Integrated unicompartmental prosthetic system and method of manufacturing an integrated unicompartmental prosthetic system

Abstract

The application relates to the technical field of orthopedic artificial joint, in particular to an integrated unicompartmental prosthesis system and a preparation method of the integrated unicompartmental prosthesis system. The integrated unicompartmental prosthesis system comprises a femoral condyle prosthesis, a tibial plateau prosthesis and a tibial plateau pad prosthesis; the femoral condyle prosthesis and the tibial plateau prosthesis are both made of a zirconium niobium alloy 3D printing; the tibial plateau pad prosthesis is made of a zirconium niobium alloy 3D printing or a zirconium niobium alloy forging; the upper surface of the femoral condyle prosthesis is in contact with the tibial plateau pad prosthesis, and the upper surface of the tibial plateau prosthesis is in contact with the lower surface of the tibial plateau pad prosthesis. The bone integration interfaces of the integrated unicompartmental prosthesis system are all formed by zirconium niobium alloy trabecular structures, and the friction contact surfaces between the prostheses are all metal ceramic interfaces formed by zirconium niobium surface oxidation, so that the bone resection amount of the tibial plateau can be reduced, the wear resistance of the friction interface can be improved, the wear debris of the friction interface can be greatly reduced, and the stability of the prosthesis in the later period is improved.

Description

Technical Field

[0001] This invention relates to the field of orthopedic artificial joint technology, and more specifically, to an integrated unicompartmental prosthesis system and a method for preparing the integrated unicompartmental prosthesis system. Background Technology

[0002] Joint replacement surgery is a surgical treatment primarily aimed at restoring joint function, relieving pain, and improving patients' quality of life. Although the surgical procedure and techniques for joint replacement are now standardized in clinical practice, various complications still occur, leading to surgical failure and the need for revision surgery. Loosening of the prosthesis-bone interface is a major cause of prosthesis failure. The causes of prosthesis loosening are complex, with aseptic loosening being the most common postoperative complication. Among the causes of joint prosthesis failure, wear and tear is one of the most significant causes of aseptic loosening. Statistics show that within 10 years after total joint replacement surgery, wear and tear accounts for approximately 50-60% of failures, and this percentage gradually increases with the length of service life. Therefore, reducing wear and tear on the joint prosthesis is a crucial means to improve its lifespan and reduce the failure rate. A significant problem currently facing total joint replacement surgery is the dispersion of ultra-high molecular weight polyethylene (UHMWPE) component debris into surrounding tissues, leading to osteolysis and prosthesis loosening. Summary of the Invention

[0003] The objectives of this invention include, for example, providing an integrated unicompartmental prosthesis system and a method for preparing such a system, which eliminates polymer material components and replaces them with zirconium-niobium metal components. This allows the use of the integrated unicompartmental prosthesis system to reduce the amount of osteotomy on the tibial plateau, improve the wear resistance of the friction interface, and thus significantly reduce wear debris at the friction interface, thereby facilitating the stability of the prosthesis in the later stages of implantation.

[0004] The embodiments of the present invention can be implemented as follows:

[0005] In a first aspect, the present invention provides an integrated unicompartmental prosthesis system, which includes a femoral condyle prosthesis, a tibial plateau prosthesis, and a tibial plateau pad prosthesis;

[0006] Both the femoral condyle prosthesis and the tibial plateau prosthesis are 3D printed from zirconium-niobium alloy; the tibial plateau pad prosthesis is either 3D printed from zirconium-niobium alloy or made from zirconium-niobium alloy forgings.

[0007] The femoral condyle prosthesis contacts the upper surface of the tibial plateau pad prosthesis, and the upper surface of the tibial plateau prosthesis contacts the lower surface of the tibial plateau pad prosthesis. Furthermore, metal-ceramic interfaces are provided between the friction contact surfaces of the femoral condyle prosthesis and the tibial plateau pad prosthesis, as well as between the friction contact surfaces of the tibial plateau prosthesis and the tibial plateau pad prosthesis.

[0008] The osseointegration interfaces of the femoral condyle prosthesis, tibial plateau prosthesis, and tibial plateau pad prosthesis are all 3D-printed trabecular bone structures.

[0009] In an optional embodiment, the surface of the femoral condyle prosthesis that is in frictional contact with the tibial plateau pad prosthesis is provided with a metal-ceramic interface, the surface of the tibial plateau pad prosthesis that is in frictional contact with both the femoral condyle prosthesis and the tibial plateau prosthesis is provided with a metal-ceramic interface, and the surface of the tibial plateau prosthesis that is in frictional contact with the tibial plateau pad prosthesis is provided with a metal-ceramic interface.

[0010] In an optional implementation, the metal-ceramic interface thickness is 3μm-35μm.

[0011] In an optional embodiment, the distance between the lowest point of the upper surface and the lower surface of the tibial plateau pad prosthesis is 1mm-10mm.

