35-40an intensive use table240is illustrated. The table240has a base242a-dhaving a vertical wall243having an outer surface244, a floor end246and a table top end248. The tabletop end248comprises a mounting surface for attachment to a tabletop250(FIG.20). The mounting surface may have a caulk groove251formed therein for acting as a contraband barrier252. The table base242a-dmay have a contoured outer surface defined by ridges260for additional support. The ridges may be linear, parallel, curved or otherwise formed to provide structural support for the As illustrated inFIGS.37and38, the top of the base has a hollow cavity262that may be filed with sand during installation. The tabletop250is attached by fasteners extending through the base242at bolt holes263and attaching to the underside264of the top250. The top may be formed as the writing surface of the desk120described above. Referring toFIGS.49and50, an alternate embodiment of an intensive use furniture component is shown as a book shelf270. Referring toFIG.49, the bookshelf272has a base273adapted to support a pair of vertical ends272and a support leg274. Bookshelf270may be formed with more or fewer legs274depending on its intended use and the size of the shelf276. Ends272and support leg274are formed with rounded corners278to prevent supporting clothes being hung thereon, a ligature or the like. The shelf276is formed with a gently sloping surface angle to allow liquids to run off and facilitate cleaning. Bolt holes280are formed in the base273to attach the book shelf to the wall W. A caulk bead is formed on the base at the back opposite the shelf276as a contraband barrier sealing between the wall W and the base. Referring toFIG.50, the bookshelf290has upper support legs292supporting shelf276on base273. Fastener pockets294are formed at the junction of the shelf276and base273. Bolt holes280are formed through the base and disposed in the fastener pockets294. The fastener pockets294are adjacent the outer edge of the base273facilitating closure of the fastener pocket with a cover as described above regarding the intensive use bed20. Referring generally toFIGS.1to17, the intensive use furniture products are preferably rotationally molded in flame retardant, plastic resin with a hollow interior. In the preferred embodiment, the plastic resin may be High Density Polyethylene (HDPE) or Linear Low Density Polyethylene (LLDPE). The resin may contain additives such as flame-retardants to meet government standards. As a means to increase product strength and durability, a secondary material is used to fill the hollow cavities left during the molding process. Molding plastic could be done by rotational, blow, injection, thermo forming or compression molding where one or more pieces may be used to create the hollow cavity. The secondary material filling the cavities of the molded products may be structural polyurethane foam selected for increased durability and sound absorption. The filler may be injected under pressure and may consist of urethane foam or other material that can conform to the irregular cavities created during the molding process. The filled, rotationally molded products are significantly more impact-resistant, with much greater load-bearing capacity, than the fiberglass predecessors. Because the products are produced from molds, the production capacity increases allow more efficient manufacturing and a product that is less expensive to ship and install. A fire retardant additive is added to the linear low-density polyethylene and molded into the intensive use furniture products to meetfire rating standards such as the State of California, Technical Bulletin No. 133, Flammability Test Procedure for Seating Furniture for Use in High-Risk and Public Environments. In the molding process, nylon may be added to the plastic mix for molding the forming the substantially hollow shell to reduce de-lamination between the polyethylene walls and polyurethane foam filler. Due to the intensive-use nature of the products, the individual components preferably include a means of securely fastening the product to a floor, wall or other desired mounting surface. In the preferred embodiment, the components are typically bolted to a structurally sound mounting surface such as a floor (bed, nightstand, stool) or a wall (Wardrobe, wall shelf, wall storage units) through molded-in bolt hole locations. Additionally each mounting position may be reinforced with metal inserts disposed in the bolt holes by insertion during the molding process or during finishing operations, to prevent crushing of the plastic surrounding the bolt holes or on a mounting flange. To facilitate a tighter fit to the floor and eliminate gaps, each product features a semicircular shaped, hidden caulk channel on the underside of the unit, along the outer edge and preferably around the entire mounting surface forming a closed circuit of caulk adjacent the perimeter of the mounting surface. The caulk channel has a diameter profile to accommodate a standard bead of sealant such as caulk to seal any seams between the intensive use furniture and the mounting surface, the size of which may vary with the particular components. This allows the end-user to seal the floor and back edges of wall or floor mounted products to prevent concealment of contraband, prevent fluids from penetrating the surface mounting areas and facilitate cleaning of the component and surrounding areas. The present invention has been shown and described with reference to the foregoing exemplary embodiments. It is to be understood, however, that other forms, details, and embodiments may be made without departing from the spirit and scope of the invention which is defined in the following claims. | 20,794 |
11857477 | DETAILED DESCRIPTION The subject matter of the present invention is described with specificity herein to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventors have contemplated that the claimed subject matter might also be embodied in other ways, to include different steps or combinations of steps similar to the ones described in this document, in conjunction with other present or future technologies. Moreover, although the terms “step” and/or “block” may be used herein to connote different elements of methods employed, the terms should not be interpreted as implying any particular order among or between various steps herein disclosed unless and except when the order of individual steps is explicitly described. As one skilled in the art will appreciate, embodiments of our invention may be embodied as, among other things: a method, system, or set of instructions embodied on one or more computer readable media, which is described herein. Accordingly, the embodiments may take the form of a hardware embodiment, a software embodiment, or an embodiment combining software and hardware. In one embodiment, the invention takes the form of a computer-program product that includes computer-usable instructions embodied on one or more computer readable media. At a high level, this disclosure describes, among other things, improved methods and systems for reducing pressure injury, such as pressure ulcers, in a human patient, which may include improvements in technologies to detect that current conditions of a human patient are likely to result in such injury and initiating an intervening action so that such injury can be averted. Examples of various stages of pressure ulcer injuries are depicted inFIG.11. In particular, an improved sensor, monitoring and decision support technology is provided for patients who may be prone to such pressure injury, including technologies for preventive and rehabilitation medicine and physical therapy pertaining to skin and soft tissue integrity and the avoidance and healing of pressure injury. In some aspects, the physical activity of a patient, whose weight is supported by a support surface, may be measured in order to automatically ascertain whether the activity, or patterns of the activity, exhibit sufficient frequency and variability such as confer certain health benefits or certain health risks, such as development of pressure ulcers in the load-bearing skin and soft tissues. Where the activity or the patterns do manifest such features associated with benefits or risks, then some embodiments described herein may adaptively provide notification to the patient or caregiver. For example, a reminder or other notification may be generated, which comprises one or more notifications emitted at irregular within-day intervals, and which are likely to establish, restore, or sustain healthy patterns of movement and pressure-relief from the load-bearing tissues in contact with the support surface. Accordingly, measurements of pressure associated with mechanical loading of a support surface by suprajacent body parts of a person may be used to determine patterns of load-bearing and moment-to-moment adjustments of position. In some embodiments, measurements may be determined using a specialized sensor apparatus associated with a support surface, such as described in connection with measurement device141ofFIG.1AandFIGS.3A-3C. The measurements may be received continuously, periodically, at intervals, or as needed. In an embodiment, a time series of these measurements are determined and used to determine frequency power spectra for a set of time-periods. In some embodiments, the set of time-periods may comprise consecutive or substantially consecutive time intervals. For instance, in one embodiment, the consecutive time-periods are approximately between 15 and 30 minutes. Other time intervals are also contemplated; such time intervals may be sufficiently long so that, if movements are inadequate to relieve focal pressure within tissues supporting the load exceeding the closing pressure for small blood vessels within the tissues, ischemia and/or ischemia-reperfusion injury are likely to develop. Chronic, frequently repeated or unremitting episodes of such ischemic exposures are causally related to injury and non-healing of the load-bearing tissue structure. For a first time-period in the set, such as the current time-period or the most recent time-period, a multi-taper filtered power spectral density is determined over a select frequency band. In some embodiments, the power spectrum for these frequencies then may be normalized. In an embodiment, the frequency band is between 0.001 Hz and 0.03 Hz, and in an embodiment, spectrum frequency values below 0.001 Hz and above 0.10 Hz are discarded. In an embodiment, where normalization is performed, the calculated power spectrum at the remaining frequencies of the selected band may be normalized to the power spectral density at 0.001 Hz, such as by setting the value at 0.001 Hz to be equal to 1.0. The resulting pressure power spectrum for the first time-period may transformed as a log-log matrix. For instance, in an embodiment it may be transformed with spectral density in dB for each value of log 10(frequency). A segmented linear regression of this log-transformed power spectra then may be computed and an optimal cut-point may be determined separating the line-segments. In an embodiment, linear regression is calculated for two piecewise line-segments, and may be in a frequency band between 0.001 Hz and 0.1 Hz. For example,FIGS.5A-5C(corresponding to normal movement) andFIGS.5D-5F(corresponding to movement likely to cause or worsen pressure injury) depict instances of two piecewise line-segments with an optimal cut-point (e.g., segments503and507, and cut-point505shown inFIG.5A). In an embodiment, least-squares or a similar method is utilized, and in an embodiment, the R-system package “segmented” may be used to facilitate this calculation and determination. The first-order (slope) coefficient for the segments' linear regressions are then compared to characteristic white-, pink-, brown-, and black-noise α values for 1/fαpower roll-off. In an embodiment, α ∈(−0.6,+0.41, α ∈(+0.4,+1.41, α ∈(+1.4,+2.01, and α>+2.0, respectively), such as shown inFIG.4. Based on this comparison, it may be inferred that the time-period has conditions for forming pressure-ulcers. In particular, in one embodiment, if the slope coefficient in the frequency band between 0.003 Hz and 0.10 Hz matches a 1/fαpower roll-off of α ∈(−0.6,+0.41, then it is determined that the condition for the time period associated with this power spectrum is pressure ulcer-prone. Accordingly, such embodiments function as a sensor (e.g., a smart sensor) by more accurately detecting, using the algorithm described above and including the comparison, those dangerous conditions which may promote ulcer formation (or impede healing). Similarly, these embodiments more accurately detect healthy conditions unlikely to promote ulcer formation. Next, according to some embodiments, the linear regression coefficients for previous (or prior) time-periods' determine pressure spectra are received. A duty-cycle may be determined of patterns whose frequency spectra are associated with pressure ulcer proneness. In particular, a duty-cycle of high-frequency pressure-ulcer-prone white-noise spectrum condition among the first (or current) time-period's regression values and the N−1 previous time-period's regression values. For example, the duty cycle may be determined as a daily cumulative percentage of time. In an embodiment, a duty-cycle of N periods (N−1 precious time periods and the current or a recent time period, N) is determined of high-frequency white noise spectrum (indicating pressure-ulcer-prone conditions) in a frequency band between 0.003 and 0.1 Hz. Where the duty cycle of the high-frequency pressure-ulcer-prone white-noise spectrum condition exceeds a threshold value, then it may be inferred that tissue breakdown occurs and pressure ulcers are likely to form. Similarly, if pressure ulcers are already present in the affected skin and soft tissue, the pressure ulcers are unlikely to heal. The threshold may be pre-determined, determined by a clinician, or determined based on a condition of the patient. For instance, a patient that is determined to be more prone to pressure injury (or a patient already having pressure injury) may have a lower threshold. Similarly a heavier patient may have a lower threshold than a lighter patient. In an embodiment, a threshold of duty-cycle of fifty percent is utilized. In one embodiment, a notification may be provided or another intervening action may be invoked. For instance, one intervening action comprises generating a notification that may be emitted or otherwise communicated to the patient or to a caregiver, such as a provider clinician responsible for the care of the patient. For example, an electronic advisory or warning message may be emitted to a human user, such as a caregiver, indicating an elevated risk of pressure injury to the user, to encourage the user to initiate more frequent movements of position with respect to the load-bearing support surface. In an embodiment, the action comprises generating and emitting or communicating the notification, which may be emitted/communicated via a bedside or patient-side alarm, user/clinician interface (such as interface142described inFIG.1A), or may be communicated to a smartphone or personal computing device of a caregiver, thereby alerting them of an impending deterioration of the patient's condition. In one embodiment, the notification comprises an event signal and includes the likelihood of future pressure injury to the user. In some embodiments, the intervening action comprises adaptively providing notification at irregular within-day intervals. In particular, the irregular intervals may be more likely—verses regularly or predictably provided alerts—to provoke a positive response to establish, restore, or sustain healthy patterns of movement and pressure-relief from the load-bearing tissues in contact with the support surface. Another action that may be initiated, based on the determined likelihood, comprises a recommendation for modifying a care plan or treatment procedure associated with the patient; for example, a recommendation may comprise one or more movements or activity to be performed by the patient or by a caregiver to the patient, increasing patient monitoring or level of care, operating on the patient, or administering another similarly effective therapeutic intervention. The recommendation may be provided in conjunction with a notification, and/or may be provided via a user/clinician interface, such as interface142, described in connection withFIG.1A. Yet another action that may be initiated, based on the determined likelihood, comprises automatically modifying computer code executed in a healthcare software program for treating the patient, thereby transforming the program at runtime. For example in one embodiment, the modification comprises modifying (or generating new) computer instructions to be executed at runtime in the program, the modification may correspond to a change in a care plan, treatment procedure, or therapeutic intervention to be administered to the patient due to the determined likelihood of pressure injury occurrence. In one instance, the modification comprises changing the executed computer instructions corresponding to monitoring the patient's condition, such as increasing the frequency of obtaining physiological measurements of the patient, or increasing sensitivity of monitoring physiological changes in a patient. Yet another action that may be initiated, based on the determined likelihood, comprises scheduling healthcare resources for the patient. For example in one embodiment, a physical therapy resource may be automatically reserved for the patient, healthcare staff may be notified and/or automatically scheduled, or transportation/support staff or resources for getting the patient to a healthcare facility may be called. In one embodiment, this action comprises modifying or updating a resource/scheduling electronic record in a resource/scheduling system, such as operated as part of a hospital or healthcare system. In one embodiment, the action comprises, upon a sufficient determined likelihood of a future pressure injury or event occurrence (wherein significance may be determined using a threshold, as described in method200ofFIG.2), initiating a computer instruction that modifies the scheduling healthcare resources, which may include computer instructions for automatically alerting, scheduling, and/or notifying staff, reserving rooms, transportation, or other equipment/space, and which may include changing the priority of the patient (when compared to other patients) for receiving these resources. As described previously, embodiments of this disclosure provide improved methods and systems for reducing pressure injury. A number of problems exist in the conventional approaches and technologies to monitoring and reducing such injuries. For example, measurement and analytics methods, such as thermal imaging or pressure heat-mapping devices, address only weekly or other longer timescale patterns, and do not address ultradian (short timescale) patterns' relationship to the likelihood of ischemia in skin and soft tissues, ischemia-reperfusion injury, necrosis, and development of pressure ulcers. These conventional measurement technologies are often only determined one time, such as a diagnostic method. It is not practical or effective to utilize these technologies in repeated or ongoing assessments of evolving risk or time-dependent load-bearing patterns and pressure exposures in the course of routine daily activities. Additionally, the underlying measurement apparatus for these technologies is expensive, and may further require expert configuration or setup, and therefore is not financially practical for routine or ongoing use in home or other ambulatory locations. Further, these apparatus are complex and not suitable for operation by individuals who have certain physical disabilities or by their caregivers. Further still, the conventional technologies lack adequate statistical sensitivity to detect conditions that give rise to pressure injury of skin and soft tissues and, therefore, suffer from excessively high false-negative determinations, giving false reassurance regarding individuals who do go on to develop pressure ulcers or fail to heal existing pressure ulcers. Moreover, many of these conventional technologies have inadequate statistical specificity to rule-out conditions that give rise to pressure injury of skin and soft tissues and to determine safe conditions that avoid injury and, therefore, suffer from excessively high false-positive determinations of pressure injury risk in individuals who are not in fact at-risk of such injury. These and other deficiencies and limitations are mitigated or overcome by the technologies described herein. Many of these embodiments are also not susceptible to biases, and are tolerant of modest amounts of missing or sensing-artifact contaminated values of model-variables information. Additionally, many embodiment of the present disclosure provide additional advantages of not requiring extensive configuration or intrusive questioning or detailed self-reporting of information from patients. Referring now to the drawings in general, and initially toFIG.1Ain particular, an aspect of an operating environment100is provided suitable for practicing an embodiment of the technologies described herein. We show certain items in block-diagram form more for being able to reference something consistent with the nature of a patent specification than to imply that a certain component is or is not part of a certain device. Similarly, although some items are depicted in the singular form, plural items are contemplated as well (e.g., what is shown as one data store might really be multiple data-stores distributed across multiple locations). But showing every variation of each item might obscure the invention. Thus for readability, we show and reference items in the singular (while fully contemplating, where applicable, the plural). As shown inFIG.1, a block diagram is provided showing aspects of an example computing system architecture suitable for implementing an embodiment of this disclosure and designated generally as example operating environment100. Example operating environment100provides an aspect of a computerized system for compiling and/or running aspects of this disclosure including monitoring, detecting or determining, and/or predicting a likely future occurrence (or event) of a pressure injury or conditions prone to induce such injury, and additional decision support technology to facilitate caring for patients who may be prone to experience these injuries. Operating environment100is one example of a suitable environment and system architecture for implementing an embodiment of the disclosure. Other arrangements and elements can be used in addition to or instead of those shown, and some elements may be omitted altogether for the sake of clarity. Further, as with operating environment100, many of the elements described herein are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, and in any suitable combination and location. As described above, some embodiments may be implemented as a system, comprising one or more computers and associated network and equipment, upon which a method or computer software application is executed. Accordingly, aspects of the present disclosure may take the form of an embodiment combining software and hardware aspects that may all generally be referred to herein as a “module” or “system.” Further, the methods of the present disclosure may take the form of a computer application embodied in computer readable media having machine-readable application software embodied thereon. In this regard, a machine-readable storage media may be any tangible medium that can contain, or store a software application for use by the computing apparatus. Computer application software for carrying out operations for system components or steps of the methods of the present disclosure may be authored in any combination of one or more programming languages, including an object-oriented programming language such as Java, Python, R, or C++ or the like. Alternatively, the application software may be authored in any or a combination of traditional non-object-oriented languages such as C or Fortran. The application may execute entirely on the user's computer (i.e., a computing device) as an independent software package, or partly on the user's computer in concert with other connected co-located computers or servers, or partly on the user's computer and partly on one or more remote computers, or entirely on a remote computer or collection of computers. In the latter cases, the remote computers may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, via the internet using an Internet Service Provider or ISP) or an arbitrary, geographically-distributed, federated system of computers, such as a cloud-based system. Moreover, the components of operating environment100, functions performed by these components, or services carried out by these components may be implemented at appropriate abstraction layer(s) such as the operating system layer, application layer, hardware layer, etc., of the computing system(s). Alternatively, or in addition, the functionality of these components and/or the embodiments described herein can be performed, at least in part, by one or more hardware logic components. For example, and without limitation, illustrative types of hardware logic components that can be used include Field-programmable Gate Arrays (FPGAs), Application-specific Integrated Circuits (ASICs), Application-specific Standard Products (ASSPs), System-on-a-chip systems (SOCs), Complex Programmable Logic Devices (CPLDs), etc. Additionally, although functionality is described herein with regards to specific components shown in example operating environment100, it is contemplated that in some embodiments functionality of these components can be shared or distributed across other components. Environment100includes one or more electronic health record (EHR) systems, such as EHR system(s)160communicatively coupled to network175, which is communicatively coupled to computer system120. In some embodiments, components of environment100that are shown as distinct components may be embodied as part of or within other components of environment100. For example, EHR system(s)160may comprise one or a plurality of EHR systems such as hospital EHR systems, health information exchange EHR systems, clinical genetics/genomics systems, ambulatory clinic EHR systems, psychiatry/neurology EHR systems, insurance, collections or claims records systems; and may be implemented in or as a part of computer system120. Similarly, EHR system(s)160may perform functions for two or more of types of EHR systems (not shown). EHR system(s)160also may include records of physiological variables (such as vital signs measurements) obtained via one or more measurement apparatus, tests, or screenings, such as measurement device141. In some embodiments of the technologies described herein, aspects of a decision support tool for patients having or at risk for developing a pressure injury condition or event occurrence or recurrence may utilize data about a population of patients derived from patient EHR or other records information. In particular, presently certain data warehouses are created for purposes of public health and observational research purposes and are derived from electronic health records repositories in such a way that they are de-identified so as to comply with applicable confidentiality laws and regulations. The Cerner Health Facts™ data warehouse is such a system that has been curated for more than 15 years. It comprises a large ‘transaction database’ where each entry corresponds to a patient's ‘basket’ (a collection of items recorded or transacted at points in time during episodes of care services provisioning in the contributing health care institutions). Each database entry is ordered by the date-time of the transaction. Transaction sequencing is implemented by grouping medical events occurring in the same ‘epoch’ for the same patient together into ‘baskets’ and ordering the ‘baskets’ of each patient by the date-time stamps where the events occurred. Epoch durations may differ according to the age of the patient, or the acute or chronic nature of the health conditions that pertain to the patient, or the rate of change of the severity of the health conditions, or other factors, Epoch durations may be as short as a few minutes (as in critical care ICU or operating room contexts) or may be as long as 10 years or more (as in chronic ambulatory care-sensitive conditions, ACSCs). Continuing withFIG.1A, network175may comprise the Internet, and/or one or more public networks, private networks, other communications networks such as a cellular network, or similar network(s) for facilitating communication among devices connected through the network. In some embodiments, network175may be determined based on factors such as the source and destination of the information communicated over network175, the path between the source and destination, or the nature of the information. For example, intra-organization or internal communication may use a private network or virtual private network (VPN). Moreover, in some embodiments items shown communicatively coupled to network175may be directly communicatively coupled to other items shown communicatively coupled to network175. In some embodiments, operating environment100may include a firewall (not shown) between a first component and network175. In such embodiments, the firewall may reside on a second component located between the first component and network175, such as on a server (not shown), or reside on another component within network175, or may reside on or as part of the first component. Embodiments of electronic health record (EHR) system(s)160include one or more data stores of health-related records, which may be stored on storage121, and may further include one or more computers or servers that facilitate the storing and retrieval of the health records. In some embodiments, EHR system(s)160and/or other records systems may be implemented as a cloud-based platform or may be distributed across multiple physical locations. EHR system(s)160may further include record systems, which store real-time or near real-time patient (or user) information, such as wearable sensor or monitor, support-surface, bedside, laboratory, or in-home patient monitors or sensors, for example, such as measurement device141. Example operating environment100further includes a user/clinician interface142and decision support application140, each communicatively coupled through network175to an EHR system160. Although environment100depicts an indirect communicative coupling between interface142and application140with EHR system160through network175, it is contemplated that an embodiment of interface142or application140are communicatively coupled to EHR system(s)160directly. For example, in one embodiment a decision support application140operating at least in part on a client device (such as a user-operated computer device like a tablet) includes an interface142(which may comprise a graphical user interface), which may be used for accessing patient information from an EHR system(s)160. An embodiment of decision support application140comprises a software application or set of applications (which may include programs, routines, functions, or computer-performed services) residing on a client computing device (or distributed in the cloud and on a client computing device) such as a personal computer, laptop, smartphone, tablet, or mobile computing device. In an embodiment, the application is a Web-based application or applet, and may be used to provide or manage user services provided by an embodiment of the technologies described herein, which may be used by a caregiver or screener to provide, for example, information about the likelihood of a specific patient or population of patients to have or develop an acute inflammatory condition or event, which may occur at a future time, and may further include a degree or level characterizing the severity of the condition or event. In some embodiments, application140includes or is incorporated into a computerized decision support tool, as described herein. Further, some embodiments of application140utilize user/clinician interface142. In some embodiments, application140and/or interface142facilitates accessing and receiving information from a user or health care provider about a specific patient or set of patients, according to the embodiments presented herein. Embodiments of application140also may facilitate accessing and receiving information from a user or health care provider about a specific patient, caregiver, or population including historical data; health care resource data; physiological variables or other patient-related measurements, time series, and predictions (including plotting or displaying the determined outcome and/or issuing an alert) described herein; or other health-related information, and facilitates the display of results, recommendations, or orders, for example. In an embodiment, application140also facilitates determining, receiving, or providing: notifications, recommendations, care plan changes, or orders, staffing scheduling, and/or queries from a user, which may be based on the results of monitoring and/or forecasted outputs, and which may in some embodiments utilize user interface142. Decision-Support application140may also be used for providing diagnostic services or evaluation of the performance of various embodiments. In some embodiments, user/clinician interface142may be used with application140, such as described above. One embodiment of user/clinician interface142comprises a user interface that may be used to facilitate access by a user (including a clinician/caregiver such as a medical caregiver, physical therapist, or the like) to a probability, likelihood, forecast, score or prediction determined according to the technologies described herein, including information indicating a likelihood that a patient is experiencing conditions likely to cause or exacerbate pressure injury or will experience such as condition or event, or other aspects described herein. One embodiment of interface142takes the form of a graphical user interface and application, which may be embodied as a software application (e.g., decision support application140) operating on one or more mobile computing devices, tablets, smartphones, front-end terminals in communication with back-end computing systems, laptops, or other computing devices. In an embodiment, the application includes the PowerChart® software manufactured by Cerner Corporation. In an embodiment, interface142includes a Web-based application (which may take the form of an applet or app) or set of applications usable to manage user services provided by an embodiment of the technologies described herein. In some embodiments, interface142may facilitate providing the output of the determined measurements, forecast(s), probabilities (or score), recommendations, scheduling orders, providing instructions (such as measuring, recording, and/or otherwise obtaining vital signs or other physiological variable measurements), confirmations or notifications (which may include, for example, confirmation that information has been received or notifications that information has not been received and there may be an error in the measuring instrument, user operation of a measurement device, or measurement procedure), reminders (such as notifications to obtain a physiological measurement sample), or outputs of other actions described herein, as well as logging and/or receiving other feedback from the user/caregiver, in some embodiments. In an embodiment, interface142also facilitates receiving orders for the patient from the clinician/user, based on the results of monitoring and predictions. Interface142also may be used for facilitating diagnostic services or evaluation of the performance of various embodiments. Example operating environment100includes measurement device141communicatively coupled through network175to an EHR system160. In an embodiment, measurement device141(sometimes referred to herein as a patient-interface component) comprises one or more sensor components operable to acquire clinical or physiological information about a patient, such as various types of physiological measurements, physiological variables, or similar clinical information associated with a particular physical (or mental state) of the patient, and which may be acquired periodically, continuously, as needed, or as they become available, and may be represented as one or more time series of measured variables. In one embodiment, measurement device141comprises one or more sensors configured for obtaining (and in some instances pre-processing or interpreting) pressure-related measurements due to force applied by a patient, which may be static or dynamic as a patient moves. In particular, in some embodiments, measurement device141includes a support surface having one or more sensors (which may further comprise or be coupled to a computer system to facilitate storing, pre-processing, processing, transforming the measurements). The pressure-related information may be obtained continuously, periodically, or at irregular intervals. Accordingly, the term measurement is used broadly herein, and it is contemplated that in some embodiments, measurement device141may not perform measurement but may receive information about the measured physiological or patient-related parameters (such as pressure caused by the patient being supported on a support surface, and/or other measurements as heart rate (HR), blood pressure (e.g., systolic blood pressure or SBP), respiratory rate (RR), or non-vital variables, for example and without limitation) which may be measured, observed, or otherwise recorded. Some embodiments of measurement device141may comprise one or more sensors, an interface component, and/or processing/communications component (not shown), such as wired or wireless telecommunications technologies described herein for communicably coupling sensors with the processors or memory described herein. Aspects of one example embodiment of a measurement device141are depicted inFIGS.3A-3G. With reference toFIG.3A, aspects of an example measurement device141are depicted and comprise a multi-layer support surface300, which in one example may comprise an outer seat-cushion surface310. In other embodiments, support surface300may comprise a mattress-cushion, pad, or other similar support surface for an individual, such as example support surface302, ofFIG.3C, which is embodied as a mattress. Continuing withFIG.3A, example support surface300further comprises a cushion layer340(which may comprise a neoprene foam rubber substrate, similar foam rubber, gel, or a similar compressible but supportive material), cover350, and air bladder layer320. Air bladder layer320may extend over the entire cross-section of support surface300(as shown) or may cover only a portion of the surface, such as the example air bladder321aand321b, depicted in support surface301ofFIG.3B. In some embodiments, air bladder320may comprise one or more air bladders. Air bladder320is coupled to a pressure sensor(s) component330. In an embodiment, pressure sensor(s) component comprises one or more sensors (not shown inFIG.3A), which may include a transducer (such as a force sensing resistor339, shown inFIG.3E), which measure pressure determined using air bladder320. In an embodiment, pressure sensor(s) component330comprises a digital pressure sensor, such as the DLV060A low-voltage digital pressure sensor, manufactured by All Sensors Inc.