WO2025226913A1

WO2025226913A1 - Cartridge assembly and methods for peripheral nerve repair

Info

Publication number: WO2025226913A1
Application number: PCT/US2025/026137
Authority: WO
Inventors: John Pepper; Steven S. Smith
Original assignee: Epineurial Coaptation Technology LLC
Current assignee: Epineurial Coaptation Technology LLC
Priority date: 2024-04-24
Filing date: 2025-04-24
Publication date: 2025-10-30
Anticipated expiration: 2026-10-24

Abstract

A cartridge assembly includes a cartridge having a cartridge frame with first and second frame ends and a first vacuum channel extending therebetween. A first and a second jaw is connected to the cartridge frame and is configured to releasably engage a conduit during a nerve repair procedure. A separator is configured to extend from the first frame end, through a vacuum port of the conduit and into the conduit's interior to provide a predetermined regeneration gap between first and second nerve stumps inserted into the conduit. A handpiece includes a handpiece chassis with first and second chassis ends and a second vacuum channel extending therebetween. The first chassis end is configured to releasably engage the second frame end in order to connect the first and second vacuum channels and to enable a vacuum source connected to the second chassis end to pull a vacuum on the conduit's interior.

Description

CARTRIDGE ASSEMBLY AND METHODS FOR PERIPHERAL NERVE REPAIR

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims benefit of priority of U.S. Provisional Patent Application No. 63/637,976, filed on April 24, 2024, and entitled "Cartridge Assembly and Methods For Peripheral Nerve Repair” the disclosure of which is hereby incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure relates to devices for nerve repair and methods of making the same. More specifically, the disclosure relates to cartridge assembly systems for epineurial coaptation nerve repair and methods of making the same.

BACKGROUND OF THE INVENTION

[0003] Nerve damage is caused by laceration, crushing, tearing or puncture. The patient will experience loss of sensory ability and motor ability. The hand and wrist are the sites of most nerve repairs, though they are performed in all appendages.

[0004] Nerves consist of many individual nerve cells, axons, grouped together in a funiculus, wrapped in perineurium, which are grouped with other grouped axons, and blood vessels, all contained in an outer sheath called the epineurium. The severed epineurium and nerves are referred to herein as proximal and distal nerve stumps. The epineurium is thin, flexible, and nearly translucent. When a nerve is cut, a scar will form over the end.

[0005] The nerve cells, axons, are capable of elongating from proximal stump of the damaged nerve bundle distally, in a growth cone, at a rate of one (1) millimeter per day. These cannot penetrate a scar, and its chemistry inhibits axon growth. Many times, the scar must be trimmed off surgically.

[0006] Repair depends on distance between viable ends of the stumps. If there is no gap, the stumps can be sutured directly to each other. The alignment and drawing together of stumps to each other is defined as coaptation in medical terms.

[0007] In injuries with gaps under five (5) millimeters, if the stumps are approximated, the cells will connect with the distal stump and regain of function is possible. The use of conduits has been an effective way to coapt the stumps. Larger gaps are treated with resorbable scaffolds or grafts. (Griffin JW. Peripheral nerve repair and reconstruction. J Bone Joint Surg Am. 2013 Dec 4;95(23):2144-51).

[0008] Problematically, effective repair of injured nerves has long been a tedious problem of repair and remains largely the purview of micro surgically trained plastic or hand surgeons. The accurate, end-to-end anastomosis of the nerves to create a stable, secure connection without causing overlapping of the fascicles remains a challenging surgical problem even for skilled and experienced surgeons.

[0009] The handling of conduits and grafts is typically done manually. Coaptation is done with manually placed fine sutures inside the scaffold to the stump, then suture ends are pulled to move stump ends into the scaffold tube. The nerve attachment is done via passing, for example, an 8-0 suture through the epineural tissue, which is thin and weak. Tear out of suture is common, requiring time consuming repetition of those steps. Sometime passing needles through conduits breaks the needles, due to their small size.

[0010] To coapt the nerves into the conduit with sutures typically means the conduit has to be over sized, and the control of advancing axons is lessened, due to the residual large radial gap. Accordingly, there is a need for devices and method of nerve repair that simplify the procedure. Further there is a need to more accurately set the gap between nerve stumps during a repair procedure.

SUMMARY OF THE INVENTION

[0011] The present disclosure offers advantages and alternatives over the prior art by providing a vacuum reducing system and method that will position the nerve stumps at a more accurate predetermined gap distance apart to allow coaptation of both stumps of a cut nerve. The system may perform the nerve repair without collapsing the conduit. The system has a simple release, that requires minimal dissection, with associated instruments facilitating simple nerve stump preparation, quick and accurate nerve size measurement, and ease of suturing tools. The disclosed invention will greatly simplify the process of repair making quality, effective nerve repairs more efficient and more ideal for subsequent nerve regrowth. Additionally, the device will allow for markedly increased control of the nerve ends during the anastomotic process, allowing for greater end-to-end gap control and gentle tissue handling. These advances will make quality nerve repair much more fluid and quick for surgeons and even make nerve repair available to surgeons without extensive microsurgical training and experience.

[0012] A cartridge assembly in accordance with one or more aspects of the present disclosure includes a cartridge and a handpiece. The cartridge includes a cartridge frame having first and second frame ends and a first vacuum channel extending therebetween. First and second jaws are connected to the cartridge frame. The first and second jaws are configured to releasably engage a conduit during a nerve repair procedure on a patient. A separator is configured to extend from the first frame end and into the conduit’s interior to provide a predetermined regeneration gap between first and second nerve stumps inserted into the conduit during the nerve repair procedure. The handpiece includes a handpiece chassis having first and second chassis ends and a second vacuum channel extending therebetween. The first chassis end is configured to releasably engage the second frame end in order to connect the first and second vacuum channels and to enable a vacuum source connected to the second chassis end to pull a vacuum through a vacuum port of the conduit and on the conduit’s interior.

