Hip cup with bone-inducing high strength

Abstract

The application provides a high-strength hip cup with bone induction and a preparation method thereof. The preparation method comprises the following steps: preparing a reinforcing body material and a base material, preparing the reinforcing body material into a multi-filled porous metal hip cup framework, placing the prepared multi-filled porous metal hip cup framework and the base material into a cavity mold, uniformly filling the base material into the filling pores of the multi-filled porous metal hip cup framework in a shaking mode, then performing pressure forming on the uniformly mixed material through the cavity mold to obtain a hip cup semi-finished product, and placing the hip cup semi-finished product into a high-temperature oven to perform sintering, so as to obtain the high-strength hip cup with bone induction. The application solves the technical problems that the fixing mode of the existing hip cup adopts bone cement and biological fixation, bone cement particles are easy to enter into pulmonary circulation through blood circulation, the bonding force between a biological coating and a prosthesis is poor, and the coating is easy to fall off in the embedding process. The application can be widely applied to the preparation of hip cups.

Description

TECHNICAL FIELD

[0001] The present application relates to an acetabular cup, in particular to an acetabular cup with bone inductivity and high strength. BACKGROUND

[0002] The medical acetabular cup is a medical device for hip replacement surgery, which is usually made of medical metal materials such as stainless steel, titanium alloy, etc., has certain strength and corrosion resistance, and is widely used.

[0003] However, since the acetabular cup is a solid structure, it has the problems of large weight and mismatched elastic modulus with human bones, which leads to the problems of acetabular cup falling off and displacement after implantation.

[0004] In view of the problems of acetabular cup falling off and displacement, two ways of bone cement fixation or biological fixation are usually used, however, bone cement is an inert material, which can only form a mechanical combination between the bone and the acetabular cup, leading to the problems of aging, fragmentation and wear of the acetabular cup, and the bone cement monomer will release heat when polymerizing, which will damage the surrounding tissues and nerves.

[0005] Biological fixation is to promote the growth of bone tissue by sandblasting, spraying coating or sintering metal beads on the outer surface of the acetabular cup, such biological prosthesis has good bone integration ability, but the sandblasting process has low friction coefficient, and the connection between the coating and the substrate is easy to crack under load, and the prosthesis will inevitably fall off the coating debris in long-term use, which will lead to prosthesis loosening. SUMMARY

[0006] The present application provides an enhanced acetabular cup with bone inductivity, which is prepared from degradable metal materials, which does not need to be used with bone cement, will not damage the surrounding tissues and nerves, can avoid the use of bone cement fixation, and will not cause the problems of aging, fragmentation and wear of the acetabular cup, and the degradable metal materials will be gradually corroded and degraded by body fluids in the body, forming a biological acetabular cup, the released metal plasma can induce the growth of bone tissue, and the remaining porous polyether ether ketone or ultra-high molecular weight polyethylene structure leaves a suitable space for the growth of bone tissue, promoting the growth of bone tissue and ensuring the long-term stable use of the acetabular cup.

[0007] Therefore, the technical scheme of the present application is an acetabular cup with bone inductivity and high strength, which is provided with a multi-filled pore metal acetabular cup framework formed by interlacing wires, and the interlaced wires form filled pores between them, and the wires are made of degradable metal materials.

[0008] The high polymer material is filled in the pores, and the outer part of the multi-porous metal acetabular cup framework is coated with a layer of high polymer material;

[0009] The top end of the multi-porous metal acetabular cup framework is provided with a first locking hole, and the middle position of the multi-porous metal acetabular cup framework is provided with a second locking hole, and the first locking hole and the second locking hole penetrate through the high polymer material coated on the outer part of the multi-porous metal acetabular cup framework;

[0010] The outer circumferential position of the first locking hole is provided with a positioning boss, and the positioning boss protrudes outward along the top end of the multi-porous metal acetabular cup framework;

[0011] The bottom end of the multi-porous metal acetabular cup framework is provided with a downwardly opening acetabular liner fixing groove, and the adjacent inner surface of the bottom end of the multi-porous metal acetabular cup framework is provided with an acetabular liner fixing boss;

[0012] The degradable metal material is corroded and degraded in the body by the body fluid, and the structure of the high polymer material left provides space for the growth of bone tissue.

[0013] Preferably, the lower end of the outer part of the multi-porous metal acetabular cup framework is located at the position of the upper end of the acetabular liner fixing groove, and a support ring is arranged, which protrudes outward from the outer part of the multi-porous metal acetabular cup framework.