[0012] In an optional embodiment, a microtexture structure is provided between the friction contact surfaces of the femoral condyle prosthesis and the tibial plateau pad prosthesis, as well as between the friction contact surfaces of the tibial plateau prosthesis and the tibial plateau pad prosthesis.

[0013] In an optional embodiment, the surface of the femoral condyle prosthesis that is in frictional contact with the tibial plateau pad prosthesis is provided with a microtexture structure, the surface of the tibial plateau pad prosthesis that is in frictional contact with both the femoral condyle prosthesis and the tibial plateau prosthesis is provided with a microtexture structure, and the surface of the tibial plateau prosthesis that is in frictional contact with the tibial plateau pad prosthesis is provided with a microtexture structure.

[0014] Secondly, the present invention provides a method for preparing an integrated unicompartmental prosthesis system, used to prepare an integrated unicompartmental prosthesis system as described in any of the foregoing embodiments. When the femoral condyle prosthesis, tibial plateau prosthesis, and tibial plateau pad prosthesis are all 3D printed from zirconium-niobium alloy, the preparation steps of the femoral condyle prosthesis, tibial plateau prosthesis, and tibial plateau pad prosthesis include:

[0015] Using zirconium-niobium alloy powder as raw material, with a particle diameter of 5μm-150μm, magnesium metal particles of 5-10μm are added to the zirconium-niobium alloy powder in the trabecular bone structure part. The magnesium metal accounts for 1%-5% of the volume of the zirconium-niobium alloy powder. The first femoral condyle sample, the first tibial plateau sample, and the first tibial plateau pad sample are obtained by 3D printing in one piece.

[0016] The first femoral condyle sample, the first tibial plateau sample, and the first tibial plateau pad sample were placed in a hot isostatic pressing furnace and heated to 1250℃-1400℃ under helium or argon protection. They were then kept at a constant temperature of 40MPa-180MPa for 1-3 hours, then cooled to atmospheric pressure and removed from the furnace at a temperature below 200℃ to obtain the second femoral condyle sample, the second tibial plateau sample, and the second tibial plateau pad sample.

[0017] The second femoral condyle sample, the second tibial plateau sample, and the second tibial plateau pad sample were placed in a programmed cooling box and cooled to -80℃ to -120℃ at a rate of 1℃ / min. They were kept at this temperature for 5-10 hours and then removed from the programmed cooling box. They were then placed in liquid nitrogen for 16-36 hours and the temperature was adjusted to room temperature to obtain the third femoral condyle sample, the third tibial plateau sample, and the third tibial plateau pad sample.

[0018] The third femoral condyle sample, the third tibial plateau sample, and the third tibial plateau pad sample were placed in a programmed cooling box and cooled to -80℃ to -120℃ at a rate of 1℃ / min, and kept at this temperature for 5-10 hours. They were then removed from the programmed cooling box and placed in liquid nitrogen for 16-36 hours, with the temperature adjusted to room temperature. This yielded the fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample.

[0019] The fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample were machined, polished, cleaned, and dried to obtain the fifth femoral condyle sample, the fifth tibial plateau sample, and the fifth tibial plateau pad sample.

[0020] The fifth femoral condyle sample, the fifth tibial plateau sample, and the fifth tibial plateau pad sample were placed in a tube furnace and inert gas with an oxygen content of 5%-15% by mass was introduced. The furnace was heated to 500-700℃ at 5℃ / min-20℃ / min, cooled to 400-495℃ at 0.4℃ / min-0.9℃ / min, and then allowed to cool naturally to below 200℃ before being removed to obtain the femoral condyle prosthesis, the tibial plateau prosthesis, and the tibial plateau pad prosthesis.

[0021] When the tibial plateau pad prosthesis is made from a zirconium-niobium alloy forging, the fabrication steps include:

[0022] The zirconium-niobium alloy forgings were machined, trimmed, polished, cleaned and dried to obtain a tibial plateau pad forging sample.

[0023] The tibial plateau pad forging sample is placed in a tube furnace and introduced with atmospheric pressure helium or argon gas containing 5%-15% oxygen by mass. It is heated to 500℃-700℃ at 5℃ / min-20℃ / min, cooled to 400℃-495℃ at 0.4℃ / min-0.9℃ / min, and then naturally cooled to below 200℃ before being removed to obtain the tibial plateau pad prosthesis.

[0024] In an optional embodiment, after machining, polishing, cleaning, and drying the fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample, the method for preparing the integrated unicompartmental prosthesis system further includes:

[0025] Microtexture structures were fabricated on the surface of the fourth femoral condyle that was in frictional contact with the tibial plateau pad prosthesis; microtexture structures were fabricated on the surface of the fourth tibial plateau that was in frictional contact with the tibial plateau pad prosthesis; microtexture structures were fabricated on the surface of the fourth tibial plateau pad that was in frictional contact with both the femoral condyle prosthesis and the tibial plateau prosthesis.

