Nerve repair fixing sleeve

Abstract

The invention relates to the technical field of medical apparatus and instruments, and discloses a nerve repair fixing cannula, a flexible connection sheet can be bent into a tubular shape, so that two ends of the flexible connection sheet respectively wrap the peripheries of two nerve broken ends, the inner side of the flexible connection sheet is provided with a growth space, a tubular structure for nerve bridging is established, nerve axons grow directionally, and the two nerve broken ends are kept aligned; the multiple microneedles are arranged at the two ends of the flexible connecting piece at intervals, the connecting tension of the nerve bundle layer and the flexible connecting piece is dispersed, and the pain feeling of a patient is relieved; a needle head of the microneedle is used for being inserted into an adventitia so as to fix the bent flexible connecting piece to the nerve broken end, a needle rod penetrates through the flexible connecting piece, and the needle rod and the outer tangent plane of the bent flexible connecting piece at the needle threading position are obliquely arranged at a first preset angle, so that the mechanical stability of the nerve repair fixing sleeve installed on the nerve broken end is improved; the nerve broken end can be quickly and conveniently fixed, meanwhile, the damage to nerve tracts is reduced, and the situation that the nerve function recovery is affected by scars is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a nerve repair and fixation sleeve. Background Art

[0002] Peripheral nerve injury is a common clinical disease, mainly caused by various reasons resulting in sensory disorders, motor disorders, nutritional disorders, etc. in the area innervated by the nerve. According to the defect distance of the peripheral nerve, an appropriate repair method can be selected. Generally, when the defect distance of the peripheral nerve is short, for example, the defect distance is less than 5 millimeters, it can be repaired by direct surgical suture; but for nerve injuries with long-distance defects, such as when the defect distance is more than 4 times the diameter of the damaged nerve or the defect length is more than 3 centimeters, direct suture will result in a large tension at the suture line, leading to an unsatisfactory surgical repair effect.

[0003] In the prior art, the commonly used treatment options clinically are autologous transplantation and allogeneic transplantation. Autologous nerve transplantation is the "gold standard" for repairing damaged peripheral nerves, but it has certain limitations due to insufficient donors, impaired donor site function, and the formation of neuromas; while allogeneic transplantation may cause problems such as immune rejection reactions and cross-infections. Based on this, the emergence of artificial nerve conduits has become an important research direction for treating peripheral nerve injuries.

[0004] Currently, for artificial nerve conduits, the commonly used surgical operation method by clinicians is still the relatively traditional needle and thread suture fixation method, where the damaged nerve and the artificial nerve conduit are sleeved through 1 to 2 stitches by threading a needle. This method requires very high skills from surgeons. The damaged nerve must be fixed first, and after correct alignment, it can be sutured. The difficulty is high and it takes a long time. Since the outer membrane of the nerve is under excessive force during the pulling process of the needle and thread, it is inevitable to cause damage to the nerve bundles and the formation of scars, affecting the recovery of nerve function. Summary of the Invention

[0005] The purpose of the present invention is to provide a nerve repair and fixation sleeve, which is simple and fast to operate, can stably fix and maintain the alignment of nerve stumps, reduce the penetrating injury to the nerve fascicle layer to relieve the pain of patients, and at the same time improve the speed of nerve function recovery.

[0006] To achieve this purpose, the present invention adopts the following technical solutions:

[0007] A nerve repair and fixation sleeve for fixing a pair of nerve stumps and guiding the relative growth of the two nerve stumps, the nerve repair and fixation sleeve comprising:

[0008] A flexible connecting piece, which can be bent so that both ends of the flexible connecting piece respectively wrap around the peripheries of the two nerve stumps; after bending, the flexible connecting piece is in a tubular shape with a growth space inside, and the two nerve stumps are respectively located on both sides of the growth space along the direction perpendicular to the bending direction of the flexible connecting piece;

[0009] Microneedles, a plurality of which are respectively arranged at intervals at both ends of the flexible connecting piece; each microneedle includes a needle rod and a needle tip, the needle rod and the needle tip are connected, the needle rod penetrates through the flexible connecting piece, and the needle rod is inclined at a first preset angle with respect to the outer tangent plane of the bent flexible connecting piece at the needle-piercing position, and the needle tip is used to insert into the perineurium to fix the bent flexible connecting piece to the nerve stump.