[0013] A cartridge assembly in accordance with one or more aspects of the present disclosure includes a cartridge and a handpiece. The cartridge includes a cartridge frame having first and second frame ends and a first vacuum channel extending therebetween. A first and a second jaw are connected to the cartridge frame. The first and second jaws are movable between a jaw closed position and a jaw open position. When in the jaw closed position, the first and second jaws are configured to engage a conduit during a nerve repair procedure on a patient. When in the jaw open position, the first and second jaws are configured to release the conduit. A separator is configured to extend from the first frame end, through a vacuum port of the conduit and into the conduit’s interior to provide a predetermined regeneration gap between first and second nerve stumps inserted into the conduit during the nerve repair procedure. The handpiece includes a handpiece chassis having first and second chassis ends and a second vacuum channel extending therebetween. The first chassis end is configured to releasably engage the second frame end in order to connect the first and second vacuum channels and to enable a vacuum source connected to the second chassis end to pull a vacuum on the conduit’s interior.

[0014] A method of performing a nerve repair procedure on a patient in accordance with one or more aspects of the present disclosure includes selecting a cartridge and an associated conduit releasably engaged by the cartridge. The cartridge and associated conduit are retained in a shipping container. The associated conduit has a predetermined size based on a determined diameter of a first nerve stump. A handpiece is releasably engaged to the cartridge. The handpiece disengages the cartridge and associated conduit from the shipping container. A vacuum is pulled, via a first vacuum channel in the cartridge and a second vacuum channel in the handpiece, on an interior of the associated conduit. The first and a second nerve stump are inserted into first and second open ends respectively of the associated conduit while pulling the vacuum. A first separator of the cartridge is utilized to provide a predetermined regeneration gap between the first and second nerve stumps.

[0015] An alternative method of performing a nerve repair procedure on a patent, in accordance with one or more aspects of the present disclosure includes selecting a cartridge and an associated conduit releasably engaged by the cartridge. The associated conduit has a predetermined size based on a determined diameter of a first nerve stump. A vacuum is pulled, via a first vacuum channel, in the cartridge on an interior of the associated conduit. The first and a second nerve stump are inserted into first and second open ends respectively of the associated conduit while pulling the vacuum. A separator of the cartridge is utilized to provide a predetermined regeneration gap between the first and second nerve stumps.

[0016] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits and advantages described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the disclosure and together with the detailed description herein, serve to explain the principles of the disclosure. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the disclosure.

[0018] FIG. 1 depicts a perspective view of a cartridge assembly, according to aspects described herein;

[0019] FIG. 2 depicts a perspective view of a cartridge and a handpiece of the cartridge assembly of FIG. 1, separated, according to aspects described herein;

[0020] FIG. 3 depicts a perspective view of a conduit releasably engageable with the cartridge assembly of FIG. 1, according to aspects described herein;

[0021] FIG. 4 depicts a perspective view of the cartridge of FIG. 2 with first and second jaws in a closed position, according to aspects described herein;

[0022] FIG. 5 depicts a perspective view of the cartridge of FIG. 2 with the first and second jaws in an open position, according to aspects described herein;

[0023] FIG. 6 depicts a side cross sectional view of the cartridge of FIG. 4, taken along the Line 6-6 of FIG. 4, according to aspects described herein;

[0024] FIG. 7 depicts an exploded view of the cartridge of FIG. 4, according to aspects described herein;

[0025] FIG. 8 depicts an enlarged view of the cartridge frame of the cartridge of FIG. 7, according to aspects described herein;

[0026] FIG. 9 depicts a first alternative embodiment of the conduit contact face and separator of the cartridge frame of FIG. 8, according to aspects described herein;

[0027] FIG. 10 depicts a second alternative embodiment of the conduit contact face and separator of the cartridge frame of FIG. 8, according to aspects described herein;

[0028] FIG. 11 depicts a cross sectional view of the cartridge assembly of FIG. 1, taken along the Line 11-11 of FIG. 1, according to aspects described herein;

[0029] FIG. 12 depicts an exploded view of the handpiece of the cartridge assembly of FIG. 1, according to aspects described herein;

[0030] FIG. 13 depicts another perspective view of the cartridge assembly of FIG. 1, with the release button depressed and with the control valve in an open position, according to aspects described herein;

[0031] FIG. 14 depicts a cross sectional view of the cartridge assembly of FIG. 13, taken along the Line 14-14 of FIG. 13, according to aspects described herein;

[0032] FIG. 15 depicts a perspective view of the shipping container with the cartridge of FIG. 2 disposed therein, according to aspects described herein;

[0033] FIG. 16 depicts a cross sectional view of the shipping container and cartridge of FIG. 15, taken along the Line 16-16 of FIG. 15, according to aspects described herein;

[0034] FIG. 17 depicts a perspective view of the shipping container and cartridge of FIG. 15, wherein the saline well of the shipping container is being filled with a saline solution from a syringe, according to aspects described herein;

[0035] FIG. 18 depicts a side view of a plurality of shipping containers with a plurality of cartridges disposed therein, according to aspects described herein;

[0036] FIG. 19 depicts a flow diagram of a method of performing a nerve repair procedure on a patient, according to aspects described herein; and

[0037] FIG. 20 depicts a flow diagram of an alternative method of performing a nerve repair procedure on a patient, according to aspects described herein.

DETAILED DESCRIPTION OF THE INVENTION

[0038] Certain examples will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the methods, systems, and devices disclosed herein. One or more examples are illustrated in the accompanying drawings. Those skilled in the art will understand that the methods, systems, and devices specifically described herein and illustrated in the accompanying drawings are non-limiting examples and that the scope of the present disclosure is defined solely by the claims. The features illustrated or described in connection with one example may be combined with the features of other examples. Such modifications and variations are intended to be included within the scope of the present disclosure.

[0039] The terms "significantly", "substantially", "approximately", "about", “relatively,” or other such similar terms that may be used throughout this disclosure, including the claims, are used to describe and account for small fluctuations, such as due to variations in processing from a reference or parameter. Such small fluctuations include a zero fluctuation from the reference or parameter as well. For example, they can refer to less than or equal to ± 10%, such as less than or equal to ± 5%, such as less than or equal to ± 2%, such as less than or equal to ± 1%, such as less than or equal to ± 0.5%, such as less than or equal to ± 0.2%, such as less than or equal to ± 0.1%, such as less than or equal to ± 0.05%. [0040] Referring to FIGS. 1 and 2, wherein FIG. 1 depicts a perspective view of a cartridge assembly 100 and FIG. 2 depicts a perspective view of a cartridge 102 and a handpiece 104 of the cartridge assembly 100 after being disconnected, according to aspects described herein. The cartridge assembly 100 includes the cartridge 102 that is releasably engageable with the handpiece 104. Also, as will be discussed in greater detail herein, the cartridge assembly 100 may include one or more shipping containers 106 (see FIG. 15) for containing one or more cartridges 102.

