Modularized system tibial component

Abstract

The invention relates to the field of medical instruments, and discloses a modular system tibia component which comprises a tibia support base body, a metal sleeve, a PE sleeve and a screw, the upper surface of the tibia support base body is of a polished type, a groove is formed in one side of the tibia support base body, a conical dovetail is arranged in the middle of the tibia support base body, and the metal sleeve is connected with the PE sleeve. A conical hole is formed in the top of the tibia support base body, the conical hole of the tibia support base body is used for being connected with a metal sleeve or a PE sleeve, a stand column is arranged at the bottom of the tibia support base body, a cavity is formed in the bottom of the stand column, and a first internal thread is arranged in the middle of the stand column. Through the combination of the conical dovetail, the conical hole and the stand column on the tibia support base body, the metal sleeve, the PE sleeve, the fixed tibia pad, the rotary tibia pad and other components, flexible combination is conducted according to different operation requirements, and therefore the adjustment requirement of a doctor for an osteotomy scheme in the operation process is greatly reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a modular system tibial component. Background Art

[0002] In the modern medical field, knee joint diseases are common and seriously affect the quality of life of patients. For patients with severe conditions, knee joint replacement surgery is an effective treatment method. As a key implant in knee joint replacement surgery, the performance and design of knee joint prostheses are directly related to the success rate of the surgery and the postoperative rehabilitation effect of patients. With the continuous development of medical technology and the increasing requirements of patients for the quality of life, higher requirements are put forward for the performance, adaptability, and personalized customization of knee joint prostheses.

[0003] Most traditional tibial components adopt a single design and manufacturing process, and the adaptability between the components of the prosthesis is poor. During the surgery, doctors need to select a suitable prosthesis according to the specific situation of the patient. However, different types of prostheses often correspond to different osteotomy methods and osteotomy amounts, which requires doctors to frequently adjust the osteotomy plan during the surgery, increasing the complexity and uncertainty of the surgery. Summary of the Invention

[0004] Aiming at the deficiencies of the prior art, the present invention provides a modular system tibial component, which solves the problems of poor adaptability between the components of the traditional tibial component prosthesis and increases the complexity and uncertainty of the surgery.

[0005] To achieve the above objectives, the present invention is realized through the following technical solutions: A modular system tibial component, including a tibial tray base body, a metal sleeve, a PE sleeve, and a screw. The upper surface of the tibial tray base body is polished. A groove is provided on one side of the tibial tray base body. A tapered dovetail is provided in the middle of the tibial tray base body. A tapered hole is provided at the top of the tibial tray base body. The tapered hole of the tibial tray base body is used to connect the metal sleeve or the PE sleeve. A column is provided at the bottom of the tibial tray base body. A cavity is provided at the bottom of the column. A first internal thread is provided in the middle of the column. The cavity and the first internal thread of the column are used to connect the screw.

[0006] Preferably, the middle of the metal sleeve is symmetrically provided with a second internal thread, and the outer wall of the metal sleeve matches the tapered hole.

[0007] Preferably, the outer wall of the PE sleeve matches the tapered hole, and the first internal thread of the column, the second internal thread of the metal sleeve, and the external thread of the screw match each other.

[0008] Preferably, it further includes a fixed tibial pad. A dovetail groove is provided at the bottom of the fixed tibial pad, and the dovetail groove is used to connect with the tapered dovetail.

[0009] Preferably, the fixed tibial pad is used to be connected to the tibial tray substrate through cooperation with a metal sleeve and screws during revision to form a fixed prosthesis, and the fixed tibial pad is also used to be connected to the tibial tray substrate through cooperation with a PE sleeve and a pin shaft during revision to form a hinge prosthesis.

[0010] Preferably, a rotating tibial pad is further included. A connecting column is fixedly connected to the bottom of the rotating tibial pad, and a limiting groove is formed on one side of the rotating tibial pad.

[0011] Preferably, the rotating tibial pad is used to be connected to the tibial tray substrate through cooperation with a metal sleeve and screws during revision to form a rotating prosthesis, and the limiting groove is used for connection with a tapered dovetail.

