High-strength tibial tray with osteoinductive properties

Abstract

This invention provides a high-strength tibial support with osteoinductive properties and its preparation method. The preparation method involves preparing a reinforcing material and a matrix material; fabricating a multi-porous metal tibial support skeleton from a biodegradable metal material; placing the prepared multi-porous metal tibial support skeleton and the matrix material into a mold cavity; uniformly filling the pores of the multi-porous metal tibial support skeleton with the matrix material; and then pressing and molding the skeleton through the mold cavity. After pressing and molding, a semi-finished tibial support is obtained, which is then subjected to high-temperature sintering to obtain a high-strength tibial support with osteoinductive properties. This invention solves the technical problems of existing tibial support fixation methods using bone cement and bio-type fixation, which lead to bone cement particles easily entering the pulmonary circulation through the bloodstream and poor adhesion between the bio-coating and the prosthesis, resulting in coating detachment during embedding. This invention can be widely applied to the preparation of high-strength tibial supports with osteoinductive properties.

Description

Technical Field

[0001] This invention relates to a medical tibial support, and more particularly to a tibial support with high strength and osteoinductive properties. Background Technology

[0002] Tibial braces are commonly used medical prosthetic implants in hip surgery. Currently, most tibial braces are made of metal, and their fixation methods mainly include bone cement fixation and biological fixation.

[0003] However, bone cement is an inert material that can only form a mechanical bond between the bone and the tibial support, which inevitably leads to problems such as aging, cracking and wear of the tibial support. Furthermore, bone cement monomers release heat during polymerization, which can damage surrounding tissues and nerves. More importantly, during the process of embedding the tibial support, bone cement particles can easily enter the pulmonary circulation through the bloodstream, potentially causing pulmonary embolism and secondary harm to the patient.

[0004] However, bio-fixation improves the bond between the tibial support and the bone by spraying bio-based coatings such as HA, Ti, and HA+Ti onto the surface of the tibial support. However, the bond between the bio-based coating and the prosthesis is poor, and there is a risk of the coating falling off during the embedding of the tibial support, which cannot guarantee the long-term stable use of the tibial support. Summary of the Invention

[0005] To address the above-mentioned technical problems, this invention provides a tibial support with osteoinductive high strength. In this osteoinductive high strength tibial support, the tibial support is prepared by mixing a biodegradable metal material and a matrix material. This material does not need to be used in conjunction with bone cement, will not damage surrounding tissues and nerves, and can avoid the problem of bone cement particles easily entering the pulmonary circulation through the bloodstream when using bone cement fixation.

[0006] Furthermore, the biodegradable metal material is gradually corroded and degraded by body fluids in the body, forming a biological tibial support. The Mg and Zn ions released by the support can induce bone tissue growth. The porous polyetheretherketone, ultra-high molecular weight polyethylene, or carbon fiber polyetheretherketone structure left behind provides suitable space for bone tissue ingrowth, promoting bone ingrowth and ensuring the long-term stable use of the tibial support.

[0007] Therefore, the technical solution of the present invention is a tibial support with osteoinductive high strength, which is provided with a multi-filled porous metal tibial support frame. The multi-filled porous metal tibial support frame includes a tibial support pillar and a tibial support platform, with the tibial support platform located at the upper end of the tibial support pillar.

[0008] The multi-filled porous metal tibial support skeleton is formed by interwoven threads, with filling pores between the interwoven threads. The threads are made of biodegradable metal material.

[0009] The pores are filled with polymer material, and the outside of the multi-pore metal tibial support frame is covered with a layer of polymer material.

[0010] A concave arc groove is provided on one side of the tibial support platform;

[0011] Biodegradable metallic materials are corroded and degraded by body fluids in the body, leaving behind a polymer structure that creates space for bone tissue ingrowth.

[0012] Preferably, a biodegradable metal mesh is fixedly provided on the lower end face of the tibial support platform and the outer surface of the tibial support support, respectively. The biodegradable metal mesh has a porous mesh structure and is formed by interwoven threads.

[0013] The biodegradable metal mesh on the lower end face of the tibial support platform extends to the side of the connected tibial support platform.

[0014] Preferably, a reinforcing support plate is fixed between the lower end face of the tibial support platform and the outer circumference of the tibial support column, and a biodegradable metal wire mesh is fixed on the outer surface of the reinforcing support plate.