[0026] In an optional embodiment, after machining, finishing, polishing, cleaning, and drying the zirconium-niobium alloy forging to obtain a tibial plateau pad forging sample, the method for preparing the integrated unicompartment prosthesis system further includes:

[0027] Microtexture structures were fabricated on the surfaces of the tibial plateau pad forging sample that correspond to the frictional contact surfaces with the femoral condyle prosthesis and the tibial plateau prosthesis.

[0028] In an optional embodiment, the surface roughness of the tibial plateau pad prosthesis, excluding the microtexture structure, is Ra≤0.050μm.

[0029] The beneficial effects of the embodiments of the present invention include:

[0030] This integrated unicompartmental prosthesis system includes a femoral condyle prosthesis, a tibial plateau prosthesis, and a tibial plateau pad prosthesis. Both the femoral condyle and tibial plateau prostheses are 3D printed from zirconium-niobium alloy. The tibial plateau pad prosthesis is either 3D printed from zirconium-niobium alloy or made from a zirconium-niobium alloy forging. The upper surfaces of the femoral condyle and the tibial plateau pad prosthesis are in contact, and the upper surface of the tibial plateau prosthesis is in contact with the lower surface of the tibial plateau pad prosthesis. A metal-ceramic interface is provided between the friction contact surfaces of the femoral condyle and the tibial plateau pad prosthesis, and between the friction contact surfaces of the tibial plateau and the tibial plateau pad prosthesis. The osseointegration interfaces of the femoral condyle, tibial plateau, and tibial plateau pad prostheses are all 3D printed trabecular bone structures. The osteointegration interfaces of the femoral condyle prosthesis, tibial plateau prosthesis, and tibial plateau pad prosthesis in this integrated unicompartmental prosthesis system are all made of zirconium-niobium alloy trabecular bone structure. Moreover, the friction contact surfaces between the femoral condyle prosthesis, tibial plateau prosthesis, and tibial plateau pad prosthesis are all metal-ceramic interfaces with zirconium-niobium surface oxidation. As a result, this integrated unicompartmental prosthesis system eliminates polymer material components and replaces them with zirconium-niobium metal components. This allows for a reduction in the amount of osteotomy on the tibial plateau, improves the wear resistance of the friction interface, and thus significantly reduces wear debris at the friction interface, which is beneficial for the stability of the prosthesis in the later stages of implantation. Attached Figure Description

[0031] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the integrated unicompartmental prosthesis system in an embodiment of the present invention;

[0033] Figure 2 This is a schematic diagram of the femoral condyle prosthesis in an embodiment of the present invention;

[0034] Figure 3 This is a schematic diagram of the tibial plateau prosthesis in an embodiment of the present invention;

[0035] Figure 4 This is a schematic diagram of the tibial plateau pad prosthesis in an embodiment of the present invention.

[0036] Icons: 200 - Integrated unicompartmental prosthesis system; 210 - Femoral condyle prosthesis; 220 - Tibial plateau prosthesis; 230 - Tibial plateau pad prosthesis. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0038] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0039] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0040] In the description of this invention, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed, they are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0041] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0042] It should be noted that, where there is no conflict, the features in the embodiments of the present invention can be combined with each other.

[0043] Please refer to Figures 1-4 This embodiment provides an integrated unicompartmental prosthesis system 200, which includes a femoral condyle prosthesis 210, a tibial plateau prosthesis 220, and a tibial plateau pad prosthesis 230.

[0044] The femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 are both 3D printed from zirconium-niobium alloy; the tibial plateau pad prosthesis 230 is either 3D printed from zirconium-niobium alloy or made from a zirconium-niobium alloy forging.

[0045] The upper surface of the femoral condyle prosthesis 210 abuts against the upper surface of the tibial plateau pad prosthesis 230, and the upper surface of the tibial plateau prosthesis 220 abuts against the lower surface of the tibial plateau pad prosthesis 230. Furthermore, a metal-ceramic interface is provided between the friction contact surfaces of the femoral condyle prosthesis 210 and the tibial plateau pad prosthesis 230, as well as between the friction contact surfaces of the tibial plateau prosthesis 220 and the tibial plateau pad prosthesis 230.

[0046] The osseointegration interfaces of the femoral condyle prosthesis 210, the tibial plateau prosthesis 220, and the tibial plateau pad prosthesis 230 are all 3D-printed trabecular bone structures.