[0012] Preferably, the tibial tray substrate comprises the following raw materials in percentages: chromium 26%-30%, molybdenum 5%-7%, nitrogen 0.15%-0.25%, niobium 0.1%-0.5%, silicon ≤0.5%, manganese ≤0.5%, carbon ≤0.14%, iron ≤0.75%, nickel ≤0.2%, phosphorus ≤0.02%, calcium ≤0.01%, yttrium 0.01%-0.05%, and the balance is cobalt.

[0013] Preferably, the preparation method of the tibial tray substrate comprises the following steps: S1. Melting: Add the raw materials into a vacuum induction melting furnace according to the percentages, evacuate the air and then heat to melt the raw materials. Stir the molten liquid during melting, and after the raw materials are completely melted, carry out refining to remove impurities and gases to obtain an alloy liquid; S2. Pre-forming: Divide the alloy liquid into two parts. One part is prepared into cobalt-chromium-molybdenum-based powder through gas atomization powder technology, and then the selective laser melting technology is adopted. According to the patient's CT data, use the cobalt-chromium-molybdenum-based powder to print the blank of the tibial tray substrate; S3. Casting: Make a mold according to the blank of the tibial tray substrate and preheat it. Pre-set a ceramic fiber network reinforcing layer on the surface of the 3D printed substrate, pour the other part of the alloy liquid into the mold with the reinforcing layer, and naturally cool and solidify in the mold to obtain a casting; S4. Heat treatment: Carry out solution treatment, quenching and aging treatment on the casting in sequence to obtain a treated part; S5. Machining: Carry out rough machining and finish machining on the treated part in sequence to obtain a machined part; S6. Surface treatment: Carry out cleaning, passivation treatment and coating treatment on the machined part, thus completing the preparation.

[0014] Preferably, in S1, the heating temperature is 1500-1700 °C, the time is 2-4 hours, and the stirring rate is 50-150 r / min; In S2, the sphericity of the cobalt-chromium-molybdenum-based powder is ≥90%, the oxygen content is ≤0.02%, the particle size is 15-45 μm, the pore structure of the tibial tray matrix blank is a gradient porosity structure, and its porosity gradually decreases from the surface to the inside. The surface porosity is 60%-80%, and the internal porosity is 20%-40%; In S3, the preheating temperature is 200-300 °C, the preheating time is 1-2 hours, the ceramic fiber is Al2O3 ceramic fiber, its diameter is 5-15 μm, and its length is 1-5 mm; In S4, the solution treatment is to heat the casting to 1100-1200 °C and hold for 1-2 hours. The quenching is to cool the casting after solution treatment in a quenching medium. The aging treatment is to heat the quenched casting to 700-800 °C and hold for 4-6 hours; In S5, rough machining is to remove the surface allowance of the workpiece through a lathe and a milling machine, and the machining accuracy is controlled within ±0.5 mm. The finish machining is to perform finish machining on the workpiece after rough machining using grinding and polishing processes to make the surface roughness Ra reach 0.4-0.8 μm, and the dimensional accuracy is controlled within ±0.05 mm; In S6, the passivation treatment is to soak the workpiece in a passivation solution containing nitric acid and potassium dichromate for 15-30 minutes, and the temperature of the passivation solution is 40-60 °C. The coating treatment is to coat a hydroxyapatite coating on the surface of the workpiece after passivation treatment, and the coating thickness is 50-100 μm.

[0015] The present invention provides a modular system tibial component. It has the following beneficial effects: 1. Through the combination of the tapered dovetail, tapered hole and upright post on the tibial tray matrix of the present invention with components such as a metal sleeve, a PE sleeve, a fixed tibial pad and a rotating tibial pad, flexible combination can be carried out according to different surgical requirements, thus greatly reducing the doctor's need to adjust the osteotomy plan during the operation. And during continuous selection, the osteotomy plan on the tibial side during the operation remains unchanged, and the matrix components on the tibial side remain unchanged, thereby solving the problem that the adaptability between the components of the traditional tibial component prosthesis is poor, increasing the complexity and uncertainty of the operation.

[0016] 2. Through the tight matching of the tapered hole at the top of the tibial tray matrix with the outer walls of the metal sleeve and the PE sleeve, and the mutual cooperation of the first internal thread of the upright post, the second internal thread of the metal sleeve and the external thread of the screw, double fixation is achieved, effectively preventing the components from loosening during use, ensuring the stability of the prosthesis in the human knee joint, and improving the service life of the prosthesis.

