Artificial metatarsophalangeal joint prosthesis and preparation method thereof

Abstract

The present application belongs to the field of medical device technology, and in particular relates to an artificial metatarsophalangeal joint prosthesis and a preparation method thereof; after the internal and external surfaces of the artificial metatarsophalangeal joint prosthesis provided by the present application are modified with hyaluronic acid, the hydrophilicity and lubricity of the joint prosthesis can be improved, the wear of the joint prosthesis can be reduced, and the possibility of wear debris generated by the wear of the joint prosthesis causing an immune response in the body is reduced. At the same time, the possibility of protein adhesion to the joint prosthesis is reduced, and the proliferation and infection of bacteria on the joint prosthesis are hindered, which can extend the service life of the joint prosthesis, thereby solving the technical problem in the prior art that artificial metatarsophalangeal joint prostheses are easy to wear and have a short service life.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular relates to an artificial metatarsophalangeal joint prosthesis and a preparation method thereof. Background Art

[0002] The metatarsophalangeal joint is composed of the heads of each metatarsal bone and the proximal base of the proximal phalanges of each toe. It is an important support point for human walking and weight-bearing. Currently, commonly used methods for treating metatarsophalangeal joint diseases include arthrotomy, arthrodesis and joint replacement. Among them, joint replacement is easier to operate than arthrodesis, and avoids the risks of thumb shortening and interphalangeal joint deformity that may be caused by arthrotomy. It is an important means of reconstructing severely diseased metatarsophalangeal joints.

[0003] The double-silicone hinged metatarsophalangeal joint prosthesis, represented by the Swanson prosthesis, is the most commonly used metatarsophalangeal joint prosthesis in clinical practice. However, the sharp bone margins of the metatarsophalangeal joint and the excessive shear force concentrated on the prosthesis can easily cause wear debris in the relatively soft silicone material, potentially leading to complications such as reactive synovitis and osteolysis. Currently, there is still considerable room for development in the field of artificial metatarsophalangeal joint prosthesis research, and there is a lack of high-performance metatarsophalangeal joint prostheses.

[0004] Artificial prostheses in other joints are often developed and researched using ultra-high molecular weight polyethylene (UHMWPE) as a base material. UHMWPE is an unbranched linear polyethylene with a molecular weight of 3.5 to 6 million. Its crystalline form is a large number of ordered crystalline thin layers embedded in a disordered amorphous matrix. The amorphous and crystalline regions are interconnected to form a network structure. It has high wear resistance, strong tensile strength and impact toughness. As an artificial joint material, it has a long history of use. However, UHMWPE is a hydrophobic material, which is quite different from the hydrophilicity of natural cartilage. After being implanted into the joint, UHMWPE is prone to wear and tear on the joint; especially The metatarsophalangeal joint is the joint between the sole of the foot and the toes. Adverse reactions can occur after implantation of UHMWPE joint prostheses in the metatarsophalangeal joint. Among the voluntarily reported adverse events related to orthopedic implants in the MAUDE database, component loosening, infection, inflammation, and allergic reactions are the main causes. This indicates that the body's physiological activities can cause shear motion at the contact interface between the metatarsophalangeal joint and the UHMWPE joint, generating friction and wear, leading to structural and functional failure of the prosthesis. The large amount of abrasive particles generated by wear may also lead to complications such as osteolysis, reactive synovitis, and allergies, significantly reducing the service life of the prosthesis. Summary of the Invention

[0005] In view of this, the present application provides an artificial metatarsophalangeal joint prosthesis and a preparation method thereof, which are used to solve the technical problems in the prior art that artificial metatarsophalangeal joint prostheses are easily worn and have a short service life.

[0006] In a first aspect, the present application provides an artificial metatarsophalangeal joint prosthesis, comprising a porous polyetheretherketone base layer, an ultra-high molecular weight polyethylene layer loaded with hyaluronic acid on the inside, and a hyaluronic acid lubricating layer on the outer surface;

[0007] The bottom of the ultra-high molecular weight polyethylene layer loaded with hyaluronic acid is embedded in the porous polyetheretherketone base layer to form a physical interlocking structure;

[0008] The outer surface hyaluronic acid lubricating layer covers the inner ultra-high molecular weight polyethylene layer loaded with hyaluronic acid.

