Three-component ceramic double-acting hip joint prosthesis

Abstract

The invention relates to a three-component ceramic double-acting hip joint prosthesis. The three-component ceramic double-acting hip joint prosthesis comprises an acetabulum outer cup, a lining and a ball head which are arranged in sequence, wherein the acetabulum outer cup and the ball head are both made of ceramic materials; the lining is made of a polyethylene material; the inner lining is embedded in a cup cavity of the acetabular outer cup and can rotate relative to the acetabular outer cup, the ball head is embedded in a ball socket of the inner lining and can rotate relative to the inner lining, the ball head is used for being connected with a femoral stem, and a bone trabecula layer is cladded on the outer wall surface of the acetabular outer cup. Therefore, the problems that in the prior art, metal chippings are generated on the friction interface of a surface hip joint prosthesis, the prosthesis is prone to loosening, an outer cup is prone to deformation, and the effect that the outer cup induces bone cells to grow in is poor are solved.

Description

Technical Field

[0001] The present disclosure relates to the technical field of artificial joints, and specifically, to a three-component ceramic bipolar hip joint prosthesis. Background Art

[0002] The bipolar total hip prosthesis is a type of hip joint prosthesis, which consists of two moving surfaces: the moving surface between the femoral head and the polyethylene liner, and the moving surface between the acetabular cup and the polyethylene bipolar liner. It can reduce the dislocation rate and wear rate of the acetabular prosthesis, improve the stability of the prosthesis and the postoperative quality of life of patients.

[0003] 1) Currently, for the selection of the friction interface of bipolar total hip prostheses on the market, the common choice is between metal materials and polyethylene materials, and the wear is relatively serious. It is necessary to upgrade and iterate the existing materials and structures to solve the current problems.

[0004] 2) In addition, for the coating on the surface of the outer cup prosthesis, the pore structure of the coating is uncontrollable, the pore diameter is extremely small, and the porosity is low, resulting in limited effect of inducing bone cell ingrowth. For the coating on the surface of the prosthesis, the bonding strength of the coating is low, it is easy to fall off, and the fallen-off substances are easy to cause particle penetration, making the soft tissue turn black and causing infection.

[0005] Regarding the current defects in the selection of traditional process coatings and materials, it is still necessary to optimize and improve the friction interface to reduce the wear rate. Summary of the Invention

[0006] The purpose of the present disclosure is to provide a three-component ceramic bipolar hip joint prosthesis, which can solve the problems that the friction interface of the surface hip joint prosthesis in the prior art is prone to generate metal debris, leading to prosthesis loosening, and the effect of inducing bone cell ingrowth of the outer cup is not good.

[0007] To achieve the above purpose, the present disclosure provides a three-component ceramic bipolar hip joint prosthesis, including an acetabular outer cup, a liner and a ball head arranged in sequence. Both the acetabular outer cup and the ball head are made of ceramic materials; the liner is made of polyethylene material; the liner is embedded in the cup cavity of the acetabular outer cup and can rotate relative to the acetabular outer cup, the ball head is embedded in the ball socket of the liner and can rotate relative to the liner, and the ball head is used to connect the femoral stem. Among them, a trabecular bone layer is cladded on the outer wall surface of the acetabular outer cup.

[0008] In a possible design, the porosity of the trabecular bone layer is 50-90%, the pore diameter is 100-400 μm, and the thickness of the trabecular bone layer is 1.4-1.6 mm.

[0009] In a possible design, a net-shaped reinforcing rib is provided on the outer surface of the acetabular outer cup.

[0010] In a possible design, an avoidance groove is provided at the edge of the acetabular outer cup.

[0011] In a possible design, multiple sets of spaced support plates are provided on the acetabular outer cup, and the support plates are located near the edge of the acetabular outer cup; each set includes two support plates.

[0012] In a possible design, multiple spaced conical pins are provided on the acetabular outer cup, and the extending direction of the conical pins is parallel to the central axis of the acetabular outer cup.

[0013] In a possible design, the ceramic material includes α-aluminum oxide powder and zirconia powder.

[0014] In a possible design, the purity of the α-aluminum oxide powder is ≥99.9%, and the particle size of the α-aluminum oxide powder is sub-micron to nano-scale; the zirconia powder includes yttrium oxide and tetragonal zirconia powder, and yttrium oxide accounts for 3% of the mass of zirconia.

[0015] In a possible design, the ceramic material further includes strontium oxide and / or chromium oxide.

[0016] In a possible design, the polyethylene material is configured as highly cross-linked ultra-high molecular weight polyethylene, or the polyethylene is configured as highly cross-linked ultra-high molecular weight polyethylene added with an antioxidant.

