WO2011091169A1 - Nerve and blood vessel repair systems - Google Patents

Nerve and blood vessel repair systems Download PDF

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Publication number
WO2011091169A1
WO2011091169A1 PCT/US2011/021930 US2011021930W WO2011091169A1 WO 2011091169 A1 WO2011091169 A1 WO 2011091169A1 US 2011021930 W US2011021930 W US 2011021930W WO 2011091169 A1 WO2011091169 A1 WO 2011091169A1
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WO
WIPO (PCT)
Prior art keywords
tubular structure
apparatus
nerve
blood vessel
attachment members
Prior art date
Application number
PCT/US2011/021930
Other languages
French (fr)
Inventor
John Elfar
Original Assignee
University Of Rochester
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US29688310P priority Critical
Priority to US61/296,883 priority
Application filed by University Of Rochester filed Critical University Of Rochester
Publication of WO2011091169A1 publication Critical patent/WO2011091169A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1128Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of nerves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132End-to-end connections

Abstract

A nerve repair and blood vessel repair apparatus are described. The nerve repair apparatus includes a tubular structure having a plurality of attachment members at an inside surface of the tubular structure. The tubular structure is configured to attach to an outer surface of a nerve via the attachment members to facilitate repair of the nerve. The blood vessel repair apparatus includes a tubular structure having a plurality of attachment members on an outside surface of the tubular structure. The tubular structure is configured to attach to an inner surface of a blood vessel via the attachment members to facilitate repair of the blood vessel.

Description

NERVE AND BLOOD VESSEL REPAIR SYSTEMS

Priority Applications

[0001] This application claims priority benefit from U.S. Provisional Application No.

61/296,883, filed on January 20, 2010, the entire contents of which is incorporated by reference herein.

Field

[0002] The subject technology generally relates to nerves and blood vessel, and more particularly to nerve and blood vessel repair systems and methods.

Background

[0003] A nerve is an enclosed, cable-like bundle of peripheral axons (the long, slender projections of neurons). A nerve can provide a common pathway for the electrochemical nerve impulses that are transmitted along each of the axons. Nerves are found only in the peripheral nervous system. Damage to nerves can be caused by physical injury, swelling (e.g. carpal tunnel syndrome), autoimmune diseases (e.g. Guillain-Barre syndrome), infection (neuritis), diabetes or failure of the blood vessels surrounding the nerve.

Summary

[0004] Various techniques are currently available for repairing a severed nerve or blood vessel. A current method of repair of a nerve is to anastamose the epineurium or fasicular perineurium individually. However, this technique is undesirable or impractical when the nerve has retracted. In the presence of retraction, effort has been made to perform a repair which is not under tension. The current techniques for relieving tension on the nerve include nerve grafting the defect, transposing or re-routing the nerve to allow more slack for a direct end-to- end repair, and using a collagen or silastic tube to bridge the defect. All of these techniques are risky and involve a fair amount of manipulation of the nerve. The operative time needed to achieve the goal of a tension-free repair can put the patient at risk for perioperative

complications.

[0005] In one aspect of the subject technology, an apparatus for nerve repair may comprise a tubular structure having a plurality of attachment members at an inside surface of the tubular structure. The tubular structure may be configured to attach to an outer surface of a nerve via the plurality of attachment members to facilitate repair of the nerve.

[0006] In another aspect of the subject technology, an apparatus for blood vessel repair may comprise a tubular structure having a plurality of attachment members on an outside surface of the tubular structure. The tubular structure may be configured to attach to an inner surface of a blood vessel via the plurality of attachment members to facilitate repair of the blood vessel.

[0007] In some configurations, a method for nerve repair is described. The method may comprise providing a tubular structure having a plurality of attachment members on an inside surface of the tubular structure. In some embodiments, the method further comprises attaching the tubular structure to an outer surface of a nerve via the plurality of attachment members to facilitate repair of the nerve.

[0008] In other configurations, a method for blood vessel repair is described. The method may comprise providing a tubular structure having a plurality of attachment members on an outside surface of the tubular structure. In some embodiments, the method further comprises attaching the tubular structure to an inner surface of a blood vessel via the plurality of attachment members to facilitate repair of the blood vessel.