[0009] Preferably, the outer surface hyaluronic acid lubricating layer includes at least two layers of hyaluronic acid lubricating layers.

[0010] A first aspect of the present application provides a method for preparing an artificial metatarsophalangeal joint prosthesis, the method comprising the steps of:

[0011] Step A1: adding a mixture of a porous polyetheretherketone base layer, ultra-high molecular weight polyethylene powder, and a porogen into a hot pressing mold in sequence, and performing compression molding to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone embryo;

[0012] Step A2, dialyzing the demolded porous ultra-high molecular weight polyethylene-polyetheretherketone embryo to remove impurities, thereby obtaining a porous ultra-high molecular weight polyethylene-polyetheretherketone preform;

[0013] Step A3, immersing the porous ultra-high molecular weight polyethylene-polyetheretherketone preform in a silanized hyaluronic acid organic solution for cross-linking to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone preform internally loaded with silanized hydrophobically modified hyaluronic acid;

[0014] Step A4, hydrolyzing the porous ultra-high molecular weight polyethylene-polyetheretherketone preform internally loaded with silanized hydrophobically modified hyaluronic acid to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone preform internally loaded with hyaluronic acid;

[0015] Step A5, immersing the porous ultra-high molecular weight polyethylene-polyetheretherketone preform loaded with hyaluronic acid in a hyaluronic acid aqueous solution for coating, and cross-linking to obtain an artificial metatarsophalangeal joint prosthesis preform;

[0016] Step A6: placing the artificial metatarsophalangeal joint prosthesis preform in a mold, and performing secondary compression molding to prepare the artificial metatarsophalangeal joint prosthesis.

[0017] Preferably, in step A1, the mass ratio of the ultra-high molecular weight polyethylene powder to the porogen is 7-9:1-3.

[0018] Preferably, in step A1, the porogen is at least one of a sodium chloride porogen, a potassium chloride porogen, and a polyethylene glycol porogen.

[0019] Preferably, in step A1, the compression molding temperature is about 160-250° C., the time is 20-60 min, and the pressure is 1-3 MPa.

[0020] Preferably, in step A2, the solvent used for dialysis to remove impurities is water, and the dialysis time is 1 to 3 hours.

[0021] Preferably, in step A3, the concentration of silanized hyaluronic acid in the silanized hyaluronic acid organic solution is 30 to 100 mg / mL.

[0022] Preferably, in step A4, the solvent used for hydrolysis is an ethanol / water solution of sodium chloride;

[0023] The concentration of the solute sodium chloride in the sodium chloride ethanol / water solution is 0.1-0.3M, and the volume ratio of the solvent water to the ethanol is 2-1:1.

[0024] Preferably, in step A5, the concentration of hyaluronic acid in the hyaluronic acid aqueous solution is 1 to 3 wt%.

[0025] Preferably, in step A5, the hyaluronic acid aqueous solution is coated at least twice.

[0026] Preferably, in steps A3 and A5, the solvent used for cross-linking is an acetone solution of hexamethylene diisocyanate;

[0027] The concentration of the hexamethylene diisocyanate acetone solution is 30-80 mg / mL.

[0028] Preferably, in step A6, the compression molding temperature is about 155-160° C., the time is 20-40 min, and the pressure is 1-3 MPa.