[0010] As an alternative technical solution of the nerve repair and fixation sleeve, the material of the flexible connecting piece is a degradable high molecular polyester material, and a collagen coating is attached to the surface of the flexible connecting piece;

[0011] And / or, a bioadhesive coating is attached to the surface of the microneedle, and the microneedle is bonded to the flexible connecting piece through the bioadhesive coating.

[0012] As an alternative technical solution of the nerve repair and fixation sleeve, the range of the first preset angle is 30° to 60°.

[0013] As an alternative technical solution of the nerve repair and fixation sleeve, the needle tip is arranged as a lobe formed by cutting a cone along two axial sections intersecting at a second preset angle, the bottom side of the lobe is a sector, and the angle of the sector is the second preset angle; the axis of the cone coincides with the axis of the needle rod, the top side of the lobe is a tip, and the tip is arranged in a direction away from the needle rod.

[0014] As an alternative technical solution of the nerve repair and fixation sleeve, the range of the second preset angle is 120° to 150°.

[0015] As an alternative technical solution of the nerve repair and fixation sleeve, the tip of the needle tip is arranged in a direction away from the needle rod, and barbs are arranged on the needle tip, and the barbs are inclined at a third preset angle with respect to the needle rod.

[0016] As an alternative technical solution of the nerve repair and fixation sleeve, the range of the third preset angle is 15° to 45°.

[0017] As an alternative technical solution of the nerve repair and fixation sleeve, the microneedle further includes a needle holder, which is connected to one end of the needle bar away from the needle tip. The needle holder is located on the side of the flexible connection piece away from the nerve outer membrane. The needle holder is arranged as a thin sheet for preventing the microneedle from being disconnected from the flexible connection piece.

[0018] As an alternative technical solution of the nerve repair and fixation sleeve, two rows of the microneedles are arranged at intervals along the axial direction of the nerve stump at both ends of the flexible connection piece. A plurality of the microneedles are arranged at intervals along the circumferential direction of the nerve stump in each row, and the two rows of the microneedles are arranged staggeredly.

[0019] As an alternative technical solution of the nerve repair and fixation sleeve, the flexible connection piece is composed of warp and weft interwoven with each other, and the arrangement density ranges of both the warp and the weft are 600 - 800 per 10 cm.

[0020] Advantages of the present invention:

[0021] The nerve repair and fixation sleeve provided by the present invention includes a flexible connection piece and microneedles. The flexible connection piece can be bent so that both ends of the flexible connection piece respectively wrap around the peripheries of two nerve stumps. After being bent, the flexible connection piece is tubular, and a growth space is left empty inside. The two nerve stumps are respectively located on both sides of the growth space along the direction perpendicular to the bending direction of the flexible connection piece, and a tubular structure for nerve bridging can be established at the stumps of the peripheral nerve injury, enabling the nerve axons to grow directionally along the growth space inside the tube cavity and keeping the two nerve stumps in alignment. A plurality of microneedles are respectively arranged at intervals at both ends of the flexible connection piece, that is, arranged at circumferential intervals at both ends of the bent flexible connection piece. Arranging an array of microneedles at the two nerve stumps can disperse the connection tension between the nerve fascicle layer and the flexible connection piece, reduce the penetration of the nerve fascicle layer, and to a certain extent, can relieve the pain of the patient. Each microneedle includes a needle bar and a needle tip, the needle bar and the needle tip are connected, the needle bar penetrates through the flexible connection piece, and the needle bar is inclined at a first preset angle with respect to the outer tangent plane of the bent flexible connection piece at the needle-piercing position, that is, the needle bar forms a first preset angle with the plane when the flexible connection piece is laid flat, improving the mechanical stability of the nerve repair and fixation sleeve installed on the nerve stump. The needle tip is used to insert into the nerve outer membrane to fix the bent flexible connection piece to the nerve stump. The microneedle is inserted into the nerve outer mold at a certain angle for wireless direct fitting of the nerve stump and the flexible connection piece, realizing rapid and convenient fixation of the nerve stump, while reducing the damage to the nerve fascicles and avoiding the formation of scars that affect the recovery of nerve function. Description of the Drawings