[0047] Please refer to Figures 1-4 The working principle of this integrated unicompartmental prosthesis system 200 is as follows:

[0048] The integrated unicompartmental prosthesis system 200 includes a femoral condyle prosthesis 210, a tibial plateau prosthesis 220, and a tibial plateau pad prosthesis 230; both the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 are 3D printed from zirconium-niobium alloy; the tibial plateau pad prosthesis 230 is either 3D printed from zirconium-niobium alloy or made from a zirconium-niobium alloy forging; the upper surfaces of the femoral condyle prosthesis 210 and the tibial plateau pad prosthesis 230 abut against each other, and the tibial plateau... The upper surface of the prosthesis 220 abuts against the lower surface of the tibial plateau pad prosthesis 230, and metal-ceramic interfaces are provided between the friction contact surfaces of the femoral condyle prosthesis 210 and the tibial plateau pad prosthesis 230, as well as between the friction contact surfaces of the tibial plateau prosthesis 220 and the tibial plateau pad prosthesis 230; the osseointegration interfaces of the femoral condyle prosthesis 210, the tibial plateau prosthesis 220 and the tibial plateau pad prosthesis 230 are all 3D printed trabecular bone structures;

[0049] In summary, the osteointegration interfaces of the femoral condyle prosthesis 210, tibial plateau prosthesis 220, and tibial plateau pad prosthesis 230 in this integrated unicompartmental prosthesis system 200 are all trabecular bone structures formed by zirconium-niobium alloy. Moreover, the friction contact surfaces between the femoral condyle prosthesis 210, tibial plateau prosthesis 220, and tibial plateau pad prosthesis 230 are all metal-ceramic interfaces with zirconium-niobium surface oxidation. Thus, this integrated unicompartmental prosthesis system 200 eliminates polymer material components and replaces them with zirconium-niobium metal components. This allows for a reduction in the amount of osteotomy on the tibial plateau, improves the wear resistance of the friction interface, and significantly reduces wear debris at the friction interface, thereby contributing to the stability of the prosthesis after implantation.

[0050] It should be noted that the osteointegration interfaces of the femoral condyle prosthesis 210, tibial plateau prosthesis 220, and tibial plateau pad prosthesis 230 of the integrated unicompartmental prosthesis system 200 are all 3D-printed trabecular bone structures, while the remaining parts of the femoral condyle prosthesis 210, tibial plateau prosthesis 220, and tibial plateau pad prosthesis 230 are solid structures of zirconium-niobium alloy.

[0051] It should also be noted that when using zirconium-niobium alloy to print femoral condyle prosthesis 210, tibial plateau prosthesis 220, and tibial plateau pad prosthesis 230, 5-10 μm magnesium metal particles are added to the zirconium-niobium alloy powder during the printing of the trabecular bone structure portion of the aforementioned structures. The magnesium metal constitutes 1%-5% of the volume of the zirconium-niobium alloy powder. The purpose is that Mg is the fourth most abundant element in the human body and has been found to be a key cofactor in hundreds of enzyme reactions, participating in various metabolic processes, especially mineral metabolism, including promoting osteoblast calcification and osteoblast proliferation; numerous studies have reported… It has been confirmed that Mg alloys, Mg-doped bioceramics, or Mg-doped biodegradable polymers used for bone regeneration can promote osteogenic differentiation and stimulate osteogenic formation. In addition to the properties of the materials themselves, the Mg2+ released from these bone substitutes also has an osteogenic effect. Therefore, by adding magnesium metal particles to the printed zirconium-niobium alloy powder, magnesium and magnesium oxide can be present in the trabecular bone structure, which in turn allows the trabecular bone structure to release magnesium ions to inhibit inflammation at the prosthesis-bone interface. Furthermore, the precipitation of magnesium ions can promote osteogenic differentiation and stimulate osteogenic formation, which is beneficial for the integration of the prosthesis-bone interface.

[0052] Further, please refer to Figures 1-4 In this embodiment, in an optional implementation, the surface of the femoral condyle prosthesis 210 that is in frictional contact with the tibial plateau pad prosthesis 230 is provided with a metal-ceramic interface. The surfaces of the tibial plateau pad prosthesis 230 that are in frictional contact with both the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 are also provided with metal-ceramic interfaces. Furthermore, the distance between the lowest point of the upper surface and the lower surface of the tibial plateau pad prosthesis 230 is 1mm-10mm. It should be noted that the metal-ceramic interfaces between the frictional contact surfaces of the femoral condyle prosthesis 210, the tibial plateau prosthesis 220, and the tibial plateau pad prosthesis 230 are all formed by the oxidation of zirconium and niobium surfaces, and the thickness of the metal-ceramic interfaces is 3μm-35μm.