[0015] Preferably, the thickness of the tibial support platform is 5mm±0.5mm, the outer diameter of the tibial support column is 3.5mm±0.5mm, and the thickness of the reinforcing support plate is 2mm±0.5mm.

[0016] Preferably, the outer surface of the tibial support is smoothly transitioned by rounded corners.

[0017] The beneficial effects of this invention are:

[0018] 1. The tibial support prepared using this method involves creating a multi-porous metal tibial support skeleton using biodegradable metal materials. This skeleton is then uniformly mixed with the matrix material via ultrasonic vibration. After mixing, the mixture is formed under isostatic pressing. Finally, the formed material is sintered in a high-temperature oven. Each step in this process increases the strength of the tibial support implant. After the entire process is completed, the strength of the tibial support implant is significantly enhanced. Therefore, the tibial support implant can withstand higher impact loads during use, minimizing the risk of breakage, fracture, and other quality problems. This greatly improves the overall mechanical properties of the tibial support implant, ensuring its long-term stable use.

[0019] 2. The tibial support product prepared by this method has a high bone induction capacity. The specific bone induction effect depends on two aspects. One is the biodegradable metal material used in the tibial support product, such as biodegradable zinc alloy and biodegradable magnesium alloy. These two materials will react with the body fluids in the human body to produce Mg ions and Zn ions. These two ions can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, regulating the immune microenvironment, and promoting bone angiogenesis, ultimately achieving the bone induction effect and thus accelerating the bone healing speed.

[0020] Another type is the porous plastic structure left after the degradation of biodegradable metal materials, such as polyetheretherketone, ultra-high molecular weight polyethylene, or carbon fiber polyetheretherketone finished structures. The pore size and porosity of the porous plastic structure match the human cancellous bone. Bone generated by the stimulation of metal ions can grow into the pores, eventually allowing the prosthesis to integrate with the human bone, thereby achieving the bone induction effect. This further improves the bonding force between the tibial support and the bone, ensuring the long-term stable use of the tibial support. There is no need to spray bio-based coatings such as HA, Ti, or HA+Ti on the surface of the tibial support. Furthermore, this tibial support implant does not need to be used with bone cement, and will not damage surrounding tissues and nerves. It can avoid the problem of bone cement particles easily entering the pulmonary circulation through the bloodstream when using bone cement fixation.

[0021] 3. This tibial support implant is made by using a mixture of biodegradable metal materials and medical plastics as filling material. Compared with traditional tibial support implants made of metal materials, it is lighter in overall weight. After the weight is reduced, it can significantly reduce the patient's bone loss and avoid a series of chain symptoms such as osteoporosis and bone calcification. Attached Figure Description

[0022] Figure 1 This is a three-dimensional view of the finished tibial support of the present invention;

[0023] Figure 2 This is a three-dimensional view of the finished tibial support of the present invention from another perspective;

[0024] Figure 3 This is a schematic diagram of the multi-pore metal tibial support skeleton structure of the present invention;

[0025] Figure 4 This is a schematic diagram of the structure of the tibial support after the biodegradable metal wire mesh is fixed on it according to the present invention;

[0026] Figure 5 This is the present invention. Figure 3 Enlarged view of point A in the middle.

[0027] Explanation of symbols in the diagram:

[0028] 1. Tibial support platform; 2. Tibial support strut; 3. Reinforcing support plate; 4. Biodegradable metal mesh; 5. Concave arc groove; 6. Multi-filled pore metal tibial support skeleton; 7. Silk thread; 8. Filling pores; 9. Rounded corners. Detailed Implementation

[0029] The present invention will be further described below with reference to embodiments.

[0030] pass Figures 1-5 It can be seen that the bone-inducing high-strength tibial support has a multi-filled porous metal tibial support frame 6, which includes a tibial support pillar 2 and a tibial support platform 1, with the tibial support platform 1 located at the upper end of the tibial support pillar 2.

[0031] The multi-filled porous metal tibial support skeleton 6 is formed by interwoven silk threads 7, with filling pores 8 formed between the interwoven silk threads 7. The silk threads 7 are made of biodegradable metal material, and the biodegradable metal material has inductive properties with bone tissue, which can promote the fusion of the tibial support and the bone injury site.

[0032] The pores 8 are filled with polymer material, and the outside of the multi-pore metal tibial support frame 6 is covered with a layer of polymer material.