[0041] The cartridge 102, of cartridge assembly 100, includes a cartridge frame 108 having a first frame end 110 and a second frame end 112 (see FIG. 7) and a first vacuum channel 114 (see FIG. 6) extending therebetween. A first jaw 116 and second jaw 118 are connected to the cartridge frame 108. The first and second jaws 116, 118 are configured to releasably engage a conduit 120 (see FIG. 3) during a nerve repair procedure on a patient.

[0042] The cartridge 102 also includes a separator 122 (see FIG. 7) that is configured to extend from the first frame end 110 of the cartridge frame 108, and into the interior 146 of the conduit 120 (see FIG. 3). The separator 122 provides a predetermined regeneration gap between a first nerve stump 124 and a second nerve stump 126 that are inserted into open ends 142 (see FIG. 3) of the conduit 120 during the nerve repair procedure.

[0043] The handpiece 104, of the cartridge assembly 100, includes a handpiece chassis 128 having a first chassis end 130 and a second chassis end 132 (see FIG. 12) and a second vacuum channel 134 (see FIG. 11) extending therebetween. The first chassis end 130 of the handpiece chassis 128 is configured to releasably engage the second frame end 112 of the cartridge frame 108 in order to connect the first and second vacuum channels 114, 134 and to enable a vacuum source 136 connected to the second chassis end 132 of the handpiece chassis 128 to pull a vacuum through a vacuum port 148 (see FIG. 3) of the conduit 120 and on the conduit’s interior. The handpiece also includes a vacuum tube 139, which may connect the vacuum source 136 directly to the second vacuum channel 134, therefore establishing fluid communication between the interior 146 of the conduit 120, the first vacuum channel 114, the second vacuum channel 134, the vacuum tube 139 and the vacuum source 136.

[0044] Advantageously, the chassis assembly 100, enables precise placement of a selected conduit 120 between the first and second nerve stumps 124, 126 during a nerve repair procedure. Additionally, a width of the separator 122 provides a precise predetermined regeneration gap between the first and second nerve stumps 124, 126 to promote regeneration of the nerve cells between the nerve stumps 124, 126.

[0045] Moreover, the handpiece 104 is releasably connectable to the cartridge 102 of the cartridge assembly 100. Additionally, the cartridge assembly 100 may include a plurality of cartridges 102 (see FIG. 18) with a plurality of sizes of conduits 120 that the handpiece 104 may select from and connect to. Accordingly, the cartridge assembly 100 advantageously enables an optimal matching of the size of the selected conduit 120 with the size of the never stumps 124, 126 to be repaired during the nerve repair procedure.

[0046] Referring to FIG. 3, a perspective view is depicted of an example of the conduit 120 of FIG. 1, which is releasably engageable with the cartridge assembly 100 of FIG. 1, according to aspects described herein. The conduit 120 includes a conduit bodyl40 including opposing first and second open end portions 142, 144 and a hollow conduit interior 146 extending therebetween. The conduit interior 146 is configured to receive the first nerve stump 124 through the first open end portion 142 and the second nerve stump 126 through the second open end portion 144, during a nerve repair procedure on a patient.

[0047] The first and second nerve stumps 124, 126 may include a proximal nerve stump and a distal nerve stump. The proximal nerve stump is positioned closer to the skeleton relative to the distal nerve stump. Nerve cells, such as axon nerve cells, generally grow from the proximal nerve stump. The distal nerve stump generally receives the out growing nerve cells from the proximal nerve stump.

[0048] A vacuum port 148 extends through an outer wall 150 of the conduit body 140. The vacuum port 148 is configured to connect to the vacuum source 136 (see FIG. 1) associated with the cartridge assembly to pull a vacuum on the conduit interior 146 while inserting the nerve stumps 124, 126 into the first and second open end portions 142, 144.

[0049] The conduit 120 may also include one or more radial support structures 152 positioned on the outer wall 150 of the conduit body 140. The radial support structures 152 are configured to structurally support the conduit body 140 when the vacuum from the vacuum source 136 is being applied.

[0050] The one or more radial support structures 152 of the conduit 120 may be any appropriate support structure configured to structurally support the conduit body 140 when the vacuum is being applied. In the example depicted in FIG. 3, the radial support structures 152 are retaining tabs 152. However, several other examples of radial support structures may also be used, including any of the radial support structures disclosed in International PCT Application No.: PCT/US2024/20669 to John Pepper et al., titled: “EPINEURIAL COAPTATION IMPLATS, INSTRUMENTS AND METHODS”, filed on March 20, 2024, which is hereby incorporated herein by reference in its entirety.

[0051] During a nerve repair procedure, the nerve stumps 124, 126 may be scarred on their distal ends, which could prevent coaptation of the nerve stumps 124, 126. The scars of the nerve stumps 124, 126 may be trimmed off using a scar trimmer (not shown) of the type described in the PCT Application No.: PCT/US2024/20669. Additionally, the sizes of the nerve stumps 124, 126 may need to be determined. The size of the nerve stumps may be determined using a nerve sizing instrument (not shown) of the type described in the PCT Application No.: PCT/US2024/20669.

[0052] Also, during a nerve repair procedure, the vacuum source 136 is used to create a low pressure within the interior 146 of the conduit 120 in order to draw the first and second nerve stumps 124, 126 into the first and second open end portions 142, 144 of the conduit 120. The conduit 120 is often composed of a flexible material to allow for added patient comfort and bending of the patient’s body part in which the conduit 120 is implanted. Problematically, when the vacuum is applied, the flexible body of the conduit 120 has a tendency to collapse before the nerve stumps 124, 126 can be inserted.

[0053] Advantageously however, the at least one radial support structures 152, such as the one or more retaining tabs 152 illustrated in FIG. 3, may be used to provide structural support to the conduit 120. The retaining tabs 152 may also be designed to engage with the first and second jaws 116, 118 of the cartridge assembly 100 to further maintain the shape of the conduit 120 when the vacuum is being applied to the interior 146 of the conduit 120. For example, the first and second jaws 116, 118 may be designed to clamp onto the retaining tabs 152 to hold the conduit body 140 in place while a vacuum is being applied.

