Adjustable nerve repair cannula and preparation method thereof

Abstract

The invention relates to the technical field of medical equipment, and discloses an adjustable nerve repair cannula and a preparation method, the adjustable nerve repair cannula is composed of a sheet fabric formed by interweaving warps and wefts, the tissue structure of the sheet fabric is a compact plain weave, the tissue structure is simple, and the weaving efficiency is higher; the linear density range of the warps and the wefts is 14tex-18tex, so that the light weight and the weaving density of the adjustable neural restoration cannula are kept, and the implantation burden of a patient is relieved on the basis of ensuring the restoration effect. Meanwhile, the microneedles are arranged at one end, in the width direction, of the flaky fabric, the flaky fabric can be directly wound and connected through the microneedles to form the tubular adjustable nerve repair cannula, the inner diameter range of the adjustable nerve repair cannula is changed by changing the connecting positions of the microneedles, and pressing-damaged nerves or broken-end nerves of different sizes can be directly wrapped conveniently; the application range of the adjustable neural restoration cannula is expanded, the manufacturing efficiency is improved, the process cost is reduced, and the growth of neurons is further facilitated.

Description

Technical Field

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

[0002] The treatment of peripheral nerve injury and defect is one of the difficult problems in microsurgery. In order to solve the problems of limited autologous nerve sources and immunogenicity of allogeneic nerves, technicians in the field are committed to the development of alternative transplants. With the development and research of science and technology, synthetic nerve repair catheters are currently the commonly used repair medical devices in clinical practice, such as artificial nerve sheaths, absorbable peripheral nerve sheaths, and Shenqiao nerve repair materials, which have a good effect on nerve repair.

[0003] However, during the development process of existing technologies, due to the differences in the diameters of nerve fibers in different parts of the human body, it is necessary to develop products of multiple specifications and models to match the diameters of clinically damaged nerves. As a result, the process cost increases sharply and is time-consuming. In addition, the size of the nerve repair catheter is relatively limited in compatibility with the size of the development specifications and models. If the degree of fit with the nerve stump is low or wrinkles are generated, it will be detrimental to the growth of neurons. Summary of the invention

[0004] The purpose of the present invention is to provide an adjustable nerve repair sleeve and a preparation method, which can reduce the implantation burden of patients and is beneficial to the growth of neurons; the structure is simple, the process cost is reduced, the manufacturing efficiency is higher, and the scope of application is wider.

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

[0006] An adjustable nerve repair sleeve, the adjustable nerve repair sleeve is composed of a sheet fabric with warp and weft interwoven with each other, the tissue structure of the sheet fabric is a tight plain weave, and the thickness range of the sheet fabric is 0.20 mm-0.30 mm; the arrangement density range of the warp is 700-900 per 10 cm, the arrangement density range of the weft is 600-800 per 10 cm, and the line density range of the warp and the weft is 14tex-18tex; a microneedle is provided at one end of the sheet fabric along the width direction, the sheet fabric can be bent along the width direction and connected to the other end of the sheet fabric along the width direction through the microneedle to form the cylindrical adjustable nerve repair sleeve, and the connection position of the microneedle can be changed to adjust the inner diameter of the adjustable nerve repair sleeve to a range of 1.50 mm-4.00 mm.

[0007] As an optional technical solution for the adjustable nerve repair sleeve, the sheet-like fabric is provided with fabric gaps in an array at preset intervals, and the pore size range of the fabric gaps is 5.00 microns-15.00 microns.

[0008] As an optional technical solution for an adjustable nerve repair cannula, the cross-section of the top of the microneedle along the length direction is wedge-shaped, the outer diameter of the neck of the microneedle is smaller than the outer diameter of the top of the microneedle, the bottom of the microneedle is arranged to be ellipsoidal, the short axis direction of the bottom of the microneedle is the same as the length direction of the microneedle, the long axis of the ellipsoid is larger than the outer diameter of the neck of the microneedle, the top of the microneedle can pass through the gap in the fabric and be clamped with one side of the sheet fabric, and the bottom of the microneedle is clamped with the other side of the sheet fabric.

[0009] As an optional technical solution for the adjustable nerve repair cannula, the top and neck lengths of the microneedle range from 0.45 mm to 0.65 mm.

[0010] As an optional technical solution for the adjustable nerve repair sleeve, the microneedle is made of degradable magnesium material.

[0011] As an optional technical solution for the adjustable nerve repair sleeve, the breaking strength range of the warp and the weft is 800 centinewtons to 1000 centinewtons.

[0012] As an optional technical solution for the adjustable nerve repair sleeve, the elongation at break of the warp and the weft is in the range of 10%-38%.

[0013] As an optional technical solution for the adjustable nerve repair sleeve, the warp threads and / or the weft threads are made of degradable polymer materials.

