Metal total knee artificial joint and method for preparing metal total knee artificial joint

Abstract

The present invention relates to the technical field of orthopedic artificial joints, and in particular, to a metal total knee artificial joint and a method for preparing a metal total knee artificial joint. The metal total knee artificial joint comprises a femoral condyle prosthesis and a tibial plateau prosthesis. Both the femoral condyle prosthesis and the tibial plateau prosthesis are made of 3D printing of zirconium-niobium alloy. The two can be slidably matched, and the sliding contact surface of the femoral condyle prosthesis and the tibial plateau prosthesis is provided with a metal-ceramic interface; the integration interface of the femoral condyle prosthesis and the tibial plateau prosthesis with the external bone body is a 3D-printed trabecular integration interface. The metal total knee artificial joint eliminates the tibial plateau pad prosthesis, and through the metal-ceramic interface, it can reduce the amount of osteotomy of the tibial plateau and optimize the wear of the friction interface, thereby avoiding the risk of osteolysis caused by debris generated by wear, which in turn causes the prosthesis to loosen. It can also improve the bone integration efficiency of the interface between the prosthesis and the bone tissue, which is beneficial to the stability of the prosthesis in the later stage of implantation.

Description

Technical Field

[0001] The present invention relates to the technical field of orthopedic artificial joints, and in particular to a metal total knee artificial joint and a method for preparing the metal total knee artificial joint. Background Art

[0002] Joint replacement is a surgical procedure aimed at restoring joint function, relieving pain, and improving the patient's quality of life. Although the procedure and technique are standardized, various complications often occur, leading to surgical failure and the need for revision surgery. Loosening of the prosthesis-bone interface is the primary cause of prosthesis failure, and the causes of prosthesis loosening are complex. Aseptic loosening is the most common postoperative complication.

[0003] Among the causes of joint prosthesis failure, active wear is one of the main causes of aseptic loosening. According to statistics, within 10 years after artificial joint replacement surgery, the proportion of active wear failure is about 50-60%. With the increase of service life, the proportion of active wear failure will gradually increase. In addition, during the wear process of artificial joints, the wear debris of their ultra-high molecular weight polyethylene components spreads to the surrounding tissues, which will induce bone dissolution and cause prosthesis loosening. Summary of the Invention

[0004] The objectives of the present invention include, for example, providing a metal total knee artificial joint and a method for preparing a metal total knee artificial joint, which eliminates the tibial plateau pad prosthesis and, through a metal-ceramic interface, can reduce the amount of osteotomy of the tibial plateau and optimize the wear of the friction interface, thereby avoiding the risk of bone dissolution caused by debris generated by wear, which in turn causes prosthesis loosening. It can also improve the bone integration efficiency of the interface between the prosthesis and bone tissue, which is beneficial to the stability of the prosthesis in the later stage of implantation.

[0005] The embodiments of the present invention can be implemented as follows:

[0006] In a first aspect, the present invention provides a metal total knee artificial joint, comprising a femoral condyle prosthesis and a tibial plateau prosthesis, both of which are made by 3D printing of zirconium-niobium alloy;

[0007] The femoral condyle prosthesis and the tibial plateau prosthesis are slidably matched, and the sliding contact surfaces of the femoral condyle prosthesis and the tibial plateau prosthesis are provided with a metal-ceramic interface;

[0008] The integration interfaces of the femoral condyle prosthesis and the tibial plateau prosthesis with the external bone are both 3D-printed trabecular integration interfaces.

[0009] In an alternative embodiment, the metal-ceramic interface is 3 μm to 35 μm thick.

[0010] In an optional embodiment, a micro-texture structure is provided between the friction contact surfaces of the femoral condyle prosthesis and the tibial plateau prosthesis, and the micro-texture structure is located on the surface of the femoral condyle prosthesis for contacting the tibial plateau prosthesis or the surface of the tibial plateau prosthesis for contacting the femoral condyle prosthesis.

[0011] In an optional embodiment, the pores of the trabecular integration interfaces of the femoral condyle prosthesis and the tibial plateau prosthesis are filled with hydrogel.

[0012] In an optional embodiment, the femoral condyle prosthesis is also configured with a femoral condyle articular surface for slidably engaging with the tibial plateau prosthesis; the femoral condyle articular surface has an arc-shaped contour, and the femoral condyle articular surface includes an anterior condyle surface, a posterior condyle surface and an intercondylar fossa, and the trabecular integration interface of the femoral condyle prosthesis is located between the anterior condyle surface and the posterior condyle surface.

[0013] In an optional embodiment, the tibial plateau prosthesis is further configured with a kidney-shaped platform support, a limiting column and a connecting handle; two intermediate concave surfaces are provided on the surface of the kidney-shaped platform support, and the two intermediate concave surfaces slide together with the articular surface of the femoral condyle; the limiting column is located between the two intermediate concave surfaces and is connected to the intercondylar fossa; the connecting handle is connected to the lower surface of the kidney-shaped platform support, and the connection between the connecting handle and the kidney-shaped platform support is located in the middle of the lower surface of the kidney-shaped platform support.