[0022] Figure 1 is a schematic structural diagram of the nerve repair and fixation sleeve provided by the specific embodiment of the present invention from the first perspective when laid flat;

[0023] Figure 2 It is a schematic structural diagram of the second perspective when the nerve repair and fixation sleeve provided by the specific embodiment of the present invention is laid flat;

[0024] Figure 3 is Figure 2 a partial enlarged view of part A in

[0025] Figure 4 It is a front view of the nerve repair and fixation sleeve provided by the specific embodiment of the present invention when laid flat;

[0026] Figure 5 It is a schematic structural diagram of the nerve repair and fixation sleeve provided by the specific embodiment of the present invention when bent;

[0027] Figure 6 It is a front view of the nerve repair and fixation sleeve provided by the specific embodiment of the present invention when bent;

[0028] Figure 7 It is a side view of the nerve repair and fixation sleeve provided by the specific embodiment of the present invention when bent;

[0029] Figure 8 It is a schematic structural diagram of the first perspective of the micro-needle for nerve connection provided by the specific embodiment of the present invention;

[0030] Figure 9 It is a schematic structural diagram of the second perspective of the micro-needle for nerve connection provided by the specific embodiment of the present invention;

[0031] Figure 10 It is a front view of the micro-needle for nerve connection provided by the specific embodiment of the present invention;

[0032] Figure 11 It is a side view of the micro-needle for nerve connection provided by the specific embodiment of the present invention;

[0033] Figure 12 It is a projection view of the micro-needle for nerve connection provided by the specific embodiment of the present invention in the extending direction of the needle bar;

[0034] Figure 13 It is a projection view of the micro-needle for nerve connection provided by the specific embodiment of the present invention in the direction perpendicular to one of the axial cross-sections.

[0035] In the figure:

[0036] a, the first preset angle; b, the second preset angle; c, the third preset angle;

[0037] 100, flexible connection piece; 110, needle-passing position; 120, growth space;

[0038] 200, Microneedle; 210, Needle tip; 211, Groove; 212, Barbs; 220, Needle shaft; 230, Needle holder. Detailed implementation mode

[0039] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present invention, rather than limiting the present invention. In addition, it should be noted that, for the sake of description, only the parts related to the present invention are shown in the drawings, rather than all the structures.

[0040] In the description of the present invention, unless otherwise clearly defined and limited, the terms "connected", "connected to", and "fixed" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0041] In the present invention, unless otherwise clearly defined and limited, the first feature being "above" or "below" the second feature may include the direct contact between the first and second features, or may include the situation where the first and second features are not in direct contact but in contact through other features between them. Moreover, the first feature being "above", "above and to the right", and "above and to the left" of the second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the horizontal height of the first feature is higher than that of the second feature. The first feature being "below", "below and to the right", and "below and to the left" of the second feature includes the first feature being directly below and obliquely below the second feature, or simply indicating that the horizontal height of the first feature is lower than that of the second feature.