[0009] In some embodiments, an apparatus for nerve repair comprises a tubular structure having a plurality of attachment members at an inside surface of the tubular structure, the tubular structure configured to attach to an outer surface of a nerve via the plurality of attachment members to facilitate repair of the nerve.

[0010] In some embodiments, the tubular structure comprises a stent. The attachment members may be configured to penetrate an epineurium and/or perineurium of the nerve.

[0011] In some embodiments, the attachment members are configured to penetrate a of the nerve or vessel. In some embodiments, the attachment members comprise at least one of a hook, a barb, and a pin. The tubular structure further comprises one or more engagement members configured to receive a suture. [0012] The one or more engagement members may comprise at least one of a coil and a ring. In some embodiments, the at least one coil comprises at least one connected and/or at least one unconnected loop. The at least one coil may comprise at least one winding, which can comprise at least one of a metal and a polymer. In some embodiments, the tubular structure comprises a resorbable material.

[0013] In some embodiments, the tubular structure is configured to expand radially. When the tubular structure is attached to the nerve or vessel, the nerve or vessel can extend through a lumen of the tubular structure. The lumen can extend from a proximal end to a distal end of the tubular structure.

[0014] In some embodiments, the tubular structure is configured such that when the tubular structure is attached to the nerve or vessel, the tubular structure expands and pulls severed ends of the nerve or vessel closer, to facilitate repair.

[0015] Some aspects of the technology include nerve repair or vessel repair methods comprising providing a tubular structure having a plurality of attachment members at an inside (e.g., for a nerve) or outside (e.g., for a vessel) surface of the tubular structure; and attaching the tubular structure to an outer surface of a nerve (or an inner surface of a vessel) via the plurality of attachment members to facilitate repair of the nerve or vessel.

[0016] Some embodiments further include suturing the tubular structure to the nerve or vessel. In some embodiments, the method further comprises expanding the tubular structure radially when the tubular structure is attached to the nerve or vessel, thereby bringing severed ends of the nerve or vessel closer together.

[0017] It is understood that other configurations of the subject technology will become readily apparent to those skilled in the art from the following detailed description, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. [0018] Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

Brief Description of the Drawings

[0019] The accompanying drawings, which are included to provide further understanding of the subject technology and are incorporated in and constitute a part of this specification, illustrate aspects of the subject technology and together with the description serve to explain the principles of the subject technology.

[0020] FIG. 1 illustrates an example of a severed nerve having a gap that is bridged with a tubular structure repair apparatus.

[0021] FIG. 2 illustrates an example of a nerve or blood vessel repair apparatus according to one aspect of the subject technology.

[0022] FIG. 3 is an example diagram illustrating the severed nerve of FIG. 1 with the tubular structure expanded to bring the severed nerve ends closer together.

[0023] FIG. 4 illustrates another example of a nerve or blood vessel repair apparatus according to one aspect of the subject technology.

[0024] FIG. 5 illustrates an example of a severed blood vessel having a gap that is bridged with a tubular structure repair apparatus.

[0025] FIG. 6 illustrates an example of a blood vessel repair apparatus according to one aspect of the subject technology.

[0026] FIG. 7 illustrates an example of a sutured or sewn blood vessel after repair using the tubular structure repair apparatus.

[0027] FIG. 8 illustrates an example diagram of a tubular structure in a partially lacerated or severed blood vessel.

[0028] FIG. 9 illustrates an example of a blood vessel repair apparatus according to one aspect of the subject technology. [0029] FIG. 10 illustrates an example of a method for nerve repair according to one aspect of the subject technology.

[0030] FIG. 1 1 illustrates an example of a method for blood vessel repair according to one aspect of the subject technology.

Detailed Description

[0031] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The appended drawings are incorporated herein and constitute a part of the detailed description. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject

technology. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. Like or similar components may be labeled with identical element numbers for ease of understanding or it may indicated in the disclosure that one component may be an example of a different component.