[0033] The tibial support platform 1 has a concave arc groove 5 on one side. The concave arc groove 5 can avoid interference between the tibial support platform 1 and the patella during tibial support implantation, which would lead to difficulties in tibial support implantation and damage to the patella. It can reproduce the physiological state of the meniscus of the knee joint, conform to the characteristics of human movement, restore the normal starting position of the natural knee joint, simulate normal knee joint movement, and maximize the depth of flexion.

[0034] The lower end face of the tibial support platform 1 and the outer surface of the tibial support pillar 2 are respectively fixed with biodegradable metal mesh 4. The biodegradable metal mesh 4 is a porous mesh structure and is formed by interwoven threads 7.

[0035] Biodegradable metal mesh 4 can further increase the osteoinductive properties of the tibial support implant, promoting the fusion of the tibial support and the bone injury site.

[0036] The biodegradable metal mesh 4 on the lower end face of the tibial support platform 1 extends to the side of the connected tibial support platform 1, which can increase the contact area between the tibial support platform 1 and the bone tissue, ensuring that the tibial support platform 1 and the bone injury site can achieve three-dimensional contact and realize the full-range fusion of the tibial support and the bone injury site.

[0037] In addition, during tibial support implantation surgery, slight deviations in the implantation position of the tibial support are inevitable. By extending the biodegradable metal mesh 4 to the side of the connected tibial support platform 1, it can be ensured that when slight deviations occur in the tibial support implantation, the biodegradable metal mesh 4 on the side of the tibial support platform 1 can also achieve effective fusion between the tibial support implant and the bone injury site.

[0038] A reinforcing support plate 3 is fixed between the lower end face of the tibial support platform 1 and the outer circumference of the tibial support pillar 2. The reinforcing support plate 3 has a wing-shaped structure. The wing-shaped reinforcing support plate 3 conforms to the human anatomical shape, which can better fit the human bone and tibial cross section, has good matching, reduces postoperative wear of the knee joint prosthesis, and makes the tibial osteotomy surface as coincident as possible, further improving the anti-rotational stability of the tibial support, improving the stress distribution of the tibial support, and thus extending the service life of the tibial support.

[0039] A biodegradable metal wire mesh 4 is fixedly provided on the outer surface of the reinforcing support plate 3.

[0040] Biodegradable metal mesh 4 can further improve the osteoinductive properties of the tibial support, and increase the fusion speed and fusion effect between the tibial support and bone tissue.

[0041] The tibial support platform 1 has a thickness of 5mm ± 0.5mm, the outer diameter of the tibial support pillar 2 is 3.5mm ± 0.5mm, and the thickness of the reinforcing support plate 3 is 2mm ± 0.5mm.

[0042] These dimensional parameters ensure the mechanical properties of the tibial prosthesis, including strength and wear resistance. Studies have shown that if the tibial prosthesis platform is too thick, it can easily lead to bone loss in patients. If it is too thin, the strength of the tibial prosthesis will be reduced, which can easily cause poor balance during use, or even prosthesis breakage and displacement. Therefore, a balance must be achieved, that is, to ensure strength while avoiding bone loss.

[0043] At the same time, it can achieve maximum coverage of the tibial osteotomy surface, so that the pressure is evenly distributed on the proximal tibia and the compression of the tibial support on the surrounding soft tissues is reduced.

[0044] The outer surface of the tibial support is smoothly transitioned by rounded corners, which can prevent damage to the connected bone tissue due to the sharp surface when the tibial support is implanted.

[0045] A method for preparing the above-mentioned osteoinductive high-strength tibial support includes preparing a reinforcing material and a matrix material. The reinforcing material is a biodegradable metallic material, and the matrix material is a polymer material. The preparation method includes the following steps:

[0046] Step (1): The biodegradable metal material is used to prepare a multi-filled porous metal tibial support skeleton 6. The preparation process is wire weaving or 3D printing.

[0047] Among them, filament weaving has a lower cost, but it has greater limitations in the design of a series of parameters for porous metal materials. In contrast, 3D printing has greater adjustability in the shape, size, and porosity of pores when preparing porous metal materials. It can be specifically adjusted according to the patient's imaging data to achieve the most suitable implantation effect. Therefore, 3D printing is chosen when the requirements for prosthesis structural parameters are high, while filament weaving is chosen when the requirements for prosthesis structural parameters are not high and cost savings are taken into consideration.

[0048] Step (2): Place the prepared multi-filled porous metal tibial support skeleton 6 and the polymer material into the cavity mold respectively. Use vibration to uniformly fill the filling pores 8 of the multi-filled porous metal tibial support skeleton 6 with the polymer material. Then, press the uniformly mixed material through the cavity mold to form a semi-finished tibial support. After pressing, a semi-finished tibial support is obtained.

