Prosthesis with bone trabecula and method for manufacturing same

Abstract

The embodiment of the invention provides a prosthesis with a bone trabecula and a manufacturing method of the prosthesis. Wherein the prosthesis with the bone trabecula is used for prefabricating the bone trabecula and the bearing casting. The prefabricated bone trabecula comprises a bone trabecula structural layer and a solid baffle layer which are integrally formed, the bone trabecula structural layer is of a porous structure, and the solid baffle layer is arranged on one side of the bone trabecula structural layer; the bearing casting is cast on the solid baffle layer, and the melting point of the prefabricated bone trabecula is higher than that of the bearing casting. It can be understood that the prefabricated bone trabecula and the bearing casting are made of two different materials, the chemical and physical continuity of a material interface is ensured through metallurgical bonding, and therefore the bearing capacity and durability of the whole structure are improved. And the arranged solid baffle layer can prevent wax liquid from flowing into multiple holes in the mold melting process. Therefore, the prosthesis with the bone trabecula has the advantages of being high in structural strength, good in bone fusion and high in safety after implantation.

Description

Technical Field

[0001] The invention relates to the technical field of human body prostheses, and in particular to a prosthesis with bone trabeculae and a method for manufacturing the prosthesis. Background Art

[0002] Joint diseases caused by various reasons require artificial joint replacement as determined by orthopedic surgeons. The conventional approaches and methods are as follows: select a mass-produced standard prosthesis of appropriate size, and implant the prosthesis into the diseased joint using a mass-produced standard prosthesis implantation tool. The integrally cast prosthesis has poor fusion with the bone block. In order to enhance the fusion between the trabeculae and the corresponding joint, the trabeculae are often set as a porous structure. However, it is difficult to cast complex porous structures with traditional casting processes.

[0003] In related technologies, 3D printing technology is used to construct objects by printing powdered metals or plastics and other bondable materials layer by layer. This realizes the concept of performance-oriented product design, which solves the problem of complex parts being difficult to form as a whole, and reduces the problem of waste of raw materials and energy caused by machining. However, if the entire prosthesis is printed using 3D printing technology, the resulting prosthesis will not only be relatively expensive, but also prone to problems such as uneven microstructure and insufficient mechanical strength. Summary of the invention

[0004] The present invention aims to solve one of the technical problems in the related art to at least a certain extent. To this end, an embodiment of the present invention provides a prosthesis with trabecular bone. The prosthesis with trabecular bone has the advantages of high structural strength, good bone fusion and high bone graft safety.

[0005] The embodiment of the present invention further provides a method for manufacturing a prosthesis having trabecular bone.

[0006] The prosthesis with trabecular bone according to the embodiment of the present invention comprises prefabricated trabecular bone and a load-bearing casting.

[0007] The prefabricated trabeculae include an integrally formed trabeculae structure layer and a solid baffle layer, the trabeculae structure layer is a porous structure, and the solid baffle layer is arranged on one side of the trabeculae structure layer; the load-bearing casting is cast on the solid baffle layer, and the melting point of the prefabricated trabeculae is higher than the melting point of the load-bearing casting. It is understandable that the prefabricated trabeculae and the load-bearing casting are two different materials.

[0008] The prosthesis with trabeculae in the embodiment of the present invention is combined by prefabrication (prefabricated trabeculae) and casting process (load-bearing casting). Compared with the traditional mechanical fixing method, the present invention utilizes the metallurgical bonding principle under high temperature to obtain higher bonding strength, and is stably used in high temperature and high load working environment, avoiding the loosening problem that may occur due to mechanical fixation. At the same time, metallurgical bonding ensures the chemical and physical continuity of the material interface, thereby improving the bearing capacity and durability of the overall structure. Moreover, the load-bearing part adopts high relative structural strength of castings, and the prefabricated trabeculae have good bone fusion. The combination of the two has the advantages of high structural strength and good bone fusion. In addition, the melting point of the prefabricated trabeculae is higher than the melting point of the load-bearing casting, indicating that it is two different metals. The metallurgical bonding ensures the chemical and physical continuity of the material interface, thereby improving the bearing capacity and durability of the overall structure.

