Ceramic-metal reverse shoulder prosthesis system and method of manufacture

Abstract

This application relates to the field of orthopedic artificial joint design and manufacturing technology, and in particular to a metal-ceramic reverse-type shoulder joint prosthesis system and its preparation method. The metal-ceramic reverse-type shoulder joint prosthesis system includes a humeral stem prosthesis, a humeral support prosthesis, a reverse-type glenoid head prosthesis, a taper adapter prosthesis, and a glenoid support prosthesis connected sequentially. The sliding contact surface of the humeral support prosthesis is adapted to the contact surface of the reverse-type glenoid head prosthesis, and both the humeral support prosthesis and the reverse-type glenoid head prosthesis are manufactured using 3D-printed zirconium-niobium alloy. A metal-ceramic interface layer formed by the oxidation of zirconium-niobium surfaces is provided between the humeral stem prosthesis and the humeral support prosthesis, between the humeral support prosthesis and the reverse-type glenoid head prosthesis, between the reverse-type glenoid head prosthesis and the taper adapter prosthesis, and between the taper adapter prosthesis and the glenoid support prosthesis. This application offers advantages such as longer service life, high wear resistance, low wear rate, no osteolysis, and no prosthesis loosening.

Description

Technical Field

[0001] This application relates to the field of orthopedic artificial joint design and manufacturing technology, and in particular to a metal-ceramic reverse shoulder joint prosthesis system and its preparation method. Background Technology

[0002] Currently, with the aging of society, joint diseases are increasing; simultaneously, due to social progress and higher health demands, the number of joint replacement surgeries has increased dramatically. Joint replacement is a surgical treatment method whose main purpose is to restore joint function, relieve pain, and improve the patient's quality of life. Although the surgical procedure and techniques for joint replacement surgery are now standardized in clinical practice, various complications still occur after joint replacement, leading to surgical failure and the need for revision surgery. Loosening of the prosthesis-bone interface is the main cause of prosthesis failure. The causes of prosthesis loosening are very complex, with aseptic loosening being the most common postoperative complication.

[0003] Among the causes of joint prosthesis failure, wear and tear is one of the most significant causes of aseptic loosening. Statistics show that wear and tear accounts for approximately 50-60% of joint replacement failures within 10 years of the initial procedure. This percentage increases gradually with the length of service life. Therefore, reducing wear and tear on joint prostheses is a crucial means to improve their lifespan and reduce failure rates.

[0004] Most existing joint prostheses are made of ultra-high molecular weight polyethylene (UHMWPE). On the one hand, UHMWPE joint prostheses are prone to spreading their wear debris to surrounding tissues, which can lead to osteolysis and cause the prosthesis to loosen. On the other hand, they have poor wear resistance and corrosion resistance.

[0005] Therefore, there is an urgent need for a metal-ceramic reverse-type shoulder joint prosthesis system and its preparation method, which can, to some extent, solve the technical problems existing in the current technology. Summary of the Invention

[0006] The purpose of this application is to provide a metal-ceramic reverse-type shoulder joint prosthesis system and its preparation method, so as to improve the wear resistance, corrosion resistance and other beneficial effects of the joint prosthesis to a certain extent.

[0007] This application provides a metal-ceramic reverse shoulder joint prosthesis system, comprising a humeral stem prosthesis, a humeral support prosthesis, a reverse glenoid head prosthesis, a tapered adapter prosthesis, and a glenoid support prosthesis connected in sequence.

[0008] The sliding contact surface of the humeral support prosthesis is adapted to the contact surface of the reverse-type glenoid head prosthesis, and both the humeral support prosthesis and the reverse-type glenoid head prosthesis are manufactured using 3D printing zirconium-niobium alloy.

[0009] A metal-ceramic interface layer formed by the oxidation of zirconium and niobium surfaces is provided between the humeral stem prosthesis and the humeral support prosthesis, between the humeral support prosthesis and the reverse-type glenoid head prosthesis, between the reverse-type glenoid head prosthesis and the tapered adapter prosthesis, and between the tapered adapter prosthesis and the glenoid support prosthesis.