[0049] The pressure forming method is isostatic pressing. Isostatic pressing can ensure that the density of the pressed blank is uniform and consistent, and the blank has a high density. Furthermore, due to the high density of the blank, the shrinkage during sintering is small, and it is not easy to deform after sintering, thus ensuring the structural stability of the blank. In addition, the blank formed by isostatic pressing has high strength and can be directly handled and machined. More importantly, the internal stress of the blank is small, which reduces defects such as cracking and delamination.

[0050] Step (3): The tibial support semi-finished product is placed in a high-temperature oven for sintering. After sintering, a tibial support with high strength and osteoinductive properties is obtained.

[0051] Example 1

[0052] When the reinforcing material is biodegradable magnesium alloy wire and the matrix material is polyetheretherketone powder, the preparation method includes the following steps:

[0053] Step (1): Biodegradable magnesium alloy wires are used to prepare a multi-pore magnesium alloy tibial support skeleton. The preparation method is wire weaving.

[0054] The biodegradable magnesium alloy wire has a diameter of 280μm-430μm, the polyetheretherketone powder has a particle size of 200μm-450μm, and the multi-pore magnesium alloy tibial support skeleton has a pore size of 600μm-830μm and a porosity of 50%-65%.

[0055] The diameter of this biodegradable magnesium alloy wire is slightly larger than that of human cancellous bone. This is to accommodate people with osteoporosis and those with high bone density, thus promoting better bone ingrowth, achieving integration between the prosthesis and human bone, and ultimately ensuring the long-term stability of the prosthesis.

[0056] Step (2): Place the prepared multi-filled porous magnesium alloy tibial support skeleton into the cavity mold, and then fill the cavity mold with polyetheretherketone powder. The filling method is to fill in equal amounts multiple times, and the filling number is five times. After each filling, the polyetheretherketone powder is uniformly filled into the filling pores 8 of the multi-filled porous magnesium alloy tibial support skeleton by ultrasonic vibration. The ultrasonic vibration time is 20 min - 35 min. After uniform filling, the mixed material is pressurized and formed by the cavity mold. The pressurization method is isostatic pressing. The pressurization pressure is 80 MPa - 180 MPa, and the holding time is 20 min - 33 min. After pressurization and forming, the tibial support semi-finished product is obtained.

[0057] Using multiple equal-volume fillings can avoid inconsistent density in different locations, which can lead to lower compressive strength of the implant, or even problems such as cracking and delamination. The five-times-filling method is the number of fillings determined through extensive experiments. It can ensure the filling density inside the implant, guarantee that the implant has sufficient compressive strength, reduce internal stress, and save processing time.

[0058] Step (3): The tibial support semi-finished product is placed in a high-temperature oven for sintering. The sintering method is hot pressing sintering, hot isostatic pressing sintering, gas pressure sintering, microwave sintering or discharge plasma sintering. The sintering temperature is 260℃-450℃ and the sintering time is 1h-1.8h. After sintering, a tibial support with high strength and osteoinductive properties is obtained.

[0059] Hot pressing sintering refers to the sintering process in which materials are accelerated to flow, rearrange, and densify under a certain external force (generally 10-40 MPa depending on the strength of the mold material). The temperature required for hot pressing sintering is 100-150℃ lower than that for atmospheric pressure sintering, but the driving force for hot pressing sintering is 20-100 times greater than that for atmospheric pressure sintering.

[0060] Hot pressing sintering can achieve better mechanical properties of materials, and can reduce sintering time or sintering temperature, reduce the amount of covalent ceramic sintering aids, thereby improving the high-temperature mechanical properties of materials.

[0061] The basic principle of hot isostatic pressing (HIP) sintering is to use high-pressure gas as a pressure medium to act on the material (including encapsulated powder, green body or sintered body), so that it is subjected to uniform pressure in all directions during the heating process, and the material is densified by the combined action of high temperature and high pressure.

[0062] Hot isostatic pressing (HIP) can reduce sintering temperature and shorten sintering time. At the same time, it can greatly reduce or even eliminate the use of sintering aids, improve ceramic performance and reliability, and is particularly suitable for manufacturing products with complex shapes.