[0014] A method for preparing an adjustable nerve repair sleeve, used for preparing the adjustable nerve repair sleeve as described in any one of the above items, comprising:

[0015] Slit warping is carried out on the warping machine, the number of warping roots is 120-150, and the warping speed ranges from 10 to 15 turns per minute;

[0016] The warp is unwound onto a winding disk head, and then fixed onto a warp beam after being removed;

[0017] The braiding machine uses an 8-page heald frame and a steel reed with a density ranging from 120 to 180 reeds per 10 cm, and the warp yarn is fed longitudinally along the back beam and sequentially passes through the healds in the heald frame and the reed teeth of the steel reed;

[0018] The warp threads are fixed on a cloth winding roller, the weft thread tube is placed inside a shuttle, and then weft insertion and beating operations are performed to form the sheet-like fabric;

[0019] The sheet of fabric is flattened, and the bottom of the microneedle is passed through the sheet of fabric along the gaps in the fabric using tweezers.

[0020] As an optional technical solution for the method for preparing an adjustable nerve repair sleeve, the method for preparing an adjustable nerve repair sleeve also includes: the top of the microneedle faces the inner side of the cylinder, and the top can adjust the connection position with the sheet of fabric according to the outer diameter of the nerve to be repaired.

[0021] Beneficial effects of the present invention:

[0022] The present invention provides an adjustable nerve repair sleeve and a preparation method, which is composed of a sheet fabric in which warp and weft are interwoven with each other. The sheet fabric has a tight plain weave structure with a simple structure and higher weaving efficiency. The thickness of the sheet fabric ranges from 0.20 mm to 0.30 mm, the density of the warp is 700 to 900 per 10 cm, the density of the weft is 600 to 800 per 10 cm, and the line density of the warp and weft is both in the range of 14 tex to 18 tex, thereby maintaining the light weight and dense weaving of the adjustable nerve repair sleeve, and reducing the implant burden on patients while ensuring the repair effect. At the same time, a microneedle is provided at one end of the sheet fabric along the width direction, and the sheet fabric can be directly rolled and bent along the width direction and connected to the other end of the sheet fabric along the width direction through the microneedle to form a cylindrical adjustable nerve repair sleeve. The connection position of the microneedle can be changed to adjust the inner diameter range of the adjustable nerve repair sleeve to 1.50 mm-4.00 mm. The wrapped inner diameter is adjustable so as to directly correspond to the wrapping of damaged nerves or broken nerves of different sizes, reduce the development of multiple specifications and models, expand the application scope of the adjustable nerve repair sleeve, improve applicability and manufacturing efficiency, reduce process costs, and further benefit the growth of neurons. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a sheet-like fabric display diagram of an adjustable nerve repair sleeve provided by a specific embodiment of the present invention;

[0024] Figure 2 It is a schematic cross-sectional view of a microneedle of an adjustable nerve repair cannula provided in a specific embodiment of the present invention.

[0025] In the figure:

[0026] 100, sheet fabric; 200, microneedle; 210, neck; 220, top; 230, bottom. DETAILED DESCRIPTION

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] Specific as Figure 1 and Figure 2 As shown in , the present invention discloses an adjustable nerve repair sleeve, which is composed of a sheet fabric 100 in which warp and weft are interwoven with each other. The tissue structure of the sheet fabric 100 is a tight plain weave, which has a simple tissue structure and higher weaving efficiency; the arrangement density of the warp is in the range of 700-900 per 10 cm, and the arrangement density of the weft is in the range of 600-800 per 10 cm. The line density range of the warp and weft is 14tex-18tex, which keeps the adjustable nerve repair sleeve light and dense, and reduces the implant burden of the patient on the basis of ensuring the repair effect. Exemplarily, the flat length range of the sheet fabric 100 is 2.00 cm-4.00 cm, the width range is 1.00 cm-2.00 cm, and the thickness range is 0.20 mm-0.30 mm.

[0032] At the same time, a microneedle 200 is provided at one end of the sheet fabric 100 in the width direction, and the sheet fabric 100 can be directly rolled and bent in the width direction and connected to the other end of the sheet fabric 100 in the width direction through the microneedle 200 to form a cylindrical adjustable nerve repair sleeve, and the connection position of the microneedle 200 can be changed to adjust the inner diameter range of the adjustable nerve repair sleeve to 1.50 mm-4.00 mm, and the inner diameter of the package can be adjusted to directly correspond to the package of compressed nerves or broken end nerves of different sizes, reduce the development of multiple specifications and models, expand the applicable scope of the adjustable nerve repair sleeve, improve applicability and manufacturing efficiency, reduce process costs, and further facilitate the growth of neurons. Exemplarily, the longitudinal spacing range of the microneedles is 3.00 mm-5.00 mm, and the lateral spacing range is 5.00 mm-8.00 mm.