[0032] By way of illustration and not limitation, aspects of the subject disclosure describe a tubular structure repair apparatus and method for the repair of severed structures such as blood vessels and nerves. A first aspect of the subject technology comprises an apparatus and method for repairing a severed structure such as a severed or partially severed peripheral nerve. A second aspect of the subject technology comprises an apparatus and method for performing vascular and microvascular repair. In particular, the second aspect comprises a method and apparatus for repairing a severed or partially severed blood vessel. In some configurations, the foregoing technique may be used for the protection of a structure, for example a blood vessel and/or a nerve, which has not been severed, from compression or scar formation after a decompression surgery, for example.

[0033] In one aspect of the subject technology, nerve repair for a complete and/or partial nerve laceration is described. Referring now to the illustrations, and more particularly to FIG. 1, FIG. 2 and FIG. 3 examples of a tubular structure repair apparatus such as a nerve repair apparatus according to one aspect of the subject technology are shown. In particular, FIG. 1 illustrates an example of a severed nerve 190 having a gap 105 that is bridged with the tubular structure repair apparatus 100. The tubular structure repair apparatus or nerve repair apparatus 100 comprises a tubular structure 110. The tubular structure 110 may comprise a tubular structure cavity 140, an outer surface 130 and an inner surface 120. The inner surface 120 may be disposed within the tubular structure cavity 140. The tubular structure 1 10 further comprises a proximal end 150 and a distal end 160.

[0034] As used herein, the term "tubular structure" is intended to have its ordinary meaning, which includes, for example and without limitation, a structure having the shape of a tube. In some embodiments, the tubular structure is substantially continuous, meaning that the perimeter of the tubular structure is substantially continuous about its circumferential perimeter. Some embodiments provide that the tubular structure can be discontinuous, meaning that a portion of the tubular structure is not continuous about its circumferential perimeter. Both embodiments may be utilized in connection with the disclosure provided herein.

[0035] In some configurations, the tubular structure 110 comprises a stent similar to those used for cardiac catheterization or an intraluminal splinting stent. The tubular structure 110 may be configured to surround an outer surface of the nerve 190 such as the epineurium 170 or the perineurium 180 enclosing a fascicle, for example. The tubular structure 110 may be configured to expand along its diameter or cross sectional configuration. The expansion of the tubular structure 1 10 along its diameter correspond to a reduction in the length of the tubular structure 110 after it is attached to the nerve 190.

[0036] In some embodiments, the tubular structure 110 is configured to reduce in length while increasing in diametrical or radial extent. Reduction of the length of the tubular structure is particularly advantageous to decrease the distance between severed or damaged edges of tissue. Reducing the distance between the edges of tissue increases the likelihood of proper healing and can reduce the amount of scarring as the tissue heals. In embodiments where the length decreases, the tubular structure 110 can be positioned over the tissue, and the tubular structure 110 is configured to provide a delayed reduction in length. After the delayed period of time, of after a determined time, the length of the tubular structure 110 can be reduced to draw the tissue ends closer toward each other. The change in length of the tubular structure 110 can be accomplished, for example, by shape-memory materials, such as Nitinol.

[0037] The nerve repair apparatus 100 can be configured to facilitate the repair of an injured or severed structure, such as a nerve or a blood vessel. In one exemplary configuration, the severed nerve 190, comprises a first severed end 115 and a second severed end 125. The first severed end 115 may be disposed within the inner surface of the proximal end 150 of the tubular structure 110 and the second severed end 125 may be disposed within the inner surface of the distal end 160 of the tubular structure 110.

[0038] In order to facilitate repair of the nerve 190, the tubular structure may be configured to attach to an outer surface 170 or 180 of the nerve. The tubular structure 110 may comprise a plurality of attachment members 210 (see FIG. 2) at an inner or inside surface 120 for attaching to the outer surface 170 or 180 of the nerve 190. FIG. 2 illustrates an exemplary configuration of FIG.1 with the tubular structure 110 comprising the attachment members 210. The plurality of attachment members 210 can be configured to attach to the nerve 190 to allow less manipulation and minimal or no use of sutures to keep the tubular structure 110 in place.

