Metal-ceramic total shoulder joint prosthesis system and its fabrication method

Abstract

This application relates to the field of orthopedic artificial joint design and manufacturing technology, and in particular to a metal-ceramic total shoulder joint prosthesis system and its preparation method. The metal-ceramic total shoulder joint prosthesis system includes a humeral stem prosthesis, a tapered adapter prosthesis, a humeral head prosthesis, and a glenoid fossa prosthesis connected sequentially. The humeral head prosthesis and the tapered adapter prosthesis are both formed using 3D zirconium-niobium metal printing or forging. The humeral stem prosthesis and the glenoid fossa prosthesis are integrally formed using 3D printed zirconium-niobium alloy. A metal-ceramic interface layer formed by the oxidation of the zirconium-niobium surface is provided at the relative motion contact surface of the humeral head prosthesis and the glenoid fossa prosthesis. The metal-ceramic total shoulder joint prosthesis system provided by this application has 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 total 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 total shoulder joint prosthesis system and its fabrication 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 full 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 total shoulder joint prosthesis system, comprising a humeral stem prosthesis, a tapered adapter prosthesis, a humeral head prosthesis, and a glenoid truss prosthesis connected in sequence;

[0008] Both the humeral head prosthesis and the tapered adapter prosthesis are formed by 3D zirconium-niobium metal printing or forging.

[0009] The humeral stem prosthesis and the glenoid fossa prosthesis are integrally molded using 3D printed zirconium-niobium alloy.

[0010] A metal-ceramic interface layer formed by the oxidation of zirconium-niobium surfaces is provided at the relative motion contact surface of the humeral head prosthesis and the glenoid fossa prosthesis.

[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 scapula support prosthesis is further provided with the metal-ceramic interface layer on all remaining surfaces except those opposite to the humeral head prosthesis.

[0014] In the above technical solution, further, the tapered adapter prosthesis is provided with a metal-ceramic interface layer or a zirconium-niobium polished surface layer oxidized from the zirconium-niobium surface between the humeral head prosthesis and the glenoid fossa prosthesis respectively.

[0015] In the above technical solution, the acromion support prosthesis is further provided with a trabecular porous structure.

[0016] In the above technical solution, a microtexture structure is further provided at the position of the relative motion contact surface between the humeral head prosthesis and the glenoid fossa prosthesis;

[0017] The metal-ceramic interface layer is formed on the microtexture structure.

[0018] In the above technical solution, the microtexture structure further includes a fixing part and a microtexture;

[0019] The microtexture is disposed on the end face of the fixation portion facing the humeral head prosthesis and / or the glenoid fossa prosthesis.

[0020] In the above technical solution, the microtexture is further described as a concave hexagonal prism microtexture or a concave cylindrical microtexture.

[0021] This application also provides a method for preparing a metal-ceramic total shoulder joint prosthesis system, comprising the following steps:

[0022] Step 100: Preparation of the humeral stem prosthesis and glenoid fossa prosthesis;

[0023] Step 101: Using zirconium-niobium alloy powder with a particle diameter of 50 micrometers as raw material, the first intermediate product of the humeral stem prosthesis and the first intermediate product of the glenoid fossa prosthesis are obtained by 3D printing in one piece. The two first intermediate products are placed in a hot isostatic pressing furnace, heated to 1250℃-1400℃ under helium or argon protection, and kept at 140MPa-180MPa for 1h-3h. The pressure is then reduced to normal and cooled to below 200℃ in the furnace before being taken out to obtain two second intermediate products.

[0024] 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.

[0025] 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.

[0026] Step 104: The two fourth intermediate products are machined, polished, cleaned and dried. Then, a microtexture structure is processed on the relatively moving contact surface. Micron-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.

[0027] 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.

[0028] Step 200: Preparation of the humeral head prosthesis and the tapered adapter prosthesis:

[0029] Step 201: The zirconium-niobium alloy forging is machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral head prosthesis and the tapered adapter prosthesis, respectively. Microtexture structure is processed on the relative motion contact surface of the humeral head prosthesis; then, the microtexture structure is made on the relative motion contact surface of the humeral head prosthesis and the tapered adapter prosthesis, or the intermediate product is obtained directly without the microtexture structure.

[0030] Step 202: The intermediate products of the humeral head prosthesis and the tapered adapter prosthesis are placed in a tube furnace and introduced with atmospheric pressure helium or argon gas containing 5%-15% oxygen by mass. The furnace is 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 humeral head prosthesis and the tapered adapter prosthesis.

[0031] In the above technical solution, further, the roughness of the outer surface of the intermediate product of the tapered adapter prosthesis in step 201 is Ra≤0.080μm; the roughness of the inner surface of the intermediate product of the humeral head prosthesis is Ra≤0.050μm.

