Manufacturing method of artificial meniscus

Abstract

The invention relates to a manufacturing method of an artificial meniscus. The problems that an existing artificial meniscus is prone to deformation and failure, not tightly attached to a human body and inconvenient to fix are solved. The manufacturing method comprises the following steps: firstly, manufacturing a required mold in a meniscus shape, and manufacturing a positioning hole for the fiber positioning line to extend out at a corresponding position of the mold; the high-strength fiber net sheets are stacked to form a supporting layer corresponding to the meniscus in shape; then high-strength fixed fibers are sequentially connected with the supporting layer in a penetrating mode to form a meniscus framework corresponding to the meniscus in shape, and high-strength fiber positioning lines are led out from the outer edge of the meniscus framework; then the meniscus framework is placed into a meniscus grinding tool, the fiber positioning lines extend out of the positioning holes, filling slurry good in compatibility with human tissue is poured into the mold for forming and grinding, a regular meniscus shape is formed, and therefore the artificial meniscus which is stable in supporting and good in compatibility with the human tissue is formed; and the meniscus prosthesis is fixed on the joint capsule and the bone surface by the fiber positioning line, so that the installation is firmer.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a method for manufacturing an artificial meniscus. Background Art

[0002] The incidence of meniscus injury is very high. Meniscus injury is divided into grade III, grade I injury, grade II injury and grade III injury. Grade I and grade II can be treated conservatively by limiting knee joint activities and paying attention to rest in daily life to avoid aggravating knee meniscus injury. Grade III injury is the most serious, and surgical treatment is the first choice during the treatment process.

[0003] The method for making an artificial meniscus is currently a common substitute for those with severe meniscus injuries. At present, the main materials for making an artificial meniscus are metals, polymer materials, ceramics, and bioactive materials. These materials have good biocompatibility, wear resistance, and mechanical strength, and can meet the needs of long-term use of the method for making an artificial meniscus in the joint. According to the design principle of the method for making an artificial meniscus, it can be divided into fixed, expandable, and bioactive types. The technology for making an artificial meniscus is constantly improving, such as the patent number: "202311077653.5", the name: "A method for making an artificial meniscus bionic scaffold and its preparation method". The existing artificial meniscus scaffolds are either not strong enough to support and are easy to deform and tear, or they are not suitable for patients with discoid meniscus. The knee joint morphology is not closely fitted to the human body, thereby losing the protective effect on the articular cartilage and failing; in addition, the existing artificial meniscus has no leads, which is inconvenient to fix. Summary of the invention

[0004] The purpose of the present invention is to solve the problems that the existing artificial meniscus is easy to deform and fail, does not fit the human body tightly and is inconvenient to fix.

[0005] The technical solution adopted to solve the technical problem proposed by the present invention is: the method for making an artificial meniscus of the present invention comprises the following steps: Step A: making a mold of the desired meniscus shape, and making positioning holes for the fiber positioning wire to extend at corresponding positions of the mold; Step B: stacking high-strength fiber mesh sheets to form a support layer corresponding to the shape of the meniscus; Step C: using high-strength fixed fiber threads to sequentially penetrate the support layers to form a meniscus skeleton corresponding to the shape of the meniscus, and drawing out a high-strength fiber positioning line from the outer edge of the meniscus skeleton; Step D: Place the meniscus skeleton into the meniscus mold, extend the fiber positioning wire from the positioning hole, pour the filling slurry with good compatibility with human tissue into the mold, and cure and shape it according to the properties of the selected filling slurry; Step F: Take out the formed meniscus prototype, and obtain the finished artificial meniscus through fine grinding and cleaning.

[0006] The technical solutions for further limiting the present invention include: In step B, the support layer is formed by cutting the fiber mesh sheet layer by layer into sheets with different sections from bottom to top and stacking them.

[0007] In step B, the support layer is formed by cutting the fiber mesh sheet layer by layer into sheets with different sections from left to right and stacking them.

[0008] In step B, the support layer is formed by folding the fiber mesh sheet back and forth layer by layer from bottom to top.

[0009] In step B, the support layer is formed by folding the fiber mesh sheet back and forth layer by layer from left to right.