[0017] This three-component ceramic double-acting hip joint prosthesis realizes the double-acting function of the hip joint through the mutual cooperation of the acetabular outer cup, the liner, and the ball head. Specifically, the ball head is embedded in the ball socket of the liner and can rotate relative to the liner, while the liner is embedded in the cup cavity of the acetabular outer cup and can rotate relative to the acetabular outer cup. This design forms two moving surfaces: one is the moving surface between the ball head and the liner, and the other is the moving surface between the liner and the acetabular outer cup. Through the relative movement of these two moving surfaces, the prosthesis can more naturally simulate the physiological movement of the human hip joint, reduce stress concentration and wear of the joint. In addition, a trabecular bone layer is cladded on the outer wall surface of the acetabular outer cup, and this layer has a microporous structure, which can induce the growth of bone cells, promote bone integration, and improve the stability and long-term service life of the prosthesis.

[0018] Through the above technical solution, since the ceramic material has high hardness and low friction coefficient, it can significantly reduce the wear between the ball head and the inner liner, reduce the debris generated by wear, and thus reduce the risk of osteolysis and prosthesis loosening. The trabecular layer of the acetabular outer cup can promote the ingrowth of bone cells, enhance the bonding force between the prosthesis and the bone tissue, and improve the long-term stability of the prosthesis. The double-motion design makes the movement of the hip joint more natural and reduces the risk of dislocation caused by abnormal joint movement. By reducing wear and improving stability, the prosthesis can effectively relieve the pain of patients, improve the range of motion and function of the joint, and thus improve the quality of life of patients. A self-healing hydrogel loaded with antibacterial drugs can be injected into the trabecular layer to construct a new antibacterial and osteogenesis-promoting bioactive interface, further improving the biocompatibility and bone integration efficiency of the prosthesis. Thus, a new antibacterial and osteogenesis-promoting bioactive interface is constructed to further improve the biocompatibility and bone integration efficiency of the prosthesis.

[0019] Other features and advantages of the present disclosure will be described in detail in the following detailed description section. Brief Description of the Drawings

[0020] The drawings are used to provide a further understanding of the present disclosure, and constitute a part of the specification. Together with the following detailed description, they are used to explain the present disclosure, but do not constitute a limitation to the present disclosure. In the drawings:

[0021] Figure 1 is a three-component ceramic double-motion hip joint prosthesis in a three-dimensional structural schematic diagram of an embodiment, where the trabeculae are not shown;

[0022] Figure 2 is a three-component ceramic double-motion hip joint prosthesis in a three-dimensional structural schematic diagram of another embodiment, where the trabeculae are not shown;

[0023] Figure 3 is a three-component ceramic double-motion hip joint prosthesis in a three-dimensional structural schematic diagram of still another embodiment, where the trabeculae are not shown;

[0024] Figure 4 is a tensile strength test diagram of part A1 in Example 1;

[0025] Figure 5 is a tensile strength test diagram of part A2 in Example 2;

[0026] Figure 6 is a tensile strength test diagram of part A3 in Example 3;

[0027] Figure 7 is a tensile strength test diagram of part A4 in Example 4;

[0028] Figure 8It is a cross-sectional view obtained after the tensile test of parts A1 and A2. Among them, the parts in the upper group are A1, and the parts in the lower group are A2;

[0029] Figure 9 It is a cross-sectional view obtained after the tensile test of parts A3 and A4. Among them, the parts in the upper group are A3, and the parts in the lower group are A4;

[0030] Figure 10 It is a schematic structural diagram of trabecular bone, where Lt refers to the cladding path spacing (that is, the groove width of the trabecular bone along the circumferential direction);

[0031] Figure 11 It is a schematic structural diagram of trabecular bone, where Lc refers to the cladding layer spacing (that is, the spacing of the trabecular bone of adjacent layers in the diameter direction);

[0032] Figure 12 It is a schematic structural diagram of a three-component ceramic bipolar hip joint prosthesis, where the coating cladded on the outer cup of the acetabulum is trabecular bone.

[0033] Explanation of reference numerals

[0034] 1 - Outer cup of acetabulum, 2 - Liner, 3 - Ball head, 4 - Trabecular bone layer, 5 - Reinforcing rib, 6 - Avoidance groove, 7 - Support plate, 8 - Cone nail. Detailed implementation manners

[0035] The following will describe the detailed implementation manners of the present disclosure with reference to the accompanying drawings.

[0036] According to the first aspect of the present disclosure, a three-component ceramic bipolar hip joint prosthesis is provided, where Figures 1 to 12 One of the specific implementation manners is shown.