[0014] Preferably, the outer part of the acetabular cup is fixedly provided with a degradable metal wire mesh, the degradable metal wire mesh is a porous mesh structure, and the degradable metal wire mesh is formed by interweaving wire lines;

[0015] The fixing mode of the outer part of the acetabular cup and the degradable metal wire mesh is buckle locking or screw locking;

[0016] The top end of the degradable metal wire mesh is provided with a third locking hole, and the middle position of the degradable metal wire mesh is provided with a fourth locking hole, and the positions of the third locking hole and the fourth locking hole are respectively symmetrical with the positions of the first locking hole and the second locking hole;

[0017] The outer circumferential position of the third locking hole is provided with a positioning boss, and the positioning boss protrudes outward along the top end of the degradable metal wire mesh.

[0018] Preferably, the number of acetabular liner fixing grooves is four, and the four acetabular liner fixing grooves are uniformly arranged along the circumferential direction of the bottom end of the multi-porous metal acetabular cup framework;

[0019] The number of acetabular liner fixing bosses is four, and the four acetabular liner fixing bosses are respectively and uniformly arranged at the middle positions of the adjacent two acetabular liner fixing grooves.

[0020] Preferably, the outer surface of the acetabular cup is smoothly transitioned through a round corner.

[0021] The beneficial effects of the present application are:

[0022] 1. The acetabular cup prepared by the acetabular cup preparation method, by using a degradable metal material to prepare a multi-filled porous metal acetabular cup framework, and then uniformly filling and mixing the multi-filled porous metal acetabular cup framework and the base material by ultrasonic oscillation, and then by isostatic pressing forming after mixing, and finally placing the formed material into a high-temperature oven for sintering, each step can increase the strength of the acetabular cup implant, and after the overall steps are completed, the strength of the acetabular cup implant is significantly improved, so that the acetabular cup implant can withstand higher impact forces during use, and a series of quality problems such as damage and fragmentation of the acetabular cup implant during use are avoided to the greatest extent, greatly improving the overall mechanical properties of the acetabular cup implant and ensuring that the acetabular cup implant can be used stably for a long time.

[0023] 2. The acetabular cup product prepared by the preparation method has high bone induction capacity, one reason is that the degradable metal material used in the acetabular cup product, such as degradable zinc alloy and degradable magnesium alloy, will react with the body fluid in the human body, and the reaction will produce Mg ions and Zn ions, which can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, regulating the immune microenvironment, and promoting bone angiogenesis, and finally achieving the bone induction effect, thereby accelerating the bone healing speed;

[0024] Another reason is that the porous structure plastic left after the degradation of the degradable metal material, such as polyether ether ketone, ultra-high molecular weight polyethylene or carbon fiber polyether ether ketone product structure, the pore size and porosity of the holes on the porous structure plastic are consistent with the human cancellous bone, and the bone generated by metal ion stimulation can grow into the holes, finally making the prosthesis and the human bone combined together, thereby achieving the bone induction effect, further improving the bonding force between the acetabular cup and the bone, ensuring the long-term stable use of the acetabular cup, without the need to spray HA, Ti, HA+Ti and other biological coatings on the surface of the acetabular cup, and the acetabular cup implant does not need to be used with bone cement, which will not damage the surrounding tissues and nerves, and can avoid the problem that bone cement particles easily enter the pulmonary circulation through blood circulation when using bone cement fixation.

[0025] 3. The acetabular cup implant is prepared by using degradable metal material and medical plastic mixed filling, compared with the traditional acetabular cup implant prepared by using metal material, the overall weight is lighter, which can significantly reduce the bone loss of patients after weight loss, and avoid a series of chain symptoms such as osteoporosis and calcification of bone mass. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 is a perspective view of the acetabular cup structure of the present application;

[0027] Figure 2 is a perspective view of the multi-porous metal acetabular cup framework structure of the present application;

[0028] Figure 3 is a perspective view of the acetabular cup and the degradable metal wire mesh decomposition structure of the present application;

[0029] Figure 4 is a perspective view of the acetabular cup and the degradable metal wire mesh decomposition structure of the present application; Figure 1 is an enlarged view of A in the present application;

[0030] Figure 5 is an enlarged view of B in the present application. Figure 2

[0031] Explanation of symbols in the drawings

[0032] 1. Multi-porous metal acetabular cup framework; 2. Acetabular liner fixation groove; 3. Support ring; 4. Second locking hole; 5. Degradable metal wire mesh; 6. First locking hole; 7. Positioning boss; 9. Wire; 10. Filling gap; 11. Fillet; 12. Acetabular liner fixation boss; 13. Third locking hole; 14. Fourth locking hole. DETAILED DESCRIPTION

[0033] The present application will be further described below in conjunction with examples.