[0017] 3. The present invention improves the strength, hardness and corrosion resistance of the alloy through elements such as chromium and molybdenum, enabling it to withstand the pressure and friction generated during daily knee joint activities; the solid solution strengthening of nitrogen further enhances the strength; niobium refines the grain structure and improves the fatigue resistance; yttrium improves the oxidation resistance, thermal stability and biocompatibility; at the same time, other impurity elements are strictly controlled to ensure the purity and stability of the alloy, so that the tibial tray matrix remains stable during long-term use, reducing the risk of wear and damage, and providing better support and guarantee for patients.

[0018] 4. The tibial tray matrix blank printed by the present invention using the selective laser melting technology has a gradient porosity structure, with a large surface porosity, providing sufficient space for the adhesion and proliferation of bone cells; the internal porosity is small, ensuring the strength and stability of the matrix. In addition, the hydroxyapatite coating applied during surface treatment is similar in composition to human bone tissue, which can promote the adhesion, proliferation and differentiation of bone cells, accelerate the integration of bone tissue and the tibial tray matrix, improve the stability of the prosthesis, contribute to the postoperative rehabilitation of patients, and enhance the quality of life.

[0019] 5. The present invention pre-sets an Al2O3 ceramic fiber network reinforcement layer on the surface of the 3D printed matrix, effectively improving the surface wear resistance of the tibial tray matrix. The high hardness and high wear resistance of the ceramic fiber can extend the wear life of its counter-grinding with components such as the polyethylene liner. At the same time, through steps such as melting, heat treatment and machining, the organizational structure of the alloy is optimized, further enhancing the mechanical properties of the tibial tray matrix, enabling it to better meet the strict requirements for component performance in knee joint replacement surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a three-dimensional structural schematic diagram of the present invention; Figure 2 is a top-view structural schematic diagram of the tibial tray matrix of the present invention; Figure 3 is an internal structural schematic diagram of the tibial tray matrix of the present invention; Figure 4 is a partial structural schematic diagram of the first internal thread of the present invention; Figure 5 is a three-dimensional structural schematic diagram of the metal sleeve of the present invention; Figure 6 is an internal structural schematic diagram of the metal sleeve of the present invention; Figure 7 is a three-dimensional structural schematic diagram of the PE sleeve of the present invention; Figure 8 is a three-dimensional structural schematic diagram of the screw of the present invention; Figure 9 is a three-dimensional structural schematic diagram of the fixed tibial pad of the present invention; Figure 10It is a bottom view structural schematic diagram of the fixed tibial pad of the present invention; Figure 11 It is a schematic diagram of the top view of the fixed tibial pad of the present invention; Figure 12 It is a schematic diagram of the three-dimensional structure of the rotational tibial pad of the present invention; Figure 13 The present invention is a flowchart of the method for preparing the tibial support base body.

[0021] Among them, 1. tibial support base; 2. groove; 3. conical dovetail; 4. column; 5. conical hole; 6. metal sleeve; 7. PE sleeve; 8. screw; 9. rotating tibial pad; 10. fixed tibial pad; 11. first internal thread; 12. cavity; 13. second internal thread; 14. limit groove; 15. connecting column. DETAILED DESCRIPTION

[0022] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] Please refer to the attached Figure 1 -Attached Figure 8 The embodiment of the present invention provides a modular system tibial component, including a tibial support base 1, a metal sleeve 6, a PE sleeve 7, and a screw 8. The upper surface of the tibial support base 1 is polished, a groove 2 is provided on one side of the tibial support base 1, a conical dovetail 3 is provided in the middle of the tibial support base 1, a conical hole 5 is provided on the top of the tibial support base 1, and the conical hole 5 of the tibial support base 1 is used to connect the metal sleeve 6 or the PE sleeve 7, a column 4 is provided at the bottom of the tibial support base 1, a cavity 12 is provided at the bottom of the column 4, a first internal thread 11 is provided in the middle of the column 4, and the cavity 12 of the column 4 and the first internal thread 11 are used to connect the screw 8; a second internal thread 13 is symmetrically provided in the middle of the metal sleeve 6, and the outer wall of the metal sleeve 6 matches the conical hole 5; the outer wall of the PE sleeve 7 matches the conical hole 5, and the first internal thread 11 of the column 4 and the second internal thread 13 of the metal sleeve 6 match the external thread of the screw 8.