[0029] In summary, the present application provides an artificial metatarsophalangeal joint prosthesis and a preparation method thereof. The artificial metatarsophalangeal joint prosthesis provided by the present application includes a porous polyetheretherketone base layer, an ultra-high molecular weight polyethylene layer loaded with hyaluronic acid inside, and a hyaluronic acid lubricating layer on the outer surface. The porous polyetheretherketone base layer has an elastic modulus similar to that of natural bone, which can effectively reduce the stress shielding effect and improve the stability of the prosthesis. The bottom of the ultra-high molecular weight polyethylene layer is embedded in the porous polyetheretherketone base layer, and the pores running through the porous polyetheretherketone base make the bottom layer of the porous ultra-high molecular weight polyethylene layer embedded in the porous polyetheretherketone base to form a physical interlocking structure. The connection is strengthened and friction is reduced. At the same time, the outer surface of the ultra-high molecular weight polyethylene layer is covered with a hyaluronic acid lubricating layer, and the interior is also loaded with hyaluronic acid molecules. The hyaluronic acid lubricating layer on the outer surface can play a role in lubrication and friction reduction, and the hyaluronic acid molecules on the inner surface can continuously replenish the degradation / wear of the hyaluronic acid lubricating layer on the outer surface. Therefore, the artificial metatarsophalangeal joint prosthesis provided in the present application reduces the wear of the porous ultra-high molecular weight polyethylene prosthesis material by improving the surface lubrication of the porous ultra-high molecular weight polyethylene layer, and can solve the technical problems in the prior art that artificial metatarsophalangeal joint prostheses are easy to wear and have a short service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the specific implementation methods or the description of the prior art. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0031] Figure 1 A schematic diagram of the structure of an artificial metatarsophalangeal joint prosthesis provided in Example 1 of the present application;

[0032] Figure 2 Schematic diagram of water contact angle test of artificial metatarsophalangeal joint prosthesis PE (HA), ultra-high molecular weight polyethylene disc PE, and porous ultra-high molecular weight polyethylene disc porous PE tested in the experimental examples of this application;

[0033] Figure 3 This is a scanning electron micrograph of the artificial metatarsophalangeal joint prosthesis PE (HA) and ultra-high molecular weight polyethylene sphere PE after relative friction (lubricated in 1M phosphate buffer (PBS), with a load of 3N and a loading speed of 12mm / s for 20min);

[0034] Figure 4This is a scanning electron micrograph of the artificial metatarsophalangeal joint prosthesis PE (HA) and ultra-high molecular weight polyethylene sphere PE after relative friction (relative friction for 20 minutes under 25% newborn calf serum (NCS) lubrication, load 3N, loading speed 12mm / s) tested in the experimental example of this application;

[0035] Figure 5 The friction properties of artificial metatarsophalangeal joint prosthesis PE (HA), ultra-high molecular weight polyethylene disc PE, porous ultra-high molecular weight polyethylene disc porous PE, ultra-high molecular weight polyethylene disc PE-HA with hyaluronic acid coated on the surface, and porous ultra-high molecular weight polyethylene disc porous PE-HA with hyaluronic acid coated on the surface, under different lubrication conditions, tested in the experimental examples of this application; Figure 5 In the PBS lubrication group and the NCS lubrication group, the friction coefficients were significantly different (n=4). DETAILED DESCRIPTION

[0036] The present application provides an artificial metatarsophalangeal joint prosthesis and a preparation method thereof, which are used to solve the technical problems in the prior art that artificial metatarsophalangeal joint prostheses are easily worn and have a short service life.

[0037] The following will clearly and completely describe the technical solution of this application in conjunction with the accompanying drawings. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of this application.