[0032] Compared with the prior art, the beneficial effects of this application are as follows:

[0033] This application provides a metal-ceramic total shoulder joint prosthesis system, comprising a humeral stem prosthesis, a tapered adapter prosthesis, a humeral head prosthesis, and a glenoid truss prosthesis connected in sequence;

[0034] Both the humeral head prosthesis and the tapered adapter prosthesis are formed by 3D zirconium-niobium metal printing or forging.

[0035] The humeral stem prosthesis and the glenoid fossa prosthesis are integrally molded using 3D printed zirconium-niobium alloy.

[0036] A metal-ceramic interface layer formed by the oxidation of zirconium-niobium surfaces is provided at the relative motion contact surface of the humeral head prosthesis and the glenoid fossa prosthesis.

[0037] In summary, the metal-ceramic total 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.

[0038] This application also provides a method for preparing a metal-ceramic total shoulder joint prosthesis system, comprising the following steps:

[0039] Step 100: Preparation of the humeral stem prosthesis and glenoid fossa prosthesis;

[0040] Step 101: Using zirconium-niobium alloy powder with a particle diameter of 50 micrometers as raw material, the first intermediate product of the humeral stem prosthesis and the first intermediate product of the glenoid fossa prosthesis are obtained by 3D printing in one piece. The two first intermediate products are placed in a hot isostatic pressing furnace, heated to 1250℃-1400℃ under helium or argon protection, and kept at 140MPa-180MPa for 1h-3h. The pressure is then reduced to normal and cooled to below 200℃ in the furnace before being taken out to obtain two second intermediate products.

[0041] 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.

[0042] 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.

[0043] Step 104: The two fourth intermediate products are machined, polished, cleaned and dried. Then, a microtexture structure is processed on the relatively moving contact surface. Micron-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.

[0044] 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.

[0045] Step 200: Preparation of the humeral head prosthesis and the tapered adapter prosthesis:

[0046] Step 201: The zirconium-niobium alloy forging is machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral head prosthesis and the tapered adapter prosthesis, respectively. Microtexture structure is processed on the relative motion contact surface of the humeral head prosthesis; then, the microtexture structure is made on the relative motion contact surface of the humeral head prosthesis and the tapered adapter prosthesis, or the intermediate product is obtained directly without the microtexture structure.

[0047] Step 202: The intermediate products of the humeral head prosthesis and the tapered adapter prosthesis are placed in a tube furnace and introduced with atmospheric pressure helium or argon gas containing 5%-15% oxygen by mass. The furnace is 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 humeral head prosthesis and the tapered adapter prosthesis.

[0048] In summary, the metal-ceramic total 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 total 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 metal-ceramic total 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 total shoulder joint prosthesis system provided in Embodiment 1 of this application.

[0053] Figure reference numerals: 1-Human stem prosthesis; 2-Human head prosthesis; 3-Tapered adapter prosthesis; 4-Glenoid shank prosthesis; 11-Head fixation; 12-Handle fixation; 13-Proximal end of the handle fixation; 14-Distal end of the handle fixation; 15-Trabecular bone of the humeral stem prosthesis; 16-Fixation; 17-Microtexture; 112-First trabecular bone; 113-Second trabecular bone; 114-Third trabecular bone; 191-Superior medial region; 192-Inferior medial region; 1101-Superior lateral region; 1102-Inferior lateral 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 1 As shown, the metal-ceramic total shoulder joint prosthesis system includes a humeral stem prosthesis 1, a tapered adapter prosthesis 3, a humeral head prosthesis 2, and a glenoid flexor prosthesis 4 connected in sequence.

[0061] Specifically, both the humeral head prosthesis 2 and the tapered adapter prosthesis 3 are formed by 3D zirconium-niobium metal printing or forging. Firstly, the use of 3D printing technology solves the problem of complex traditional machining. Secondly, the 3D zirconium-niobium metal printing or forging process has better wear resistance, lower wear rate, and is less prone to falling off, thus improving the lifespan of the metal-ceramic total shoulder joint prosthesis system. Thirdly, the 3D zirconium-niobium metal printing or forging process prevents wear debris from spreading to surrounding tissues, thus avoiding osteolysis and prosthesis loosening.

[0062] Specifically, the humeral stem prosthesis 1 and the glenoid fossa prosthesis 4 are integrally formed using 3D printed zirconium-niobium alloy. Similarly, integral forming using 3D printed zirconium-niobium alloy has better wear resistance, lower wear rate, and is not easy to fall off. Its wear debris is not easily scattered to the surrounding tissues, will not cause osteolysis, and will not cause the prosthesis to loosen.