[0024] Specifically, the upper surface of the tibial tray base body 1 is polished, reducing the friction with other components, decreasing the degree of wear, and increasing the service life of the prosthesis. The groove 2 opened on one side can be used to accommodate specific auxiliary instruments or soft tissues, facilitating the surgical operation and better adapting to the physiological structure of the human knee joint. The tapered dovetail 3 in the middle can not only precisely cooperate with the dovetail groove at the bottom of the fixed tibial pad 10, but also play a role in angle limitation when cooperating with the rotating tibial pad 9. In the usage scenario of the rotating prosthesis, after the connecting column 15 at the bottom of the rotating tibial pad 9 is inserted into the tapered hole 5 of the tibial tray base body 1, through the cooperation of the limiting groove 14 and the tapered dovetail 3, it can ensure that the rotating tibial pad 9 rotates flexibly within a certain angle range without excessive rotation, guaranteeing the stability and safety of the prosthesis.

[0025] The tapered hole 5 opened at the top matches the outer walls of the metal sleeve 6 and the PE sleeve 7, enabling the metal sleeve 6 and the PE sleeve 7 to be tightly connected to the tibial tray base body 1. When the metal sleeve 6 is connected to the tapered hole 5, the second internal threads 13 symmetrically opened in the middle of the metal sleeve 6 and the first internal threads 11 in the middle of the column 4 of the tibial tray base body 1 jointly cooperate with the screw 8 to achieve a firm connection. This connection method plays an important role in both primary knee replacement surgery (the metal sleeve 6 and the screw 8 may not be used) and revision surgery. In revision surgery, through the cooperation of the metal sleeve 6, the screw 8 and the fixed tibial pad 10, a stable fixed prosthesis can be formed. After the PE sleeve 7 is connected to the tibial tray base body 1, it is used to install the pin shaft of the hinge prosthesis, enabling the hinge-type prosthesis to achieve specific movement functions and meet the special needs of patients in terms of knee joint movement.

[0026] The column 4 at the bottom of the tibial tray base body 1, with the cavity 12 at the bottom and the first internal threads 11 in the middle for connecting the screw 8. During the actual installation process, the screw 8 enters the cavity 12, passes through the first internal threads 11 of the column 4 and then screws into the second internal threads 13 of the metal sleeve 6, thereby achieving double fixation, greatly enhancing the firmness of the connection between components and effectively preventing loosening during use.

[0027] Through structures such as the tapered dovetail 3, tapered hole 5, and upright post 4 on the tibial tray base body 1, components such as the metal sleeve 6, PE sleeve 7, fixed tibial pad 10, and rotating tibial pad 9 can be flexibly combined according to different surgical requirements. During the primary total knee arthroplasty, the doctor can choose whether to use the metal sleeve 6 and screws 8 according to the specific situation of the patient, and select the appropriate type of tibial pad (fixed or rotating). In revision surgery, the combination method of the components can also be flexibly adjusted according to the patient's condition and the previous prosthesis usage, forming a fixed prosthesis or a hinge prosthesis, which greatly reduces the doctor's need to adjust the osteotomy plan during the operation, thus solving the problem of poor adaptability between the components of the traditional tibial component prosthesis, increasing the complexity and uncertainty of the operation.

[0028] Please refer to the appendix Figure 9 - appendix Figure 11 It also includes a fixed tibial pad 10. A dovetail groove is opened at the bottom of the fixed tibial pad 10, and the dovetail groove is used to connect with the tapered dovetail 3. The fixed tibial pad 10 is used to connect it to the tibial tray base body 1 through cooperation with the metal sleeve 6 and screws 8 during revision to form a fixed prosthesis. The fixed tibial pad 10 is also used to connect it to the tibial tray base body 1 through cooperation with the PE sleeve 7 and pin during revision to form a hinge prosthesis.