[0014] In a second aspect, the present invention provides a method for preparing a metal total knee artificial joint, which is used to prepare the above-mentioned metal total knee artificial joint, comprising:

[0015] Using zirconium-niobium alloy powder as raw material, a first femoral condyle sample and a first tibial plateau sample are integrally formed by 3D printing. The first femoral condyle sample and the first tibial plateau sample are placed in a hot isostatic pressing furnace. Under the protection of helium or argon, the temperature is raised to 1250°C-1400°C, and the pressure is kept constant at 140MPa-180MPa for 1 hour-3 hours. The pressure is then reduced to normal pressure, and the sample is removed from the furnace after cooling to below 200°C, thereby obtaining a second femoral condyle sample and a second tibial plateau sample.

[0016] The second femoral condyle sample and the second tibial plateau sample were placed in a programmed cooling box and cooled at a rate of 1°C / min to -80°C to -120°C, kept at a constant temperature for 5-10 hours, and then removed from the programmed cooling box; the samples were placed in liquid nitrogen for another 16-36 hours, and the temperature was adjusted to room temperature to obtain a third femoral condyle sample and a third tibial plateau sample;

[0017] The third femoral condyle sample and the third tibial plateau sample were placed in a programmed cooling box and cooled to -80°C to -120°C at a rate of 1°C / min, and kept at a constant temperature for 5-10 hours; the samples were taken out of the programmed cooling box; and the samples were placed in liquid nitrogen for another 16-36 hours, and then the temperature was adjusted to room temperature to obtain the fourth femoral condyle sample and the fourth tibial plateau sample;

[0018] machining, trimming, polishing, cleaning and drying the fourth femoral condyle sample and the fourth tibial plateau sample to obtain a fifth femoral condyle sample and a fifth tibial plateau sample;

[0019] The fifth femoral condyle sample and the fifth tibial plateau sample were placed in a tube furnace, and an inert gas with an oxygen mass percentage of 5%-15% at normal pressure was introduced. The samples were heated to 500°C-700°C at 5°C / min-20°C / min, cooled to 400°C-495°C at 0.4°C / min-0.9°C / min, and then naturally cooled to below 200°C and taken out to obtain the femoral condyle prosthesis and tibial plateau prosthesis.

[0020] In an optional embodiment, the particle diameter of the zirconium-niobium alloy powder is 5 μm-150 μm, and when printing the trabecular integration interface of the femoral condyle prosthesis and the tibial plateau prosthesis, 5 μm-10 μm magnesium metal particles are added to the zirconium-niobium alloy powder, and the magnesium metal particles account for 1%-5% of the volume of the zirconium-niobium alloy powder.

[0021] In an optional embodiment, the method for preparing a metal total knee artificial joint further includes immersing the femoral condyle prosthesis and the tibial plateau prosthesis in a hydrogel container respectively, so that the hydrogel fills the pores of the trabecular integration interface.

[0022] In an optional embodiment, after machining, finishing, polishing, cleaning and drying the fourth femoral condyle sample and the fourth tibial plateau sample, the method for preparing a metal total knee artificial joint further comprises:

[0023] A micro-texture structure is produced on the surface of the femoral condyle prosthesis that is used to contact the tibial plateau prosthesis or the surface of the tibial plateau prosthesis that is used to contact the femoral condyle prosthesis.

[0024] The beneficial effects of the embodiments of the present invention include:

[0025] This metal total knee prosthesis includes a femoral condyle prosthesis and a tibial plateau prosthesis, both of which are 3D-printed from a zirconium-niobium alloy. The femoral condyle prosthesis and tibial plateau prosthesis are slidably mated, and the sliding contact surfaces of the femoral condyle prosthesis and tibial plateau prosthesis are provided with a metal-ceramic interface. The integration interfaces of the femoral condyle prosthesis and tibial plateau prosthesis with external bone are both 3D-printed trabecular bone integration interfaces. This metal total knee prosthesis eliminates the tibial plateau pad prosthesis and, by forming a metal-ceramic interface on the sliding contact surfaces of the femoral condyle prosthesis and tibial plateau prosthesis, reduces the amount of tibial plateau osteotomy and optimizes the wear of the friction interface, thereby avoiding the risk of osteolysis caused by wear debris and the subsequent loosening of the prosthesis. The trabecular bone integration interface of the femoral condyle prosthesis and tibial plateau prosthesis improves the efficiency of bone integration between the prosthesis and bone tissue, facilitating the stability of the prosthesis after implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0027] Figure 1 This is a schematic structural diagram of a metal total knee artificial joint from a first perspective according to an embodiment of the present invention;