[0033] In this embodiment, the base material of the adjustable nerve repair sleeve is the warp and weft used to weave the sheet fabric 100. The warp and / or weft are made of a degradable polymer material, specifically one of polyglycolic acid, polycaprolactone, polylactic acid, etc., which has good softness and is easier to roll into shape, thus simplifying the operation techniques of technicians and eliminating the need for secondary processing.

[0034] Specifically, the warp and weft of the sheet fabric 100 overlap with each other to obtain a uniform fabric gap structure, and the fabric gaps are arranged in an array at preset intervals. The pore size range of the fabric gaps is 5.00 microns-15.00 microns, which is conducive to the internal and external exchange of nutrient factors in the tissue fluid around the nerves and provides a good microenvironment for nerve regeneration.

[0035] Furthermore, the cross-section of the top 220 of the microneedle 200 along the length direction is wedge-shaped, and the outer diameter of the neck 210 of the microneedle 200 is smaller than the outer diameter of the top 220; the bottom 230 of the microneedle 200 is set to be ellipsoidal, and the short axis direction of the ellipsoid is the same as the length direction of the microneedle, and can be directly inserted from the fabric gap on the back side of the sheet fabric 100 to be fixed, and the long axis of the ellipsoid is larger than the outer diameter of the neck 210; the top 220 of the microneedle can pass through the fabric gap and be clamped with one side of the sheet fabric 100, and the bottom 230 of the microneedle is clamped with the other side of the sheet fabric, and the microneedle 200 can be connected and fixed to the edge of the sheet fabric 100 of the adjustable nerve repair sleeve during winding. In actual use, the short axis of the bottom 230 of the microneedle 200 should be as small as possible to avoid the microneedle 200 protruding too much from the sheet fabric 100, or the bottom 230 of the microneedle 200 can be other shapes, as long as it can be clamped to the sheet fabric 100 and ensures that there are no sharp edges or corners; similarly, the outer contour of the top 220 of the microneedle 200 can also be a slightly convex arc shape, which can smoothly pass through the gaps in the fabric and clamp the sheet fabric 100.

[0036] Optionally, the length of the top 220 plus the neck 210 of the microneedle 200 ranges from 0.45 mm to 0.65 mm, which is slightly greater than the double thickness of the sheet fabric 100, so as to prevent the microneedle 200 from protruding and scratching other tissues. Exemplarily, the microneedles 200 are arranged in 4 columns and 8 rows, the fixing method is firm, and the length of the microneedle 200 matches the thickness of the sheet fabric 100, there is no protruding foreign matter, and there will be no scratches on the surrounding tissues of the nerves, which can ensure the structural connection stability of the adjustable nerve repair sleeve.

[0037] In this embodiment, the microneedle 200 is made of a degradable magnesium alloy metal material, which not only has a certain strength to achieve edge fixation of the adjustable nerve repair sleeve, but also after being implanted in the body, the released magnesium ions can promote the transmission of surrounding nutrients and the activity of Schwann cells, thereby promoting nerve growth.

[0038] Specifically, in order to make the sheet fabric 100 have a certain strength and extend its service life so as to better adapt to the repair of nerve tissue, the breaking strength range of the warp and weft is set to 800-1000 centinewtons; at the same time, the breaking elongation range of the warp and weft is 10%-38%. For example, the breaking strength is represented by the breaking strength of the fiber, that is, the relative strength of the fiber, which is a comprehensive indicator of the strength and fineness of the fiber, and the breaking strength ranges from 4.1 cN / dtex to 5.2 cN / dtex.

[0039] The present invention discloses a method for preparing an adjustable nerve repair sleeve, which is used to prepare the above-mentioned adjustable nerve repair sleeve, specifically comprising: performing strip-type warping on a warping machine, the number of warping roots is 120-150, and the warping speed ranges from 10 to 15 turns per minute; then the warp is unwound onto the winding disk head, and fixed on the warp beam after being removed; the weaving machine selects 8-page heald frames and a steel reed with a density range of 120-180 reeds per 10 cm, and then the warp is longitudinally fed along the back beam, and sequentially passes through the healds in the 8-page heald frames and the reed teeth of the steel reed, illustratively, according to the threading sequence of 224888888888888422, through the reed teeth of the steel reed. The movement law of the heald frame is a plain weave trajectory; the next step is to fix the warp on the cloth winding roller, place the weft tube inside the shuttle, and then perform weft insertion and beating operations to form a sheet fabric 100. After the sheet fabric 100 is woven into shape, the sheet fabric 100 is flattened, and the bottom 230 of the microneedle 200 is passed through the fabric gap of the sheet fabric 100 along the fabric gap with tweezers, and is clamped on the sheet fabric 100 to fix the microneedle 200. In order to stably form an adjustable nerve repair catheter to adapt to the nerve to be repaired, it is necessary to first measure the outer diameter circumference of the nerve to be repaired, and correspondingly set and adjust the connection position between the top 220 of the microneedle 200 and the sheet fabric 100, so that the sheet fabric 100 can be wound and connected to form a cylindrical adjustable nerve repair sleeve.