[0054] In some embodiments of the conduit 120, one or more vacuum port flaps 154 are configured to close over the vacuum port 148 when the vacuum is not being applied. More specifically, the vacuum port flaps 154 can close over the vacuum port 148 when the nerve repair procedure is complete. When the vacuum port flaps 154 are closed over the vacuum port 148, the vacuum port flaps 154 prevents nerve cells from the first and second nerve stumps 124, 126 from growing through the vacuum port 148.

[0055] Referring to FIGS. 4 and 5, a perspective view is depicted of the cartridge 102 of FIG. 2 with first and second jaws 116, 118 in a closed position (FIG. 4), and with the first and second jaws 116, 118 in an open position (FIG. 5), according to aspects described herein.

[0056] Referring also to FIG. 6, a side cross sectional view is depicted of the cartridge of FIG. 4, taken along the line 6-6 of FIG. 4, according to aspects described herein.

[0057] The first and second jaws 116, 118 of the cartridge 102 are movable between a jaw closed position (FIG. 4) and a jaw open position (FIG. 5). When in the jaw closed position, the first and second jaws 116, 118 are configured to engage the conduit 120 and the separator 122 (FIG. 6) extends from the first vacuum channel 114 of the cartridge 102, between the first and second jaws 116, 118, through the vacuum port 148 (see FIG. 3) of the conduit 120 and into the interior 146 of the conduit 120 to provide the predetermined regeneration gap. When in the jaw open position (FIG. 5, the first and second jaws 116, 118 are configured to release the conduit [0058] The vacuum channel 114 also extends longitudinally past the second frame end 112 and through a cartridge boss 164. As will be explained in greater detail herein, the cartridge boss 164 includes at least one cartridge latch 166 disposed on an end portion of the cartridge boss 164. The cartridge latches 166 are configured to releasably engage with the handpiece 104 of the cartridge assembly 100. In the embodiment illustrated in FIG. 6, the cartridge boss 164 includes two cartridge latches 166.

[0059] The first and second j aws 116, 118 are movable laterally relative to the cartridge frame 108 between the jaw closed position (FIG. 4) and the jaw open position (FIG. 5).

Advantageously, when moving from the jaw closed position (FIG. 4) to the jaw open position (FIG. 5), the first and second jaws 116, 118 are configured not to extend further longitudinally into an interior of the patient in order to release the conduit 120. This feature reduces the potential for causing structural damage to the patient’s anatomy when the conduit 120 is being released from the cartridge 102 during a nerve repair procedure.

[0060] Referring again to FIGS. 6 and 3, the separator 122 is configured as extending through the vacuum port 148 of the conduit 120. However, the separator 122 may also be configured to extend through another port (not shown) of the conduit other than the vacuum port 148. Moreover, the separator 122 may be configured to penetrate the outer wall 150 of the conduit 148 to provide its own self-sealing port (not shown) into the interior 146 of the conduit

[0061] Referring to FIGS. 7 and 8, an exploded view (FIG. 7) is depicted of the cartridge 102 of FIG. 4, and an enlarged view (FIG. 8) is depicted of the cartridge frame 108 of the cartridge 102 of FIG. 7, according to aspects described herein.

[0062] The first frame end 110 of the cartridge frame 108 of the cartridge 102 includes a conduit contact face 156 which conforms to a shape of the conduit 120 and through which the separator 122 is configured to extend. The conduit contact face 156, the first jaw 116 and the second jaw 118 substantially surround the conduit 120 when the first and second jaws 116, 118 are in the closed position (see FIG. 4).

[0063] A first jaw pivot boss 158 and a second jaw pivot boss 160 are disposed on opposing sides of the cartridge frame 108. The first and second jaw pivot bosses 1 8, 160 are configured to engage with the first and second jaws 116, 118 respectively to provide a fulcrum about which the first and second jaws 116, 118 can pivot between their respective jaw closed position (FIG. 4) and jaw open position (FIG. 5). A cartridge spring 162 is disposed on the carrier frame 108. The cartridge spring 162 is configured to engage with the first and second jaws 116, 118 to urge the first and second jaws 116, 118 to pivot into their respective jaw closed positions (FIG. 4).

[0064] The cartridge frame 108 also includes the cartridge boss 164 extending longitudinally from the second frame end 112 (see FIG. 6). The cartridge boss 164 includes at least one cartridge latch 166 disposed on an end portion of the cartridge boss 164. As will be explained in greater detail herein, the cartridge boss 164 and cartridge latches 166 are configured to releasably engage with the handpiece 104 of the cartridge assembly 100.

[0065] The cartridge 102 may also include a conduit block-off plate 168. The conduit block-off plate 168 includes a circular vacuum closing face 170 and a pair of parallel support legs 172 extending from the vacuum closing face 170. The pair of support legs 172 form a capture slot 174 therebetween. Each support leg 172 includes one or more first position detents 176, which are configured to mate with a second position detent 178 disposed on the cartridge frame 108.

[0066] The conduit block-off plate 168 is movable longitudinally relative to the cartridge frame 108 from a retracted position to an extended position. In doing so, the first position detents 176 on the support legs 172 mate with second position detents 178 on the cartridge frame 108 to releasably secure the conduit block-off plate in either the retracted or extended positions. In the extended position, the vacuum closing face 170 is configured to block off one of the first or second open ends 142, 144 of the conduit 120. By blocking off an open end 142, 144 of the conduit 120, a relatively deeper vacuum can be pulled more rapidly in the interior 146 of the conduit 120. [0067] Referring to FIGS. 9 and 10, a first alternative embodiment (FIG. 9) and a second alternative embodiment (FIG. 10) is depicted of the conduit contact face 156 and separator 122 of the cartridge frame 108 of FIG. 8, according to aspects described herein.

[0068] Regardless of the geometric shapes of the different embodiments of separators 122 illustrated in FIGS. 8, 9 and 10, it is the overall width 180 of the separators 122 that define the predetermined regeneration gap between the nerve stumps 124, 126 during the nerve repair procedure.