[0053] For smooth friction interfaces of prostheses, traditional tribological views hold that the smoother the surface, the less friction. Surface microtextures have a significant impact on reducing interfacial friction and wear. With the further development of bionics, it has been discovered that in the long process of evolution, organisms develop special microstructures on their body surfaces to adapt to harsh environments and protect themselves from harm. Examples include the barbs on the body surface of pigeons, the skin texture of sharks, and the scales on the body surface of desert lizards. The existence of these microstructures can effectively reduce friction and wear on the contact surface. Microtextures have been proven to be an effective means of forming anti-friction and friction-reducing surfaces. Experimental tests show that non-smooth surfaces with certain regular shapes in the biological world have the effect of improving surface lubrication and anti-adhesion friction reduction. The type, distribution, and size of surface microtextures have a significant impact on the tribological performance of the friction pair. Under lubrication conditions, designing and processing reasonable surface microtextures can effectively improve the friction performance of the friction pair, achieving the effect of reducing drag and wear. Therefore, based on the aforementioned structure, in this embodiment, the friction contact surfaces between the femoral condyle prosthesis 210 and the tibial plateau pad prosthesis 230, and between the tibial plateau prosthesis 220 and the tibial plateau pad prosthesis... The friction contact surfaces of the 230 alloy are all equipped with microtextured structures. These microtextured structures are created by laser machining on a dense solid structure before the zirconium-niobium alloy is oxidized to form a metal-ceramic interface. The microtextured structures not only enhance the bonding force between the metal-ceramic interface and the zirconium-niobium alloy body but also reduce frictional wear on the contact surfaces. Furthermore, the microtextured structures can be fabricated using one or more of the following mechanical methods: micro-milling, turning, and laser processing, resulting in micron-scale and / or nano-scale microtextures. Moreover, the surface microtextures... The type, distribution, and size of the structure can be different, thus obtaining concave or convex microstructures of different shapes, or multi-level scale composite structures, on the surface of zirconium-niobium alloy solids. Among them, when microtexture structures are configured between the friction contact surfaces of the femoral condyle prosthesis 210 and the tibial plateau pad prosthesis 230, and when microtexture structures are configured between the friction contact surfaces of the tibial plateau prosthesis 220 and the tibial plateau pad prosthesis 230, single-sided configuration or double-sided configuration can be adopted, that is, microtexture structures can be set simultaneously between the two contact friction surfaces or one of the surfaces can be selected to set microtexture structures.

[0054] In this embodiment, a double-sided configuration of microtexture structure is adopted. Specifically, the surface of the femoral condyle prosthesis 210 that is in frictional contact with the tibial plateau pad prosthesis 230 is configured with a microtexture structure, the surface of the tibial plateau pad prosthesis 230 that is in frictional contact with both the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 is configured with a microtexture structure, and the surface of the tibial plateau prosthesis 220 that is in frictional contact with the tibial plateau pad prosthesis 230 is configured with a microtexture structure.

[0055] Taking microtexture (a surface with micro-concave or micro-convex shapes arranged according to a certain pattern) as an example, it can maintain a series of qualities of implant materials, keeping the material itself unchanged, while significantly improving the overall performance of the material. The lubrication state between friction pairs in an artificial hip joint is determined by the interaction between biomolecules in the synovial fluid and the artificial joint, and this interaction is related to the wettability of the material. Wettability characterizes the ability of a liquid to spread on a solid surface. The hydrophilicity and hydrophobicity of a surface can be defined by the contact angle θ. When θ < 90°, the material surface is hydrophilic, and vice versa when θ ≥ 90°. Wettability affects the wetting of the lubricating fluid on the hip joint surface and the slip characteristics of the interface. For implantable biomaterials, the friction and wear of the implanted prosthesis contact interface will occur in the physiological tissue fluid. Therefore, microtexture has the following advantages in reducing friction and wear:

[0056] The micro-textured structure of the micro-pits can store the wear debris generated during friction, avoiding the formation of three-body wear, which is extremely detrimental to the friction process, by the rough peaks and abrasive grains on the contact mating surfaces. The micro-textured structure of the micro-pits can store joint fluid, which can change the boundary lubrication state between the friction pairs to a mixed lubrication state, or even a fluid lubrication state. The fluid dynamic pressure generated enhances the bearing capacity of the lubricating film and improves the friction lubrication state. The presence of the micro-textured structure increases the bonding strength of the zirconium-niobium alloy oxide layer.

[0057] Based on the aforementioned integrated unicompartmental prosthesis system 200, please refer to... Figures 1-4 The present invention also provides a method for preparing an integrated unicompartmental prosthesis system, used to prepare an integrated unicompartmental prosthesis system 200 as described in any of the foregoing embodiments. When the femoral condyle prosthesis 210, the tibial plateau prosthesis 220, and the tibial plateau pad prosthesis 230 are all 3D printed from zirconium-niobium alloy, the preparation steps of the femoral condyle prosthesis 210, the tibial plateau prosthesis 220, and the tibial plateau pad prosthesis 230 include:

[0058] Using zirconium-niobium alloy powder as raw material, with a particle diameter of 5μm-150μm, magnesium metal particles of 5-10μm are added to the zirconium-niobium alloy powder in the trabecular bone structure part. The magnesium metal accounts for 1%-5% of the volume of the zirconium-niobium alloy powder. The first femoral condyle sample, the first tibial plateau sample, and the first tibial plateau pad sample are obtained by 3D printing in one piece.