[0010] In step B, the support layer is formed by rolling up a fiber mesh sheet.

[0011] The materials of the support layer, the fixed fiber filaments and the fiber positioning line described in step B and step C are made of one or more of polyurethane, polyetheretherketone, carbon fiber, poly-glycolide copolymer, poly(p-xylylene dimethyl ester), polyvinyl alcohol or polyacetamide.

[0012] In step C, the mold and the meniscus skeleton are in a C-shape, a circular ring shape, an eccentric hole shape, or a disc shape.

[0013] In step D, the material of the filling slurry is polyethylene, polyester or polyamide slurry.

[0014] Through the above technical scheme, the beneficial effects of the present invention are as follows: during the manufacturing method of the artificial meniscus of the present invention, a mold of the desired meniscus shape is first manufactured, and a positioning hole for the fiber positioning line to extend out is manufactured at a corresponding position of the mold; a high-strength fiber mesh sheet is then stacked to form a support layer corresponding to the shape of the meniscus; then a high-strength fixed fiber thread is sequentially passed through the support layer to form a meniscus skeleton corresponding to the shape of the meniscus, and a high-strength fiber positioning line is drawn out from the outer edge of the meniscus skeleton; then the meniscus skeleton is placed in a meniscus mold, and the fiber positioning line is extended from the positioning hole The mold is extended inward, and a filling slurry with good compatibility with human tissue is poured into the mold, and the mold is cured and formed according to the properties of the selected filling slurry; finally, the formed meniscus prototype is taken out, and the artificial meniscus product is obtained through fine grinding and cleaning. The filling fixer with good compatibility with human tissue is filled in the meniscus skeleton to wrap the meniscus skeleton, and a regular meniscus shape is formed while strengthening the meniscus skeleton, thereby forming an artificial meniscus with stable support and good compatibility with human tissue. The fiber positioning line fixes the meniscus prosthesis on the joint capsule and bone surface to make the installation more secure. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 The present invention is a schematic structural diagram of a method for manufacturing an artificial meniscus in which a meniscus skeleton is C-shaped.

[0016] Figure 2 The present invention is a schematic structural diagram of a method for manufacturing an artificial meniscus in which a meniscus skeleton is in an eccentric hole shape.

[0017] Figure 3 The present invention is a schematic structural diagram of a method for manufacturing an artificial meniscus in which a meniscus skeleton is in a circular ring shape.

[0018] Figure 4 The present invention is a schematic structural diagram of a method for manufacturing an artificial meniscus in which a meniscus skeleton is in a disc shape.

[0019] Figure 5 It is a schematic diagram of the stacked structure of the meniscus skeleton in Example 1 of a method for manufacturing an artificial meniscus of the present invention.

[0020] Figure 6 It is a schematic diagram of the stacked structure of the meniscus skeleton in the second embodiment of the method for manufacturing an artificial meniscus of the present invention.

[0021] Figure 7 It is a schematic diagram of the stacked structure of the meniscus skeleton in Example 3 of a method for manufacturing an artificial meniscus of the present invention.

[0022] Figure 8 It is a schematic diagram of the stacked structure of the meniscus skeleton in the fourth embodiment of the method for manufacturing an artificial meniscus of the present invention.

[0023] Fig. 9 It is a schematic diagram of the stacked structure of the meniscus skeleton in Example 5 of a method for manufacturing an artificial meniscus of the present invention. DETAILED DESCRIPTION

[0024] The structure of the present invention is further described below in conjunction with the accompanying drawings.

[0025] Reference Figures 1 to 9 The method for making an artificial meniscus of the present invention comprises the following steps: Step A: Make a mold of the desired meniscus shape, and make positioning holes for the fiber positioning wire to extend at corresponding positions of the mold; the mold can be designed into a C-shape, a circular ring shape, an eccentric hole shape, or a disc shape as needed.