® of Morgan Hill, California.FIG.3Ddepicts an example aspect of an embodiment of pressure sensor(s) component330(shown as item335) with the DLV060A pressure sensor chip (item337aofFIG.3D). In an embodiment, the sensor(s) or component330may comprise an ultrasonic-based sensor. Furthermore, some embodiments of the measurement device141may comprise ambient condition sensors (not shown) for providing processors described herein with information regarding ambient conditions proximate to the air bladder320and the processors. Using instructions from computer memory associated therewith, the processors may modify the pressure measurements from the pressure sensor component330as a function of the information from the ambient condition sensors regarding the ambient conditions of temperature and/or atmospheric pressure so as to compensate for artifacts due to changes in at least one of the ambient temperature and the ambient pressure. In some embodiments, air bladder320may include a pump335and a release value333. Additional aspects of example support surfaces are depicted inFIGS.3B-3G. In particular,FIG.3Bincludes an outer seat-cushion surface311, a cushion layer341, cover351, an air bladder layer321aand321bcoupled to pressure sensor(s) component330, and may also include pressure pump335a, pressure release value333a.FIG.3Cincludes an outer mattress or pad surface312, a cushion layer342, cover352, an air bladder layer322aand322bcoupled to pressure sensor(s) component330, and may also include pressure pump335b, pressure release value333b.FIGS.3F and3Gdepict additional aspects of example support surfaces. With continuing reference toFIG.1AandFIGS.3A-3G, in some embodiments, measurement device141comprises a medical-grade sphygmomanometer-type air-inflatable rubber bladder, such as example bladder320, which is rectangular and approximately 18 inches (45 cm) long and 6 inches (15 cm) wide, which may be fixedly or removably affixed to the upper surface of a closed-cell neoprene foam rubber substrate (e.g., cushion layer340) that is cut so as to have areal dimensions corresponding to the seat cushion. In one embodiment, the cushion layer340has a thickness approximately equal to 1 inch (2.54 cm) and having density of 9 lb/ft3, 25% compression strain at 7 psi, and elastomeric shore “OO” indentor rating equal to 50 durometer per ASTM D-3575 testing. In an embodiment, bladder320comprises an inflatable bladder and is affixed to and positioned on the cushion layer340to be vertically directly under where the user's ischial bones will be positioned when seated. In some embodiments, bladder320is equipped with a port that is connected to a length of gas-tight hollow elastomeric tubing325and an expansile, hand-squeezable rubber air bulb335and finger-operated gas valve333, such that by way of example and without limitation, a seated user is able to inflate and adjust the bladder to contain a small amount of air, which may be sufficient so that the two sides of the rubber bladder are not in contact with each other under normal conditions of sitting (or laying, in the case of a mattress) and movement upon the cushion assembly (bladder does not “bottom out” as the user moves or leans when sitting). In some embodiments, bladder320is furthermore connected to non-distensible tubing whose distal end is connected to the pressure sensor(s) component330for the purpose of measuring air pressure within the inflated bladder320assembly when the user is seated upon (or lying on) the cushion assembly. In some embodiments, the bladder-sensor-substrate portions of measurement device341(e.g., items320,330, and340ofFIG.3A) may be placed inside a suitable cover350, such as a fabric cover. In one example embodiment actually reduced to practice, cover350comprises a ballistic nylon sleeve of the same sort that was provided by the manufacturer of the wheelchair seat cushion. The upper fabric surface of the bladder-sensor-substrate module cover was equipped with hook-and-loop fastener patches, in opposing locations to match and mate with corresponding hook-and-loop fastener patches affixed to the underside of the wheelchair seat cushion cover. This enables the bladder-sensor-substrate portions to be accurately and repeatably fastened to a wheelchair seat cushion in such a manner as to insure that the user's anatomy is consistently positioned directly over the bladder-sensor-substrate module when seated. Other removable fastening devices for removably securing portions of the measurement device341may be used without departing from the scope of the invention described herein. Likewise, permanent methods of fixing some portions of the measurement device341together may be utilized without departing from the scope of the invention described herein. In some embodiments, measurement device141includes or operates in conjunction with a wheelchair seat cushion. In operation, the user sits upon measurement device141, inflates and adjusts the pressure in the bladder320. Thereafter, pressure sensor(s) component330then may commence acquisition of pressure data. In an example embodiment, the pressure data may be sampled at 20 Hz and used to create a pressure measurements time series. In an embodiment, the pressure measurements time series may be telemetered to a receiving computer120and may be stored in storage121for ongoing analysis and/or later analysis. In one example embodiment reduced to practice, the pressure data was transferred to a laptop computer's solid-state disk storage as an ASCII file, to which were appended ongoing updates. Successive 2,000-second measurement periods (40,000 samples long) were stored, and spectrum analysis was performed upon the pressure time series from each measurement period, as further described in connection to method200ofFIG.2. Continuing withFIG.1A, in some embodiments, measurement device141may include a Bluetooth or wireless communication data-transfer capability and may be wirelessly communicatively coupled with an application on a computing device, such as a smartphone an app or aspect of decision support application140. Embodiments of measurement device141may store user-derived data locally or communicate data over network175to be stored remotely. Some embodiments of measurement device141include a monitor interface, which may be embodied as I/O such as buttons and sounds emitted from the measurement device141, its firmware or software application or app operating on a user's mobile device or computer system120, and in an embodiment may facilitate uploading of measured (or recorded, or otherwise received) information from measurement device141to computer system120. Additionally, some embodiments of measurement device141include functionality for processing user-derived information locally or for communicating the information to computer system120, where it is processed. In some embodiments, the processing may be carried out or facilitated by one or more software agents, as described below. In some embodiments the processing functionality, performed on measurement device141and/or computer system120includes pre-processing and/or signal conditioning, such as removing noise or erroneous information. Example operating environment100further includes computer system120, which may take the form of one or more servers, and which is communicatively coupled through network175to EHR system160, and storage121. Computer system120comprises one or more processors operable to receive instructions and process them accordingly, and may be embodied as a single computing device or multiple computing devices communicatively coupled to each other. In one embodiment, processing actions performed by system120are distributed among multiple locations such as one or more local clients and one or more remote servers, and may be distributed across the other components of example operating environment100. For example, aspects of application140or interface142may operate on or utilize computer system120. Similarly, a portion of computing system120may be embodied on user interface142, application140, and/or EHR system(s)160. In one embodiment, system120comprises one or more computing devices, such as a server, desktop computer, laptop, or tablet, cloud-computing device or distributed computing architecture, a portable computing device such as a laptop, tablet, ultra-mobile P.C., or a mobile phone. Embodiments of computer system120include computer software stack125, which in some embodiments operates in the cloud, as a distributed system on a virtualization layer within computer system120, and includes operating system129. Operating system129may be implemented as a platform in the cloud, and which is capable of hosting a number of services such as122,124,126, and128. Some embodiments of operating system129comprise a distributed adaptive agent operating system. Embodiments of services122,124,126, and128run as local services or may be distributed across one or more components of operating environment100, in the cloud, on one or more personal computers or servers such as system120, and/or a computing device running interface142or application140. In some embodiments, interface142and/or application140operate in conjunction with software stack125. In embodiments, model variables indexing (or mapping) service122facilitate retrieving patient variables such as physiological or other measurements, which may include frequent item sets, extracting database records, and/or cleaning the values of variables in records. For example, service122may perform functions for synonymic discovery, indexing or mapping variables in records, or mapping disparate health systems' ontologies, such as determining that a particular medication frequency of a first record system is the same as another record system. Predictive models service124in general is responsible for providing models such as multi-variable models, for detecting or predicting a pressure-injury event or conditions prone to causing or exacerbating pressure injury. In some embodiments, services122and/or124may invoke computation services126. Computation services126may perform statistical software operations, and may include statistical calculation packages such as, in one embodiment, the R system (the R-project for Statistical Computing, which supports R-packages or modules tailored for specific statistical operations, and which is accessible through the Comprehensive R Archive Network (CRAN) at http://cran.r-project.org) or similar services. In an embodiment, computation services126and predictive models service124include the services or routines, which may be embodied as one or more software agents or routines such as the example embodiments of computer program routines illustratively provided inFIGS.7A-10. In one embodiment, computation services126comprises the R-System psd package for performing power spectral density estimation, and segmented package for determining cut-points (e.g., breakpoints) or segments in a regression model. Both of these example computation services are utilized on a time series of cushion pressure measurements in the example computer program routines ofFIGS.7A-B,8A-B, and9A-B. Computation services126also may include natural language processing services (not shown) such as Discern nCode′ developed by Cerner Corporation, or similar services. In an embodiment, computation services126include the services or routines, which may be embodied as one or more software agents or computer software routines such as the example embodiments of computer program routines illustratively provided inFIGS.7A-10. Computation services126also may include services or routines for utilizing one or more prediction or detection models or methods, such as described in connection toFIG.2and the example computer program routines illustratively provided inFIGS.7A-10. In some embodiments, computation services126use EHR system(s)160, model data and model storage services (not shown), and/or other components of example operating environment100, and may also include services to facilitate receiving and/or pre-processing physiological (or other patient-related) data. For instance, model data and model storage services may be utilized to perform services for facilitating storage, retrieval, and implementation of the forecasting models described herein and of the data used in the models or predictive services. In some embodiments, stack125includes file system or cloud-services128. Some embodiments of component128may comprise an Apache Hadoop and Hbase framework, or similar frameworks operable for providing a distributed file system, and which in some embodiments facilitate provide access to cloud-based services, such as those provided by Cerner Healthe Intent®. Additionally or alternatively, some embodiments of file system or cloud-services128or embodiments of stack125may comprise one or more stream processing service(s). For example, such stream processing service(s) may be embodied using IBM InfoSphere stream processing platform, Twitter Storm stream processing, Ptolemy or Kepler stream processing software, or similar complex event processing (CEP) platforms, frameworks, or services, which may include the user of multiple such stream processing services (in parallel, serially, or operating independently). Some embodiments of the invention also may be used in conjunction with Cerner Millennium®, Cerner CareAware® (including CareAware iBus®), Cerner CareCompass®, or similar products and services. Example operating environment100also includes storage121(or data store121), which in some embodiments includes patient data for a candidate or target patient (or information for multiple patients), including raw and processed patient data; variables associated with patient diagnoses or determinations, recommendations; recommendation knowledge base; recommendation rules; recommendations; recommendation update statistics; an operational data store, which stores events, frequent itemsets (such as “X often happens with Y”, for example), and item sets index information; association rulebases; agent libraries, solvers and solver libraries, and other similar information including data and computer-usable instructions; patient-derived data; and health care provider information, for example. It is contemplated that the term data includes any information that can be stored in a computer-storage device or system, such as user-derived data, computer usable instructions, software applications, or other information. In some embodiments, data store121comprises the data store(s) associated with EHR system160. Further, although depicted as a single storage data store, data store121may comprise one or more data stores, or may be in the cloud. Turning briefly toFIG.1B, there is shown one example embodiment of computing system900representative of a system architecture that is suitable for computer systems such as computer system120. Computing device900includes a bus910that directly or indirectly couples the following devices: memory912, one or more processors914, one or more presentation components916, input/output (I/O) ports918, input/output components920, radio924, and an illustrative power supply922. Bus910represents what may be one or more busses (such as an address bus, data bus, or combination thereof). Although the various blocks ofFIG.1Bare shown with lines for the sake of clarity, in reality, delineating various components is not so clear, and metaphorically, the lines would more accurately be grey and fuzzy. For example, one may consider a presentation component, such as a display device, to be an I/O component. Also, processors have memory. As such, the diagram ofFIG.1Bis merely illustrative of an example computing system architectures that can be used in connection with one or more embodiments of the present disclosure. Distinction is not made between such categories as “workstation,” “server,” “laptop,” “hand-held device,” etc., as all are contemplated within the scope ofFIG.1Band reference to “computing system.” Computing system900typically includes a variety of computer-readable media. Computer-readable media can be any available media that can be accessed by computing system900and includes both volatile and nonvolatile media, and removable and non-removable media. By way of example, and not limitation, computer-readable media may comprise computer storage media and communication media. Computer storage media includes both volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by computing system900. Computer storage media does not comprise signals per se. Communication media typically embodies computer-readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media. The term “modulated data signal” means a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal. By way of example, and not limitation, communication media includes wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, RF, infrared and other wireless media. Combinations of any of the above may be included within the scope of computer-readable media. Memory912includes computer-storage media in the form of volatile and/or nonvolatile memory. The memory may be removable, non-removable, or a combination thereof. Exemplary hardware devices include solid-state memory, hard drives, optical-disc drives, etc. Computing system900includes one or more processors that read data from various entities such as memory912or I/O components920. In an embodiment, storage121is embodied as memory912. Presentation component(s)916present data indications to a user or other device. Exemplary presentation components include a display device, speaker, printing component, vibrating component, etc. In an embodiment, functionality provided via user/clinician interface142is facilitated by one or more presentation components916. In some embodiments, computing system924comprises radio(s)924that facilitates communication with a wireless-telecommunications network. Illustrative wireless telecommunications technologies include CDMA, GPRS, TDMA, GSM, LTE, WiMAX, and the like. Radio924may additionally or alternatively facilitate other types of wireless communications including Wi-Fi, Bluetooth, NFC, other types of RF communication, light, infrared, or the like. As can be appreciated, in various embodiments, radio924can be configured to support multiple technologies and/or multiple radios can be utilized to support multiple technologies. I/O ports918allow computing system900to be logically coupled to other devices, including I/O components920, some of which may be built in. Illustrative components include a microphone, joystick, game pad, satellite dish, scanner, printer, wireless device, etc. The I/O components920may provide a natural user interface (NUI) that processes air gestures, voice, or other physiological inputs generated by a user. In some instances, inputs may be transmitted to an appropriate network element for further processing. An NUI may implement any combination of speech recognition, stylus recognition, facial recognition, biometric recognition, gesture recognition both on screen and adjacent to the screen, air gestures, head and eye tracking, and touch recognition (as described in more detail below) associated with a display of the computing system900. The computing system900may be equipped with depth cameras, such as stereoscopic camera systems, infrared camera systems, RGB camera systems, touchscreen technology, and combinations of these, for gesture detection and recognition. Additionally, the computing system900may be equipped with accelerometers or gyroscopes that enable detection of motion. The architecture depicted inFIG.1Bis provided as one example of any number of suitable computer architectures, such as computing architectures that support local, distributed, or cloud-based software platforms, and are suitable for supporting computer system120. Returning toFIG.1A, in some embodiments, computer system120is a computing system made up of one or more computing devices. In some embodiments, computer system120includes one or more software agents, and in an embodiment includes an adaptive multi-agent operating system, but it will be appreciated that computer system120may also take the form of an adaptive single agent system or a non-agent system. Computer system120may be a distributed computing system, a data processing system, a centralized computing system, a single computer such as a desktop or laptop computer or a networked computing system. Turning now toFIG.2, one example embodiment of a method200for conditionally generating a notification regarding a patient's risk for pressure injury. In particular, method200may be employed to automatically ascertain whether the patterns of movements of a human patient, whose weight is supported on a support surface, exhibit sufficient frequency and variability of activity such as will confer either certain health benefits or expose the individual to certain health risks, such as development of pressure ulcers in the load-bearing skin and soft tissues. Accordingly, embodiments of method200utilize an embodiment of a pressure measurement device such as measurement device141described in connection toFIG.1Aand the aspects of measurement devices141depicted inFIGS.3A-3G. Example method200begins at step202, wherein support surface pressure time series data are acquired. Embodiments of step202utilize a pressure measurement device, such as measurement device141described previously, to obtain a series of pressure measurements for a human target, such as a patient sitting on an embodiment of measurement device141embodied as a wheelchair cushion. Thus, measurements of pressure associated with mechanical loading of a support surface by suprajacent body parts of a person may be used to determine patterns of load-bearing and moment-to-moment adjustments of position. The measurements may be received continuously, periodically, at intervals, or as needed. In an embodiment, measurements are obtained at a frequency of 20 Hz. In an embodiment, the sampling measurement rate is at least 10 times the Nyquist frequency of the highest-frequency of the spectral band of interest with regard to pressure ulcer development, such as further described herein. Some embodiments of step202may further include associating a particular patient with the measurement device141, and/or binding information about the patient or patient's EHR and initializing a data.frame (e.g., attirbutes and current date) for acquiring the pressure data. At step205, retrieve time series of pressure data for the patient and over a set of previous time intervals or time periods. In some embodiments, the set of time-periods may comprise consecutive or substantially consecutive time intervals. For instance, in one embodiment, the consecutive time-periods are approximately between 15 and 30 minutes. Other time intervals are also contemplated; such time intervals may be sufficiently long so that, if movements are inadequate to relieve focal pressure within tissues supporting the load exceeding the closing pressure for small blood vessels within the tissues, ischemia and/or ischemia-reperfusion injury are likely to develop. Chronic, frequently repeated or unremitting episodes of such ischemic exposures are causally related to injury and non-healing of the load-bearing tissue structure. Embodiments of step205may retrieve the past time series data from an operational data store207, which may be embodied as storage121or the patient's EHR160. At step210, determine multi-taper frequency power spectrum on the time series information. In an embodiment, for a first time-period in the set of time periods, such as the current time-period or the most recent time-period, or upon acquiring time series information for a new time period, a multi-taper filtered power spectral density is determined over a select frequency band. As described herein, operational aspects of embodiments of this disclosure depend on a capability of distinguishing power-law properties of the frequency power spectrum at different frequency bands. Therefore the measurement system, such as measurement device141, that is utilized in method200(and in particular with step202), is able to acquire measurements that will enable the system to distinguish white-noise-like spectra associated with pressure-ulcer-proneness (e.g., in the upper band from approximately 0.003 Hz to 0.1 Hz) from black- or brown-noise-like spectra in the same band, which characterizes a pattern of movements that are actually protective against the formation or pressure injury. But quantization noise associated with analog-to-digital conversion (ADC) in data has its own frequency power spectrum. This quantization noise spectrum is determined by the ADC sampling frequency and the size of the smallest quantum or step between adjacent levels in the ADC's least-significant bit (LSB). Therefore, in order to avoid an error, the measurement circuitry of measurement device141(e.g., in an embodiment this circuitry may comprise or utilize the transducer339and pressure sensor337ashown inFIGS.3E and3D, respectively) may have an LSB size that is smaller than the meaningful variations in the signal that is to be measured. Likewise, measurement device141(or its measurement circuitry) should be operated at a sampling frequency that is higher than the minimum Nyquist rate (where fN, is the Nyquist frequency of data acquisition time series of sampled measurements). In some embodiments for addressing pressure-ulcer-related risk in a sitting position for tissues in contact with a support surface such as a wheelchair seat, an ADC with an LSB quantum size of 0.04 kPa (0.3 mmHg) or smaller is utilized on a sensor device having a full-scale dynamic range from 0 to 60 psia (approximately 3100 mmHg, 4.1 atm, or 413 kPa), which in turn entails a resolution or precision of at least 13 bits in the sensor and analog-to-digital converter circuitry across this range of pressures. For example, an embodiment actually reduced to practice utilizes a measurement device141with a DLV-060A pressure sensor by All Sensors Inc.® having a 14-bit ADC operating in the range 0-60 psia. The power spectrum of a quantizer output is equal to the power spectrum of the input signal, plus the power spectrum of the quantization noise. The quantization noise power spectrum is flat with respect to frequency and has a total power equal to q2/12 where q is the LSB quantum size in the units of measurement. In general, quantization noise power spectra of contemporary ADC circuitry exhibit approximately white-noise flat (1/f0) power-law behavior. In connection with the linear superposition of quantization-noise and input signal, it is desirable that the total power of the quantization noise be substantially smaller than the power of the input signal in the bands of interest, between about 0.001 Hz and 0.10 Hz. In an embodiment, the total power of the ADC quantization noise is less than 10% of the power of the input signal between about 0.001 Hz and 0.10 Hz. Accordingly, at step215frequencies of a select band are retained. For example, in an embodiment, the retained frequency band is between 0.001 Hz and 0.03 Hz, and spectrum frequency values below 0.001 Hz and above 0.10 Hz are discarded. At step220, the power spectrum for these frequencies then may be normalized. In embodiments where normalization is performed, the determined power spectrum at the remaining frequencies of the selected band may be normalized to the power spectral density at 0.001 Hz, such as by setting the value at 0.001 Hz to be equal to 1.0. In some embodiments, the resulting pressure power spectrum for the first time-period may transformed as a log-log matrix. For instance, in an embodiment it may be transformed with spectral density in dB for each value of log 10(frequency). At step225, determine frequency cut-point for two-segment frequency roll-off linear regressions. In embodiments of step225, for the current pressure power spectrum, a linear regression of two piecewise line-segments maybe calculated, in the retained frequency band (e.g., between 0.001 Hz and 0.1 Hz). In an embodiment of step225, a least-squares or similar method is utilized. An optimal cut-point is determined separating the slide-segments. In some embodiments of step225, the segmented package (computational services126) may be utilized to facilitate determining the cut-point, as described above and shown in connection toFIGS.7A-B,8A-B, and9A-B. Illustrative examples showing the output of step225and in particular, optimal cut-points and regression segments are depicted in in graphs501,520, and530ofFIGS.5A-5C(corresponding to normal movement, showing cut-points505and segments503and507forFIG.5A; showing cut-points525and segments523and527forFIG.5B; and showing cut-points535and segments533and537forFIG.5C) and graphs540,550, and560ofFIGS.5D-5F(corresponding to movement likely to cause or worsen pressure injury, showing cut-points545and segments543and547forFIG.5D; showing cut-points555and segments553and557forFIG.5E; and showing cut-points565and segments563and567forFIG.5F). The line-segment regression coefficients for the current power spectra may be stored in step240, with the regression determinations from previous power spectra, for use in subsequent steps of method200. At step230, determine the two-segment log-log frequency roll-off. In embodiments of step230, a first-order (slope) coefficient for the segments' linear regressions may be determined and in step235may be compared to characteristic white-, pink-, brown-, and black-noise α values for 1/fαpower roll-off. For example, in an embodiment, α ∈(−0.6,+0.4], α ∈(+0.4,+1.4], α ∈(+1.4,+2.01, and α>+2.0, respectively), such as shown inFIG.4. Based on this comparison in step235, it may be inferred that the instant time-period has conditions for forming pressure-ulcers. In particular, in one embodiment, if the slope coefficient in the frequency band between 0.003 Hz and 0.10 Hz matches a 1/fαpower roll-off of α ∈(−0.6,+0.4], then it is determined that the condition for the time period associated with this power spectrum is pressure ulcer-prone. That is, the patient is at risk for developing pressure injury. Accordingly, such embodiments function as a sensor (e.g., a smart sensor) by more accurately detecting, using the algorithm described above and including the comparison, those dangerous conditions which may promote ulcer formation (or impede healing). Similarly, these embodiments more accurately detect healthy conditions unlikely to promote ulcer formation. At step245, the current regression values and risk determination (or likelihood of forming pressure injury) determined in step235are stored. At step250the regression coefficients from N−1 time periods' pressure spectra (or previous pressure-injury-risk determinations) for previous (or prior) N−1 time periods are received. The received data may be retrieved from operational data store207, which may be embodied as storage221or the patient's EHR160. At step255, a duty-cycle may be determined of patterns whose frequency spectra are associated with pressure ulcer proneness. In particular, a duty-cycle of high-frequency pressure-ulcer-prone white-noise spectrum condition among the first (or current) time-period's regression values and the N−1 previous time-period's regression values. For example, the duty cycle may be determined as a daily cumulative percentage of time. In an embodiment, a duty-cycle of N periods (N−1 precious time periods and the current or a recent time period, N) is determined of high-frequency white noise spectrum (indicating pressure-ulcer-prone conditions) in a frequency band between 0.003 and 0.1 Hz. At step257, where the duty cycle of the high-frequency pressure-ulcer-prone white-noise spectrum condition exceeds a threshold value, then it may be inferred that tissue breakdown occurs and pressure ulcers are likely to form. Similarly, if pressure ulcers are already present in the affected skin and soft tissue, the pressure ulcers are unlikely to heal. The threshold may be pre-determined, determined by a clinician, or determined based on a condition of the patient. For instance, a patient that is determined to be more prone to pressure injury (or a patient already having pressure injury) may have a lower threshold. Similarly a heavier patient may have a lower threshold than a lighter patient. In an embodiment, a threshold of duty-cycle of fifty percent is utilized. If the threshold is not satisfied, then method200proceeds to step260and the patient may continue his or her present course because there is no (or little) risk of pressure injury forming. But if the threshold is satisfied or exceeded, then method200proceeds to step270. At step270, At step270, an action may be evoked, for example a notification may be emitted or a recommendation generated and provided, such as for the patient to alter their activity so as to create helpful movement that reduces the risk of pressure injury. In one embodiment of step270, a notification may be provided or another intervening action may be initiated. For instance, one intervening action comprises generating a notification that may be emitted or otherwise communicated to the patient or to a caregiver, such as a provider clinician responsible for the care of the patient. For example, an electronic advisory or warning message may be emitted to a human user, such as a caregiver, indicating an elevated risk of pressure injury to the user, to encourage the user to initiate more frequent movements of position with respect to the load-bearing support surface. In an embodiment, the action comprises generating and emitting or communicating the notification, which may be emitted/communicated via a bedside or patient-side alarm, user/clinician interface (such as interface142described inFIG.1A), or may be communicated to a smartphone or personal computing device of a caregiver, thereby alerting them of an impending deterioration of the patient's condition. In one embodiment, the notification comprises an event signal and includes the likelihood of future pressure injury to the user. In some embodiments, the intervening action comprises adaptively providing notification at irregular within-day intervals. In particular, the irregular intervals may be more likely—verses regularly or predictably provided alerts—to provoke a positive response to establish, restore, or sustain healthy patterns of movement and pressure-relief from the load-bearing tissues in contact with the support surface. Another action that may be initiated, based on the determined likelihood, comprises a recommendation for modifying a care plan or treatment procedure associated with the patient; for example, a recommendation may comprise one or more movements or activity to be performed by the patient or by a caregiver to the patient, increasing patient monitoring or level of care, operating on the patient, or administering another similarly effective therapeutic intervention. The recommendation may be provided in conjunction with a notification, and/or may be provided via a user/clinician interface, such as interface142, described in connection withFIG.1A. Yet another action that may be initiated, based on the determined likelihood, comprises automatically modifying computer code executed in a healthcare software program for treating the patient, thereby transforming the program at runtime. For example in one embodiment, the modification comprises modifying (or generating new) computer instructions to be executed at runtime in the program, the modification may correspond to a change in a care plan, treatment procedure, or therapeutic intervention to be administered to the patient due to the determined likelihood of pressure injury occurrence. In one instance, the modification comprises changing the executed computer instructions corresponding to monitoring the patient's condition, such as increasing the frequency of obtaining physiological measurements of the patient, or increasing sensitivity of monitoring physiological changes in a patient. Yet another action that may be initiated, based on the determined likelihood, comprises scheduling healthcare resources for the patient. For example in one embodiment, a physical therapy resource may be automatically reserved for the patient, healthcare staff may be notified and/or automatically scheduled, or transportation/support staff or resources for getting the patient to a healthcare facility may be called. In one embodiment, this action comprises modifying or updating a resource/scheduling electronic record in a resource/scheduling system, such as operated as part of a hospital or healthcare system. In one embodiment, the action comprises, upon a determined likelihood of a future pressure injury or event occurrence, initiating a computer instruction that modifies the scheduling healthcare resources, which may include computer instructions for automatically alerting, scheduling, and/or notifying staff, reserving rooms, transportation, or other equipment/space, and which may include changing the priority of the patient (when compared to other patients) for receiving these resources. Example Reduction to Practice With reference toFIGS.3A,4,6A-6C,7A-10, and12, and with continuing reference to method200ofFIG.2an example is provided of an embodiment of the disclosure constructively reduced to practice. Here, computer system120running the Linux operating system (129) was utilized with the open-source statistical software package R, and the R modules psd and segmented (computation services126). This example embodiment used the example computer program routine provided inFIGS.7A-7B;8A-B; and9A-B. This example implementation was for a human user seated in a wheelchair in a sitting position on a seat cushion support surface (e.g., a support surface comprising measurement device141); however, as described herein, other embodiments could equally well be applied to a human user lying upon a bed in a recumbent position on a mattress support surface or other arrangement, such as shown in the example mattress302ofFIG.3C. The measurement device141in this example reduction-to-practice includes an All Sensors Inc DLV-060A with a 14-bit ADC operating in the range 0-60 psia. Further, in this example embodiment, to insure that the “floor” of the power density at 0.1 Hz that is related to ADC quantization noise is preferably at least 3 dB below the power of typical seated support surface pressure signal fluctuations at 0.1 Hz (Nyquist frequency fN=2*0.1 Hz=0.2 Hz), a sampling rate fS>10*fNis needed. This example reduction to practice implementation utilizes fS=100*fN=20 Hz. Under such conditions, the autocorrelation of the quantizer output is equal to the autocorrelation of the input signal plus the autocorrelation of the quantization noise, such that the transition of the resulting spectrum to a white-spectrum associated with ADC quantization occurs in a high-frequency band that is more than a decade in log 10-frequency above the 0.003 Hz to 0.10 Hz region of interest. In operation, successive 2,000-second measurement periods (40,000 samples long) were stored, and spectrum analysis was performed upon the pressure time series from each measurement period, such as described in connection to method200ofFIG.2. This was performed on 6 wheelchair-bound “experimental” volunteer subjects (4 men and 2 women; aged 29 to 45 years; weight between 161 and 252 lb.) whose care was provided in Cerner Corporation's employee health clinic. These volunteers were studied for a period of 180 days during 2017, during which time 2 volunteers experienced newly-incident pressure ulcers on buttocks and/or sacral regions of skin and soft tissue in contact with the wheelchair support surface. Also studied during this same time period were 6 healthy ambulatory “control” volunteer subjects (3 men and 3 women), also attending Cerner's clinic (aged 30 to 53 years; 145 to 202 lb.), whose roles involved sedentary, seated work for the majority of each working day. Members of “experimental” and “control” groups granted informed consent for the study, and the study was conducted in conformity with applicable Good Clinical Practices (GCP) regulations under the supervision of the Medical Director of Cerner's occupational health clinic. The wheelchair cushions provisioned to both “experimental” and “control” groups were closed-cell Jay “Basic Wheelchair Cushions”® (model SM-300, 18 in. wide left-to-right×16 in. deep front-to-back, enclosed in a black ballistic nylon fabric cover). Data analysis for this example implementation actually reduced to practice with these “experimental” and “control” groups was accomplished using the computer program routines depicted inFIGS.7A-B,8A-B, and9A-B, which use the R open-source statistical software package psd to calculate multi-taper filtered power spectral density within a frequency band between 0.001 Hz and 0.03 Hz. The R package segmented is used to calculate two-segment linear regressions of the log-transformed power spectra and to determine the optimal cut-point separating the two line-segments. The first-order (slope) coefficient for the segments' linear regressions are then compared to characteristic white-, pink-, brown-, and black-noise α α values for 1/fαpower roll-off with frequency α ∈(−0.6,+0.4], α ∈(+0.4,+1.4], α ∈(+1.4,+2.01, and α>+2.0, respectively). While simple comparison of each regression segment slope to these a ranges was used for the reduction to practice, such as illustratively depicted inFIGS.6A-6C(from which it can clearly be seen that there are differences in slope from the pressure ulcer (PU) vs. normal time series power spectra), other embodiment may utilize analysis of variance (ANOVA or ANCOVA) to statistically determine agreement of the measured slope with characteristic a values. A duty-cycle exceeding 50% for any 10 successive 2,000-second segments of pressure measurement was a basis in the reduction-to-practice for emitting advisory messages about increased pressure ulcer risk and a need to move about more frequently in the seated position, or to ambulate if the subject was able to rise from the chair and walk at least briefly. The threshold of duty-cycle=50% was also utilized for the purpose of calculating the receiver operating characteristic (ROC) curve, as shown inFIG.12, for the purpose of ascertaining the statistical accuracy of the risk-predicting system and method. Other embodiments of the invention as described herein may include any of the following features. Specifically, the invention herein may be a system for determining a likelihood of a condition for inducing pressure ulcers comprising a measurement device having one or more sensors configured to measure pressure from the weight of a human patient; a processor; computer memory having instructions stored thereon that when executed by the processor perform operations comprising: acquire a series of pressure measurements from the measurement device to determine a set of pressure measurement time series including a first time series comprising pressure measurements for a first time interval and one or more previous time series corresponding to pressure measurements received during one or more previous time intervals; determine a multi-taper frequency power spectrum utilizing the first time series; determine a linear regression for two piece-wise linear segments of the power spectrum, and based on the regressions, the two segments joining at a frequency cut-point, and each regression having a first-order coefficient; utilize the regression coefficients to perform a comparison against noise alpha values; based on the comparison, determine that the first time period has conditions likely to induce pressure injury; and evoke an action based on the determined likelihood that the first time period has conditions likely to induce pressure injury. The noise alpha values can comprise white-, pink-, brown-, and black-noise α values for 1/fαpower roll-off. The multi-taper frequency power spectrum can be determined over a frequency band of 0.003 to 0.1 Hz. The pressure measurements acquired from the measurement device can be sampled at a rate of at least 20 Hz. Additionally or alternatively, some embodiments of the invention include a smart sensor for detecting conditions likely to result in pressure injury to a human patient, comprising: a pressure sensor; a pressure transducer