[0028] Figure 2 This is a schematic structural diagram of a metal total knee artificial joint from a second perspective according to an embodiment of the present invention;

[0029] Figure 3 This is a schematic structural diagram of a metal total knee artificial joint from a third perspective in an embodiment of the present invention;

[0030] Figure 4 2. It is a schematic structural diagram of a metal total knee artificial joint from a fourth perspective according to an embodiment of the present invention;

[0031] Figure 5 Schematic diagram of the structure of the tibial plateau prosthesis in an embodiment of the present invention;

[0032] Figure 6 Schematic diagram of the configuration of the trabecular integration interface in an embodiment of the present invention;

[0033] Figure 7 Schematic diagram of a circular pit micro-texture structure in an embodiment of the present invention;

[0034] Figure 8 Schematic diagram of a square pit micro-texture structure in an embodiment of the present invention;

[0035] Figure 9 Schematic diagram of circular and square pit micro-texture structures in an embodiment of the present invention.

[0036] Icons: 100-metal total knee prosthesis; 110-femoral condyle prosthesis; 120-tibial plateau prosthesis; 101-trabecular integration interface; 102-microtexture structure; 111-femoral condyle articular surface; 112-anterior condyle surface; 113-posterior condyle surface; 114-intercondylar fossa; 121-kidney-shaped platform support; 122-limiting column; 123-connecting handle; 124-middle concave surface. DETAILED DESCRIPTION

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings herein can be arranged and designed in various different configurations.

[0038] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort shall fall within the scope of protection of the present invention.

[0039] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0040] In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the accompanying drawings, or is the orientation or position relationship in which the product of the invention is usually placed when in use. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be understood as a limitation on the present invention.

[0041] In addition, the terms "first", "second", etc., if used, are merely used to distinguish and describe, and should not be understood as indicating or implying relative importance.

[0042] It should be noted that, in the absence of conflict, the features in the embodiments of the present invention may be combined with each other.

[0043] Please refer to Figures 1-6This embodiment provides a metal total knee artificial joint 100, which includes a femoral condyle artificial body 110 and a tibial plateau artificial body 120. The femoral condyle artificial body 110 and the tibial plateau artificial body 120 are both made of zirconium-niobium alloy 3D printing;

[0044] The femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are slidably matched, and the sliding contact surface of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 is provided with a metal-ceramic interface;

[0045] The integration interfaces of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 with the external bone are both 3D-printed trabecular integration interfaces 101 .

[0046] It should be noted that, as can be seen from the above content, the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 can be slidably matched, thereby eliminating the tibial plateau pad prosthesis in the metal total knee artificial joint 100, so that the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 directly form a contact and friction interface; and because the integration interfaces of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 with the external bone body are both 3D-printed trabecular integration interfaces 101, therefore, the other parts of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are all dense solid structures of zirconium-niobium alloy.

[0047] Please refer to Figures 1-6 The working principle of the metal total knee artificial joint 100 is:

[0048] The metal total knee prosthesis 100 is used for joint replacement and includes a femoral condyle prosthesis 110 and a tibial plateau prosthesis 120. The femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are slidably matched. Thus, the metal total knee prosthesis 100 eliminates the tibial plateau pad prosthesis. The femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are both made of zirconium-niobium alloy 3D printing, and the sliding contact surface of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 is provided with a metal-ceramic interface. Therefore, by forming the metal-ceramic interface on the sliding contact surface of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120, the amount of tibial plateau osteotomy can be reduced, the amount of friction interface wear can be optimized, and the risk of osteolysis caused by debris generated by wear and tear, which in turn causes prosthesis loosening, can be avoided.

[0049] In addition, the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are both integrated with external bone bodies using 3D-printed trabecular bone integration interfaces 101. The trabecular bone integration interfaces 101 of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 can improve the efficiency of bone integration between the prosthesis and bone tissue, which is beneficial for the stability of the prosthesis after implantation.

[0050] In summary, the metal total knee prosthesis 100 can reduce the amount of bone resection, and the retained bone volume can increase the bonding force of the bone-tibial plateau prosthesis 120, thereby enhancing the fixation of the prosthesis.

[0051] For further information, please refer to Figures 1-6 In this embodiment, the metal-ceramic interface has a thickness of 3μm-35μm. Furthermore, magnesium metal particles are present within the trabecular integration interface 101. This is because 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, particularly mineral metabolism, including promoting bone cell calcification and proliferation. Numerous research reports have confirmed that Mg alloys, Mg-doped bioceramics, or Mg-doped biodegradable polymers for bone regeneration can promote osteogenic differentiation and stimulate osteogenesis. In addition to the inherent properties of the materials themselves, the Mg2+ released from these bone substitutes also has an osteogenic effect. Therefore, the trabecular integration interface 101 can also release magnesium ions after implantation, further facilitating the integration of the prosthesis with the bone interface.