[0039] In some embodiments, the attachment members 210 are configured to penetrate up to the epineurium 170 of the nerve. Some embodiments provide that the attachment members 210 penetrate no deeper than the epineurium 170 of the nerve. In some embodiments, the attachment members 210 are configured to penetrate up to the perineurium 180 of the nerve. Some embodiments provide that the attachment members 210 penetrate no deeper than the perineurium 180 of the nerve.

[0040] In some configurations, the attachment members may comprise a hook, a barb, a pin or any combination thereof. The tubular structure 110 and/or the plurality of attachment members 210 may comprise one or more coils, one or more rings and or a mesh configured to receive a suture. The one or more coils or rings may comprise one or more connected loops, one or more unconnected loops, one or more windings or a combination thereof. The one or more windings, for example, may comprise at least one of a metal and a polymer. The one or more coils, rings or windings, for example, can be configured to facilitate suturing or sewing the tubular structure 1 10 in place during nerve repair. [0041] The size of each of the plurality of attachment members 210 may be in the order of microns and can be positioned towards the inside of the tubular structure 110 to prevent retraction of the nerve 190. The tubular structure 110 can be configured such that when it is attached to the nerve, the diameter or cross-sectional configuration of the tubular structure 110 expands and pulls the first severed end 115 and the second severed end 125 of the nerve 190 closer together as illustrated in FIG. 3. In particular, the tubular structure 110 exerts a static expansile force which serves to better approximate the ends of the nerve or bring the ends of the nerve together as illustrated in FIG. 3.

[0042] FIG. 4 illustrates an exemplary diagram of a nerve repair apparatus 400 comprising one or more engagement sleeves 470 configured to attach to a tubular structure 410. The tubular structure 410 comprises a tubular structure cavity 440, an outer surface 430 and an inner surface 420. The inner surface 420 may be disposed within the tubular structure cavity 440. The tubular structure 410 further comprises a proximal end 450 and a distal end 460. In some configurations, the tubular structure 410 comprises a stent such as those used for cardiac catheterization. The tubular structure 410 may be configured to surround an outer surface of the nerve such as the epineurium 170 or the perineurium 180 enclosing a fascicle, for example. The tubular structure 410 may be configured to expand along its diameter or cross sectional configuration. The expansion of the tubular structure 410 along its diameter may be due to a reduction in the length of the tubular structure 410 after it is attached to the nerve 190.

[0043] One or more engagement sleeves 470 can be configured to attach to the proximal end 450 and/or the distal end 460 of the tubular structure 410. The one or more engagement sleeves 470 may comprise an engagement sleeve cavity 405, a proximal engagement end 480 and a distal engagement end 490. The one or more engage sleeve 470 may be configured to attach to the outer surface 430 and/or the inner surface 420 of the tubular structure 410. In some configurations, the one or more engagement sleeves 470 are an integral part of the tubular structure 410. In other configurations, the one or more engagement sleeves 470 may be independent but attached to the tubular structure 410 via various attachment means including sewing or suturing and/or via one or more attachment means disposed on the inner and/or outer surface of the engagement sleeves 470 and/or disposed on the inner and/or outer surface of the tubular structure 410. [0044] The one or more attachment means 407 may be similar to the plurality of attachment members 210 described with respect to FIG. 2. The tubular structure 410 may be similar to the tubular structure 110 of FIG.1, 2 and 3. In order to facilitate repair of the nerve 190, the one or more engagement sleeve 470 may be configured to attach to an outer surface 170 or 180 of the nerve. The one or more attachment means 407 may be positioned at an inner surface 420 of the of the one or more engagement sleeves 470 for attaching to the outer surface 170 or 180 of the nerve 190 or an outer surface of a blood vessel. The one or more attachment means 407 can be disposed within the engagement sleeve cavity 405. In some configurations, the tubular structure 410 may be similar to the tubular structure 110 of FIG. 3 while in other configurations the tubular structure 410 may not include the plurality of engagement members 210 of FIG. 2.