[0037] The three-component ceramic bipolar hip joint prosthesis includes an outer cup 1 of the acetabulum, a liner 2, and a ball head 3 arranged in sequence. Both the outer cup 1 of the acetabulum and the ball head 3 are made of ceramic materials; the liner 2 is made of polyethylene material; the liner 2 is embedded in the cup cavity of the outer cup 1 of the acetabulum and can rotate relative to the outer cup 1 of the acetabulum, the ball head 3 is embedded in the ball socket of the liner 2 and can rotate relative to the liner 2, and the ball head 3 is used to connect the femoral stem. Among them, a trabecular bone layer 4 is cladded on the outer wall surface of the outer cup 1 of the acetabulum.

[0038] This three-component ceramic double-acting hip joint prosthesis realizes the double-acting function of the hip joint through the mutual cooperation of the acetabular outer cup 1, the liner 2 and the ball head 3. Specifically, the ball head 3 is embedded in the socket of the liner 2 and can rotate relative to the liner 2, while the liner 2 is embedded in the cup cavity of the acetabular outer cup 1 and can rotate relative to the acetabular outer cup 1. This design forms two moving surfaces: one is the moving surface between the ball head 3 and the liner 2, and the other is the moving surface between the liner 2 and the acetabular outer cup 1. Through the relative movement of these two moving surfaces, the prosthesis can more naturally simulate the physiological movement of the human hip joint, reduce stress concentration and wear of the joint. In addition, the outer wall surface of the acetabular outer cup 1 is clad with a trabecular layer 4, which has a microporous structure and can induce the growth of bone cells, promote bone integration, and improve the stability and long-term service life of the prosthesis.

[0039] The surgical procedure of this three-component ceramic double-acting hip joint prosthesis is as follows: According to the specific situation of the patient, select the appropriate prosthesis model and size. Conduct a detailed preoperative assessment, including imaging examinations and patient medical history assessment. In total hip arthroplasty, first implant the acetabular outer cup 1 into the acetabulum to ensure its close fit with the bone tissue. Then embed the liner 2 into the cup cavity of the acetabular outer cup 1, and finally embed the ball head 3 into the socket of the liner 2 and connect it to the femoral stem. After the operation, the patient needs to undergo rehabilitation training, including early activities and gradually increasing the load. Regular follow-up is required to monitor the stability of the prosthesis and the patient's recovery.

[0040] Through the above technical solution, since the ceramic material has high hardness and low friction coefficient, it can significantly reduce the wear between the ball head 3 and the liner 2, reduce the debris generated by wear, and thus reduce the risk of osteolysis and prosthesis loosening. The trabecular layer 4 of the acetabular outer cup 1 can promote the growth of bone cells, enhance the bonding force between the prosthesis and the bone tissue, and improve the long-term stability of the prosthesis. The double-acting design makes the movement of the hip joint more natural and reduces the risk of dislocation caused by abnormal joint movement. By reducing wear and improving stability, this prosthesis can effectively relieve the pain of patients, improve the range of motion and function of the joint, and thus improve the quality of life of patients. The self-healing hydrogel loaded with antibacterial drugs can be injected into the trabecular layer 4 to construct a new antibacterial and osteogenesis-promoting bioactive interface, further improving the biocompatibility and bone integration efficiency of the prosthesis. Thus, a new antibacterial and osteogenesis-promoting bioactive interface is constructed to further improve the biocompatibility and bone integration efficiency of the prosthesis.

[0041] In a possible design, the porosity of the trabecular layer 4 is 50-90%, which is beneficial to promoting the growth of bone tissue. The trabecular layer 4 can provide sufficient space for the migration, proliferation and differentiation of bone cells, thereby promoting the growth of new bone tissue. The pore size is 100-400 μm. Such a setting is beneficial to the penetration of bone cells and ensures good mechanical support to prevent the structure from being too fragile.

[0042] By setting appropriate pore sizes and porosities, mechanical properties similar to those of human bones can be provided, stress shielding effects can be reduced, and the long-term stability of the implant can be improved. In this way, not only can good integration of bone tissue be promoted, but also the necessary mechanical strength can be maintained, which is of great significance for ensuring the successful implantation and long-term stability of the prosthesis. In addition, such a design also reflects the efforts of modern biomaterials engineering in optimizing the performance of implants.

[0043] In a possible design, the thickness of the trabecular layer 4 is 1.4 - 1.6 mm. The appropriate thickness helps to maintain the structural strength of the implant, ensuring that it can withstand the mechanical loads during daily activities. In this way, the bone tissue can be stably combined with the trabecular layer 4, improving the compressive strength and fatigue life of the implant, and thus reducing the problems that may occur during long-term use.

[0044] In the present disclosure, the thickness of the trabecular layer 4 is 1.5 mm, which can balance biocompatibility and mechanical properties while meeting the requirements of clinical applications.