[0069] Referring to FIGS. 11 and 12, a cross sectional view (FIG. 11) is depicted of the cartridge assembly 100 of FIG. 1, taken along the line 11-11 of FIG. 1, and an exploded view (FIG. 12) is depicted of the handpiece 104 of the cartridge assembly 100 of FIG. 1, according to aspects described herein.

[0070] In FIG. 11, the cartridge 102 and the handpiece 104 of the cartridge assembly 100 are shown releasably engaged. That is, the cartridge 102 and handpiece 104 are connected together, but may be released (or disengaged) with the push of release button 182.

[0071] The handpiece chassis 128 of the handpiece 104 includes a cartridge boss recess 184 disposed in the first chassis end 130 of the handpiece chassis 128. The cartridge boss recess 184 is configured to receive the cartridge boss 164 therein (see FIG. 11). A capture spring 186 is mounted on the handpiece chassis 128. When the cartridge boss 164 is inserted into the cartridge boss recess 184, at least one of the one or more cartridge latches 166 releasably engage with the capture spring 186.

[0072] More specifically, the capture spring 186 includes first and second parallel spring wrap portions 188 mounted on opposing sides of the handpiece chassis 128. The capture spring 186 also includes first and second parallel active leg portions 190 extending from the first and second spring wrap portions 188 respectively. Additionally, the capture spring 186 incudes a crossing beam portion 192 integrally connected between the distal ends of the first and second active leg portions 190. The release button 182 is mounted on a top surface of the handpiece chassis 128. The release button has first and second spring contact bosses 194 extending vertically downward into the handpiece chassis 128. The first and second spring contact bosses 194 are configured to engage with, and push down on, the first and second active leg portions 190 respectively of the capture spring 186, when the release button 182 is depressed downward. When the cartridge boss 164 is inserted into the cartridge boss recess 184, the at least one cartridge latch 166 releasably engages with the crossing beam portion 192 of the capture spring 186. When the release button 182 is depressed downward, the first and second spring contact bosses 194 move active leg portions 190 and the crossing beam portion 192 downward to disengage the cartridge frame 108 from the handpiece chassis 128, and therefore disengage the cartridge 102 from the handpiece 104.

[0073] A cartridge boss ejector 196 includes a head portion 200 and a latching portion 202 connected therebetween by a cylindrical hollow body portion 204. An ejector spring 198 is configured to mount over the body portion 204 and abut against the head portion 200 of the cartridge boss ejector. The cartridge boss ejector 196 and mounted ejector spring 198 are configured to fit into the cartridge boss recess 184 of the handpiece chassis 128. Once inserted into the cartridge boss recess, the latching portion 202 enables the cartridge boss ejector 196 to move from a retracted position, wherein the ejector spring 198 is compressed by the head portion 200, to an extended position, wherein the ejector spring 198 is extended.

[0074] When the cartridge boss 164 of the cartridge 102 is inserted into the cartridge boss recess 184 of the handpiece 104 and cartridge latch 166 releasably engages with the capture spring 186, the cartridge boss 164 abuts against the head portion 200 of the cartridge boss ejector 196 to compress the ejector spring 198 and urge the cartridge boss ejector 196 into its retracted position. When the release button 182 is depressed to disengage the cartridge boss 164 from the capture spring 186, the ejector spring 198 is free to urge the cartridge boss ejector 196 into its extended position, which pushes the cartridge boss 164 out of the cartridge boss recess 184. In this way, the cartridge boss ejector 196 and ejector spring 198 facilitate the automatic separation of the cartridge 102 from the handpiece 104.

[0075] The vacuum tube 139 of the handpiece 104 includes a first tube end 206 and second tube end 208, with a vent slot 210 disposed therebetween. The first tube end 206 is configured to be inserted into the second chassis end 132. The vacuum tube 139 is secured to the handpiece chassis 128 with a dowel pin 212 that inserts through the handpiece chassis 128 and into a cross hole 214 of the vacuum tube 139 that is located near the first tube end 206 of the vacuum tube 139. The second tube end 208 is configured to connect to the vacuum source 136, thereby establishing fluid communication from the vacuum source 136, through the vacuum tube 139, the second vacuum channel 134, the first vacuum channel 114 and into the interior 146 of the conduit 120.

[0076] A handpiece cover 216 is configured to mount over the handpiece chassis 128 and a control valve 218 is configured to be mounted over the outside diameter of the vacuum tube 139. The control valve 218 is configured to threadedly engage the second chassis end 132 and to cover all or a portion of the vent slot 210, depending on whether all or a portion of the threads 220 on the second chassis end 134 are engaged with the control valve 218. The larger the portion of the vent slot 210 that is covered by the control valve 218, the deeper the vacuum that can be pulled by the vacuum source 136 on the interior 146 of the conduit 120.

[0077] Referring to FIGS. 13 and 14, another perspective view (FIG. 13) of the cartridge assembly 100 of FIG. 1 is depicted with the release button depressed, and a cross sectional view (FIG. 14) of the cartridge assembly of FIG. 13 is depicted taken along the line 14-14 of FIG. 13, according to aspects described herein. The line 14-14 is offset from the centerline of the cartridge assembly 100 to show the spring contact boss 194 of the depressed release button 182 in contact with, and pushing down on, the active leg portion 190 of the capture spring 186. Therefore, the cross beam portion 192 is also depressed, which releases the cartridge boss 164 from the cartridge boss recess 184 and, therefore, disengages the cartridge 102 from the handpiece 104.

[0078] Referring to FIGS. 15 and 16, a perspective view (FIG. 15) is depicted of the shipping container 106 with the cartridge 102 of FIG. 2 disposed therein, a cross sectional view (FIG. 16) is depicted of the shipping container 106 and cartridge 102 of FIG. 15, taken along the line 16-16 of FIG. 15, according to aspects described herein. Referring also to FIG. 17, a perspective view is depicted of the shipping container 106 and cartridge 102 of FIG. 15, wherein the saline well 224 of the shipping container 106 is being filled with a saline solution 226 from a syringe 240, according to aspects described herein;

[0079] The shipping container 106 of the cartridge assembly 100 includes a housing 222 configured to receive the cartridge 102 and its associated conduit 120, which is engaged by the cartridge 102 therein. A saline well 224 is disposed in the housing 222. The saline well 224 is configured to receive the conduit 120 therein. The saline well 224 is operable to be filled with a saline solution 226 to soak the conduit 120 for a predetermined amount of time prior to releasably engaging the cartridge 102 to the handpiece 104. By soaking the conduit 120, the conduit advantageously gains flexibility and grows to its proper size. The saline well 224 may be filled with a syringe 240 (see FIG. 17) that is configured to inject saline solution 226 into the first vacuum channel 114 of the cartridge 102.