[0045] The one or more engagement sleeves 470 can be configured such that when attached to the nerve 190, the diameter or cross-sectional configuration of the one or more engagement sleeves 470 expands and pulls the severed end 115, for example, towards the distal engagement end 490 of the one or more engagement sleeves 470. In particular, the tubular structure 110 exerts a static expansile force which serves to better approximate the ends of the nerve 190 or bring the ends of the nerve 190 together as illustrated in FIG. 3. The tubular structure 410 may comprise a collagen tube, a stent, other tubular structures or a combination thereof. The one or more engagement sleeves 410 effectively secure the nerve 190 to the tubular structure 410. This feature allows the freedom to place the tubular structure 410 on the nerve 190 and then engage the nerve 190 when convenient for a user and allows the freedom to customize the nerve repair apparatus 400. The foregoing implementations can also be used to repair a partially severed nerve. The individual nerve fascicles which are severed can be incorporated into a single engagement sleeve 470 or tubular structure 410 or a combination thereof. The tubular structure 110, 410 or the engagement sleeve 470 can be attached to the nerve 190 such that the nerve 190 extends through the lumen of the tubular structure 110, 410 or the engagement sleeve 470.

[0046] The tubular structure (e.g., stent) may be structurally configured to withstand pressure of overlying muscles, for example. The tubular structure 410 can also be configured to attach to the nerve 190 with the right amount of compliance to facilitate manipulation of the tubular structure 410. The tubular structure 410 can physically sequester the nerve 190 without preventing near-by vascular in-growth. The tubular structure 410 could be porous or solid, permanent or resorbable. The tubular structure 410 can be snug fitting so as to provide resistance to tension and sequestration of the contents of the tube (possible avenue for pharmaceutical treatments inside the tube) or it can be loosely fitting to allow side invasion of vessels along the side of the injured structure. The tubular structure can be manufactured from either resorbable or non-resorbable material. Examples of resorbable materials include but are not limited to collagen, dextran, or other cloth based materials and silk . Examples of non- resorbable materials include but are not limited to silastic, metal, polymethylmethacrylate and polyethylene.

[0047] In another aspect of the subject technology, vascular and microvascular repair of vessels are described. In some configurations, blood vessel repair for a complete and/or partial blood vessel laceration or sever are described. In general, vascular anastomoses typically are performed under the operative microscope when the vessels are on the order of 1-4 mm. Such small vessels may be difficult to repair when injured— largely owing to the difficulty in manipulating them. The nature of the repair typically involves the use of microvascular clamps, placed in close proximity so as to allow the ends of the vessel to be juxtaposed. Sutures with ultra fine suture are then placed carefully in the vessel walls to allow a recomposition of the vessel lumen. Tubular structures can be placed within the blood vessel to allow a structural substrate for the placement of sutures, for example.

[0048] Referring now to the illustrations, and more particularly to FIG. 5, FIG. 6, FIG. 7 and FIG. 8 examples of a blood vessel repair apparatus 500 according to one aspect of the subject technology are shown. In particular, FIG. 5 illustrates an example of a severed blood vessel 590 having a gap 505 that is bridged with the tubular structure repair apparatus 500. The tubular structure repair apparatus 500 comprises a tubular structure 510. The tubular structure 510 can be similar to the tubular structure 110 described with respect to FIG. 1 above. In some configurations, the tubular structure 510 can be implemented on the outer surface of the blood vessel, similar to the implementation described with respect to FIG. 1, FIG. 2, FIG. 3 and FIG. 4. Accordingly, the tubular structure may comprise a plurality of attachment members 210, for example, configured to attach the outer surface 170 of the severed blood vessel 590. Likewise, the implementation of FIG. 4 can also be applied to the severed blood vessel 590. [0049] In one aspect of the subject technology, the tubular structure 510 can be configured to attach to an inner surface 570 of the blood vessel 570 such as the endothelium. The tubular structure 510 may comprise a tubular structure cavity 540 (see FIG. 7), an outer surface 530 and an inner surface 520. The inner surface 520 may be disposed within the tubular structure cavity 540. The tubular structure 510 further comprises a proximal end 550 and a distal end 560. In some configurations, the tubular structure 510 comprises a stent such as those used for cardiac catheterization. The tubular structure 510 may be configured to expand along its diameter or cross sectional configuration. The expansion of the tubular structure 510 along its diameter may be due to a reduction in the length of the tubular structure 510 after it is attached to the blood vessel 590.