[0040] Furthermore, since the insertion position is not the outermost edge of the sheet fabric 100, there will inevitably be an overlapping portion of a certain width. In order to avoid the friction between the excess overlapping portion and other tissues outside the adjustable nerve repair sleeve, the top 220 of the microneedle 200 is facing the inner side of the cylindrical adjustable nerve repair sleeve. The connection method is that the top 220 of the microneedle 200 is inserted from the reverse side of the other end of the sheet fabric 100 along the width direction, so that the excess overlapping portion can be left on the inner side of the adjustable nerve repair sleeve, effectively avoiding tissue damage or thrombosis.

[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. An adjustable nerve repair cannula, characterized in that: The adjustable nerve repair sleeve is composed of a sheet fabric (100) in which warp and weft are interwoven with each other. The tissue structure of the sheet fabric (100) is a tight plain weave. The thickness of the sheet fabric (100) ranges from 0.20 mm to 0.30 mm. The arrangement density of the warp is in the range of 700 to 900 per 10 cm, and the arrangement density of the weft is in the range of 600 to 800 per 10 cm. The line density of the warp and the weft is in the range of 14 tex to 18 tex. A microneedle (200) is provided at one end of the sheet fabric (100) in the width direction. The sheet fabric (100) can be bent in the width direction and connected to the other end of the sheet fabric (100) in the width direction through the microneedle (200) to form the cylindrical adjustable nerve repair sleeve. The connection position of the microneedle (200) can be changed to adjust the inner diameter of the adjustable nerve repair sleeve to range from 1.50 mm to 4.00 mm.

2. The adjustable nerve repair sleeve according to claim 1, characterized in that: The sheet-like fabric (100) is provided with fabric gaps in an array at preset intervals, and the pore size of the fabric gaps ranges from 5.00 microns to 15.00 microns.

3. The adjustable nerve repair sleeve according to claim 2, characterized in that: The cross-section of the top of the microneedle (200) along the length direction is wedge-shaped, and the outer diameter of the neck of the microneedle (200) is smaller than the outer diameter of the top of the microneedle (200); the bottom of the microneedle (200) is arranged to be ellipsoidal, the short axis direction of the bottom of the microneedle (200) is the same as the length direction of the microneedle (200), the long axis of the ellipsoid is larger than the outer diameter of the neck of the microneedle (200), the top of the microneedle (200) can pass through the gap of the fabric and be clamped with one side of the sheet fabric (100), and the bottom of the microneedle (200) is clamped with the other side of the sheet fabric (100).

4. The adjustable nerve repair sleeve according to claim 1, characterized in that: The top and neck lengths of the microneedle (200) range from 0.45 mm to 0.65 mm.

5. The adjustable nerve repair sleeve according to claim 1, characterized in that: The microneedle (200) is made of a degradable magnesium material.

6. The adjustable nerve repair sleeve according to claim 1, characterized in that: The breaking strength of the warp and the weft is in the range of 800 centinewtons to 1000 centinewtons.

7. The adjustable nerve repair sleeve according to claim 1, characterized in that: The elongation at break of the warp and the weft is in the range of 10%-38%.

8. The adjustable nerve repair sleeve according to claim 1, characterized in that: The warp threads and / or the weft threads are made of degradable polymer materials.

9. A method for preparing an adjustable nerve repair sleeve, used for preparing the adjustable nerve repair sleeve as claimed in any one of claims 1 to 8, characterized in that: include: Slit warping is carried out on the warping machine, the number of warping roots is 120-150, and the warping speed ranges from 10 to 15 turns per minute; 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 a steel reed with a density ranging from 120 to 180 reeds per 10 cm, and the warp yarn is fed longitudinally along the rear beam and sequentially passes through the healds in the heald frame and the reed teeth in the steel reed; Fixing the warp thread on a cloth winding roller, placing the weft thread tube inside a shuttle, and then performing weft insertion and beating operations to form the sheet-like fabric (100); The sheet-like fabric (100) is flattened, and the bottom of the microneedle (200) is passed through the sheet-like fabric (100) along the gaps in the fabric using tweezers.

10. The method for preparing an adjustable nerve repair sleeve according to claim 9, characterized in that: The method for preparing the adjustable nerve repair sleeve also includes: the top of the microneedle (200) faces the inner side of the cylinder, and the top can adjust the connection position with the sheet-like fabric (100) according to the outer diameter of the nerve to be repaired.

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