Artificial rotator cuff patch and knitting method

Abstract

The invention relates to an artificial rotator cuff patch and a knitting method, and relates to the technical field of rotator cuff repair. An artificial rotator cuff patch comprises an upper-layer woven structure, a middle-layer woven structure and a lower-layer woven structure which are stacked from top to bottom, the middle-layer woven structure and the lower-layer woven structure are used for bearing medicine, a circle of overlock fixing structure is formed on the edge of the patch, a plurality of lock holes are formed in the inner side of the overlock fixing structure, and a ring is defined by the lock holes. The knitting method of the artificial rotator cuff patch comprises the following steps: respectively knitting to form an upper-layer knitting structure, a middle-layer knitting structure and a lower-layer knitting structure; the upper-layer woven structure, the middle-layer woven structure and the lower-layer woven structure are stacked into a whole, and the edges are subjected to edge locking to form an edge locking fixing structure; a protruding annular edge is formed on the inner side of the overlock fixing structure in a woven mode, and the annular edge forms the lock hole in a surrounding mode. According to the artificial rotator cuff patch and the knitting method, integrated knitting is adopted, cutting does not exist, and the strength and durability are better.

Description

Technical Field

[0001] The invention belongs to the technical field of rotator cuff repair, and in particular relates to an artificial rotator cuff patch and a knitting method. Background Art

[0002] A massive rotator cuff tear is a severe rotator cuff injury caused by acute trauma, degenerative changes or multiple factors. The surgery is difficult and the prognosis is poor. The re-tear rate after repair is as high as 40%. Therefore, it is a difficult and hot issue in the current research field of sports medicine.

[0003] In the current medical field, there are many types of patch materials used to repair rotator cuff injuries, among which artificial woven patches are a common choice. This type of patch is mainly woven from filamentary materials to form a single-layer sheet structure. After weaving, multiple small holes are cut on the edge of the patch. The purpose of these small holes is to fix the patch to the patient's rotator cuff and humerus during surgery. However, after cutting, the edges of these holes for fixation will be damaged to a certain extent, which requires special edge sealing treatment to ensure that the patch can remain stable after implantation in the human body and will not fail due to damage to the edges.

[0004] Although the edge of the hole has been sealed, it has been damaged. After the patch is implanted in the human body, especially when it is subjected to the pressure of body movement, these edge parts may crack or fail, thus affecting the service life and treatment effect of the patch. In addition, this patch composed of a single layer of woven material has a relatively simple structure and is not easy to carry drugs or other therapeutic substances. Therefore, when treating damaged rotator cuff tissue, this patch cannot provide additional drug treatment support, which to a certain extent limits its application effect in tissue repair and regeneration. Summary of the invention

[0005] We hope to reduce the occurrence of patch edge cracking or failure to increase the service life of the patch while enabling the patch to carry drugs.

[0006] In the first aspect, the present application provides an artificial rotator cuff patch, which adopts the following technical solution: An artificial rotator cuff patch comprises an upper woven structure, a middle woven structure for carrying drugs and a lower woven structure which are stacked from top to bottom. A locking edge fixing structure is formed at the edge of the patch. A plurality of locking holes are arranged inside the locking edge fixing structure. The plurality of locking holes form a ring.

[0007] By adopting the above technical solution, using a layered structure design, and setting the patch as a three-layer sandwich structure, the "patch creep" phenomenon can be reduced, the mechanical strength weakening caused by the stretching and deformation of the patch during the healing process can be reduced, and the premature tearing and failure of the patch can be reduced. The strength and durability of the patch are enhanced, so that it can better withstand the stress generated during shoulder movement. In addition, the middle-layer braided structure has the dual functions of mechanical support and drug release. It not only acts as a barrier to protect the tendon and bone interface, but also slowly releases drugs and plays a role in drug treatment, thus providing patients with a more comprehensive and efficient treatment plan.

[0008] Optionally, the upper third of the upper braided structure and the upper third of the lower braided structure are both tendon ends, the pore size range of the tendon ends is 0.1 mm to 0.5 mm, and the porosity is between 10% and 20%; The lower third of the upper braided structure and the lower braided structure are both humeral ends, the pore diameter of the humeral ends are both in the range of 1 mm to 1.5 mm, and the porosity is between 20% and 30%; The middle of the upper braided structure and the lower braided structure are both smooth transition areas with an aperture range of 0.5-1mm; the aperture range of the middle braided structure is 0.1mm-0.3mm.

[0009] By adopting the above technical solutions, the pores at the tendon end are smaller and conducive to tendon growth, which can reduce wear and impact, promote tendon-bone healing, and simulate the natural microenvironment of the tendon, thereby improving the effect of tendon repair. The pores at the humeral end are larger and conducive to bone growth. In the case of osteoporosis, larger pore size and porosity help to improve the bonding strength between the patch and the bone and reduce the risk of patch loosening or falling off. Setting a higher porosity at the humeral end helps promote the healing and integration of the patch and the humerus, while supporting good blood perfusion and cell transplantation. In short, through this layered design, the patch can provide different mechanical properties and biological responses in different areas to meet the complex needs of rotator cuff repair.