[0038] Example 1

[0039] When traditional ultra-high molecular weight polyethylene (UHMWPE) material is used as a joint prosthesis, due to its surface hydrophobicity, it is difficult to form a hydrating lubricating layer with the hydrophilic human cartilage. After the ultra-high molecular weight polyethylene material is implanted in the joint, it is easy to wear against the joint. The wear debris generated by the wear of ultra-high molecular weight polyethylene is easy to accumulate in the body, which can induce a series of matrix immune reactions in the matrix cells, which may lead to bone dissolution and aseptic loosening around the prosthesis, seriously affecting the service life of the joint prosthesis. In addition, proteins are easy to adhere to the ultra-high molecular weight polyethylene material. The proteins adhered to the implanted prosthetic material will induce further colonization of bacterial biofilms. The antibodies generated by the release of antigens stimulated by these bacteria not only cannot kill bacteria, but will form immune complexes to destroy surrounding tissues, causing infection and failure of the prosthesis. Therefore, the current artificial metatarsophalangeal joint prosthesis has the defects of easy wear and short service life. In view of this, Example 1 of the present application provides an artificial metatarsophalangeal joint prosthesis. The schematic diagram of the artificial metatarsophalangeal joint prosthesis is shown in the figure. Figure 1As shown, the artificial metatarsophalangeal joint prosthesis provided by the present application includes a porous polyetheretherketone (PEEK) base layer, an internal UHMWPE layer loaded with hyaluronic acid, and an outer surface hyaluronic acid HA lubricating layer; the porous polyetheretherketone base layer is a structure in which the internal pore structure is interconnected, so that ultra-high molecular weight polyethylene powder and a porogen are hot-pressed on the porous polyetheretherketone base layer, so that the bottom of the ultra-high molecular weight polyethylene layer having a porous structure before the secondary hot-pressing is embedded in the porous polyetheretherketone base layer to form a physical interlocking structure, and after the secondary hot-pressing, the hyaluronic acid molecules loaded in the porous structure of the ultra-high molecular weight polyethylene layer are stably encapsulated. The hyaluronic acid lubricating layer on the outer surface of the ultra-high molecular weight polyethylene layer can be continuously renewed for a long time to maintain the lubricating effect of the hyaluronic acid lubricating layer on the outer surface. The porous ultra-high molecular weight polyethylene layer and the porous polyetheretherketone substrate of the present patent application can be stably connected through a physical interlocking structure, and are not easily worn by each other; at the same time, the internal hyaluronic acid molecules in the ultra-high molecular weight polyethylene layer replenish the hyaluronic acid lubricating layer on the outer surface, effectively alleviating the defect of increased wear of the joint prosthesis caused by the rupture and shedding of the outer hyaluronic acid lubricating layer. The artificial metatarsophalangeal joint prosthesis provided by the present application greatly extends the service life of the artificial metatarsophalangeal joint prosthesis by improving the hyaluronic acid lubricating layer;

[0040] At the same time, the provision of a hyaluronic acid lubricating layer can also reduce the wear debris generated by polyethylene wear and reduce the occurrence of the body's immune response. At the same time, the excellent lubricity of the hyaluronic acid lubricating layer can also reduce the adhesion of proteins on the prosthetic material, thereby hindering bacterial colonization, and can effectively reduce the impact of chronic infection on the service life of the implant. Therefore, the artificial metatarsophalangeal joint prosthesis provided in the present application reduces the wear of the porous ultra-high molecular weight polyethylene prosthetic material by improving the surface lubrication of the porous ultra-high molecular weight polyethylene layer, and can solve the technical problem in the prior art that artificial metatarsophalangeal joint prostheses are easily worn and have a short service life.

[0041] Preferably, in order to effectively introduce hyaluronic acid molecules into the porous structure of the ultra-high molecular weight polyethylene layer for loading, the lubricating modification effect of the hyaluronic acid layer is improved; the present application sets up an ultra-high molecular weight polyethylene layer, and the loading process of the hyaluronic acid molecules is to first perform silanization hydrophobic modification on the hyaluronic acid. The hydrophobic silanized hyaluronic acid can more easily enter the interior of the hydrophobic porous ultra-high molecular weight polyethylene layer and can restore its original hydrophilic properties through hydrolysis after loading; at the same time, the outer hyaluronic acid lubricating layer is coated at least twice, and the number of layers of the outer hyaluronic acid lubricating layer is at least two.

[0042] Example 2

[0043] Example 2 of the present application provides a method for preparing the artificial metatarsophalangeal joint prosthesis described in Example 1, the preparation method including the steps of preparing a silanized hyaluronic acid solution, a molding step, a dialysis step, a coating step of a silanized hydrophobically modified hyaluronic acid layer, a coating step of a hyaluronic acid layer, and a molding reshaping step.