[0034] By Figures 1-5 As can be seen, the high-strength acetabular cup with bone induction is provided with a multi-porous metal acetabular cup framework 1 formed by interweaving wire 9, filling gaps 10 are formed between the interwoven wire 9, and the wire 9 is a degradable metal material.

[0035] The filling gaps 10 are filled with a high polymer material, and the multi-porous metal acetabular cup framework 1 is coated with a layer of high polymer material on the outside.

[0036] The top end of the multi-porous metal acetabular cup framework 1 is provided with a first locking hole 6, and the middle position of the multi-porous metal acetabular cup framework 1 is provided with a second locking hole 4, and the first locking hole 6 and the second locking hole 4 penetrate through the high polymer material coated on the outside of the multi-porous metal acetabular cup framework 1.

[0037] The outer circumference of the first locking hole 6 is provided with a positioning boss 7, and the positioning boss 7 protrudes outward along the top end of the multi-porous metal acetabular cup framework 1.

[0038] ​In the surgical implantation, the acetabular cup fixing rod is inserted into the first locking hole 6 from the inside of the acetabular cup, then the acetabular cup is placed into the acetabular fossa by holding the acetabular cup fixing rod, then the outer surface of the acetabular cup is tightly fitted with the inner surface of the acetabular fossa by means of external tools, then the acetabular cup fixing rod is taken out, and the locking screw is respectively passed through the first locking hole 6 and the second locking hole 4 to be fixed and locked with the acetabular bone.

[0039] By arranging the positioning boss 7 on the outer circumference of the first locking hole 6, the positioning boss 7 and the central position of the acetabular fossa are in contact, which can play a good positioning and anti-skid role. Specifically, if the positioning boss 7 is not arranged, after the top end of the acetabular cup is fitted with the inside of the acetabular fossa, the acetabular cup will inevitably be displaced or even fall off under the action of its own gravity or external force impact, resulting in difficult positioning of the acetabular cup, and the doctor needs to install and position the acetabular cup again, prolonging the operation time. By arranging the positioning boss 7, the face contact between the top end of the acetabular cup and the inside of the acetabular fossa is replaced by line contact, increasing the friction between the acetabular cup and the acetabular fossa, so that the acetabular cup can be quickly and accurately positioned, shortening the operation time.

[0040] The bottom end of the multi-porous metal acetabular cup framework 1 is provided with a downwardly opening acetabular liner fixing groove 2, and the adjacent inner surface of the bottom end of the multi-porous metal acetabular cup framework 1 is provided with an acetabular liner fixing boss 12. The acetabular liner fixing groove 2, the acetabular liner fixing boss 12 and the fixing buckle position on the acetabular liner are matched with each other, which can increase the firmness between the acetabular liner and the acetabular cup 1, and avoid the problems of twisting, loosening or even falling off between the acetabular liner and the acetabular cup 1.

[0041] The lower end of the outer part of the hole metal acetabular cup framework 8 is located at the position of the upper end of the acetabular liner fixing groove 2, and is provided with a support ring 3 which protrudes outwardly from the multi-porous metal acetabular cup framework 1.

[0042] After the surgical implantation, the support ring 3 is in contact with the edge of the acetabular fossa, and after the acetabular cup is implanted into the acetabular fossa, an inner large and outer small structure is formed, thereby enhancing the stability of the acetabular cup in the human acetabulum. At the same time, the position close to the bottom end of the acetabular cup is a position prone to wear, and the support ring 3 provides sufficient friction thickness between the acetabular cup and the acetabular fossa, so that the acetabular cup implant can be used stably for a long time.

[0043] In addition, the support ring 3 can increase the overall strength of the acetabular cup, increase the torsional resistance and compressive resistance of the acetabular cup, prevent the acetabular cup from being extruded by external force, and prevent the acetabular cup from being deformed.

[0044] The outer part of the acetabular cup 1 is fixedly provided with a degradable metal wire mesh 5, the degradable metal wire mesh 5 is a porous mesh structure, and the degradable metal wire mesh 5 is formed by interweaving wire lines 9.

[0045] The degradable metal wire mesh 5 is prepared by degradable metal wire or degradable metal powder, and the preparation process is wire weaving or 3D printing.