[0050] The tubular structure repair apparatus 500 can be configured to facilitate the repair of an injured structure, such as a blood vessel 590. In one exemplary configuration, the severed blood vessel 590 comprises a first severed end 515 and a second severed end 525. The first severed end 515 may be disposed around the outer surface of the proximal end 550 (see FIG. 6) of the tubular structure 510 and the second severed end 525 may be disposed around the outer surface of the distal end 560 (see FIG. 6) of the tubular structure 110. In order to facilitate repair of the blood vessel, the tubular structure 510 may be configured to attach to an inner surface 570 of the blood vessel.

[0051] The tubular structure 510 may comprise a plurality of attachment members 512 (see FIG. 5 & FIG. 6) at an outer surface 530 of the tubular structure 510 for attaching to the inner surface 570 of the blood vessel 590. FIG. 6 illustrates an exemplary configuration of the tubular structure 510 of FIG. 5 comprising the plurality of attachment members 512. The plurality of attachment members 512 can be configured to attach to the blood vessel 590 to allow less manipulation and minimal or no use of sutures to keep the tubular structure 510 in place.

[0052] In some embodiments, the attachment members 512 are positioned on the outer surface 530 of the tubular structure and face outward from the tubular structure 510 from the outer surface 530. This permits the attachment members 510 to engage the inner surface of the blood vessel 590 and resist removal of the tubular structure from within the vessel 590 once deployed. In some embodiments, as shown in Figures 7 and 8, the attachment members 510 or barbs that face a direction that opposes withdrawal of the tubular structure 510 from being removed from the vessel 590 once the structure 510 is implanted. In applications where the tubular structure is used to attach opposed ends of a severed or cut blood vessel, as shown in the figures, the barbs projection outward from the outer surface 530 of the tubular structure, so as to penetrate or extend into the vessel wall, and in opposite directions, so as to resist removal of the tubular structure 510 from within the vessel 590.

[0053] Although minimal use of sutures is desirable for sewing or suturing the tubular structure 510 in place, some configurations may implement attaching the tubular structure to the blood vessel via the plurality of engagement members and by suturing or sewing the tubular structure 510 in place. FIG. 7 illustrates an example of a sutured or sewn blood vessel 590 after repair using the tubular structure 510. Although the plurality of attachment members 512 are shown penetrating from the interior of the blood vessel 590 to the exterior of the blood vessel 590, it is not required for plurality of engagement members 512 to penetrate to the exterior of the blood vessel 590. For example, the plurality of attachment members 512 may be configured to penetrate an inner surface of the blood vessel 590. The severed portion of the blood vessel 590 may be configured to be sutured or sewn (for example, with a suture 514 of FIG. 7) after the tubular structure 510 is placed within the blood vessel 590.

[0054] In yet another aspect of the subject technology, partial vessel lacerations or sever can also be treated or repaired with the tubular structure 510 described above. This implementation allows for approximation of the wall of a lacerated or severed vessel without compromising the patency or opening of the lumen. This implementation further reduces the chances of an errant stitch closing the vessel.

[0055] In some configurations, the structure for facilitating repair of the partially severed vessel or nerve may comprise a portion 810 of the tubular structure 590, for example a small sheets of meshed material that functions in a similar manner as the tubular structure 590 described above. The portion of the tubular structure 810 may be positioned in a planar configuration such as a single plane or along a single axis, for example, as illustrated in FIG. 9.

A large nerve or vessel 590 that is to be re-connected but only requires a small area of mesh or does not need to be fully enveloped could be covered with mesh material akin to the tubular structure such as a stent. Such material could be manufactured in many sizes like stents and be employed in the patching over of defects which are partial in nature. FIG. 9 illustrates an example of a small mesh used in the repair of a partially lacerated nerve. In other configurations, the meshing material can be used for the protection of blood vessels or nerves from compression or re-compression. Wrapping such material around nerves or vessels which have been manipulated affords some amount of protection from local compression. FIG. 9 illustrates an example diagram of a tubular structure in a partially lacerated or severed blood vessel with a suture 914 after repair.