[0010] The main body of the humeral stem prosthesis, the main body of the humeral support prosthesis, the main body of the reverse-type glenoid head prosthesis, the main body of the tapered adapter prosthesis, and the main body of the glenoid support prosthesis are all solid structures of zirconium-niobium alloy.

[0011] In the above technical solution, the metal-ceramic interface layer further includes a superimposed oxide layer and an oxygen-rich diffusion layer;

[0012] The thickness of the metal-ceramic interface layer is set between 3μm and 35μm.

[0013] In the above technical solution, the contact friction interface of the shoulder support prosthesis facing the tapered adapter prosthesis is further provided with a microtexture structure;

[0014] The metal-ceramic interface layer is formed on the microtexture structure.

[0015] In the above technical solution, the contact friction interface of the reverse-type acromion head prosthesis facing the tapered adapter prosthesis is further provided with a microtexture structure;

[0016] The metal-ceramic interface layer is formed on the microtexture structure.

[0017] In the above technical solution, the contact and friction interface of the humeral support prosthesis facing the reverse-type glenoid head prosthesis is further provided with a microtexture structure.

[0018] The metal-ceramic interface layer is formed on the microtexture structure.

[0019] In the above technical solution, the microtexture structure further includes microtexture;

[0020] The microtexture is disposed on the dense solid structure of the zirconium-niobium alloy.

[0021] In the above technical solution, the microtexture is further described as a concave hexagonal prism microtexture or a concave cylindrical microtexture.

[0022] In the above technical solution, the humeral stem prosthesis further includes a cylindrical top 11 and a stem 12; the stem 12 includes a proximal end 13 and a distal end 14; the outer surface of the proximal end 13 of the stem is provided with humeral stem trabeculae.

[0023] This application also provides a method for preparing a metal-ceramic reverse-type shoulder joint prosthesis system, comprising the following steps:

[0024] Step 100: Preparation of the humeral stem prosthesis and glenoid fossa prosthesis;

[0025] Step 101: Using zirconium-niobium alloy powder with a particle diameter of 50 micrometers as raw material, the first intermediate product of the glenoid fossa and the first intermediate product of the humeral stem are obtained by 3D printing. The two first intermediate products are placed in a hot isostatic pressing furnace and heated to 1250℃-1400℃ under the protection of helium or argon. They are kept at 140MPa-180MPa for 1h-3h, then cooled to atmospheric pressure and taken out with the furnace to below 200℃ to obtain two second intermediate products.

[0026] Step 102: Place the two second intermediate products in a programmed cooling box and cool them to 80℃~120℃ at a rate of 1℃ / min. Keep them at the same temperature for 5h to 10h. Remove them from the programmed cooling box and place them in liquid nitrogen for another 16h to 36h. Adjust the temperature to room temperature to obtain the two third intermediate products.

[0027] Step 103: Place the two third intermediates in a programmed cooling box and cool them to 80℃~120℃ at a rate of 1℃ / min, and keep them at a constant temperature for 5h to 10h; remove them from the programmed cooling box; place them in liquid nitrogen for another 16h to 36h, and adjust the temperature to room temperature; to obtain the two fourth intermediates.

[0028] Step 104: The two fourth intermediate products are machined, polished, cleaned and dried. Then, microtexture structures are processed on the dense solid structure of zirconium-niobium alloy. Micro-scale and / or nano-scale microtexture structures are prepared by using mechanical methods such as micro-milling, turning and laser processing. The microtexture structure and the metal-ceramic interface layer have different shapes of concave or convex microstructures or multi-level scale composite structures. Two fifth intermediate products are obtained, or the fifth intermediate products are obtained directly without the preparation of microtexture structures. Step 105: The two fifth intermediate products are placed in a tube furnace and atmospheric pressure helium or argon gas with an oxygen mass percentage of 5%-15% is introduced. The temperature 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℃ and removed to obtain glenoid fossa prosthesis and humeral stem prosthesis, respectively.