[0046] The top end of the degradable metal wire mesh 5 is provided with a third locking hole 13, and the middle position of the degradable metal wire mesh 5 is provided with a fourth locking hole 14. The positions of the third locking hole 13 and the fourth locking hole 14 are respectively symmetrical with the positions of the first locking hole 6 and the second locking hole 4.

[0047] The outer circumferential position of the third locking hole 13 is provided with a positioning boss 7, and the positioning boss 7 protrudes outward along the top end of the degradable metal wire mesh 5.

[0048] The number of the acetabular liner fixing grooves 2 is four, and the four acetabular liner fixing grooves 2 are uniformly arranged along the circumferential direction of the bottom end of the multi-filled pore metal acetabular cup framework 1.

[0049] The number of the acetabular liner fixing bosses 12 is four, and the four acetabular liner fixing bosses 12 are respectively and uniformly arranged at the middle positions of the adjacent two acetabular liner fixing grooves 2.

[0050] The fixing mode of the acetabular cup 1 and the degradable metal wire mesh 5 is buckle locking or screw locking.

[0051] The fixing mode of the acetabular cup 1 and the degradable metal wire mesh 5 can also adopt embedded fixing, and the degradable metal wire mesh 5 is embedded inward from the external position of the acetabular cup 1, and the embedding depth is 0.5mm-2mm.

[0052] Among them, the embedded fixing mode is the best, which can increase the cooperation precision between the acetabular cup and the degradable metal wire mesh, and can avoid the loosening between the acetabular cup and the degradable metal wire mesh to the greatest extent.

[0053] The screw locking mode has the characteristics of simple structure, various types, convenient disassembly and assembly, and low cost. Compared with the above two connection modes, firstly, the buckle can be directly pressure formed on the implant, and no other locking accessories are needed during assembly, which is convenient to operate and saves cost. Secondly, the connection strength of the buckle can meet the design of most products. In some products that require higher connection strength, the buckle can be used as an auxiliary connection, such as the combination of screws and buckles. Thirdly, through reasonable design, the buckle connection can realize quick assembly and disassembly, and the disassembly process can be completed without auxiliary tools. The buckle connection can further ensure the integrity of the appearance of the implant and reduce the wear of the implant. Especially in the field of products with high appearance requirements, the buckle connection is the most widely used connection mode.

[0054] The embedding depth is consistent with the depth of the hole in the finished acetabular cup after the degradable metal is completely degraded. For example, if the embedding depth is 2 mm, then the depth of the hole in the finished acetabular cup is 2 mm, and the depth of the hole is the depth of the bone tissue growth. For severely damaged bone sites, the embedding depth is usually increased to ensure that the bone tissue has sufficient growth depth, thereby ensuring long-term stability of the implant.

[0055] The outer surface of the acetabular cup is smoothly transitioned through a round corner, which can prevent damage to bone tissue caused by the sharp outer surface of the acetabular cup.

[0056] A preparation method of the above-mentioned high-strength acetabular cup with bone induction, which prepares a reinforcing body material and a matrix material, the reinforcing body material being a degradable metal material, and the matrix material being a polymer material, the preparation method comprising the following steps:

[0057] Step (1): The degradable metal material is prepared into a multi-filled porosity metal acetabular cup framework 1.

[0058] Step (2): The prepared multi-filled porosity metal acetabular cup framework 1 and the polymer material are respectively placed into a cavity mold, the polymer material is uniformly filled into the filling porosity 10 of the multi-filled porosity metal acetabular cup framework by using a shaking method, and then the uniformly mixed material is subjected to pressure forming through the cavity mold. After pressure forming, a semi-finished acetabular cup is obtained.

[0059] Step (3): The semi-finished acetabular cup is placed into a high-temperature oven for sintering. After sintering, a high-strength acetabular cup with bone induction is obtained.

[0060] Example 1

[0061] When the reinforcing body material is degradable magnesium alloy powder and the matrix material is polyether ether ketone powder, the preparation method comprises the following steps:

[0062] Step (1): The degradable magnesium alloy powder is prepared into a multi-filled porosity magnesium alloy acetabular cup framework by 3D printing.

[0063] The particle size of the degradable magnesium alloy powder is 50-68 μm, the particle size of the polyether ether ketone powder is 63-80 μm, the pore size of the multi-filled porosity magnesium alloy acetabular cup framework is 62-81 μm, and the porosity is 52-68%.