[0045] In an embodiment provided by the present disclosure, a reticular reinforcing rib 5 is provided on the outer surface of the acetabular outer cup 1. This can enhance the overall structural stability of the acetabular outer cup 1, effectively disperse the loads brought by daily activities, reduce local stress concentration, and thus reduce the risk of prosthesis loosening or failure. Based on the reticular structure of the reinforcing rib 5, the surface area of contact between the acetabular outer cup 1 and the host bone can be effectively increased, promoting the ingrowth of bone cells and enhancing the biofixation effect. The structure of the reticular reinforcing rib 5 can also produce an effect similar to the trabecular structure inside the human bone, providing a more suitable growth environment for bone cells and enhancing the biocompatibility between the implant and the host bone.

[0046] It should be noted that for the term "and / or" appearing in this article, it is merely a description of the association relationship of associated objects, indicating that three relationships can exist. For example, A and / or B can represent: A exists alone, B exists alone, and A and B exist simultaneously. For the term " / and" appearing in this article, it describes another association relationship of associated objects, indicating that two relationships can exist. For example, A / and B can represent: A exists alone, and A and B exist alone. In addition, for the character " / " that may appear in this article, it generally represents that the associated objects before and after are in an "or" relationship.

[0047] Furthermore, an avoidance groove 6 is provided at the edge of the acetabular outer cup 1. The design of the avoidance groove 6 can provide a larger operating space for the installation of the prosthesis, making the implantation of the acetabular outer cup 1 more convenient and accurate, helping to reduce the surgical time and difficulty, and improving the success rate of the surgery. At the same time, the avoidance groove 6 can reduce the direct contact between the acetabular outer cup 1 and the surrounding tissues or other components of the prosthesis, thereby reducing friction and wear, helping to extend the service life of the prosthesis, and reducing complications caused by wear.

[0048] In another embodiment provided by the present disclosure, multiple sets of spaced support plates 7 are provided on the acetabular outer cup 1. The support plates 7 are located near the edge of the acetabular outer cup 1; each set includes two support plates 7. The multiple sets of spaced support plates 7 can provide additional mechanical support, enhance the contact area and stability between the acetabular outer cup 1 and the bone tissue, and help reduce the risk of loosening and displacement of the prosthesis during implantation. The design of the support plates 7 can promote the growth and integration of bone tissue, thereby improving the long-term stability of the prosthesis. In addition, the support plates 7 can also disperse the stress received by the acetabular outer cup 1 during use, reduce stress concentration, and lower the risk of prosthesis fracture and wear.

[0049] Furthermore, the support plates 7 are arranged in four sets evenly spaced along the circumferential direction of the acetabular outer cup 1. This can provide more uniform mechanical support, enhance the contact area and stability between the acetabular outer cup 1 and the bone tissue, reduce the risk of loosening and displacement of the prosthesis during implantation, and improve the initial stability and long-term stability of the prosthesis. In addition, the support plates 7 can disperse the stress received by the acetabular outer cup 1 during use, reduce stress concentration, and lower the risk of prosthesis fracture and wear. The microporous structure on the support plates 7 can allow bone cells to grow in, thereby improving the biocompatibility and bone integration efficiency of the prosthesis, and thus extending the service life of the prosthesis.

[0050] In still another embodiment provided by the present disclosure, a plurality of spaced cone nails 8 are provided on the acetabular outer cup 1. The extending direction of the cone nails 8 is parallel to the central axis of the acetabular outer cup 1. The design of the cone nails 8 can provide additional mechanical support, enhance the contact area and stability between the acetabular outer cup 1 and the bone tissue. Since the extending direction of the cone nails 8 is parallel to the central axis of the acetabular outer cup 1, it helps to better fix the prosthesis during implantation and reduce the risk of loosening and displacement. The cone nails 8 can disperse the stress received by the acetabular outer cup 1 during use, reduce stress concentration, and lower the risk of prosthesis fracture and wear. It is extremely suitable for patients with severe acetabular bone defects, can provide better fixation effect, and help reconstruct the structure and function of the acetabulum.

[0051] When setting, trabecular bone can be cladded on the surface of the cone nails 8 to form a rough or microporous structure, which is beneficial to the growth of bone cells and the growth of bone tissue, thereby improving the biocompatibility and bone integration efficiency of the prosthesis.

[0052] Furthermore, four conical pins 8 are provided and evenly spaced along the circumferential direction of the acetabular outer cup 1, which can provide more uniform mechanical support, enhance the contact area and stability between the acetabular outer cup 1 and bone tissue, help reduce the risk of loosening and displacement of the prosthesis during implantation, and improve the initial stability and long-term stability of the prosthesis.