[0009] The prosthesis with trabeculae in the embodiment of the present invention is made by dividing the prefabricated trabeculae into a trabecular structure layer and a solid baffle layer. When the load-bearing casting and the prefabricated trabeculae are combined, a wax mold needs to be made. The solid baffle layer can prevent the wax liquid from flowing into the porous interior during the melt molding. Furthermore, the residual wax liquid will be further carbonized during the later roasting and hot melting process, and the carbonized residue may cause an immune response or an allergic reaction after being implanted in the human body. In addition, the carbonized residue can become a breeding ground for bacteria and other microorganisms, increasing the risk of infection. Therefore, the solid baffle layer can prevent the wax liquid from flowing into the porous interior during the melt molding during injection molding, thereby reducing the problem of infection and rejection of the trabecular prosthesis after implantation in the human body, thereby improving the safety of the prosthesis after implantation.

[0010] In addition, the trabecular structure layer is set to a porous structure, which can achieve excellent biocompatibility and bone ingrowth of the bone integration interface and has the advantage of good bone fusion.

[0011] Therefore, the prosthesis with trabecular bone according to the embodiment of the present invention has the advantages of high structural strength, good bone fusion and high safety after implantation.

[0012] In some embodiments, the solid baffle layer has a texture on one side thereof that is connected to the load-bearing casting.

[0013] In some embodiments, the prefabricated trabeculae are embedded within the load bearing cast.

[0014] In some embodiments, the prefabricated trabeculae are 3D printed prefabricated trabeculae.

[0015] In some embodiments, the load-bearing casting is a titanium alloy prosthesis or a cobalt-chromium-molybdenum alloy prosthesis.

[0016] In some embodiments, the prefabricated trabecular bone is a titanium alloy prosthesis and a tantalum metal prosthesis.

[0017] In some embodiments, the thickness of the trabecular structure layer is 20%-50% of the overall thickness of the prosthesis; and / or the thickness of the solid baffle layer is 0.8 mm-2.0 mm.

[0018] In some embodiments, the prosthesis having trabeculae further comprises an anti-oxidation layer, and the anti-oxidation layer covers the surfaces of the trabecular structure layer and the solid baffle layer.

[0019] In some embodiments, the anti-oxidation layer has a thickness of 6-35 μm.

[0020] In some embodiments, the anti-oxidation material is one of TiAl-based materials, TiN-based materials, and aluminum oxide-based coatings.

[0021] The method for manufacturing the prosthesis with trabeculae in the embodiment of the present invention comprises the following steps:

[0022] 1) preparing the prefabricated trabeculae according to the design model, taking the solid baffle layer side as a reference, performing wax mold pressing according to the design model of the load-bearing casting to obtain a wax initial mold, trimming the wax initial mold to obtain a wax mold consistent with the load-bearing casting, and providing the solid baffle layer to separate the wax mold from the trabecular structure layer to prevent the wax liquid from flowing into the interior of the porous structure;

[0023] 2) coating the wax mold obtained in step 1) with gypsum slurry, sprinkling sand, drying and calcining to obtain a casting shell;

[0024] 3) placing the casting material into the casting shell obtained in step 2) for hot melting, removing the casting shell after cooling and forming, and performing sandblasting and polishing on the cast load-bearing casting to obtain an integrally formed prosthesis.

[0025] In some embodiments, the method further includes spraying an anti-oxidation layer and a sintering process. In step 1), the prefabricated trabeculae are directly sprayed with an anti-oxidation layer; or in step 2), the whole formed by the casting shell and the prefabricated trabeculae is sprayed with an anti-oxidation layer and a sintering process.

[0026] In some embodiments, the calcination temperature is 800° C.-1100° C., and the calcination time is 1 h-2 h.