coupled to the pressure sensor; an air bladder configurable to hold a volume of air that is in contact with the pressure transducer; a support surface comprising a cushion substrate attached to and below the air bladder; a processor; computer memory having instructions stored thereon that when executed by the processor perform operations comprising a step of determining a series of pressure measurements of the air bladder utilizing the pressure sensor. Additionally or alternatively, some embodiments of the invention include a system for detecting conditions likely to result in pressure injury to a human patient, comprising: a multi-layer support surface supporting comprising at least one gas-tight inflatable elastomeric bladder positioned subjacent to weight-bearing parts of the human anatomy; a control system including one or a plurality of sensors that generate pressure data signals indicative of continuous pressure within the at least one inflatable bladder arising from a person's body tissue supported by the support surface; a processor operatively coupled to the pressure sensor or sensors and the associated analog-to-digital conversion apparatus, the processor being configured to execute operating logic to determine the pressure frequency spectrum from time series measurements by the sensor apparatus, to band-limit the frequency range of the spectrum so determined, to normalize said band-limited spectrum, to determine a frequency roll-off of the power spectrum by two-segment linear regression on a log-log scale as a function of the data signals, to store said band-limited normalized power spectra and regression coefficients, to compare the regression coefficients for each such power spectrum to power-law roll-off exponents corresponding to white, pink, brown, and black-noise spectral exponents, to retrieve a series of such comparisons, to determine the duty-cycle of segments of said series that correspond to a spectral pattern in the upper frequency band that is associated with excess risk of development of, or non-healing of, pressure injury, and to emit an electronic advisor or warning message in the event that the duty-cycle exceeds a threshold associated with development of, or non-healing of, pressure injury. The system can further comprise an inflating mechanism to inflate and adjust gas pressure within the inflatable bladder. The control system and processor system can be coupled to an electronic medical record (EMR) over a network and receives information from the EMR for use by the processor in associating the multi-layer support surface and associated apparatus with a particular person and associating the apparatus and information determined from the pressure time series and power spectra with said person, for the purpose of recording the emitted advisory messages and determinations of pressure ulcer risk. The pressure sensor can be attached to the support surface and can measure pressure time series by repeated, periodic, and ongoing sampling in a multi-layer cushion underlying the load-bearing tissues of an individual, in a series of time periods. Each period can be of equal duration T, between 15 and 30 minutes in length. Sampling measurements can be acquired at a sampling rate at least 10 times the Nyquist frequency of the highest-frequency of the spectral band of interest with regard to pressure ulcer development. Furthermore, transferring the measured pressures in each time period to a computer can be accomplished via a telemetry apparatus utilizing a digital computer interface that is wired, such as a network or USB cable, or can alternatively involve a radiofrequency wireless interface, such as Bluetooth or WiFi or cellular connection to the computer. In some embodiments, after each period ti has elapsed and data transfer has been completed, the computer calculates a multi-taper filtered power spectrum of the pressure time series, by a Fast Fourier Transform or wavelet transform or other means as are known in the art. The spectrum frequency values below 0.001 Hz and above 0.10 Hz can be discarded or ignored in subsequent processing. Furthermore, the calculated power spectrum at the remaining frequencies can be normalized to the power spectral density at 0.001 Hz, setting the value at 0.001 Hz to be exactly equal to 1.0. The resulting current-period pressure power spectrum as a log-log matrix (with spectral density in dB for each value of log 10(frequency)) can be stored in machine-readable storage associated with the person upon whom the measurements have been made, along with previous power spectra in the system's persistent memory. Furthermore, for the current pressure power spectrum, linear regressions can be calculated for two piecewise line-segments in the frequency band between 0.001 Hz and 0.1 Hz by least-squares or similar methods, as are known to those in the art, to determine the log-log roll-off of power density in dB as a function of frequency in log10(Hz). The current two line-segment regression coefficient values can be stored in machine-readable storage along with regression determinations from previous power spectra in the system's persistent memory. The first-order (slope) coefficient for the linear regressions can be compared against characteristic white-, pink-, brown-, and black-noise α values for 1/fa power roll-off with frequency a between (0.6,+0.41, a between (0.4,+1.41, a between (1.4,+2.01, and α>+2.0, respectively). In some embodiments, if the slope coefficient in the frequency band between 0.003 Hz and 0.10 Hz matches a 1/fαpower roll-off of a between (0.6,+0.41, then they system can conclude that the condition for the time period associated with this power spectrum is pressure ulcer-prone. The system can retrieve the stored regression coefficients from N−1 time periods' pressure spectra for said person. In some embodiments, the duty-cycle of high-frequency pressure-ulcer-prone white-noise spectrum condition among the current time period's regression values and the N−1 previous time periods' regression values is determined as a numerical percentage of the time periods. Additionally or alternatively, if the duty-cycle of high-frequency pressure-ulcer-prone white-noise spectrum condition exceeds a threshold value, then the system can electronically emit an advisory or warning message to the human user, indicating an elevated risk of pressure injury to the user so as to encourage the user to initiate more frequent movements of position with respect to the load-bearing support surface, such as would result in more effective relief of pressure in the affected skin and soft tissues and prevention of ischemia and/or ischemia-reperfusion injury. In some embodiments, the multi-layer support surface comprises a contact layer (such as a conventional wheelchair seat and its associated fabric covering), a pressure-measuring layer (comprised of at least one pressure sensor subjacent to load-bearing body parts), and a substrate layer of suitable density and stiffness such as will mechanically isolate the measuring layer from ambient vibrations that may be transmitted through the floor, furniture, or other intervening articles upon which the apparatus is mounted. Furthermore, the control system can receive information regarding ambient conditions proximate to the support surface and modify the pressure measurements as a function of the information regarding the ambient conditions of temperature and atmospheric pressure so as to compensate for artifacts that may arise due to changes in ambient temperature and/or pressure. The inflatable bladder subsystem can be configured to enable adjustment of the internal gas pressure via an elastomeric expansile bulb or other mechanism connected to the at least one inflatable bladder, such that the bladder contains a small amount of pressure above ambient atmospheric pressure so that the bladder does not entirely collapse under support surface load-bearing of the weight of the human user. The at least one bladder can be affixed to the substrate layer that extends over substantially the entire length and width of the person support surface. Additionally or alternatively, the bladder and substrate layer can be enclosed in a fabric cover of areal dimension substantially the same as the areal dimension of the suprajacent cushion layer and its associated fabric covering. The layers and their fabric coverings can be mechanically joined to each other, so that the apparatus can be periodically disassembled for cleaning or other purposes and accurately reassembled such that serial time periods' measurements of pressures can be made in a controlled and consistent, repeatable manner. In some embodiments, the calculation of the power spectral density roll-off calculations are performed at ultradian intervals, preferably less than 60 min and more preferably between 15 and 30 min. Each successive determination of power spectral density roll-off measure within a specified time interval can be checked against normative values for persons who develop pressure ulcers and those who do not develop pressure ulcers. Additionally or alternatively, if the duty-cycle of ultradian within-day consecutive determinations showing features associated with pressure ulcer development exceeds a threshold value (in one embodiment, duty cycle>50% denotes increased risk of pressure ulcer formation or non-healing), then that can be used as a trigger to cause the generation of an electronic reminder to prompt the user to commence a increase activity or light exercise in their wheelchair or bed, or ambulate briefly if able to do so. Furthermore, the user's physical activity (or lack thereof) subsequent to receiving an alert or reminder can be ascertained and logged in the device's machine-readable storage for subsequent analysis and personalization of future reminders. In some embodiments, the advisory or warning signal can be emitted to the human user for not less than 10 seconds. The monitoring and analysis of activity variability and of compliance with the emitted reminders can be implemented by periodically synchronizing the monitoring device with data storage and software applications that are present on the user's laptop computer, on a cloud- or web-based host service, or other computational resources. Many different arrangements of the various components depicted, as well as components not shown, are possible without departing from the spirit and scope of the present invention. Embodiments of the present invention have been described with the intent to be illustrative rather than restrictive. Alternative embodiments will become apparent to those skilled in the art that do not depart from its scope. A skilled artisan may develop alternative means of implementing the aforementioned improvements without departing from the scope of the present invention. It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations and are contemplated within the scope of the claims. Not all steps listed in the various figures need be carried out in the specific order described. Accordingly, the scope of the invention is intended to be limited only by the following claims. | 91,413 |
11857478 | DETAILED DESCRIPTION OF THE INVENTION Below the invention is described in more detail with reference to preferred aspects and embodiments thereof. The present invention as shown inFIG.1, includes a patient lifting robot with two telescopic collapsible columns1and one telescopic collapsible beam2, sliding trolley3with an interchangeable hook4, base with omni-directional driving mechanism5that have capacity for moving in any direction on a surface, base assembly6, battery housing7, an interface allowing human-robot interaction8and force control sensing9. Telescopic columns1are generally formed from several tubes of different sections, adapted to slide in each other through the presence of linear guide means disposed over the length of these tubes between each of them. The present invention is comprised of two vertical telescopic collapsible columns, and one horizontal telescopic collapsible beam2which collapse and expand to a plurality of heights and widths. An omni-directional driving mechanism5and its position within the base assembly6for movement of mobile robot of the invention can be seen inFIG.4that enable the robot to have capacity for moving in any direction on a surface using multiple rollers that when used in pairs, allows vehicle motion in any direction (i.e., holonomic motion). Omni-directional driving is so as to enable effective and efficient movement of the robots on a work surface. Such movement is made possible through the wheels being individually driven. The patient lifting robot is controlled by force sensing control9. The user can move the robot forwardly with a forward force and backwardly with a rearward force. This action may be detected by one or more of load sensors, potentiometers, strain gauges, capacitive sensors, piezoresistive or piezoelectric sensors, or any other types of sensors that are capable of detecting forces exerted by a user, and used to control the powered movement of patient lifting robot. As was noted above, force sensors may include load cells, potentiometers, strain gauges, capacitive, piezoresistive or piezoelectric sensors, or any other types of sensing structures that are capable of detecting forces exerted by a user thereon. Typically such force sensors are arranged or configured so as to detect any and all force components that are exerted in generally any horizontal orientation, or that have any horizontal components to them. In one exemplary embodiment the patient lifting robot further includes an intuitive interface for human-robot interaction8that may be a touch display module, providing an easy-to-use interface without significant preparation time. Hoisting systems for internally moving persons is an important part of the equipment in e.g. a hospital or a nursing home. These enable moving entirely or partially immobile persons or inhabitants between their bed, toilet, bath or other place of stay, without the care assistants having to do heavy lifting. Hoisting systems of this type often consist of an overhead rail system with a trolley that enables horizontal displacement, and a hoisting system suspended from the trolley that enables vertical displacement. The disclosed invention contains a sliding trolley allowing horizontal movement and a hoisting function carried out by the vertical telescopic collapsible columns1allowing vertical movement with an interchangeable hook4. The patient lifting robot is wireless and thus must operate on battery power. The system also includes a battery charging module10that mate with the mobile robot battery plug module, and an alignment system that aligns the battery plug module with the battery charging module. | 3,674 |
11857479 | DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION Referring now to the drawings, where the present invention is generally referred to with numeral10, it can be observed that it basically includes a liner assembly20, a conduit assembly40and a drawstring assembly60. It should be understood there are modifications and variations of the invention that are too numerous to be listed but that all fit within the scope of the invention. Also, singular words should be read as plural and vice versa and masculine as feminine and vice versa, where appropriate, and alternative embodiments do not necessarily imply that the two are mutually exclusive. The liner assembly20may include an upper portion22and a lower portion24. In a preferred embodiment the upper portion22and the lower portion24of the liner assembly20may be made of biodegradable Low-Density Polyethylene (LDPE). It also may be suitable for the upper portion22and the lower portion24of the liner assembly20to be made of polyvinyl chloride (PVC), cloth or any other flexible and resistant material. In a preferred embodiment the width of the upper portion22may be larger than the width of the lower portion24. The upper potion22and the lower portion24may be continuous defining a liner. The thickness of the liner assembly20may be enough to receive and support wastes of a user without leaking. The liner assembly20may have a shape such that fits within a bedpan80. The lower portion24may be fitted into the bedpan80through the opening82. In a preferred embodiment the opening82may have a circular shape. It also may be suitable for the opening82to have a rectangular shape, an ovoid shape, or any other suitable shape. The sidewalls of the bedpan80may have a profile of a convex arc. It also may be suitable for the sidewalls of the bedpan80to have any other suitable shape such as a rectangular shape, a polygon shape, an irregular shape, or the like. The sidewalls of the bedpan80may be defined for a bottom wall of the bedpan80defining a container. The bottom wall of the bedpan80may have a circular shape, a rectangular shape, or any other suitable shape. The bottom of the lower portion24may be in constant abutting contact with the bottom wall of the bedpan80. The sides of the lower portion24may be in constant abutting contact with the sidewalls of the bedpan80. In a preferred embodiment the lower portion24may have a shape substantially equal to the inside of the bedpan80. The upper portion22may cover the uppermost end of the bedpan80. In a preferred embodiment the upper portion22may partially cover the sides of the bedpan80. In an alternative embodiment the liner assembly20may have fragrances such as jasmine fragrance, cinnamon fragrance, or fruit fragrance to avoid odor of the waste. The fragrance may be sprayed to the bedpan liner10. It also may be suitable to add the fragrance when manufacturing the material from which the liner assembly20is made of. It also may be suitable for the liner assembly20that only the lower portion24have fragrances such as jasmine fragrance, cinnamon fragrance, or fruit fragrance to avoid odor of the waste. Referring now toFIG.4, the conduit assembly40may include a union42, a first opening44and a second opening46. The union42may connect the edges of the upper portion22with the outer sides of the upper portion22defining a conduit48. In a preferred embodiment the union42may be a seam. The conduit48may perimeterly surround the edges of the upper portion22. The conduit48may be hollow. In a preferred embodiment the conduit48may have a toroid shape. It also may be suitable for the conduit48to have a rectangular shape, a triangular shape, or any other suitable shape. The conduit48may have a first opening44and a second opening46. The drawstring assembly60may include a drawstring62, a first aglet64aand a second aglet64b. In a preferred embodiment the drawstring62may be made of plastic. It also may be suitable for the drawstring62to be made of cloth, hemp yarn, or any other resistant material. In a preferred embodiment the drawstring62may be elongated and planar. It also may be suitable for the drawstring62to be cylindrical. The drawstring62may have two distal ends. It may be suitable to insert one of the distal ends of the drawstring62into the first aglet64a. It may be suitable to insert the another distal ends of the drawstring62into the second aglet64b. In a preferred embodiment the first aglet64amay have a rectangular shape. It also may be suitable for the first aglet64ato have a circular shape, a rectangular shape, an ovoid shape, a triangular shape, or any other suitable shape. The first aglet64amay have an opening where a distal end of the drawstring62is inserted. In a preferred embodiment the first aglet64amay be made of biodegradable plastic. It also may be suitable for the first aglet64ato be made of metal, bamboo, or any other resistant material. In a preferred embodiment the second aglet64bmay have a rectangular shape. It also may be suitable for the second aglet64bto have a circular shape, a rectangular shape, an ovoid shape, a triangular shape, or any other suitable shape. In a preferred embodiment the second aglet64bmay be made of biodegradable plastic. It also may be suitable for the second aglet64bto be made of metal, bamboo, or any other resistant material The second aglet64amay have an opening where the other distal end of the drawstring62is inserted. Optionally, the drawstring62may be a double drawstring or a triple drawstring. In a preferred embodiment a distal end of the drawstring62is inserted into the first opening46going through the conduit48. It also may be suitable for the distal end of the drawstring62to be inserted into the second opening44. In a preferred embodiment the drawstring62may be partially inside of the conduit48. In a preferred embodiment the distal ends of the drawstring62, the first aglet64and the second aglet24bmay be exposed to be manipulate for a user. In a preferred embodiment the conduit48is retractable. In a preferred embodiment the conduit48contracts slidably through the drawstring62to close the bedpan liner10. In an alternative embodiment the drawstring may perimeterly surround the edges of the upper portion22to tie the bedpan liner10. The drawstring62may be configurated to make an overhead bow knot, a sheet bend knot, a slipknot knot, or any other knot that allows to correctly tie the bedpan liner10. The first aglet64aand the second aglet64bmay help to avoid the knot to untie. The foregoing description conveys the best understanding of the objectives and advantages of the present invention. Different embodiments may be made of the inventive concept of this invention. It is to be understood that all matter disclosed herein is to be interpreted merely as illustrative, and not in a limiting sense. | 6,834 |
11857480 | DESCRIPTION OF EMBODIMENTS In order to make technical problems, technical solutions and beneficial effects to be solved in the present invention clearer, the present invention will be further described below in detail in conjunction with accompanying drawings and embodiments. It should be understood that specific embodiments described herein are only used to explain the present invention and not to limit the present invention. It should be noted that when an element is referred to as “fixed to” or “arranged on” another element, it can be directly or indirectly on another element. When an element is referred to as “connected to” another element, it can be directly or indirectly connected to another element. It should be understood that the orientational or positional relationship indicated by terms “length”, “width”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, and the like is based on the orientational or positional relationship shown in the accompanying drawings, and is only for the sake of describing the present invention and simplifying the description instead of indicating or implying that the apparatus or element referred to must have a specific orientation, and must be constructed and operated in a specific orientation, so it cannot be understood as a limitation of the present invention. Also, terms “first” and “second” are only used for describing purposes, and cannot be understood as indicating or implying relative importance or implying the number of technical features indicated. Therefore, features defined with “first” and “second” can explicitly or implicitly include one or more of these features. In the description of the present invention, “a plurality of” means two or more, unless otherwise specified. Now, referring toFIG.1toFIG.4together, the sexual stimulation device provided by an embodiment of the present invention will be described. The sexual stimulation device includes a ring structure100, at least one first function member200, at least one second function member300and at least one battery311. The ring structure100is annular and elastic, and allows for inserting of the penis or the finger. After the penis or the finger is inserted into the ring structure100, the ring structure100may be tightly mounted around the penis or the finger. With the ring structure100mounted around the penis, the sexual duration may be prolonged. The ring structure100has two opposite sides. The at least one first function member200is arranged on one side of the ring structure100. The at least one second function member300is arranged on the other side of the ring structure100. When the sexual stimulation device is used, the first function member200can stimulate the clitoris and/or the vagina, and the second function member300can stimulate the perineum and/or the anus and/or the testis. As shown inFIG.1, one first function member200is arranged above the ring structure100, and used to stimulate the clitoris and/or the vagina of the female partner. One second function member300extending backwards is arranged at a bottom side of the ring structure100, and used to stimulate the perineum and/or the anus and/or the testicles of the male partner. In other embodiments, the second function member300may extend forwards, and thus can stimulate the perineum and/or the anus of the female partner. The number of the batteries311may be one or more. The battery311is arranged within the first function member200and/or the second function member300. The first function member200and the second function member300have a total of N stimulation sources, and N is greater than or equal to 3. The battery311can supply power to each stimulation source. That is, the first function member200is provided with at least one stimulation source, the second function member300is provided with at least one stimulation source, and the number of the stimulation sources provided by the first function member200and the second function member300is greater than or equal to 3. The stimuli provided by the N stimulation sources include at least one of mechanical stimulus, electrical stimulus and heating stimulus. The stimuli provided by the first function member200include at least one of mechanical stimulus, electrical stimulus and heating stimulus. The stimuli provided by the second function member300include at least one of mechanical stimulus, electrical stimulus and heating stimulus. The mechanical stimulus is at least one of vibrating, swinging, twisting, buckling, slapping, extending-retracting and suctioning. A mode selection key may be arranged on the corresponding function member, and a user can select a corresponding mode according to his or her needs to obtain one of the mechanical stimulus or multiple mechanical stimuli that may be automatically on/off keyed. The electrical stimulus may be stimulus on the skin by micro-currents. The heating stimulus may be formed by heating to a preset temperature or gradually heating. The stimuli provided by the first function member200and the stimuli provided by the second function member300may be the same or different. When the first function member200and the second function member300each have multiple stimuli, some stimuli of the first and second function members200,300may be the same, and some stimuli of the first and second function members200,300may be different. When the user uses the sexual stimulation apparatus, all or part of the stimulation functions may be energized, which provides the user with more choices and different experiences. Compared with the prior art, the sexual stimulation device of the present invention is provided with the ring structure allowing for inserting of the finger or the penis without fixing components such as bandages, thereby being simple in overall structure and convenient to wear and operate. After the male partner wears the sexual stimulation device, the penis is inserted into the ring structure100, which can effectively prolong the sexual duration. The first function member200can stimulate the clitoris and/or the vagina. The second function member300can stimulate the testis and/or the perineum and/or the anus. Accordingly, the sexual stimulation device can provide stimulations to the male partner and the female, which increases the sexual interest. The sexual stimulation device is provided with N stimulation sources. Users can turn on or off the corresponding stimulation sources according to their own needs, thereby providing the users with more choices and enriching the use functions of the device. The ring structure100can adopt a single-ring structure or a multi-ring structure. When the ring structure adopts the multi-ring structure, the number of the ring structures may be two or more. The first function member200is provided with a first on/off key212, which can at least control the On or Off of the stimulation sources provided by the first function member200. In some embodiments, the first on/off key212can control the On or Off of all the stimulation sources. Referring toFIG.1toFIG.4, in this embodiment, the ring structure100adopts the single-ring structure. The at least one second function member300of the sexual stimulation device includes a proximal second function member310connected to the ring structure100. The proximal second function member310extends backwards to stimulate the male partner's perineum and the testis. When a male partner wears the sexual stimulation device, the proximal second function member310abuts against the perineum of the male partner, thereby stimulating the male partner's perineum and the testicles. Arc-shaped ribs are provided on a top surface of one end of the proximal second function member310away from the ring structure100. A heating device may be arranged within the proximal second function member310, and a temperature change can be generated by the heating device, which can stimulate the perineum of the male partner. In other embodiments, the proximal second function member310may extend forwards, and thus can stimulate the perineum of the female partner. Referring toFIG.1,FIG.3andFIG.4, the at least one first function member200includes a proximal first function member210connected to the ring structure100. A first vibration stimulation source211is arranged within the proximal first function member210, and a third vibration stimulation source311is arranged within the proximal second function member310. The first vibration stimulation source211and the third vibration stimulation source311may both include motors. A plurality of motors may be arranged within the proximal first function member210, and a plurality of motors may be arranged within the proximal second function member310. It should be understood that when proximal the second function member310is short, the proximal second function member310can stimulate the testis. When the proximal second function member310is long, the proximal second function member310can stimulate the testis and the perineum. A first circuit board212is arranged within the proximal first function member210. The first vibration stimulation source211is electrically connected to the first circuit board212. The first circuit board212includes a program to implement a vibration mode. A second circuit board312is arranged within the proximal second function member310. The third vibration stimulation source311is electrically connected to the second circuit board312. The second circuit board312includes a program to implement a vibration mode. A first on/off key212is arranged on a rear wall of the proximal first function member210to turn on or off the first vibration stimulation source211. In some embodiments, the first on/off key212can turn on the first vibration source211and the second vibration source221in more than one mode. In this embodiment, the second on/off key314is arranged at a bottom of the second function member300to turn on or off the third vibration stimulation source311. A battery313is arranged within the second function member300, and a charging port is arranged at a position corresponding to the battery313. The first circuit board212and the second circuit board312share the same battery313. It should be understood that only one on/off key may be provided on the proximal first function member210or the proximal second function member310to control the On or Off of the first vibration stimulation source211and the second vibration stimulation source221. Referring toFIG.2toFIG.4, a protrusion230is arranged on a front side wall of the proximal first function member210, and may include multiple ribs or multiple bulges. After the man wears the sexual stimulation device, the protrusion on the front side of the proximal first function member210abuts against the clitoris of the female partner and the area around the clitoris. In this way, the protrusion230can massage the clitoris after the first vibration stimulation source210is turned on. In an embodiment, the protrusion230includes a plurality of ribs on the front side wall of the proximal first function member210, and the ribs may be arc-shaped or spiral. In this embodiment, the protrusion230includes a plurality of bulges231protruding from the front side wall of the proximal first function member210. The front ends of the bulges231all are of a dome structure. As such, the bulge231will not scratch the skin of the female partner, and can provide a more comfortable massage stimulus. The proximal first function member210has a width greater than or equal to its thickness. In this way, the proximal first function member210has a larger width. When the sexual stimulation device is used, the contact area between the proximal first function member210and the clitoris and the skin around the clitoris is larger, which can improve the stimulation effect. Referring toFIG.5andFIG.6, in this embodiment, the ring structure100adopts the single-ring structure. The second function member300of the sexual stimulation device includes an anal plug330. The anal plug330is provided with at least one stimulation source. The anal plug330is suitable for inserting into the anus of the male partner to stimulate the anus. The anal plug330may be of a shape of a water drop with a small and smooth top, which brings the convenience for inserting into the anus. The anal plug330is connected to the ring structure100through a connecting member331extending from a front side to a rear side. A width of an adjoining part of the connecting member331adjacent to the ring structure100gradually decreases from a joint to the ring structure100in the extension direction, that is, the adjoining part of the connecting member331has a larger width at the joint between the connecting member331and the ring structure100and the width is gradually reduced, such that the joint has a greater structural strength. The remaining part of the connecting member331is of an elongated and curved column shape, which facilitates to extending from the perineum to the anus of the male partner. A heating device may be arranged within the anal plug330, and a temperature change may be generated by the heating device, which stimulate the anus of the male partner. It should be understood that when the second function member300extends forwards, the anal plug330can stimulate the anus of the female partner. Referring toFIG.7toFIG.9, in this embodiment, the ring structure100adopts the double-ring structure. The at least one first function member200includes a proximal first function member210and a distal first function member220. The proximal first function member210is connected to the ring structure100. The distal first function member220extends further from the proximal first function member210. The stimuli provided by the distal first function member220include at least one of mechanical stimulus, electrical stimulus and heating stimulus. Particularly, the distal first function member220is connected to a front end of the proximal first function member210and extends in a forward direction. After the finger or the penis is inserted into the ring structure100, the distal first function member220enters the vagina along with the finger or the penis, thus enabling the distal first function member220to stimulate the a sexually sensitive region at the anterior wall inside the vagina, namely, the G-spot. The stimuli provided to the vagina include at least one of mechanical stimulus, electrical stimulus and heating stimulus. When a male partner is about to wear the sexual stimulation device, the penis is aligned with the ring structure100and inserted into the ring structure100. At this time, the distal first function member220conforms to the top of the penis. When the penis of the male partner is inserted into the vagina of the female, a side wall of a front side of the proximal first function member210abuts against the clitoris of the female partner and the area around the clitoris, and the distal first function member220enter the vagina together with the penis. When the stimulation source provided by each function member is energized, the proximal first function member210stimulates the clitoris of the female, and the distal first function member220stimulates the vagina of the female partner. A second vibration stimulation source221is arranged within the distal first function member220, such that after the second vibration stimulation source221is actuated, the distal first function member220can provide vibration massage to the vagina. Particularly, the second vibration stimulation source221may use a motor. It should be understood that since the distal first function member220conforms to the penis, and the distal first function member220can provide vibration massage to the penis, which can simultaneously provide the vibration massage for the male partner and the female partner. Preferably, threads are arranged on a top surface of one end of the distal first function member220away from the proximal first function member210, which can improve the vibration massage effect. Preferably, the distal first function member220is provided with an electrical stimulation source, which can provide an electrical stimulus sensation to the vagina and/or the penis. The electrical stimulation source can provide an electrical stimulus sensation to the vagina when being positioned on the top surface of distal the first function member220. When the electrical stimulation sources are arranged on the top surface and the bottom surface of the distal first function member220and the ring structure100is mounted around the penis, the electrical stimulus may be simultaneously provided to the vagina and the penis. The electrical stimulation source in this embodiment includes a plurality of conductive members spaced from each other. The conductive members are spaced apart on the top surface of the distal first function member220. In this way, the conductive members are in contact with the vagina, and the conductive members generate micro-currents, which provide an electrical stimulus sensation to the vagina. The second vibration stimulation source221is arranged within the distal first function member220and the electrical stimulation source is arranged on the top surface of the distal first function member220, such that the distal first function member220can not only provide a vibration massage to the vagina and the penis, but also provide an electrical stimulus sensation to the vagina, which can make the male partner and the female partner reach excited states. The at least one second function member300includes a proximal second function member310and a distal second function member320. The proximal second function member310is connected to the ring structure100. The distal second function member310extends further from the proximal second function member320. Particularly, the proximal second function member310is connected to the bottom side of the ring structure100and extends backwards to stimulate the perineum of the male partner. The distal second function member320is connected to the rear end of the proximal second function member310and extends upwards. The distal second function member320is suitable for inserting into the anus of the male partner to stimulate the anus. A third vibration stimulation source311is arranged within the proximal second function member310and a fourth vibration stimulation source321is arranged within the distal second function member320, such that the second function member300can provide vibration massage to the perineum and the anus of the male partner. Both the third vibration stimulation source311and the fourth vibration stimulation source321can use motors. It should be understood that the first vibration stimulation source210, the second vibration stimulation source221, the third vibration stimulation source311and the fourth vibration stimulation source321can share a same circuit board, and function keys may be provided on the function member that is provided with the circuit board, and the corresponding vibration stimulation source may be turned on or off by pressing the corresponding function keys. The function keys can include an on/off key, a mode selection key and a power add-substrate key, which facilitates operation. The sexual stimulation device may include a hard inner casing and a flexible outer casing, and the flexible outer casing surrounds the hard inner casing. All the vibration stimulation sources may use motors. The proximal first function member210may be designed to slightly inclined forwards, that is, the proximal first function member210is arranged to inclined forwards with respect to a vertical direction, such that after the male partner wears the sexual stimulation device, the proximal first function member210may abut against the clitoris area of the female partner. The ring structure100includes a first sleeve110and a second sleeve120spaced from each other. The first sleeve110and the second sleeve120are both elastic and can extend and retract and deform radially, which is suitable for the male partner to wear. The first sleeve110is connected between the proximal first function member210and the proximal second function member310. The second sleeve120is connected to one end of a bottom of the distal first function member220adjacent to the first sleeve110. A gap is formed between the first sleeve110and the second sleeve120. When the ring structure100is mounted around the penis, the penis passes through the first sleeve110and the second sleeve120sequentially. The second sleeve120plays a role of auxiliary fixation of the penis and makes