[0059] The first femoral condyle sample, the first tibial plateau sample, and the first tibial plateau pad sample were placed in a hot isostatic pressing furnace and heated to 1250℃-1400℃ under helium or argon protection. They were then kept at a constant temperature of 40MPa-180MPa for 1-3 hours, then cooled to atmospheric pressure and removed from the furnace at a temperature below 200℃ to obtain the second femoral condyle sample, the second tibial plateau sample, and the second tibial plateau pad sample.

[0060] The second femoral condyle sample, the second tibial plateau sample, and the second tibial plateau pad sample were placed in a programmed cooling box and cooled to -80℃ to -120℃ at a rate of 1℃ / min. They were kept at this temperature for 5-10 hours and then removed from the programmed cooling box. They were then placed in liquid nitrogen for 16-36 hours and the temperature was adjusted to room temperature to obtain the third femoral condyle sample, the third tibial plateau sample, and the third tibial plateau pad sample.

[0061] The third femoral condyle sample, the third tibial plateau sample, and the third tibial plateau pad sample were placed in a programmed cooling box and cooled to -80℃ to -120℃ at a rate of 1℃ / min, and kept at this temperature for 5-10 hours. They were then removed from the programmed cooling box and placed in liquid nitrogen for 16-36 hours, with the temperature adjusted to room temperature. This yielded the fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample.

[0062] The fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample were machined, polished, cleaned, and dried to obtain the fifth femoral condyle sample, the fifth tibial plateau sample, and the fifth tibial plateau pad sample.

[0063] The fifth femoral condyle sample, the fifth tibial plateau sample, and the fifth tibial plateau pad sample were placed in a tube furnace and inert gas with an oxygen content of 5%-15% by mass was introduced. The furnace was heated to 500-700℃ at 5℃ / min-20℃ / min, cooled to 400-495℃ at 0.4℃ / min-0.9℃ / min, and then allowed to cool naturally to below 200℃ before being removed, yielding the femoral condyle prosthesis 210, the tibial plateau prosthesis 220, and the tibial plateau pad prosthesis 230.

[0064] When the tibial plateau pad prosthesis 230 is manufactured from a zirconium-niobium alloy forging, the preparation steps of the tibial plateau pad prosthesis 230 include:

[0065] The zirconium-niobium alloy forgings were machined, trimmed, polished, cleaned and dried to obtain a tibial plateau pad forging sample.

[0066] The tibial plateau pad forging sample was placed in a tube furnace and introduced with atmospheric pressure helium or argon gas containing 5%-15% oxygen by mass. It was heated to 500℃-700℃ at 5℃ / min-20℃ / min, cooled to 400℃-495℃ at 0.4℃ / min-0.9℃ / min, and then naturally cooled to below 200℃ before being removed to obtain the tibial plateau pad prosthesis 230.

[0067] It should be noted that, as described above, since both the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 are 3D printed from zirconium-niobium alloy, while the tibial plateau pad prosthesis 230 is either 3D printed from zirconium-niobium alloy or made from zirconium-niobium alloy forgings, the tibial plateau pad prosthesis 230 can be manufactured using either zirconium-niobium alloy 3D printing or zirconium-niobium alloy forging. Therefore, when using zirconium-niobium alloy 3D printing, it can be manufactured simultaneously with the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 to improve manufacturing efficiency. However, when the tibial plateau pad prosthesis 230 is made from zirconium-niobium alloy forgings, the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 need to be 3D printed, and the steps are the same as described above; therefore, they will not be described separately here.

[0068] Further, please refer to Figures 1-4 As can be seen from the above, in this embodiment, a double-sided microtexture structure is adopted. That is, the surface of the femoral condyle prosthesis 210 that is in frictional contact with the tibial plateau pad prosthesis 230 is equipped with a microtexture structure; the surface of the tibial plateau pad prosthesis 230 that is in frictional contact with both the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220 is equipped with a microtexture structure; and the surface of the tibial plateau prosthesis 220 that is in frictional contact with the tibial plateau pad prosthesis 230 is equipped with a microtexture structure. Therefore, when the tibial plateau pad prosthesis 230 is manufactured using zirconium-niobium alloy 3D printing, after machining, polishing, cleaning, and drying the fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample, the integrated unicompartmental prosthesis system preparation method further includes:

[0069] Microtexture structures are fabricated on the surface of the fourth femoral condyle remnant that is in frictional contact with the tibial plateau pad prosthesis 230; microtexture structures are fabricated on the surface of the fourth tibial plateau remnant that is in frictional contact with the tibial plateau pad prosthesis 230; microtexture structures are fabricated on the surface of the fourth tibial plateau pad remnant that is in frictional contact with the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220.