[0053] In a possible design, the ceramic material includes α-aluminum oxide powder and zirconia powder. α-aluminum oxide (α-Al2O3) has the characteristics of high hardness, wear resistance, high temperature resistance, good chemical stability and electrical insulation. As a raw material, it can provide high strength and hardness while maintaining a low coefficient of thermal expansion, enabling it to maintain dimensional stability. In addition, α-aluminum oxide has a high corrosion resistance, which allows the prosthesis made of it to be used for a long time in a harsh environment.

[0054] Zirconia (ZrO2) is a very hard and tough ceramic material with the characteristics of high fracture toughness and relatively high flexural strength. By adding zirconia to the matrix, the toughness of the composite material can be significantly improved because zirconia undergoes a transformation toughening mechanism under stress, that is, energy is absorbed during the process of t-ZrO2 transforming into m-ZrO2, thus preventing crack propagation. In addition, zirconia also has good thermal shock resistance and can withstand a large temperature difference during rapid heating and cooling without cracking.

[0055] In the present disclosure, α-aluminum oxide and zirconia are used in combination. Yttrium oxide can replace Zr 4+ ions in the zirconia lattice to form a solid solution, thereby stabilizing the tetragonal phase of zirconia, inhibiting its spontaneous phase transformation at low temperatures, and improving the toughness and strength of the ceramic material. This not only improves the wear resistance of the prosthesis but also enhances its mechanical strength and toughness, making it more suitable for the treatment needs of young and active patients.

[0056] In a possible design, the purity of the α-aluminum oxide powder is ≥99.9%, which helps reduce defects and impurities inside the material, thereby improving its chemical stability and resisting the erosion of various chemical media. The particle size of the α-aluminum oxide powder is in the submicron to nanometer range. The α-aluminum oxide powder with a submicron to nanometer particle size has a larger specific surface area, which can improve the activity of the material, promote the diffusion between particles during sintering, and thus obtain a denser ceramic product. The increase in density can improve the mechanical strength and fatigue resistance of the acetabular outer cup 1 and the ball head 3.

[0057] In a possible design, yttrium oxide accounts for 3% of the mass of zirconia. By mixing a salt solution containing zirconium and yttrium and then adding a precipitating agent, the two metal ions are simultaneously precipitated, and the required powder is obtained through steps such as filtration, drying, and calcination. This method involves the hydrolysis and polymerization reactions of metal alkoxides or their derivatives in solution to form a gel with a three-dimensional network structure, and then nano-scale oxide powders are obtained through drying and calcination.

[0058] Under high-temperature and high-pressure conditions, adding yttrium oxide with a molar ratio of 3% can effectively stabilize the tetragonal phase of zirconia, thereby improving the fracture toughness and flexural strength of the material and enabling the structure and properties to remain stable in a high-temperature environment.

[0059] In a possible design, the ceramic material further includes strontium oxide. The addition of strontium oxide helps to form a liquid phase, can reduce the sintering temperature and accelerate the rearrangement and densification process between particles, thereby changing the diffusion mechanism during sintering, promoting more uniform grain growth, and thus improving the density and mechanical strength of the final product. In this way, the acetabular outer cup 1 and the ball head 3 prepared therefrom can have good comprehensive mechanical properties, including but not limited to higher fracture toughness and impact resistance. In addition, the presence of the solid solution may also improve the thermal expansion coefficient matching of the material and reduce the stress concentration problem caused by temperature changes.

[0060] Strontium oxide can not only be used alone as an additive but also form a solid solution with other oxides such as alumina. For example, the SrO-Al2O3 solid solution can replace pure alumina to a certain extent, providing higher chemical stability and thermal stability while reducing the volume change caused by phase transformation.

[0061] In one embodiment, the ceramic material further includes chromium oxide. Chromium oxide (Cr2O3) reduces the sintering temperature and shortens the sintering time, helps to form a more uniform and dense microstructure, is beneficial to increasing the density of the material, also reduces pores and other defects, and further enhances the mechanical properties of the material. By forming a solid solution with the matrix material or through the second-phase strengthening mechanism, chromium oxide can significantly increase the hardness, wear resistance, and fracture toughness of the ceramic material. In addition, due to its high melting point and good thermal stability, chromium oxide can also improve the thermal shock stability of the material, making it not easy to crack during rapid heating and cooling cycles.

[0062] In yet another embodiment, the ceramic material further includes strontium oxide and chromium oxide. As an additive, strontium oxide can change the diffusion state during sintering, promote more uniform grain growth, and thus refine the grain size in the ceramic material. Strontium oxide can reduce the sintering temperature and accelerate the rearrangement and densification process between particles, thereby improving the density and mechanical strength of the final product. The ability of strontium oxide to form solid solutions with other oxides such as alumina can, to a certain extent, replace pure alumina and better control the microstructure of the ceramic material, such as refining grains and reducing porosity, and improving material density and mechanical properties.