the penis abut against the distal first function member220. When the male partner wears the sexual stimulation device, the gap between the first sleeve110and the second sleeve120becomes smaller. The ring structure100has a function of blocking ejaculation, and the second sleeve120properly blocks the blood flow of the penis of the male partner, thereby increasing the volume and the stiffness of the penis. In this way, the ring structure100can effectively prolong the sexual duration. It should be understood that a plurality of second sleeves120that are spaced apart may be provided on the distal first function member220. An area of the distal first function member220between the first sleeve110and the second sleeve120may be in smooth transition. A joint between the second sleeve120and the bottom surface of the distal first function member220may be in smooth transition. Preferably, the width of the top end of the second sleeve120is greater than that of other areas, that is, the top end of the second sleeve120has a transition portion121, and the width of the transition portion121gradually increases from top to bottom, such that strong structural strength between the second sleeve120and the distal first function member220is obtained. After the penis of the male partner is inserted into the ring structure100, the distal first function member220may abut against the penis. Preferably, the front side and the rear side of the transition portion121extend to a side surface of the distal first function member220, which can enhance the structural strength of the second sleeve120as well. The second sleeve120is difficultly pulled and damaged or fall off from the distal first function member220during the use. Referring toFIG.7andFIG.8, the overall dimension of the first sleeve110is set to be greater than that of the second sleeve120. That is, the inner diameter of the first sleeve110is set to be greater than the inner diameter of the second sleeve120, such that the scrotum will not extend into the first sleeve110when the penis passes through the first sleeve110. The first sleeve110is inclined backwards with respect to a longitudinal axis P of the distal first function member220. The first sleeve110is substantially perpendicular to the longitudinal axis P of the distal first function member220, such that the first sleeve110is inclined with respect to the second sleeve120, and the penis is more stable and unlikely to fall off after being inserted into the ring structure100. Referring toFIG.10andFIG.11, in this embodiment, the ring structure100adopts the double-ring structure. The at least one first function member200includes a proximal first function member210and a distal first function member220. The at least one second function member300includes a proximal second function member310. The ring structure100includes a first sleeve110and a second sleeve120spaced from each other. The proximal second function member310is used to stimulate the perineum of the male partner. The distal first function member220is connected to the front end of the first function member200and extends in a forward direction. After the penis of the male partner is inserted into the ring structure100, the distal first function member220enters the vagina along with the penis, thereby stimulating the vagina. The first vibration stimulation source is arranged within the proximal first function member210, the second vibration stimulation source is arranged within the distal first function member220, and the third vibration stimulation source is arranged within the proximal second function member310. After the male partner wears the sexual stimulation device, the vibration massage may be generated on the perineum of the male partner, the vagina of the female partner, the clitoris and the area around the clitoris. Referring toFIG.12andFIG.13, in this embodiment, the ring structure100adopts the double-ring structure. The at least one first function member200includes a proximal first function member210and a distal first function member220. The at least one second function member300includes an anal plug330. The ring structure100includes a first sleeve110and a second sleeve120spaced from each other. The distal first function member220is connected to the front end of the proximal first function member210and extends in a forward direction. After the penis of the male partner is inserted into the ring structure100, the distal first function member220enters the vagina along with the penis, thus stimulating the vagina. The anal plug330is suitable for inserting into the anus of the male partner to stimulate the anus. The anal plug330is connected to the ring structure100through the connecting member331. The width of the connection region of the connection member331to the ring structure100gradually decreases from the front side to the rear side. The remaining portion of the connecting member331is of the elongated and curved column shape. The first sleeve110is inclined backwards with respect to the longitudinal axis P of the distal first function member220, and the proximal first function member210is inclined forwards with respect to the longitudinal axis P of the distal first function member220. The sexual stimulation device of the present invention may be equipped with a remote control, such that the sexual stimulation device may be controlled in a wireless remote control manner. Alternatively, the sexual stimulation device of the present invention may be further provided with a communication module, which can achieve a wireless connection with a mobile terminal. The user can control the sexual stimulation device remotely through a mobile phone, a tablet and other applications on the mobile terminal, which can improve the convenience of use. It should be understood that each function member of the sexual stimulation device of the present invention may be configured with different or the same stimulation sources, such as mechanical stimulus sources, electrical stimulation sources, and heating stimulation sources. The user can turn on or off some of the stimulation sources according to their own needs, which can provide users with more choices, enrich the functions of the sexual stimulation device, and improve the adaptability. The above are only preferable embodiments of the present invention and are not intended to limit the present invention. Any modification, equivalent replacements and improvements made within the spirit and principle of the present invention shall be included in a scope of protection of the present invention. | 27,279 |
11857481 | Like numerals refer to like parts throughout the several views of the drawings. DETAILED DESCRIPTION The following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are not described in order to avoid obscuring the description. References to one or another embodiment in the present disclosure can be, but not necessarily are, references to the same embodiment; and, such references mean at least one of the embodiments. Reference in this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Appearances of the phrase “in one embodiment” in various places in the specification do not necessarily refer to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but not other embodiments. The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Certain terms that are used to describe the disclosure are discussed below, or elsewhere in the specification, to provide additional guidance to the practitioner regarding the description of the disclosure. For convenience, certain terms may be highlighted, for example using italics and/or quotation marks: The use of highlighting has no influence on the scope and meaning of a term; the scope and meaning of a term is the same, in the same context, whether or not it is highlighted. It will be appreciated that the same thing can be said in more than one way. Consequently, alternative language and synonyms may be used for any one or more of the terms discussed herein. Nor is any special significance to be placed upon whether or not a term is elaborated or discussed herein. Synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any exemplified term. Likewise, the disclosure is not limited to various embodiments given in this specification. Without intent to further limit the scope of the disclosure, examples of instruments, apparatus, methods and their related results according to the embodiments of the present disclosure are given below. Note that titles or subtitles may be used in the examples for convenience of a reader, which in no way should limit the scope of the disclosure. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In the case of conflict, the present document, including definitions, will control. It will be appreciated that terms such as “front,” “back,” “top,” “bottom,” “side,” “short,” “long,” “up,” “down,” and “below” used herein are merely for ease of description and refer to the orientation of the components as shown in the figures. It should be understood that any orientation of the components described herein is within the scope of the present disclosure. While many embodiments are described herein, at least some of the described embodiments provide an apparatus, system, and method for a reciprocating treatment device. This disclosure contains concepts related to U.S. patent application Ser. No. 17/244,278, filed Apr. 29, 2021, which is a continuation-in-part of U.S. patent application Ser. No. 17/018,099, filed Sep. 11, 2020, which is a continuation-in-part of U.S. patent application Ser. No. 16/869,402, filed May 7, 2020, now U.S. Pat. No. 10,857,064, which is a continuation-in-part of U.S. patent application Ser. No. 16/796,143, filed Feb. 20, 2020, now U.S. Pat. No. 10,940,081, which claims the benefit of U.S. Provisional Application No. 62/844,424, filed May 7, 2019, U.S. Provisional Application No. 62/899,098, filed Sep. 11, 2019 and U.S. Provisional Application No. 62/912,392, filed Oct. 8, 2019. U.S. patent application Ser. No. 16/869,402 is also a continuation-in-part of U.S. patent application Ser. No. 16/675,772, filed Nov. 6, 2019, which claims the benefit of U.S. Provisional Application No. 62/785,151, filed on Dec. 26, 2018. This disclosure also includes concepts related to the benefit of U.S. Provisional Application No. 63/133,591, filed Jan. 5, 2021 and U.S. Provisional Application No. 63/017,472, filed Apr. 29, 2020. All applications listed above are incorporated by reference herein in their entireties. FIG.1shows an embodiment of a percussive massage device400that includes a rechargeable battery (and replaceable or removable battery)114(FIG.19). As shown inFIG.1, in an embodiment, the percussive massage device400includes three handle portions (referred to herein as first handle portion143, second handle portion145and third handle portion147) that cooperate to define a central or handle opening149. All of the handle portions are long enough that they are configured such that a person can grasp that particular handle portion to utilize the device. The ability to grasp the different handle portions allows a person (when using the device on their own body) to use the device on different body parts and from different angles, thus providing the ability to reach body parts, such as the back, that might not be possible without the three handle portions. As shown inFIG.1, the first handle portion143defines a first handle portion axis A1, the second handle portion145defines a second handle portion axis A2and the third handle portion147defines a third handle portion axis A3that cooperate to form a triangle. In an embodiment, the battery114is housed in the second handle portion145and the motor406(FIG.19) is housed in the third handle portion147. In an embodiment, the first handle portion143has an interior edge143a, the second handle portion145has an interior edge145aand the third handle portion147has an interior edge147a, which all cooperate to at least partially define the handle opening149. As shown inFIG.1, in an embodiment, the first handle portion143includes a finger protrusion151that includes a finger surface151aor fourth interior surface that extends between the interior edge143aof the first handle portion and the interior edge147aof the third handle portion147and at least partially defines the handle opening149. In use, a user can place their index finger against the finger surface151a. The finger protrusion and surface provide a feedback point or support surface such that when a user places their index finger against the surface it helps the user with control and comfort of using the device. In an embodiment, at least a portion of the finger surface151ais straight, as shown inFIG.1(as opposed to the other “corners” of the handle opening149being rounded). As shown inFIG.1, with the finger surface151abeing straight, the first handle portion interior surface, second handle portion interior surface, third handle portion interior surface and finger surface cooperate to define a quadrilateral with radii or rounded edges between each of the straight surfaces. FIGS.2-20show embodiments in accordance with a percussion massage device with a force meter.FIG.2is a block diagram showing interconnected components of a percussive therapy device with a force meter400. In an embodiment, the percussive therapy device with force meter400includes a microcontroller unit701, a battery pack management unit702, an NTC sensor703, a power charging management unit704, a wireless charging management unit705, a wireless charging receiving system706, a voltage management unit707(5V 3.3V Voltage Management in drawings), battery charging inputs708(20V 2.25 A Charging Inputs in drawings), a display709(Force/Battery/Speed Display in drawings), a wireless control unit710(Bluetooth Control in drawings), an OLED screen711, an OLED screen control system712, a motor713, a motor drive system714, a PWM speed setup unit715, an over-current protection unit716, and a power switch unit717(Power On/Off OLED Screen SW in drawings). In the embodiment shown in accordance withFIG.2, each block in the diagram is shown as a separate component. In alternative embodiments, however, certain components may be combined without departing from the scope of the present disclosure. The microcontroller unit701, in an embodiment, is a microcontroller unit including a processor, a memory, and input/output peripherals. In other embodiments, however the microcontroller unit701is an ST Microelectronics STM32F030K6 series of microcontroller units, STM32F030C8T6 series of microcontrollers, STM32F030CCT6 series of microcontrollers, or an equivalent microcontroller. One of ordinary skill would understand that the memory of the microcontroller unit701is configured to store machine-readable code for processing by the processor of the microcontroller unit701. Various other configurations may exist depending on whether the designer of the percussive massage device with force meter400desires to implement the machine-readable code in software, firmware, or both. In an embodiment, the machine-readable code is stored on the memory and configured to be executed by a processor of the microcontroller701. In an embodiment, the machine-readable code is stored on computer-readable media. The battery pack management unit702, in an embodiment, is implemented in firmware or software and configured to be used in connection with the microcontroller unit701. In this embodiment, the firmware or software is stored in memory (not shown) and configured to be obtainable by the microcontroller unit701. The battery pack management unit702may also be a combination of firmware, software, and hardware, in another embodiment. The battery pack management unit702is coupled with the NTC sensor703. The NTC sensor703is a negative temperature coefficient thermistor used by the battery pack management unit702to sense temperature of the battery pack. For example, the NTC sensor703is a thermistor with B value of 3950+/−1%, and a resistance of 10 kΩ. In another example, the thermistor has a resistance of 100 kΩ. One of ordinary skill in the art would recognize that a thermistor is a resistor whose resistance is dependent upon temperature. In other embodiments, however, the NTC sensor703may be another type of temperature sensing device or component used in connection with the battery pack management unit702. The power charging management unit704, in an embodiment, is implemented in firmware or software and configured to be used in connection with the microcontroller unit701. Similarly to the battery pack management unit702, the power charging management unit704firmware or software is stored in memory (not shown) and configured to be obtainable by the microcontroller unit701. The power charging management unit704may also be a combination of firmware, software, and hardware, in another embodiment. In various embodiments, the power charging management unit704is configured to charge a battery pack via a direct connection or through an external charger, such as when configured to be operable with rechargeable batteries. The wireless charging management unit705, in an embodiment, is coupled to the battery pack management unit702and the battery charging inputs708. In other embodiments, the battery or battery pack is charged using other conventional methodologies, such as, for example, charging the battery or battery pack using a wire or cord coupled to the battery charging inputs708. The wireless charging receiving system706, in an embodiment, is coupled to the power charging management unit704and the display709. The wireless charging receiving system706includes one or more of firmware, software, and hardware. In an embodiment, the wireless charging receiving system706is configured to receive information pertaining to battery capacity, charging metrics, and other information pertaining to wireless charging, and to pass along the information to the power charging management unit704. The wireless charging receiving system706may include a wireless charging pad used to charge the percussive massage device with force meter400. One of ordinary skill in the art would understand that a variety of wireless charging devices may be utilized to wirelessly charge the percussive massage device with force meter400. As one example, the Qi wireless charging standard and related devices may be utilized to wirelessly charge the percussive massage device with force meter400. The voltage management unit707, in an embodiment, is a DC voltage regulator that steps down 5 volt to 3.3 volt power for use by the microcontroller unit701. The voltage management unit707may also perform additional functions for management of 3.3 volt power for use by the microcontroller unit701. In an embodiment, the voltage management unit707is implemented using a series of electronic components such as, for example, implementing a resistive divider using electronic components. In another embodiment, the voltage management unit707is a stand-alone voltage regulator module and/or device designed to step down voltage from 5 volts to 3.3 volts. One of ordinary skill in the art would understand the various methodologies and devices available to step down 5 volts to 3.3 volts. The battery charging inputs708, in an embodiment, are interfaces by which a wire or cord may be inserted for charging the percussive massage device with force meter400. For example, a standardized barrel connector is the battery charging inputs708. In another example, the battery charging inputs708is a USB connector. Other more specialized charging methodologies may require a particular battery charging input not described above. The display709, in an embodiment, displays a series of LEDs depicting an amount of force applied by the percussive massage device with force meter400. In an alternative embodiment, the display709displays a series of LEDs depicting the current battery or battery pack charge of the percussive massage device with force meter400. In yet another embodiment, the display709displays a series of LEDs depicting the current speed of the percussive massage device with force meter400. One of ordinary skill in the art would recognize that while LEDs have been specified in the above-referenced embodiments, other embodiments not using LEDs are within the scope of this disclosure, such as, for example, liquid crystal displays, OLEDs, CRT displays, or plasma displays. One of ordinary skill in the art would also understand that it may be advantageous in an embodiment utilizing a battery or battery pack to use low-power options to ensure battery power longevity. In an embodiment, the display709is a 128×64 pixel OLED display. The wireless control unit710is a wireless connectivity device that may be implemented in a wireless microcontroller unit. In an embodiment, the wireless control unit710is a Bluetooth transceiver module configured to couple, via Bluetooth, to a remote device. In an embodiment, the Bluetooth module is a Bluetooth Low-Energy (BLE) module configured to be run in broadcast mode. The wireless control unit710is coupled to the microcontroller unit701. In an embodiment, the remote device is a smartphone having an embedded Bluetooth module. In an alternative embodiment, the remote device is a personal computer having Bluetooth connectivity. In other embodiments, other wireless connectivity standards besides the Bluetooth wireless standard may be utilized. It will be appreciated that the Bluetooth connectivity or other wireless connectivity may be described herein as being implemented in a wireless connection device. The wireless connection device can be a separate module, can be included in the MCU or other component of the device, or can be a separate chip. In summary, the percussive therapy device including a wireless connection device means that the percussive massage device can connect to another electronic device wirelessly (e.g., a phone, tablet, computer, computer, voice controlled speaker, regular speaker, etc.). One of ordinary skill in the art would recognize that low-power wireless control modules may be advantageous when the percussive massage device with force meter400is utilizing a battery or battery pack. The OLED screen711and the OLED screen control system712, in an embodiment, are configured to display substantially the same information as the display709referenced above. The OLED screen711is coupled to the OLED screen control system511. The OLED screen control system712is coupled to the microcontroller unit701, the OLED screen711, and the power switch unit717. In an embodiment, the display709and the OLED screen711may be redundant and it may only be necessary to utilize one or the other. The motor713, in an embodiment, is a brushless direct current (BLDC) motor. The motor713and the motor drive system714, in an embodiment, are configured to vary the speed (i.e., rotational motion) that may be converted to reciprocal motion. In other embodiments, the motor713is a brushed DC motor, a brushed AC motor, or a brushless AC motor. One of ordinary skill in the art would understand that choosing a brushless or brushed motor, or direct current or alternating current, may vary depending on the application and intended size, battery power, and use. The PWM speed setup unit715, in an embodiment, is used to control pulse width modulation utilized to drive the motor713. The PWM speed setup unit715is coupled to the microcontroller unit701and the over-current protection unit716. One of ordinary skill in the art would understand that pulse width modulation is one way to vary the average power applied to the motor713, resulting in varying speed as desired. In alternative embodiments, one of ordinary skill in the art would understand that there are a variety of methods to vary the speed of a brushless DC motor. For example, voltage to the motor713may be controlled in other non-PWM methods. The over-current protection unit716, in an embodiment, may be a feature of an integrated system-in-package to prevent damage caused by high currents to the motor. In other embodiments, the over-current protection unit716is implemented using a series of electronic components configured to protect the motor from excessively high current. The power switch unit717, in an embodiment, is configured to turn on and turn off the percussive massage device with force meter400. The power switch unit717is coupled to the OLED screen control system712and the microcontroller unit701. In an embodiment, the power switch unit717is the switch405. FIG.3shows a circuit diagram of the microcontroller unit701with pin outputs. In this embodiment, the STM32F030K6 series of microcontroller units is utilized. The circuit diagram depicts+3.3 volt power being provided to the VDD inputs of the microcontroller unit701. Input PA3 is labeled “Motor_VOL”, the voltage of the motor713. Input PA2 is “bt_v”, the battery or battery pack voltage. The microcontroller unit is configured to receive analog voltage on inputs PA2 and PA3 and to convert it to digital voltage using the microcontroller's analog-to-digital converter. In this embodiment, the analog-to-digital converter is a 12-bit ADC. One of ordinary skill in the art would understand that other microcontrollers may utilize voltage sensing and analog-to-digital converters to perform similar functions. In yet other embodiments, an analog-to-digital converter module separate from a microcontroller may be utilized. FIG.4shows a circuit diagram used for battery voltage detection. In this embodiment, +BT, the positive battery terminal602, is coupled to a circuit consisting of a P-channel MOSFET604, an N-Channel MOSFET608, 0.1 μF capacitor610,100resistors612,614, 68 kΩ resistor616, 1 kΩ resistors618,620, and 10 kΩ resistors622,624. The circuit is configured to provide an input analog voltage of the battery or battery pack, or bt_v, to the microcontroller unit701ofFIG.2. In other embodiments, voltage of the battery or battery pack may be achieved using a voltage reader coupled to the terminals of the battery or battery pack. FIG.5shows a circuit diagram for detection and measurement of voltage of the motor713of the percussive massage device. In this embodiment, voltage sensing resistor626is coupled in parallel with the microcontroller unit701, and coupled to the motor713. In an embodiment, the voltage sensing resistor has a value of 0.0025Ω. The circuit depicted inFIG.5is configured to provide the Motor_VOL input into the microcontroller unit701ofFIG.2. In an embodiment, the input analog voltage is amplified. In another embodiment, the voltage of the motor713is measured or sensed using a separate series of electronic components or a standalone device and input into a microprocessor for use with the method of displaying a force on the percussive massage device. FIG.6is a flow diagram showing a method800of detecting force applied by the percussive massage device in accordance with an embodiment. At Step802, a voltage magnitude V is obtained. In an embodiment, voltage magnitude V is an analog voltage obtained by using the circuit disclosed inFIG.2. In that circuit, a block curve signal from the motor713(i.e., a Hall effect sensor) is simulated in the circuit as current using the resistor R, which is placed in parallel with the microcontroller unit701. In other embodiments, voltage that corresponds to the current operating speed of the motor713may be generated in a variety of other ways. The voltage magnitude V may be input to a microcontroller unit701that converts analog voltage to digital voltage using an analog-to-digital converter, such as that implemented in the STM32F030K6 microcontroller unit. The STM32F030K6 microcontroller unit coverts analog voltage magnitude to a digital code corresponding to the 12-bit ADC (i.e., 0 to 4096). The digital code represents a voltage magnitude corresponding to the original voltage magnitude V obtained. At Step804, a lookup table is generated that correlates voltage V to force magnitude F. In an embodiment, the lookup table is generated using a method900of generating a lookup table correlating voltage to force. For example, the force magnitude F may be expressed in pounds of force. In an alternative embodiment, the force magnitude F may be expressed in Newtons of force. At Step806, the force magnitude F corresponding to voltage magnitude V is displayed on the percussive massage device with force meter400. In an embodiment, a series of LED lights may be utilized to depict varying amounts of force as the force is being applied by the percussive massage device with force meter400. Thus, as the amount of force magnitude F increases, more LEDs on the series of LED lights will be lit. The series of LED lights may include 12 LED lights. FIG.7is a flow diagram showing a method900of generating a lookup table correlating voltage to force. At Step902, a maximum magnitude of force, FMAX, is determined. The magnitude of FMAXmay be determined by assessing the maximum desired force to apply using the percussive massage device with force meter400. As an example, FMAXis 60 pounds of force. At Step904, a maximum magnitude of voltage, VMAX, is determined. The magnitude of VMAXmay be determined by assessing the maximum theoretical voltage change possible by the percussive massage device with force meter400. As an example, VMAXis 1.8 volts. At Step906, FMAXis divided into equal increments. Using the above example from Step902, 60 pounds of force is divided into 60 one-pound increments. At Step908, VMAXis divided into the same amount of increments as determined in Step906above. Thus, using the above example from Step904, 1.8 volts is divided into 60 0.03-volt increments. At Step910, a lookup table (LUT) is generated that correlates the increments of pounds of force with the increments of voltage. This necessarily creates a linear relationship between force and voltage.FIG.8is a graph plotting the LUT for use by the method of detecting force ofFIG.6that was generated using the specific example identified inFIG.7. The graph depicts calculated force that was calculated using the method900. A problem may arise in that the theoretical maximum voltage assumption at Step904in the method900is inaccurate. It may also be the case that as the percussive massage device with force meter400is used, the maximum available voltage degrades over time. In other words, the battery or battery pack voltage may decrease. Accordingly, a method1000of calibrating the LUT generated by method900may be advantageous.FIG.9is a flow diagram showing a method1000of calibrating a LUT. At Step1002, battery pack voltage BV is obtained. In an embodiment, battery pack voltage magnitude BV is an analog voltage obtained by using the circuit disclosed inFIG.4. In that circuit, the battery pack voltage magnitude BV may be input to a microcontroller unit701that converts analog voltage to digital voltage using an analog-to-digital converter, such as that implemented in the STM32F030K6 microcontroller unit. The STM32F030K6 microcontroller unit coverts analog voltage magnitude to a digital code corresponding to the 12-bit ADC (i.e., 0 to 4096). The digital code represents a voltage magnitude corresponding to the original battery pack voltage magnitude BV obtained. At Step1004, VMAXis set to the actual battery voltage magnitude BV output. As an example, may decrease from 1.8 volts to 1.74 volts, a 0.6 volt decrease. At Step1006, the LUT linear correlation is adjusted to reflect the lower VMAX.FIG.10is a graph plotting the LUT calculated by the method900against the LUT calibrated by using the method1000. The LUT resulting from method1000depicts a calibrated force rather than a calculated force. FIG.11is a flow diagram showing a method1100of calibrating a LUT. The method1100may be performed after the method900, or entirely separately from the method900. At Step1102, battery pack voltage BV is measured. In an embodiment, the measurement is done without applying any force from the percussive massage device with force meter400. In an embodiment, the battery pack voltage BV is measured using an external voltage meter. In another embodiment, the battery pack and/or microcontroller unit701have embedded solutions for directly measuring battery pack voltage BV. At Step1104, the display on the percussive massage device with force meter400that displays the force magnitude F is read to determine the force magnitude F corresponding to the measured battery pack voltage BV. At Step1106, a force meter is used to measure actual force being applied. In an embodiment, the force meter is a push/pull force meter. The direct measurement of force allows calibration of the LUT by comparing the displayed force magnitude F with the measured actual force. At Step1108, the LUT is updated with a corrected force corresponding with the measured battery pack voltage BV. After Step1108, Steps1102-1106are repeated for each successive voltage increment. In the embodiment depicted in accordance with the method900, Steps1102-1106are repeated for every 0.03-volt increment.FIG.12is a graph plotting the LUT calculated by the method1100after all 3-volt increments had been updated. FIG.13is a flow diagram showing a method1200of detecting force applied by a percussive massage device in accordance with an embodiment. At Step1202, current magnitude C of a battery pack is obtained. In an embodiment, current magnitude C is input into the microcontroller unit701. At Step1204, voltage magnitude BV of a battery pack is obtained. In an embodiment, voltage magnitude BV is input into the microcontroller unit701. At Step1206, power is calculated using the product of C and BV. In an embodiment, the microcontroller unit701is configured to calculate power by multiplying C and BV. At Step1208, a lookup table is generated that correlates power magnitude P to force magnitude F. In an embodiment, the lookup table is generated using a method1300of generating a lookup table correlating power to force. For example, the power magnitude P may be expressed in watts. In an alternative embodiment, force magnitude F may be expressed in pounds of force or Newtons of force. At Step1210, the force magnitude F corresponding to power magnitude P is displayed on the percussive massage device with force meter400. In an embodiment, a series of LED lights may be utilized to depict varying amounts of force as the force is being applied by the percussive massage device with force meter400. Thus, as the amount of force magnitude F increases, more LEDs on the series of LED lights will be lit. The series of LED lights may include 12 LED lights. FIG.14is a flow diagram showing a method1300of generating a lookup table correlating power to force. At Step1302, a maximum magnitude of power, FMAX, is determined. A theoretical maximum magnitude of power, however, is not a reasonable assumption if the total effective power may be calculated. Equation 1 may be utilized to determine Total Maximum Effective Power (EPMAX). TotalEPMAX=PMAX×TotalEPEquation 1: Equation 2 may be utilized to calculate Total EP, which is then input into Equation 1 above. TotalEP=EPBATTERY×EPPCBA×EPMOTOREquation 2: where Total EP, EPBATTERY, EPPCBA, and EPMOTORare all expressed in percentages, and where PCBA is a printed circuit board assembly. In an embodiment, EP (Battery) is 85%, EP (PCBA) is 95%, and EP (Motor) is 75%. Thus, using Equation 2, Total EP is 85%*95%*75%=60.5625%. In this embodiment, PMAXis calculated by multiplying the maximum voltage VMAXand the maximum amperage CMAXof the battery pack such as in Equation 3. PMAXis then input into Equation 1. PMAX=VMAX×CMAX In this embodiment, VMAXis 16.8 volts and CMAXis 20 amperes. Thus, PMAXis 336 watts. Turning back now to Equation 1, if PMAXis 336 watts and Total EP is 60.5625%, then Total EPMAXis 203 watts. At Step1304, a minimum amount of power PMIN, is determined. It will be recognized by one of ordinary skill in the art that the power without any force being applied (i.e., no load) will be non-zero. Thus, PMINof 12 watts is assumed. One of ordinary skill will also understand that the value of is equivalent to the rated power without load, which may be derived from VMAXand CMIN. At Step1306, a maximum magnitude of force, FMAX, is determined. The magnitude of FMAXmay be determined by assessing the maximum desired force to apply using the percussive massage device with force meter400. As an example, FMAXis 60 pounds of force. At Step1308, Total EPMAXis divided into equal increments. In an embodiment, Total EPMAXis divided in 3 watt increments per one pound of force, starting at PMIN(12 watts). It will be recognized by one of ordinary skill in the art that if FMAXis 60 pounds of force, the total desired force output of the percussive massage device with force meter400, then 60 pounds of force correlates to 189 watts, within the calculated Total EPMAX. At Step1310, a LUT is generated that correlates the increments of pounds of force with the increments of power in watts. This necessarily creates a linear relationship between force and voltage.FIG.15is a graph plotting the LUT for use by the method of detecting force ofFIG.13that was generated using the specific example identified inFIG.10. The graph depicts calculated force that was calculated using the method1200. Similarly to the method900, a problem may arise in that the measured voltage of the battery pack at Step1204in the method1200is inaccurate. It may also be the case that as the percussive massage device with force meter400is used, the maximum available voltage degrades over time. In other words, the battery or battery pack voltage may decrease. FIG.16is a flow diagram showing a method1400of calibrating a LUT. The method1400may be performed after the method900or the method1200, or entirely separately from the method900or the method1200. At Step1402, current magnitude C of a battery pack is obtained. In an embodiment, current magnitude C is input into the microcontroller unit701. At Step1404, battery pack voltage BV is measured. In an embodiment, the measurement is done without applying any force from the percussive massage device with force meter400. In an embodiment, the battery pack voltage BV is measured using an external voltage meter. In another embodiment, the battery pack and/or microcontroller unit701have embedded solutions for directly measuring battery pack voltage BV. At Step1406, power is calculated using the product of C and BV. In an embodiment, the microcontroller unit701is configured to calculate power by multiplying C and BV. At Step1408, the display on the percussive massage device with force meter400that displays the force magnitude F is read to determine the force magnitude F corresponding to the calculated power. At Step1410, a force meter is used to measure actual force being applied. In an embodiment, the force meter is a push/pull force meter. The direct measurement of force allows calibration of the LUT by comparing the displayed force magnitude F with the measured actual force. At Step1412, the LUT is updated with a corrected force corresponding with the measured power. After Step1412, Steps1402-1410are repeated for each power or force increment. In the embodiment depicted in accordance with the method900, Steps1402-1410are repeated for every 3-watt increment.FIG.17is a graph plotting the LUT calculated by the method1400after all 3-watt increments had been updated. FIGS.18-19show an exemplary percussive massage device400that embodies the features disclosed herein. Generally, the percussive massage device400includes a housing101, an electrical source or battery pack114, a motor406positioned in the housing101, and a switch405for activating the motor406. The electronics (see printed circuit board408inFIG.19) includes the controller that is configured to obtain a voltage of the motor, generate a lookup table correlating voltage to force applied by the percussive massage device, and display a force magnitude corresponding to the obtained voltage using the lookup table.FIG.20is a perspective view of the motor406. As shown inFIGS.21-23, in an embodiment, the motor406is located in the head portion12. The percussive massage device400can include a rotatable arm that is part of rotation housing44. The motor406is located in the rotation housing44, which is housed with the head portion12of the housing101. In another embodiment, the rotation capability can be omitted. In an embodiment, the device includes a push rod or shaft14that is connected directly to a shaft16that is rotated by the motor406and the motor shaft21extending therefrom. The shaft16can be part of a counterweight assembly17that includes a counterweight19. In an embodiment, the push rod14is L-shaped or includes an arc shape, as shown inFIGS.22A-22B. The point where the push rod14is connected to the shaft16is offset from the reciprocating path that the distal end18of the push rod14(and the massage attachment628) travel. This capability is provided by the arc or L-shape. It should be appreciated that the push rod14is designed such that it can transmit the force at least partially diagonally or in an arc along its shape instead of vertically so the motor can be located at or near the middle of the device, otherwise a large protrusion would be necessary to keep the shaft in the center with the motor offset therefrom (and positioned in the protrusion). The arc also allows the push rod14to have a close clearance with the motor, as shown inFIGS.22A and22Band allows the outer housing to be smaller than similar prior art devices, therefore making the device400lower profile.FIG.22Ashows the push rod14at the bottom dead center of its travel andFIG.22Bshows the push rod14at the top dead center of its travel. One or more bearings20are included at the proximal end of the push rod14where it connects to the motor to counteract the diagonal forces and preventing the push rod14from moving and touching the motor406. The bearing20is received on shaft16and a threaded fastener26is received in a co-axial opening16ain shaft16. The proximal end of the push rod14is received on bearing20. These components are all shown inFIG.23. In an embodiment, device400includes a number of dampening