[0080] The shipping container also includes a first retaining tab 228 and a second retaining tab 230 disposed on opposing sides of the housing 222. Each retaining tab 228, 230 includes a first retaining tab end 232 connected to the housing 222, from which the retaining tab 228, 230 extends resiliently upwards to a distal second retaining tab end 234. A first retaining latch 236 and a second retaining latch 238 are disposed on the distal second retaining tab ends 234 of the first and second retaining tabs 228, 230 respectively. When the cartridge 102 is inserted into the housing 222 of the shipping container 106, the first and second retaining latches 236, 238 engage with the second frame end 112 of the cartridge frame 108 to retain the cartridge 102 within the housing 222 of the shipping container 106. When the handpiece 104 engages the second frame end 108, the handpiece chassis 128 urges the first and second retaining latches 236, 238 apart to release the cartridge 102 from the shipping container 106.

[0081] Referring to FIG. 18, a side view is depicted of a plurality of shipping containers 106A-F with a plurality of cartridges 102A-7 disposed therein, according to aspects described herein. The cartridge assembly 100 may include a plurality of cartridges 102A-F and a plurality of conduits 120A-F. Each cartridge 102 of the plurality of cartridges 102A-F engages with an associated conduit 120 of the plurality of conduits 120A-F. The associated conduit 102 has a predetermined size (for example 1 .5 mm to 6 mm in diameter) that is different from the size of the other conduits 120A-F of the plurality of conduits 120A-F.

[0082] In other words, the cartridge assembly 100 may have a variety of cartridges 102 to choose from, wherein each cartridge 102 is configured to hold a different size conduit 120. In the example illustrated in FIG. 18, there are 6 conduit sizes, which have the diameters of 1.5mm, 2 mm, 3 mm, 4 mm, 5 mm and 6 mm to choose from. The jaws 116, 118 of each cartridge 102 are sized appropriately to hold the conduit 120 associated with that cartridge.

[0083] Additionally, the cartridge assembly 100 may include a plurality of shipping containers 106A-F, wherein each shipping container 106 of the plurality of shipping containers 106A-F is configured to contain a single cartridge 102 of the plurality of cartridges 102A-F and a single associated conduit 120 of the plurality of conduits 120A-F. In other words, the cartridge assembly 100 may include a shipping container 106 for each sized cartridge 102A-F that holds a different sized conduit 120A-F.

[0084] Advantageously, during operation, once a user determines the proper size of the conduit needed for the nerve repair procedure, the user can then select the properly sized conduit 120 from the plurality of cartridges 102A-F and associated conduits 120A-F that are prepackaged in their own shipping container 106A-F. The user can then soak the selected conduit 120 in the saline well 224 of the selected shipping container 106. Thereafter, the user can releasably attach the handpiece 104 to the selected cartridge 102 to perform the procedure.

[0085] Referring to FIG. 19, a flow diagram is depicted of a method 300 of performing a nerve repair procedure on a patient, according to aspects described herein.

[0086] The method 300 begins at 302 by selecting a cartridge 102 and an associated conduit 120 releasably engaged by the cartridge 102. The cartridge 102 and associated conduit 120 are retained in a shipping container 106. The associated conduit 120 has a predetermined size based on a determined diameter of a first nerve stump 124. [0087] The cartridge 102 and associated conduit 120 retained in a shipping container 106 may be selected from a plurality of cartridges 102A-F and a plurality of conduits 120A-F retained in a plurality of shipping containers 106A-F. Each cartridge 102 of the plurality of cartridges 102A-F engages with an associated conduit 120 of the plurality of conduits 120A-F. The associated conduit 120 selected has a predetermined size that is different from the size of the other conduits 120 of the plurality of conduits 120A-F.

[0088] Moreover, a saline well 224 disposed in the selected shipping container 106 may be filled with a saline solution 226. Thereafter the selected associated conduit 120 may be soaked for a predetermined amount of time in the saline solution 226.

[0089] The method continues at 304, wherein a handpiece 104 is releasably engaged the cartridge 102. The handpiece 104 is configured to disengage the cartridge 102 and associated conduit 120 from the shipping container 106.

[0090] At 306, a vacuum is pulled, via a first vacuum channel 114 in the cartridge 102 and a second vacuum channel 134 in the handpiece 104, on an interior 146 of the associated conduit 120.

[0091] The vacuum may be pulled by first inserting a vacuum tube 139 into the handpiece 104. A vacuum source 136 may be connected to the vacuum tube 139. The vacuum may be pulled by the vacuum source through the vacuum tube 139, through a second vacuum channel 134 of the handpiece 104, through a first vacuum channel 114 of the cartridge 102 and on the interior 146 of the conduit 120. The vacuum pressure of the vacuum in the interior 146 of the conduit 120 may be controlled via a control valve 218 disposed over the vacuum tube 139.

[0092] At 308, the first and a second nerve stump 124, 126 are inserted into first and second open ends 142, 144 respectively of the associated conduit 120 while pulling the vacuum.

[0093] At 310, a separator 122 of the cartridge 102 is utilized to provide a predetermined regeneration gap 180 between the first and second nerve stumps 124, 126. [0094] Referring to FIG. 20, a flow diagram is depicted of an alternative method 320 of performing a nerve repair procedure on a patient, according to aspects described herein.

[0095] The method 320 begins at 322 by selecting a cartridge 102 and an associated conduit 120 releasably engaged by the cartridge 102. The associated conduit 120 has a predetermined size based on a determined diameter of a first nerve stump 124.

[0096] The cartridge 102 and associated conduit 120 may be selected from a plurality of cartridges 102A-F and a plurality of conduits 120A-F retained in a plurality of shipping containers 106A-F. Each cartridge 102 of the plurality of cartridges 102A-F engages with an associated conduit 120 of the plurality of conduits 120A-F. The associated conduit 120 selected has a predetermined size that is different from the size of the other conduits 120 of the plurality of conduits 120A-F.