[0029] Specifically, by connecting the dovetail groove at the bottom of the fixed tibial pad 10 to the tapered dovetail 3 of the tibial tray base body 1, during revision surgery, the fixed tibial pad 10 can form a fixed prosthesis through cooperation with the metal sleeve 6 and screws 8; it can also construct a hinge prosthesis through cooperation with the PE sleeve 7 and pin. Different combination methods provide more choices for doctors to adapt to the conditions and surgical requirements of different patients. Please refer to the appendix Figure 12 It also includes a rotating tibial pad 9. A connecting column 15 is fixedly connected to the bottom of the rotating tibial pad 9, and a limiting groove 14 is opened on one side of the rotating tibial pad 9. The rotating tibial pad 9 is used to connect it to the tibial tray base body 1 through cooperation with the metal sleeve 6 and screws 8 during revision to form a rotating prosthesis, and the limiting groove 14 is used to connect with the tapered dovetail 3.

[0030] Specifically, the connecting column 15 at the bottom of the rotating tibial pad 9 is used to insert into the tapered hole 5 of the tibial tray base body 1 to achieve preliminary positioning. The limiting groove 14 opened on one side is connected to the tapered dovetail 3. In the rotating prosthesis, the rotating tibial pad 9 can rotate freely within a certain range and is restricted by the tapered dovetail 3 at the same time, ensuring the stability and safety of rotation.

[0031] The tibial tray base body 1 comprises raw materials in the following percentages: chromium 26%-30%, molybdenum 5%-7%, nitrogen 0.15%-0.25%, niobium 0.1%-0.5%, silicon ≤0.5%, manganese ≤0.5%, carbon ≤0.14%, iron ≤0.75%, nickel ≤0.2%, phosphorus ≤0.02%, calcium ≤0.01%, yttrium 0.01%-0.05%, and the balance is cobalt.

[0032] Specifically, the addition of chromium and molybdenum can significantly improve the strength, hardness, and corrosion resistance of the alloy, enabling it to withstand various pressures and frictions generated during daily knee joint activities. Chromium forms a dense chromium oxide protective film on the surface of the alloy, preventing the erosion of the alloy by external media and effectively improving the corrosion resistance of the alloy. At the same time, chromium and molybdenum atoms form a solid solution with the cobalt matrix, strengthening the lattice structure and increasing the resistance to dislocation movement, thereby improving the strength and hardness of the alloy and ensuring the stability and reliability of the tibial tray base body during long-term use.

[0033] The addition of nitrogen can play a role in solution strengthening and further enhance the strength of the alloy. Nitrogen atoms are relatively small and can dissolve in the lattice interstitial of the cobalt matrix, causing lattice distortion and hindering the movement of dislocations, thereby improving the strength of the alloy. While improving the overall performance of the alloy, it will not significantly reduce the toughness of the alloy, making the tibial tray base body less likely to deform and fracture under large pressures.

[0034] By adding niobium, it can form stable carbides with carbon, refine the grain structure, improve the mechanical properties of the alloy, and enhance its fatigue resistance. The carbides formed by the combination of niobium and carbon play a role in heterogeneous nucleation during the solidification and heat treatment processes of the alloy, promoting the refinement of grains. Fine grains can increase the grain boundary area, and grain boundaries can hinder the propagation of cracks, improving the toughness and fatigue resistance of the alloy. During the frequent flexion and extension movements of the knee joint, this fatigue resistance can effectively extend the service life of the tibial tray base body.

[0035] By adding yttrium, as a rare earth element, it can improve the oxidation resistance and thermal stability of the alloy and have a positive impact on the biocompatibility of the alloy. Yttrium can combine with impurity elements in the alloy, reducing the segregation of impurities at grain boundaries, thereby improving the oxidation resistance of the alloy. At the same time, yttrium can improve the thermal expansion coefficient and thermal conductivity of the alloy, enhancing the thermal stability of the alloy. In terms of biocompatibility, yttrium can regulate the charge distribution and chemical properties on the surface of the alloy, reduce the stimulation to surrounding tissues, and promote the adhesion, proliferation, and differentiation of bone cells, which is beneficial to the integration of bone tissue and the tibial tray base body.

[0036] By strictly controlling the addition of elements such as silicon, manganese, carbon, iron, nickel, phosphorus, and calcium, it helps to improve the purity and stability of the alloy, reduce the adverse effects of impurities on the alloy properties. When the content of these elements is too high, they may form harmful compounds or phases, reducing the strength, toughness, and corrosion resistance of the alloy. Strictly controlling their content can ensure the uniformity and stability of the alloy composition and improve the comprehensive performance of the alloy.