[0070] When the tibial plateau pad prosthesis 230 is manufactured from a zirconium-niobium alloy forging, after machining, trimming, polishing, cleaning, and drying the zirconium-niobium alloy forging to obtain the tibial plateau pad forging sample, the preparation method of the integrated unicompartmental prosthesis system also includes:

[0071] Microtexture structures were fabricated on the surfaces of the tibial plateau pad forging sample that correspond to the surfaces in frictional contact with the femoral condyle prosthesis 210 and the tibial plateau prosthesis 220.

[0072] It should be noted that, based on the presence of microtexture structures on the friction contact surfaces between the femoral condyle prosthesis 210 and the tibial plateau pad prosthesis 230, and between the tibial plateau prosthesis 220 and the tibial plateau pad prosthesis 230, when the tibial plateau pad prosthesis 230 is fabricated using the aforementioned zirconium-niobium alloy 3D printing or zirconium-niobium alloy forging method, the surface roughness of the tibial plateau pad prosthesis 230, excluding the microtexture structures, is Ra≤0.050μm.

[0073] Based on the above, please refer to Figures 1-4 The integrated unicompartmental prosthesis system 200 and its fabrication method have the following advantages:

[0074] Compared to traditional unicompartmental prosthesis systems, the tibial plateau pad is made of ultra-high molecular weight polyethylene, while the zirconium-niobium alloy tibial plateau pad saves more tibial plateau osteotomy, preserving more bone volume for patients in further revision surgery; the zirconium-niobium alloy tibial plateau pad can avoid the risk of osteolysis caused by debris generated by ultra-high molecular weight polyethylene wear, which could lead to prosthesis loosening.

[0075] The integrated unicompartmental prosthesis system 200 is made entirely of zirconium-niobium alloy. Its friction interface is a ceramic layer with microtexture, which is more wear-resistant. Furthermore, the friction interface between the structures and the osseointegration interface between the structure and the external bone body are integrated into a dual function, which can improve the wear resistance and long-term stability of the prosthesis.

[0076] The 3D-printed integrated prosthesis contains magnesium and magnesium oxide within its trabecular bone structure, which can release magnesium ions to promote osteogenesis.

[0077] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. An integrated unicompartmental prosthesis system, characterized in that... : The integrated unicompartmental prosthesis system includes a femoral condyle prosthesis, a tibial plateau prosthesis, and a tibial plateau pad prosthesis; Both the femoral condyle prosthesis and the tibial plateau prosthesis are 3D printed from zirconium-niobium alloy; the tibial plateau pad prosthesis is either 3D printed from zirconium-niobium alloy or made from a zirconium-niobium alloy forging. The femoral condyle prosthesis abuts against the upper surface of the tibial plateau pad prosthesis, the upper surface of the tibial plateau prosthesis abuts against the lower surface of the tibial plateau pad prosthesis, and a metal-ceramic interface is provided between the friction contact surfaces of the femoral condyle prosthesis and the tibial plateau pad prosthesis and between the friction contact surfaces of the tibial plateau prosthesis and the tibial plateau pad prosthesis. The osteointegration interfaces of the femoral condyle prosthesis, the tibial plateau prosthesis, and the tibial plateau pad prosthesis are all 3D-printed trabecular bone structures; The femoral condyle prosthesis has the metal-ceramic interface on the surface that is in frictional contact with the tibial plateau pad prosthesis. The tibial plateau pad prosthesis has the metal-ceramic interface on the surface that is in frictional contact with both the femoral condyle prosthesis and the tibial plateau prosthesis. The tibial plateau prosthesis has the metal-ceramic interface on the surface that is in frictional contact with the tibial plateau pad prosthesis. The metal-ceramic interface is 3μm-35μm thick; The distance between the lowest point of the upper surface and the lower surface of the tibial plateau pad prosthesis is 1mm-10mm; Microtextile structures are provided between the friction contact surfaces of the femoral condyle prosthesis and the tibial plateau pad prosthesis, as well as between the friction contact surfaces of the tibial plateau prosthesis and the tibial plateau pad prosthesis.

2. The integrated unicompartmental prosthesis system according to claim 1, characterized in that... : The femoral condyle prosthesis has the microtextural structure on the surface that is in frictional contact with the tibial plateau pad prosthesis. The tibial plateau pad prosthesis also has the microtextural structure on the surface that is in frictional contact with both the femoral condyle prosthesis and the tibial plateau prosthesis. The tibial plateau prosthesis also has the microtextural structure on the surface that is in frictional contact with the tibial plateau pad prosthesis.