[0052] For the smooth friction interface of prostheses, the traditional tribological view is that the smoother the surface, the less friction, and surface microtexture has an important influence on reducing interface friction and wear. With the further development of bionics, it is found that in the long-term evolution process, in order to adapt to harsh environments and protect themselves from damage, organisms will form special microstructures on their body surfaces, such as the feathers on the surface of homing pigeons, the skin texture of sharks, and the scales on the surface of desert lizards. The existence of these microstructures can effectively reduce the friction and wear of the contact surface. Microtexture has been proven to be an effective means of forming anti-resistance and friction-reducing surfaces. Experimental tests have shown that non-smooth surfaces with certain regular shapes in the biological world have the effect of improving surface lubrication and anti-sticking and friction-reducing. The type, distribution and size of surface microtexture have an important influence on the tribological properties of the friction pair. Under lubrication conditions, the design and processing of reasonable surface microtexture can effectively improve the friction performance of the friction pair and play a role in reducing drag and wear. Therefore, please refer to Figures 1-9 In this embodiment, a micro-texture structure 102 is provided between the friction contact surfaces of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120. The micro-texture structure 102 is located on the surface of the femoral condyle prosthesis 110 for contacting the tibial plateau prosthesis 120 or the surface of the tibial plateau prosthesis 120 for contacting the femoral condyle prosthesis 110. That is, the micro-texture structure 102 can be on one side or both sides. Moreover, the micro-texture structure 102 is machined on a dense solid structure before the zirconium-niobium alloy is oxidized, and then the zirconium-niobium alloy is oxidized to form a metal-ceramic interface. Moreover, when manufacturing the micro-texture structure 102, one or more of micro-milling, turning and laser processing mechanical methods can be used to prepare micron-scale micro-textures and / or nano-scale micro-textures, wherein the type, distribution and size of the surface micro-texture can be different, such as Figure 7-Figure 9As shown, a concave or convex microstructure of varying shapes, or a multi-scale composite structure, is formed on the surface of the zirconium-niobium alloy. In this embodiment, using laser processing as an example, microtexture 102 (a surface with micro-concave or micro-convex shapes arranged in a certain pattern) can both maintain a range of implant material qualities without altering the material itself and significantly improve the material's overall performance.

[0053] Since the lubrication state between the friction pairs of artificial hip joints is determined by the interaction between the biomolecules in the synovial fluid and the artificial joint, and this interaction is related to the wettability of the material, wettability is a characterization of the ability of a liquid to spread on a solid surface. The hydrophilicity and hydrophobicity of the surface can be defined by the size of the contact angle θ. When θ<90°, the material surface is hydrophilic, and when θ≥90°, the wettability will affect the infiltration of the lubricating fluid on the surface of the hip joint and the slip characteristics of the interface. For implantable biomaterials, the friction and wear of the contact interface of the implanted prosthesis will be carried out in the physiological tissue fluid. Therefore, on the basis of the aforementioned micro-texture structure 102, the presence of the micro-texture structure 102 can reduce friction and wear: its micro-pits can store wear debris generated during the friction process, avoiding the three-body wear caused by the rough peaks and abrasive particles on the contact pair surfaces, which is extremely unfavorable to the friction process; its micro-pits can store joint fluid, so that the friction pair is transformed from a boundary lubrication state to a mixed lubrication state, or even a fluid lubrication state; the generated fluid dynamic pressure enhances the bearing capacity of the lubricating film and improves the friction lubrication state; the presence of the micro-texture structure 102 increases the bonding strength of the zirconium-niobium alloy oxide layer.

[0054] Hydrogel is a cross-linked polymer with a three-dimensional network structure that absorbs a large amount of water but is insoluble in water. Due to its closeness to the extracellular matrix, it has good hydrophilicity, excellent swelling properties and biocompatibility, etc., and has broad application prospects in the fields of biomedicine and tissue engineering materials. For example, hydrogel can be used as a medical device for wound dressing, adhesion, sealing and anti-leakage during surgery, hemostasis during surgery, tissue filling, anti-adhesion after surgery, or it can be used to uniformly wrap cells, proteins, peptides, hormones and other bioactive substances and drug carriers and tissue engineering materials in biomedical fields. According to the gelation mode of hydrogel, it can be divided into in vitro gel and in vivo in situ gel. In vivo in situ gel has the advantage of injectability. It uses an injectable hydrogel precursor solution with good fluidity to form a hydrogel by in situ crosslinking under physiological conditions. It can be used not only for open surgery but also for minimally invasive surgery and even to avoid surgical operations. Only a very small needle is used for in situ injection, which reduces damage to the patient. According to the formation principle of hydrogels, they can be divided into two categories: chemically cross-linked hydrogels and physically cross-linked hydrogels. Physical cross-linking is mainly formed by intermolecular interaction forces (van der Waals forces, hydrophobic interactions, charge interactions, hydrogen bonds, etc.). Since this type of gel does not involve chemical reactions during its formation process, it forms quickly and is simpler and safer to use. In particular, thermosensitive injectable polymer hydrogels have been widely studied for medical purposes. This type of thermosensitive gel remains liquid at low temperatures, can evenly encapsulate cells / drugs, and does not require surgical implantation, thereby improving patient compliance. Once it enters the body at 37°C, it quickly forms a gel to avoid the loss of cells and bioactive molecules, promoting repair and regeneration of damaged areas. Because temperature response is the relatively easiest and most effective response, this type of smart hydrogel has attractive development prospects in the fields of biomedicine and tissue engineering materials.