[0026] Step B: stacking high-strength fiber mesh sheets to form a support layer 1 corresponding to the shape of the meniscus; in this embodiment, the materials of the support layer, the fixed fiber filaments and the fiber positioning wires are made of one or more of polyurethane, polyetheretherketone, carbon fiber, poly-glycolide copolymer, poly(p-xylylene dimethyl ester), polyvinyl alcohol or polyacetamide. Polyurethane has good biocompatibility and wear resistance. Polyetheretherketone is a high-performance thermoplastic material with excellent mechanical properties and biocompatibility. Carbon fiber reinforced composite materials can provide higher strength and rigidity. Poly-glycolide copolymer is a biocompatible, degradable synthetic polymer with good strength and toughness. Poly-glycolide copolymer meniscus scaffold can provide mechanical support, promote tissue regeneration, and degrade into harmless byproducts over time. Poly(p-xylylene dimethyl ester) is a strong, semi-crystalline thermoplastic polymer with high wear resistance and low friction coefficient. The poly(p-xylylene dimethyl ester) meniscus prosthesis has excellent stability and durability and can provide long-lasting mechanical support. Polyvinyl alcohol is a water-soluble, biocompatible polymer with excellent flexibility and plasticity. Polyvinyl alcohol meniscal scaffolds can be customized into complex shapes to fit the injured area closely. Polyacetamide is a tough, wear-resistant synthetic polymer with good biocompatibility and antibacterial properties. Polyacetamide meniscal prostheses have excellent strength and durability and can withstand high loads.

[0027] Step C: Use high-strength fixing fiber filaments 2 to sequentially penetrate the supporting layers to form a meniscus skeleton corresponding to the shape of the meniscus, and draw out high-strength fiber positioning wires 4 from the outer edge of the meniscus skeleton; In step B and step C, the support layer can be made by different manufacturing methods according to the needs during the specific implementation. In the first embodiment, the support layer is formed by cutting the fiber mesh sheet layer by layer into shape pieces with different sections from bottom to top and stacking them. That is, according to the shape of the meniscus, the fiber mesh sheet is cut into shape pieces corresponding to it, and then these shape pieces are stacked from bottom to top to form a semicircular plate shape, and then the shape pieces are connected to the support layer from bottom to top in sequence by fixing the fiber filaments to form a meniscus skeleton corresponding to the shape of the meniscus.

[0028] In the second embodiment, the support layer is formed by cutting the fiber mesh sheet layer by layer into shape pieces with different sections from left to right and stacking them. That is, according to the shape of the meniscus, the fiber mesh sheet is cut into shape pieces corresponding to it, and then these shape pieces are stacked from left to right to form a semicircular plate shape, and then the shape pieces are connected to the support layer from bottom to top in sequence by fixing the fiber filaments to form a meniscus skeleton corresponding to the shape of the meniscus.

[0029] In the third embodiment, the support layer is formed by folding the fiber mesh sheet from bottom to top layer by layer. Then, the shape sheet is passed through the support layer from bottom to top in sequence by fixing the fiber filaments to form a meniscus skeleton corresponding to the shape of the meniscus.

[0030] In the fourth embodiment, the support layer is formed by folding the fiber mesh sheet back and forth layer by layer from left to right. Then, the shape sheet is passed through the support layer from left to right in sequence by fixing the fiber filaments to form a meniscus skeleton corresponding to the shape of the meniscus.

[0031] In the fifth embodiment, the support layer is formed by rolling up a fiber mesh sheet, and then the support layer is connected in sequence by fixing fiber threads to form a meniscus skeleton corresponding to the shape of the meniscus.

[0032] The meniscus skeleton can be made into a C-shape, a circular ring shape, an eccentric hole shape or a disc shape according to the shape of the mold.

[0033] Step D: Place the meniscus skeleton into the meniscus mold, extend the fiber positioning line from the positioning hole, pour the filling slurry with good compatibility with human tissue into the mold, and maintain and shape it according to the properties of the selected filling slurry; after the filling slurry is solidified, it becomes a filling fixture 3, and the filling fixture with good compatibility with human tissue is filled in the meniscus skeleton to wrap the meniscus skeleton. In this embodiment, the material of the filling slurry is polyethylene, polyester or polyamide slurry. These materials have good compatibility with human tissue and have certain wear resistance and elasticity. Its main function is to reduce cartilage wear in the knee joint, relieve pain and improve functional disorders. After using imported artificial meniscus, the symptoms that patients may experience include swelling, pain, stiffness and limited range of motion. Multiple fiber positioning lines are drawn out from the outer edge of the meniscus to fix the meniscus prosthesis on the joint capsule and bone surface.

