Connector and wrap for end-to-side nerve anastomosis

Abstract

To attach a donor nerve stump to a recipient nerve for an end-to-side anastomosis.SOLUTION: The problem is solved by the use of a tissue connector. The tissue connector can have a body for receiving the donor nerve stump, and one or more overflaps for attaching the tissue connector having the donor nerve stump therein to the epineurium on the side of the recipient nerve. Suture can also be used to secure the tissue connector and nerves in place.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 251,901, filed on Nov. 6, 2015. The entire disclosure of the application, including all drawings and tables, is incorporated herein by reference.

Background Art

[0002] Background of the Invention The current gold standard for nerve repair is autologous nerve grafting, especially in the presence of significant loss of nerve tissue. However, this technique may not be feasible when the amount of available graft tissue is limited, when the proximal nerve stump is not available, when the nerve is transected too far distal from the target organ, or when there is an excessive morbidity rate at the donor site. Surgical alternatives have been proposed, such as the use of synthetic conduits and biological conduits, the application of cultured Schwann cells, and the use of end - to - side neurorrhaphy (M. G. Lykissas, "Current concepts in end - to - side neurorrhaphy," World Journal of Orthopaedics, vol. 2, no. 11, pp. 102 - 106, 2011 (Non - Patent Document 1)).

[0003] End-to-side neurorrhaphy has been known to surgeons for over 100 years. This technique involves transplanting the distal stump of a damaged nerve onto the side of a healthy adjacent nerve. This technique can help maintain the integrity and viability of the distal nerve to prevent loss of function and atrophy. Interest in this technique has been increasing, and in recent years, numerous studies have been conducted to further understand the mechanism of nerve regeneration by this technique and ways to improve clinical applications and positive patient outcomes. End-to-side neurorrhaphy is accepted as a viable alternative for restoring nerve function when the proximal stump of the damaged donor nerve is not available or when the injury occurs too distally from the target organ. This technique is also used to avoid symptomatic (painful) neuroma formation by transplanting the proximal sensory nerve stump onto a small branched motor or sensory nerve.

[0004] This technique is based on the idea that if the distal stump is sutured end-to-side to a local recipient nerve, collateral axonal sprouting from the healthy local recipient nerve can occur at the distal stump of the donor severed nerve. Also, studies have shown that there is no need to create an epineurial window, i.e., an opening, at the recipient nerve site to promote collateral axonal sprouting. However, when an untreated or open distal nerve stump is joined to the recipient site, axonal growth may not be limited to the recipient and donor nerves, and random axonal growth may occur outside the nerve, causing various symptoms including soft tissue adhesion and painful neuroma.

[0005] The ability to cover and isolate the coaptation site between the recipient nerve and the donor nerve stump can reduce or eliminate unwanted axonal growth into the surrounding area. Also, the healing time can be shortened by directing axonal growth to the preferred nerve regeneration site rather than non-target areas. Covering the coaptation site can also provide reinforcement to that area and prevent separation of the coaptated nerves. The use of implant devices for covering and isolating nerve ends in end-to-end procedures is known. Implants that can provide the same or similar benefits in end-to-side procedures are thought to make this technique more acceptable by reducing or eliminating unwanted side effects and improving patient outcomes.

Prior Art Documents

Non-Patent Documents

[0006]

Non-Patent Document 1

Summary of the Invention

[0007] Summary The present invention provides an advantageous novel nerve connector. More specifically, the present invention provides a nerve connector for facilitating end-to-side nerve repair. The devices and methods of the present invention can provide improved healing with fewer side effects in patients who require such procedures. Covering the coaptation site can also provide protection to the repair site by holding the sutured nerves in place and preventing tearing of the repair in the event of sudden tension, rather than just preventing separation of the repair.

[0008] The present invention provides certain attributes and advantages that can successfully address the above side effects associated with end-side neurosurgery, improve nerve repair, and enhance positive patient outcomes. In particular, aspects of the present invention provide novel and highly effective methods and devices for the simple and effective anastomosis of donor distal nerve stumps to the side of healthy and sufficiently intact adjacent recipient nerves.