[0027] In some embodiments, in step 3), the heat melting is performed using a medium frequency heating vacuum furnace at a heating temperature of 1500° C.-1600° C. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 4 is a three-dimensional diagram of a prosthesis with trabeculae according to an embodiment of the present invention.

[0029] Figure 24 is a front view of a prosthesis with trabeculae according to an embodiment of the present invention.

[0030] Figure 3 is a side view of a prosthesis with trabeculae according to an embodiment of the present invention.

[0031] Figure 4 4 is a top view of a prosthesis with trabeculae according to an embodiment of the present invention.

[0032] Figure 5 1 is a three-dimensional diagram of a load-bearing casting according to an embodiment of the present invention.

[0033] Figure 6 It is a stereoscopic view of the prefabricated trabeculae according to an embodiment of the present invention.

[0034] Figure 7 is another stereoscopic view of the prefabricated trabeculae according to an embodiment of the present invention.

[0035] Figure 8 It is another stereoscopic view of the prefabricated trabeculae according to the embodiment of the present invention.

[0036] Fig. 9 The pattern of the entity baffle layer of the embodiment of the present invention is Figure 1 .

[0037] Fig.10 The pattern of the entity baffle layer of the embodiment of the present invention is Figure 2 .

[0038] Fig.11 The pattern of the entity baffle layer of the embodiment of the present invention is Figure 3 .

[0039] Reference numerals:

[0040] A prosthesis with trabecular bone 100;

[0041] Prefabricated trabeculae 1; trabecular structure layer 11; solid baffle layer 12; texture 121;

[0042] Load-bearing castings2. DETAILED DESCRIPTION

[0043] Embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to be used to explain the present invention, but should not be understood as limiting the present invention.

[0044] Reference below Figure 1-Figure 11 A prosthesis 100 with trabecular bone and a method for manufacturing the prosthesis according to an embodiment of the present invention are described.

[0045] The prosthesis 100 with trabeculae according to the embodiment of the present invention comprises prefabricated trabeculae 1 and a load-bearing casting 2 .

[0046] The prefabricated trabecular bone 1 includes an integrally formed trabecular bone structure layer 11 and a solid baffle layer 12, wherein the trabecular bone structure layer 11 is a porous structure, and the solid baffle layer 12 is arranged on one side of the trabecular bone structure layer 11; the load-bearing casting 2 is cast on the solid baffle layer 12, and the melting point of the prefabricated trabecular bone 1 is higher than that of the load-bearing casting 2. It can be understood that the prefabricated trabecular bone 1 and the load-bearing casting 2 are two different materials.

[0047] The prosthesis 100 with trabeculae in the embodiment of the present invention is combined by prefabricated trabeculae 1 and casting process (load-bearing casting 2). Compared with the traditional mechanical fixing method, the present invention utilizes the metallurgical bonding principle under high temperature to obtain higher bonding strength, and can be stably used under high temperature and high load working environment, thereby avoiding the loosening problem that may occur due to mechanical fixation. At the same time, metallurgical bonding ensures the chemical and physical continuity of the material interface, thereby improving the bearing capacity and durability of the overall structure. Moreover, the load-bearing part adopts high relative structural strength of castings, and the prefabricated trabeculae 1 has good bone fusion, and the combination of the two has the advantages of high structural strength and good bone fusion. In addition, the melting point of the prefabricated trabeculae 1 is higher than the melting point of the load-bearing casting 2, and the metallurgical bonding ensures the chemical and physical continuity of the material interface, thereby improving the bearing capacity and durability of the overall structure.