[0029] Step 200: Preparation of the humeral support prosthesis and the reverse-type glenoid head prosthesis:

[0030] Step 201: The zirconium-niobium alloy forgings are machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral support prosthesis and the reverse glenoid head prosthesis, respectively; then, microtexture structure is fabricated on the relative motion contact surface of the humeral support prosthesis and the reverse glenoid head prosthesis, or the intermediate products are obtained directly without fabricating microtexture structure.

[0031] Step 202: Place the intermediate products of the humeral support prosthesis and the reverse glenoid head prosthesis into a tube furnace, respectively, and introduce atmospheric pressure helium or argon gas with an oxygen mass percentage of 5%-15%. Heat to 500℃-700℃ at 5℃ / min-20℃ / min, and cool to 400℃-495℃ at 0.4℃ / min-0.9℃ / min. Then allow to cool naturally to below 200℃ and remove to obtain the humeral support and the reverse glenoid head.

[0032] In the above technical solution, further, the roughness of the inner surface of the intermediate product of the humeral support prosthesis in step 201 is Ra≤0.050μm; the roughness of the outer surface of the intermediate product of the reverse-type glenoid prosthesis is Ra≤0.050μm.

[0033] Compared with the prior art, the beneficial effects of this application are as follows:

[0034] This application provides a metal-ceramic reverse shoulder joint prosthesis system, comprising a humeral stem prosthesis, a humeral support prosthesis, a reverse glenoid head prosthesis, a tapered adapter prosthesis, and a glenoid support prosthesis connected in sequence.

[0035] The sliding contact surface of the humeral support prosthesis is adapted to the contact surface of the reverse-type glenoid head prosthesis, and both the humeral support prosthesis and the reverse-type glenoid head prosthesis are manufactured using 3D printing zirconium-niobium alloy.

[0036] A metal-ceramic interface layer formed by the oxidation of zirconium and niobium surfaces is provided between the humeral stem prosthesis and the humeral support prosthesis, between the humeral support prosthesis and the reverse-type glenoid head prosthesis, between the reverse-type glenoid head prosthesis and the tapered adapter prosthesis, and between the tapered adapter prosthesis and the glenoid support prosthesis.

[0037] The main body of the humeral stem prosthesis, the main body of the humeral support prosthesis, the main body of the reverse-type glenoid head prosthesis, the main body of the tapered adapter prosthesis, and the main body of the glenoid support prosthesis are all solid structures of zirconium-niobium alloy.

[0038] In summary, the metal-ceramic reverse-type shoulder joint prosthesis system provided in this application has advantages such as longer service life, strong wear resistance, low wear rate, no osteolysis, and no prosthesis loosening.

[0039] This application also provides a method for preparing a metal-ceramic reverse-type shoulder joint prosthesis system, comprising the following steps:

[0040] Step 100: Preparation of the humeral stem prosthesis and glenoid fossa prosthesis;

[0041] Step 101: Using zirconium-niobium alloy powder with a particle diameter of 50 micrometers as raw material, the first intermediate product of the glenoid fossa and the first intermediate product of the humeral stem are obtained by 3D printing. The two first intermediate products are placed in a hot isostatic pressing furnace and heated to 1250℃-1400℃ under the protection of helium or argon. They are kept at 140MPa-180MPa for 1h-3h, then cooled to atmospheric pressure and taken out with the furnace to below 200℃ to obtain two second intermediate products.

[0042] Step 102: Place the two second intermediate products in a programmed cooling box and cool them to 80℃~120℃ at a rate of 1℃ / min. Keep them at the same temperature for 5h to 10h. Remove them from the programmed cooling box and place them in liquid nitrogen for another 16h to 36h. Adjust the temperature to room temperature to obtain the two third intermediate products.

[0043] Step 103: Place the two third intermediates in a programmed cooling box and cool them to 80℃~120℃ at a rate of 1℃ / min, and keep them at a constant temperature for 5h to 10h; remove them from the programmed cooling box; place them in liquid nitrogen for another 16h to 36h, and adjust the temperature to room temperature; to obtain the two fourth intermediates.