components that are made of an elastomer or the like and damp vibrations to keep the device relatively quiet. For example, as shown inFIG.23, device400includes dampening rings426(similar to inner suspension rings219) that surround the rotation housing44(with first and second rotation housing halves44aand44b) and help dampen the sound of vibration between the rotation housing and outer housing101. As shown inFIGS.23and23A, the device400also includes a motor mount24that secures the motor406in place and is secured to the housing101. Motor406includes a receiving member28with three protrusions30(and number between one and ten can be included) that is received in a protrusion opening32defined in the motor mount24(in first wall38). Flanges34extending from the motor mount24help keep the protrusions30in place. The motor406is secured via threaded fasteners or the like to the motor mount24. Motor shaft21extends into the motor mount interior36, which is defined between first and second walls38and a side40that extends part of the way around the circumference. The counterweight assembly17, proximal end of the push rod14and related components for converting the rotation of the motor shaft21to reciprocating motion are position in the motor mount interior36. The push rod14extends downwardly out of the motor mount interior and through a push rod opening42in the side40. In an embodiment, the motor mount24is connected directly to the housing101via fasteners46that are secured to mounting members48in the housing (seeFIG.23A). It will be appreciated that the term push rod assembly used herein includes any of the components discussed herein or combinations thereof, e.g., push rod14, output shaft108, reciprocator310, second rod portion236, that extend from the rotating motor shaft21, shaft246or the like that provide reciprocating motion and include the attachment on the distal end thereof. The push rod assembly also includes the male connector110(and any related components) or any other connector at the end of the reciprocating components that allows connection of an attachment to be used for massage or therapy. In an embodiment, the device400is associated with and can be operated by an app or software that runs on a mobile device such as a phone, watch or tablet (or any computer). The app can connect to the device400via bluetooth or other wireless connection protocol. The app can have any or all of the following functions. Furthermore, any of the functions discussed herein can be added to the touch screen/scroll wheel or button(s) capability directly on the device. If the user walks or is located too far away from the device, the device will not work or activate. The device can be turned on an off using the app as well as the touch screen or button on the device. The app can control the variable speeds (e.g., anywhere between 1750-3000 RPM). A timer can be implemented so the device stops after a predetermined period of time. In an embodiment the device, via the app or the touch screen and other functional buttons, etc. includes different treatment protocols or routines associated therewith. During the routine, the device can vary different aspects or outputs of the device or make changes based on time, speed (frequency), amplitude (stroke), arm position, force, temperature, grip (i.e., which handle portion to grip), attachment (e.g., cone, ball, dampener, etc.) and body part. The device (via the app, touch screen, haptic feedback or audibly via a speaker) can also prompt the user to make some of these changes at certain points throughout the routine, e.g., arm position, grip, attachment changes and body part changes. One of ordinary skill in the art will understand that, depending upon the particular design of the device, one or more of these outputs are applicable, while in other devices, all options described are applicable. When the start of the protocol is selected, the device runs through a preprogrammed routine. For example, the device may operate at a first RPM for a first period of time and then operate at a second RPM for a second period of time and/or at a first amplitude for a first period of time and then operate at a second amplitude for a second period of time. The routines can also include prompts (e.g., haptic feedback) for letting the user to know to move to a new body part. These routines or treatments can be related to recovery, blood flow increase, performance, etc. and can each include a preprogrammed routine or protocol. These routines can also help facilitate certain activities, such as sleep, interval training, stairs, post-run, post-workout, recovery, wellness, post-core exercise, high intensity (plyometric) workouts, among others. The routines can also assist in providing relief and recovery from ailments such as plantar fasciitis, “tech neck,” muscle cramps, jet lag, sciatica, carpal tunnel, knots, and shin splints, among others. The routines can also prompt or instruct the user to switch attachments (e.g., attachment628shown inFIG.21) or positions of the arm or rotation housing. The prompts can include sounds, haptic feedback (e.g., vibration of the device or mobile device), textual instructions or visual representation such as a graphic or picture on the app or touch screen, etc. For example, the app may instruct the user to start with the ball attachment with the arm in position two. Then the user hits start and the device runs at a first frequency for a predetermined amount of time. The app or device then prompts the user to begin the next step in the routine and instructs the user to change to the cone attachment and to place the arm in position 1 (e.g., see the arm position inFIG.18). The arm can include any number of positions, e.g., 1-10 positions or 1-3 positions or 1-2 positions. The user hits start again and the device runs at a second frequency for a predetermined amount of time. The protocol can be divided into steps where, at each step, varied outputs are predetermined or specified. Referring again toFIGS.18-19, in an embodiment, the device400includes a housing101, an electrical source114, a motor406positioned in the housing101, a switch405(which can be any of the touch screen409, rocker button447, button403or any other switch or button) for activating the motor406, and a routine controller630. The device400is configured to mate with an attachment628. The attachment can be, for example, the attachment628shown inFIG.21. The attachment is affixed to the male connector110so that the shaft or push rod assembly108moves the attachment reciprocally in accordance with a specified amplitude. For example, the amplitude is depicted inFIGS.22A and22B, whereFIG.22Ashows the attachment at a maximum extended position andFIG.22Bshows the attachment at a minimum extended position. The distance between maximum and minimum extended positions can, in an embodiment, define the amplitude. The routine controller630is configured to perform a routine in connection with one or more specified protocols. The routine controller630can be, for example, the microcontroller unit701depicted inFIG.2. The routine controller630can also be a standalone microcontroller separate from the microcontroller701. The routine controller can step through different steps of a specified protocol designed to target specified muscle groups and to provide certain therapeutic effects, as described herein. FIG.24is a table showing an example of a protocol in accordance with an embodiment. Protocol1is divided into four steps, each depicting a specified time, speed, amplitude, attachment, force, temperature, and grip. At Step1, the device400is activated for 30 seconds at a speed of 1550 RPM. A routine controller630may be utilized to turn on the percussive massage device and implement a speed of the attachment628of 1550 RPM. One of ordinary skill in the art would understand that the speed of the attachment628is directly proportional to the speed of the motor406. The amplitude of the percussive massage device is set to be 2 in accordance with Protocol1. This may translate to a specified distance that an attachment628moves while in use, as described above. Step1also specifies a dampener attachment affixed to the device400, a force of “1” be applied by the device400, and a temperature of 21° C. be applied to the attachment. One of ordinary skill in the art would understand that the force to be applied by the device400may depend upon the pressure exerted by the user in pressing the attachment onto a person's body part. As described more fully herein, the force to be applied by the device400may be the target force. In an embodiment where the user provides pressure to exert a particular force upon a person's body part, the routine controller630may adjust the output of the device400to ensure that the force actually applied by the attachment is the target force. The routine controller630may also be configured to provide feedback to the user to increase or decrease pressure on a person's body part to meet the target force. Each of these embodiments is applicable to each of the steps of a given protocol, including in Steps2-4below, as well as Steps1-4of the protocol shown inFIG.25. Step1also specifies that the device400is to be operated using grip1. Grip1, for example, may be a grip on the first handle portion143, otherwise referred to as a “regular” or “standard” grip. Grip2, for example, may be a grip on the third handle portion147, otherwise referred to as a “reverse” grip. An “inverse” grip can also be used on third handle portion147. Grip3, for example, may be a grip shown on the second handle portion145, otherwise referred to as a “base” grip. At Step2, Protocol1specifies that the device400be activated for 15 seconds at 2100 RPM, with an amplitude of “3”, a force of “3”, and a temperature of 26° C. Step2specifies that the small ball attachment628be used, and that the device400is to be operated using grip1. Step2therefore requires that the dampener attachment in Step1be replaced by the small ball attachment, but specifies that the same grip is to be used. At Step3, Protocol1specifies that the device400be activated for 30 seconds, at 2200 RPM, with an amplitude of “1”, a force of “3”, and a temperature of 29° C. Step3specifies that the dampener attachment628be used, and that the device400is to be operated using grip1. Step3therefore requires that the small ball attachment in Step2be replaced by the dampener attachment, but specifies that the same grip is to be used. At Step4, Protocol1specifies that the device400be activated for 45 seconds, at 2400 RPM, with an amplitude of “4”, a force of “2”, and a temperature of 32° C. Step3specifies that the large ball attachment be used, and that the device400is to be operated using grip1. Step3therefore requires that the dampener attachment in Step2be replaced by the large ball attachment, but specifies that the same grip is to be used. It will be appreciated that Protocol1is provided as an example to the reader of many of the different outputs that can be changed during a myriad of treatment protocols that can be provided or developed. It will be further appreciated that any one or more of the outputs can be a part of a protocol or routine and any of the outputs discussed herein can be omitted. For example, a protocol may only include time and speed or only time speed and force, or only time, speed and grip or any other combination of the outputs described herein. FIG.25is a table showing an example of a “Shin Splints” protocol in accordance with an embodiment. Like Protocol1, the Shin Splints protocol is divided into four steps, each depicting a specified time, speed, amplitude, attachment, force, temperature, and grip, but also specifying a particular arm position and body part to which to apply the attachment. At Step1, the device400is activated for 1 minute at a speed of 1500 RPM, with an amplitude of “1”, a force of “2”, and a temperature of 21° C. Step1specifies that the dampener attachment be used, and that the device400is to be operated using grip2(“Reverse”), to the right shin. Step1also specifies the arm position to be used is arm position1. One of ordinary skill in the art would understand that the numbers of arm position (e.g., 1, 2, 3, 4, etc.) are predetermined arm positions intended to be used during a particular protocol. The part of the body to which the attachment628is to be applied is one of the factors in determining an optimal arm position. The arm position, however, may be determined by the user and is not required to otherwise implement a protocol. As discussed above, a “standard” grip may be utilized with arm position to apply to specific parts of the body, a “reverse” grip may be utilized with arm position to apply to specific parts of the body, and a “base” grip may be utilized with arm position to apply to specific parts of the body. One of ordinary skill in the art would recognize that the any arm position in combination with the particular grip143,145,147may vary depending on the application. One of ordinary skill in the art will understand that setting the arm position of a device400depends upon the specific device. For example, certain devices may allow a user to adjust arm position while others do not. For those that do not, this step does not apply. In other embodiments, this step may be performed during execution of the steps of the particular protocol. At Step2, the Shin Splints protocol specifies that the device400be activated for 1 minute at 1500 RPM, with an amplitude of “1”, a force of “2”, and a temperature of 21° C. Step2specifies that the dampener attachment be used, and that the device400is to be operated using grip2(“Reverse”), at an arm position1, to the left shin. Step2therefore uses the same attachment, grip, and arm position as Step1, but is applied to the other shin. At Step3, the Shin Splints protocol specifies that the device400be activated for 1 minute at 2000 RPM, with an amplitude of “3”, a force of “3”, and a temperature of 24° C. Step2specifies that the dampener attachment be used, and that the device400is to be operated using grip3(“Base”), at an arm position1, to the right calf. Step3therefore requires that the user change grips from “reverse” to “base” grips, but specifies that the same attachment and arm position be used. At Step4, the Shin Splints protocol specifies that the device400be activated for 1 minute at 2000 RPM, with an amplitude of “3”, a force of “3”, and a temperature of 24° C. Step2specifies that the dampener attachment be used, and that the device400is to be operated using grip3(“Base”), at an arm position1, to the left calf. Step2therefore uses the same attachment, grip, and arm position as Step1, but is applied to the other calf. FIGS.26A-Care a series of flow diagrams showing a method1500of executing a routine for a percussive massage device. FIG.26Ais a flow diagram showing an exemplary protocol initiation. At Step1502, Protocol1is initiated. Protocol1, for example, is the Protocol1depicted inFIG.24or the “Shin Splints” Protocol depicted inFIG.25. One of ordinary skill in the art would understand that Protocol1depicted inFIG.24does not include all of the outputs that are specified in the Shin Splints Protocol depicted inFIG.25, and thus, not all steps of the method1500apply to the Protocol1depicted inFIG.24. At Step1504, a user is prompted to set the arm position to the specified arm position. The user may be the person using the device400on their own body or on the body of another person. The arm position specified in the Shin Splints Protocol is arm position1, for example. At Step1506, the user is prompted to use a specified grip or handle portion143,145,147on the device400. The grip specified in the Shin Splints Protocol is the third handle portion147, for example. As described herein, the grip may vary depending on the particular protocol or step. At Step1508, the user is prompted to affix a specified attachment to the device400. As described herein, the attachment may vary depending on the particular protocol or step. At Step1510, the method determines whether the arm position and the grip position143,145,147are configured appropriately and whether the attachment628is affixed. Step1510may involve a prompt to the user by haptic feedback, application interface, or touch screen (among other types of prompts) in which the user is asked to proceed when the appropriate arm position, grip, and attachment are ready. In other embodiments, the device400may sense that the arm position and grip are appropriate and that an attachment is affixed before proceeding automatically. In an embodiment, Step1510is repeated until the arm position, grip, and attachment are ready. FIG.26Bis a flow diagram showing an exemplary Step1of the protocol, continuing the method1500whereFIG.26Aleft off. At Step1512, Step1of the protocol is initiated. Step1, for example, is Step1depicted inFIGS.24and25, for example. At Step1514, the method1500applies a specified time period (T1) in which the device400is activated, a speed of the attachment, an amplitude of the attachment, a force of the attachment, and a temperature of the attachment. In an embodiment, one or more of these outputs of the device400are applied. These outputs may be applied by the routine controller630. One of ordinary skill in the art would understand that a user's implementation of the device400on a body part is not required to apply certain of these outputs. For example, the time period, speed, amplitude, and temperature are not necessarily dependent upon a user applying pressure to a body part. On the other hand, the force applied by the attachment628may require a user to exert pressure on a body part for a target force (or a target force range) to be reached. Further, the temperature may vary depending on whether the attachment628is applied to a body part, or not, and to which body part it is applied. Thus, the temperature may need to be adjusted during application of the attachment628to reach a desired temperature predetermined by the protocol. In another embodiment, the temperature may be adjusted by a user. After time period T1, the user may be prompted to change the attachment628, arm position, and/or grip position143,145,147. These outputs may need to be implemented prior to the start of Step2of a protocol. In the Shin Splints Protocol depicted inFIG.25, the attachment628, arm position and grip position143,145,147remain the same. At Step1516, after time period T1, the user is prompted to set the arm position to the specified arm position. The user may be the person using the device400on their own body or on the body of another person. At Step1518, the user is prompted to use a specified grip143,145,147on the device400. As described herein, the grip may vary depending on the particular protocol or step. At Step1520, the user is prompted to affix a specified attachment628to the device400. As described herein, the attachment628may vary depending on the particular protocol or step. At Step1522, the method determines whether the arm position and the grip position143,145,147are configured appropriately and whether the attachment628is affixed. This step and all other like steps are optional. Step1510may involve a prompt to the user by haptic feedback, application interface, or touch screen (among other types of prompts) in which the user is prompted to move to the next step in the routine and/or requested to proceed when the appropriate arm position, grip, and attachment are ready. In other embodiments, the device400may sense that the arm position and grip are appropriate and that an attachment is affixed before proceeding automatically. In an embodiment, Step1522is repeated until the arm position, grip, and attachment are ready. FIG.26Cis a flow diagram showing an exemplary Step2of the protocol, continuing the method1500whereFIG.26Bleft off At Step1524, Step2of the protocol is initiated. Step2, for example, is Step2depicted inFIGS.44and45, for example. At Step1526, the method1500applies a specified time period (T2) in which the device400is activated, a speed of the attachment, an amplitude of the attachment, a force of the attachment, and a temperature of the attachment. In an embodiment, one or more of these outputs of the device400are applied. These outputs may be applied by the routine controller630. One of ordinary skill in the art would understand that a user's implementation of the device400on a body part is not required to apply certain of these outputs. For example, the time period, speed, amplitude, and temperature are not necessarily dependent upon a user applying pressure to a body part. On the other hand, the force applied by the attachment628may require a user to exert pressure on a body part for a target force to be reached. Further, the temperature may vary depending on whether the attachment628is applied to a body part, or not, and to which body part it is applied. Thus, the temperature may need to be adjusted during application of the attachment628to reach a desired temperature predetermined by the protocol. In another embodiment, the temperature may be adjusted by a user. After time period T2, the user may be prompted to change the attachment628, arm position and/or grip position143,145,147. These outputs may need to be implemented prior to the start of Step3of a protocol. In the Shin Splints Protocol depicted inFIG.25, the attachment628and arm position remain the same, but the grip143,145,147is adjusted to the base grip. At Step1528, after time period T2, the user is prompted to set the arm position to the specified arm position. The user may be the person using the device400on their own body or on the body of another person. At Steps1528-1534, therefore, steps substantially the same as Steps1516-1522are performed. After Step1534, Steps3-4are initiated in substantially the same manner as Steps1-2. For example, Steps3and4may be Steps3and4of the Protocol1depicted inFIG.24or the Shin Splints Protocol depicted inFIG.25. Furthermore, Step1534can be omitted in a device where none of the grip, arm position or attachment can be sensed by the device. In this embodiment, the given protocol simply moves from step1to step2prompting the user to make a change (but regardless of whether the user has actually made a change). As an alternative toFIG.26C,FIG.26Dis a flow diagram depicting an alternative Step2of a protocol. In the alternative Step2, a force meter adjustment is implemented. Steps1536-1538are performed substantially the same as Steps1524-1526in previous Step2above. At Step1540, the force being applied by the attachment628is monitored. In the embodiment shown inFIG.26D, the method1500utilizes the force meter400to monitor the force actually being applied by the user. At Step1542, the force is displayed to the user. In an embodiment, the force is displayed on an application interface1584such as a graphical user interface. In other embodiments, individual use or combined use of the application interface1584, touch screen1582, the OLED screen711, or the like, may be used to display the force. At Step1546, the user is prompted to increase or decrease the force being applied to a body part according to the specified protocol during T2.FIG.28is a diagram showing a touch screen1582in accordance with an exemplary embodiment of the display of the force. A force display1590shows an exemplary embodiment of Step1546. The force display1590shows a series of force measurements over the course of the “Right Bicep” step of a protocol. A force display prompt1592is used to display a message to the user such as “PERFECT PRESSURE: WELL DONE” when the force applied by the attachment628matches or corresponds to a target force predetermined by the protocol. In this embodiment, the force display prompt1592may recite “INCREASE PRESSURE” or the like if the measured force applied by the attachment628is lower than the target force predetermined by the protocol. Consequently, if the measured force applied by the attachment628is higher than the target force predetermined by the protocol, then the force display prompt1592may recite “DECREASE PRESSURE” or the like. The user may then adjust the pressure the user is exerting on the body part to either increase pressure or decrease pressure according to the force display prompt1592so that the measured force is equivalent or substantially equivalent to the target force. After time period T2, the user may be prompted to change the attachment628, arm position and/or grip position143,145,147. These outputs may need to be implemented prior to the start of Step3of a protocol. In the Shin Splints Protocol depicted inFIG.25, the attachment628and arm position remain the same, but the grip143,145,147is adjusted to the base grip. At Step1528, after time period T2, the user is prompted to set the arm position to the specified arm position. The user may be the person using the device400on their own body or on the body of another person. At Steps1548-1552, therefore, steps substantially the same as Steps1516-1522are performed. After Step1534, Steps3-4are initiated in substantially the same manner as Steps1-2. For example, Steps3and4may be Steps3and4of the Protocol1depicted inFIG.24or the Shin Splints Protocol depicted inFIG.25. FIG.27is a diagram in accordance with an exemplary embodiment of an application interface1584. At the top of the interface1584, a protocol field1556is displayed to the user. In this embodiment, the protocol field1556is “TECH NECK.” The protocol title1556also shows the overall time period of the protocol. The next portion of the interface1584shows step fields1558-1568of the protocol that are displayed to the user. In this embodiment, the step fields identify the title of the step and time period of the step. For example, step field1558is titled “RIGHT BICEP” (where the treatment will be provided) and the time period of activation is “0:30 MIN.” The interface1584also includes a current step field1570that identifies the current step title1570, a grip title display1572, and an attachment title display1574. The interface1584also includes a time display1576and a time remaining display1578to show the user how much time has occurred during that step and the time remaining in that step. Finally, the interface1584includes a control field1580to play, skip back, and skip forward from step to step. As described above,FIG.28shows a touch screen1582on a mobile device. The touch screen1582displays a graphic depicting a starting point1586“A” and an end point1588“B” (thereby defining a treatment path) showing the user where to apply the attachment628to the specified body part. InFIG.27, the display instructs the user to move the attachment from the lower portion of the right bicep to the upper portion of the right bicep (the treatment path) during the current step. In some embodiments, during a single step, the user may be prompted or shown on the graphical user interface more than one treatment path (or a first treatment path and a second treatment path) on the same body part/muscle or on different body parts/muscles. For example, during the right bicep step, the user may be prompted to first move the device along the path shown inFIG.28, but, during the same thirty second step may also be prompted or shown a path that is parallel to the path shown inFIG.28. FIGS.29-33show a device457similar to device400described above. However, the motor402is oriented differently (the motor shaft axis A4extends perpendicular to the motor shaft axis in device400), as shown inFIG.29. It will be appreciated that all embodiments discussed herein or shown in different drawings are interchangeable and the components or concepts in one embodiment can be substituted with or into components or concepts in other embodiments. All parts in all embodiments are optional and are interchangeable or usable with parts from or with other embodiments. As shown inFIG.30, the motor mount401includes a mounting wall427with first and second mounting flanges429extending therefrom and a shaft opening430defined therein. The boss members432include a threaded opening433defined therein. The boss members432receive cylindrical dampening feet461with annular slots425defined therein on the outside thereof and threaded fasteners46in the threaded openings433. As shown inFIGS.31-33, the motor mount401attaches to both housing halves103of the housing101. The mounting members48, which are essentially an inwardly extending ring are received in annular slots425of the cylindrical dampening members461. In other words, the cylindrical dampening members461are received in the opening435of mounting members48and the ring portion434of the mounting members48is received in the annular slots425. The threaded fasteners46extend through the central openings of the cylindrical dampening members461(and the openings in the mounting members48) and are threaded into the threaded openings433in the boss members432. This secures the motor mount401to the housing halves103and the housing101. The cylindrical dampening members are made of rubber or the like and help reduce vibrations. Furthermore, the motor mount401mounts the motor402so that the motor shaft axis A4(the rotation axis), extends forwardly and backwardly with respect to the orientation of the device457in use. This direction is also considered longitudinally. The motor shaft axis A4(or a plane defined by the motor shaft axis) bisects the housing101. FIGS.34-36show another embodiment where the percussive massage device436includes a heart rate sensor437that is located on the top handle or first handle portion143of the device. Any type of heart rate sensor is within the scope of the disclosure. Heart rate sensor437is a heart rate sensor that uses infrared to measure and record heart rate and can also measure and record heart rate variability, if desired. In an exemplary use, heart rate is measured using a process called photoplethysmography or PPG. This involves shining a specific wavelength of light, which usually appears green, from a pulse oximeter sensor on the underside or upper side (e.g., top of the first handle portion) of the device where it touches the skin. As the light illuminates the tissue, the pulse oximeter measures changes in light absorption and the device then uses this data to generate a heart rate measurement. The electronics associated with heart rate sensor437are included in the housing101and can be separate or on the main PCB. The screen409displays the heart rate data. A heart rate monitor opening438is defined in the housing and the heart rate sensor437is mounted therein, as shown inFIG.34. FIG.35shows another type of heart rate monitor or sensor439that can be utilized and includes first and second pulse sensors or contacts440. A first pulse sensor is positioned so that it contacts the user's palm in use and the second pulse sensor is positioned so that it contacts the user's fingers in use. The first handle portion143can also include an indent where the contact is located so the user knows where to place their index finger. It will be appreciated that the any of the heart rate sensors can be positioned on the second and third handle portions or on all three handle portions. FIGS.36and36Ashow device457including a thermal sensor462. Any type of thermal sensor is within the scope of the disclosure. In the embodiment ofFIG.34, the thermal sensor462is an infrared thermometer module installed in the housing101of the device (shown in a non-limiting position inFIG.36on the third handle portion147) that allows the user to measure the temperature of the user's muscles or other body part.FIG.36Ashows the temperature readout on the screen409. The thermal sensor462is in data and/or electrical communication with the PCB. The temperature data can also be communicated to the app. In an infrared thermometer, infrared light is focused on the body part to be measured or to be treated or while being treated and the infrared thermometer module measures energy or radiation coming from the surface. The detector then translates the amount of electricity generated into a temperature reading of the particular muscle, body part, etc. The infrared beam (seeFIG.36) is emitted through an opening in the third handle portion147of the housing101and the module is mounted within the housing. In an embodiment, the temperature reading capability is integrated with and a part of the treatment routines or protocols described herein. For example, instead of a routine or a step within a routine running or extending for a predetermined period of time, the routine or step (i.e., the amount of time a particular muscle or body part is treated or targeted) can extend until the muscle or body part (referred to generally herein as a body part) reaches a predetermined temperature. Accordingly, reaching a predetermined temperature can be substituted for predetermined period of time for any of the routines discussed herein. For example, step1526inFIG.26Ccan be substituted with the method1500applies the device400is activated until a specified temperature is reached. This can be used to be sure that a body part has been warmed up properly prior to exercise. Therefore, in use, the temperature will rise from a starting temperature to a predetermined finishing temperature and the routine can then go to the next step or end. There also may be a number of “temperature steps” that are each part of the routine. For example, in the first step, the muscle may go from the starting temperature and move to a second temperature. The next step may treatment and temperature reading from the second temperature to a higher third temperature. The temperature range between the starting and the finish temperature within the routine may also be different for each user. Furthermore, haptic feedback or other notification or instructions can be provided to let the user know when the finish temperature or predetermined temperature has been reached and they can move to the next step in the routine. As shown inFIG.34, in an embodiment, the device400includes screen409, which may or may not be a touch screen, as well as button(s) for operating the device. In the embodiment shown inFIG.34, the device also includes a center button403for turning the device on and off and a ring/rocker button447that provides the ability to scroll left and right (e.g., to the preset treatments discussed herein) and up and down (e.g., to control the speed or frequency). As shown inFIG.35, in an embodiment, the arm cover449includes a rounded edge or surface to prevent a user's fingers from getting caught therein. and the upper portion of the male connector110each include rounded edges As shown inFIG.29, in an embodiment, the male connector110includes an alignment tab497above each ball that mates with a slot in the female opening. These tabs497help with proper alignment with the treatment structure. In another embodiment, any of the devices taught herein can include a mechanism for heating or changing the temperature of the attachment (massage element, treatment structure, Ampbit) on the end of the reciprocating shaft. The attachment can include an electrical resistance element therein that is provides to heat to the muscles. In an embodiment, the electrical resistance element is connected to the PCB via a hollow shaft. The two outwardly biased metal spring balls on the male connector act as the electrical connector to the attachment. FIGS.37-40show embodiments of a percussive massage device that includes a heated massage attachment or massage member. In the embodiment shown inFIG.37, the male attachment member110includes a heating pad or heating element502therein. The heating element502may be electrically connected via electrical wiring506or the like to the PCB504of the device. Any type of heating is within the scope of the present disclosure. In an embodiment, the heating element is an electrical resistance member that is located in the end of the male connector110. In this embodiment, a wire connects the electrical resistance member to the PCB and the battery. The wiring506may extend through a hollow shaft or other conduit and is guided through the housing, down the shaft and into the male connector110. The heating element502may be internal within the male connector110or may be part of the exterior surface, as shown inFIG.37. In an embodiment with a female connector on the device (at the end of the shaft), the heating element can be in the female connector. In use, the heated male attachment member transfers heat to the massage member, which heats the outer surface of the massage member, which can then be applied to the user's body part. The PCB can include a controller for controlling the temperature. More than one temperature setting can be provided (e.g., 2-10 settings) so that different temperatures can be utilized by the user as desired. Cooler temperatures can also be provided. The attachment member and the massage member can be made of or partially made of a material that is a good conductor of heat. FIGS.38-40show another embodiment with a heated or temperature controlled massage member508. All disclosure related to theFIG.37embodiment is repeated for this embodiment. In this embodiment, the female or male attachment member110is electrically connected to the complementary male or female attachment member in the massage member to provide power to heat or cool the massage member508.FIG.38shows the device with power running from the PCB504to the male attachment member110. As shown inFIG.39, the male attachment member110includes positive and negative electrical contacts510that mate with opposing positive and negative electrical contacts512in the female attachment member in the massage member508, as shown inFIG.40.FIG.39shows a male attachment member with metal balls514that are received in indentations in the female attachment member. The metal balls514can be the electrical contacts510and the electrical contacts512can be positioned in the indentations in the female attachment member. The heating element502may be internal within the massage member508or may be part of the exterior surface. In use, an electrical connection is made when the massage member508is secured to the device and to the male attachment member110. When heating or cooling is turned on, the heating element502in the massage member508is heated, which can then be applied to the user's body part. The heating element or electrical resistance member (e.g., heated pad) can be located in or on the massage member (e.g., ball, cone, etc.) and the metal connection between the male connector and the massage member is used to electrically connect to the battery. The electrical connection between the male or female attachment member110permits a variety of uses beyond heating with the heating element502. In an embodiment, a heating element502radiates wavelengths to produce heat on a user's body part. The male or female attachment member110, for example, may be utilized for a variety of other uses, such as vibration, percussion, cooling, and exfoliating. The male or female attachment member110may be configured as an actuator designed to provide these uses. For example, percussion is already achieved using the attachment628. However, the attachment628or508may be modified to add or replace the heating element502with a cooling, vibration, or exfoliating element. Other uses and actuators may be utilized without departing from the scope of the present disclosure. As shown inFIGS.41-42C, in an embodiment, the percussive therapy device100includes an angular position sensor516and a linear position sensor518. SeeFIG.37. For example, the angular position sensor516is a gyroscope516and the linear position sensor518is an accelerometer518. One or more gyroscopes, accelerometers, sensors or the like can be included on or in the device for detecting and gathering data. The system including the device100and the angular position sensor516and the linear position sensor518allows data to be gathered regarding the angular and linear positioning of the device100. Data can include angular positioning (α,β, γ) (i.e., angular position data) and linear movement in three axes (x,y,z) (i.e., linear position data), for example. In an embodiment, a sensor chipboard504is included in the device100to measure variations in its angular position in three axes, α, β and γ via a gyroscope516and to track linear movement of the device in three axes x, y and z via an accelerometer518. SeeFIG.37. The angular position sensor516and the linear position sensor518may be implemented on the sensor chipboard504, or they may constitute separate electronic devices operably connected to the sensor chipboard504. Other suitable configurations of the angular position sensor516and the linear position sensor518exist without departing from the scope of this disclosure. In an embodiment, the printed circuit board408of the device100powers the angular position sensor516and a linear position sensor518and stores the data the sensors generate. For example, the sensor data may be stored in a memory (not shown). In another embodiment, the PCB408integrally incorporates the sensor chipboard504. The PCB408may broadcast and/or transmit data generated by the sensors through a wireless connectivity standard, such as Bluetooth. For example, the wireless connectivity standard is implemented via the wireless control unit710(FIG.2). The sensors are configured to accurately map how the device100moves with respect to the user's muscle during the treatment. In an embodiment, the sensors may also include an oxygen saturation sensor to monitor an amount of oxygen content in the user's blood (e.g., a pulse oximeter or the like), and a blood flow sensor to monitor magnitude and/or velocity of the user's blood flow. FIGS.42A-42Cshow exemplary angular positioning using the angular position sensor516. As the device100is rotated left and right (seeFIGS.42A and42B) in x and γ axes, and tilted upwardly (seeFIG.42C) in the z axis, the angles and direction of the device100are shown on a computer monitor or display. The depictions shown inFIGS.42A-42Cillustrate a graphical representation of the device100as the device100is moved. WhileFIGS.42A-42Cillustrate