[0048] The prosthesis 100 with trabeculae in the embodiment of the present invention is made by dividing the prefabricated trabeculae 1 into a trabecular structure layer 11 and a solid baffle layer 12. When the load-bearing casting 2 and the prefabricated trabeculae 1 are combined, a wax mold needs to be made. The solid baffle layer 12 can prevent the wax liquid from flowing into the interior of the porous structure during the melt molding. Furthermore, the residual wax liquid will be further carbonized during the later roasting and hot melting process, and the carbonized residue may cause an immune response or an allergic reaction after being implanted in the human body. In addition, the carbonized residue can become a breeding ground for bacteria and other microorganisms, increasing the risk of infection. Therefore, the solid baffle layer 12 can prevent the wax liquid from flowing into the porous interior during the melt molding during injection molding, thereby reducing the problem of infection and rejection of the trabecular prosthesis 100 after being implanted in the human body, thereby improving the safety of the prosthesis after implantation.

[0049] In addition, the trabecular structure layer 11 is set to a porous structure, which can achieve excellent biocompatibility and bone ingrowth of the bone integration interface and has the advantage of good bone fusion.

[0050] Therefore, the prosthesis 100 with trabecular bone according to the embodiment of the present invention has the advantages of high structural strength, good bone fusion and high safety after implantation.

[0051] like Figures 7 to 11 As shown, the side of the solid baffle layer 12 connected to the load-bearing casting 2 has a texture 121 .

[0052] The prosthesis 100 with trabeculae in the embodiment of the present invention is provided with a texture 121 on the side where the solid baffle layer 12 is connected to the load-bearing casting 2. During the casting process of the load-bearing casting 2, the texture 121 structure of the solid baffle layer 12 can effectively increase the contact area of ​​the casting liquid, thereby improving the cooling efficiency, thereby shortening the molding cycle, and further contributing to the advantage of improving the efficiency of prosthesis manufacturing.

[0053] In addition, the texture 121 structure can also improve fluidity and adhesion, reduce internal stress and deformation during cooling, and help the casting liquid fill the mold better. Therefore, the prosthesis 100 with trabeculae in the embodiment of the present invention has the advantages of improving the bonding strength between the prefabricated trabeculae 1 and the load-bearing casting 2 and having a good molding effect.

[0054] Optionally, the types of texture 121 can be divided into two categories: regular patterns and irregular patterns. Regular texture structures have repeated patterns and simple structures, which help provide consistent surface quality, thereby ensuring the consistency and predictability of castings, and are suitable for products with uniform thickness; irregular textures are more random, have higher design freedom, and have a larger contact surface area, and can be used to design specific surface effects according to the specific needs of the product. Irregular textures are more suitable when preparing products with uneven size and thickness uniformity.

[0055] Furthermore, the texture structure can be designed in a barb-like manner, which helps to increase the friction fixation during the casting process and ensure the chemical and physical continuity of the material interface.

[0056] In some embodiments, the prefabricated trabeculae 1 are embedded in the load-bearing casting 2, and the load-bearing casting 2 partially wraps the prefabricated trabeculae 1. Thus, the structural stability is good.

[0057] The prefabricated trabeculae 1 are 3D printed prefabricated trabeculae 1. The 3D printed prefabricated trabeculae 1 can be used to customize a prosthesis for the patient according to a prosthesis that matches the patient's diseased joint.

[0058] It should be noted that 3D printing, or rapid prototyping technology, is also known as additive manufacturing. It is a technology that uses a digital model file as the basis and uses powdered metal or plastic and other bondable materials to construct objects by printing layer by layer. Specifically, the CT image data acquisition module can be used to acquire CT image data of the patient's diseased joints.

[0059] The load-bearing casting 2 is a titanium alloy prosthesis or a cobalt-chromium-molybdenum alloy prosthesis; and / or the prefabricated trabeculae 1 is a titanium alloy prosthesis or a tantalum metal prosthesis. The metals or alloys used in the load-bearing casting 2 and the prefabricated trabeculae 1 have excellent corrosion resistance, mechanical properties and good biocompatibility, as well as good compression resistance and plasticity, and can be used in the field of medical devices.