[0010] Optionally, both the upper woven structure and the lower woven structure are woven into a mesh shape using fibers, and the woven directions of the upper woven structure and the lower woven structure are opposite.

[0011] By adopting the above technical solution, since the rotator cuff patch will be subjected to more tension in the up and down directions or more tension at a certain inclination angle in the upper and lower directions during use, and these tensions are at different angles, the upper and lower weaving structures are weaved in different weaving directions, which can enable the patch to maintain a certain strength when subjected to tension at any angle.

[0012] Optionally, the material of the upper woven structure, the middle woven structure and the lower woven structure is one or more of polyester, polytetrafluoroethylene (PTFE), polyethylene, polycaprolactone (PCL), polylactic acid-co-glycolic acid (PLGA), polylactic acid (PLLA), and polyvinyl alcohol (PEG).

[0013] By adopting the above technical solution, the rotator cuff patch has sufficient strength and stability, which is conducive to the combination of the patch and the humerus and long-term support.

[0014] Optionally, the inner diameter of the locking hole is 2 mm to 5 mm, and the number of the locking holes (5) is 6 to 8.

[0015] The adoption of the technical solution is conducive to the insertion of the needle suture, so that the rotator cuff patch, tendon and humerus are fixed.

[0016] Optionally, the locking density of the locking structure is 5 to 10 stitches / cm.

[0017] By adopting the above technical solution, the durability, comfort and overall quality of the patch can be effectively improved, thereby ensuring the success of the rotator cuff repair surgery.

[0018] Optionally, a through hole with a diameter less than 1 mm is provided in the central portion of the middle layer woven structure.

[0019] By adopting the above technical solution, the through hole facilitates the penetration of the drug into the surface of the humerus and the rotator cuff.

[0020] In a second aspect, the present application provides a method for knitting an artificial rotator cuff patch, which is used for the aforementioned artificial rotator cuff patch and adopts the following technical solution: A method for knitting an artificial rotator cuff patch comprises the following steps: Weaving respectively to form an upper layer weaving structure, a middle layer weaving structure and a lower layer weaving structure; The upper braided structure, the middle braided structure and the lower braided structure are stacked together, and the edges are locked to form a locked edge fixed structure; A raised annular edge is woven inside the edge-locking fixing structure, and the area surrounded by the annular edge is the locking hole.

[0021] By adopting the above technical solution, weaving a keyhole on the already stacked three-layer braided structure to form an integrated patch structure can maintain the connection between the yarns, not only maintaining the integrity of the patch structure and improving the stability of the hole, but also because the three-layer braided structure itself has pores, it will not affect the passage of the needle suture, so that the patch and tendon are fixed to the humerus. It avoids the cumbersome production steps caused by the traditional method of cutting small holes on the edge of the patch and then sealing the edges again, and avoids the occurrence of edge cracking or failure caused by cutting. It not only improves work efficiency, but also ensures that the quality of the product is not affected. In this way, we can control the production process more flexibly, while also reducing potential errors and cost increases caused by complex process flows.

[0022] Optionally, the outer diameter of the annular rim is not greater than 8 mm.

[0023] In summary, the present application includes at least one of the following beneficial technical effects: The mechanical properties of the patch are significantly improved through the layered structural design. This sandwich design not only enhances the strength and durability of the patch, enabling it to better withstand the stress generated during shoulder movement, but also optimizes the drug loading performance of the patch. Through this layered technology, the patch can more effectively carry and release drugs, which is of great significance for promoting the healing process of rotator cuff injuries. This design allows the patch to provide mechanical support while also playing the role of drug therapy, thus providing patients with a more comprehensive and efficient treatment plan. Through this innovative design, the artificial rotator cuff patch is not only more stable in structure, but also more diversified in function, which can better meet the needs of clinical treatment; In order to reduce the dependence on the complexity of the keyhole structure in the production process, we no longer use the traditional and cumbersome process to handle the keyhole structure, but choose to weave directly on the already formed patch. This method not only simplifies the production steps and improves work efficiency, but also ensures that the quality of the product is not affected. In this way, we can control the production process more flexibly, while also reducing potential errors and cost increases caused by complex process flows. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic diagram of the overall structure of the artificial rotator cuff patch of the present application; Figure 2 yes Figure 1 Sectional view at AA; Figure 3 It is a structural diagram reflecting the upper braided structure; Figure 4 It is a structural diagram reflecting the lower layer weaving structure; Figure 5 It is a structural diagram showing the middle layer weaving structure.