[0009] One aspect of the present invention is a nerve sleeve or tube device having at least two lateral slits or lateral cutouts at one end. This provides at least two overlaps such that the ends of the tube suggest something in a V or U shape or resemble a fish's mouth. The nerve stumps of damaged or healthy donor nerves can be inserted into the ends of the tube, with the overlaps extending beyond the nerve stumps. The overlaps can be positioned outside or around the epineurium of either a living or dead recipient nerve such that the donor nerve is positioned alongside the recipient nerve. In some examples, an incision or opening, called an "epineurial fenestration," can be made in the epineurium of the recipient nerve where the donor nerve stump is positioned and fixed by sutures or other means, such as fibrin-derived products or equivalents, to promote axonal growth between the nerves. Once the nerve tube is positioned, sutures can be used to secure the nerve tube and overlaps onto the donor and recipient nerves.

[0010] Another aspect is a nerve wrap device of expandable diameter. One end of the wrap device can have two or more lateral slits or lateral cutouts as described above to create at least two overlaps. In this aspect, the tube is a wound material that can be opened or expanded to be positioned around the distal nerve stump, and again, the overlaps extend beyond the ends of the donor nerve stump. The overlaps can be used as described above to secure the distal nerve stump to the outside or epineurium of the recipient or adjacent nerve. [Invention 1001] A hollow body having an insertion end and an adjacent end, and a lumen extending through the body therebetween. One or more overlaps extending from the adjacent end and continuous with the body, and At least one separation part between the one or more overlaps that enables separation of the one or more overlaps. A nerve connector device for connecting two nerves, comprising the above. [Invention 1002] The nerve connector device of Invention 1001, wherein the body comprises a biocompatible material that is transparent or translucent. [Invention 1003] The nerve connector device of Invention 1002, comprising a biomaterial selected from the group consisting of high-density polyethylene (HDPE), polyethylene glycol (PEG) hydrogel, and purified protein of human or source origin. [Invention 1004] The nerve connector device of Invention 1002, comprising a biomaterial selected from the group consisting of small intestinal submucosal tissue (SIS), amnion, dermis, collagen, and decellularized fascia. [Invention 1005] The nerve connector device of Invention 1002, comprising porous HDPE or PEG surrounded by a layer of non-porous HDPE or PEG. [Invention 1006] The nerve connector device of Invention 1002, wherein the body is a continuous tubular structure. [Invention 1007] The nerve connector device of Invention 1002, wherein the body is a discontinuous tubular structure of a rounded material. [Invention 1008] The nerve connector device of Invention 1006, wherein the separation part is a cut. [Invention 1009] The nerve connector device of Invention 1006, wherein the separation part is a slit. [Invention 1010] A method for connecting a donor nerve stump to a recipient nerve in a patient who requires such treatment, A hollow body having an insertion end and an adjacent end, and a lumen extending through the body therebetween, One or more overlaps extending from the adjacent end and continuous with the body, and At least one separation between the one or more overlaps that allows the one or more overlaps to be separated Using a nerve connector device having; Introducing the donor nerve stump through the insertion end into the lumen for a distance therein; Wrapping the one or more overlaps around the recipient nerve such that the donor nerve stump is at least directed neurally around the recipient nerve; and Fixing the one or more overlaps to the recipient nerve using one or more sutures and fixing the body to the donor nerve using one or more sutures Including the method. [Invention 1011] The method of Invention 1010, further comprising creating a neurilemma fenestration in the recipient nerve. [Invention 1012] The method of Invention 1010, further comprising introducing the donor nerve stump into the lumen until the end of the donor nerve stump reaches or is near the insertion end of the at least one separation. [Invention 1013] The method of Invention 1010, further comprising wrapping the overlaps around the recipient nerve such that the adjacent ends of the overlaps can be sutured to each other.

Brief Description of the Drawings

[0011] To obtain a more accurate understanding of the above invention, a more detailed description of the invention briefly described above is given by referring to its specific embodiments shown in the accompanying drawings. The drawings presented herein may not be drawn to scale, and any reference to dimensions in the drawings or the following detailed description is specific to the disclosed embodiments. Any change in these dimensions that enables the invention to function for its intended purpose is considered to be within the scope of the invention. Accordingly, with the understanding that these drawings merely illustrate typical embodiments of the invention and should not be construed as limiting in scope, the invention will be described more specifically and in detail using the accompanying drawings.