[0042] In the description of this embodiment, the orientation or positional relationship terms such as "above", "below", "right", and "left" are based on the orientation or positional relationship shown in the drawings. They are only for the convenience of description and simplifying the operation, rather than indicating or implying that the device or component referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be understood as a limitation to the present invention. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0043] Such as Figures 1 to 13As shown in the figure, the present invention discloses a nerve repair and fixation sleeve, which is used to fix a pair of nerve stumps located at both ends of a defect distance in an area with peripheral nerve injury and guide the relative growth of the two nerve stumps. The nerve repair and fixation sleeve includes a flexible connection piece 100 and micro needles 200. Among them, the flexible connection piece 100 can be bent so that both ends of the flexible connection piece 100 respectively wrap around the peripheries of the two nerve stumps; after bending, the flexible connection piece 100 is tubular, and a growth space 120 is vacant inside it. The two nerve stumps are respectively located on both sides of the growth space 120 along the direction perpendicular to the bending direction of the flexible connection piece 100, and a tubular structure for nerve bridging can be established at the stumps of the peripheral nerve injury, so that nerve axons can grow directionally along the growth space 120 in the lumen and keep the two nerve stumps in alignment. A plurality of micro needles 200 are respectively arranged at intervals at both ends of the flexible connection piece 100, that is, circumferentially spaced at both ends of the bent flexible connection piece 100. An array of micro needles 200 is arranged at the two nerve stumps, which can disperse the connection tension between the nerve fascicle layer and the flexible connection piece 100, reduce the penetration of the nerve fascicle layer, and to a certain extent, can relieve the pain of the patient. Each micro needle 200 includes a needle rod 220 and a needle tip 210. The needle rod 220 and the needle tip 210 are connected. The needle rod 220 penetrates through the flexible connection piece 100, and the needle rod 220 is inclined at a first preset angle a with respect to the outer tangent plane of the bent flexible connection piece 100 at the needle-passing position 110, that is, the needle rod 220 forms an angle of the first preset angle a with the plane when the flexible connection piece 100 is laid flat, which improves the mechanical stability of the nerve repair and fixation sleeve installed on the nerve stump; the needle tip 210 is used to insert into the epineurium to fix the bent flexible connection piece 100 to the nerve stump. The micro needle 200 is inserted into the epineurium of the nerve at a certain angle for the wireless direct fitting of the nerve stump and the flexible connection piece 100, replacing the traditional suture method with a needle and thread, reducing the technical requirements for surgeons, and shortening the operation time.

[0044] When using the nerve repair and fixation sleeve, it is first necessary to clamp and fix the two nerve stumps at the correct alignment position; then place the flexible connection piece 100 parallel to one side of the two nerve stumps, and at the same time ensure that the micro needles 200 at both ends of the flexible connection piece 100 can be inserted into the peripheries of the nerve stumps; bend the flexible connection piece 100 to fit around the peripheries of the nerve stumps, and press the micro needles 200 into the epineurium of the nerve. The flexible connection piece 100 rotates slightly relative to the peripheries of the nerve stumps as the micro needles 200 are inserted until the flexible connection piece 100 is fixedly wrapped around the peripheries of the two nerve stumps, completing the connection of the two nerve stumps, which can reduce the operation difficulty of docking and fixation, realize the rapid and convenient fixation of the nerve stumps, and at the same time reduce the damage to the nerve fascicles and avoid forming scars that affect the recovery of nerve function.

[0045] In this embodiment, the length of the flexible connecting piece 100 can be specifically set according to the size of the nerve defect distance. The length of the flexible connecting piece 100 should be greater than the nerve defect distance, so that the two ends of the flexible connecting piece 100 can stably overlap the nerve stumps and accurately and stably align the two nerve stumps. The width of the flexible connecting piece 100 is limited by the diameter of the defective nerve, and the width of the flexible connecting piece 100 should match the circumference of the stump port of the defective nerve. After the flexible connecting piece 100 is bent, the two sides will be relatively close. If the width of the flexible connecting piece 100 is exactly equal to the circumference of the stump port of the defective nerve, the two sides of the flexible connecting piece 100 will just butt together, so that the flexible connecting piece 100 forms a laterally closed and complete sleeve. However, in actual operation, it is often difficult to easily and accurately ensure that the width of the flexible connecting piece 100 is exactly equal to the circumference of the stump of the defective nerve. For the sake of safety, a flexible connecting piece 100 with a larger width is generally reserved. If the width of the flexible connecting piece 100 is greater than the circumference of the stump of the defective nerve, the two sides of the flexible connecting piece 100 will overlap after bending. It is necessary to ensure that the part of the microneedles 200 located at the overlap of the two sides will not interfere, or it can be achieved by reducing the number of microneedles 200 at the side. It should be understood that the width of the flexible connecting piece 100 only needs to be slightly greater than the circumference of the stump of the defective nerve. As long as at least one overlapping part is ensured on both sides of the flexible connecting piece 100, it can not only stably form the structure of the sleeve, but also reduce the implant as much as possible, and facilitate the management of the overlapping sides. If the flexible connecting piece 100 has a large surplus width after surrounding the stump of the defective nerve, some of the sides can be appropriately cut off.