[0056] In some configurations, the plurality of attachment members 512, for example, may comprise a hook, a barb, a pin or any combination thereof. The tubular structure 510 and/or the plurality of attachment members 512 may comprise one or more coils or one or more rings and may be configured to receive a suture. The one or more coils or rings may comprise one or more connected loops, one or more unconnected loops, one or more windings or a combination thereof. The one or more windings, for example, may comprise at least one of a metal and a polymer. The one or more coils, rings or windings, for example, can be configured to facilitate suturing or sewing the tubular structure 510 in place during vessel repair. The size of each of the plurality of attachment members may be in the order of microns.

[0057] The tubular structure 510 can be configured such that when it is attached to the vessel, the diameter or cross-sectional configuration of the tubular structure 510 expands and pulls the first severed end 515 and the second severed end 525 of the blood vessel 590 closer together. In particular, the tubular structure 510, exerts a static expansile force which serves to better approximate the ends of the blood vessel or bring the ends of the blood vessel together. In some embodiments, the tubular structure 510 can reduce in length without expanding in diametrical or radial extent. The tubular structures (e.g. stent) can incorporate the elution of antithrombotic agents for the purpose of promoting flow in an anastamosis as opposed to the classically used agents in the setting of cardiac placement.

[0058] FIG. 10 illustrates an example of a method for nerve repair according to one aspect of the subject technology. The method begins in block 1000. The method continues to block

1010 where a tubular structure having a plurality of attachment members on an inside surface of the tubular structure is provided. The process continues to block 1020 where the tubular structure is attached to an outer surface of a nerve via the plurality of attachment members to facilitate repair of the nerve. The process ends in block 1030. [0059] FIG. 11 illustrates an example of a method for blood vessel repair according to one aspect of the subject technology. The method begins in block 1100. The method continues to block 1110 where a tubular structure having a plurality of attachment members on an outside surface of the tubular structure is provided. The process continues to block 1120 where the tubular structure is attached to an inner surface of a blood vessel via the plurality of attachment members to facilitate repair of the blood vessel. The process ends in block 1130.

[0060] The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the present subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.

[0061] There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these

configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.

[0062] A phrase such as an "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as a "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa. [0063] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

[0064] A reference to an element in the singular is not intended to mean "one and only one" unless specifically stated, but rather "one or more." The term "some" refers to one or more. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for." Furthermore, to the extent that the term "include," "have," or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term "comprise" as "comprise" is interpreted when employed as a transitional word in a claim.