Figure 1

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Figure 5

Figure 6

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] DETAILED DISCLOSURE The present invention provides an implant useful for tissue anastomosis. More specifically, the present invention provides a nerve connector or similar device for use in such procedures in patients requiring nerve anastomosis. Even more specifically, aspects of the present invention provide a nerve connector implant useful for end-to-side nerve coaptation, particularly end-to-side nerve repair procedures.

[0013] In the following description, several terms related to medical devices and nerve repair are used. To provide a clear and consistent understanding of the specification and claims, including the scope in which such terms are given, the following definitions are provided.

[0014] As used herein, the term "patient" refers to any animal, including mammals, to which the devices and methods of the present invention are applicable. Mammalian species that can benefit from the disclosed systems and methods include humans, anthropoids, chimpanzees, orangutans, monkeys; domestic animals such as dogs, cats, guinea pigs, hamsters (e.g., pets); veterinary use for large animals such as cows, horses, goats, sheep; and any wild animals for veterinary or tracking purposes, but are not limited thereto. Human or non-human animal patients can be in an age range from neonatal to geriatric.

[0015] The term "surgeon" as used in this specification is for merely linguistic convenience. This term should not be construed as limiting in any way. The devices, instruments, methods, techniques and / or procedures of the present invention can be used by any person who desires or needs to use them and who has the necessary skills and understanding of the present invention.

[0016] The terms "nerve" and "nervous tissue" as used in this specification are for merely linguistic convenience. It is contemplated that any tissue to which the aspects of the present invention are applicable and can be useful is encompassed by these terms. By way of non-limiting example, aspects of the present invention can also be used in vascular or urinary tissue, tendon or muscle tissue.

[0017] The term "suture" is also used in this specification for merely linguistic convenience. This term should not be construed as limiting in any way. Aspects of the present invention can be used in conjunction with any of a variety of devices, substances, and techniques useful for fixing and / or connecting tissues including nervous tissue. This can include, but is not limited to, sutures, staples, vascular clips, hydrogels, fibrin, urethane adhesives and other medical adhesives or combinations thereof.

[0018] Any reference in this specification to "one aspect", "an aspect", "exemplary aspect", "further aspect", "alternative aspect", etc. is for merely linguistic convenience. What is meant is that any particular feature, structure or characteristic described in connection with such an aspect is included in at least one aspect of the present invention. The appearance of such phrases in various places in this specification does not necessarily refer to the same aspect. Additionally, any element or limitation of any invention or aspect thereof disclosed in this specification can be combined with any and / or all other elements or limitations of any other invention or aspect thereof disclosed in this specification (individually or in any combination), and all such combinations are considered to be within the scope of the present invention without limitation thereto.

[0019] Finally, throughout this application, reference is made to the "adjacent end" and the "insertion end" of aspects of the present invention. As used herein, the adjacent end of a device is the end that is disposed closest to or can be attached to the recipient tissue or nerve. Conversely, the "insertion end" of a device is the end into which the severed end of the donor nerve is inserted and is generally, but not exclusively, furthest away from the adjacent end.

[0020] The invention is more specifically described in the following examples which are intended to be merely illustrative, and numerous changes and modifications will be apparent to those skilled in the art. The singular forms "a", "an", and "the" as used in this specification and the claims include plural referents unless the context clearly dictates otherwise.

[0021] For manufacturing the devices of the present invention, any natural and synthetic biomaterials can be used. In certain aspects, the biomaterial is a homogeneous material. Examples of biomaterials for use in the manufacture of the present invention include, but are not limited to, high density polyethylene (HDPE), polyethylene glycol (PEG) hydrogel, purified proteins from human or animal sources (such as purified collagen or fibrin membranes), cellularized and decellularized tissue constructs (such as demineralized bone, small intestinal submucosa (SIS), dermis, muscle, fascia, or placental tissues such as amnion). HDPE or PEG devices can comprise or consist of a porous HDPE or PEG cylinder surrounded by a non-porous layer of HDPE or PEG. Biomaterials that can form a fluid material, such as soluble purified collagen or particulate SIS and dermis, can be directly molded without an intermediate membrane to form the device.