[0046] Specifically, the flexible connecting piece 100 is formed by textile weaving, and is composed of warp and weft interwoven to obtain a uniform fabric gap structure. The arrangement density of the warp and weft is 600-800 per 10 cm, which maintains a high degree of softness and can meet the needs of manual bending of the flexible connecting piece 100, so that the flexible connecting piece 100 is tubular and curled, and the flexible connecting piece 100 is kept light and dense, which reduces the patient's implant burden while ensuring the repair effect. The gap structure of the flexible connecting piece 100 is spread throughout the whole piece, and the gap structures at both ends can be directly used as the needle insertion position 110, which is convenient for the insertion of the microneedle 200 array and will not damage the sleeve formed by the fabric; the gap structure in the middle section is conducive to the mutual transfer of nutrients in the tissue fluid around the nerve, providing a good microenvironment for nerve regeneration.

[0047] Exemplarily, the flexible connecting piece 100 is woven from a medical-grade polymer biodegradable polyester material. The polyester material can preferably be one or more of, for example, polyglycolic acid, polycaprolactone, polylactic acid, etc. The reason for selecting this type of material is that the polyester material has a high mechanical strength ratio and a large elastic modulus, has good mechanical strength and flexibility, can simplify the operation method, and makes the formed flexible connecting piece 100 easier to wind and form. The bent flexible connecting piece 100 can be stably maintained as a three-dimensional tubular body and fixed at the nerve stump during subsequent treatment operations, and is not prone to collapse.

[0048] Moreover, a collagen coating is attached to the surface of the flexible connecting piece 100. Through the affinity of collagen cells, it is beneficial to secrete trophic factors and transmit Schwann cells, and can better promote the growth and alignment of nerves from the proximal end to the distal end. Moreover, the collagen coating can fill the fabric void structure of the flexible connecting piece 100, and at the same time endow the sleeve formed by the flexible connecting piece 100 with semi-permeability, which can effectively prevent the invasion of scar tissue and avoid the generation of neuromas and other complications.

[0049] In this embodiment, two rows of microneedles 200 are arranged at both ends of the flexible connecting piece 100 at intervals along the axial direction of the nerve stump. Each row of microneedles 200 is arranged at intervals along the circumferential direction of the nerve stump. The two rows of microneedles 200 are arranged staggeredly. The distribution array of the microneedles 200 at one end of the flexible connecting piece 100 is such that the microneedles 200 at both ends of the flexible connecting piece 100 are symmetrically arranged.

[0050] Exemplarily, the microneedles 200 are made of a biodegradable metal, have the characteristics of high specific strength and high specific stiffness, can effectively relieve the stress shielding effect, and fix the flexible connecting piece 100 more firmly, so as to cancel the permanent implants such as nylon threads in the traditional suture fixation method that cannot be degraded and absorbed by the human body, and avoid the risk of foreign body reaction. Through the biodegradable microneedle 200 array, a suture-free method for rapid alignment, fixation and regeneration guidance of nerve stumps is realized; the microneedles 200 are processed from materials with good biocompatibility and are more suitable for the repair of peripheral nerve injuries.