[0044] The steps of preparing the silanized hyaluronic acid solution include: first, under stirring, adding 0.5 mg / mL hexadecyltrimethylammonium bromide CTAB solution dropwise to 0.25 mg / mL hyaluronic acid HA solution, in excess until the generated white complex precipitates completely and the upper solution is clear; then, the white complex precipitate obtained by centrifugation of the reaction solution is repeatedly washed three times by pure water centrifugation to remove residual CTAB, and then the washed precipitate is dried at 50°C under vacuum conditions for 24 hours to obtain ammonium salt precipitated hyaluronic acid; then, the ammonium salt precipitated hyaluronic acid and anhydrous dimethyl sulfoxide solvent DMS are mixed. O was mixed and allowed to stand overnight, and then heated at 60° C. with stirring to obtain an ammonium salt precipitated hyaluronic acid solution; then hexamethyldisilazane HMDS was added to the ammonium salt precipitated hyaluronic acid solution, and the reaction was carried out at 55-76° C. with vigorous stirring and nitrogen protection for 24 hours; after the reaction, the upper HMDS layer in the mixed solution that was allowed to stand and separate was taken out, and the HMDS was removed by drying at 50° C. under vacuum conditions, and the residual solid was washed five times with xylene, and continued to be dried at 50° C. under vacuum conditions to obtain silanized hyaluronic acid; then the silanized hyaluronic acid was dissolved in xylene to obtain a 50 mg / mL silanized hyaluronic acid solution.

[0045] The steps of compression molding include: first placing the porogen sodium chloride powder in a planetary ball mill and grinding it at a frequency of 10 Hz for 5 minutes to obtain uniform porogen sodium chloride powder; then mixing the ultra-high molecular weight polyethylene powder and the porogen sodium chloride in a mass ratio of 3:7, drying and removing water in a 60°C oven to obtain a mixed powder for use; then placing the 3D printed porous PEEK bracket at the bottom, adding the ultra-high molecular weight polyethylene powder and the porogen sodium chloride mixed powder into the mold, using a flat vulcanizer to maintain a pressure of about 2 MPa and a temperature of about 200°C for 40 minutes, cooling to room temperature, and demolding to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone embryo. A release agent can be sprayed in the mold to facilitate demolding.

[0046] The dialysis step includes: placing the molded porous ultra-high molecular weight polyethylene-polyetheretherketone embryo in a large amount of pure water, dialyzing to remove the porogen, and drying the sample in a 60°C oven after dialysis for 2 days to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone preform; wherein, vacuum or ultrasound can be used to assist dialysis, and the water is changed every 6 hours during the dialysis process.

[0047] The steps of coating the silanized hydrophobically modified hyaluronic acid layer include: ultrasonically washing the porous ultra-high molecular weight polyethylene-polyetheretherketone preform with anhydrous ethanol, immersing it in a xylene solution of silanized hyaluronic acid after drying, adding a hexamethylene diisocyanate acetone solution under a dry nitrogen atmosphere for cross-linking, and vibrating the mixed solution containing the preform for 5 to 10 minutes during the cross-linking process, and then standing at room temperature for 1 day for cross-linking; wherein the concentration of the xylene solution of silanized hyaluronic acid used is 50 mg / mL, and the concentration of the hexamethylene diisocyanate acetone solution is 20 mg / mL; and immersing the preform after cross-linking in an ethanol / water solution of sodium chloride for hydrolysis for 40 hours, and replacing the solution every 10 hours during the hydrolysis process.

[0048] The step of coating the hyaluronic acid layer includes: immersing the hydrolyzed preform in a pure hyaluronic acid aqueous solution for coating; wherein the coating time is 10 minutes, the number of times is twice, and between each immersion and coating, the preform is dried in a 50°C oven for 1 hour; after the two coating and drying steps, the preform is again immersed in a hexamethylene diisocyanate acetone solution with a concentration of 20 mg / mL for cross-linking.

[0049] The reshaping step of compression molding includes: drying the preform coated with the hyaluronic acid layer in an oven at 50°C, then placing it in a mold, using a flat vulcanizer at a pressure of about 2 MPa and a temperature range of 155-160°C for 30 minutes, cooling to room temperature, and demolding to obtain an artificial metatarsophalangeal joint prosthesis.