[0097] Moreover, a saline well 224 disposed in the selected shipping container 106 may be filled with a saline solution 226. Thereafter the selected associated conduit 120 may be soaked for a predetermined amount of time in the saline solution 226.

[0098] The method continues at 324, wherein a vacuum is pulled, via a first vacuum channel 114 in the cartridge 102 on an interior 146 of the associated conduit 120.

[0099] The vacuum may be pulled by first releasably engaging a handpiece 104 to the selected cartridge 102, wherein the handpiece 104 includes a second vacuum channel 134. The handpiece 104 may be configured to disengage the selected cartridge 102 and associated conduit 120 from the shipping container 106 that the selected cartridge 102 is retained in, when the handpiece releasably engages the selected cartridge 102.

[0100] A vacuum tube 139 may be inserted into the handpiece 104. A vacuum source 136 may be connected to the vacuum tube 139. The vacuum may be pulled by the vacuum source through the vacuum tube 139, through the second vacuum channel 134 of the handpiece 104, through the first vacuum channel 114 of the cartridge 102 and on the interior 146 of the conduit 120. The vacuum pressure of the vacuum in the interior 146 of the conduit 120 may be controlled via a control valve 218 disposed over the vacuum tube 139.

[0101] At 326, the first and a second nerve stump 124, 126 are inserted into first and second open ends 142, 144 respectively of the associated conduit 120 while pulling the vacuum.

[0102] At 328, a separator 122 of the cartridge 102 is utilized to provide a predetermined regeneration gap 180 between the first and second nerve stumps 124, 126.

[0103] 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 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.

[0104] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. 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.

[0105] The disclosure has been described with reference to the preferred embodiments. It will be understood that the architectural and 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 disclosure be construed as including all such modifications and alterations.

Claims

CLAIMS: What is claimed is:

1. A cartridge assembly comprising: a cartridge comprising: a cartridge frame having first and second frame ends and a first vacuum channel extending therebetween, a first and second jaw connected to the cartridge frame, the first and second jaw configured to releasably engage a conduit during a nerve repair procedure on a patient, and a separator configured to extend from the first frame end and into the conduit’s interior to provide a predetermined regeneration gap between first and second nerve stumps inserted into the conduit during the nerve repair procedure; and a handpiece comprising: a handpiece chassis having first and second chassis ends and a second vacuum channel extending therebetween, the first chassis end configured to releasably engage the second frame end in order to connect the first and second vacuum channels and to enable a vacuum source connected to the second chassis end to pull a vacuum through a vacuum port of the conduit and on the conduit’s interior.

2. The cartridge assembly of claim 1, comprising: the first and second jaws movable between a jaw closed position and a jaw open position; wherein, when in the jaw closed position, the first and second jaws are configured to engage the conduit and the separator extends between the first and second jaws, through the vacuum port of the conduit and into the interior of the conduit to provide the predetermined regeneration gap; and wherein, when in the jaw open position, the first and second jaws are configured to release the conduit.

3. The cartridge assembly of claim 2, wherein: the first and second jaws are movable laterally relative to the cartridge frame between the jaw closed position and the jaw open position; wherein, when moving from the jaw closed position to the jaw open position, the first and second jaws are configured not to extend further longitudinally into an interior of the patient in order to release the conduit.

4. The cartridge assembly of claim 2, comprising: the first frame end of the cartridge frame comprising a conduit contact face which conforms to a shape of the conduit and through which the separator is configured to extend; and wherein, the conduit contact face, the first jaw and the second jaw substantially surround the conduit when the first and second jaws are in the closed position.

5. The cartridge assembly of claim 2, comprising: a first and a second jaw pivot boss disposed on opposing sides of the cartridge frame, the first and second jaw pivot bosses configured to engage with the first and second jaws respectively to provide a fulcrum about which the first and second jaws can pivot between their respective jaw closed position and jaw open position; and a cartridge spring disposed on the carrier frame, the spring configured to engage with the first and second jaws to urge the first and second jaws to pivot into their respective jaw closed positions.

6. The cartridge assembly of claim 1, comprising: the cartridge frame comprising a cartridge boss extending longitudinally from the second frame end, the cartridge boss comprising at least one cartridge latch disposed on an end portion of the cartridge boss; the handpiece chassis comprising a cartridge boss recess disposed in the first chassis end, the cartridge boss recess configured to receive the cartridge boss therein; and a capture spring mounted on the handpiece chassis; wherein, when the cartridge boss is inserted into the cartridge boss recess, the at least one cartridge latch releasably engages with the capture spring.

7. The cartridge assembly of claim 6, comprising: the capture spring comprising: first and second parallel spring wrap portions mounted on opposing sides of the handpiece chassis, first and second parallel active leg portions extending from the first and second spring wrap portions respectively, and a crossing beam portion integrally connected between the distal ends of the first and second active leg portions; and a release button mounted on a top surface of the handpiece chassis, the release button having first and second spring contact bosses extending vertically downward into the handpiece chassis, the first and second spring contact bosses configured to engage with, and push down on, the first and second active leg portions respectively of the capture spring, when the release button is depressed downward; wherein, when the cartridge boss is inserted into the cartridge boss recess, the at least one cartridge latch releasably engages with the crossing beam portion of the capture spring; and wherein, when the release button is depressed downward, the first and second spring contact bosses move the crossing beam portion downward to disengage the cartridge frame from the handpiece chassis.

8. The cartridge assembly of claim 1, comprising: a vacuum tube having first and second tube ends and a vent slot disposed therebetween, the first tube end configured to be inserted into the second chassis end and the second tube end configured to connect to the vacuum source; and a control valve configured to be mounted over the outside diameter of the vacuum tube, the control valve configured to thread edly engage the second chassis end and to cover all or a portion of the vent slot; wherein the larger the portion of the vent slot that is covered by the control valve, the deeper the vacuum that can be pulled by the vacuum source on the interior of the conduit.

9. The cartridge assembly of claim 1, comprising: a shipping container, comprising: a housing configured to receive the cartridge and associated conduit engaged by the cartridge therein; and a saline well disposed in the housing, the saline well configured to receive the conduit therein, the saline well operable to be filled with a saline solution to soak the conduit for a predetermined amount of time prior to releasably engaging the cartridge to the handpiece.