[0060] The thickness of the trabecular structure layer 11 is 20%-50% of the overall thickness of the prosthesis. Thus, the problem of poor biocompatibility of the bone integration interface due to the small thickness of the trabecular structure layer 11 and the large weight of the prosthesis as a whole due to the small thickness are avoided. In addition, the problem of poor overall prosthesis structural strength due to the excessive thickness of the trabecular structure layer 11 is also avoided. Thus, the prosthesis 100 with trabecular bone has the advantages of good compatibility and high structural strength.

[0061] The thickness of the solid baffle layer 12 is 0.8 mm to 2.0 mm, which avoids the problem of high material consumption caused by excessive thickness of the solid baffle layer 12 and the problem of low structural strength caused by too small thickness.

[0062] Optionally, the thickness of the solid baffle layer 12 is 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm or 2.0 mm.

[0063] The prosthesis 100 with trabeculae in the embodiment of the present invention further includes an anti-oxidation layer, which covers the surfaces of the trabecular structure layer 11 and the solid baffle layer 12 .

[0064] The anti-oxidation layer provided on the prosthesis 100 with trabeculae in the embodiment of the present invention can reduce the release of metal ions and has excellent biocompatibility, that is, has excellent biocompatibility of bone integration interface. It can also reduce the wear rate. The joint surface with low wear rate is organically compatible with the bone integration interface (trabeculae) with excellent bone ingrowth performance, which can make the prosthesis achieve the advantages of two interfaces at the same time. The anti-oxidation layer has a strong adhesion with the prefabricated trabeculae 1 and the load-bearing casting 2, avoiding the problem of easy oxidation layer shedding and corrosion after the prosthesis is oxidized. In addition, it not only avoids the oxidation problem, but also maintains the purity of the material and the integrity of the microstructure, so that the performance of the final product can be improved to meet the needs of high-performance applications.

[0065] The thickness of the anti-oxidation layer is 6-12 μm; the anti-oxidation material is one of TiAl series, TiN series and aluminum oxide series coatings.

[0066] The thickness of the anti-oxidation layer of the prosthesis 100 with trabecular bone according to the embodiment of the present invention is set to 6-35 μm, which has the advantage of good anti-oxidation ability.

[0067] Optionally, the thickness of the anti-oxidation layer is set to 6μm, 7μm, 8μm, 9μm, 11μm, 13μm, 15μm, 17μm, 19μm, 21μm, 23μm, 25μm, 27μm, 29μm, 31μm, 33μm or 35μm.

[0068] Alternatively, the prosthesis 100 having trabecular bone may be a knee prosthesis or a hip prosthesis.

[0069] The method for manufacturing the prosthesis 100 with trabeculae according to any one of the above embodiments of the present invention comprises the following steps:

[0070] 1) Prefabricated trabeculae 1 are prepared according to the design model, and wax molds are pressed according to the model of the designed load-bearing casting 2, with the solid baffle layer 12 side as the reference, and a wax mold consistent with the load-bearing casting 2 is obtained after wax trimming. The solid baffle layer 12 can separate the wax mold from the trabecular structure layer 11 to prevent the wax liquid from flowing into the interior of the porous structure;

[0071] 2) coating the wax mold obtained in step 1) with gypsum slurry, sprinkling sand, drying and calcining to obtain a casting shell;

[0072] 3) The casting material is placed in the mold shell obtained in step 2) for hot melting, and after cooling and forming, the casting shell is removed, and the load-bearing casting 2 formed by the casting is sandblasted and polished to obtain an integrally formed prosthesis.

[0073] Therefore, the method for manufacturing the prosthesis 100 with trabecular bone according to the embodiment of the present invention has the advantages of high structural strength, good bone fusion and high safety after implantation.

[0074] The method further includes spraying an anti-oxidation layer and sintering process. In step 1), the prefabricated trabeculae 1 are directly sprayed with an anti-oxidation layer with a spraying thickness of 6-12 μm. Or in step 2), the whole formed by the casting shell and the prefabricated trabeculae 1 is sprayed with an anti-oxidation layer and sintered with a spraying thickness of 15-35 μm.