[0022] Aspects of the present invention can advantageously be flexible and transparent or at least translucent or semi-transparent. In certain aspects, small intestinal submucosa (SIS) material is used. The SIS material can provide sufficient transparency, flexibility, and strength for the nerve connectors of the present invention. During the procedure, the surgeon can typically view the donor nerve stump through the SIS material, which is advantageous for positioning the nerve stump at an appropriate distance from the recipient nerve and aligning the nerve stump with the epineurial fenestration, i.e., the opening in the epineurium, if used. The flexibility of the material also allows the material to be bent or wrapped around the nerve without damaging or injuring the nerve. The SIS material is also suitable for use with sutures to hold it in place once it is positioned on the nerve.

[0023] Reference is made to the accompanying drawings, which are used throughout to indicate the same or similar components. Referring to the accompanying drawings that illustrate certain aspects of the present invention, in FIG. 1, it can be seen that the nerve connector 20 of the present invention has an insertion end 100 and an adjacent end 200. Generally, the nerve connector includes a body 30 having a lumen 35 therein for receiving a donor nerve stump and is open to both the adjacent end and the insertion end. The adjacent end can further have at least one overlap 40. Alternative aspects can include two or more overlaps 40 separated by a slot 45 capable of receiving a recipient nerve. Each of these general components can have one or more sub-components, which will be described in detail below.

[0024] One aspect of the present invention has a hollow body 30 that is generally tubular, and the body is a continuous tubular structure. Further, there can be a lumen 35 that passes through the longitudinal length of the body and has openings 36 at both the insertion end 100 and the adjacent end 200. In this aspect, a donor nerve stump 5 can be inserted into the insertion end 100 and pushed or pulled toward the adjacent end 200. FIGS. 1, 2, and 6 show examples of donor nerves within the lumen.

[0025] In one embodiment, the diameter of the lumen 35 is generally constant along the length of the continuous body, and the opening 36 has the same or approximately the same diameter. In an alternative embodiment shown in FIG. 4D, the diameter of the lumen 35 gradually increases toward the insertion end 100, and the opening 36 at its end is larger than the opening at the other end, which can make it easier to insert the donor nerve stump and enable end-to-side connection of nerves having different diameters. The flexibility of the material allows the material around the opening to be drawn, gathered, or crimped around the epineurium 7 of the donor nerve and, if necessary, closed or fixed by suture 250.

[0026] In another embodiment, the diameter of the lumen 35 is substantially consistent along a portion of the body 30 at the adjacent end 200, for example, along at least half of the length of the body from the adjacent end, and then the body and the lumen can flare toward the insertion end 100, as shown in FIG. 4C for example. This can make it easier to insert the donor nerve stump at the insertion end, and the thinner, non-flared portion of the lumen can assist in holding the nerve stump within the lumen. The flared opening can be gathered or crimped around the epineurium 7 of the donor nerve and fixed by one or more sutures to help hold the nerve connector 20 in place.

[0027] In one embodiment, the body of the device is made by rolling up a sheet of biomaterial to form a tubular structure, an example of which is shown in FIG. 4F, in which the body of the device is a "roll" of layers, overlapping layers, or partially overlapping layers of the biomaterial that form a non-continuous tubular structure. The layers of the roll can expand to receive nerves or other tissues of various diameters. In a particular related embodiment, when the inner diameter of the device is expanded to receive a larger diameter nerve, the layers of the rolled-up biomaterial overlap to an extent sufficient to maintain the wall of the tubular structure.

[0028] The length of the body can vary depending on a variety of factors understood by those skilled in the art, including but not limited to the length of the donor nerve, the diameter of the donor nerve, the integrity of the donor nerve and / or the amount of damage thereto, the location where sutures can be used and the number of sutures that can be used, and the in-body position of the recipient nerve, among other factors. In one aspect, the length of the body 30 is from about 0.5 cm to about 3.0 cm. In a more specific aspect, the length of the body is from about 0.75 cm to about 2.0 cm. In a particular aspect, the body has a length of about 1.0 cm.

[0029] Similarly, the diameter of the lumen can vary depending on a variety of factors understood by those skilled in the art, including the above factors. In one aspect, the diameter of the lumen is from about 0.25 cm to about 0.5 cm. In a more specific aspect, the diameter of the lumen is about 0.3 cm.