[0051] Furthermore, a bioadhesive coating is attached to the surface of the microneedles 200. The microneedles 200 are adhered to the flexible connecting piece 100 through the bioadhesive coating. The bioadhesive coating can specifically be selected as a collagen coating, or the composition of the bioadhesive coating can also be specifically such as chitosan, laminin, etc. On the one hand, it is beneficial to the fixation and adhesion with the flexible connecting piece 100, and on the other hand, it is beneficial to promote nerve growth, and can provide a nerve repair and fixation sleeve with both biocompatibility and mechanical stability and suture-free, completely subverting the traditional repair of peripheral nerve injuries and optimizing the repair effect.

[0052] Specifically such as Figure 1 and Figure 11As shown, the microneedle 200 further includes a needle holder 230. The needle holder 230 is connected to one end of the needle rod 220 away from the needle tip 210. The needle holder 230 is located on the side of the flexible connection piece 100 away from the perineurium. The needle holder 230 is set as a thin sheet for preventing the microneedle 200 from being disconnected from the flexible connection piece 100. The plane of the flexible connection piece 100 when laid flat is parallel to the needle holder 230. The needle rod 220 is arranged at a first preset angle a with the flexible connection piece 100, that is, the needle rod 220 is inclined at the first preset angle a with the needle holder 230. Exemplarily, the needle holder 230 of the microneedle 200 is bonded to the flexible connection piece 100 through a bioadhesive coating, which can make the microneedle 200 and the flexible connection piece 100 bond more stably.

[0053] In this embodiment, the range of the first preset angle a is 30° to 60°, which can effectively reduce the penetration of the nerve fascicle layer. The height range of the microneedle 200 with the outer section plane of the needle-piercing position 110 as the horizontal reference is 20 microns - 100 microns. Optionally, the directions and angles of the microneedles 200 at the same end of the flexible connection piece 100 are the same, reducing the traction damage to the perineurium; however, the directions of the microneedles 200 at both ends of the flexible connection piece 100 can be the same to stabilize the connection structure between the flexible connection piece 100 and the nerve stump and avoid circumferential torsion; the directions of the microneedles 200 at both ends of the flexible connection piece 100 can also be opposite, which can improve the firmness of the microneedles 200 inserted into the perineurium.

[0054] It can be understood that the thin sheet structure of the needle holder 230 can be attached to the flexible connection piece 100 and bend along with the bending of the flexible connection piece 100, avoiding the edges of the structure from warping up and interfering with the surrounding tissues; and ensuring that the needle holder 230 has no sharp edges and corners, and the outer surface is polished smooth to further prevent the needle holder 230 from scratching the human body.

[0055] Specifically as Figures 8 to 13 shown, the microneedle 200 is set with a special needle structure. Among them, the needle tip 210 is set as a lobe formed by cutting a cone along two axial sections intersecting at a second preset angle b. The bottom side of the lobe projects as a sector along the axis of the cone, and the angle of the sector is the second preset angle b; the axis of the cone coincides with the axis of the needle rod 220. The top side of the lobe is a tip, and the tip is set in the direction away from the needle rod 220. The setting of the tip is to further facilitate the needle tip 210 to break through and pierce into the perineurium and reduce the resistance. Exemplarily, the range of the second preset angle b is 120° to 150°.

[0056] In this embodiment, the tip of the needle 210 is arranged in a direction away from the needle shaft 220. Barbs 212 are also arranged on the needle 210. The barbs 212 are inclined at a third preset angle c with respect to the needle shaft 220, which can effectively prevent the needle 210 of the microneedle 200 from slipping out of the nerve sheath. The barbs 212 of the microneedle 200 are interlocked with the nerve sheath to form a mechanical fixation. During the clinical operation, the doctor manually winds the flexible connection piece 100 with the microneedle 200 array, locks and connects the nerve sheath with the flexible connection piece 100, and directly wraps the nerve stump, forming a growth space 120 with a pipeline structure in the middle.

[0057] Exemplarily, the needle 210 of the microneedle 200 is formed by the aforementioned petal body with a V-shaped groove 211 dug on the bottom surface of the petal body. The bottom side of the petal body cooperates with the groove 211 to form barbs 212, and at this time, the microneedles 200 at one end of the flexible connection piece 100 are distributed in a fishbone shape. The range of the third preset angle c is 15° to 45°, and the third preset angle c is half of the taper of the cone.