[0075] The manufacturing method of the prosthesis 100 with trabeculae of the embodiment of the present invention, the spraying of the oxide layer can reduce the release of metal ions, has excellent biocompatibility, that is, has excellent biocompatibility of the bone integration interface. And it can reduce the wear rate, the joint surface with low wear rate and the bone integration interface (trabeculae) with excellent bone ingrowth performance are organically compatible, so that the prosthesis can achieve the advantages of two interfaces at the same time, and the anti-oxidation layer has a large adhesion to the prefabricated trabeculae 1 and the load-bearing casting 2, avoiding the problem of easy corrosion of the oxide layer after oxidation of the prosthesis. And then not only avoid the oxidation problem, but also maintain the purity of the material and the integrity of the microstructure, so that the performance of the final product can be improved to meet the needs of high-performance applications. In addition, the spraying of the anti-oxidation layer has the advantage of good relative uniformity.

[0076] The calcination temperature is 800°C-1100°C and the calcination time is 1h-2h. In step 3), the heating temperature in a medium frequency heating vacuum furnace is 1500°C-1600°C during hot melting.

[0077] Alternatively, the calcination temperature may be 800°C, 850°C, 900°C, 950°C, 1000°C, 1050°C or 1100°C.

[0078] Optionally, the calcination time may be 1 h, 1.5 h or 2 h.

[0079] Example 1:

[0080] The designed product is divided into two parts, one part is designed as a porous trabecular bone structure layer 11, and the other part is designed as a casting model;

[0081] 1) Prefabricated trabeculae 1 of titanium alloy are prepared according to the design model, and anti-oxidation material is sprayed on the prefabricated trabeculae 1 with a spraying thickness of 10 μm. Based on the side of the solid baffle layer 12, a wax mold is pressed according to the model of the designed load-bearing casting 2 to produce a wax initial mold, and the wax initial mold is trimmed to obtain a wax mold consistent with the load-bearing casting 2;

[0082] 2) coating the wax mold obtained in step 1) with gypsum slurry, pouring sand, drying and baking, wherein the coating slurry, pouring sand and drying process can be repeated for multiple times, for example, 6 times, with a baking temperature of 900° C. and a baking time of 1 hour to obtain a casting shell;

[0083] 3) The cobalt-chromium-molybdenum rod for casting is placed in the casting shell obtained in step 2) for hot melting, and the casting shell is removed after cooling. During hot melting, medium-frequency heating is used for casting in a vacuum furnace at a heating temperature of 1550°C, and the cast load-bearing casting 2 is sandblasted and polished to obtain a prosthesis integrating a titanium alloy porous structure and a cobalt-chromium-molybdenum solid material.

[0084] Example 2:

[0085] 1) Prefabricated trabeculae 1 of titanium alloy are prepared according to the design model, and anti-oxidation material is sprayed on the prefabricated trabeculae 1 with a spraying thickness of 10 μm. Based on the side of the solid baffle layer 12, a wax mold is pressed according to the model of the designed load-bearing casting 2 to produce a wax initial mold, and the wax initial mold is trimmed to obtain a wax mold consistent with the load-bearing casting 2;

[0086] 2) The wax mold is coated with slurry and sanded to obtain a casting shell. In order to prevent the titanium alloy porous layer inside the shell from being oxidized during the roasting process, the mold shell after sanding is sprayed with an antioxidant material and then dried. This slurry coating, sanding, spraying with an antioxidant material, and drying process are repeated 6 times, and then placed in a gas roasting furnace for roasting treatment to obtain a casting shell. The spraying thickness is 20 μm each time, the roasting temperature is 1050° C., and the roasting time is 1.5 h to obtain a casting shell;

[0087] 3) The cobalt-chromium-molybdenum rod for casting is placed in the casting shell obtained in step 2) for hot melting, and the casting shell is removed after cooling. During hot melting, medium-frequency heating is used for casting in a vacuum furnace at a heating temperature of 1550°C, and the cast load-bearing casting 2 is sandblasted and polished to obtain a prosthesis integrating a titanium alloy porous structure and a cobalt-chromium-molybdenum solid material.