[0064] Step (2): Put the prepared multi-filled pore magnesium alloy acetabular cup framework into the cavity mold, then fill the polyether ether ketone powder in the cavity mold, and fill the powder in multiple times. After each filling, the polyether ether ketone powder is uniformly filled into the filling pores 10 of the multi-filled pore magnesium alloy acetabular cup framework by oscillation. The oscillation is mechanical oscillation or ultrasonic oscillation. The oscillation time is 22 min-33 min. The uniformity of ultrasonic oscillation is higher than that of mechanical oscillation. When the mixing precision requirement is high, ultrasonic oscillation is usually used, and mechanical oscillation is used instead.

[0065] After uniform filling, the mixed material is pressurized and formed by the cavity mold. The pressurized forming method is vacuum hot isostatic pressing or vacuum cold isostatic pressing. The pressure is 88 MPa-108 MPa. The pressure holding time is 15 min-25 min. After pressurized forming, the acetabular cup semi-finished product is obtained.

[0066] The isostatic pressing can ensure the uniform density of the compact, and the green body has high density. During the sintering process, the sintering shrinkage is small, and the sintered body is not easy to deform, which ensures the structural stability of the blank. In addition, the strength of the isostatic pressing body is high, which can be directly transported and machined. More importantly, the internal stress of the body is small, which reduces the defects such as cracking and delamination of the body.

[0067] Step (3): Put the acetabular cup semi-finished product into a high-temperature oven for sintering. The sintering method is hot pressing sintering, vacuum hot isostatic pressing sintering, gas pressure sintering, microwave sintering, discharge plasma sintering or solid state metal sintering. The sintering temperature is 280℃-360℃. The sintering time is 33 min-48 min. After sintering, the high-strength acetabular cup with bone induction is obtained.

[0068] Hot pressing sintering refers to a sintering process in which materials flow, rearrange and densify under a certain external force (generally 10-40 MPa according to the strength of the mold material). The temperature required for hot pressing sintering is 100-150℃ lower than that for normal pressure sintering, but the driving force for hot pressing sintering is 20-100 times greater than that for normal pressure sintering.

[0069] Using hot pressing sintering can obtain better material mechanical properties, reduce sintering time or reduce sintering temperature, reduce the amount of covalent bond ceramic sintering aid, and thus improve the high-temperature mechanical properties of the material.

[0070] The basic principle of vacuum hot isostatic pressing sintering is to use high-pressure gas as a pressure medium to act on the material (including the enclosed powder, green body or sintered body), so that it undergoes balanced pressure in the heating process, and achieves material densification by the combined action of high temperature and high pressure.

[0071] Using hot isostatic sintering can reduce the sintering temperature, shorten the sintering time, and at the same time, can greatly reduce or even not use sintering aids, improve ceramic performance and reliability, and is particularly suitable for manufacturing complex-shaped products.

[0072] Gas pressure sintering refers to the application of a certain gas pressure during high-temperature sintering, with a pressure range of usually 1-10 MPa, in order to inhibit the decomposition and weight loss of materials at high temperature, thereby increasing the sintering temperature and further promoting the densification of materials to obtain high-density products. Gas pressure sintering and vacuum hot isostatic sintering both use gas as the method of transferring pressure.

[0073] Compared with hot pressing sintering and vacuum hot isostatic sintering processes, the biggest advantage of gas pressure sintering process is that it can reduce the investment cost, prepare better performance, be suitable for complex-shaped products, and realize batch production.

[0074] Microwave sintering is commonly used for sintering of ceramic materials, which uses the dielectric loss of ceramic materials in the microwave electromagnetic field to achieve sintering temperature, thereby realizing the sintering and densification of ceramics.

[0075] Discharge plasma sintering, also known as "plasma activated sintering", is a new material preparation technology that realizes material sintering by directly applying a large pulse current in the mold or sample through thermal effect or other field effect.

[0076] Discharge plasma sintering can ensure the uniformity of heating temperature, has fast heating speed, low sintering temperature, short sintering time, high production efficiency, and product organization is small and uniform, can maintain the natural state of raw materials, and can obtain high-density materials, and is commonly used in sintering gradient materials and complex workpieces.

[0077] Solid-state metal sintering is a sintering process by using powdered materials, which can be molded into the desired shape, and can produce complex-shaped and delicate-designed parts. In addition, solid-state sintering can improve the mechanical properties of materials. Compared with traditional processes, the cycle time of solid-state sintering is shorter, which means that the sintering process can be completed in a few minutes instead of several hours or longer. This high productivity and rapid material development capability makes solid-state metal sintering more widely used.