[0063] Gas pressure sintering refers to applying a certain gas pressure during the high-temperature sintering process. The pressure range is usually 1-10 MPa, in order to suppress the decomposition and weight loss of the material at high temperatures, thereby increasing the sintering temperature and further promoting the densification of the material to obtain high-density products. Gas pressure sintering and vacuum hot isostatic pressing both use gas as a method to transmit pressure.

[0064] Compared with hot pressing sintering and vacuum hot isostatic pressing sintering, the biggest advantage of gas pressure sintering is that it can reduce input costs, produce products with better performance, is suitable for products with complex shapes, and can achieve mass production.

[0065] Microwave sintering is commonly used for sintering ceramic materials. It utilizes the dielectric loss of the ceramic material in the microwave electromagnetic field to bring the material to the sintering temperature, thereby achieving the sintering and densification of the ceramic.

[0066] Spark plasma sintering, also known as "plasma-activated sintering," is a novel material preparation technology that achieves material sintering through thermal effects or other field effects by directly applying a large pulse current to a mold or sample.

[0067] Spark plasma sintering can ensure uniform heating temperature, rapid heating rate, low sintering temperature, short sintering time, high production efficiency, fine and uniform product structure, maintain the natural state of raw materials, and obtain high-density materials. It is commonly used in sintering gradient materials and complex workpieces.

[0068] Solid-state metal sintering is a sintering process that uses powdered materials. These powdered materials can be molded into the desired shapes, enabling the production of complex and intricately designed parts. Furthermore, solid-state sintering can improve the mechanical properties of materials. Compared to traditional processes, solid-state sintering has a shorter cycle time, meaning the sintering process can be completed in minutes instead of hours or longer. This high productivity and rapid material development capability have led to the wider application of solid-state metal sintering.

[0069] More importantly, solid-state metal sintering can be carried out at lower temperatures compared to traditional sintering processes, which is a significant advantage as it helps to minimize energy consumption and reduce the risk of thermal damage to the sintered materials. Furthermore, solid-state metal sintering is an extremely versatile process that can be used for densification sintering of low-melting-point metals and ultra-high-temperature ceramics, and even for bonding dissimilar materials that require non-uniform temperatures. In addition, solid-state sintering can also be used to sinter porous and fully dense components, making its applications very broad.

[0070] In summary, solid-state metal sintering offers numerous advantages, including the ability to produce complex shapes, better mechanical properties, shorter sintering time, lower sintering temperature, versatility, high-precision process control, and cost-effectiveness. These advantages make solid-state sintering an ideal manufacturing method for widespread applications.

[0071] In Example 1, the diameter of the biodegradable magnesium alloy wire in step (1) is 380 μm, the particle size of the polyether ether ketone powder is 300 μm, and the pore size of the multi-pore magnesium alloy tibial support skeleton is 700 μm and the porosity is 60%.

[0072] In step (2), the ultrasonic oscillation time is 30 min, the pressure is 100 MPa, and the pressure holding time is 30 min.

[0073] The sintering method in step (3) is hot isostatic pressing sintering, the sintering temperature is 340℃, and the sintering time is 1.5h.

[0074] Example 2

[0075] When the reinforcing material is biodegradable zinc alloy powder and the matrix material is ultra-high molecular weight polyethylene powder, the preparation method includes the following steps:

[0076] Step (1): The biodegradable zinc alloy powder is used to prepare a multi-pore zinc alloy tibial support skeleton by 3D printing.

[0077] The particle size of biodegradable zinc alloy powder is 11μm-23μm, the particle size of ultra-high molecular weight polyethylene powder is 60μm-150μm, and the pore size of multi-porosity zinc alloy tibial support skeleton is 480μm-700μm with a porosity of 60%-83%.

[0078] The particle size range of this biodegradable zinc alloy powder is within the standard parameters for conventional 3D printing.

[0079] Step (2): Place the prepared multi-filled porous zinc alloy tibial support skeleton into the cavity mold, and then fill the cavity mold with ultra-high molecular weight polyethylene powder. The filling method is to fill in equal amounts multiple times, and the filling number is five times. After each filling, the ultra-high molecular weight polyethylene powder is uniformly filled into the filling pores 8 of the multi-filled porous zinc alloy tibial support skeleton by ultrasonic vibration. The ultrasonic vibration time is 25 min - 36 min. After uniform filling, the mixed material is pressurized and formed by the cavity mold. The pressurization method is isostatic pressing. The pressurization pressure is 150 MPa - 310 MPa, and the holding time is 32 min - 52 min. After pressurization and forming, the tibial support semi-finished product is obtained.