[0034] Step F: Take out the formed meniscus prototype, and obtain the finished artificial meniscus by fine grinding and cleaning. The artificial meniscus made by the method for making the artificial meniscus of the present invention uses high-strength fixed fiber filaments to sequentially penetrate the supporting layer to form a meniscus skeleton corresponding to the shape of the meniscus, and draws out high-strength fiber positioning lines from the outer edge of the meniscus skeleton; then the meniscus skeleton is placed in the meniscus mold, and the fiber positioning lines extend from the positioning holes, and the mold is filled with a filling slurry with good compatibility with human tissue, and a filling fixed body with good compatibility with human tissue is filled in the meniscus skeleton to wrap the meniscus skeleton, and a regular meniscus shape is formed while strengthening the meniscus skeleton, thereby forming an artificial meniscus with stable support and good compatibility with human tissue, and the fiber positioning lines fix the meniscus prosthesis on the joint capsule and the bone surface to make the installation more secure.

[0035] Although the specific embodiments of the present invention are described in detail in conjunction with the accompanying drawings, it should not be understood as limiting the scope of protection of the present invention. Within the scope described in the claims, various modifications and variations that can be made by those skilled in the art without creative work still belong to the scope of protection of the present invention.

Claims

1. A method for making an artificial meniscus, characterized in that: The production method comprises the following steps: Step A: making a mold of the desired meniscus shape, and making positioning holes for the fiber positioning wire to extend at corresponding positions of the mold; Step B: stacking high-strength fiber mesh sheets to form a support layer corresponding to the shape of the meniscus; Step C: using high-strength fixed fiber threads to sequentially penetrate the support layers to form a meniscus skeleton corresponding to the shape of the meniscus, and drawing out a high-strength fiber positioning line from the outer edge of the meniscus skeleton; Step D: Place the meniscus skeleton into the meniscus mold, extend the fiber positioning wire from the positioning hole, pour the filling slurry with good compatibility with human tissue into the mold, and cure and shape it according to the properties of the selected filling slurry; Step F: Take out the formed meniscus prototype, and obtain the finished artificial meniscus through fine grinding and cleaning.

2. The method for making an artificial meniscus according to claim 1, characterized in that: In step B, the support layer is formed by cutting the fiber mesh sheet layer by layer into sheets with different sections from bottom to top and stacking them.

3. The method for making an artificial meniscus according to claim 1, characterized in that: In step B, the support layer is formed by cutting the fiber mesh sheet layer by layer into sheets with different sections from left to right and stacking them.

4. The method for manufacturing an artificial meniscus according to claim 1, characterized in that: In step B, the support layer is formed by folding the fiber mesh sheet back and forth layer by layer from bottom to top.

5. The method for manufacturing an artificial meniscus according to claim 1, characterized in that: In step B, the support layer is formed by folding the fiber mesh sheet back and forth layer by layer from left to right.

6. The method for manufacturing an artificial meniscus according to claim 1, characterized in that: In step B, the support layer is formed by rolling up a fiber mesh sheet.

7. The method for manufacturing an artificial meniscus according to claim 1, characterized in that: The materials of the support layer, the fixed fiber filaments and the fiber positioning line described in step B and step C are made of one or more of polyurethane, polyetheretherketone, carbon fiber, poly-glycolide copolymer, poly(p-xylylene dimethyl ester), polyvinyl alcohol or polyacetamide.

8. The method for manufacturing an artificial meniscus according to claim 1, characterized in that: In step A and step C, the mold and the meniscus skeleton are in a C-shape, a circular ring shape, an eccentric hole shape, or a disc shape.

9. The method for manufacturing an artificial meniscus according to claim 1, characterized in that: In step D, the material of the filling slurry is polyethylene, polyester or polyamide slurry.

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