10. The cartridge assembly of claim 9, wherein the shipping container comprises: a first and a second retaining tab disposed on opposing sides of the housing, each retaining tab including a first retaining tab end connected to the housing, from which the retaining tab extends resiliency upwards to a distal second retaining tab end; and a first and a second retaining latch disposed on the distal second retaining tab ends of the first and second retaining tabs respectively; wherein, when the cartridge is inserted into the housing, the first and second retaining latches engage with the second frame end of the cartridge frame to retain the cartridge within the housing; and wherein, when the handpiece engages the second frame end, the handpiece chassis urges the first and second retaining latches apart to release the cartridge from the shipping container.

11. The cartridge assembly of claim 9, wherein: the cartridge and associated conduit comprise a plurality of cartridges and a plurality of conduits, wherein each cartridge of the plurality of cartridges engages with an associated conduit of the plurality of conduits, the associated conduit having a predetermined size that is different from the size of the other conduits of the plurality of conduits; and the shipping container comprises a plurality of shipping containers, wherein each shipping container of the plurality of shipping containers is configured to contain a single cartridge of the plurality of cartridges and a single associated conduit of the plurality of conduits.

12. A cartridge assembly comprising: a cartridge comprising: a cartridge frame having first and second frame ends and a first vacuum channel extending therebetween, a first and a second jaw connected to the cartridge frame, the first and second jaws movable between a jaw closed position and ajaw open position, wherein: when in the jaw closed position, the first and second jaws are configured to engage a conduit during a nerve repair procedure on a patient, and when in the jaw open position, the first and second jaws are configured to release the conduit, and a separator configured to extend from the first frame end, through a vacuum port of the conduit and into the conduit’s interior to provide a predetermined regeneration gap between first and second nerve stumps inserted into the conduit during the nerve repair procedure; and a handpiece comprising: a handpiece chassis having first and second chassis ends and a second vacuum channel extending therebetween, the first chassis end configured to releasably engage the second frame end in order to connect the first and second vacuum channels and to enable a vacuum source connected to the second chassis end to pull a vacuum on the conduit’s interior.

13. The cartridge assembly of claim 12, comprising: a first and a second jaw pivot boss disposed on opposing sides of the cartridge frame, the first and second jaw pivot bosses configured to engage with the first and second jaws respectively to provide a fulcrum about which the first and second jaws can pivot between the jaw closed position and jaw open position; and a cartridge spring disposed on the carrier frame, the cartridge spring configured to engage with the first and second jaws to urge the first and second jaws to pivot into their respective jaw closed positions.

14. The cartridge assembly of claim 12, comprising: the cartridge frame comprising a cartridge boss extending longitudinally from the second frame end, the cartridge boss comprising a cartridge latch disposed on an end portion of the cartridge boss; the handpiece chassis comprising a cartridge boss recess disposed in the first chassis end, the cartridge boss recess configured to receive the cartridge boss therein; and a capture spring mounted on the handpiece chassis; wherein, when the cartridge boss is inserted into the cartridge boss recess, the cartridge latch releasably engages with the capture spring.

15. The cartridge assembly of claim 12, comprising: a vacuum tube having first and second tube ends and a vent slot disposed therebetween, the first tube end configured to be inserted into the second chassis end and the second tube end configured to connect to the vacuum source; and a control valve configured to be mounted over the outside diameter of the vacuum tube, the control valve configured to thread edly engage the second chassis end and to cover all or a portion of the vent slot; wherein the larger the portion of the vent slot that is covered by the control valve, the deeper the vacuum that can be pulled by the vacuum source on the interior of the conduit.

16. The cartridge assembly of claim 12, comprising a shipping container comprising: a housing configured to receive the cartridge and associated conduit engaged by the cartridge therein; a saline well disposed in the housing, the saline well configured to receive the conduit therein, the saline well operable to be filled with a saline solution to soak the conduit for a predetermined amount of time prior to releasably engaging the cartridge to the handpiece; a first and a second retaining tab disposed on opposing sides of the housing, each retaining tab including a first retaining tab end connected to the housing, from which the retaining tab extends resiliently upwards to a distal second retaining tab end; and a first and a second retaining latch disposed on the distal second retaining tab ends of the first and second retaining tabs respectively; wherein, when the cartridge is inserted into the housing, the first and second retaining latches engage with the second frame end of the cartridge frame to retain the cartridge within the housing; and wherein, when the handpiece engages the second frame end, the handpiece chassis urges the first and second retaining latches apart to release the cartridge from the shipping container.

17. A method of performing a nerve repair procedure on a patent, the method comprising: selecting a cartridge and an associated conduit releasably engaged by the cartridge, wherein the associated conduit has a predetermined size based on a determined diameter of a first nerve stump; pulling a vacuum, via a first vacuum channel in the cartridge on an interior of the associated conduit; inserting the first and a second nerve stump into first and second open ends respectively of the associated conduit while pulling the vacuum; and utilizing a first separator of the cartridge to provide a predetermined regeneration gap between the first and second nerve stumps.

18. The method of claim 17, comprising: releasably engaging a handpiece to the cartridge, the handpiece including a second vacuum channel; inserting a vacuum tube into the handpiece; connecting a vacuum source to the vacuum tube; pulling a vacuum, via the vacuum source, on the first and second vacuum channels and on the interior of the associated conduit; and controlling vacuum pressure of the vacuum in the interior of the associated conduit via a control valve disposed over the vacuum tube.

19. The method of claim 17, comprising: selecting the cartridge and associated conduit from a plurality of cartridges and a plurality of conduits retained in a plurality of shipping containers, wherein each cartridge of the plurality of cartridges engages with an associated conduit of the plurality of conduits, and wherein the associated conduit has a predetermined size that is different from the size of the other conduits of the plurality of conduits; and releasably engaging a handpiece to the selected cartridge, wherein the handpiece disengages the selected cartridge and associated conduit from the shipping container the selected cartridge is retained in.

20. The method of claim 17, comprising: retaining the cartridge and associated conduit in a shipping container; filling a saline well disposed in the shipping container with a saline solution; and soaking for a predetermined amount of time the selected associated conduit in the saline solution prior to releasably engaging the handpiece to the cartridge.