[0080] Step (3): The tibial support semi-finished product is placed in a high-temperature oven for sintering. The sintering method is hot pressing sintering, hot isostatic pressing sintering, gas pressure sintering, microwave sintering or discharge plasma sintering. The sintering temperature is 280℃-390℃ and the sintering time is 0.5h-1.2h. After sintering, a tibial support with high strength and osteoinductive properties is obtained.

[0081] In Example 2, the degradable zinc alloy powder in step (1) has a particle size of 15 μm, the ultra-high molecular weight polyethylene powder has a particle size of 100 μm, and the multi-pore zinc alloy tibial support skeleton has a pore size of 650 μm and a porosity of 75%.

[0082] In step (2), the ultrasonic oscillation time is 30 min, the pressure is 200 MPa, and the pressure holding time is 40 min.

[0083] The sintering method in step (3) is hot isostatic pressing, the sintering temperature is 360℃, and the sintering time is 1h.

[0084] Example 3

[0085] When the reinforcing material is biodegradable zinc alloy wire and the matrix material is polyetheretherketone powder, the preparation method includes the following steps:

[0086] Step (1): The biodegradable zinc alloy wire is used to prepare a multi-pore zinc alloy tibial support skeleton by wire weaving.

[0087] The biodegradable zinc alloy wire has a diameter of 360μm-520μm, the polyetheretherketone powder has a particle size of 670μm-790μm, and the multi-pore zinc alloy tibial support skeleton has a pore size of 720μm-840μm and a porosity of 72%-85%.

[0088] Step (2): Place the prepared multi-filled porous zinc alloy tibial support skeleton into the cavity mold, and then fill the cavity mold with polyetheretherketone powder. The filling method is to fill in equal amounts multiple times, and the filling number is five times. After each filling, the polyetheretherketone powder is uniformly filled into the filling pores 8 of the multi-filled porous zinc alloy tibial support skeleton by ultrasonic vibration. The ultrasonic vibration time is 26 min - 36 min. After uniform filling, the mixed material is pressurized and formed by the cavity mold. The pressurization method is isostatic pressing. The pressurization pressure is 80 MPa - 110 MPa, and the holding time is 42 min - 56 min. After pressurization and forming, the tibial support semi-finished product is obtained.

[0089] Step (3): The tibial support semi-finished product is placed in a high-temperature oven for sintering. The sintering method is hot pressing sintering, hot isostatic pressing sintering, gas pressure sintering, microwave sintering or discharge plasma sintering. The sintering temperature is 260℃-360℃ and the sintering time is 0.6h-1.2h. After sintering, a tibial support with high strength and osteoinductive properties is obtained.

[0090] In Example 3, the biodegradable zinc alloy wire in step (1) has a diameter of 450 μm, the polyether ether ketone powder has a particle size of 700 μm, and the multi-pore zinc alloy tibial support skeleton has a pore size of 800 μm and a porosity of 80%.

[0091] In step (2), the ultrasonic oscillation time is 30 min, the pressure is 100 MPa, and the pressure holding time is 50 min.

[0092] The sintering method in step (3) is hot isostatic pressing sintering, the sintering temperature is 300℃, and the sintering time is 1h.

[0093] Example 4

[0094] When the reinforcing material is biodegradable magnesium alloy powder and the matrix material is ultra-high molecular weight polyethylene powder, the preparation method includes the following steps:

[0095] Step (1): The biodegradable magnesium alloy powder is used to prepare a multi-pore magnesium alloy tibial support skeleton by 3D printing.

[0096] The particle size of biodegradable magnesium alloy powder is 32μm-51μm, the particle size of ultra-high molecular weight polyethylene powder is 85μm-112μm, and the pore size of the multi-pore magnesium alloy tibial support skeleton is 650μm-820μm with a porosity of 65%-79%.

[0097] Step (2): Place the prepared multi-filled porous magnesium alloy tibial support skeleton into the cavity mold, and then fill the cavity mold with ultra-high molecular weight polyethylene powder. The filling method is to fill in equal amounts multiple times, and the filling number is five times. After each filling, the ultra-high molecular weight polyethylene powder is uniformly filled into the filling pores 8 of the multi-filled porous magnesium alloy tibial support skeleton by ultrasonic vibration. The ultrasonic vibration time is 35 min - 46 min. After uniform filling, the mixed material is pressurized and formed by the cavity mold. The pressurization method is isostatic pressing. The pressurization pressure is 100MPa - 168MPa, and the holding time is 18 min - 42 min. After pressurization and forming, the tibial support semi-finished product is obtained.