[0088] In the description of the present invention, it is to be understood that the terms “center”, “longitudinal”, “lateral”, “length”, “width”, “thickness”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “clockwise”, “counterclockwise”, “axial”, “radial”, “circumferential”, etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0089] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0090] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0091] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0092] In the present invention, the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" etc. mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the described specific features, structures, materials or characteristics may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0093] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may change, modify, replace and vary the above embodiments within the scope of the present invention.

Claims

1. A prosthesis having trabecular bone, characterized in that: include: Prefabricated trabeculae, the prefabricated trabeculae comprising an integrally formed trabecular structure layer and a solid baffle layer, the trabecular structure layer being a porous structure, and the solid baffle layer being arranged on one side of the trabecular structure layer; and A load-bearing casting is cast on the solid baffle layer, and the melting point of the prefabricated trabeculae is higher than the melting point of the load-bearing casting.

2. The prosthesis with trabecular bone according to claim 1, characterized in that: The side of the solid baffle layer connected to the load-bearing casting has a texture; and / or the prefabricated trabeculae are embedded in the load-bearing casting.

3. The prosthesis with trabecular bone according to claim 1, characterized in that: The prefabricated trabeculae are 3D printed prefabricated trabeculae; and / or, the load-bearing casting is a titanium alloy prosthesis or a cobalt-chromium-molybdenum alloy prosthesis; and / or, the prefabricated trabeculae are a titanium alloy prosthesis and a tantalum metal prosthesis.

4. The prosthesis with trabecular bone according to claim 1, characterized in that: The thickness of the trabecular structure layer is 20%-50% of the overall thickness of the prosthesis; and / or the thickness of the solid baffle layer is 0.8mm-2.0mm.

5. The prosthesis with trabecular bone according to claim 1, characterized in that: It also includes an anti-oxidation layer, which covers the surfaces of the trabecular structure layer and the solid baffle layer.

6. The prosthesis with trabecular bone according to claim 5, characterized in that: The thickness of the anti-oxidation layer is 6-35 μm; and / or the anti-oxidation material is one of TiAl-based materials, TiN-based materials, and aluminum oxide-based coatings.

7. A method for manufacturing a prosthesis having trabecular bone according to any one of claims 1 to 6, characterized in that: The steps include: 1) preparing the prefabricated trabeculae according to the design model, taking the solid baffle layer side as a reference, performing wax mold pressing according to the design model of the load-bearing casting to obtain a wax initial mold, trimming the wax initial mold to obtain a wax mold consistent with the load-bearing casting, and providing a solid baffle layer to separate the wax mold from the trabecular structure layer to prevent the wax liquid from flowing into the interior of the porous structure; 2) coating the wax mold obtained in step 1) with gypsum slurry, sprinkling sand, drying and calcining to obtain a casting shell; 3) placing the casting material into the casting shell obtained in step 2) for hot melting, removing the casting shell after cooling and forming, and performing sandblasting and polishing on the cast load-bearing casting to obtain an integrally formed prosthesis.

8. The method for manufacturing a prosthesis having trabecular bone according to claim 7, characterized in that: The method further includes spraying an anti-oxidation layer and a sintering process. In step 1), the prefabricated trabeculae are directly sprayed with an anti-oxidation layer; or in step 2), the whole formed by the casting shell and the prefabricated trabeculae is sprayed with an anti-oxidation layer and a sintering process is performed.

9. The method for manufacturing a prosthesis having trabecular bone according to claim 8, characterized in that: The calcination temperature is 800° C.-1100° C., and the calcination time is 1 h-2 h.

10. The method for manufacturing a prosthesis having trabecular bone according to claim 7, characterized in that: In step 3), the heat melting is performed in a medium frequency heating vacuum furnace at a heating temperature of 1500° C.-1600° C.

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