[0030] At the adjacent end 200, there can be one or more overlaps 40 that are continuous with the body 30 and extend outward from or around the opening of the adjacent end 200 of the body. In one aspect, for example, as shown in FIG. 4A, there is only one overlap 40. This aspect can be useful when only a portion of the recipient nerve upper membrane 15 is accessible. In this aspect, for example, the nerve connector 20 having the donor nerve therein can be brought close to the recipient nerve, and one of its overlaps can be placed over or around the accessible portion of the recipient nerve upper membrane 15 and sutured in place.

[0031] Figures 3 and 4B - 4E show examples of other embodiments where there are two overlaps 40 that are continuous with the body 30 and extend out from or around the opening of the adjacent end 200 of the body. In this embodiment, as shown, for example, in Figures 2 and 6, the overlaps can be positioned on each side of the epineurium 15 of the recipient nerve 10 so that the overlaps can surround or at least partially surround the recipient nerve. The overlaps can be positioned 180° or about 180° apart, or substantially opposite the opening, so as to resemble an open mouth of a fish, as shown in Figure 5. However, this is not a necessary configuration, and in some situations, it may be beneficial for the overlaps to be offset or not positioned directly opposite each other around the opening. Further, the overlaps can be of different sizes and / or lengths, an example of which is shown in Figure 4B.

[0032] In alternative embodiments, more than two overlaps 40 can be present. This embodiment can be useful when the recipient nerve 10 or perhaps the donor nerve has an irregular shape or position that makes the use of just two overlaps difficult, inefficient, or ineffective. The multiple overlaps can have the same characteristics and variations as described above for the one and two overlap embodiments. Those skilled in the art, upon the benefit of this disclosure, will understand how to incorporate more than two overlaps into the nerve connector 20 in accordance with the present invention. Accordingly, examples thereof are not included in the drawings of this specification.

[0033] Two or more overlaps 40 can have a separating portion 41 therebetween that defines the shape or structure of the overlap. The separating portion can be of any shape or size and can create a point or line at which the overlaps can be separated or deployed. In one embodiment, the separating portion is one or more slits 42 between the overlaps so that they can be separated for placement around or on each side of the recipient nerve as described above. Generally, a slit is a very narrow separating portion with little or no loss of material between the overlaps. Such a slit can extend from the opening of the adjacent end 200 toward the insertion end 100, an example of which is shown in FIG. 4F. The slit can also be made at an angle to the body. For example, the slit 42 can be substantially collinear with the body 30 as shown in FIG. 4F or can be angled or non - collinear with the body as illustrated by the dotted line in FIG. 4F.

[0034] In one embodiment, the separating portion between two or more overlaps 40 can be something like a slit 45 that is larger than a slit and provides more space and less material between the overlaps. The slit can further have any of a variety of configurations to facilitate placement of the overlap over or around the recipient nerve 10. The slit can have a straight edge, a curved edge, or some combination thereof that facilitates joining or wrapping around the recipient nerve. FIGS. 4B - 4E show some examples of variously shaped slits that can be used in conjunction with embodiments of the present invention. Preferably, the length and shape of the slit are such that it can wrap sufficiently around the recipient nerve so that sutures can be used to secure the overlap. The slit can also be of a length sufficient to allow the overlap to fully extend around the recipient nerve so that, for example, as shown in FIG. 2, the adjacent ends of the overlap can be secured using at least one suture.

[0035] The length of the slit and conversely the length of the overlap can vary depending on any of a variety of factors understood by those skilled in the art. For example, a connector used for sciatic nerve tissue can be larger than a connector used for nerve tissue in the hand or face. In one embodiment, the length of the overlap is from about 0.1 cm to about 4.0 cm. In another embodiment, the length of the overlap is from about 0.2 cm to 2.0 cm. In a more specific embodiment, the length of the overlap is from about 0.3 cm to about 0.7 cm. In a particular embodiment, the length of the overlap is about 0.5 cm.

[0036] The use of the tissue connector 20 can include introducing the donor nerve stump 5 into the lumen, typically by inserting it into the lumen from the insertion end 100 of the body 30 or by pushing it in. The end 8 of the donor nerve stump can be brought close to the opening 36 of the adjacent end. It can be advantageous to ensure that there is at least some space between the epineurium of the recipient nerve and the end of the donor nerve. Thus, the end 8 of the donor nerve can be positioned just behind the cut 42 or slot 45. Then, one or more overlaps 40 of the tissue connector can be partially or fully wrapped around the side of the recipient nerve 10 so that the end 8 of the donor nerve stump 5 comes sufficiently close to the side of the recipient nerve to effect an end-to-side junction.