[0098] Step (3): The tibial support semi-finished product is placed in a high-temperature oven for sintering. The sintering method is hot pressing sintering, hot isostatic pressing sintering, gas pressure sintering, microwave sintering or discharge plasma sintering. The sintering temperature is 280℃-420℃ and the sintering time is 1h-1.8h. After sintering, a tibial support with high strength and osteoinductive properties is obtained.

[0099] In Example 4, the degradable magnesium alloy powder in step (1) has a particle size of 40 μm, the ultra-high molecular weight polyethylene powder has a particle size of 100 μm, and the multi-pore magnesium alloy tibial support skeleton has a pore size of 750 μm and a porosity of 75%.

[0100] In step (2), the ultrasonic oscillation time is 40 min, the pressure is 150 MPa, and the pressure holding time is 30 min.

[0101] The sintering method in step (3) is hot isostatic pressing sintering, the sintering temperature is 340℃, and the sintering time is 1.5h.

[0102] This tibial support is made of biodegradable zinc alloy and biodegradable magnesium alloy. These materials react with body fluids in the human body and are gradually corroded and degraded by the body fluids.

[0103] Specifically, biodegradable zinc alloy materials and biodegradable magnesium alloy materials produce magnesium ions or zinc ions when they react with body fluids. These two ions, as the most important trace elements in bone tissue and as indispensable active components in human biological activities, play an important role in bone tissue repair. They can effectively accelerate the fusion speed and fusion effect of bone injury sites and play a very good role in promoting the fusion of bone injury sites.

[0104] The preparation process of this osteoinductive tibial support implant involves using biodegradable metal materials to prepare a multi-filled porous metal tibial support skeleton, then uniformly filling and mixing the multi-filled porous metal tibial support skeleton with the matrix material through ultrasonic vibration, followed by isostatic pressing to form the material, and finally placing the formed material in a high-temperature oven for sintering.

[0105] It is evident that each step contributes to increasing the strength of the tibial support implant. After the entire process is completed, the strength of the tibial support implant is significantly enhanced. As a result, the tibial support implant can withstand higher load impacts during use, minimizing the risk of damage, breakage, and other quality issues. This greatly improves the overall mechanical properties of the tibial support implant and ensures its long-term stable use.

[0106] Furthermore, the tibial support product prepared by this method has significant osteoinductive ability. The specific osteoinductive effect depends on two aspects. One is the biodegradable metal material used in the tibial support product, such as biodegradable zinc alloy and biodegradable magnesium alloy. These two materials react with the body fluids in the human body, producing Mg ions and Zn ions. These two ions can promote bone regeneration through three main strategies, including balancing osteoblasts and osteoclasts, regulating the immune microenvironment, and promoting bone angiogenesis, ultimately achieving the osteoinductive effect.

[0107] Another type is the porous plastic structure left after the degradation of biodegradable metal materials, such as polyetheretherketone, ultra-high molecular weight polyethylene, or carbon fiber polyetheretherketone finished structures. The pore size and porosity of the porous plastic structure match the human cancellous bone. Bone generated by the stimulation of metal ions can grow into the pores, eventually allowing the prosthesis to combine with the human bone, thus achieving the bone induction effect.

[0108] More importantly, the osteoinductive high-strength tibial support prepared using this method is made by mixing different types of reinforcing and matrix materials. For example, the reinforcing material can be biodegradable metal wire or biodegradable metal powder, and the matrix material can be polyetheretherketone powder, ultra-high molecular weight polyethylene powder, or carbon fiber polyetheretherketone composite material. Each reinforcing and matrix material has its own fixed preparation parameter values, such as the diameter and particle size of the reinforcing material, the particle size of the matrix material, and the pore size and porosity of the prepared multi-filled porous metal tibial support skeleton.

[0109] The selected reinforcing material and matrix material are uniformly mixed, pressurized, and sintered to obtain a tibial support with high osteoinductive strength. The above preparation process has strict and specific preparation parameters and processes, such as the pressurization method, sintering method, sintering temperature and sintering time. The above preparation parameters and processes are the key to preparing the finished tibial support material with high osteoinductive strength.