[0078] More importantly, solid state metal sintering can be performed at lower temperatures compared to conventional sintering processes, which is very advantageous because it helps to minimize energy consumption and reduce the risk of thermal damage to the sintered material. In addition, solid state metal sintering is a versatile process that can be used for the densification of low melting point metals, ultra-high temperature ceramics, and even the bonding of dissimilar materials that require non-uniform temperatures. Furthermore, solid state sintering can be used for the sintering of both porous and fully dense components, making it a widely applicable process.

[0079] In summary, solid state metal sintering has several advantages, including the ability to produce complex shapes, better mechanical properties, shorter sintering times, lower sintering temperatures, versatility, high precision process control, and cost-effectiveness, making it an ideal manufacturing method for a wide range of applications.

[0080] In Example 1, the degradable magnesium alloy powder in Step (1) has a particle size of 60 μm, the polyether ether ketone powder has a particle size of 70 μm, and the multi-filled pore magnesium alloy hip cup framework has a pore size of 75 μm and a porosity of 60%.

[0081] The oscillation method in Step (2) is ultrasonic oscillation, and the oscillation time is 30 min.

[0082] The pressure forming method in Step (2) is vacuum hot isostatic pressing, the pressure intensity is 100 MPa, and the pressure holding time is 20 min.

[0083] The sintering method in Step (3) is vacuum hot isostatic pressing sintering, the sintering temperature is 330°C, and the sintering time is 40 min.

[0084] The particle size of the degradable metal powder is within the standard parameters commonly used for 3D printing.

[0085] Example 2

[0086] When the reinforcing material is a degradable zinc alloy wire and the matrix material is an ultra-high molecular weight polyethylene powder, the preparation method includes the following steps:

[0087] Step (1): Prepare a multi-filled pore zinc alloy hip cup framework from the degradable zinc alloy wire, using a wire weaving method.

[0088] The degradable zinc alloy wire has a diameter of 490 μm-620 μm, and the polyether ether ketone powder has a particle size of 60 μm-82 μm.

[0089] The multi-filled pore zinc alloy hip cup framework has a pore size of 71 μm-86 μm and a porosity of 61%-75%.

[0090] Step (2): Put the prepared multi-pore filling zinc alloy acetabular cup framework into the cavity mold, then fill the ultra-high molecular weight polyethylene powder in the cavity mold, and the filling method is multiple equal filling, the number of multiple equal filling is five times, after each filling, the ultra-high molecular weight polyethylene powder is uniformly filled into the filling pores 10 of the multi-pore filling zinc alloy acetabular cup framework by oscillation, the oscillation mode is mechanical oscillation or ultrasonic oscillation, the oscillation time is 22min-34min, after uniform filling, the mixed material is pressure formed by the cavity mold, the pressure forming mode is vacuum hot isostatic pressing or vacuum cold isostatic pressing, the pressure intensity is 110MPa-175MPa, the pressure holding time is 22min-35min, after pressure forming, the acetabular cup semi-finished product is obtained.

[0091] The multiple equal filling can ensure that the base material powder and the multi-pore filling metal acetabular cup framework are fully and uniformly filled, avoid the problem that the density at different positions is inconsistent, lead to the low compression strength of the prosthesis, and even the prosthesis cracking, delamination and other problems, and the filling number of 5 times is obtained through a large number of experiments, which can not only ensure the filling density of the prosthesis and the sufficient compression capacity of the prosthesis, but also save the processing time.

[0092] Step (3): Put the acetabular cup semi-finished product into a high temperature oven for sintering, the sintering mode is hot pressing sintering, vacuum hot isostatic pressing sintering, gas pressure sintering, microwave sintering, discharge plasma sintering or solid state metal sintering, the sintering temperature is 305℃-365℃, the sintering time is 0.6h-1.2h, after sintering, the bone inductive high strength acetabular cup is obtained.

[0093] In example 2, the diameter of the degradable zinc alloy wire in step (1) is 550μm, the particle size of the polyether ether ketone powder is 75μm, and the pore size of the multi-pore filling zinc alloy acetabular cup framework is 80μm and the porosity is 70%.

[0094] The oscillation mode in step (2) is ultrasonic oscillation, and the oscillation time is 30min.

[0095] The pressure forming mode in step (2) is vacuum hot isostatic pressing, the pressure intensity is 150MPa, and the pressure holding time is 30min.