[0037] In some situations, an incision or opening, often referred to as an epineurial window 17, can be created in the epineurium 15 of the recipient nerve to promote or facilitate axonal growth between nerves. As described above, it can be useful if the material of the tissue connector is transparent or translucent or semi-transparent, enabling the surgeon to see the position of the donor nerve stump within the lumen 35 and also the position of the donor nerve stump relative to the recipient nerve and / or the epineurial window. This helps the surgeon to accurately position the tip 8 and ensures that the nerve is not placed in a position that is too close or distorted before joining the tissue connector to the nerve by suturing.

[0038] Once the tip of the donor nerve stump 5 is correctly positioned relative to the recipient nerve 10, one or more sutures can be used between the donor nerve stump and the tissue connector and between the recipient nerve and one or more overlaps and / or between the overlaps if the overlap completely surrounds the recipient nerve.

[0039] Alternatively, after the overlaps are joined, the overlap 40 of the adjacent end 200 can be joined to the recipient nerve and the donor nerve disposed within the lumen 35. This also enables the surgeon to position the opening 36 of the adjacent end 200 at the optimal position on the recipient nerve and ensures that the tip 8 of the donor nerve is correctly positioned when inserted into the lumen.

[0040] In another alternative embodiment, one or some of the overlaps can be joined to the recipient nerve to assist in the optimal placement. Then, the donor nerve can be inserted and positioned within the lumen such that the donor nerve is correctly positioned relative to the recipient nerve when the remaining one or more overlaps are joined. Additional sutures can be used to secure the remaining one or more overlaps and the donor nerve.

[0041] In some cases, a nerve repair technique of joining a donor nerve stump from a damaged peripheral nerve to the side of an adjacent, usually intact recipient nerve is useful. Joining the donor nerve to the recipient nerve can ensure the survival of the donor nerve and prevent atrophy of the tissues weakened by the damaged peripheral nerve. When the donor nerve stump is joined to the side of the recipient nerve, the nerve repair device used for end-to-end nerve repair may not be applicable to end-to-side nerve repair.

[0042] Aspects of the present invention provide a new biocompatible device that can make end-to-side nerve repair easier to perform, inhibit unwanted axonal growth, and provide improved patient outcomes. The tissue connector device and technique of the present invention can be useful for joining a donor nerve to a recipient nerve and, when formed from a suitable material, can enable a surgeon to actually view the nerve through the device during placement for improved accuracy.

[0043] The scope of the present invention is not limited by the specific examples and proposed procedures and uses related herein, as such scope can be varied from the information provided to those skilled in the art by this specification.

[0044] The present invention is described in considerable detail herein in order to comply with the patent law, provide those skilled in the art with the information necessary to apply the novel principles, and construct and use the dedicated components as required. However, the present invention can also be implemented by differently equipped and arranged devices, and various changes can be made to both the details of the equipment and the operating procedures without departing from the scope of the present invention. Further, although the present invention has been described with reference to specific details of its particular aspects and by the examples disclosed herein, such details are not intended to be regarded as limitations on the scope of the present invention except to the extent included in the claims.

Claims

1. a hollow body formed of a material having an insertion end, an abutment end and a lumen therebetween; at least two overflaps extending from the proximal end of the hollow body, the at least two overflaps being sized to extend at least partially around an outer periphery of a non-end side of the recipient tissue to position the non-end side of the recipient tissue adjacent the proximal end of the hollow body; two or more separation portions between the at least two overflaps that facilitate securing the recipient tissue to the tissue connector device; said tissue connector device adapted to facilitate an end-to-end connection of tissue, comprising: At least one of the two or more separation portions is between two adjacent overlapping flaps and configured to receive a portion of the recipient tissue; the two or more separation portions separate the at least two overflaps from one another; the at least two overflaps separated from one another are disposed about the outer periphery of the recipient tissue. The tissue connector device.

2. 10. The tissue connector device of claim 1, wherein the material forming the hollow body comprises a biological material that is transparent, semi-transparent, or translucent.