[0050] Experimental Example 1

[0051] Experimental Example 1 of the present application performs performance tests on the artificial metatarsophalangeal joint prosthesis, dense ultra-high molecular weight polyethylene, and porous ultra-high molecular weight polyethylene prepared in Example 2, including water contact angle test, friction performance, and wear scar characterization test.

[0052] The test process of the water contact angle test is as follows: 5 μL of pure water is added to the surface of dense ultra-high molecular weight polyethylene UHMWPE, porous ultra-high molecular weight polyethylene porous UHMWPE and artificial metatarsophalangeal joint prosthesis UHMWPE (HA), and the water contact angle is observed after stabilization.

[0053] The test results of water contact angle test are as follows Figure 2 As shown, from Figure 2 It can be seen that compared with dense ultra-high molecular weight polyethylene and porous ultra-high molecular weight polyethylene, the artificial metatarsophalangeal joint prosthesis provided in Example 2 of the present application has a significantly lower water contact angle, is easier to wet, and has better hydrophilicity, indicating that the modification of porous UHMWPE with hyaluronic acid molecules can improve the hydrophilicity of the artificial metatarsophalangeal joint prosthesis, which is beneficial to reduce wear with human cartilage, reduce protein adhesion and bacterial infection, and extend the service life of the artificial metatarsophalangeal joint prosthesis.

[0054] In order to further illustrate the lubricity of the artificial metatarsophalangeal joint prosthesis modified with hyaluronic acid, a friction wear scar characterization test was carried out on the artificial metatarsophalangeal joint prosthesis PE (HA) using dense ultra-high molecular weight polyethylene balls PE as the upper friction pair.

[0055] Among them, the test process of the wear scar characterization test includes: dense ultra-high molecular weight polyethylene balls PE and artificial metatarsophalangeal joint prostheses PE (HA) are lubricated with 1M PBS or 25% NCS, with a load of 3N and a loading speed of 12mm / s, and the wear scar morphology of the PE (HA) and PE balls is observed using a scanning electron microscope and a metallographic microscope, respectively.

[0056] The test results of wear scar characterization test under PBS lubrication and NCS lubrication conditions are as follows: Figure 3-4 As shown, from Figure 3-4 It can be seen that dense ultra-high molecular weight polyethylene balls PE undergo abrasive wear and adhesive wear, while artificial metatarsophalangeal joint prosthesis PE (HA) undergoes abrasive wear, indicating that dense ultra-high molecular weight polyethylene balls PE are prone to produce wear debris that accumulates in the body, inducing a series of matrix immune responses in matrix cells, thereby shortening the service life of the joint prosthesis.

[0057] To further illustrate that the internal hyaluronic acid molecules in the artificial metatarsophalangeal joint prosthesis provided by this application continuously replenish the hyaluronic acid lubricating layer on the outer surface to reduce the degradation / wear of the artificial metatarsophalangeal joint prosthesis, this application also conducted a friction performance test. The test process includes: a dense ultra-high molecular weight polyethylene disc PE, a porous ultra-high molecular weight polyethylene disc porousPE, a dense ultra-high molecular weight polyethylene disc PE-HA with hyaluronic acid wrapped on the surface, a porous ultra-high molecular weight polyethylene disc porous PE-HA with hyaluronic acid wrapped on the surface and an artificial metatarsophalangeal joint prosthesis PE (HA) are lubricated with PBS or NCS, the upper friction pair is an ultra-high molecular weight polyethylene ball, the load is 3N, and the loading speed is 12mm / s. Relative friction is performed under the conditions.

[0058] The test results of friction performance are as follows Figure 5 As shown, from Figure 5 It can be seen that in the PBS or NCS lubrication environment, compared with the dense ultra-high molecular weight polyethylene disc PE-HA with hyaluronic acid wrapped on the surface and the porous ultra-high molecular weight polyethylene disc porous PE-HA with hyaluronic acid wrapped on the surface, the friction coefficient of the artificial metatarsophalangeal joint prosthesis PE (HA) provided in the present application is smaller, indicating that the internal hyaluronic acid lubricating layer in the artificial metatarsophalangeal joint prosthesis PE (HA) provided in the present application continuously replenishes the hyaluronic acid lubricating layer on the outer surface, thereby improving its lubricity.