[0096] The sintering mode in step (3) is vacuum hot isostatic sintering, the sintering temperature is 340℃, and the sintering time is 1h.

[0097] The diameter of the degradable metal wire is close to the porosity of human bone tissue, which is conducive to the growth of bone tissue.

[0098] The multi-filled porous metal acetabular cup framework is prepared by adopting wire weaving and 3D printing, wherein the wire weaving has a low cost and a large design limitation for a series of parameters of the porous metal material, and the 3D printing has a higher adjustability for the shape, size and porosity of the pores when the porous metal material is prepared, so that the 3D printing can be adjusted according to the image data of the patient to achieve the most suitable implantation effect.

[0099] In the preparation method, the degradable zinc alloy material and the degradable magnesium alloy material are used, and the two materials will react with the body fluid in the human body and be gradually corroded and degraded by the body fluid.

[0100] The acetabular cup implant is prepared by using the degradable metal material to form the multi-filled porous metal acetabular cup framework, then the multi-filled porous metal acetabular cup framework is uniformly filled and mixed with the base material through ultrasonic oscillation, then the mixed material is formed through isostatic pressing, finally the formed material is put into a high-temperature oven for sintering to obtain the finished acetabular cup.

[0101] It can be seen that each step can increase the strength of the acetabular cup implant, and the strength of the acetabular cup implant is obviously enhanced after the completion of the overall steps, so that the acetabular cup implant can withstand a higher impact force when in use, and a series of quality problems such as damage and fragmentation of the acetabular cup implant during use can be avoided to a maximum extent, thereby greatly improving the overall mechanical properties of the acetabular cup implant and ensuring that the acetabular cup implant can be used stably for a long time.

[0102] And the acetabular cup product prepared by the preparation method has obvious osteoinductive ability. The realization of the specific osteoinductive effect depends on two aspects. One is the degradable metal material used in the acetabular cup product, such as degradable magnesium alloy and degradable zinc alloy. The two will react with the body fluid in the human body to produce Mg ions and Zn ions. The two ions can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, regulating the immune microenvironment, and promoting bone angiogenesis, and finally achieving the osteoinductive effect. The other is the porous plastic structure left after the degradation of the degradable metal material, such as polyether ether ketone, ultra-high molecular weight polyethylene, or carbon fiber polyether ether ketone product structure. The pore size and porosity of the porous plastic structure are consistent with the human cancellous bone. The bone generated by metal ion stimulation can grow into the hole, and finally the prosthesis is combined with the human bone, thereby realizing the osteoinductive effect.

[0103] More importantly, the acetabular cup with high strength and osteoinductive ability prepared by the preparation method is prepared by mixing different types of reinforcing materials and matrix materials, such as degradable metal wire or degradable metal powder as the reinforcing material, and polyether ether ketone powder, ultra-high molecular weight polyethylene powder, or carbon fiber polyether ether ketone composite as the matrix material. Each reinforcing material and matrix material has its fixed preparation parameter value, such as the diameter and particle size of the reinforcing material, the particle size of the matrix material, and the pore size and porosity of the prepared multi-filled porous metal acetabular cup framework. Then the selected reinforcing material and matrix material are uniformly mixed, pressure formed, sintered, and the like to obtain the acetabular cup with high strength and osteoinductive ability.

[0104] And the above preparation processes have strict and specific preparation parameters and preparation processes, such as the way of pressure forming, the sintering method in the sintering process, the sintering temperature and time, and the like. The above preparation parameters and preparation processes are the key to preparing the acetabular cup material product with high strength and osteoinductive ability.

[0105] Secondly, the acetabular cup implant is prepared by mixing and filling degradable metal materials and medical plastics. Compared with the traditional acetabular cup implant prepared by using metal materials, the overall weight is lighter, which can significantly reduce the bone loss of patients and avoid a series of chain symptoms such as osteoporosis and calcification of bone mass.

[0106] Example 3

[0107] The internal part of the acetabular cup product material can be prepared from polyether ether ketone powder, ultra-high molecular weight polyethylene powder, or carbon fiber polyether ether ketone composite material alone. The specific method is as follows:

[0108] Step (1): Prepare the degradable metal material and the base material, and prepare the multi-filled porous metal acetabular cup shell framework from the degradable metal material. The multi-filled porous metal acetabular cup shell framework has a hollow structure, and the preparation process is wire weaving or 3D printing.

[0109] The degradable metal material is degradable metal wire or degradable metal powder, and the base material is polyether ether ketone powder, ultra-high molecular weight polyethylene powder or carbon fiber polyether ether ketone composite material.

