Preparation method of integrated nerve repair cannula and integrated nerve repair cannula

Abstract

The invention relates to the technical field of medical instruments, and discloses a preparation method of an integrated nerve repair sleeve and the integrated nerve repair sleeve, magnesium wires and yarns are jointly used as warps according to a preset proportion and are placed on a warping frame for sectional warping, and the warps are longitudinally fed along a rear beam and sequentially penetrate through harness wires in eight harness frames and dents of a reed; a double-layer weaving technology is adopted, the two edges of a double-layer fabric weave are connected, the sewing-free tubular integrated nerve repairing sleeve is formed by shuttling up and down through weft, and magnesium wires are added into warp, so that the integrated nerve repairing sleeve has softness, and the radial supporting capacity is improved; after implantation, the magnesium wire can be slowly degraded, magnesium ions are released, and nerve growth is promoted. The integrated seamless structure is uniform in thickness and not prone to deformation; and the friction between the joint bulge and other tissues is avoided, the tissue damage or thrombus is effectively avoided, and the use safety is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a preparation method of an integrated nerve repair sleeve and the integrated nerve repair sleeve. Background Art

[0002] Peripheral nerve injury is a common clinical disease, mainly due to various reasons that cause sensory disorders, motor disorders and nutritional disorders in the area innervated by the nerve. The appropriate repair method can be selected according to the distance of the peripheral nerve defect. The commonly used treatment options in clinical practice are autologous transplantation and allogeneic transplantation. Autologous nerve transplantation is the preferred option for repairing peripheral nerve damage, but it has certain limitations due to factors such as insufficient donors, impaired donor site function and the formation of neuromas. Allogeneic transplantation may cause problems such as immune rejection and cross-infection. Based on this, the birth of artificial nerve catheters has become a hot research direction for the treatment of peripheral nerve injury.

[0003] Artificial nerve catheters, also known as "nerve regeneration chambers", mainly provide bridges and a good microenvironment for nerve damage sites. Nerve axons can grow from the proximal end to the distal end through the catheter lumen, and can also prevent the invasion of fibrous scar tissue. At this stage, the market application rate of artificial nerve repair catheters is relatively small, and the structure of the catheter itself is relatively simple. Most of them use medical polymer materials to directly form straight tubes through electrospinning or injection molding processes. Although they have good mechanical strength, the tube body has poor softness and will collapse if bent at will. In addition, the polymer material used in the catheter has low biological activity and poor affinity with cells, which is relatively limited in promoting nerve growth biologically. Summary of the invention

[0004] The purpose of the present invention is to provide a preparation method of an integrated nerve repair sleeve and an integrated nerve repair sleeve, which can improve the radial support capacity and anti-deformation ability of the integrated nerve repair sleeve and improve the safety of use; make the integrated nerve repair sleeve have stronger biological affinity and improve the nerve growth environment.

[0005] To achieve this object, the present invention adopts the following technical solutions:

[0006] A method for preparing an integrated nerve repair sleeve comprises the following steps:

[0007] The magnesium wire reel and the yarn reel are placed on the warping frame as warps for slitting warping, and the number of warping roots is 120-130;

[0008] The warp is unwound onto a winding disk head, and then fixed onto a warp beam after being removed;

[0009] The braiding machine uses an 8-page heald frame, and the warp yarn is fed longitudinally along the back beam, and passes through the healds in the heald frame and the reed teeth of the steel reed in sequence;

[0010] The warp thread is fixed on the cloth winding roller, and the double-layer weaving technology is adopted. The weft thread tube is placed in the shuttle box, and passes through the yarn guide eye and the spring in sequence, and then the weft insertion and beating operation is performed to connect the two edges of the double-layer fabric tissue, and the weft thread shuttles up and down to form a seamless tubular one-piece nerve repair sleeve.

[0011] As an optional technical solution for the preparation method of the integrated nerve repair sleeve, after the warp threads are fixed on the cloth winding roller, the tension range of the warp threads is adjusted to 2.0N-3.5N, so that the warp threads are in a taut and weavable state.

[0012] As an optional technical solution for the preparation method of the integrated nerve repair sleeve, the warp threads are threaded in a plain weave straight threading method and introduced into the heddle eyelet.

[0013] As an optional technical solution for the preparation method of the integrated nerve repair sleeve, the arrangement density of the warp threads is in the range of 600-700 threads per 10 cm, and the arrangement density of the weft threads is in the range of 200-400 threads per 10 cm.