[0055] The self-healing mechanism commonly employed by self-healing hydrogels is based on reversible intermolecular interactions, meaning that the bonds between polymers can be broken and reconstructed. Common intermolecular interactions include hydrogen bonds, coordination effects of metal ion ligands, electrostatic interactions, or hydrophobic interactions. Colloidal gel self-healing materials are attracting significant attention as emerging material systems. The design of composite materials with organic / inorganic components is a common approach to enhancing mechanical properties and can also impart greater functionality to material systems. For example, a silica / gelatin composite colloidal gel has both high mechanical strength and self-healing properties, and it is confirmed that the composite gel can still quickly recover its mechanical strength after being damaged by multiple shear forces; moreover, the composite gel has excellent injectability and plasticity, and can be used as a matrix material for injectable biomaterials for in vitro cell culture; the gelatin colloidal gel system of composite silica nano-colloidal particles shows significantly enhanced mechanical strength, and the elastic modulus of the composite gel is enhanced 100 times relative to the elastic modulus of the single-phase gelatin-based colloidal gel (the volume fraction of the colloidal particles in the system is the same); at the same time, regulating the volume fraction of the colloid in the composite colloidal system can achieve the regulation of the gel elastic modulus in the range of 10Pa to 200kPa; at high volume fractions (volume fractions), high-strength colloidal gels can be obtained.

[0056] Currently, prostheses have severe interference fit during use, otherwise the prosthesis is prone to loosening. Based on the above, in this embodiment, the pores of the trabecular integration interface 101 of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are filled with hydrogel; and the self-repairing and high-strength hydrogel can play the role of drug carrier, and the simultaneous application of this self-repairing hydrogel with the prosthesis can enhance the integration strength in the gap between the prosthesis and the bone interface, which is equivalent to the bonding effect of bone cement, and can enhance the initial stability of the prosthesis and the long-term stability of bone ingrowth into the trabeculae after the gel is degraded.

[0057] Please refer to Figures 1-9 In this embodiment, the hydrogel includes silica / gelatin composite colloidal gel, acrylylglycinamide-based supramolecular hydrogel, high-strength chitosan-based hydrogel, etc., which can construct a new type of antibacterial and osteogenesis-promoting bioactive interface, and the high-strength hydrogel fixes the prosthesis in the early stage of implantation, thereby improving the efficiency of bone integration at the interface between the prosthesis and bone tissue; on this basis, before the prosthesis is implanted into the cancellous bone cavity, self-repairing and high-strength hydrogels loaded with antibacterial drugs can also be injected into the cancellous bone cavity;

[0058] Specifically, when injecting hydrogel into the pores of the trabecular integration interface 101 of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120, the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are respectively immersed in self-repairing and high-strength hydrogel containers loaded with antibacterial drugs. Under the action of the negative pressure in the container, the hydrogel in the container is fully filled into the pores of the trabecular integration interface 101 and is ready for use during surgery; and before the tibial plateau prosthesis 120 is implanted into the cancellous bone cavity of the tibial plateau, a certain dose of self-repairing and high-strength hydrogel can be injected into the cancellous bone cavity to fill the gap between the bone and the prosthesis, so as to improve the immediate stability of the prosthesis in the initial stage of implantation; and as the bone grows into the pores in the prosthesis, the hydrogel gradually degrades, forming long-term stability of the prosthesis.

[0059] Based on the above content, when preparing the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120, the femoral condyle prosthesis 110 is also configured with a femoral condyle articular surface 111 for slidably cooperating with the tibial plateau prosthesis 120; the femoral condyle articular surface 111 has an arc-shaped contour, and the femoral condyle articular surface 111 includes an anterior condyle surface 112, a posterior condyle surface 113 and an intercondylar fossa 114, and the trabecular integration interface 101 of the femoral condyle prosthesis 110 is located between the posterior condyle surface 113 and the anterior condyle surface 112.

[0060] The tibial plateau prosthesis 120 is also equipped with a kidney-shaped platform support 121, a limiting column 122 and a connecting handle 123; two intermediate concave surfaces 124 are provided on the surface of the kidney-shaped platform support 121, and the two intermediate concave surfaces 124 slide together with the femoral condyle articular surface 111; the limiting column 122 is located between the two intermediate concave surfaces 124 and is connected to the intercondylar fossa 114; the connecting handle 123 is connected to the lower surface of the kidney-shaped platform support 121, and the connection between the connecting handle 123 and the kidney-shaped platform support 121 is located in the middle of the lower surface of the kidney-shaped platform support 121.