[0058] Obviously, the above embodiments of the present invention are only examples for clearly explaining the present invention, and are not intended to limit the implementation manners of the present invention. For those of ordinary skill in the art, various obvious changes, re-adjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to enumerate all the implementation manners here. Any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the claims of the present invention.

Claims

1. Nerve repair and fixation cannula, characterized in that, For fixing a pair of nerve stumps and guiding the relative growth of the two nerve stumps, the nerve repair and fixation sleeve comprises: A flexible connecting piece (100), which can be bent so that both ends of the flexible connecting piece (100) respectively wrap around the peripheries of the two nerve stumps; after bending, the flexible connecting piece (100) is in a tubular shape with a growth space (120) inside, and the two nerve stumps are respectively located on both sides of the growth space (120) along the direction perpendicular to the bending direction of the flexible connecting piece (100); Microneedles (200), which are respectively provided with a plurality of them at intervals at both ends of the flexible connecting piece (100); each microneedle (200) comprises a needle rod (220) and a needle tip (210), the needle rod (220) is connected to the needle tip (210), the needle rod (220) penetrates through the flexible connecting piece (100), and the needle rod (220) is inclined at a first preset angle (a) with respect to the outer tangent plane of the bent flexible connecting piece (100) at the needle-piercing position (110), and the needle tip (210) is used for inserting into the nerve epineurium to fix the bent flexible connecting piece (100) to the nerve stump.

2. The nerve repair and fixation sleeve according to claim 1, wherein The material of the flexible connecting piece (100) is a degradable high molecular polyester material, and a collagen coating is attached to the surface of the flexible connecting piece (100); And / or, a biological adhesive coating is attached to the surface of the microneedle (200), and the microneedle (200) is adhered to the flexible connecting piece (100) through the biological adhesive coating.

3. The nerve repair and fixation sleeve according to claim 1, characterized in that, The range of the first preset angle (a) is 30° to 60°.

4. The nerve repair and fixation sleeve according to claim 1, characterized in that, The needle tip (210) is arranged as a lobe formed by cutting a cone along two axial sections intersecting at a second preset angle (b), the bottom side of the lobe is a sector, and the angle of the sector is the second preset angle (b); the axis of the cone coincides with the axis of the needle rod (220), the top side of the lobe is a tip, and the tip is arranged in a direction away from the needle rod (220).

5. The nerve repair and fixation cannula according to claim 4, wherein The range of the second preset angle (b) is 120° to 150°.

6. The nerve repair and fixation cannula according to claim 1, characterized in that, The tip of the needle tip (210) is arranged in a direction away from the needle rod (220), and barbs (212) are arranged on the needle tip (210), and the barbs (212) are inclined at a third preset angle (c) with respect to the needle rod (220).

7. The nerve repair and fixation cannula according to claim 6, wherein, The range of the third preset angle (c) is 15° to 45°.

8. The nerve repair and fixation sleeve according to claim 1, characterized in that, The microneedle (200) further comprises a needle holder (230), the needle holder (230) is connected to the end of the needle rod (220) away from the needle tip (210), the needle holder (230) is located on the side of the flexible connecting piece (100) away from the nerve epineurium, and the needle holder (230) is arranged as a thin sheet for preventing the microneedle (200) from being disconnected from the flexible connecting piece (100).

9. The nerve repair and fixation cannula according to claim 1, wherein Two rows of the microneedles (200) are arranged at both ends of the flexible connection piece (100) at intervals along the axial direction of the nerve stump. A plurality of the microneedles (200) are arranged at intervals along the circumferential direction of the nerve stump in each row, and the two rows of the microneedles (200) are arranged in a staggered manner.

10. The nerve repair and fixation cannula according to any one of claims 1-9, characterized in that, The flexible connection piece (100) is composed of interwoven warp and weft threads, and the arrangement density ranges of the warp and the weft threads are both 600 - 800 threads per 10 cm.

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