[0044] Step 104: The two fourth intermediate products are machined, polished, cleaned and dried. Then, microtexture structures are processed on the dense solid structure of zirconium-niobium alloy. Micro-scale and / or nano-scale microtexture structures are prepared by using mechanical methods such as micro-milling, turning and laser processing. The microtexture structure and the metal-ceramic interface layer have different shapes of concave or convex microstructures or multi-level scale composite structures. Two fifth intermediate products are obtained, or the fifth intermediate products are obtained directly without the preparation of microtexture structures. Step 105: The two fifth intermediate products are placed in a tube furnace and atmospheric pressure helium or argon gas with an oxygen mass percentage of 5%-15% is introduced. The temperature 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℃ and removed to obtain glenoid fossa prosthesis and humeral stem prosthesis, respectively.

[0045] Step 200: Preparation of the humeral support prosthesis and the reverse-type glenoid head prosthesis:

[0046] Step 201: The zirconium-niobium alloy forgings are machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral support prosthesis and the reverse glenoid head prosthesis, respectively; then, microtexture structure is fabricated on the relative motion contact surface of the humeral support prosthesis and the reverse glenoid head prosthesis, or the intermediate products are obtained directly without fabricating microtexture structure.

[0047] Step 202: Place the intermediate products of the humeral support prosthesis and the reverse glenoid head prosthesis into a tube furnace, respectively, and introduce atmospheric pressure helium or argon gas with an oxygen mass percentage of 5%-15%. Heat to 500℃-700℃ at 5℃ / min-20℃ / min, and cool to 400℃-495℃ at 0.4℃ / min-0.9℃ / min. Then allow to cool naturally to below 200℃ and remove to obtain the humeral support and the reverse glenoid head.

[0048] In summary, the metal-ceramic reverse shoulder joint prosthesis system prepared using the same method has advantages such as longer service life, high wear resistance, low wear rate, no osteolysis, and no prosthesis loosening. Attached Figure Description

[0049] To more clearly illustrate the technical solutions in the specific embodiments of this application or the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0050] Figure 1 This is a schematic diagram of the metal-ceramic reverse-type shoulder joint prosthesis system provided in Embodiment 1 of this application;

[0051] Figure 2 This is a schematic diagram of a microtexture structure in the structural schematic diagram of the metal-ceramic reverse shoulder joint prosthesis system provided in Embodiment 1 of this application;

[0052] Figure 3 This is a schematic diagram of another microtexture structure in the structural schematic diagram of the metal-ceramic reverse shoulder joint prosthesis system provided in Embodiment 1 of this application.

[0053] Figure reference numerals: 1-Humeral stem prosthesis; 2-Humeral support prosthesis; 3-Reverse glenoid head prosthesis; 4-Tapered adapter prosthesis; 5-Glenoid support prosthesis; 11-Cylindrical top; 12-Stalk; 13-Proximal end of stalk; 14-Distal end of stalk; 15-Humeral stem trabeculae; 16-Mounting part; 17-Microtexture; 112-Trabeculae No. 1; 113-Trabeculae No. 2; 114-Trabeculae No. 3; 191-First superior region; 192-First inferior region; 1101-Second superior region; 1102-Second inferior region. Detailed Implementation

[0054] The technical solutions of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of this application, but not all embodiments.

[0055] The components of the embodiments of this application described and shown in the accompanying drawings can be arranged and designed in a variety of different configurations. Therefore, the following detailed description of the embodiments of this application provided in the drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application.

[0056] Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0057] In the description of this application, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application 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. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0058] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0059] Example 1

[0060] Combination Figure 1As shown, the metal-ceramic reverse shoulder joint prosthesis system includes a humeral stem prosthesis 1, a humeral support prosthesis 2, a reverse glenoid head prosthesis 3, a tapered adapter prosthesis 4, and a glenoid support prosthesis 5, which are connected in sequence.