[0061] Based on the above, please refer to Figures 1-9 The present invention provides a method for preparing a metal total knee artificial joint, which is used to prepare the above-mentioned metal total knee artificial joint 100, comprising:

[0062] Using zirconium-niobium alloy powder as raw material, a first femoral condyle sample and a first tibial plateau sample are integrally formed by 3D printing. The first femoral condyle sample and the first tibial plateau sample are placed in a hot isostatic pressing furnace. Under the protection of helium or argon, the temperature is raised to 1250°C-1400°C, and the pressure is kept constant at 140MPa-180MPa for 1 hour-3 hours. The pressure is then reduced to normal pressure, and the sample is removed from the furnace after cooling to below 200°C, thereby obtaining a second femoral condyle sample and a second tibial plateau sample.

[0063] The second femoral condyle sample and the second tibial plateau sample were placed in a programmed cooling box and cooled at a rate of 1°C / min to -80°C to -120°C, kept at a constant temperature for 5-10 hours, and then removed from the programmed cooling box; the samples were placed in liquid nitrogen for another 16-36 hours, and the temperature was adjusted to room temperature to obtain a third femoral condyle sample and a third tibial plateau sample;

[0064] The third femoral condyle sample and the third tibial plateau sample were placed in a programmed cooling box and cooled to -80°C to -120°C at a rate of 1°C / min, and kept at a constant temperature for 5-10 hours; the samples were taken out of the programmed cooling box; and the samples were placed in liquid nitrogen for another 16-36 hours, and then the temperature was adjusted to room temperature to obtain the fourth femoral condyle sample and the fourth tibial plateau sample;

[0065] machining, trimming, polishing, cleaning and drying the fourth femoral condyle sample and the fourth tibial plateau sample to obtain a fifth femoral condyle sample and a fifth tibial plateau sample;

[0066] The fifth femoral condyle sample and the fifth tibial plateau sample are placed in a tube furnace, and an inert gas with a normal pressure content of 5%-15% oxygen by mass is introduced. The samples are heated to 500°C-700°C at 5°C / min-20°C / min, cooled to 400°C-495°C at 0.4°C / min-0.9°C / min, and then naturally cooled to below 200°C and taken out to obtain the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120.

[0067] For further information, please refer to Figures 1-9 In this embodiment, the zirconium-niobium alloy powder has a particle diameter of 5-150 μm. When printing the trabecular integration interface 101 of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120, magnesium metal particles of 5-10 μm are added to the zirconium-niobium alloy powder, with the magnesium metal particles accounting for 1%-5% of the zirconium-niobium alloy powder volume. The magnesium and magnesium oxide in the trabecular integration interface 101 can inhibit inflammation at the prosthesis-bone interface. The magnesium ion precipitation promotes osteoblast differentiation and stimulates osteogenesis, and the magnesium ion is slowly released, facilitating interface integration.

[0068] For further information, please refer to Figures 1-9In this embodiment, the method for preparing a metal total knee artificial joint further includes immersing the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 into a hydrogel container respectively, so that the hydrogel fills the pores of the trabecular integration interface 101. Specifically, before joint replacement, the micropores of the trabecular integration interface 101 of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are injected with self-repairing and high-strength hydrogels loaded with antimicrobial drugs, and can also be injected into the implanted trabecular cavity. Such hydrogels include silica / gelatin composite colloidal gels, supramolecular hydrogels based on acryloylglycine amide, or high-strength chitosan-based hydrogels, etc. The loaded antimicrobial drugs are gentamicin, penicillin, cefprozil, levofloxacin, metronidazole, clarithromycin and other drugs, which can construct a new type of antibacterial and osteogenesis-promoting bioactive interface, and the high-strength hydrogel fixes the prosthesis in the early stage of implantation, thereby improving the bone integration efficiency of the prosthesis and bone tissue interface; the hydrogel can adopt a high-strength, self-repairing and injectable silica / gelatin composite colloidal gel assembled by nano-colloidal particles. This hydrogel is prepared by uniformly blending two phases of colloidal particles with opposite charges in an alkaline (or acidic) environment, and then adding an acidifier. (or alkalizing agent) induces the pH of the solution to return to neutrality, thereby triggering electrostatic self-assembly between the two-phase colloidal particles to form a uniformly dispersed composite gel network; the hydrogel has high mechanical strength and a wide controllable range: the elastic modulus can be controlled between 10Pa and 100kPa; the self-repair efficiency is ≥100%; the hydrogel has both high mechanical strength and self-repair properties, and it has been proven that the hydrogel can still quickly recover its mechanical strength after being damaged by multiple shear forces; in addition, the hydrogel has excellent injectability and plasticity, and can be used as an injectable biomaterial for matrix materials for in vitro cell culture; when injecting the hydrogel into the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120, the steps include: immersing the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 in self-repairing and high-strength hydrogel containers loaded with antibacterial drugs, respectively, and under the action of the negative pressure in the container, the hydrogel in the container is fully filled into the pores of the trabecular integration interface 101 and is ready for use during surgery;