[0014] As an optional technical solution for the preparation method of the integrated nerve repair sleeve, the warping is arranged in a ratio of the number of magnesium wires to the number of yarns within a range of 5:16 to 15:16.

[0015] As an optional technical solution for the preparation method of the integrated nerve repair sleeve, the warping is arranged according to the ratio of the number of magnesium wires to the number of yarns of 10:16.

[0016] As an optional technical solution for the preparation method of an integrated nerve repair sleeve, the diameter range of the magnesium wire is 0.01 mm-0.03 mm, the diameter range of the yarn serving as the warp is 0.01 mm-0.025 mm, and the diameter range of the weft is 0.4 mm-0.8 mm.

[0017] As an optional technical solution for the method for preparing an integrated nerve repair sleeve, the yarn and / or the weft is made of a degradable polymer material.

[0018] An integrated nerve repair sleeve is made using the method for making an integrated nerve repair sleeve as described in any one of the above items.

[0019] As an optional technical solution for the integrated nerve repair cannula, the diameter of the integrated nerve repair cannula ranges from 1.8 mm to 4.7 mm, and the length ranges from 30 mm to 40 mm.

[0020] Beneficial effects of the present invention:

[0021] The preparation method of the integrated nerve repair sleeve provided by the present invention comprises: first, placing the magnesium wire reel and the yarn reel as the warp on the warping frame for slit warping, and the number of warping roots is 120-130; then, the warp is unwound onto the winding disk head, and fixed on the warp shaft after being removed; then, the braiding machine selects an 8-page heald frame, and the warp is fed longitudinally along the rear beam, and passes through the heald wire in the heald frame and the reed teeth of the steel reed in turn; next, the warp is fixed on the cloth winding roller, and the double-layer weaving technology is used to place the weft tube in the shuttle box, and after passing through the yarn guide eye and the spring in turn, then Then the weft is inserted and beaten to connect the two edges of the double-layer fabric tissue, and the weft is shuttled up and down to form a seamless tubular integrated nerve repair sleeve. By adding magnesium wire to the warp, the integrated nerve repair sleeve has good mechanical strength and a certain degree of softness, which not only improves the radial support capacity of the integrated nerve repair sleeve, but also allows it to be bent at will without collapse. After being implanted in the patient's body, the magnesium wire can slowly degrade and release magnesium ions, which can promote the transmission of surrounding nutrients and the activity of Schwann cells, thereby promoting nerve growth. The integrated nerve repair sleeve has a strong affinity with biological cells, and due to the integrated seamless structure and uniform thickness, it further improves the ability to bear force evenly without deformation, while avoiding the protrusion of excess seams that may cause friction and scratches with other tissues outside the integrated nerve repair sleeve, effectively avoiding tissue damage or thrombosis, and improving the safety of use. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a structural schematic diagram of a braiding machine used in a method for preparing an integrated nerve repair sleeve provided in a specific embodiment of the present invention.

[0023] In the figure:

[0024] 1. Warp beam; 2. Warp thread; 3. Back beam; 4. Heald frame; 5. Cloth winding roller; 6. Weft thread tube. DETAILED DESCRIPTION

[0025] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0026] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0027] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0028] In the description of this embodiment, the terms "upper", "lower", "right", "left" and other directions or positional relationships are based on the directions or positional relationships shown in the drawings, and are only for the convenience of description and simplification of operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operate in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0029] like Figure 1As shown, the present invention discloses a method for preparing an integrated nerve repair sleeve: first, a magnesium wire reel and a yarn reel are placed on a warping frame as warps for strip-type warping, and the number of warping roots is 120-130; then, the warp is unwound onto a winding disk head, and fixed on a warp shaft after being removed; then, an 8-page heald frame is selected for the weaving machine, and the warp yarn is fed longitudinally along the rear beam, and sequentially passes through the healds in the 8-page heald frame and the reed teeth of the steel reed; next, the warp is fixed on a cloth winding roller, and a double-layer weaving technology is adopted to place the weft tube in a shuttle box, and sequentially passes through the yarn guide eye and the spring, and then the weft is introduced and beaten, and the two edges of the double-layer fabric structure are connected, and the weft is shuttled up and down to form a seamless tubular integrated nerve repair sleeve. By adding magnesium wire into the warp, the one-piece nerve repair sleeve has good mechanical strength and a certain degree of softness, which not only improves the radial support capacity of the one-piece nerve repair sleeve and allows it to be bent at will without collapse; after being implanted in the patient's body, the magnesium wire can slowly degrade and release magnesium ions. Magnesium ions are the second most abundant cation in intracellular fluid. While maintaining electrolyte balance, they can also help sodium ions and potassium ions coordinate the osmotic pressure of cells and maintain the excitement of nerves and muscles. It plays an important role in the conduction of nerve impulses and can promote the transmission of surrounding nutrients and the activity of Schwann cells, thereby promoting nerve growth.