[0061] Specifically, the sliding contact surface of the humeral support prosthesis is adapted to the contact surface of the reverse-type glenoid head prosthesis 3, and both the humeral support prosthesis and the reverse-type glenoid head prosthesis 3 are manufactured using 3D-printed zirconium-niobium alloy. The use of 3D-printed zirconium-niobium alloy solves the problem of complex traditional machining processes. Secondly, it offers better wear resistance, a lower wear rate, and is less prone to detachment, thus improving the lifespan of the metal-ceramic reverse-type shoulder joint prosthesis system. Thirdly, its wear debris is less likely to spread to surrounding tissues, preventing osteolysis and prosthesis loosening.

[0062] Furthermore, the matching of the sliding contact surface of the humeral support prosthesis with the contact surface of the reverse glenoid head prosthesis 3 means that: the surface of the humeral support prosthesis facing the reverse glenoid head is the sliding contact surface, and a sliding mounting ball hole is provided on the sliding contact surface; the contact surface of the reverse glenoid head prosthesis 3 facing the humeral support prosthesis is a spherical surface, which can slide (rotate) within the sliding mounting ball hole.

[0063] Specifically, a metal-ceramic interface layer formed by the oxidation of zirconium and niobium surfaces is provided between the humeral stem prosthesis 1 and the humeral support prosthesis 2, between the humeral support prosthesis 2 and the reverse glenoid head prosthesis 3, between the reverse glenoid head prosthesis 3 and the tapered adapter prosthesis 4, and between the tapered adapter prosthesis 4 and the glenoid support prosthesis 5. The metal-ceramic interface layer can improve the adhesion between the humeral stem prosthesis 1 and the humeral support prosthesis 2, between the humeral support prosthesis 2 and the reverse glenoid head prosthesis 3, between the reverse glenoid head prosthesis 3 and the tapered adapter prosthesis 4, and between the tapered adapter prosthesis 4 and the glenoid support prosthesis 5, prevent oxidation and detachment, and prevent the prosthesis from loosening.

[0064] Specifically, the humeral stem prosthesis 1 includes a cylindrical top 11 and a stem 12; the stem includes a proximal end 13 and a distal end 14; the outer surface of the proximal end of the stem is provided with humeral stem trabeculae 15, which are divided into a second upper region 1101, a second lower region 1102, a first upper region 191, and a first lower region 192; the trabeculae provided in the second upper region 1101 and the first lower region 192 are first trabeculae 112; the trabeculae provided in the first upper region 191 are first trabeculae 112; the trabeculae provided in the second lower region 1102 are first trabeculae 112; the first intermediate product, second intermediate product, third intermediate product, fourth intermediate product, and fifth intermediate product of the humeral support prosthesis 2 and the structure and performance characteristics of the humeral support prosthesis 2 are optimized.

[0065] Furthermore, the structural and performance characteristics of the first, second, third, fourth, and fifth intermediate products of the trabecular-bonded zirconium-niobium alloy prosthesis with oxide layer are optimized compared with those of the trabecular-bonded zirconium-niobium alloy prosthesis with oxide layer.

[0066] Furthermore, the pore size and porosity of the first trabecular bone 112, the second trabecular bone 113, and the third trabecular bone 114 increase sequentially.

[0067] In summary, the metal-ceramic reverse-type shoulder joint prosthesis system provided in this application has advantages such as longer service life, strong wear resistance, low wear rate, no osteolysis, and no prosthesis loosening.

[0068] In this embodiment, the metal-ceramic interface layer includes a superimposed oxide layer and an oxygen-rich diffusion layer; the thickness of the metal-ceramic interface layer is set between 3μm and 35μm.

[0069] Preferably, the thickness of the metal-ceramic interface layer is 18 μm.

[0070] Furthermore, the oxygen-rich diffusion layer acts as a transition layer, which can improve the adhesion between the oxide layer and the humeral support prosthesis 2 and the glenoid support prosthesis 5, and prevent the oxide layer from falling off.

[0071] Furthermore, the oxide layer has a higher hardness, making it more wear-resistant.

[0072] In this embodiment, the bodies of the humeral stem prosthesis 1, the humeral support prosthesis 2, the reverse-type glenoid head prosthesis 3, the tapered adapter prosthesis 4, and the glenoid support prosthesis 5 are all solid zirconium-niobium alloy structures.