[0059] The above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A method for preparing an artificial metatarsophalangeal joint prosthesis, characterized in that: Including steps: Step A1: adding a mixture of a porous polyetheretherketone base layer, ultra-high molecular weight polyethylene powder, and a porogen into a hot pressing mold in sequence, and performing compression molding to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone embryo; Step A2, dialyzing the demolded porous ultra-high molecular weight polyethylene-polyetheretherketone embryo to remove impurities, thereby obtaining a porous ultra-high molecular weight polyethylene-polyetheretherketone preform; Step A3, immersing the porous ultra-high molecular weight polyethylene-polyetheretherketone preform in a silanized hyaluronic acid organic solution for cross-linking to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone preform internally loaded with silanized hydrophobically modified hyaluronic acid; Step A4, hydrolyzing the porous ultra-high molecular weight polyethylene-polyetheretherketone preform internally loaded with silanized hydrophobically modified hyaluronic acid to obtain a porous ultra-high molecular weight polyethylene-polyetheretherketone preform internally loaded with hyaluronic acid; Step A5, immersing the porous ultra-high molecular weight polyethylene-polyetheretherketone preform loaded with hyaluronic acid in a hyaluronic acid aqueous solution for coating, and cross-linking to obtain an artificial metatarsophalangeal joint prosthesis preform; Step A6: placing the artificial metatarsophalangeal joint prosthesis preform in a mold, and performing secondary compression molding to prepare the artificial metatarsophalangeal joint prosthesis; The artificial metatarsophalangeal joint prosthesis comprises: a porous polyetheretherketone base layer, an ultra-high molecular weight polyethylene layer loaded with hyaluronic acid inside, and a hyaluronic acid lubricating layer on the outer surface; The bottom of the ultra-high molecular weight polyethylene layer loaded with hyaluronic acid is embedded in the porous polyetheretherketone base layer to form a physical interlocking structure; The outer surface hyaluronic acid lubricating layer covers the inner ultra-high molecular weight polyethylene layer loaded with hyaluronic acid; The outer surface hyaluronic acid lubricating layer comprises at least two hyaluronic acid lubricating layers.

2. The method for preparing an artificial metatarsophalangeal joint prosthesis according to claim 1, characterized in that: In step A1, the compression molding temperature is 160-250° C., the time is 20-60 min, and the pressure is 1-3 MPa.

3. The method for preparing an artificial metatarsophalangeal joint prosthesis according to claim 1, characterized in that: In step A2, the solvent used for dialysis to remove impurities is water, and the dialysis time is 1 to 3 days.

4. The method for preparing an artificial metatarsophalangeal joint prosthesis according to claim 1, characterized in that: In step A3, the concentration of silanized hyaluronic acid in the silanized hyaluronic acid organic solution is 30-100 mg / mL.

5. The method for preparing an artificial metatarsophalangeal joint prosthesis according to claim 1, characterized in that: In step A4, the solvent used for hydrolysis is an ethanol / water solution of sodium chloride; The concentration of the solute sodium chloride in the sodium chloride ethanol / water solution is 0.1-0.3 M, and the volume ratio of the solvent water to the ethanol is 2-1:

1.

6. The method for preparing an artificial metatarsophalangeal joint prosthesis according to claim 1, characterized in that: In step A5, the concentration of hyaluronic acid in the hyaluronic acid aqueous solution is 1-3 wt%.

7. The method for preparing an artificial metatarsophalangeal joint prosthesis according to claim 1, characterized in that: In steps A3 and A5, the solvent used for crosslinking is an acetone solution of hexamethylene diisocyanate; The concentration of the hexamethylene diisocyanate acetone solution is 30-80 mg / mL.

8. The method for preparing an artificial metatarsophalangeal joint prosthesis according to claim 1, characterized in that: In step A5, the secondary compression molding is performed at a temperature of 155-160° C., for 20-40 min, and at a pressure of 1-3 MPa.

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