[0030] The integrated nerve repair sleeve has biomedical magnesium wire added to the weaving process, which has a strong affinity with biological cells, and can directly form tubular tissue using double-layer weaving technology. Specifically, it is interwoven with two groups of warps and one group of wefts. This group of wefts is arranged in a spiral order, serving as both the surface weft and the inner weft, playing the role of two groups of wefts, alternately from the surface layer to the inner layer, and then from the inner layer to the surface layer, in a reciprocating cycle. The surface and inner layers of the tissue are only connected at the edges on both sides and are completely separated in the middle, forming a cylindrical hollow bag tissue, also called tubular tissue. Due to the integrated seamless structure and uniform thickness, the ability to bear force evenly without deformation is further improved, while avoiding the protrusion of excess seams that may cause friction and scratches with other tissues outside the integrated nerve repair sleeve, effectively avoiding tissue damage or thrombosis, and improving the safety of use.

[0031] In this embodiment, the yarn and / or weft are made of degradable polymer materials, specifically, they can be made of one of the materials such as polyglycolic acid, polycaprolactone, polylactic acid, etc. They have good softness, are easier to wind and shape, and can automatically degrade after a period of time, which simplifies the operation of technicians and does not require secondary processing.

[0032] Specifically, the warp is threaded in a plain weave and introduced into the heddle eyelet, which has a simple structure and higher weaving efficiency. Exemplarily, the warp is threaded through the reed teeth according to the threading sequence of 4488888888888844. Furthermore, after the warp is fixed on the cloth roller, in order to improve the weaving quality of the integrated nerve repair sleeve, the tension range of the warp is adjusted to 2.0N-3.5N, so that the warp is in a taut and weavable state.

[0033] It is understandable that the creation of a microenvironment mainly lies in the preparation of the artificial nerve conduit and its own performance, which can be artificially controlled and changed. The warp and weft of the one-piece nerve repair sleeve are woven together to obtain a uniform pore structure with a pore size range of 25 microns to 60 microns. During nerve regeneration, the nutrient factors in the surrounding tissue fluid can be exchanged internally and externally, providing a good microenvironment for nerve regeneration.

[0034] For example, the diameter of the magnesium wire ranges from 0.01 mm to 0.03 mm, the diameter of the yarn used as the warp ranges from 0.01 mm to 0.025 mm, and the diameter of the yarn used as the weft ranges from 0.4 mm to 0.8 mm. The density of the warp is 600 to 700 per 10 cm, and the density of the weft is 200 to 400 per 10 cm, so as to maintain the light weight and density of the integrated nerve repair sleeve, and reduce the implant burden on the patient while ensuring the repair effect.

[0035] In order to meet the required softness of the one-piece nerve repair cannula without destroying the mechanical strength of the one-piece nerve repair cannula, in actual operation, after many tests, the various characteristic indicators of the one-piece nerve repair cannula at different ratios of magnesium wire and yarn were obtained, so as to meet the selection of magnesium wire in an appropriate proportion and add it to the warp for weaving. The warping was arranged in the range of 5:16 to 15:16 according to the ratio of the number of magnesium wires to the number of yarns. The test results of different proportions of magnesium wires to yarns are shown in the following table.

[0036]

[0037] It can be seen from the above table that in Example 1, the warping arrangement is carried out according to the ratio of the number of magnesium wires to the number of yarns of 5:16, and the obtained one-piece nerve repair sleeve has a certain radial support force and breaking strength, and is also flexible. Its affinity with cells far exceeds that of the ordinary sleeve without adding magnesium wire in the control example, and can well resist the collapse and deformation caused by bending, meet the safety of use, and create an environment conducive to nerve growth.