3. A method for fabricating an integrated unicompartmental prosthesis system, used to fabricate the integrated unicompartmental prosthesis system as described in claim 1 or 2, characterized in that: When the femoral condyle prosthesis, the tibial plateau prosthesis, and the tibial plateau pad prosthesis are all 3D printed from zirconium-niobium alloy, the preparation steps of the femoral condyle prosthesis, the tibial plateau prosthesis, and the tibial plateau pad prosthesis include: Using zirconium-niobium alloy powder as raw material, the particle diameter of the powder is 5μm-150μm. Magnesium metal particles of 5-10μm are added to the zirconium-niobium alloy powder used to print the trabecular bone structure. The magnesium metal accounts for 1%-5% of the volume of the zirconium-niobium alloy powder. The first femoral condyle sample, the first tibial plateau sample, and the first tibial plateau pad sample are obtained by 3D printing in one piece. The first femoral condyle sample, the first tibial plateau sample, and the first tibial plateau pad sample were placed in a hot isostatic pressing furnace and heated to 1250℃-1400℃ under helium or argon protection. They were then kept at a constant temperature of 40MPa-180MPa for 1-3 hours, then cooled to atmospheric pressure and removed from the furnace at a temperature below 200℃ to obtain the second femoral condyle sample, the second tibial plateau sample, and the second tibial plateau pad sample. The second femoral condyle sample, the second tibial plateau sample, and the second tibial plateau pad sample were placed in a programmed cooling box and cooled to -80℃ to -120℃ at a rate of 1℃ / min. They were kept at this temperature for 5-10 hours and then removed from the programmed cooling box. They were then placed in liquid nitrogen for 16-36 hours and the temperature was adjusted to room temperature to obtain the third femoral condyle sample, the third tibial plateau sample, and the third tibial plateau pad sample. The third femoral condyle sample, the third tibial plateau sample, and the third tibial plateau pad sample were placed in the programmed cooling box and cooled to -80℃ to -120℃ at a rate of 1℃ / min, and kept at this temperature for 5-10 hours. They were then removed from the programmed cooling box and placed in liquid nitrogen for 16-36 hours, with the temperature adjusted to room temperature. This yielded the fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample. The fourth femoral condyle sample, the fourth tibial plateau sample, and the fourth tibial plateau pad sample are machined, polished, cleaned, and dried to obtain the fifth femoral condyle sample, the fifth tibial plateau sample, and the fifth tibial plateau pad sample. The fifth femoral condyle sample, the fifth tibial plateau sample, and the fifth tibial plateau pad sample are placed in a tube furnace and inert gas with an oxygen content of 5%-15% by mass is introduced. The furnace is heated to 500℃-700℃ at a rate of 5℃ / min-20℃ / min, cooled to 400℃-495℃ at a rate of 0.4℃ / min-0.9℃ / min, and then allowed to cool naturally to below 200℃ before being removed to obtain the femoral condyle prosthesis, the tibial plateau prosthesis, and the tibial plateau pad prosthesis. When the tibial plateau pad prosthesis is made from a zirconium-niobium alloy forging, the preparation steps of the tibial plateau pad prosthesis include: The zirconium-niobium alloy forging was machined, trimmed, polished, cleaned and dried to obtain a tibial plateau pad forging sample. The tibial plateau pad forging sample is placed in a tube furnace, and atmospheric pressure helium or argon gas with an oxygen mass percentage of 5%-15% is introduced. It is heated to 500℃-700℃ at 5℃ / min-20℃ / min, cooled to 400℃-495℃ at 0.4℃ / min-0.9℃ / min, and then naturally cooled to below 200℃ before being removed to obtain the tibial plateau pad prosthesis.

4. The method for fabricating an integrated unicompartmental prosthesis system according to claim 3, characterized in that: After the steps of machining, polishing, cleaning, and drying the fourth femoral condyle specimen, the fourth tibial plateau specimen, and the fourth tibial plateau pad specimen, the method for preparing the integrated unicompartmental prosthesis system further includes: Microtexture structures are fabricated on the surface of the fourth femoral condyle specimen that is in frictional contact with the tibial plateau pad prosthesis; microtexture structures are fabricated on the surface of the fourth tibial plateau specimen that is in frictional contact with the tibial plateau pad prosthesis; microtexture structures are fabricated on the surface of the fourth tibial plateau pad specimen that is in frictional contact with both the femoral condyle prosthesis and the tibial plateau prosthesis.

5. The method for fabricating an integrated unicompartmental prosthesis system according to claim 3, characterized in that: After the step of machining, trimming, polishing, cleaning, and drying the zirconium-niobium alloy forging to obtain a tibial plateau pad forging sample, the method for preparing the integrated unicompartmental prosthesis system further includes: Microtexture structures are fabricated on the surfaces of the tibial plateau pad forging sample that are in frictional contact with the femoral condyle prosthesis and the tibial plateau prosthesis.

6. A method for fabricating an integrated unicompartmental prosthesis system according to claim 4 or 5, characterized in that: The surface roughness of the tibial plateau pad prosthesis, excluding the microtexture structure, is Ra≤0.050μm.

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