Claims

WHAT IS CLAIMED IS:
1. An apparatus for nerve repair, comprising:
a tubular structure having a plurality of attachment members at an inside surface of the tubular structure, the tubular structure configured to attach to an outer surface of a nerve via the plurality of attachment members to facilitate repair of the nerve.
2. The apparatus of claim 1 , wherein the tubular structure comprises a stent.
3. The apparatus of claim 1, wherein the attachment members are configured to penetrate an epineurium of the nerve.
4. The apparatus of claim 1, wherein the attachment members are configured to penetrate a perineurium of the nerve.
5. The apparatus of claim 1, wherein the attachment members comprise at least one of a hook, a barb, and a pin.
6. The apparatus of claim 1, wherein the tubular structure further comprises one or more engagement members configured to receive a suture.
7. The apparatus of claim 6, wherein the one or more engagement members comprises at least one of a coil and a ring.
8. The apparatus of claim 7, wherein the at least one coil comprises at least one connected loop.
9. The apparatus of claim 7, wherein the at least one coil comprises at least one unconnected loop.
10. The apparatus of claim 7, wherein the at least one coil comprises at least one winding.
11. The apparatus of claim 10, wherein the at least one winding comprises at least one of a metal and a polymer.
12. The apparatus of claim 1, wherein the tubular structure comprises a resorbable material.
13. The apparatus of claim 1, wherein the tubular structure is configured to expand radially.
14. The apparatus of claim 1, wherein, when the tubular structure is attached to the nerve, the nerve extends through a lumen of the tubular structure.
15. The apparatus of claim 14, wherein the lumen extends from a proximal end to a distal end of the tubular structure.
16. The apparatus of claim 1, wherein the tubular structure is configured such that when the tubular structure is attached to the nerve, the tubular structure expands and pulls severed ends of the nerve closer, to facilitate repair.
17. An apparatus for blood vessel repair, comprising:
a tubular structure having a plurality of attachment members at an outside surface of the tubular structure, the tubular structure configured to attach to an inner surface of a blood vessel via the plurality of attachment members to facilitate repair of the blood vessel.
18. The apparatus of claim 17, wherein the tubular structure comprises a stent.
19. The apparatus of claim 17, wherein the attachment members are configured to penetrate an endothelium of the blood vessel.
20. The apparatus of claim 17, wherein the attachment members comprise at least one of a hook, a barb, and a pin.
21. The apparatus of claim 20, wherein the attachment members project outwardly from an outer surface of the tubular structure.
22. The apparatus of claim 21, wherein the attachment members extend in opposed directions from the outer surface.
23. The apparatus of claim 17, wherein the tubular structure comprises one or more engagement members configured to receive a suture.
24. The apparatus of claim 23, wherein the one or more engagement members comprises at least one of a coil and a ring.
25. The apparatus of claim 24, wherein the at least one coil comprises at least one connected loop.
26. The apparatus of claim 24, wherein the at least one coil comprises at least one unconnected loop.
27. The apparatus of claim 24, wherein the at least one coil comprises at least one winding.
28. The apparatus of claim 27, wherein the at least one windings comprises at least one of a metal and a polymer.
29. The apparatus of claim 17, wherein the tubular structure comprises a resorbable material.
30. The apparatus of claim 17, wherein the tubular structure is configured to expand radially.
31. The apparatus of claim 17, wherein, when the tubular structure is attached to the blood vessel, the blood vessel extends through a lumen of the tubular structure.
32. The apparatus of claim 31, wherein the lumen is configured to extend from a proximal end to a distal end of the tubular structure.
33. The apparatus of claim 17, wherein the tubular structure is configured such that when the tubular structure is attached to the blood vessel, the tubular structure reduces in length and pulls severed ends of the blood vessel closer, to facilitate repair.
34. A nerve repair method comprising:
providing a tubular structure having a plurality of attachment members at an inside surface of the tubular structure;
attaching the tubular structure to an outer surface of a nerve via the plurality of attachment members to facilitate repair of the nerve.
35. The method of claim 34, further comprising suturing the tubular structure to the nerve.
36. The method of claim 34, wherein the tubular structure comprises a stent.
37. The method of claim 34, wherein the attaching the tubular structure comprises attaching the tubular structure to an epineurium of the nerve.
38. The method of claim 34, further comprising expanding the tubular structure radially when the tubular structure is attached to the nerve, thereby bringing severed ends of the nerve closer together.
39. The method of claim 34, further comprising reducing the tubular structure in length when the tubular structure is attached to the nerve, thereby bringing severed ends of the nerve closer together.
40. A method for blood vessel repair comprising:
providing a tubular structure having a plurality of attachment members at an outside surface of the tubular structure;
attaching the tubular structure to an inner surface of a blood vessel via the plurality of attachment members to facilitate repair of the blood vessel.
41. The method of claim 39, further comprising suturing the tubular structure to the blood vessel.
42. The method of claim 39, wherein the tubular structure comprises a stent.
43. The method of claim 39, wherein the attaching the tubular structure comprises attaching the tubular structure to an endothelium of the blood vessel.
44. The method of claim 39, further comprising expanding the tubular structure radially when the tubular structure is attached to the blood vessel, thereby bringing severed ends of the blood vessel closer together.
45. The method of claim 39, further comprising reducing the tubular structure in length when the tubular structure is attached to the blood vessel, thereby bringing severed ends of the blood vessel closer together.
PCT/US2011/021930 2010-01-20 2011-01-20 Nerve and blood vessel repair systems WO2011091169A1 (en)

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