[0069] Before the tibial plateau prosthesis 120 is implanted into the cancellous bone cavity of the tibial plateau, a certain dose of self-repairing, high-strength hydrogel can be injected into the cancellous bone cavity to fill the gap between the bone and the prosthesis, so as to improve the immediate stability of the prosthesis in the initial stage of implantation. It can usually increase the integration strength by 10%-30%, which is equivalent to the bonding effect of bone cement. At the same time, the gel has a self-repair process during exercise to maintain the initial stability of the prosthesis and the bone. As the bone grows into the pores in the prosthesis, the hydrogel gradually degrades. The degradation time of the hydrogel is adjustable, so as to form long-term stability of the prosthesis.

[0070] For further information, please refer to Figures 1-9In this embodiment, after machining, finishing, polishing, cleaning, and drying the fourth femoral condyle prosthesis and the fourth tibial plateau prosthesis, the metal total knee artificial joint preparation method further includes: forming a micro-texture structure 102 on the surface of the femoral condyle prosthesis 110 that contacts the tibial plateau prosthesis 120 or the surface of the tibial plateau prosthesis 120 that contacts the femoral condyle prosthesis 110. When forming the micro-texture structure 102, taking a high-precision femtosecond laser as an example, the parameters are selected from one of the processing depths of 5μm, 8μm, 10μm, 15μm, and 20μm. The laser parameters obtained by processing under horizontal conditions are a repetition frequency of 40f / KHz, a scan number of 3, an energy of 3Ep / μJ, and a spot movement speed of 5v / mm∙s. -1 A surface-processed concave micro-texture morphology is obtained, and the surface is free of melt and smooth with a surface roughness Ra ≤ 0.050 μm after processing. It should be noted that, from the above content, it can be seen that after oxidation of the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120, the magnesium at the trabecular integration interface 101 of the zirconium-niobium alloy is converted into magnesium oxide; while the metal-ceramic interface formed after oxidation of the zirconium-niobium alloy surface with the micro-texture structure 102 still has the micro-texture structure 102. This micro-texture structure 102 not only enhances the bonding strength between the metal-ceramic interface and the zirconium-niobium alloy body, but also reduces friction and wear on the contact surface.

[0071] Based on the above, please refer to Figures 1-9 The metal total knee artificial joint 100 and the method for preparing the metal total knee artificial joint have the following advantages:

[0072] Compared to the traditional metal total knee prosthesis 100 system, the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 made of zirconium-niobium alloy of the present invention are in direct contact and friction surfaces during movement, thus avoiding the risk of osteolysis caused by debris generated by wear of the ultra-high molecular weight polyethylene tibial plateau pad prosthesis, which in turn causes the prosthesis to loosen.

[0073] Both the femoral condyle prosthesis 110 and the tibial plateau prosthesis 120 are made of zirconium-niobium alloy. Their kinematic contact and friction interface is a metal-ceramic interface with a micro-textured structure 102, which is more wear-resistant. The friction interface and the osseointegration interface of the femoral condyle prosthesis 110 are integrated to improve the wear resistance and long-term stability of the prosthesis.

[0074] 3D printed integrated prosthesis, magnesium and magnesium oxide exist in the trabeculae, releasing magnesium ions and promoting osteogenesis;

[0075] The micropores of the trabecular integration interface 101 of the femoral condyle prosthesis 110 and the tibial plateau pad prosthesis are injected with self-repairing hydrogel loaded with antimicrobial drugs to construct a new type of antibacterial and osteogenesis-promoting bioactive interface, and the prosthesis is fixed in the early stage of implantation to improve the bone integration efficiency of the prosthesis and bone tissue interface.

[0076] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A metal total knee prosthesis, characterized by: The metal total knee artificial joint includes a femoral condyle prosthesis and a tibial plateau prosthesis, eliminating the tibial plateau pad prosthesis, and the femoral condyle prosthesis and the tibial plateau prosthesis are both made of zirconium-niobium alloy 3D printing; The femoral condyle prosthesis and the tibial plateau prosthesis are slidably matched, and the sliding contact surfaces of the femoral condyle prosthesis and the tibial plateau prosthesis are provided with a metal-ceramic interface; The integration interfaces of the femoral condyle prosthesis and the tibial plateau prosthesis with the external bone body are both 3D-printed trabecular integration interfaces; A micro-texture structure is provided between the friction contact surfaces of the femoral condyle prosthesis and the tibial plateau prosthesis, and the micro-texture structure is located on the surface of the femoral condyle prosthesis used for contacting the tibial plateau prosthesis or the surface of the tibial plateau prosthesis used for contacting the femoral condyle prosthesis; The pores of the trabecular integration interfaces of the femoral condyle prosthesis and the tibial plateau prosthesis are filled with hydrogel.