[0063] In the present disclosure, the inner lining 2 is made of a polyethylene material. Specifically, the polyethylene material is configured as highly crosslinked ultra-high molecular weight ethylene (UHMWPE), or the polyethylene is configured as highly crosslinked ultra-high molecular weight ethylene added with an antioxidant.

[0064] For highly crosslinked ultra-high molecular weight polyethylene (UHMWPE), the highly crosslinked UHMWPE significantly improves the wear resistance and fatigue resistance of the material and reduces the generation of wear debris through irradiation crosslinking treatment. UHMWPE has good biocompatibility and a low friction coefficient and is suitable as the material for the inner lining 2 of hip joint prostheses.

[0065] For highly crosslinked ultra-high molecular weight polyethylene added with an antioxidant, the addition of an antioxidant (such as vitamin E) can effectively inhibit the oxidation reaction of the material and reduce the degradation of material properties caused by oxidation. This material can maintain stable mechanical properties during long-term use and reduce wear and failure caused by material aging.

[0066] According to the second aspect of the present disclosure, a coating preparation method for a three-component ceramic double-acting hip joint prosthesis is provided. The coating preparation method is used for a three-component ceramic double-acting hip joint prosthesis, and the trabecular layer 4 is the coating. Among them, the coating includes a base layer fused to the substrate, a transition layer fused to the base layer, and a working layer fused to the transition layer. The transition layer is configured as at least one layer. The preparation method includes: pre-treating the substrate; using a synchronous laser cladding device to fuse titanium-based alloy powder onto the surface of the cladding substrate to form a base layer; using a synchronous laser cladding device to fuse titanium-based alloy powder onto the surface of the base layer to form a transition layer; using a synchronous laser cladding device to fuse titanium-based alloy powder onto the surface of the transition layer to form a working layer; and performing heat preservation treatment on the cladding substrate after laser cladding strengthening and then cooling. Such a design enables the cladded coating to have a porosity greater than 30%, which is beneficial for the ingrowth of host bone after prosthesis implantation, thereby improving the stability of the prosthesis.

[0067] In a possible design, preset cladding process parameters are provided in a synchronous laser cladding device. The cladding process parameters include: laser power, cladding speed, cladding basic parameters, powder feeding rate, and protective gas pressure. Among them, the cladding basic parameters include: cladding layer thickness, cladding path spacing, cladding layer spacing, number of cladding layers, and cladding layer width.

[0068] Specifically, the laser power is at least 1 kW; the cladding speed is less than 200 mm / s; the cladding layer thickness is 0.15 - 1.0 mm; the cladding path spacing is 0.5 - 0.9 mm; the cladding layer spacing is 0.1 - 0.3 mm; the number of cladding layers is 1 - 4 layers, the cladding layer width is 0.2 - 0.5 mm; the powder feeding rate is 6 g / min - 12 g / min; the protective gas pressure value is 1.8 - 2.2 bar.

[0069] In a possible design, the laser power is 1.5 kW; the cladding speed is 50 mm / s; the cladding layer thickness is 0.25 mm; the cladding path spacing is 0.5 mm; the cladding layer spacing is 0.2 mm; the number of cladding layers is 3 layers, the cladding layer width is 0.2 mm; the powder feeding rate is 8 g / min; the protective gas pressure value is 2 bar.

[0070] In a possible design, the protective gas is argon; the titanium-based alloy powder is configured as Ti6Al4V alloy powder.

[0071] In a possible design, the coating on the acetabular outer cup 1 starts to be coated from the 40 mm ring diameter of the acetabular outer cup 1 and increases in size by 2 mm until the coating stops at the 70 mm ring diameter; the coating on the ball head 3 starts to be coated from the 35 mm ring diameter of the ball head 3 and increases in size by 2 mm until the coating stops at the 65 mm ring diameter.

[0072] The coating includes a base layer clad on the substrate, an intermediate layer clad on the base layer, and a working layer clad on the intermediate layer. The intermediate layer is configured to be at least one layer. It can be understood that the coating forms the trabecular layer 4 below. Hereinafter, the application of this preparation method to a three-component ceramic dual-motion hip joint prosthesis will be used as an example to detail the present disclosure. Among them, the maximum diameter of the substrate (the three-component ceramic dual-motion hip joint prosthesis without a coating) is 72 mm.

[0073] In the present disclosure, a titanium-based alloy powder is configured as a titanium 6 aluminum 4 vanadium alloy powder and cladded onto the surface of a part (a substrate made of a ceramic material) by using the coating preparation method of the second aspect, so as to measure the coating strength of the part after cladding. Specifically, two parts are selected, one with a cladded coating and the other without a cladded coating. After the two parts are fusion bonded, a combined part for the test is obtained. Then, both ends of the combined part are respectively clamped by a tensile strength testing machine, and in accordance with ASTM F1147 "Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings", the combined part is broken from the bonding surface, and the coating tensile strength is calculated.