3. 3. The tissue connector device of claim 2, wherein the biomaterial is selected from the group consisting of high density polyethylene (HDPE), polyethylene glycol (PEG) hydrogels, purified proteins from human, animal, or synthetic sources.

4. 3. The tissue connector device of claim 2, wherein the biomaterial is selected from the group consisting of small intestinal submucosa (SIS), amniotic membrane, dermis, collagen, and decellularized fascia.

5. 3. The tissue connector device of claim 2, wherein the biomaterial comprises a porous HDPE or PEG surrounded by a layer of non-porous HDPE or PEG.

6. The tissue connector device of any one of claims 1 to 5, wherein the body is a continuous tubular structure.

7. The tissue connector device of any one of claims 1 to 5, wherein the body is a discontinuous tubular structure of rolled material.

8. The tissue connector device of any one of claims 1 to 7, wherein the material is capable of passing a suture.

9. 10. The tissue connector device of claim 8, wherein the at least two overflaps are configured to surround an epineurium of the recipient tissue.

10. 10. The tissue connector device of claim 9, wherein a length of the at least two overlap flaps facilitates attachment around the epineurium using a suture.

11. The tissue connector device of any one of claims 1 to 10, wherein the two or more separation portions are curvilinear in shape.

12. The tissue connector device of any one of claims 1 to 11, wherein the insertion end is flared.

13. The tissue connector device of any one of claims 1 to 12, wherein the length of one overflap is between about 0.1 cm and about 4.0 cm.

14. The tissue connector device of claim 13, wherein the length of one overflap is between about 0.2 cm and about 2.0 cm.

15. 15. The tissue connector device of claim 14, wherein the length of one overflap is about 0.5 cm.

16. The tissue connector device of any one of claims 1 to 15, wherein the at least two overflaps have different lengths.

17. 17. The tissue connector device of any one of claims 1 to 16, wherein the hollow body further comprises a diameter that enables an end of a donor tissue to be positioned within the lumen such that the end of the donor tissue is positioned behind the two or more separation portions and the end-to-side connection is suitable for creating an end-to-side joint between the end of the donor tissue and a non-end side of the recipient tissue.

18. The tissue connector device of any one of claims 1 to 17, wherein the two or more separation portions are slits.

19. a hollow body having an insertion end, an abutment end and a lumen therebetween; at least two overflaps contiguous with the hollow body and extending from the proximal end of the hollow body, the at least two overflaps being sized to extend at least partially around an outer periphery of a non-end side of a recipient tissue to position the non-end side of the recipient tissue adjacent the proximal end of the hollow body; and two or more separation portions between the at least two overflaps that facilitate securing the recipient tissue to the tissue connector device; said tissue connector device adapted to facilitate an end-to-end connection of tissue, comprising: the two or more separation portions provide a space between the at least two overflaps that separates the at least two overflaps from each other; the at least two overflaps separated from one another are disposed about the outer periphery of the recipient tissue; the diameter of the lumen increases from the proximal end toward the insertion end; The tissue connector device.

20. 20. The tissue connector device of claim 19, wherein the material forming the hollow body comprises a biological material that is transparent, semi-transparent, or translucent.

21. 21. The tissue connector device of claim 20, wherein the biomaterial is selected from the group consisting of high density polyethylene (HDPE), polyethylene glycol (PEG) hydrogels, purified proteins from human, animal, or synthetic sources.

22. 21. The tissue connector device of claim 20, wherein the biomaterial is selected from the group consisting of small intestinal submucosa (SIS), amniotic membrane, dermis, collagen, and decellularized fascia.

23. 21. The tissue connector device of claim 20, wherein the biomaterial comprises a porous HDPE or PEG surrounded by a layer of non-porous HDPE or PEG.

24. The tissue connector device of any one of claims 19 to 23, wherein the body is a continuous tubular structure.

25. The tissue connector device of any one of claims 19 to 23, wherein the body is a discontinuous tubular structure of rolled material.

26. The tissue connector device of any one of claims 19 to 25, wherein the material is capable of passing a suture.

27. 27. The tissue connector device of claim 26, wherein the at least two overflaps are configured to surround an epineurium of the recipient tissue.