[0110] Secondly, this tibial support implant is made by using a mixture of biodegradable metal materials and medical plastics as filling material. Compared with traditional tibial support implants made of metal materials, it is lighter in overall weight. After the weight is reduced, it can significantly reduce the patient's bone loss and avoid a series of chain symptoms such as osteoporosis and bone calcification.

[0111] Example 5

[0112] The internal structure of the finished tibial support material can be prepared solely from polyetheretherketone powder, ultra-high molecular weight polyethylene powder, or carbon fiber polyetheretherketone composite material. The specific method is as follows:

[0113] Step (1): Prepare biodegradable metal materials and matrix materials, and prepare the biodegradable metal materials into a multi-filled porous metal tibial support shell skeleton. The interior of the multi-filled porous metal tibial support shell skeleton is a hollow structure. The preparation process is filament weaving or 3D printing.

[0114] The biodegradable metal material is biodegradable metal wire or biodegradable metal powder, and the matrix material is polyetheretherketone powder, ultra-high molecular weight polyethylene powder or carbon fiber polyetheretherketone composite material.

[0115] Step (2): Place the prepared multi-filled porous metal tibial bracket shell skeleton into the cavity mold, and then fill the cavity mold with polyetheretherketone powder, ultra-high molecular weight polyethylene powder or carbon fiber polyetheretherketone composite material. The filling method is to fill in equal amounts multiple times. After each filling is completed, the polyetheretherketone powder, ultra-high molecular weight polyethylene powder or carbon fiber polyetheretherketone composite material is uniformly filled into the interior of the multi-filled porous metal tibial bracket shell skeleton through the pores of the multi-filled porous metal tibial bracket shell skeleton by ultrasonic vibration until it is full.

[0116] Step (3): After filling, the mixed material is pressed and molded through a cavity mold to obtain a tibial support semi-finished product.

[0117] Step (4): The tibial support semi-finished product is placed in a high-temperature oven for sintering. After sintering, a tibial support with high strength and osteoinductive properties is obtained.

[0118] The tibial support product prepared by this method has lower strength compared to the tibial support products prepared by mixing a multi-porous metal tibial support frame and a matrix material in Examples 1-4. For patients with low postoperative activity levels, this tibial support implant can be used. If the patient has high postoperative activity levels, it is still necessary to use the tibial support implant prepared by mixing a multi-porous metal tibial support frame and a matrix material to meet the requirements of high support force and the ability to withstand high impact force in the relevant area, thereby further ensuring the long-term stable use of the tibial support implant.

[0119] However, the above description is merely a specific embodiment of the present invention and should not be construed as limiting the scope of the present invention. Therefore, any substitution of equivalent components or equivalent changes and modifications made in accordance with the scope of protection of the present invention should still fall within the scope of the claims of the present invention.

Claims

1. A tibial support with osteoinductive properties, characterized in that: A multi-filled porous metal tibial support frame is provided, the multi-filled porous metal tibial support frame includes a tibial support strut and a tibial support platform, the tibial support platform being located at the upper end of the tibial support strut; The multi-filled porous metal tibial support frame is formed by interwoven threads, with filling pores formed between the interwoven threads, and the threads are made of biodegradable metal material; The pores are filled with polymer material, and the outside of the multi-pore metal tibial support frame is covered with a layer of polymer material. One side of the tibial support platform is provided with a concave arc groove; Biodegradable metallic materials are corroded and degraded by body fluids in the body, leaving behind a polymer structure that creates space for bone tissue ingrowth.

2. The tibial support with osteogenic properties according to claim 1, characterized in that: The lower end face of the tibial support platform and the outer surface of the tibial support pillar are respectively fixed with biodegradable metal mesh. The biodegradable metal mesh has a porous mesh structure and is formed by interlacing the wires. The biodegradable metal mesh on the lower end face of the tibial support platform extends to the side of the connected tibial support platform.

3. The tibial support with osteoinductive properties according to claim 1, characterized in that: A reinforcing support plate is fixed between the lower end face of the tibial support platform and the outer circumference of the tibial support pillar, and a biodegradable metal wire mesh is fixed on the outer surface of the reinforcing support plate.

4. The tibial support with osteoinductive properties according to claim 3, characterized in that: The thickness of the tibial support platform is 5mm ± 0.5mm, the outer diameter of the tibial support pillar is 3.5mm ± 0.5mm, and the thickness of the reinforcing support plate is 2mm ± 0.5mm.

5. The tibial support with osteoinductive properties according to claim 1, characterized in that: The outer surface of the tibia support is smoothly transitioned by rounded corners.

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