[0074] Example 1:

[0075] In this example, the cladding process parameters in the synchronous laser cladding device are as follows: the laser power is 1.5 kW; the cladding speed is 50 mm / s; the cladding layer thickness is 0.25 mm; the cladding path spacing is 0.5 mm; the cladding layer spacing is 0.1 mm; the number of cladding layers is 4 layers, and the cladding layer width is 0.2 mm.

[0076] The titanium-based alloy powder is configured as a titanium 6 aluminum 4 vanadium alloy powder; the powder feeding rate is 8 g / min; the protective gas pressure value is 2 bar. Among them, the protective gas is argon, and the titanium-based alloy powder is configured as a titanium 6 aluminum 4 vanadium alloy powder.

[0077] Example 2:

[0078] In this example, the cladding process parameters in the synchronous laser cladding device are as follows: the laser power is 1.5 kW; the cladding speed is 55 mm / s; the cladding layer thickness is 0.3 mm; the cladding path spacing is 0.6 mm; the cladding layer spacing is 0.2 mm; the number of cladding layers is 3 layers, and the cladding layer width is 0.3 mm.

[0079] The titanium-based alloy powder is configured as a titanium 6 aluminum 4 vanadium alloy powder; the powder feeding rate is 9 g / min; the protective gas pressure value is 2 bar. Among them, the protective gas is argon, and the titanium-based alloy powder is configured as a titanium 6 aluminum 4 vanadium alloy powder.

[0080] Example 3:

[0081] In this example, the cladding process parameters in the synchronous laser cladding device are as follows: the laser power is 1.5 kW; the cladding speed is 60 mm / s; the cladding layer thickness is 0.4 mm; the cladding path spacing is 0.7 mm; the cladding layer spacing is 0.2 mm; the number of cladding layers is 3 layers, and the cladding layer width is 0.4 mm.

[0082] The titanium-based alloy powder is configured as a titanium 6 aluminum 4 vanadium alloy powder; the powder feeding rate is 9 g / min; the protective gas pressure value is 2 bar. Among them, the protective gas is argon, and the titanium-based alloy powder is configured as a titanium 6 aluminum 4 vanadium alloy powder.

[0083] Example 3:

[0084] In this example, the cladding process parameters in the synchronous laser cladding device are as follows: laser power is 1.5 kW; cladding speed is 55 mm / s; cladding layer thickness is 0.35 mm; cladding path spacing is 0.6 mm; cladding layer spacing is 0.25 mm; number of cladding layers is 3 layers, and cladding layer width is 0.35 mm.

[0085] The titanium-based alloy powder is configured as titanium 6 aluminum 4 vanadium alloy powder; powder feeding rate is 9 g / min; protective gas pressure value is 2 bar. Among them, the protective gas is argon, and the titanium-based alloy powder is configured as titanium 6 aluminum 4 vanadium alloy powder.

[0086] Example 4:

[0087] In this example, the cladding process parameters in the synchronous laser cladding device are as follows: laser power is 1.5 kW; cladding speed is 55 mm / s; cladding layer thickness is 0.35 mm; cladding path spacing is 0.65 mm; cladding layer spacing is 0.3 mm; number of cladding layers is 3 layers, and cladding layer width is 0.35 mm.

[0088] Powder feeding rate is 8 g / min; protective gas pressure value is 2 bar. Among them, the protective gas is argon, and the titanium-based alloy powder is configured as titanium 6 aluminum 4 vanadium alloy powder.

[0089] Select a clad part from Example 1, and then bond it with an unclad part to obtain the corresponding part marked as A1 (refer to Figure 4 ). Select a clad part from Example 2, and then bond it with an unclad part to obtain the corresponding combined part marked as A2 (refer to Figure 5 ); select a clad part from Example 3, and then bond it with an unclad part to obtain the corresponding part marked as A3 (refer to Figure 6 ), select a clad part from Example 4, and then bond it with an unclad part to obtain the corresponding combined part marked as A4 (refer to Figure 7 ). It should be noted that according to the standard YY 0118-2016 "Hip Joint Prosthesis for Joint Replacement Implants", the tensile strength requirement of the part is greater than 22 MPa.

[0090] Conduct laser cladding coating mechanical tensile strength tests on the combined parts A1, A2, A3, and A4 respectively, and obtain the following data.