28. 28. The tissue connector device of claim 27, wherein a length of the at least two overlap flaps facilitates attachment around the epineurium using a suture.

29. The tissue connector device of any one of claims 19 to 28, wherein the two or more separation portions are curvilinear in shape.

30. The tissue connector device of any one of claims 19 to 29, wherein the insertion end is flared.

31. The tissue connector device of any one of claims 19 to 30, wherein the length of one overflap is between about 0.1 cm and about 4.0 cm.

32. 32. The tissue connector device of claim 31, wherein the length of one overflap is between about 0.2 cm and about 2.0 cm.

33. 33. The tissue connector device of claim 32, wherein the length of one overflap is about 0.5 cm.

34. The tissue connector device of any one of claims 19 to 33, wherein the at least two overflaps have different lengths.

35. 35. The tissue connector device of any one of claims 19 to 34, wherein the hollow body further comprises a diameter that enables an end of a donor tissue to be positioned within the lumen such that the end of the donor tissue is positioned behind the two or more separation portions and the end-to-side connection is suitable for creating an end-to-side joint between the end of the donor tissue and a non-end side of the recipient tissue.

36. The tissue connector device of any one of claims 19 to 35, wherein the two or more separation portions are slits.

37. 1. A tissue connector device for use in a method for connecting donor tissue adjacent to a lateral side of recipient tissue, the method comprising: a hollow body having an insertion end, an abutment end and a lumen extending therebetween through the body; at least two overflaps extending from the adjacent ends and continuous with the body; and two or more separation sections between the at least two overflaps that facilitate securing the recipient tissue to the tissue connector device; wherein one or more of the at least two separation portions are configured to receive a portion of an outer surface of the recipient tissue. using inserting the donor tissue through the insertion end of the tissue connector device and into the lumen; wrapping at least one of the at least two overflaps around at least a portion of the recipient tissue; and using one or more sutures to secure the at least two overflaps to the recipient tissue and using one or more sutures to secure the body to the donor tissue. The tissue connector device.

38. 38. The tissue connector device for use according to claim 37, wherein the method further comprises the step of inserting the donor tissue into the lumen until a terminal end of the donor tissue is at or near the opening at the proximal end of the tissue connector device.

39. 38. The tissue connector device for use according to claim 37, wherein the method further comprises wrapping the at least two overflaps around the recipient tissue such that the adjacent ends of the at least two overflaps overlap one another.

40. 1. A method of manufacturing a tissue connector device for connecting an end portion of a donor tissue adjacent to a lateral surface of a recipient tissue, comprising: forming a hollow body having an insertion end, an abutment end and a lumen extending therebetween through the body; and forming at least two overflaps extending from the adjacent ends and contiguous with the body, and at least two separations between the at least two overflaps. Including, A method, wherein one or more of the at least two separation portions are configured to receive a portion of an outer surface of the recipient tissue.

41. 41. The method of claim 40, wherein the body comprises a biomaterial that is transparent, translucent, or semi-transparent.

42. 41. The method of claim 40, wherein the tissue connector device comprises a biomaterial selected from the group consisting of high density polyethylene (HDPE), polyethylene glycol (PEG) hydrogel, purified proteins from human, animal, or synthetic sources, cellularized tissue constructs, and decellularized tissue constructs.

43. 41. The method of claim 40, wherein the tissue connector device comprises a biomaterial selected from the group consisting of fibrin, demineralized bone, small intestinal submucosa (SIS), dermis, collagen, muscle, fascia, and birth tissue.

44. The method of claim 43, wherein the biological material is amniotic membrane.

45. 41. The method of claim 40, wherein the tissue connector device comprises a porous HDPE or PEG surrounded by a layer of non-porous HDPE or PEG.

46. The method of claim 40, wherein the body is a continuous tubular structure.

47. The method of claim 40, wherein the body is a discontinuous tubular structure.

48. 48. The method of claim 47, wherein forming a hollow body comprises rolling a biomaterial to form the discontinuous tubular structure.

49. 41. The method of claim 40, wherein the tissue connector device comprises small intestinal submucosa (SIS).

50. 50. The method of any one of claims 40 to 49, wherein the tissue connector device is a neural connector device, the donor tissue is a donor nerve, and the recipient tissue is a recipient nerve.

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