2. The metal total knee prosthesis according to claim 1, characterized in that: The metal-ceramic interface has a thickness of 3 μm to 35 μm.

3. The metal total knee artificial joint according to claim 1 or 2, characterized in that: The femoral condyle prosthesis is also configured with a femoral condyle articular surface for slidably cooperating with the tibial plateau prosthesis; the femoral condyle articular surface has an arc-shaped contour, and the femoral condyle articular surface includes an anterior condyle surface, a posterior condyle surface and an intercondylar fossa, and the trabecular integration interface of the femoral condyle prosthesis is located between the posterior condyle surface and the anterior condyle surface.

4. The metal total knee artificial joint according to claim 3, characterized in that: The tibial plateau prosthesis is also equipped with a kidney-shaped platform support, a limiting column and a connecting handle; the surface of the kidney-shaped platform support is provided with two intermediate concave surfaces, and the two intermediate concave surfaces are slidably matched with the femoral condyle articular surface; the limiting column is located between the two intermediate concave surfaces and is connected to the intercondylar fossa; the connecting handle is connected to the lower surface of the kidney-shaped platform support, and the connection between the connecting handle and the kidney-shaped platform support is located in the middle of the lower surface of the kidney-shaped platform support.

5. A method for preparing a metal total knee artificial joint, for preparing the metal total knee artificial joint according to any one of claims 1 to 4, characterized in that: include: Using zirconium-niobium alloy powder as raw material, a first femoral condyle sample and a first tibial plateau sample are integrally formed by 3D printing. The first femoral condyle sample and the first tibial plateau sample are placed in a hot isostatic pressing furnace. Under the protection of helium or argon, the temperature is raised to 1250° C.-1400° C., and the pressure is kept constant at 140 MPa-180 MPa for 1 hour-3 hours. The pressure is then reduced to normal pressure, and the furnace is cooled to below 200° C., and the sample is removed to obtain a second femoral condyle sample and a second tibial plateau sample. placing the second femoral condyle sample and the second tibial plateau sample in a programmed cooling box, cooling them to -80°C to -120°C at a rate of 1°C / min, keeping them at a constant temperature for 5-10 hours, and then taking them out of the programmed cooling box; placing them in liquid nitrogen for another 16-36 hours, and adjusting the temperature to room temperature to obtain a third femoral condyle sample and a third tibial plateau sample; The third femoral condyle sample and the third tibial plateau sample are placed in the programmed cooling box and cooled to -80°C to -120°C at a rate of 1°C / min, and kept at a constant temperature for 5-10 hours; taken out of the programmed cooling box; placed in liquid nitrogen for another 16-36 hours, and then adjusted to room temperature to obtain a fourth femoral condyle sample and a fourth tibial plateau sample; Machining, trimming, polishing, cleaning and drying the fourth femoral condyle sample and the fourth tibial plateau sample to obtain a fifth femoral condyle sample and a fifth tibial plateau sample; The fifth femoral condyle sample and the fifth tibial plateau sample are placed in a tube furnace, and an inert gas at normal pressure with an oxygen mass percentage of 5%-15% is introduced. The furnace is heated to 500°C-700°C at 5°C / min-20°C / min, cooled to 400°C-495°C at 0.4°C / min-0.9°C / min, and then naturally cooled to below 200°C and taken out to obtain the femoral condyle prosthesis and the tibial plateau prosthesis.

6. The method for preparing a metal total knee artificial joint according to claim 5, characterized in that : The particle diameter of the zirconium-niobium alloy powder is 5 μm-150 μm, and when printing the trabecular integration interface of the femoral condyle prosthesis and the tibial plateau prosthesis, 5 μm-10 μm magnesium metal particles are added to the zirconium-niobium alloy powder, and the magnesium metal particles account for 1%-5% of the volume of the zirconium-niobium alloy powder.

7. The method for preparing a metal total knee artificial joint according to claim 5, characterized in that : The method for preparing a metal total knee artificial joint further comprises immersing the femoral condyle prosthesis and the tibial plateau prosthesis in a hydrogel container respectively, so that the hydrogel fills the pores of the trabecular integration interface.

8. The method for preparing a metal total knee artificial joint according to claim 5, characterized in that : After the steps of machining, finishing, polishing, cleaning and drying the fourth femoral condyle-like body and the fourth tibial plateau-like body, the method for preparing a metal total knee artificial joint further comprises: A micro-texture structure is manufactured on the surface of the femoral condyle prosthesis that is used to contact the tibial plateau prosthesis or the surface of the tibial plateau prosthesis that is used to contact the femoral condyle prosthesis.

Images