[0073] Specifically, the contact friction interface of the shoulder support prosthesis 5 facing the tapered adapter prosthesis 4 is provided with a microtexture structure; the metal-ceramic interface layer is formed on the microtexture structure.

[0074] Specifically, the contact friction interface of the reverse-type shoulder head prosthesis 3 facing the tapered adapter prosthesis 4 is provided with a microtexture structure; the metal-ceramic interface layer is formed on the microtexture structure.

[0075] Specifically, the humeral support prosthesis 2 has a microtextured structure at its contact and friction interface with the reverse-type glenoid head prosthesis 3; the metal-ceramic interface layer is formed on the microtextured structure.

[0076] In the actual preparation process, the microtexture structure is first prepared, and then the metal-ceramic interface layer is formed on the surface of the microtexture structure, that is, the zirconium-niobium surface is oxidized and formed on the microtexture structure.

[0077] Specifically, the microtexture structure includes a mounting portion 16 and a microtexture 17; the microtexture 17 is disposed on the mounting portion 16.

[0078] Furthermore, the mounting part 16 is integrally formed with the zirconium-niobium alloy solid structure, which is equivalent to the microtexture 17 being disposed on the zirconium-niobium alloy solid structure.

[0079] In summary, the surface of the metal-ceramic layer formed after the oxidation of the zirconium-niobium alloy with microtexture 17 still has microtexture 17. This microtexture 17 not only enhances the bonding force between the metal-ceramic layer and the zirconium-niobium alloy body, but also reduces the friction and wear of the contact surface.

[0080] Preferably, combined with Figure 2 As shown, a microtextured structure with a concave hexagonal prism is provided.

[0081] Preferably, combined with Figure 3 As shown, a microtextured structure with a concave cylinder is provided.

[0082] It is worth noting that this application is not limited to microtexture structures of concave hexagonal prisms or concave cylinders, but can also include other structures, such as ellipsoidal microtexture structures.

[0083] Example 2

[0084] This embodiment provides a method for fabricating a metal-ceramic reverse-type shoulder joint prosthesis system, including the following steps:

[0085] Step 100: Preparation of the humeral stem prosthesis and glenoid fossa prosthesis;

[0086] Step 101: Using zirconium-niobium alloy powder with a particle diameter of 50 micrometers as raw material, the first intermediate product of the glenoid fossa and the first intermediate product of the humeral stem are obtained by 3D printing. The two first intermediate products are placed in a hot isostatic pressing furnace and heated to 1250℃-1400℃ under the protection of helium or argon. They are kept at 140MPa-180MPa for 1h-3h, then cooled to atmospheric pressure and taken out with the furnace to below 200℃ to obtain two second intermediate products.

[0087] Step 102: Place the two second intermediate products in a programmed cooling box and cool them to 80℃~120℃ at a rate of 1℃ / min. Keep them at the same temperature for 5h to 10h. Remove them from the programmed cooling box and place them in liquid nitrogen for another 16h to 36h. Adjust the temperature to room temperature to obtain the two third intermediate products.

[0088] Step 103: Place the two third intermediates in a programmed cooling box and cool them to 80℃~120℃ at a rate of 1℃ / min, and keep them at a constant temperature for 5h to 10h; remove them from the programmed cooling box; place them in liquid nitrogen for another 16h to 36h, and adjust the temperature to room temperature; to obtain the two fourth intermediates.

[0089] Step 104: The two fourth intermediate products are machined, polished, cleaned and dried. Then, a microtexture structure is processed on the dense solid structure of the zirconium-niobium alloy. Micro-scale and / or nano-scale microtexture structures are prepared by using mechanical methods such as micro-milling, turning and laser processing. The microtexture structure and the metal-ceramic interface layer have concave or convex microstructures or multi-level scale composite structures with different shapes. Two fifth intermediate products are obtained, or the fifth intermediate product is obtained directly without the preparation of the microtexture structure.