[0063] Specifically, a metal-ceramic interface layer formed by the oxidation of zirconium and niobium surfaces is provided at the relative movement contact surface of the humeral head prosthesis 2 and the glenoid fossa prosthesis 4. The metal-ceramic interface layer can improve the adhesion between the humeral head prosthesis 2 and the glenoid fossa prosthesis 4, prevent oxidation and detachment, and prevent the prosthesis from loosening.

[0064] Specifically, the humeral stem prosthesis 1 includes a head fixation portion 11 and a stem fixation portion 12; the stem fixation portion 12 includes a proximal end 13 and a distal end 14 of the stem fixation portion; the outer surface of the proximal end 13 of the stem fixation portion is provided with trabeculae 15 of the humeral stem prosthesis, and the trabeculae 15 of the humeral stem prosthesis is divided into a lateral superior region 1101, a lateral inferior region 1102, a medial superior region 191 and a medial inferior region 192; the trabeculae provided in the lateral superior region 1101 and the medial inferior region 192 are the first trabeculae 112; the trabeculae provided in the medial superior region 191 are the second trabeculae 113; and the trabeculae provided in the lateral inferior region 1102 are the third trabeculae 114.

[0065] 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.

[0066] In summary, the metal-ceramic total 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.

[0067] 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.

[0068] Preferably, the thickness of the metal-ceramic interface layer is 18 μm.

[0069] Furthermore, the oxygen-rich diffusion layer acts as a transition layer, which can improve the adhesion between the oxide layer and the humeral head prosthesis 2 and the glenoid fossa prosthesis 4, and prevent the oxide layer from falling off.

[0070] Furthermore, the oxide layer has a higher hardness, making it more wear-resistant.

[0071] In this embodiment, the glenoid plexus prosthesis 4, except for the surface opposite to the humeral head prosthesis 2, is provided with the metal-ceramic interface layer. Further, combined with... Figure 1 As shown, the glenoid prosthesis 4 has multiple surfaces. In the above embodiment, a metal-ceramic interface layer is provided between the surface of the glenoid prosthesis 4 that contacts the humeral head prosthesis 2. However, in addition to the surface of the glenoid prosthesis 4 that contacts the humeral head prosthesis 2 having a metal-ceramic interface layer, metal-ceramic interface layers are also provided on the other surfaces of the glenoid prosthesis 4. The metal-ceramic interface layer is used to improve the stable connection between the glenoid prosthesis 4 and other substrates (other substrates are not described in detail here, as they are understood by those skilled in the art).

[0072] In this embodiment, the tapered adapter prosthesis 3 is provided with a metal-ceramic interface layer or a zirconium-niobium polished surface layer formed by oxidation of the zirconium-niobium surface between it and the humeral head prosthesis 2 and the glenoid support prosthesis 4, respectively.

[0073] Specifically, the use of the cerium-ceramic interface layer or the zirconium-niobium polished surface layer with zirconium-niobium surface oxidation can improve the adhesion between the tapered adapter prosthesis 3 and the humeral head prosthesis 2, and between the tapered adapter prosthesis 3 and the glenoid fossa prosthesis 4, thereby improving the stability of the connection and preventing the problem of detachment.

[0074] In this embodiment, the glenoid prosthesis 4 is provided with a trabecular porous structure.

[0075] Optionally, the pore size of the trabecular porous structure is 0.35 mm, the porosity is 55%, and the open porosity is 100%.

[0076] Optionally, the trabecular porous structure has a pore size of 1.10 mm, a porosity of 78%, and a permeability of 100%.

[0077] In this embodiment, a microtexture structure is further provided at the position of the relative motion contact surface between the humeral head prosthesis 2 and the glenoid fossa prosthesis 4; the metal-ceramic interface layer is formed on the microtexture structure.

[0078] 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.

[0079] Specifically, the microtexture structure includes a fixing part 16 and a microtexture 17; the microtexture 17 is disposed on the end face of the fixing part 16 facing the humeral head prosthesis 2 and / or the glenoid fossa prosthesis 4. The microtexture 17 remains on the surface of the cermet layer formed after the zirconium-niobium alloy is oxidized. This microtexture 17 not only enhances the bonding force between the cermet layer and the zirconium-niobium alloy body, but also reduces frictional wear on 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 total shoulder joint prosthesis system, comprising 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 humeral stem prosthesis and the first intermediate product of the glenoid fossa prosthesis are obtained by 3D printing in one piece. The two first intermediate products are placed in a hot isostatic pressing furnace, heated to 1250℃-1400℃ under helium or argon protection, and kept at 140MPa-180MPa for 1h-3h. The pressure is then reduced to normal and cooled to below 200℃ with the furnace 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 relatively moving contact surface. Micron-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 head prosthesis and the tapered adapter prosthesis:

[0092] Step 201: The zirconium-niobium alloy forging is machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral head prosthesis and the tapered adapter prosthesis, respectively. Microtexture structure is processed on the relative motion contact surface of the humeral head prosthesis; then, the microtexture structure is made on the relative motion contact surface of the humeral head prosthesis and the tapered adapter prosthesis, or the intermediate product is obtained directly without the microtexture structure.