angular movement of the device100, the linear movement of the device100is also graphically represented on a computer monitor or display in like manner. It will be appreciated that the movement is shown on the computer monitor in the drawings to provide an example of how the angular position sensor516senses the movement. In an embodiment, the angular and linear position sensors516,518, coupled with the force meter of the percussive therapy device400discussed above, can be used to map the treatment of a muscle or body part as the device400is being used in a three-dimensional display. This “map” or data can be displayed through or on an application or on the touch screen1582. For example, angular and linear position data obtained from the angular and linear position sensors516,518can be graphically represented via the application or on the touch screen1582. The angular and linear position data can assist the user in applying a particular protocol or routine, for example, such as those depicted inFIGS.24-28and accompanying descriptions, or the like. In addition to angular and linear movement, the force meter of device400(or device457) can obtain force magnitude data to assist the user in administering a routine or protocol constituting a therapeutic treatment to the user (or to another person to whom the user is administering the treatment). For example, the map of angular and linear position and force magnitude can be compared against the routine or protocol. The routine or protocol, in this example, will specify a muscle group, a linear and/or angular path (seeFIG.28, for example, with the starting point1586and the ending point1588, in two dimensions), and a force magnitude that the user is intended to exert on the muscle group (seeFIG.28, for example, with the force display1590and force display prompt1592). In an embodiment, the muscle group, linear and angular position, and force magnitude (i.e., depression on the muscle group) is graphically presented in a three dimensional display. The display may also graphically illustrate when the user's linear movement, angular movement, or force magnitude exerted on the muscle group is following the protocol or routine. If the user is not following the routine or protocol, the user will receive a prompt to take corrective action to follow the routine or protocol correctly. For example, the prompt may alert the user that the user is applying the attachment628to a different muscle group than that specified by the protocol. The prompt may be haptic feedback, application interface, or touch screen (among other types of prompts). The prompt may also be presented in a two-dimensional or three-dimensional graphical representation. As a result, the device can track over time what regions of a user's muscles or body parts are being worked the most and whether the user is positioning the device correctly. The prompt may also let the user know they are positioning the device incorrectly or they are working on the wrong body part (e.g., during the treatment protocols). Referring again toFIG.36, the device457is shown depressing the attachment628onto a user's body part. In accordance with the description above, the depression may be graphically represented in two or three dimensions on a display. In practice, the attachment628shown inFIG.36is configured to provide percussive effect to the user's body part, and thus, exerts a force onto the user's body part. The force meter measures the force magnitude of the attachment628when depressed onto the user's body part. The force magnitude data is then transmitted to a monitor/display, application, or touch screen1582, or the like, to show a user (or other person) the amount of force exerted on the user's body part during a protocol or routine. Gathering multi-sensory data allows for augmented reality features that can be used to train users and recovery professionals virtually on how to use the device400,457. As an example, while a user's quad muscle is not a uniform shape, it is possible to simplify the user's quad muscle to the shape of a cylinder. The angular and linear position can be ascertained, and thus, a determination can be made concerning how the device400,457is positioned relative to the cylinder. Further, a determination can be made concerning the direction the percussive arm (e.g., push rod assembly14, shaft16, and/or attachment628) is directed of the device400,457. The determination can also be made concerning how the device is moving relative to the cylinder in linear coordinates. The force magnitude from the force meter of the device400,457allows confirmation that the device400,457is in contact with the muscle, as well as the intensity and duration of that interaction. Similarly, the device400,457can also include a thermal sensor462or thermometer462that can determine the temperature of the user's muscle and to provide feedback to the device and/or application. SeeFIG.36, thermal sensor462. For example, an electronic thermometer462that reads the temperature of the user's skin or muscle before, during and/or after treatment can be included. In an embodiment, the thermal sensor462is located in the housing12of the device400,457where infrared radiation or wavelengths can be used to measure temperature. In another embodiment, the thermometer462can be positioned to require direct contact to measure the temperature and/or it may utilize wireless technology, like an infrared sensor, to make the temperature readings. For example,FIG.40illustrates how the attachment508may function as (or include) a thermal sensor462, a heating element502, or both. Similarly to the heating element502as shown inFIG.37, for example, the thermal sensor462may be connected to the PCB504via the electrical wiring506and may be located in the attachment628. The electrical contacts510,512(or metal balls514) as shown in the embodiments ofFIGS.38-39provide electrical connectivity between the PCB504, the male or female connector110, and thus, the thermal sensor462. As with the heating element502, a thermal sensor462may be utilized as part of a protocol or routine. In an embodiment, a three-dimensional rendering of thermal readings from the thermal sensor462is provided to a user to show incremental increases in temperature over time. For example, a three-dimensional rendering may show varying colors from blue (e.g., cool) to yellow/orange (e.g., medium temperature) to red (e.g., hot) to illustrate to the user the increase in temperature over time. An accessory, module or attachment module520can be used with and attached or secured to a percussive massage or percussive therapy device100,400,457as part of a percussive therapy system500. In an embodiment, the attachment module520includes a thermal sensor or thermometer462that can determine the temperature of the user's muscle and to provide feedback to a device and/or application. In an embodiment, the thermal sensor462allows the application to determine or customize the timing of each step within a protocol. The temperature can be used to determine blood flow and therefore muscle readiness for a specific goal (e.g., relaxation, performance, focus). As shown inFIGS.43-45, in an embodiment, the attachment module520includes a housing522, a thermal sensor524, a battery526, a printed circuit board (PCB)528(that includes a gyroscope516or other angular/positional device, e.g., the angular position sensor516, and/or an accelerometer518or other linear/positional device, e.g., the linear position sensor518), a button530and a wireless communication module532(e.g., a Bluetooth module). In an embodiment, the housing522includes a securement portion534defined therein so that the attachment module520can be secured to a percussive therapy device400,457. The securement portion534or recess534can include rubber on the inside thereof to provide grip on the percussive therapy device. Protrusions536are included on both sides of the housing522to provide grip when securing and removing the attachment module520from the percussive therapy device400,457. In another embodiment, the wireless connection module can be omitted and the attachment module can include a display or screen for displaying information, such as temperature, angular and linear position, or any other information obtained or sensed by the attachment module. As described above with respect toFIG.36, any type of thermal sensor524is within the scope of the disclosure. In the embodiment shown inFIGS.43-45, the thermal sensor524is an infrared thermometer module installed in the housing522and directed downwardly when installed on a percussive therapy device100as shown inFIGS.46-47(shown in a non-limiting position on the front arm of the percussive therapy device100). In another embodiment, the thermal sensor524is the thermal sensor462and can be secured to the third handle portion147or bottom of a percussive therapy device400,457or on any handle portion143,145,147or part of a percussive therapy device400,457where it can be positioned and allow the user to measure the temperature of the user's muscles or other body part. SeeFIG.36. The attachment module520can be used with any type of percussive therapy device500, massage device or other device where temperature and/or positioning measurements are desired. It will be appreciated that all embodiments and components thereof are interchangeable with all other embodiments and components thereof. In an embodiment, the attachment module520communicates wirelessly with the percussive therapy device400and/or the application on the user's mobile device. SeeFIG.2, the wireless control unit710, and accompanying discussion. In another embodiment, the attachment module520is physically and electrically connected to the device400and no wireless module is needed as communication is achieved through conventional electrical wires or the like. Referring again toFIG.36A, a temperature readout on the screen409of the percussive therapy device100is shown. The thermal sensor524is in data and/or electrical communication with the PCB528and the data is communicated to one or both of the device400or application. In an embodiment, the temperature reading capability is integrated with and a part of the treatment routines or protocols described herein or by reference. For example, instead of a routine or a step within a routine running or extending for a predetermined period of time, the routine or step (i.e., the amount of time a particular muscle or body part is treated or targeted) can extend until the muscle or body part (referred to generally herein as a body part) reaches a predetermined temperature. Accordingly, reaching a predetermined temperature can be substituted for predetermined period of time for any of the routines. For example, step1526inFIG.26Ccan be substituted for the step of “apply attachment to specified body part until a specified temperature is reached.” This can be used to be sure that a body part has been warmed up properly prior to exercise. Therefore, in use, the temperature will rise from a starting temperature to a predetermined finishing temperature and the routine can then go to the next step or end. There also may be a number of “temperature steps” that are each part of the routine. For example, during the first step, the muscle may increase in temperature from the starting temperature to a second temperature. The next step may involve additional treatment until the temperature reading increases from the second temperature to a higher third temperature. The temperature range between the starting and the finish temperature within the routine may also be different for each user. Furthermore, haptic feedback or other notification or instructions can be provided to let the user know when the finish temperature or predetermined temperature has been reached and that they can move to the next step in the routine. In an embodiment, the attachment module520includes an angular position sensor516(e.g., gyroscope516) and/or a linear position sensor518(e.g., accelerometer518). Each or both can be implemented as part of the PCB18. One or more gyroscopes516, accelerometers518, sensors or the like can be included on or in the device400for detecting and gathering data. One or more actuators may also be included on or in the device400for providing at least one therapeutic effect. Thus, the description above referencing gyroscopes,516, accelerometers518, attachments628,508, male or female attachment members110, or sensors or actuators within or without the housing101is instructive and within the scope of the attachment module520. SeeFIGS.36-42C. For example, a heating element502may be implemented in the attachment module520to utilize radiation to penetrate skin and muscle to a certain depth. This treatment can result in muscle recovery. In an embodiment, the percussive therapy system500is configured to determine at least one characteristic of the attachment628,508. For example, a percussive therapy device100,400itself may include circuitry and wired or wireless communication to sense the type of attachment the user intends to use in connection with the device100,400. For example, the device100,400may sense that the attachment628is a dampener. Other characteristics of the attachment628,508may be sensed. For example, the existence of one or more sensors included in the attachment628,508may be sensed. In addition, the existence of one or more actuators included in the attachment628,508may be sensed. In an embodiment, the device100,400senses when the attachment628,508is attached to a distal end of the push rod assembly14. Once the attachment628,508is attached, then the device may, through wired connections (e.g., positive/negative contacts510,512or the like, or other wired electrical connections), sense the various characteristics of the attachment628,508. In this embodiment, the wired connections may communicate with the PCB408,504so that the device100,400determines the characteristics. In another embodiment, the attachment628,508may include wireless communication capabilities and communicate the characteristics wirelessly. One of ordinary skill in the art would understand that there are a variety of methodologies to employ to communicate the characteristics to the device100,400and/or the user, through, for example, communication on a remote device or touch screen1582. FIG.48is a flow diagram of a method1600of providing at least one therapeutic effect to a user in accordance with an embodiment of the present disclosure. At Step1602, a percussive therapy device400,457is operated on a user's body part. For example, the user initiates a protocol such as that shown inFIGS.24-28and accompanying descriptions, or the like. In accordance with the specified protocol initiated, the user typically is instructed to operate the percussive therapy device (or other suitable therapeutic treatment or effect) in accordance with steps of the protocol in a specified fashion. For example, the user may be instructed to orient the device400,457at a specified angle relative to a muscle group, along a linear path relative to the specified muscle group, and/or with a certain amount of force exerted on the specified muscle group. At Step1604, angular position data is obtained from a gyroscope516in three rotational axes (α,β, γ). The gyroscope may also be an angular position sensor516or suitable replacement. At Step1606, adjustment of an angular position of the percussive massage device400,457is recommended in response to the angular position data. As illustrated inFIGS.42A-C, the angular position data may show that the angular position of the device400,457is correctly oriented relative to a body part. It may also reveal that the angular position of the device400,457is incorrectly oriented. Thus, the recommendation instructs the user to orient the device400,457properly relative to the body part. At Step1608, linear position data is obtained from an accelerometer518in three linear axes (x, y, z). The accelerometer may also be a linear position sensor518or suitable replacement. At Step1610, adjustment of a linear position of the percussive massage device400,457is recommended in response to the linear position data. For example, inFIG.28, a right bicep routine is shown that instructs the user to move the device400,457from the starting point1586(A) to the ending point1588(B). If the user correctly follows the linear path from (A) to (B), then the recommendation may indicate so to the user. If the user is not correctly following the linear path from (A) to (B), then the recommendation instructs the user to adjust the linear position of the device400,457and/or attachment628to correctly follow the linear path and the predetermined routine. At Step1612, force magnitude data is obtained from a force meter included in the percussive therapy device400,457. At Step1614, application of the attachment628of device400,457to the user's body part is recommended if the attachment628is not in contact with the user's body part in response to the force magnitude data. For example, the force magnitude is approximately zero (or a de minimus threshold amount) that may be predetermined if the attachment is not in contact with the user's body part. At Step1616, adjustment of a force magnitude exerted on the user by the attachment628of the device400,457is recommended in response to the force magnitude data. For example, inFIG.28, a force magnitude exerted on a right bicep is illustrated in accordance with the force display1590. In that embodiment, the force display prompt1592reads “PERFECT PRESSURE: WELL DONE”, indicating that the pressure the user is exerting on the right bicep is in accordance with the pressure specified by the predetermined right bicep routine. In the event that the force magnitude is lower or higher than the pressure specified by the routine, the recommendation will read “INCREASE PRESSURE” or “DECREASE PRESSURE” as needed. At Step1618, a three-dimensional representation of the device400,457and its angular and/or linear position and/or force magnitude is displayed on a display. The angular position of the device400,457, in an embodiment, is displayed similarly to the graphic shown inFIG.42A-C. The display may be situated on a touch screen1582, a mobile device, or other remote device. The display of the three-dimensional device is utilized to assist the user in adjustment of the angular and/or linear position of the device and/or the pressure (e.g., force magnitude) exerted on the user's body part. SeeFIGS.42A-Cand accompanying description concerning “mapping” of device400,457relative to the user's body part. FIG.49is a flow diagram of a method1620of preparing a user's body part for exercise in accordance with an embodiment of the present disclosure. At Step1622, a therapeutic effect is provided to the user's body part using the percussive therapy device400,457. The therapeutic effect may include a variety of massage or other treatments, including vibration, concussion, heat, or exfoliation. A heating element502or other heating actuator may be implemented to increase the temperature during the time that the therapeutic effect is provided to the user. At Step1624, a temperature of the user's body part is monitored. At Step1626, it is determined whether the temperature reading is greater than or equal to a predetermined threshold temperature. Once the temperature reaches the predetermined threshold temperature, for example, the user's body part is ready for exercise. This may vary depending on the user and the user's body part. If the temperature is less than the predetermined threshold temperature, Steps1622and1624are repeated. If the temperature is greater than or equal to the predetermined threshold temperature, then Step1628is implemented. At Step1628, user instructions are provided to cease providing the therapeutic effect to the user's body part. The user's body part is warm enough to exercise safely and effectively with lower risk for exercise-related injury, and can also improve performance of the user during the exercise. Although the operations of the method(s) herein are shown and described in a particular order, the order of the operations of each method may be altered so that certain operations may be performed in an inverse order or so that certain operations may be performed, at least in part, concurrently with other operations. In another embodiment, instructions or sub-operations of distinct operations may be implemented in an intermittent and/or alternating manner. FIGS.50-54show an embodiment of an electrical connection assembly200that can be used to electrically connect or power an attachment to the percussive massage device. In an embodiment, the electrical connection extends from the connection member on the distal end of the reciprocating shaft (that connects to the attachment) to the PCB in the percussive massage device. This allows the attachment to be powered and data can be communicated to the attachment if necessary. Aspects of the present disclosure relate to an electrical connection assembly200that includes a coil shaped wire or cable202that extends around a portion of the push rod assembly (see reciprocating shaft108in the figures) so that the longitudinal length of the cable202can change (extend and retract) as the reciprocating shaft108reciprocates. In short, the coil shape or coil portion208provides slack in the cable202so that the cable can reciprocate with the push rod assembly. In an embodiment, the disclosure also includes a coil shaped spring204or metal wire that helps contain the cable202therebetween. The cable202then runs inside or extends into the reciprocating shaft108(through, e.g., opening205) and is electrically connected to a connection member206. For example, see the three prong connection member, as represented by the lines inFIG.51. Two of the prongs are for electrical connection/communication (to provide a voltage to power the attachment) and one is for data connection/communication. For example, the data connection can communicate to the PCB what type of attachment has been connected to the end of the reciprocating shaft. The attachments can include heating, cooling, or LED/light therapy elements. It will be appreciated that the reciprocating shaft108and many of the components associated therewith reciprocate at a high frequency (e.g., 40 times per second) and a predetermined distance (e.g., 16 mm). Therefore, it is desirable to allow a portion of the cable202to move longitudinally during reciprocation to prevent the cable from breaking or wearing out during use. In use, as the shaft reciprocates, the coil portion208of the cable compresses and expands, thereby preventing any axial tension in that portion of the cable202. As shown inFIGS.50-54, in an embodiment, at least a portion of the coil portion208of the cable202(referred to herein as a segment) is contained between two sections of the spring204. The sections of the spring204help guide the cable202as the shaft reciprocates. Therefore, as the shaft reciprocates, the coil portion208and spring204both collapse and expand together. As shown inFIG.50, the opposite ends of the spring204and coil portion208are contained by a stationary stop member210at the distal end and a movable stop member212at the reciprocating end. This provides a contained space214in which the spring204and coil portion208expand and contract. Movable stop member212of the illustrated example is an outer flange of shaft108located at a proximal end of shaft108. Stationary stop member210of the illustrated example is an inner flange of housing201. Stop members210,212each define a respective plane. Coil portion208is defined between the planes defined by stop members210,212. FIGS.52-54show an example of the movement of the shaft and components and the resulting collapsing of the spring204and coil portion208.FIG.52shows the contained space214between stationary stop member210and movable stop member212when it is fully expanded.FIG.53shows the contained space214between stationary stop member210and movable stop member212when it is partially collapsed andFIG.54shows the contained space214between stationary stop member210and movable stop member212when it is almost fully collapsed. As can be seen from a review of these figures, the spring204and coil portion208collapse or compress as the distal end of the shaft reciprocates outwardly. Accordingly, the present disclosure is an electrical connection assembly for use in a percussive massage device that includes a reciprocating shaft. The electrical connection assembly includes a cable having a coil portion that surrounds at least a portion of the reciprocating shaft. The coil portion is configured to expand and contract when the reciprocating shaft reciprocates. The electrical connection assembly also includes a movable stop member and a stationary stop member that define a contained space therebetween. The coil portion extends between the movable stop member and stationary stop member. The coil portion contracts when the movable stop member moves axially toward the stationary stop member. The coil portion defines an axially length that changes as the reciprocating shaft reciprocates. The electrical connection assembly may include a spring having a plurality of coil sections spanning the contained space. At least a first segment of the coil portion is contained between two of the coil sections. The electrical connection assembly communicates power and data between a PCB and/or battery in the percussive massage device to a connection member at the distal end of the reciprocating shaft. FIGS.55and56show a percussive massage device1700including a housing1701and a shaft1718configured to reciprocate linearly along a reciprocation axis X1defined relative to housing1701. Housing1701is partially cut away inFIGS.55-57for illustrative purposes. A massage attachment1710, which may be alike in any or all respects to any therapeutic attachment described above, is attached to a distal end of shaft1718. Housing1701includes a handle1702. In the illustrated example, handle1702includes three handle portions1702A,1702B,1702C in a triangular arrangement, but in other examples handle1702may be any shape that may be grasped by a user for application of device1700to the user or a patient. Device1700includes a motor1714mounted at a fixed location relative to the housing and configured to output torque about a motor axis X2. Device1700also includes a push rod1722having a proximal end1722A and a distal end1722B. Proximal end1722A is rotatably connected to motor1714at a location offset from motor axis X2so that, when motor1714is active, proximal end1722A travels in a circle that is centered on motor axis X2and located on a plane that is normal to motor axis X2. Distal end1722B is rotatably connected to a proximal end of shaft1718. Shaft1718is constrained to only be movable along reciprocation axis X1, so motor1714, push rod1722, and shaft1718collectively act as a piston assembly. Accordingly, when motor1714is active, push rod1722transfers the torque output by motor1714to linear pushing and pulling forces on shaft1718so that shaft1718reciprocates linearly along reciprocation axis X1. The above description of the mechanics of housing101, motor402, push rod14, shaft108, may apply equally to the housing1701, motor1714, push rod1722, and shaft1718. Device1700includes a screen1705and a switch1706that together form a control panel. The above description of switch403, screen409, and rocker button447may apply equally to the control panel formed by screen1705and switch1706. Thus, switch1706may refer collectively to both a switch that is alike to switch403and a rocker button that is alike to rocker button447or, in other examples, to a solitary switch. Screen1705is optional, and in other examples the control panel may have one or more indicator lights or other types of display instead of screen1705, or the control panel may lack a display altogether. Device1700further includes an electronics assembly1704that may be or include any one or any combination of the features described above with regard to printed circuit board408,504, and which receives and processes user inputs through the control panel. Electronics assembly1704includes a controller. Device1700includes a battery1707, which may be alike to any battery or battery pack described above. An electrical connection1708, such as a wire, cable, or any other suitable conducting element, connects battery1707to electronics assembly1704. Electronics assembly1704selectively distributes power received from battery1707to motor1714and attachment1710in response to user inputs through the control panel provided by screen1705and switch1706. Battery1707is located in handle portion1702B in the illustrated example, but may be located anywhere in device1700in various examples. All of the foregoing references to features of other embodiments within the present disclosure indicate that the features of device1700may be alike in one, some, or all respects to analogous features of the other embodiments, except to any extent the features of the other embodiments are incompatible with what is illustrated or described herein with respect to the device1700. With additional reference toFIG.57, device1700includes a cable1726that provides an electrical connection between electronics assembly1704and shaft1718. Cable1726includes a coil portion1727defined between a proximal plane1734and a distal plane1736. Proximal plane1734and distal plane1736are both normal to reciprocation axis X1. Proximal plane1734is a plane normal to reciprocation axis X1that includes a point at which a portion of cable1726is retained to be axially immovable while in regular use, with respect to reciprocation axis X1, relative to housing1701. Thus, cable1726includes a portion at the proximal end of coil portion1727that remains on proximal plane1734as shaft1718reciprocates. Because proximal plane1734is stationary relative to housing1701, the portion of cable1726on proximal plane1734remains stationary relative to housing1701, but varies in distance relative to shaft1718, as shaft1718reciprocates. Distal plane1736is a plane normal to reciprocation axis X1that includes a point at which a portion of cable1726is retained to be axially immovable while in regular use, with respect to reciprocation axis X1, relative to shaft1718. Thus, cable1726includes a portion at the distal end of coil portion1727that remains at distal plane1736as shaft1718reciprocates. Because distal plane1736is stationary relative to shaft1718, the portion of cable1726with a fixed location on distal plane1736remains stationary relative to shaft1718, but moves linearly relative to housing1701, as shaft1718reciprocates. The coil portion1727of cable1726is centered about and extends along a coil axis X3. Coil axis X3in the illustrated example is perpendicular to both proximal plane1734and distal plane1736, though in other examples coil axis X3may extend at any angle from 45° to 90° relative to the proximal plane1734and distal plane1736. Coil axis X3in the illustrated example is parallel to reciprocation axis X1, though coil axis X3is not coaxial with reciprocation axis X1. In some other examples, coil axis X3is coaxial with reciprocation axis X1. In the illustrated example, coil portion1727extends at a constant radius about coil axis X3from the proximal end of coil portion1727to the distal end of coil portion1727. Coil portion1727of the illustrated example is therefore helical. In other examples, coil portion1727may not be strictly helical, and may therefore be spaced from coil axis X3by a radial distance that varies at different locations along coil axis X3. In some examples, some or all of coil portion1727may define a conic spiral. Device1700also includes a coil spring1728that gives coil portion1727the illustrated and above described coil shape. In the illustrated example, coil spring1728extends along an entirety of coil portion1727. In further examples, coil spring1728extends along at least a majority of coil portion1727. In the illustrated example, coil spring1728is coupled to at least coil portion1727of cable1726in any manner that causes coil portion1727to follow the shape of coil spring1728. In other examples, coil portion1727may be coupled to coil spring1728in a manner that causes coil portion1727to have a coil shape without strictly following the shape of coil spring1728. For example, coil portion1727may be coupled to coil spring1728at multiple discrete, spaced apart locations so as to have a coil shape without strictly following the shape of coil spring1728. In the illustrated example, coil portion1727is coupled to coil spring1728by an adhesive, glue, tape, or the like. Coil portion1727may be spot glued to coil spring1728at spaced intervals or glued to coil spring1728along the entire length of coil portion1727. In further examples, the jacket of cable1726may include a channel for receiving coil spring1728. The channel may have an interference fit with coil spring1728to securely connect cable1726to coil spring1728. The channel may be located at an exterior of the jacket of cable1726, so that coil spring1728is visible at an exterior of cable1726, or the channel may be enclosed within the jacket so that coil spring1728is not visible at an exterior of cable1726. Coil spring1728may be both received with an interference fit in a channel defined in a jacket of cable1726and glued to cable1726. The connection of cable1726to coil spring1728causes coil portion1727to remain in a coil shape, or at least generally in a coil shape, at all positions within the motor1714driven reciprocation cycle of device1700. Whereas a cable without support from a spring might hang at various angles within housing1701whenever shaft1718arrives at a position that gives the cable slack, cable1726is supported by coil spring1728within coil portion1727and therefore remains within a relatively confined space within housing1701. Cable1726is therefore free to move as necessary to maintain connection between electronics assembly1704and shaft1718throughout the reciprocation cycle without having enough slack that cable1726could interfere with other components of device1700within housing. In contrast to cable202ofFIGS.50-54, cable1726is supported by coil spring1728to maintain a coiled shape without being wrapped around shaft108. Shaft1718may be relatively short as a result because shaft1718does not need to be long enough to include a segment about which cable1726could be coiled. The shorter shaft1718tends to reciprocate more quietly than a longer shaft. Additionally, the reduction in distance between motor axis X2and the user-contacting surface of attachment1710resulting from a shorter shaft1718may make device1700more stable during use. Instead of being coiled around shaft1718, coil portion1727may be located elsewhere within housing1701. Coil portion1727may be located adjacent to push rod1722, as shown in the illustrated example. In further examples, coil portion1727could be located adjacent to shaft1718, motor1714, or any other component in housing1701. Coil spring1728is distinct from the conductive wires enclosed by cable1726. Coil spring1728may be made of any resilient material suitable for repeated compression and extension at any of the reciprocation speeds disclosed herein and having enough stiffness to cause coil portion1727to maintain the coil shape illustrated inFIGS.55-58B. In some examples, coil spring1728is a material having an elastic modulus in the range of 2206 MPa to 2697 MPa. In various examples, coil spring1728may be steel, spring steel, piano wire, or SWP-B steel wire, such as ASTM A228 steel wire. In various examples, the diameter of the wire of coil spring1728may be between 0.2 mm and 1.0 mm, between 0.4 and 0.8 mm, or approximately 0.6 mm. In various examples, an axial length of coil spring1728along coil axis X3in an unloaded state may be from 30 mm to 50 mm, from 35 mm to 45 mm, or approximately 36 mm. In various examples, a diameter of coil spring1728normal to coil axis X3may be from 15 mm to 30 mm, from 20 mm to 25 mm, or approximately 23.6 mm. In some examples, the diameter of coil spring1728may be more than half of the distance between proximal plane1734and distal plane1736at all positions in the reciprocation cycle. In various examples, coil spring1728and device1700may be respectively configured such that the axial length of coil spring1728with respect to coil axis X3in either or both of the most extended state and the most compressed state of coil spring1728is within 10% of the unloaded length of coil spring1728, within 20% of the unloaded length of coil spring1728, within 35% of the unloaded length of coil spring1728, or within 50% of the unloaded length of coil spring1728. FIGS.58A and58Bshow the distal-most and proximal-most positions of shaft1718in its motor1714driven reciprocation cycle. Proximal plane1734is immovable while in regular use relative to housing1701and motor1714, while distal plane1736is immovable while in regular use relative to shaft1718. Because coil portion1727is defined between proximal plane1734and distal plane1736, an axial length of coil portion1727with respect to reciprocation axis X1varies as shaft1718reciprocates. The pitch of the coil shape of coil portion1727can increase or decrease to enable the axial length of coil portion1727with respect to reciprocation axis X1to vary as necessary to accommodate an entire range of motion of shaft1718relative to housing1701and motor1714without any sharp corners being formed in the cable1726within coil portion1727. The pitch of coil spring1728varies along with the pitch of coil portion1727. An axial length of coil portion1727with respect to coil axis X3also varies as shaft1718reciprocates. In the illustrated example, wherein coil axis X3is parallel to reciprocation axis X1, the axial length of coil portion1727is the same with respect to both reciprocation axis X1and coil axis X3, and the angle of coil axis X3relative to reciprocation axis X1does not change as shaft reciprocates. In other examples, wherein coil axis X3is not parallel to reciprocation axis X1, the angle of coil axis X3relative to reciprocation axis X1may vary as shaft1718reciprocates. Turning toFIG.59, with continued reference toFIG.57, device1700of the illustrated example includes a bracket1730that retains a portion of cable1726relative to housing1701to define proximal plane1734. Bracket1730may be, in various examples, integrally formed with a portion of housing1701as in the illustrated example, or a separate piece mounted to housing1701. Bracket1730includes at least one proximal tab1731A and at least one distal tab1731B between which a portion of cable1726is trapped at a fixed location relative to housing1701. The trapped portion of cable1726can rotate between tabs1731A,1731B, which prevents cable1726from being forced into a sharp angle at or adjacent to bracket1730when coil portion1727is stretched or compressed. Tabs1731A,1731B also bear the axial forces of a proximal portion of coil spring1728that corresponds to the retained portion of cable1726so that coil spring1728will be elongated or compressed along coil axis X3when a distal portion of coil spring1728moves. The proximal portion of coil spring1728is therefore also retained at a fixed location relative to housing1701. By retaining a portion of cable1726relative to housing1701and bearing the axial forces from a proximal portion of coil spring1728, bracket1730defines proximal plane1734between tabs1731A,1731B. However, in other examples, any other structure that retains a portion of cable1726relative to housing1701and bears axial forces from a portion of coil spring1728that corresponds to the retained portion of cable1726may serve to define proximal plane1734at the retained portion of cable1726. Proximally of proximal plane1734, cable1726passes around motor1714to connect to electronics assembly1704. Bracket1730is located distally of a distal-most location reached by proximal end1722A of push rod1722at any point during the reciprocation cycle. Proximal plane1734is therefore always distal of proximal end1722A, even though a distance between proximal end1722A and proximal plane1734varies throughout the reciprocation cycle. Bracket1730and proximal plane1734are also located distally of motor axis X2. In other examples, proximal plane1734may be located proximally of either or both of a distal-most location reached by proximal end1722A at any point during the reciprocation cycle and motor axis X2. As shown inFIG.60, shaft1718includes a base1732at the proximal end of shaft1718. Base1732includes a hitch1720for rotatable connection to distal end1722B of push rod1722. Base also includes a clip1758that retains a portion of cable1726at a distal end of coil portion1727. The portion of cable1726retained by clip1758can rotate between within clip1758, which prevents cable1726from being forced into a sharp angle at or adjacent to base1732when coil portion1727is stretched or compressed. Clip1758bears the axial forces of a distal portion of coil spring1728that corresponds to the retained portion of cable1726so that coil spring1728will be elongated or compressed along coil axis X3when shaft1718reciprocates. The distal portion of coil spring1728is therefore also retained at a fixed location relative to shaft1718. By retaining a portion of cable1726relative to shaft1718and bearing the axial forces from a distal portion of coil spring1728, base1732defines distal plane1736at clip1758. However, in other examples, any other structure that retains a portion of cable1726relative to shaft1718and bears axial forces from a portion of coil spring1728that corresponds to the retained portion of cable1726may serve to define distal plane1736at the retained portion of cable1726. Distally of distal plane1736, cable1726enters shaft1718. Specifically, cable1726enters a proximal end of plug1740, which is detailed below, and within plug1740the wires within cable1726are connected to electrical contacts1748located at a distal end of plug1740. Because base1732is a proximal end of shaft1718, distal plane1736is located at a proximal end of shaft1718. Because base1732includes both hitch1720and clip1758, the distance between distal end1722B of push rod1722and distal plane1736does not vary during the reciprocation cycle. FIG.61shows a distal end of shaft1718without attachment1710. As shown inFIG.60, shaft1718includes a plug1740. Turning toFIG.62, plug1740includes a proximal barrel1744and a distal end1746. Distal end1746is shaped to be complementary to internal geometry of a corresponding socket1760defined in a proximal end of attachment1710as shown inFIG.63. Distal end1746includes electrical contacts1748. Electrical contacts1748of the illustrated example are arranged in three pairs, with two pairs for supplying power and a third pair for a signal connection. Other arrangements of electrical contacts may be used in other examples as needed for the functionality of a given attachment. Distal end1740also includes features for coupling attachment1710to shaft1740. In the illustrated example, the coupling features include two detents1750configured to receive corresponding elements of attachment1710, such as, for example, balls of metal or other solid material biased radially inward into socket1760. The two detents1750are located symmetrically on either side of distal end1740such that one detent1750is visible inFIG.62. However, in further examples, distal end1740and socket1760may be respectively configured with any type of features for releasably or permanently coupling attachment1710to shaft1718. As shown inFIG.63, a proximal end of attachment1710includes a socket1760configured to receive a distal end of plug1740. Attachment1710further includes electrical contacts1762biased into socket1760to be in connection with electrical contacts1748of plug1740when plug1740is received in socket1760. Such connection between contacts1748,1762establishes an electronic connection between attachment1710and shaft1718. Because shaft1718is in electronic connection with electronics assembly1704through cable1726, a power and data connection may be provided between attachment1710and electronics assembly1704enabling any of the above described functions of electrical wiring506and related aspects of the embodiment ofFIGS.37-40. In various examples, attachment1710may include a heating element, a cooling element, LED/light therapy element, such as, for example, an infrared or far infrared light therapy element or LED, or a Peltier plate that can be activated through the control panel provided by screen1705and switch1706. In various examples, attachment may include a temperature sensor or another type of biometric sensor, the measurements of which may be observed through screen1706. Any of the foregoing elements of attachment1710may be powered through cable1726. Data communication between electronics assembly1704and attachment1710for controlling or receiving feedback or measurements from any of the foregoing elements of attachment1710may be provided through cable1726. Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. The word “or” in reference to a list of two or more items, covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list. Embodiments are envisioned where any of the aspects, features, component or steps herein may be omitted and/or are option. Furthermore, where appropriate any of these optional aspects, features, component or steps discussed herein in relation to one aspect of the disclosure may be applied to another aspect of the disclosure. The above-detailed description of embodiments of the disclosure is not intended to be exhaustive or to limit the teachings to the precise form disclosed above. While specific embodiments of and examples for the disclosure are described above for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while processes or blocks are presented in a given order, alternative embodiments may perform routines having steps, or employ systems having blocks, in a different order, and some processes or blocks may be deleted, moved, added, subdivided, combined, and/or modified to provide alternative or subcombinations. Each of these processes or blocks may be implemented in a variety of different ways. Also, while processes or blocks are at times shown as being performed in series, these processes or blocks may instead be performed in parallel, or may be performed, at different times. Further any specific numbers noted herein are only examples: alternative implementations may employ differing values or ranges. The above-detailed description of embodiments of the disclosure is not intended to be exhaustive or to limit the teachings to the precise form disclosed above. While specific embodiments of and examples for the disclosure are described above for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. Further, any specific numbers noted herein are only examples: alternative implementations may employ differing values, measurements or ranges. It will be appreciated that any dimensions given herein are only exemplary and that none of the dimensions or descriptions are limiting on the present disclosure. The teachings of the disclosure provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various embodiments described above can be combined to provide further embodiments. Any patents and applications and other references noted above, including any that may be listed in accompanying filing papers, are incorporated herein by reference in their entirety. Aspects of the disclosure can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments of the disclosure. These and other changes can be made to the disclosure in light of the above Detailed Description While the above description describes certain embodiments of the disclosure, and describes the best mode contemplated, no matter how detailed the above appears in text, the teachings can be practiced in many ways. Details of the system may vary considerably in its implementation details, while still being encompassed by the subject matter disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features or aspects of the disclosure with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the disclosures to the specific embodiments disclosed in the specification unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the disclosure encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the disclosure under the claims. Accordingly, although exemplary embodiments of the disclosure have been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the disclosure. | 130,218 |
11857482 | DETAILED DESCRIPTION The Detailed Description merely describes exemplary embodiments of the invention and is not intended to limit the scope of the claims in any way. Indeed, the invention is broader than and unlimited by the exemplary embodiments, and unless specifically indicated otherwise, the terms used in the claims have their full ordinary meaning. “Circuit communication” as used herein indicates a communicative relationship between devices. Direct electrical, electromagnetic and optical connections and indirect electrical, electromagnetic and optical connections are examples of circuit communication. Two devices are in circuit communication if a signal from one is received by the other, regardless of whether the signal is modified by some other device. For example, two devices separated by one or more of the following—amplifiers, filters, transformers, optoisolators, digital or analog buffers, analog integrators, other electronic circuitry, fiber optic transceivers or satellites—are in circuit communication if a signal from one is communicated to the other, even though the signal is modified by the intermediate device(s). As another example, an electromagnetic sensor is in circuit communication with a signal if it receives electromagnetic radiation from the signal. As a final example, two devices not directly connected to each other, but both capable of interfacing with a third device, such as, for example, a processor, are in circuit communication. Also, as used herein, voltages and values representing digitized voltages are considered to be equivalent for the purposes of this application, and thus the term “voltage” as used herein refers to either a signal, or a value in a processor representing a signal, or a value in a processor determined from a value representing a signal. “Signal,” as used herein includes, but is not limited to one or more electrical signals, analog or digital signals, one or more computer instructions, a bit or bit stream, or the like. “Logic,” synonymous with “circuit” as used herein includes, but is not limited to hardware, firmware, software and/or combinations of each to perform a function(s) or an action(s). For example, based on a desired application or needs, logic may include a software-controlled processor, microprocessor or microcontroller, discrete logic, such as an application specific integrated circuit (ASIC) or other programmed logic device. Logic may also be fully embodied as software. The circuits identified and described herein may have many different configurations to perform the desired functions. Any values identified in the detailed description are exemplary, and they are determined as needed for a particular massaging device. Accordingly, the inventive concepts disclosed and claimed herein are not limited to particular values or ranges of values used to describe the embodiments disclosed herein. FIG.1is a perspective view of an exemplary embodiment of a hand-held massaging device100. The exemplary massaging device100includes a main housing102that houses a motor and a drive unit and an upper housing104that includes a heat sink and a fan. In addition, massaging device100includes a first handle106, and a second optional handle108. Handle106has a longitudinal axis that extends away from the housing102. The massaging device100also includes a massaging head130. As discussed in more detail below, in some embodiments massaging head130includes a quick-release connection. Massaging device100includes a control panel124. In one embodiment, control panel124comprises a first momentary pushbutton126and a second momentary pushbutton128. First and second pushbuttons126,128may serve multiple purposes. In one embodiment, pushing the first pushbutton126once moves the massaging device100to a first preset speed. Pushing the first pushbutton126a second time moves the massaging device100to a second preset speed. Accordingly, multiple preset speeds may be selected by pushing a single pushbutton. In addition, pushing pushbutton126and holding it down may increase the speed of the massaging head until the user releases the pushbutton126. In addition, if the massaging device100is turned off, pushing second pushbutton128once and holding it in for a period of time turns on the massaging device100. Pushing the second pushbutton128in and holding it in for a period of time, such as, for example one second, causes massaging device100to turn off. While massaging device100is turned on, pushing and releasing second pushbutton128decreases the speed of the massaging device100to the next lowest preset speed. Pushing and releasing pushbutton128again further reduces the speed of the massaging device100. In some embodiments, the operating speed of the massaging device is generally between about 600 and 3600 strokes per minute. The control panel124is located above handle106on upper housing104. Control panel124is located off of the handle106, which prevents accidental contact between a user's hand and the control panel124and allows a user to move her hand to any position on the handle106during operation. Preferably, control panel124is located so that it is reachable by a user's thumb without the user having to remove her hand from the handle106. In addition, massaging device100includes a power cord132for providing power to the massaging device100. Although the exemplary control panel124illustrates two pushbuttons126,128, other controls may be used, such as dials and switches. In addition, visual or audible signals may be generated and displayed on control panel124. To that extent, control panel124may include a visual display (not shown), an audible device (not shown) or the like, such as, for example a speaker, or the like. If a visual or audible device is used, the visual or audible device may be located proximate the pushbuttons or other controls, or may be located apart from such controls. Upper housing104includes an air intake aperture covered by intake grate120and one or more air outlet apertures covered by outtake grate(s)122. As described in more detail below, the heat-generating internal components of massaging device100are cooled by air passing through upper housing portion104. FIGS.2and3are cross-sections of massaging device100. Located within handle106is control circuitry260. Control circuitry260is in circuit communication with power cord132, control panel124, fan222and motor210. Motor210is located in housing102opposite handle106. Motor210is a variable speed DC motor; however, motor210may be a constant speed motor, an AC motor or the like. In one embodiment, motor210has an operating speed of between about 600 and 3600 revolutions per minute (RPMs). Motor210includes a shaft211that extends into a flywheel212. Flywheel212includes a cylindrical projecting member or crank pin213positioned offset from the centerline400(FIG.4) of the flywheel212. Crank pin213is inserted in an aperture410(FIG.4) of a crank bearing214. Crank bearing214is inserted into a pocket232of a piston230. The piston also has an elongated cutout402to receive part of the flywheel212for compactness while permitting piston reciprocation. Crank bearing214is cuboid in the exemplary embodiment, however, in some exemplary embodiments, crank bearing214may cylindrical. FIG.4is an exploded perspective view of piston230, flywheel212and crank bearing214. Piston230may be made of any suitable material, and in some embodiments, piston230is made of aluminum. As illustrated in the drawings, in some embodiments, motor210is located on one side of the longitudinal axis of piston230and handle106is located on a second side of the longitudinal axis. Piston230includes a pocket232(or transverse slot) having a first wall232A and a second wall232B. In some embodiments, piston230is hollow on either side of pocket232to reduce weight. Flywheel212includes a cylindrical projecting member213. Crank pin213is off set from the centerline400of flywheel212. Accordingly, as flywheel212rotates, crank pin213rotates in a circular path around the centerline400of the flywheel212. Rotation of crank pin213causes crank bearing214to travel in a circular motion within piston pocket232causing reciprocal motion of piston230. Piston230is restrained by two spaced apart bearings310,311(FIG.3). Bearing310is located on a first side of flywheel212and bearing311is located on a second side of flywheel212. Accordingly, piston230may only move in a back-and-forth motion along its longitudinal axis. The arrangement of the bearings310,311on both ends of the piston230provides for a very sturdy and robust drive mechanism. Because piston230is constrained to a linear back-and-forth motion, as crank bearing214rotates in a circular motion, it acts against side walls232A and232B of pocket232. This mechanism for converting rotary to linear motion is known as a “Scotch yoke.” In order to correctly assemble the components of a Scotch yoke drive, the pocket232(or walls of transverse slot) must be milled larger than the outside dimensions of the crank bearing214. The gap between the inside of pocket232and the outside of crank bearing214is typically mm inches. Motor210rotates at between about 600 and 3600 RPMs and each time the crank bearing214switches from moving, for example, toward side wall232A of pocket232to moving toward the other side wall232B, the bearing block214travels the small gap and smacks or strikes the side wall, e.g., side232B, which causes a significant amount of noise and wear. In one exemplary embodiment, crank bearing214is made with one spring bar412. Figure is an enlarged elevation view of side420of crank bearing214andFIG.5Bis an enlarged plan view showing top422of crank bearing214. The spring bars412are created by milling the outside of the spring block214proud by 0.4 mm in the area of the desired spring bar. As illustrated inFIG.5A, the surface of spring bar412bows outward. The size of the bow is set to increase the width of the crank bearing214to be slightly larger (0.4 mm) than the width of the pocket232. In some embodiments, slots502and504are milled into the surfaces of side420and top422below the spring bar412to allow spring bar412to deflect inwards. In some embodiments, slots502and504intersect thereby leaving spring bar412supported only on each end. Thus, when crank bearing214is inserted into pocket232, the spring bar412contacts the corresponding surface of the pocket232and deflects inward which causes crank bearing214to fit snuggly in pocket232. Accordingly, as crank bearing214changes directions from, for example, moving toward side wall232A to moving toward side wall232B, the spring bar412takes up the slack in the gap and prevent noise and wear that would otherwise be generated by the crank bearing214striking the side walls232A,232B of the pocket232. Crank bearing214may be made of any suitable material; in some embodiments, crank bearing214is made of plastic. Although the exemplary embodiment is shown and described as having one spring bar, exemplary embodiments may have any number of spring bars. Massaging device100includes a drive housing218. Drive housing218is made of a heat conducting material, such as, for example, aluminum and has a longitudinal bore327passing therethrough to receive piston230. As shown inFIG.3, drive housing218includes a first internal cylindrical groove308for holding bearing310and a second internal cylindrical groove309for holding bearing311. Spaced bearings310and311mount and guide the piston230relative to the drive housing218. Drive housing318surrounds piston230and flywheel212. In some embodiments, drive housing318is made up of multiple components, such as an upper drive housing and a lower drive housing. In addition, motor210includes a motor housing209that bolts onto drive housing218. Motor housing209is also made of a heat-conducting material, such as, for example, aluminum. Secured to drive housing218is heat sink220. Heat sink220includes a plurality of fins221. Heat sink220is made of a heat conducting-material, such as, for example, aluminum. Main housing102contains a first cavity281. Upper housing104contains a second cavity282. First cavity281and second cavity282are separated by a barrier280. Motor housing209and drive housing218are located in the first cavity281. Heat sink220is located in second cavity282. The exemplary embodiment describes a main housing102and upper housing104. These may be portions made up of a single structure or multiple structures secured to each other. Second cavity282includes an air inlet aperture340which is covered by grate120and one or more air outlet apertures342covered by one or more grates122. A fan222is located in second cavity282. When the fan222is activated, air enters second cavity282through air inlet aperture340and passes over cooling fins221of heat sink220, and the air then passes out of second cavity282through the one or more air outlets342. The fan may be activated by a switch (not shown) on control panel124, activated automatically when the massaging device100is turned on, or may be activated by a thermostat (not shown). Thus, the cooling system for massaging device100is located in second cavity282and is isolated from the other components in the massaging device100. In typical massaging devices, cooling air is blown over the motor. Because the massaging devices operate for long periods of time in an atmosphere that is subject to a significant amount of dust and lint because the massaging device is often used on a person wearing clothes, a towel or a robe. Over time, the dust and lint may build up on the motor and cause the prior art massaging devices to overheat. Locating the cooling system in a cavity282that is isolated from the rest of the internal components minimizes this type of failure. The air outlet grates122may be sized larger to allow any lint and dust to freely pass out of the cavity282. In addition, the surface of the heat sink220is smooth and thus, there will be few pockets for dust and lint to get trapped. FIGS.6and6Aillustrate an exemplary embodiment of a quick-connect system600for connecting a massaging head620to a piston602. When providing a deep tissue massage using a massaging device, such as, for example, massaging device100, it may be desirable to switch massaging heads to work on different muscles or different portions of muscles during the massage. The exemplary quick-connect system600allows a user to quickly switch massaging heads620. Moreover, the exemplary quick-connect system600may be used without turning off the massaging device100. Quick-connect system600includes a piston602that has a hollow-end bore608for receiving the shaft621of a massaging head620. Located within the bore608of piston602is a cylindrical seat604. Cylindrical seat604retains a magnet606. Magnet606is illustrated with its north pole located flush with the seat and facing toward the opening in bore608. Massaging head620includes a shaft621having a cylindrical pocket622at the distal end. Located within the cylindrical pocket622is a magnet624. Magnet624is positioned so that its south pole is located at the distal end of shaft621. Accordingly, when the shaft621of massaging head620is slid into opening in bore608, the magnets606and624are attracted to one another and magnetically hold massaging head620firmly in place. To remove massaging head620, a user need only apply a sufficient amount of force to separate the two magnets606,624. The strength of the magnets606,624are sized to prevent the massaging head620from separating from the piston602during normal use, and yet allow a user to quickly remove and replace the massaging head620. In some embodiments the end626of the massaging head620is rounded, pointed or tapered (not shown) to allow it to easily slip into the opening608even while the piston608is moving. FIG.6Billustrates another quick-connect massaging head630. Quick-connect massaging head630is substantially the same as massaging head620except that the head portion639has a different shape than head portion629of massaging head620. In some instances, it may be desirable to adjust the throw or the stroke length of the massaging head to work on larger or smaller muscle groups, or deeper or shallower points of stress or soreness in the muscles.FIG.7illustrates an exemplary embodiment of a lost motion system700. Although lost motion system700is a hydraulic lost motion system, other mechanical lost motion devices may be used in accordance with embodiments of the present invention. Lost motion system700is contained in housing702. Housing702may be similar to drive housing218described above except it may need to be larger to accommodate lost motion system700. Housing702includes a floating piston720located in first cylindrical bore708. Floating piston720includes a sealing member722for forming a seal between floating piston720and first cylindrical bore708. A cam706secured to housing702may be rotated to adjust the amount of travel that floating piston720may move. A passage710fluidically connects first cylindrical bore708to second cylindrical bore704. A drive piston730is located in second cylindrical bore704. Drive piston730includes a sealing member732to seal between the drive piston730and second cylindrical bore704. Drive piston730may be driven in substantially the same way as described above with respect to piston230. A passage705fluidically connects second cylindrical bore704and passage710to third cylindrical bore706. Located within third cylindrical bore706is an output piston740. Output piston740includes a sealing member742, such as, for example, an o-ring to form a seal between drive piston730and third cylindrical bore706. Hydraulic fluid712is located in passages705,710and portions of the first, second, and third cylindrical cavities708,704and706as illustrated. A massaging head (not shown) is connected to output piston740. During operation, if cam706is set so that floating piston720is retained at the proximate end of first cylindrical bore708(as illustrated), movement of the drive piston730moves output piston740its maximum stroke length. If cam706is set so that floating piston720moves to adjacent the distal end of first cylindrical bore708, movement of the drive piston730moves output piston740its minimum stroke length. The cam may also be selectively rotated to intermediate positions to choose different magnitudes of floating piston movement resulting in different selected magnitudes of output piston movement. In some embodiments, floating piston720is physically connected to the cam or other adjustment mechanism so that it is positioned in a predetermined position and remains stationary during operation of the drive piston730. Thus, floating piston720does not float during operation of the massaging device. In some embodiments, the lost motion system may be contained in the massaging head itself, or in an adaptor that connects between the piston and the massaging head. Thus, rather than having a cam in the housing of the massaging device, different applicator heads or adaptors having a set lost motion, or variable lost motion systems integral therein may be used. In some embodiments, such adaptors and massaging heads may be adapted with a quick-connect system similar to the ones described with respect toFIGS.6and6A. FIG.8illustrates a simplified exemplary electrical schematic diagram800of an embodiment of a massaging device. The components disclosed as being on a particular circuit board may be on multiple circuit boards or individually mounted and hardwired to one another. Circuit board801includes memory804, motor control circuitry810and fan control circuitry816, which are in circuit communication with processor802. Fan control circuitry816is in circuit communication with fan817. Power circuitry812may be included on circuit board801or may be located on its own external to the massager. Power circuitry812includes the necessary power conditioning circuitry to provide power to both the electronics and the motors. In circuit communication with power circuitry812is plug814. Optionally two or more power circuits may be utilized. All of the connections between power circuitry812and the other components may not be shown inFIG.8; however, those skilled in the art have the required knowledge to provide power to the devices that require power. Motor control circuitry810is in circuit communication with drive motor811. Drive motor811is used to drive the piston and massaging head as described above. Memory804is a processor readable media and includes the necessary logic to operate the massaging device. Examples of different processor readable media include Flash Memory, Read-Only Memory (ROM), Random-Access Memory (RAM), programmable read-only memory (PROM), electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic disk, and optically readable mediums, and others. Still further, the processes and logic described herein can be merged into one large process flow or divided into many sub-process flows. The order in which the process flows herein have been described is not critical and can be rearranged while still accomplishing the same results. Indeed, the process flows described herein may be rearranged, consolidated and/or reorganized in their implementation as warranted or desired. In addition, processor802is in circuit communication with control panel806. Control panel806includes any desired pushbuttons, dials, displays or the like. Control panel806provides the operator interface to operate and control the massaging device. Processor802is also in circuit communication with data connection820. Representative data connections820include an Ethernet wire, Bluetooth, WiFi, optical transmitter/reader, an IR reader and the like. Combinations of two or more different data connections820may be used. Data connection820may be used to transmit data to an outside device, such as, for example, a computer or hand-held portable device. Various uses for transmitting such data are described below. In some embodiments, processor802includes logic to collect and store data related to use of the massaging device. Exemplary types of data may include usage rates, operating times or the like. In some embodiments, different massaging heads include an RFID chip and when inserted into the massaging device, an RFID reader (not shown) identifies and stores the type of massaging head utilized. In some embodiments, a customer number may be associated with the data. This data may be used to determine lease rates of the massaging device, for calculating cost/benefit analysis, or for setting up customized massages. In some embodiments, data may be uploaded from a computer or hand-held portable device to the massaging device. Such data may include customized massaging programs tailored for individual needs. In some embodiments, the customized massaging program may be reflective of prior massages given to a customer that were particularly well-received by the customer. In some embodiments, the customized massaging program may indicate to the user on a display on the control panel806massage times, locations, type of massage head to use or the like to ensure covering the desired locations with the customized massage. While various inventive aspects, concepts and features of the inventions may be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present inventions. Still further, while various alternative embodiments as to the various aspects, concepts and features of the inventions—such as alternative materials, structures, configurations, methods, circuits, devices and components, software, hardware, control logic, alternatives as to form, fit and function, and so on—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts or features into additional embodiments and uses within the scope of the present inventions even if such embodiments are not expressly disclosed herein. Additionally, even though some features, concepts or aspects of the inventions may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present disclosure; however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of an invention, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified as such or as part of a specific invention. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. | 25,668 |
11857483 | DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The technical solutions in the embodiment of this invention will be described clearly and completely below. Obviously, the described embodiment is only the part of the embodiment of this invention, but not the whole embodiment. Based on the embodiments in this invention, all other embodiments obtained by ordinary technicians in the field without creative labor belong to the scope of protection of this invention. Referring toFIGS.1-6, in the embodiment of this invention, a sex toy with universal connecting structure includes an outer cup body10, a sperm collection cup sleeve20, an inner cup body30, a guide part40, a power part50, an eccentric wheel drive assembly60and an electric control part70. The sperm collection cup sleeve20is installed by using the outer cup body10as the main body, and then the sperm collection cup sleeve20is pushed by the inner cup body30to extract sperm. Generally, the sperm collection cup sleeve20is made of soft material; the cup mouth of the sperm collection cup sleeve20is fixed, and the operation of sperm collection could be realized by pushing the inner cup body30inside. Specifically, the inner cup body30is slidably connected inside the outer cup body10through the guide part40, the sperm collection cup sleeve20is positioned between the outer cup body10and the inner cup body30, the cup mouth of the sperm collection cup sleeve20is hermetically connected with the cup mouth of the outer cup body10, the outer cup bottom of the sperm collection cup sleeve20is connected with the inner cup bottom of the inner cup body30. The power part50and the electric control part70are fixedly installed in the outer cup body10, and are electrically connected, the eccentric wheel drive assembly60is drivingly connected between the power part50and the outer cup bottom of the inner cup body30, the power part50drives the inner cup body30to reciprocate through the eccentric wheel drive assembly60, and is combined with the guide part40under the action of the eccentric wheel drive assembly60, so that the power generated by the power part50could drive the inner cup body30to reciprocate. Based on the cooperation of this structure, the inner cup body30could swing while reciprocating, this invention improves the structure of the guide part40, which is embodied in that the guide part40includes a guiding rod41arranged inside the outer cup body10, a guiding slider42slidably connected to the guiding rod41, and a universal ball head piece43arranged outside the inner cup body30, the guiding slider42is provided with a universal ball head hole421matched with the universal ball head piece43, and the universal ball head piece43is movably connected to the universal ball head hole421. The matching of the universal ball head piece43and the universal ball head hole421is utilized, so that the inner cup body30could rotate along the position of the universal ball head hole421during the process of reciprocating along the guide part40; in addition, due to the transmission structure adopts the eccentric wheel transmission assembly60, the inner cup body30could swing while reciprocating, so that the reciprocating and swinging are simultaneously transmitted to the sperm collection cup sleeve20, and the reciprocating action could assist the sperm collection and with the effect of swinging or generating vibration, which is beneficial to improving the efficiency of sperm collection. Besides, the matching of the universal ball head piece43and the universal ball head hole421is utilized, so that the smoothness and stability of the reciprocating operation of the inner cup body30could be greatly improved, and finally, the power transmission efficiency is improved, and the noise generated by the operation of internal parts is reduced. Referring toFIG.6, in order to make the sperm collection cup sleeve20generate reciprocating and swinging movements and also equipped with the effect of vibration, the vibrator21could be arranged inside the sperm collection cup sleeve20, and the vibration effect generated by the vibrator21could urge the sperm collection cup sleeve20to generate vibration effect. In order to solve the arrangement and wiring problems of the vibrator21, the capsule bin22with the backward opening could be formed on the outer side of the sperm collection cup sleeve20, the vibrator21is arranged in the capsule bin22, and the vibrator21is electrically connected with the electric control part70through the opening of the capsule bin22, as for the problem of blocking the circuit of the vibrator21, due to the inner cup body30only provides power to the sperm collection cup sleeve20and has no sealing requirement, the inner cup body30could be set as the hollow structure, so that the wires connecting the vibrator21could enter the outer cup body10through the hollow structure on the inner cup body30after passing through the capsule bin22. Referring toFIGS.3-5, considering the stability of sliding fit between the inner cup body30and the outer cup body10, there are two guide parts40, which are evenly distributed between the outer cup body10and the inner cup body30. The fixing of the guiding rod41is that, the guiding rod41includes two fixing seats411fixedly installed inside the outer cup body10and two guiding rods412connected between the two fixing seats411; the two guiding rods412are arranged in parallel, and the guiding slider42is slidably connected with the two guiding rods412, the structural cooperation of the universal ball head piece43and the universal ball head hole421is based on the fact that the universal ball head piece43comprises the connecting column431arranged outside the inner cup body30and the universal ball432rotatably connected to the connecting column431, and the universal ball432could be movably connected with the universal ball head hole421; the universal ball head hole421is in the structure of cylindrical, and the universal ball432is in sliding contact with the inner wall of the universal ball head hole421. Referring toFIGS.3and5, the eccentric wheel drive assembly60includes the eccentric wheel part61dynamically connected to the power main body and the push block62rotatably connected to the eccentric wheel part61. The push block62is fixedly connected with the inner cup body30, and the eccentric operation of the eccentric wheel part61drives the rotationally connected push block62to realize reciprocating and swinging motion, so that the eccentric wheel drive assembly60could drive the inner cup body30to realize the reciprocating and swinging motion. The power part50includes the motor base51fixedly installed in the outer cup body10and the motor52fixedly installed in the motor base51. The eccentric wheel part61is provided with the turntable63dynamically connected with the motor52and the eccentric column64which is arranged on the turntable63and deviates from the axis of the turntable63, and the push block62is rotatably connected with the eccentric column64. Referring toFIGS.1-2, the electric control part70includes the electric control board71and the battery72arranged inside the outer cup body10. The electric control board71is provided with the operation button73and the charging interface74exposed outside the outer cup body10. The battery72, the charging interface74, the operation button73, the power part50and the vibrator21are all electrically connected with the electric control board71. Referring toFIGS.1-2, the cup cover11is also clamped at the cup mouth of the outer cup body10to protect the sperm collection cup sleeve20. It is obvious to those skilled in this field that this invention is not limited to the details of the above-mentioned exemplary embodiments, but could be realized in other specific forms without departing from the spirit or essential characteristics of this invention. Therefore, the embodiments should be considered in all aspects as illustrative and not restrictive, and the scope of the invention is defined by the appended claims rather than the above description, so it is intended to embrace all changes that come within the meaning and range of equivalents of the claims. | 8,170 |