[0090] Step 105: Place the two fifth intermediate products in a tube furnace, introduce atmospheric pressure helium or argon gas with an oxygen mass percentage of 5%-15%, heat to 500℃-700℃ at 5℃ / min-20℃ / min, cool to 400℃-495℃ at 0.4℃ / min-0.9℃ / min, and then allow to cool naturally to below 200℃ before removing them to obtain the glenoid fossa prosthesis and the humeral stem prosthesis, respectively.

[0091] Step 200: Preparation of the humeral support prosthesis and the reverse-type glenoid head prosthesis:

[0092] Step 201: The zirconium-niobium alloy forgings are machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral support prosthesis and the reverse glenoid head prosthesis, respectively; then, microtexture structure is fabricated on the relative motion contact surface of the humeral support prosthesis and the reverse glenoid head prosthesis, or the intermediate products are obtained directly without fabricating microtexture structure.

[0093] Step 202: Place the intermediate products of the humeral support prosthesis and the reverse glenoid head prosthesis into a tube furnace, respectively, and introduce atmospheric pressure helium or argon gas with an oxygen mass percentage of 5%-15%. Heat to 500℃-700℃ at 5℃ / min-20℃ / min, and cool to 400℃-495℃ at 0.4℃ / min-0.9℃ / min. Then allow to cool naturally to below 200℃ and remove to obtain the humeral support and the reverse glenoid head.

[0094] Furthermore, the roughness of the inner surface of the intermediate product of the humeral support prosthesis in step 201 is Ra≤0.050μm; the roughness of the outer surface of the intermediate product of the reverse-type glenoid prosthesis is Ra≤0.050μm.

[0095] In summary, the metal-ceramic reverse shoulder joint prosthesis system prepared using the same method has advantages such as longer service life, high wear resistance, low wear rate, no osteolysis, and no prosthesis loosening.

[0096] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A metal-ceramic reverse-type shoulder joint prosthesis system, characterized in that, It includes a humeral stem prosthesis, a humeral support prosthesis, a reverse-type glenoid head prosthesis, a tapered adapter prosthesis, and a glenoid support prosthesis connected in sequence; The sliding contact surface of the humeral support prosthesis is adapted to the contact surface of the reverse-type glenoid head prosthesis, and both the humeral support prosthesis and the reverse-type glenoid head prosthesis are manufactured using 3D printing zirconium-niobium alloy. A metal-ceramic interface layer formed by the oxidation of zirconium and niobium surfaces is provided between the humeral stem prosthesis and the humeral support prosthesis, between the humeral support prosthesis and the reverse-type glenoid head prosthesis, between the reverse-type glenoid head prosthesis and the tapered adapter prosthesis, and between the tapered adapter prosthesis and the glenoid support prosthesis. The body of the humeral stem prosthesis, the body of the humeral support prosthesis, the body of the reverse-type glenoid head prosthesis, the body of the tapered adapter prosthesis, and the body of the glenoid support prosthesis are all solid structures of zirconium-niobium alloy; The metal-ceramic interface layer includes a superimposed oxide layer and an oxygen-rich diffusion layer. The thickness of the metal-ceramic interface layer is set between 3μm and 35μm; The contact and friction interface of the shoulder girdle prosthesis facing the tapered adapter prosthesis is provided with a microtextured structure; The contact friction interface of the reverse-type shoulder head prosthesis facing the tapered adapter prosthesis is provided with a micro-textured structure; The contact and friction interface of the humeral support prosthesis facing the reverse-type glenoid head prosthesis is provided with a microtexture structure. The metal-ceramic interface layer is formed on the microtexture structure.

2. The metal-ceramic reverse-type shoulder joint prosthesis system according to claim 1, characterized in that, The microtexture structure includes microtexture; The microtexture is disposed on the dense solid structure of the zirconium-niobium alloy.

3. The metal-ceramic reverse-type shoulder joint prosthesis system according to claim 1, characterized in that, The microtexture is a concave hexagonal prism microtexture or a concave cylindrical microtexture.