[0091]

[0092]

[0093] Table 1 - Tensile Strength Test Results Table of Parts

[0094] Referring to Table 1 and Figures 3 to 6 it can be seen that among the combined parts A1 (refer to Figure 8 ), A2 (refer to Figure 8 ), A3 (refer to Figure 9 ), and A4 (refer to Figure 9 ), the fracture cross-sections are all located in the cladding layer, that is, the fusion-solidification joint surface between the two parts, rather than the fracture between the cladding layer and the part. The above tests can all prove that: the bonding strength between the coating (trabecular bone layer) and the part (substrate) is greater than the strength of the fusion-solidification layer itself. Therefore, in this way, it makes the bonding strength between the coating and the substrate relatively high, avoiding the situation of coating peeling off during use. At the same time, it can also confirm that the substrate is not prone to debris and other situations. After the mechanical tensile strength tests of the cladding coatings of 4 groups of parts after cladding are carried out respectively, the mechanical strength of the parts after cladding is much higher than the industry standard value, and the test results all meet the standard ASTM F1147. The coating quality of the cladding products is qualified, and the stability is all above 97%.

[0095] In summary, through the coating preparation method provided in the second aspect of the present disclosure, the coating can be formed into a reticular trabecular bone structure. Based on its rough and porous surface structure, it can well induce the generation of heterotopic bone and improve the adhesion, proliferation, and differentiation abilities of osteoblasts. Research data show that the internal fixation micro-motion range less than 28μm can meet the requirements of biological fixation bone ingrowth, and when the micro-motion is greater than 150μm, a soft tissue membrane will be generated at the prosthesis-bone interface, affecting the fixation effect. The surface roughness at the macroscopic scale can greatly reduce the micro-motion and is conducive to bone ingrowth. At the same time, cladding the titanium-based alloy powder on the surface of the substrate can enable the formed coating to be tightly combined with the substrate, thus ensuring the coating strength. At the same time, the formed three-component ceramic double-moving hip joint prosthesis has a stable and reliable structure and high fatigue strength, effectively ensuring the service life of the three-component ceramic double-moving hip joint prosthesis.

[0096] The preferred embodiments of the present disclosure have been described in detail above with reference to the accompanying drawings. However, the present disclosure is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present disclosure, various simple modifications can be made to the technical solutions of the present disclosure, and these simple modifications all belong to the protection scope of the present disclosure.

Claims

1. A three-component ceramic dual-motion hip prosthesis, characterized in that: It comprises an acetabular outer cup, an inner liner and a ball head which are arranged in sequence, wherein the acetabular outer cup and the ball head are both made of ceramic material; the inner liner is made of polyethylene material; the inner liner is embedded in the cup cavity of the acetabular outer cup and can rotate relative to the acetabular outer cup, the ball head is embedded in the ball socket of the inner liner and can rotate relative to the inner liner, and the ball head is used to connect to the femoral stem, wherein the outer wall surface of the acetabular outer cup is clad with a trabecular bone layer.

2. The three-component ceramic dual-motion hip prosthesis according to claim 1, characterized in that: The porosity of the trabecular bone layer is 50-90%, the pore size is 100-400 μm, and the thickness of the trabecular bone layer is 1.4-1.6 mm.

3. The three-component ceramic dual-motion hip prosthesis according to claim 1, characterized in that: The outer surface of the acetabulum outer cup is provided with mesh-shaped reinforcing ribs.

4. The three-component ceramic dual-motion hip prosthesis according to claim 3, characterized in that: An avoidance groove is arranged on the edge of the acetabulum outer cup.

5. The three-component ceramic dual-motion hip prosthesis according to claim 1, characterized in that: The acetabular outer cup is provided with a plurality of groups of support plates arranged at intervals, and the support plates are located close to the edge of the acetabular outer cup; each group includes two support plates.

6. The three-component ceramic dual-motion hip prosthesis according to claim 1, characterized in that: The acetabular outer cup is provided with a plurality of tapered screws arranged at intervals, and the extending direction of the tapered screws is parallel to the central axis of the acetabular outer cup.

7. The three-component ceramic dual-motion hip prosthesis according to claim 1, characterized in that: The ceramic material includes α-alumina powder and zirconium oxide powder.

8. The three-component ceramic dual-motion hip prosthesis according to claim 7, characterized in that: The purity of the α-alumina powder is ≥99.9%, and the particle size of the α-alumina powder is from submicron to nanometer level; the zirconium oxide powder includes yttrium oxide and tetragonal zirconium oxide powder, and the yttrium oxide accounts for 3% of the mass of the zirconium oxide.

9. The three-component ceramic dual-motion hip prosthesis according to claim 7, characterized in that: The ceramic material also includes strontium oxide and / or chromium oxide.

10. The three-component ceramic dual-motion hip prosthesis according to claim 1, characterized in that: The polyethylene material is configured as highly cross-linked ultra-high molecular weight ethylene, or the polyethylene is configured as highly cross-linked ultra-high molecular weight ethylene added with an antioxidant.

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