11857484 | DETAILED DESCRIPTION OF THE INVENTION It goes without saying that the embodiments and variants described here are only for illustrative purposes, and must not be construed as limiting for the invention; rather, the protective scope of the invention extends to all embodiments that the expert can find based upon the description, wherein the protective scope is established by the claims. The same reference numbers are used on the figures for the same or comparable elements to simplify the explanations and illustrations. The reference numbers used in the claims are further intended solely to make the claims easier to read and the invention easier to understand, and by no means have a character that detracts from the protective scope of the invention. FIG.1shows a perspective front view of the upper end area101of a forearm crutch100, comprising an essentially forked arm guiding portion102and a gripping portion103, which are covered by a cover200of the crutch accessory set according to the invention.FIG.2shows a rear view,FIG.3shows a front view, andFIG.4shows a side view of the arrangement shown onFIG.1. The basic structural design of a forearm crutch, parts of which are shown onFIG.1-4, is generally known. The forearm crutch100comprises an essentially elongated (entire length not shown) support rod104, typically made out of metal, with a foot (not shown) at its lower end. Depending on the height of the person with impaired or restricted mobility, the upper end area101of the forearm crutch100is provided with support means, which have the gripping portion103and the forked arm guiding portion102, in which the forearm of the person is supportively accommodated. The gripping portion103comprises a handle105of a known kind. As ready evident fromFIG.1-4, areas of the arm guiding portion102and the gripping portion103of the crutch100are covered with a single-part cover200, with the cover200specifically extending primarily over those areas of the upper end area101which support the forearm or the hand of the user while walking. In the example shown, the cover200is fastened by means of a drawstring201in the upper area of the arm guiding portion102, and with a lacing202to the gripping portion103. However, as will be clear to the expert, the cover200can also be fixed to the crutch100by means of other fastening mechanisms, for example Velcro fasteners or buttons. Each gripping area106of the handle105facing away from the palm of the user is here exposed, so that the user can easily hold the grooves107located thereon with his or her fingers. Further arranged on the cover is a plurality of connecting elements204(in the form of buttons in the example shown), so as to releasably fasten a bag component301of a bag300thereto, as will be explained in more detail below. As already explained at length above in the introduction to the specification, the covers200can be fabricated out of all possible materials suitable for covers and known to the expert, in particular out of fabric, laminate, leather, or combinations thereof. As likewise outlined in detail above, the cover200can additionally comprise impact- and pressure-absorbing paddings203; in the example shown, the paddings203are arranged in the upper area of the arm guiding portion102as well as the gripping portion105, and depicted as dashed fields on the figures. Reference is hereby made to the above statements in the introduction to the specification. The crutch accessory set according to the invention is provided for two forearm crutches, and thus advantageous for people who require two forearm crutches for walking. Therefore, a crutch accessory set according to the invention comprises a cover200depicted onFIG.1-4, provided at least in duplicate. The crutch accessory set according to the invention further comprises a container arrangement300that is described below and depicted onFIGS.5and6. FIG.5shows a schematic view of a handbag-like container arrangement300(hereinafter referred to as bag300for short) of a crutch accessory set according to the invention.FIG.6shows the bag300onFIG.5in a semi-assembled form, andFIG.7shows an individual container (hereinafter referred to as bag component301) of the bag300onFIG.5. The bag300is composed of two essentially congruent bag components301. The bag components301can be releasably connected with each other by means of connecting elements302(in the form of buttons302in the example shown), so as to yield the bag300in the connected state. The bag300is fabricated out of a soft, flexible material, e.g., fabric, laminate, or leather. It also has a shoulder belt303as the carrying means; the shoulder belt303can be fastened to the bag300and removed again by means of buttons304. Reference is made to the above statements in the introduction to the specification with respect to the types of materials (e.g., fabrics, laminates, leather, etc.) and the design of the bag300or bag components301. FIG.8now shows a schematic view of how one of the two bag components301of the bag300is fastened to a cover200, which according to the illustration onFIG.1is fastened at the end area101of the crutch100. The bag component301is fastened to the corresponding connecting elements204of the cover200by means of the connecting elements302. As a consequence, a respective bag component301can be fastened to each of the crutches100by being fastened to the cover200. This allows people who need two forearm crutches to easily and practically transport small items, in particular belongings such as money, keys, or medication, on the one hand, while this solution is unlimitedly suitable for everyday use and satisfies the aesthetic requirements on the other. In the examples shown, buttons are depicted as the connecting elements204and302. However, as is clear to the expert, all types of connecting mechanisms are possible that enable a releasable connection between the covers200and the respective bag components301or between the two bag components301; apart from buttons, possible connecting elements include Velcro fasteners, zippers, magnetic fasteners, lace fasteners along with all other fastening elements known to the expert and suitable for the present invention. As readily evident fromFIGS.6and7, the two bag components301have an essentially trapezoidal shape. As depicted onFIG.8, the respective bag component301is now fastened to the respective cover200of the respective forearm crutch100in such a way that the shape of the bag component301tapers from the arm guiding portion102toward the gripping portion103. This is realized in an especially easy way by the trapezoidal shape of the bag components301. The bag component301fastened to the cover200is very slender in shape, and thus does not bother the user while walking. FIG.9shows a further development of the arrangement depicted onFIG.8of a crutch100with a cover200and a bag component301in a front view, andFIG.10shows the further development onFIG.9as viewed in perspective from the side. In the further development shown onFIG.9, a protective wrap400is additionally provided to protect the hand of the user. The protective wrap400protects the hand of the user, e.g., against cold, moisture, or sunlight, and is dimensioned and can be releasably fastened to the wrap200or to the forearm crutch100in such a way that at least an area of the respective hand of the user grasping the handle105is covered by the protective wrap400. The user can slip his or her hand through the opening401under the protective wrap400, so that the hands are protected against cold and moisture, e.g., rain or snow, or against sunlight. For example, the protective wrap400is fabricated out of a warming and weatherproof material, e.g., a multiply material comprised of a warming fabric panel of wool felt in combination with a rainproof and windproof outer layer made out of a membrane laminate (e.g., Gore-Tex). A crutch accessory set for two crutches according to the further development of the invention shown onFIGS.9and10thus comprises a cover200depicted onFIG.1-4, at least in duplicate, a container arrangement300as well as a protective cover400, at least in duplicate. The invention can be modified in any way known to the expert, and is not limited to the embodiments shown. Individual aspects of the invention can also be taken and largely combined with each other. The ideas underlying the invention are essential, which in view of this instruction can be implemented by an expert in manifold ways, and still be sustained as such. | 8,527 |
11857485 | DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS The present invention may be understood more readily by reference to the following detailed description of example embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Any and all patents and other publications identified in this specification are incorporated by reference as though fully set forth herein. Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. With reference now to the drawing figures, wherein like reference numbers represent corresponding parts throughout the several views,FIG.1shows a user on a knee walker10according to an example embodiment of the present invention. The knee walker10generally comprises a body frame20, a cushion or kneeling-pad assembly30, front axle assemblies40′ and40″, rear axle assemblies50′ and50″, and a four-wheel steering system60. In some example embodiments, knee walker10further comprises a body frame cover or chassis19. The four-wheel steering system60allows the user to control the directional orientation or turning of the front axle assemblies40′ and40″ and rear axle assemblies50′ and50″ in tandem. Generally, the front axle assemblies40′ and40″ rotate in a first rotational or angular direction while the rear axle assemblies50′ and50″ rotate in an opposite second rotational or angular direction. For example, as the front axle assemblies40′ and40″ are rotated counter-clockwise, the rear axle assemblies50′ and50″ are caused to rotate in the opposite, clockwise direction, as shown inFIG.3A. Conversely, if the front axle assemblies40′ and40″ are rotated clockwise, the rear axle assemblies50′ and50″ are rotated in the opposite, counter-clockwise direction, as shown inFIG.3B. The opposing rotational alignment of the front axle assemblies40′ and40″ and the rear axle assemblies50′ and50″ enables the knee walker to achieve a tighter or smaller turning radius compared to traditional knee walkers with two-wheel steering. In the neutral position, the front axle assemblies40′ and40″ and rear axle assemblies50′ and50″ are collaterally aligned, as shown inFIG.2. As shown inFIGS.1and2, body frame20generally comprises a head tube or sleeve22, front crossbar or cross-member24, a center crossbar or cross-member26, a knee-pad tube or sleeve28, and a rear crossbar or cross-member27. Body frame20generally comprises a tubular structure and is preferably constructed from a rigid material, including, but not limited to, metals, polymers, fiber-reinforced plastics, and/or combinations thereof. As shown inFIG.2, head tube22comprises a first, top end and a second, bottom end. At its second, bottom end, headtube22is welded, or otherwise affixed, to the front crossbar24. In example embodiments, the front crossbar24, spanning about 12-30 inches, preferably about 12-15 inches, or more preferably about 13.5 inches, is affixed at its center to the bottom end of head tube22and extends substantially perpendicular thereto. According to example embodiments, the front crossbar24has an arced or curved profile. However, the front crossbar24may comprise other profiles such as linear, angled, curved or any combination thereof. In example embodiments, front crossbar24comprises a left, proximal end24A′ and a right, distal end24A″ where each end comprises a cylindrical hinge or pivot body about which front axle assemblies40′ and40″ are hingeably secured as described below. As best shown inFIG.4, front axle assemblies40′ and40″ are pivotally mounted to the left and right ends24A′,24A″ of the front crossbar24, respectively. In the depicted embodiment, the left front axle assembly40′ comprises a left front axle bracket41′ having generally a C-shaped profile. The left front axle bracket includes a vertical portion or section having a top end and a bottom end. At its top end, the left front axle bracket includes a top prong or member which extends transversely from the vertical portion to a free end. The vertical portion also includes a bottom prong or member which extends transversely from the vertical portion to a free end in the same general direction of the top prong. The top and bottom members are generally positioned such that they are substantially parallel to one another and substantially perpendicular to the vertical portion. Space or gap is provided between the top and bottom horizontal prongs, the space or gap having sufficient area to receive the left end24A′ of the front crossbar24. In depicted embodiments, the free ends of the top and bottom prongs are concentrically aligned with and pivotally mounted to the left end24A′ of the front crossbar24, for example by a bolt or pivot pin. In the example embodiments, the left front axle bracket41′ further comprises a left front axle42′ on which left front wheel43′ is rotatably mounted. The left front axle is generally secured to the vertical portion of the axle bracket and extends transversely from the vertical portion in a direction opposite the top and bottom horizontal prongs. In example embodiments, the left front axle42′ is a bolt or axle pin having a head end and a threaded end, wherein the bolt is secured to the left front axle bracket41′ by its threaded end and the left front wheel43′ is rotatably mounted on the bolt between the head and threaded ends. In other example embodiments, the left front axle42′ may be a fixed component of the left front axle41′ which extends transversely therefrom. Axle bracket41′ also includes a front tie-rod connection tab or member44′, as best shown inFIG.4. The front tie-rod connection tab44′ is configured for mounting thereon one end of a front tie-rod67′ as described further below. Similarly, in the depicted embodiment, the right front axle assembly40″ comprises a right front axle bracket41″ having generally a C-shaped profile. The right front axle bracket41″ includes a vertical portion or section having a top end and a bottom end. At its top end, the right front axle bracket includes a top prong or member which extends transversely from the vertical portion to a free end. The vertical portion also includes a bottom prong or member which extends transversely from the vertical portion to a free end in the same general direction of the top prong. The top and bottom members are generally positioned such that they are substantially parallel to one another and substantially perpendicular to the vertical portion. Space or gap is provided between the top and bottom horizontal prongs, the space or gap having sufficient area to receive the right end24A″ of the front crossbar24. In depicted embodiments, the free ends of the top and bottom prongs are concentrically aligned with and pivotally mounted to the right end24A″ of the front crossbar24, for example by a bolt or pivot pin. In the example embodiments, the right front axle bracket41″ further comprises a right front axle42″ on which right front wheel43″ is rotatably mounted. The right front axle is generally secured to the vertical portion of the axle bracket and extends transversely from the vertical portion in a direction opposite the top and bottom horizontal prongs. In example embodiments, the right front axle42″ is a bolt or axle pin having a head end and a threaded end, wherein the bolt is secured to the right front axle bracket41″ by its threaded end and the right front wheel43″ is rotatably mounted on the bolt between the head and threaded ends. In other example embodiments, the right front axle42″ may be a fixed component of the left front axle41′ which extends transversely therefrom. Axle bracket41″ also includes a front tie-rod connection tab or member44″, as best shown inFIG.4. The front tie-rod connection tab44″ is configured for mounting thereon one end of a front tie-rod67″ as described further below. The center crossbar26, having a front, proximal end and a rear, distal end, extends between the head tube22and rear crossbar27. At its front end, center crossbar26is welded, or otherwise attached, to the vertical head tube22and extends generally transversely therefrom. At its rear end, center crossbar26is welded, or otherwise affixed, to the center of rear crossbar27. In example embodiments, the center crossbar spans about 19-22 inches, or preferably about 20-21 inches, or more preferably about 20.5 inches. In the depicted embodiment, the center crossbar26is attached to and extends transversely from near the top end of head tube22. In alternative embodiments, the center crossbar26may be attached to the bottom end of the head tube22, the center of the head tube22, or any position or location along the length of the head tube22. In yet other example embodiments, there may be multiple center crossbars or support bars arranged in various configurations for increased stability and rigidity. The center crossbar26also comprises a knee-pad tube or sleeve28configured to receive the knee-pad assembly30as described below. The knee-pad tube28comprises a top end and a bottom end and is hollow therethrough. The knee-pad tube generally extends transversely from the center crossbar and substantially perpendicular to the ground or riding surface. The location of the knee-pad tube28may vary along the length of the center crossbar26between its front and rear ends. Knee-pad tube28may also include a locking pin hole29, a post collar lock, or other similar locking mechanisms to hold the knee-pad assembly in place during use. According to example embodiments, the knee-pad tube28is positioned on the center crossbar26at about 10-20 inches, preferably about 12-18 inches, or more preferably about 14-16 inches, from head tube22and is marginally angled relative to the ground. Alternatively, the knee-pad tube28is secured to the center crossbar26wherein the distance between the knee-pad tube and the front end of the crossbar is equal to or greater than, for example about 1.5-2 times, the distance between the knee-pad tube and the back end of the crossbar. The cushion or knee-pad assembly generally comprises a cushion31, a cushion base plate32, and a cushion post33. In use, the user places one knee on the cushion or knee-pad31to reduce the pressure or force applied to the knee, lower leg, ankle, and/or foot. The cushion generally comprises a pliable or resilient core encased in an elastic shell or casing. According to the example embodiment, the cushion is made from resilient foam enveloped in a synthetic leather shell. In other example embodiments, the cushion core may comprise fillers such as rubbers, gels, natural and/or synthetic fibers, or other suitable materials known in the art. Similarly, the cushion casing may be constructed from natural or synthetic leather, natural or synthetic fibers, rubbers, or other suitable materials known in the art. Cushion31generally comprises a top surface, a bottom surface, and a side surface between the peripheries of the top and bottom surfaces. According to example embodiments, the top surface of cushion31is contoured to provide greater support and stability. The cushion base plate or panel32is secured to the bottom surface of cushion31thereby providing structure and support to the cushion. The cushion post or column33is a tubular member secured to the cushion base plate32. The cushion column33extends transversely from the cushion base plate32in the direction opposite cushion31. The cushion column33comprises a plurality of through-holes34spaced equally apart along its length. The through-holes34are configured to align with the locking pin hole29on knee-pad tube28. In example embodiments, the knee-pad assembly30is secured to the body frame20by inserting the cushion post33into knee-pad tube28and locking the knee-pad assembly30to the body frame20, for example by using a locking pin25. The height of the knee-pad or cushion31may be adjusted between a plurality of predetermined intervals by aligning the appropriate cushion column through-hole34to the locking pin hole29and securing the position with locking pin25. In alternative embodiments, locking pin25may be replaced with, or used in addition to, other post locking mechanisms known in the art, including, but not limited to, locking knobs, locking buttons, post clamps, and split collar locks. In example embodiments, the height of cushion31is adjustable between about 12-26 inches, or preferably about 16-22.5 inches, from the ground or riding surface. The rear crossbar27is affixed at its center to the distal end of center crossbar26and extends substantially perpendicular thereto. In example embodiments, the rear crossbar27, comprising a left, proximal end27A′ and a right, distal end27A″, spans about 4-7 inches, preferably about 4.5-6.5 inches, or more preferably 5.5 inches. At each end, rear crossbar27comprises a cylindrical hinge or pivot body about which rear axle assemblies50′ and50″ are hingeably secured as described below. According to example embodiments, the rear crossbar27has a linear profile. However, the rear crossbar27may comprise other profiles such as arced, angled, curved or any combination thereof. As shown inFIGS.2and5, the rear axle assemblies50′ and50″ are pivotally attached to the left, proximal end27A′ and right, distal end27A″ of the rear crossbar27, respectively. In the depicted embodiment, the left rear axle assembly50′ comprises a left rear axle bracket51′ having generally a C-shaped profile. The left rear axle bracket includes a vertical portion or section having a top end and a bottom end. At its top end, the left rear axle bracket includes a top prong or member which extends transversely from the vertical portion to a free end. The vertical portion also includes a bottom prong or member which extends transversely from the vertical portion to a free end in the same general direction of the top prong. The top and bottom members are generally positioned such that they are substantially parallel to one another and substantially perpendicular to the vertical portion. Space or gap is provided between the top and bottom horizontal prongs, the space or gap having sufficient area to receive the left end27A′ of the rear crossbar27. In depicted embodiments, the free ends of the top and bottom prongs are concentrically aligned with and pivotally or rotationally mounted to the left end27A′ of the rear crossbar27, for example by a bolt or pivot pin. According to example embodiments, the left rear axle bracket51′ further comprises a left rear axle52′ on which left rear wheel53′ is rotatably mounted. The left rear axle is generally secured to the vertical portion of the axle bracket and extends transversely from the vertical portion in the direction opposite the top and bottom horizontal prongs. In example embodiments, the left rear axle52′ is a bolt or axle pin having a head end and a threaded end, wherein the bolt is secured to the left rear axle bracket51′ by its threaded end and the left rear wheel53′ is rotatably mounted on the bolt between the head and threaded ends. In other example embodiments, the left rear axle52′ may be a fixed component of the left rear axle51′ which extends transversely therefrom. Axle bracket51′ also includes a rear tie-rod connection tab or member54′ and a center tie-rod connection tab or member55′, as best shown inFIG.5. The rear tie-rod connection tab54′ is configured for mounting thereon one end of a rear tie-rod68as described further below. Similarly, the center tie-rod connection tab55′ is configured for mounting thereon one end of a left center tie-rod65′ as described below. Similarly, in example embodiments, the right rear axle assembly50″ comprises a right rear axle bracket51″ having generally a C-shaped profile. The right rear axle bracket includes a vertical portion or section having a top end and a bottom end. At its top end, the right rear axle bracket includes a top prong or member which extends transversely from the vertical portion to a free end. The vertical portion also includes a bottom prong or member which extends transversely from the vertical portion to a free end in the same general direction of the top prong. The top and bottom members are generally positioned such that they are substantially parallel to one another and substantially perpendicular to the vertical portion. Space or gap is provided between the top and bottom horizontal prongs, the space or gap having sufficient area to receive the right end27A″ of the rear crossbar27. In depicted embodiments, the free ends of the top and bottom prongs are concentrically aligned with and pivotally or rotationally mounted to the right end27A″ of the rear crossbar27, for example by a bolt or pivot pin. In example embodiments, the left rear axle bracket51′ further comprises a right rear axle52″ on which a right rear wheel53″ is rotatably mounted. The left rear axle is generally secured to the vertical portion of the axle bracket and extends transversely away from the vertical portion in the direction opposite the top and bottom horizontal prongs. In example embodiments, the right rear axle52″ is a bolt or axle pin having a head end and a threaded end, wherein the bolt is secured to the right rear axle bracket51″ by its threaded end and the right rear wheel53″ is rotatably mounted on the bolt between the head and threaded ends. In other example embodiments, the right rear axle52″ may be a fixed component of the right rear axle51″ which extends transversely therefrom. Axle bracket51″ also includes a rear tie-rod connection tab or member54″ and a center tie-rod connection tab or member55″, as best shown inFIG.5. The rear tie-rod connection tab54″ is configured for mounting thereon an end of the rear tie-rod68opposite the end mounted to the left rear tie-rod connection tab54′, as described further below. Similarly, the center tie-rod connection tab55″ is configured for mounting thereon one end of a right center tie-rod65″ as described below. According to example embodiments, the front and rear wheels43′,43″,53′,53″ comprise 8-inch polyurethane or hard rubber tires. In alternate embodiments, the wheels comprise 12-inch air-filled or pneumatic knobby all-terrain tires. The wheel diameters may vary depending on the application, for example between about 4-18 inches, between about 6-14 inches, or between about 8-12 inches. The wheels may also comprise tires manufactured from other suitable materials known in the art. The steering system60comprises a T-bar steering handlebar61, a steering column62, a steering column sleeve63, a steering yoke or mount64, center tie-rods65′ and65″, a steering or pitman arm63B, front tie-rods67′ and67″, and a rear tie-rod68, as shown inFIGS.1-5. T-bar handlebar61comprises a horizontal handle portion61A and a vertical column portion61B. The horizontal handle portion includes handle grips61C′ and61C″ secured to each end of the horizontal handle portion61A, and a brake handle or lever81configured to operate a brake system80, as described below. In example embodiments, vertical column61B extends transversely from the center of the horizontal handle portion61A and includes a plurality of holes61D along its length for adjusting the height of the handlebar61, as shown inFIG.2. In example embodiments, vertical column61B has an outer diameter smaller than the inner diameter of the steering column62, allowing the vertical column to be inserted into or pass through within the steering column62. The steering column62features a locking pin or through hole62A which aligns to the plurality of holes61D on handlebar61. In use, the height of the handlebar61may be adjusted and locked or secured to a user-preferred height by aligning the locking pin hole62A to one of the plurality of holes61D on the handlebar and inserting or engaging a locking pin62B, locking knob, locking button, or other suitable locking mechanisms or systems for telescoping components. In example embodiments, the height of handle bar61and handle grips61C′ and61C″ is adjustable between about 24-48 inches, or preferably about 30-41 inches, from the ground or riding surface. The steering column62generally has a tubular structure comprising a top end and a bottom end. The top end of the steering column is configured to receive the bottom end of the vertical portion61B of the handlebar61, as described above. The bottom portion of the steering column62is inserted into the steering column sleeve63. Steering column62is detachably locked or secured to the steering column sleeve63such that they operate as a single component when assembled while enabling disassembly as needed for easy storage and/or transportation. The steering column sleeve63, having a top end and a bottom end, includes a top expanded lip63A′ at its top end and a bottom expanded lip63A″ at its bottom end, as best shown inFIG.4. The steering column sleeve63is passed through the head tube22and confined therein between the top and bottom expanded lips of the steering column sleeve. The steering column sleeve is thereby prevented from being removed from head tube22while still being able to rotate axially therein. Effectively, handlebar61, steering column62, and steering column sleeve63rotate or pivot axially in unison within the head tube22during use. However, the handlebar and the steering column may be disassembled from each other and from the steering column sleeve and head tube as needed for, for example, easier storage and/or transportation. As best shown inFIG.4, steering column sleeve63further comprises a steering arm63B having a fixed end and a free end. Generally, the fixed end is welded, or otherwise attached, to the bottom expanded lip63A″ of the steering column63and front tie-rods67′ and67″ are secured to the opposite, free end. In example embodiments, as the user rotates the handlebar61, steering column sleeve63is rotated about its axial axis inside head tube22thereby pivoting the steering arm63B about its fixed end. As the free end of the steering arm63B moves arcuately, the front tie-rods67′ and67″ are driven by the steering arm wherein the angular or rotational motion of the free end of the steering arm translates the front tie-rods laterally. In the depicted embodiment, the steering arm63B extends transversely from the bottom expanded lip63A″ towards the rear of the knee walker. In the depicted embodiment, steering arm63B comprises a Z-shaped profile but the profile need not be so limited. The steering arm may comprise, for example, other flat, arced, or angled profiles, or any combination thereof. As further shown inFIG.4, steering arm63B comprises a turn-stop post63C extending transversely therefrom. The turn-stop post is configured to engage a turn-stop guide22A mounted on the head tube22. The turn-stop guide protrudes laterally from head tube22and includes a contoured groove or notch between two extended protrusions which act as bumpers or backstops for the turn-stop post63C. For example, when the user rotates the handlebar61, steering arm63B pivots about the axial axis of the steering column sleeve63and steering column62. During normal operations, the turn-stop post63C moves freely within the contoured notch of the turn-stop guide22A. However, if the handlebar is rotated too much, the turn-stop post collides with the extended protrusions on either side of the contoured notch and the turn-stop post, and effectively handlebar61, is prevented from rotating any further. In example embodiments, the turn-stop guide prevents the user from over-turning the handlebar thereby preventing unintended accidents, such as for example, abrupt turns or over-extending the center tie-bars. As shown inFIG.4, the steering yoke or mount64is affixed to the top end of steering column sleeve63. Generally, center tie-rods65′ and65″ are coupled to the steering mount64which transfers the rotational motion of the handlebar to the center tie-rods as described in more detail below. In example embodiments, steering mount64comprises a main body with a pair of flanges or extensions64A′ and64A″ for mounting the front, proximal ends of center tie-rods65′ and65″. The left vertical flange64A′ is generally affixed to a first, left side of the steering mount body. Similarly, the right vertical flange64A″ is generally affixed to a second, right side of the steering mount body. The free ends of the left and right flanges64A′,64A″ are configured for securing thereon ends of center tie-rods65′ and65″, for example by mechanical fasteners, such as for example bolts or rivets. In other example embodiments, center tie-rods65′ and65″ may be welded, or otherwise permanently affixed, to flanges64A′ and64A″, respectively. In still other example embodiments, the front, proximal ends of the center tie-rods65′ and65″ may be mounted directly to the steering mount64. Generally, knee walker10comprises a system or plurality of tie-rod connectors which assist in the transfer of the operation and movement of the handlebar61to the front and rear axle assemblies40′,40″,50′, and50″. In example embodiments, front tie-rods67′ and67″—each having two opposing ends—connect the front axle assemblies40′ and40″ to the steering arm63B, as best shown inFIGS.3A-3B. For example, at its first end, the left front tie-rod67′ is secured to tie-rod connector member44′ of left front axle assembly40′ while its second end is secured to the steering arm63B. Similarly, the right front tie-rod67″ is secured to the steering arm63B at its first end and secured to tie-rod connector member44′ of the right front axle assembly40″ at its second end. As shown inFIGS.2-5, the center tie-rods65′ and65″ act as linkages between the steering mount64and rear axle assemblies50′ and50″. In example embodiments, both left and right center tie-rods65′ and65″ comprise a first, front end and a second, rear end. The front end of the left center tie-rod65′ is secured to the left vertical flange64A′ of steering mount64while the rear end is secured to the center tie-rod connector member55′ of the left rear axle assembly50′. Similarly, the front end of the right center tie-rod65″ is secured to the right vertical flange64A″ of steering mount64while the rear end is secured to the center tie-rod connector member55″ of the right rear axle assembly50″. As shown inFIG.5, the rear tie-rod68connects the left rear axle assembly50′ to the right rear axle assembly50″. In example embodiments, rear tie-rod68comprises a first, proximal end and a second, distal end wherein its first, proximal end is secured to the rear tie-rod connector member54′ of the left rear axle assembly50′ and its second, distal end is secured to the rear tie-rod connector member54″ of the right rear axle assembly50″. In example methods or modes of use, knee walker10provides ambulatory assistance to its users. Generally, the user places one knee on the knee cushion or knee-pad31to reduce any pressure or force applied to an injured foot and/or lower leg while walking or moving by pushing off with their uninjured foot and leg to roll the walker10forward or back. Handlebar61is provided for operating and maneuvering the knee walker. When fully assembled, handlebar61, steering column62, and steering column sleeve63are coupled together and rotate synchronously within head tube22. As the user rotates the handlebar, the steering arm63B and steering mount flanges64A′ and64A″ also hinge or rotate about the axial axis of head tube22. When the free end of the steering arm63B moves, its arcuate motion pushes and pulls the front tie-rods67′ and67″ laterally which in turn drives the front axle assemblies40′ and40″. For example, as shown inFIG.3A, when the handlebar61is rotated counter-clockwise, the steering arm63B hinges about its fixed end, or axial axis of steering column sleeve63. As a result, the free end of the steering arm63B pushes left front tie-rod67′ towards the left front axle assembly40′ wherein the left front tie-rod67′ in turn pushes front tie-rod connector44′ and drives left front axle assembly40′ to rotate about the left end24A′ of front crossbar24. At the same time, as the steering arm63B hinges about the axial axis of the steering column sleeve, the free end of the steering arm pulls the right front tie-rod67″ towards the left front axle assembly40′ which in turn causes right front axle assembly40″ to rotate counter-clockwise about right end24A″ of front crossbar24. The rotation of the handlebar61also rotates the steering mount64and its flanges64A′ and64A″. As the left and right steering mount flanges64A′,64A″ rotate about the axial axis of the steering column sleeve, one flange pulls one center tie-rod while the other flange pushes the other center tie-rod. For example, as shown inFIG.3A, when the handlebar is rotated counter-clockwise, left steering mount flange64A′ pulls left center tie-rod65′ towards the front of the knee walker and right steering mount flange64A″ pushes right center tie-rod65″ towards the rear of the knee walker. In turn, the left center tie-rod pulls the left center tie-rod connector55′ towards the front of the knee walker and thereby rotates the left rear axle assembly50′ clockwise about left end27A′ of rear crossbar27. At the same time, the right center tie-rod65″ pushes the left center tie-rod connector55″ towards the rear of the knee walker and thereby rotates the right rear axle assembly50″ clockwise about right end27A″ of rear crossbar27. The rear tie-rod68secured to rear tie-rod connector members54′ and54″ provides additional linkage between the rear axle assemblies50′ and50″. The additional linkage reinforces the interconnection between the steering mount, center tie-rods, and rear axle assemblies, and improves the responsiveness of the overall system. According to example embodiments, knee walker10further includes a brake system80. The brake system comprises a brake handle81; brake cables or lines82A,82B′, and82B″; brake line anchors84′ and84″; brake levers85′ and85″; brake housings86′ and86″; and brake rotors or discs87′ and87″. As shown inFIG.2, brake handle81is generally secured to the handlebar61near one of the handle grips. For example, in the depicted embodiment, the brake handle is attached to the handlebar near the right handle grip61C″. However, the brake handle may be provided near the left handle grip61C′, or near both left and right handle grips. In example embodiments, a single brake line82A extends out from brake handle81but is later split into two separate brake lines82B′ and82B″. Brake line82B′ leads to the left brake housing86′ attached to the left rear axle bracket51′. Brake line82B″ leads to the right brake housing86″ attached to the right rear axle bracket51″. The brake lines are generally sheathed inside a polyurethane sheath or sleeve83; however, sheath83may also be made from natural or synthetic rubbers, fibers, or other suitable materials. In example embodiments, brake lines82B′ and82B″ are secured to brake levers85′ and85″, respectively, as shown inFIG.5. Brake levers85′ and85″ are pivotally mounted to the brake housings86′ and86″, respectively. The brake housings enclose brake calipers (not shown) which are actuated by the brake levers and are configured to apply pressure to the brake rotors87′ and87″ to slow or stop the rear wheels as needed. The brake discs are affixed to the rear axles such that motion of the rear wheels are locked to the motion of the brake discs. In other words, for example, the left brake disc and left rear wheel rotate together as a unitary body. In example embodiments, brake lines82A,82B′ and82B″ are typically made from twisted or braided steel but may also be constructed from other metals, natural and/or synthetic fibers and fiber composites, plastics, or other suitable materials. In use, the user clenches or contracts the brake handle81by squeezing their hand to apply the brakes as needed. The contraction of the brake handle causes brake lines82B′ and82B″ to be pulled forward towards the front of the knee walker. The pull of the brake lines causes brake levers85′ and85″ to pivot which in turn actuates the brake calipers causing them to engage and apply resistive pressure on the brake rotors. Because brake lines82B′ and82B″ are split from a single brake line82A, actuation of the left and right brakes occurs simultaneously. According to another example embodiment of the present invention, and with reference toFIG.6, a knee walker100comprises a four-wheel cable-actuated steering system. The cable steering system generally replaces the center tie-rods of knee walker10with durable cables, for example made from twisted or braided steel. Knee walker100comprises a center crossbar126having a front, proximal end and a rear, distal end. At its rear, distal end, the center crossbar126comprises a hinge mechanism126A. The hinge mechanism is configured to receive and secure a rear axle assembly150. The rear axle assembly comprises a rear crossbar127having a left, first end and a right, second end, a left rear wheel153′ rotatably mounted to the left end of the rear crossbar127, and a right rear wheel153″ rotatably mounted to the right end of the rear crossbar127. The rear crossbar127is pivotally secured to the hinge mechanism126A, for example by a pivot pin or bolt, about its center. The rear crossbar127further comprises steering cable anchor points167′ and167″ equal distances apart from the rear crossbar's center. In the example embodiment, rear crossbar127has a tubular structure and spans about 4-12 inches, preferably about 5-10 inches, and more preferably about 6-8 inches. The cable anchors167′ and167″ are secured about 1-4 inches, or preferably 2-3 inches, from the rear crossbar's center. According to the example embodiment, the knee walker comprises two steering cables—a first steering cable163′ and a second steering cable163″, as shown inFIG.6. The steering cables are typically made from twisted or braided steel but may also be constructed from other metals, natural and/or synthetic fibers and fiber composites, plastics, or other suitable materials. The first steering cable163′ is secured to the left steering mount flange162′ at its first, front end and to the right rear axle anchor167″ at its second, rear end. The second steering cable163″ is secured to the right steering mount flange162″ at its first, front end and left rear axle anchor167′ at its second, rear end. Both steering cables163′ and163″ are loosely retained adjacent to the center crossbar126at predetermined points along its length. In the depicted embodiment, steering cables163′ and163″ are guided through retaining elements or points164′,164″,166′, and166″ to maintain the steering cables along the length of the center crossbar and prevent any unwanted entanglement. In example embodiments, the steering cables are further at least partially encased in a polyurethane sheaths or sleeves165′ and165″. In other example embodiments, sheaths165′ and165″ may be made from natural or synthetic rubbers, fibers, or other suitable materials. According to the depicted embodiment, crossing of the steering cables163′ and163″ across the center crossbar forces the rear axle assembly150to rotate in the opposite direction from the handlebar161and front axle assemblies140′ and140″. The opposing rotations of the front and rear axle assemblies allow knee walker100to achieve a smaller turning radius. For example, when the user rotates the steering handlebar161in the clockwise direction, front axle assemblies140′ and140″ are rotated in the same clockwise direction via tie rods177′ and177″. Simultaneously, the steering mount is rotated in the same clockwise direction which rotates forward the right steering mount flange162″ placing steering cable163″ under tension. As a result of the tension in the steering cable163″, the left anchor point127′ and left end of the rear crossbar127is pulled forward, rotating the rear axle assembly150in a counter-clockwise direction, opposite the front axle assemblies140′ and140″. Conversely, turning the handlebar161in the counter-clockwise direction causes the rear axle assembly150to rotate in the opposite, clockwise direction. Opposing rotations of the front and rear axle assemblies eliminate rear wheel drag and improve the effective turning radius of the knee walker. In this manner, tighter turns and improved maneuverability, relative to previously known knee walkers, are achieved. Improved stability may also be provided, for example due to shifting the turning or yaw axis toward, or coincident with, the center of gravity of the walker and person carried thereon, for example to a position at or around the knee cushion. In some example embodiments, the knee walker may comprise a steering system comprising only cables or chains. In other example embodiments, the knee walker may comprise a steering system comprising a rack-and-pinion. In yet other example embodiments, the knee walker may comprise steering systems incorporating hydraulics, chain-and-gear, and/or belt-and-wheel mechanisms operably configured to provide four-wheel steering. Motors and electronic actuators may be further incorporated to fully or partially automate the operation of the steering system. While the invention has been described with reference to example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims. | 38,397 |
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