[0093] Step 202: The intermediate products of the humeral head prosthesis and the tapered adapter prosthesis are placed in a tube furnace and introduced with atmospheric pressure helium or argon gas containing 5%-15% oxygen by mass. The furnace is heated to 500℃-700℃ at 5℃ / min-20℃ / min, and then cooled to 400℃-495℃ at 0.4℃ / min-0.9℃ / min. The furnace is then allowed to cool naturally to below 200℃ before being removed to obtain the humeral head prosthesis and the tapered adapter prosthesis.

[0094] In addition, the roughness of the outer surface of the intermediate product of the tapered adapter prosthesis in step 201 is Ra≤0.080μm; the roughness of the inner surface of the intermediate product of the humeral head prosthesis is Ra≤0.050μm.

[0095] In summary, the metal-ceramic total 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 total shoulder joint prosthesis system, characterized in that, It includes the humeral stem prosthesis, the tapered adapter prosthesis, the humeral head prosthesis, and the glenoid fossa prosthesis, which are connected in sequence. Both the humeral head prosthesis and the tapered adapter prosthesis are formed by 3D zirconium-niobium metal printing or forging. The humeral stem prosthesis and the glenoid fossa prosthesis are integrally molded using 3D printed zirconium-niobium alloy. A metal-ceramic interface layer formed by the oxidation of zirconium-niobium surfaces is provided at the relative motion contact surface of the humeral head prosthesis and the glenoid fossa prosthesis. 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 scapula prosthesis, except for the surface opposite to the humeral head prosthesis, is provided with the metal-ceramic interface layer. The tapered adapter prosthesis is provided with a metal-ceramic interface layer or a polished zirconium-niobium surface layer formed by oxidation of the zirconium-niobium surface between itself and the humeral head prosthesis and the glenoid prosthesis, respectively.

2. The metal-ceramic total shoulder joint prosthesis system according to claim 1, characterized in that, The glenoid prosthesis is equipped with a trabecular porous structure.

3. The metal-ceramic total shoulder joint prosthesis system according to claim 1, characterized in that, A microtextured structure is also provided at the position of the relative motion contact surface between the humeral head prosthesis and the glenoid fossa prosthesis; The metal-ceramic interface layer is formed on the microtexture structure.

4. The metal-ceramic total shoulder joint prosthesis system according to claim 3, characterized in that, The microtexture structure includes a fixing part and a microtexture; The microtexture is disposed on the end face of the fixation portion facing the humeral head prosthesis and / or the glenoid fossa prosthesis.

5. The metal-ceramic total shoulder joint prosthesis system according to claim 4, characterized in that, The microtexture is a concave hexagonal prism microtexture or a concave cylindrical microtexture.

6. A method for preparing a metal-ceramic total shoulder joint prosthesis system as described in any one of claims 1-5, characterized in that, The fabrication method of the metal-ceramic total 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 products of the humeral stem prosthesis and the first intermediate products of the glenoid fossa prosthesis are obtained by 3D printing in one piece. 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 relatively moving contact surface. Micron-scale and / or nanoscale microtexture structures are prepared by using mechanical methods such as micro-milling, turning, and laser processing. This results in the microtexture structure having a concave or convex microstructure or a multi-level scale composite structure with different shapes from the overall metal-ceramic interface layer. Two fifth intermediate products are obtained; or the fifth intermediate product can be obtained directly without the fabrication 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 head prosthesis and the tapered adapter prosthesis: Step 201: The zirconium-niobium alloy forging is machined, trimmed, polished, cleaned and dried to obtain intermediate products of the humeral head prosthesis and the tapered adapter prosthesis, respectively. Microtexture structure is processed on the relative motion contact surface of the humeral head prosthesis; then, the microtexture structure is made on the relative motion contact surface of the humeral head prosthesis and the tapered adapter prosthesis, or the intermediate product is obtained directly without the microtexture structure. Step 202: The intermediate products of the humeral head prosthesis and the tapered adapter prosthesis were placed in a tube furnace and introduced with 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 is heated to 495℃ and then naturally cooled to below 200℃ before being removed, yielding the humeral head prosthesis and the tapered adapter prosthesis.

7. The method for preparing the metal-ceramic total shoulder joint prosthesis system according to claim 6, characterized in that, The roughness of the outer surface of the intermediate product of the tapered adapter prosthesis in step 201 is Ra≤0.080μm; the roughness of the inner surface of the intermediate product of the humeral head prosthesis is Ra≤0.050μm.

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