[0038] In Example 2, the warping is arranged according to the ratio of the number of magnesium wires to the number of yarns of 10:16. Compared with ordinary sleeves, the integrated nerve repair sleeve has greatly improved radial support force and breaking strength without affecting its flexibility. Compared with the integrated nerve repair sleeve in Example 1, it is stronger and more resistant to deformation, and the cell survival rate is also better than the use environment of the integrated nerve repair sleeve in Example 1, and the overall performance is further improved.

[0039] In order to explore the influence of magnesium wire on nerve repair, Example 3 was further tested. In Example 3, the warping was arranged according to the ratio of the number of magnesium wires to the number of yarns of 15:16. The radial support force and breaking strength of the one-piece nerve repair sleeve were only slightly improved on the basis of Example 2. However, due to the excessive proportion of magnesium wire, the one-piece nerve repair sleeve became difficult to bend and deform, and the flexibility was greatly reduced. This is not suitable for the requirement to further improve the nerve repair ability, and the cell survival rate did not increase further, which was not more helpful for improving the affinity of the nerve repair environment. Therefore, it is necessary to control the proportion of magnesium wire to avoid excessive rigidity of the sleeve affecting the progress of nerve repair.

[0040] The present invention also discloses an integrated nerve repair cannula, which is made by the above-mentioned integrated nerve repair cannula preparation method. The diameter range of the integrated nerve repair cannula is set to 1.8 mm-4.7 mm, and the length range is 30 mm-40 mm, which can meet the specifications of artificial nerve cannula required by most clinical situations, and has a good application prospect.

[0041] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, various obvious changes, readjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A method for preparing an integrated nerve repair cannula, characterized in that: The following steps are involved: The magnesium wire reel and the yarn reel are placed on the warping frame as warps for slitting warping, and the number of warping roots is 120-130; The warp is unwound onto a winding disk head, and then fixed onto a warp beam after being removed; The braiding machine uses an 8-page heald frame, and the warp yarn is fed longitudinally along the back beam, and passes through the healds in the heald frame and the reed teeth of the steel reed in sequence; The warp thread is fixed on the cloth winding roller, and the double-layer weaving technology is adopted. The weft thread tube is placed in the shuttle box, and passes through the yarn guide eye and the spring in sequence, and then the weft insertion and beating operation is performed to connect the two edges of the double-layer fabric tissue, and the weft thread shuttles up and down to form a seamless tubular one-piece nerve repair sleeve.

2. The method for preparing the integrated nerve repair sleeve according to claim 1, characterized in that: After the warp threads are fixed on the cloth winding roller, the tension of the warp threads is adjusted to a range of 2.0N-3.5N, so that the warp threads are in a taut state for weaving.

3. The method for preparing the integrated nerve repair sleeve according to claim 1, characterized in that: The warp threads are threaded in a plain weave method and introduced into the heddle eye.

4. The method for preparing the integrated nerve repair sleeve according to claim 1, characterized in that: The arrangement density of the warp threads is in the range of 600-700 threads per 10 cm, and the arrangement density of the weft threads is in the range of 200-400 threads per 10 cm.

5. The method for preparing the integrated nerve repair sleeve according to claim 1, characterized in that: The warping is arranged in the range of 5:16-15:16 according to the ratio of the number of magnesium wires to the number of yarns.

6. The method for preparing the integrated nerve repair sleeve according to claim 5, characterized in that: The warping is arranged according to the ratio of the number of magnesium wires to the number of yarns being 10:

16.

7. The method for preparing the integrated nerve repair sleeve according to claim 1, characterized in that: The diameter of the magnesium wire is in the range of 0.01 mm to 0.03 mm, the diameter of the yarn used as the warp is in the range of 0.01 mm to 0.025 mm, and the diameter of the weft is in the range of 0.4 mm to 0.8 mm.

8. The method for preparing the integrated nerve repair sleeve according to any one of claims 1 to 7, characterized in that: The yarn and / or the weft are made of degradable polymer material.

9. An integrated nerve repair cannula, characterized in that: The integrated nerve repair sleeve is made using the preparation method of any one of claims 1-8.

10. The integrated nerve repair sleeve according to claim 9, characterized in that: The integrated nerve repair sleeve has a diameter ranging from 1.8 mm to 4.7 mm and a length ranging from 30 mm to 40 mm.

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