[0110] Step (2): Put the prepared multi-filled porous metal acetabular cup shell framework into the cavity mold, and then fill the polyether ether ketone powder, ultra-high molecular weight polyethylene powder or carbon fiber polyether ether ketone composite material in the cavity mold. The filling method adopts multiple equal fillings. After each filling is completed, the polyether ether ketone powder, ultra-high molecular weight polyethylene powder or carbon fiber polyether ether ketone composite material is uniformly filled into the interior of the multi-filled porous metal acetabular cup shell framework through the multi-filled porous metal acetabular cup shell framework pores by ultrasonic oscillation until it is filled.

[0111] Step (3): After filling is completed, the mixed material is pressurized and formed by the cavity mold. After pressurized forming, the acetabular cup semi-finished product is obtained.

[0112] Step (4): Put the acetabular cup semi-finished product into a high-temperature oven for sintering. After sintering is completed, the high-strength acetabular cup with bone induction is obtained.

[0113] The acetabular cup implant prepared by the preparation method has lower strength compared with the acetabular cup implants prepared by mixing the multi-filled porous metal acetabular cup framework and the base material in examples 1 and 2. For patients with low postoperative activity, the acetabular cup implant can be used. If the patient has a large postoperative activity, the acetabular cup implant prepared by mixing the multi-filled porous metal acetabular cup framework and the base material in examples 1 and 2 is still needed to meet the demand of having large support force and being able to withstand large impact force in the relevant part, further ensuring the long-term stable use of the acetabular cup implant.

[0114] The above is only a specific embodiment of the present application, which cannot limit the scope of the present application. The replacement of equivalent components or equivalent changes and modifications made within the scope of the patent protection of the present application shall still fall within the scope of the claims of the present application.

Claims

1. An osteoinductive acetabular cup, characterized in that: A multi-porosity metal acetabular cup skeleton is provided, which is formed by interwoven wires, and the interwoven wires form filling pores. The wires are made of biodegradable metal material. The pores are filled with polymer material, and the outside of the multi-pore metal acetabular cup skeleton is covered with a layer of polymer material. The top of the multi-filled porous metal acetabular cup skeleton is provided with a first locking hole, and the middle position of the multi-filled porous metal acetabular cup skeleton is provided with a second locking hole. The first locking hole and the second locking hole pass through the polymer material covering the outside of the multi-filled porous metal acetabular cup skeleton. A positioning boss is provided on the outer circumference of the first locking hole, and the positioning boss protrudes outward along the top of the multi-filled pore metal acetabular cup skeleton; The bottom end of the multi-filled porous metal acetabular cup skeleton is provided with a downward-opening acetabular liner fixing groove, and the adjacent inner surface of the bottom end of the multi-filled porous metal acetabular cup skeleton is provided with an acetabular liner fixing boss. Biodegradable metallic materials are corroded and degraded by body fluids in the body, leaving behind a polymer structure that creates space for bone tissue ingrowth.

2. The osteoinductive acetabular cup according to claim 1, characterized in that: The lower end of the multi-filled porous metal acetabular cup skeleton is provided with a support ring located at the upper end of the acetabular liner fixing groove, and the support ring protrudes outward from the multi-filled porous metal acetabular cup skeleton.

3. The osteoinductive acetabular cup according to claim 1, characterized in that: The acetabular cup is externally fixed with a biodegradable metal mesh, which has a porous mesh structure and is formed by interwoven wires. The external structure of the acetabular cup and the biodegradable metal mesh are fixed by snap-fit ​​locking or screw locking. The biodegradable metal wire mesh has a third locking hole at its top and a fourth locking hole at its middle position. The positions of the third and fourth locking holes are symmetrical to the positions of the first and second locking holes, respectively. A positioning boss is provided on the outer circumference of the third locking hole, and the positioning boss protrudes outward along the top of the biodegradable metal wire mesh.

4. The osteoinductive acetabular cup according to claim 1, characterized in that: The number of the acetabular liner fixing grooves is four, and the four acetabular liner fixing grooves are evenly arranged along the bottom circumferential direction of the multi-filled pore metal acetabular cup skeleton. The number of acetabular liner fixing bosses is four, and the four acetabular liner fixing bosses are evenly arranged in the middle position of two adjacent acetabular liner fixing grooves.

5. The osteoinductive acetabular cup according to claim 1, characterized in that: The outer surface of the acetabular cup is smoothly transitioned by rounded corners.

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