[0025] Description of reference numerals: 1. Upper weaving structure; 2. Middle weaving structure; 3. Lower weaving structure; 4. Locking edge fixing structure; 5. Locking hole; 21. Through hole. DETAILED DESCRIPTION

[0026] The following is combined with Figure 1-Figure 5 This application is described in further detail.

[0027] The embodiment of the present application discloses an artificial rotator cuff patch.

[0028] See also Figure 1 , Figure 2 and Figure 3 An artificial rotator cuff patch includes an upper braided structure 1, a middle braided structure 2 for carrying drugs, and a lower braided structure 3 arranged in sequence from top to bottom. The shape and size of the patch are woven according to the specific conditions of the patient to ensure the best fit and functional recovery. A circle of locking edge fixing structure 4 is formed at the edge of the patch, and the locking edge fixing structure 4 is higher than the upper braided structure 1, so that the edge of the entire patch is higher than the internal area surrounded by the edge.

[0029] The locking density of the locking structure 4 is 5-10 stitches / cm, which can effectively improve the durability, comfort and overall quality of the patch, thereby ensuring the success of the rotator cuff repair surgery.

[0030] Please also read Figure 4 Since the rotator cuff patch is subjected to more tension in the up and down directions or tension at a certain inclination angle up and down, the upper braided structure 1 and the lower braided structure 3 are both made of fibers woven into a mesh, and the weaving directions of the upper braided structure 1 and the lower braided structure 3 are opposite. The upper and lower braided structures are weaved in different directions, so that the patch can be subjected to tension at different angles during use and can maintain a certain strength.

[0031] The materials of the upper braided structure 1, the middle braided structure 2 and the lower braided structure 3 are one or more of polyester, polytetrafluoroethylene (PTFE), polyethylene, polycaprolactone (PCL), polylactic acid-co-glycolic acid (PLGA), polylactic acid (PLLA) and polyvinyl alcohol (PEG). The above materials are selected to make the patch have sufficient strength and stability, which is conducive to the combination of the patch and the humerus and long-term support.

[0032] A plurality of locking holes 5 are arranged inside the locking edge fixing structure 4, preferably 6 to 8, and the plurality of locking holes 5 are arranged in a ring shape. Figure 1The number of the locking holes 5 is shown as 7, but is not limited to 7. The locking holes 5 have a diameter of 2 mm to 5 mm, which is conducive to the insertion of the needle and suture and the fixation of the tendon and the humerus.

[0033] The upper third of the upper braided structure 1 and the lower braided structure 3 are both tendon ends, and three lock holes 5 are arranged at intervals in the width direction of the tendon ends. The lower third of the upper braided structure 1 and the lower braided structure 3 are both humeral ends, and two lock holes 5 are distributed at both ends in the width direction of the tendon ends. The middle of the upper braided structure 1 and the lower braided structure 3 are both smooth transition areas, and two lock holes 5 are distributed at both ends in the width direction.

[0034] The pore size of the tendon end ranges from 0.1mm to 0.5mm, and the porosity ranges from 10% to 20%. The pores at the tendon end are smaller, which is conducive to tendon ingrowth. The pore size of the humeral end ranges from 1mm to 1.5mm, and the porosity ranges from 20% to 30%. The pores at the humeral end are larger, which is conducive to bone ingrowth. Setting a higher porosity at the humeral end helps promote the healing and integration of the patch and the humerus, and can also support good blood perfusion and cell transplantation.

[0035] In addition, the tendon end is subjected to tensile forces, and smaller pore size and porosity can provide sufficient mechanical strength to withstand the tensile forces of the tendon during movement. The humeral end is subjected to compressive forces, and larger pore size helps to disperse these forces and reduce local stress concentration, thereby reducing the risk of damage to the patch or bone.

[0036] The diameter of the holes in the middle of the tendon end and the humeral end of the upper and lower braided structures 1 ranges from 0.5 to 1 mm. The moderate diameter of the holes between the tendon end and the humeral end is to meet the biomechanical requirements of different areas in the rotator cuff repair and ensure that the patch can provide appropriate support and fixation in the entire rotator cuff area.

[0037] Please also read Figure 5 The pore size of the middle braided structure 2 is in the range of 0.1mm-0.3mm. A through hole 21 with a diameter less than 1mm is arranged in the center of the middle braided structure 2. There are multiple through holes 21 and the overall layout is circular. The through holes 21 facilitate the penetration of drugs into the surface of the humerus and rotator cuff. The middle braided structure 2 has the dual functions of mechanical support and drug release. It not only acts as a barrier to protect the tendon and bone interface, but also slowly releases drugs and plays a role in drug treatment, thereby providing patients with a more comprehensive and efficient treatment plan.

[0038] The embodiment of the present application also discloses a weaving method for the above-mentioned artificial rotator cuff patch.