4. The metal-ceramic reverse-type shoulder joint prosthesis system according to claim 1, characterized in that, The humeral stem prosthesis includes a cylindrical top and a stem portion; the stem portion includes a proximal end and a distal end; the outer surface of the proximal end of the stem portion is provided with trabeculae of the humeral stem.

5. A method for preparing a metal-ceramic reverse-type shoulder joint prosthesis system as described in any one of claims 1-4, characterized in that, The fabrication method of the metal-ceramic reverse-type shoulder joint prosthesis system includes the following steps: Step 100: Preparation of the humeral stem prosthesis and glenoid fossa prosthesis; Step 101: Using zirconium-niobium alloy powder with a particle diameter of 50 micrometers as raw material, the first intermediate product of the glenoid fossa and the first intermediate product of the humeral stem are obtained by 3D printing. The two first intermediate products are placed in a hot isostatic pressing furnace and heated to 1250℃ under the protection of helium or argon. 1400℃, at 140MPa 180MPa, constant temperature for 1 hour After 3 hours, the pressure was reduced to normal, and the furnace was cooled to below 200°C before being removed, yielding two second intermediate products. Step 102: Place the two second intermediate products in a programmed cooling box and cool them at a rate of 1℃ / min to [temperature missing]. 80℃~ Place at 120℃ for 5 hours After 10 hours, remove it from the programmed cooling box; then place it in liquid nitrogen for another 16 hours. After 36 hours, the temperature was adjusted to room temperature to obtain two third intermediate products. Step 103: Place the two third intermediate products in a programmed cooling box and cool them at a rate of 1℃ / min to [temperature missing]. 80℃~ Place at 120℃ for 5 hours 10 hours; remove from the programmed cooling box; place in liquid nitrogen for another 16 hours. After 36 hours, the temperature was adjusted to room temperature, and two fourth intermediate products were obtained. Step 104: The two fourth intermediate products are machined, polished, cleaned and dried. Then, a microtexture structure is processed on the dense solid structure of the zirconium-niobium alloy. Micro-scale and / or nano-scale microtexture structures are prepared by using mechanical methods such as micro-milling, turning and laser processing. The microtexture structure and the metal-ceramic interface layer have concave or convex microstructures or multi-level scale composite structures with different shapes. Two fifth intermediate products are obtained, or the fifth intermediate product is obtained directly without the preparation of the microtexture structure. Step 105: Place the two fifth intermediate products in a tube furnace and introduce oxygen at a mass percentage of 5%. 15% atmospheric pressure helium or argon gas, at 5℃ / min Heating at 20℃ / min to 500℃ 700℃, at 0.4℃ / min Cooling rate: 0.9℃ / min to 400℃ The prosthesis was removed at 495℃ and then allowed to cool naturally to below 200℃, yielding glenoid fossa and humeral stem prostheses respectively. Step 200: Preparation of the humeral support prosthesis and the reverse-type glenoid head prosthesis: Step 201: The zirconium-niobium alloy forgings are machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral support prosthesis and the reverse glenoid head prosthesis, respectively; then, microtexture structure is fabricated on the relative motion contact surface of the humeral support prosthesis and the reverse glenoid head prosthesis, or the intermediate products are obtained directly without fabricating microtexture structure. Step 202: Place the intermediate products of the humeral support prosthesis and the reverse-type glenoid head prosthesis into a tube furnace, and introduce oxygen with a mass percentage of 5%. 15% atmospheric pressure helium or argon gas, at 5℃ / min Heating at 20℃ / min to 500℃ 700℃, at 0.4℃ / min Cooling rate: 0.9℃ / min to 400℃ 495℃, then naturally cooled to below 200℃ and removed to obtain the humeral support and the reverse-shaped glenoid head.

6. The method for preparing the metal-ceramic reverse-type shoulder joint prosthesis system according to claim 5, characterized in that, The roughness of the inner surface of the intermediate product of the humeral support prosthesis in step 201 is Ra≤0.050μm; the roughness of the outer surface of the intermediate product of the reverse-type glenoid prosthesis is Ra≤0.050μm.

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