[0039] See also Figure 1 , Figure 2 and Figure 3, a weaving method of an artificial rotator cuff patch, comprising the steps of: Step S1: Weaving to form an upper layer braided structure 1, a middle layer braided structure 2 and a lower layer braided structure 3 respectively; Specifically, the main body of the upper, middle and lower layer braided structures is first formed by braiding.

[0040] Step S2: stacking the upper braided structure 1, the middle braided structure 2 and the lower braided structure 3 into one, and performing edge locking on the edges to form an edge locking fixing structure 4; Specifically, the upper braided structure 1, the middle braided structure 2 and the lower braided structure 3 are stacked to form a three-layer sandwich shape, which can reduce the mechanical strength weakening caused by the stretching and deformation of the patch during the healing process, and reduce the premature tearing and failure of the patch; The edge of the patch body is woven to form a lock edge fixing structure 4, so that the entire patch is an integrated structure, which can maintain the connection relationship between the various yarns and avoid the occurrence of edge cracking or failure that may be caused by cutting.

[0041] Step S3: a raised annular edge 6 is knitted inside the locking edge fixing structure 4, and the annular edge 6 surrounds the locking hole 5. The outer diameter of the annular edge 6 is not greater than 8 mm, which is the sum of the diameter of the locking hole 5 and the width of the annular edge 6.

[0042] Specifically, the lock holes are formed by weaving on the upper, middle and lower patch main structures that have been locked, thus completing the positioning of the lock holes, rather than cutting holes in the patch main structure. This not only avoids the edge cracking or failure that may be caused by cutting, but also because the three-layer woven structure itself has pores, it will not affect the insertion of the needle suture, so that the patch and tendon are fixed to the humerus.

[0043] In this way, we can control the production process more flexibly and reduce potential errors and cost increases caused by complex process flows. This not only improves work efficiency, but also ensures that product quality is not affected.

[0044] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. An artificial rotator cuff patch, characterized in that: The invention comprises an upper braided structure (1), a middle braided structure (2) for carrying drugs, and a lower braided structure (3) which are stacked from top to bottom. The edge of the patch forms a circle of locking edge fixing structure (4). A plurality of locking holes (5) are arranged inside the locking edge fixing structure (4). The plurality of locking holes (5) form a ring.

2. The artificial rotator cuff patch according to claim 1, characterized in that: The upper third of the upper braided structure (1) and the upper third of the lower braided structure (3) are both tendon ends, the pore size of the tendon ends are both in the range of 0.1 mm to 0.5 mm, and the porosity is both between 10% and 20%; The lower third of the upper braided structure (1) and the lower braided structure (3) are both humeral ends, the pore diameter of the humeral ends are both in the range of 1 mm to 1.5 mm, and the porosity is both between 20% and 30%; The middle of the upper braided structure (1) and the lower braided structure (3) are both smooth transition areas with a pore size range of 0.5-1 mm; the pore size range of the middle braided structure (2) is 0.1 mm-0.3 mm.

3. The artificial rotator cuff patch according to claim 1, characterized in that: The upper woven structure (1) and the lower woven structure (3) are both woven into a mesh shape using fibers, and the upper woven structure (1) and the lower woven structure (3) have opposite woven directions.

4. The artificial rotator cuff patch according to claim 3, characterized in that: The material of the upper braided structure (1), the middle braided structure (2) and the lower braided structure (3) is one or more of polyester, polytetrafluoroethylene (PTFE), polyethylene, polycaprolactone (PCL), polylactic acid-co-glycolic acid (PLGA), polylactic acid (PLLA) and polyvinyl alcohol (PEG).

5. The artificial rotator cuff patch according to claim 1, characterized in that: The diameter of the locking hole (5) is 2 mm to 5 mm, and the number of the locking holes (5) is 6 to 8.

6. The artificial rotator cuff patch according to claim 1, characterized in that: The locking density of the locking structure (4) is 5 to 10 stitches / cm.

7. The artificial rotator cuff patch according to any one of claims 1 to 7, characterized in that: A through hole (21) with a diameter less than 1 mm is provided at the center of the middle layer braided structure (2).

8. A method for knitting an artificial rotator cuff patch, used for the artificial rotator cuff patch according to any one of claims 1 to 7, characterized in that: Includes steps: Weaving respectively to form an upper layer braided structure (1), a middle layer braided structure (2) and a lower layer braided structure (3); The upper braided structure (1), the middle braided structure (2) and the lower braided structure (3) are stacked together, and the edges are locked to form a locked edge fixing structure (4); A raised annular edge (6) is woven inside the edge-locking fixing structure (4), and the area surrounded by the annular edge (6) serves as the locking hole (5).

9. The method for knitting an artificial rotator cuff patch according to claim 8, characterized in that: The outer diameter of the annular edge (6) is no greater than 8 mm.

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