[0037] By adding cobalt, as a matrix element, it provides the basic strength and toughness for the alloy. Cobalt has good high-temperature performance and corrosion resistance and can remain stable in a complex physiological environment. At the same time, the crystal structure and chemical properties of cobalt are beneficial to the dissolution and uniform distribution of other alloy elements, providing a good basis for other elements to play their roles. It can also form solid solutions and intermetallic compounds with other elements to further strengthen the properties of the alloy, ensuring that the tibial tray matrix can meet the requirements of knee replacement surgery.

[0038] Please refer to the attached Figure 13 , and the preparation method of the tibial tray matrix 1 includes the following steps: S1. Melting: Add the raw materials according to the percentage into a vacuum induction melting furnace, evacuate the air and then heat to melt the raw materials. Stir the molten liquid during melting, and after the raw materials are completely melted, carry out refining to remove impurities and gases to obtain alloy liquid. The heating temperature in S1 is 1500 - 1700 °C, the time is 2 - 4 hours, and the stirring rate is 50 - 150 r / min.

[0039] Specifically, by adding the raw materials according to the percentage into a vacuum induction melting furnace, evacuating the air and then heating to melt the raw materials, stirring the molten liquid during melting, and carrying out refining to remove impurities and gases after the raw materials are completely melted to obtain alloy liquid, it ensures the uniformity and purity of the alloy composition. Heating and melting the raw materials in a vacuum environment can avoid the reaction of the raw materials with oxygen, nitrogen, etc. in the air, reduce the formation of impurities such as oxides and nitrides. Stirring the molten liquid helps to fully mix various alloy elements and ensure the uniform distribution of the alloy composition throughout the molten liquid. The refining process can remove gases (such as hydrogen, oxygen, etc.) and non-metallic inclusions in the molten liquid, improve the quality of the alloy liquid, and lay a good foundation for the subsequent preparation steps.

[0040] S2. Pre-forming: Divide the alloy liquid into two parts. One part is prepared into cobalt-chromium-molybdenum-based powder through gas atomization powder technology, and then the selective laser melting technology is used to print the tibial tray matrix blank according to the patient's CT data using the cobalt-chromium-molybdenum-based powder. In S2, the sphericity of the cobalt-chromium-molybdenum-based powder is ≥90%, the oxygen content is ≤0.02%, the particle size is 15 - 45 μm, the pore structure of the tibial tray matrix blank is a gradient porosity structure, and its porosity gradually decreases from the surface to the inside, with the surface porosity being 60% - 80% and the internal porosity being 20% - 40%.

[0041] Specifically, the alloy liquid is divided into two parts. One part is prepared into cobalt-chromium-molybdenum-based powder by gas atomization powder-making technology. Then, using selective laser melting technology and based on the patient's CT data, the tibial tray matrix blank is printed with the cobalt-chromium-molybdenum-based powder, thus realizing the personalized customization of the tibial tray matrix. The powder prepared by gas atomization powder-making technology, with high sphericity, low oxygen content and appropriate particle size, has good fluidity and spreadability, which is conducive to the precise forming of selective laser melting technology. And printing according to the patient's CT data can make the shape and size of the tibial tray matrix blank perfectly match the knee joint bone structure of the patient, improving the adaptability of the prosthesis. The gradient porosity structure is conducive to the ingrowth of bone tissue. The larger surface porosity provides sufficient space for the adhesion and proliferation of bone cells, while the smaller internal porosity ensures the strength and stability of the tibial tray matrix, promoting the integration of bone tissue and the prosthesis.

[0042] S3. Casting: Make a mold according to the tibial tray matrix blank and preheat it. Pre-place a ceramic fiber mesh reinforcing layer on the surface of the 3D printed matrix. Pour the other part of the alloy liquid into the mold with the reinforcing layer and let it cool and solidify naturally in the mold to obtain a casting; the preheating temperature in S3 is 200 - 300 °C, the preheating time is 1 - 2 hours, the ceramic fiber is Al2O3 ceramic fiber, its diameter is 5 - 15 μm, and its length is 1 - 5 mm.

[0043] Specifically, by making a mold according to the tibial tray matrix blank and preheating it, pre-placing a ceramic fiber mesh reinforcing layer on the surface of the 3D printed matrix, pouring the other part of the alloy liquid into the mold with the reinforcing layer and letting it cool and solidify naturally in the mold to obtain a casting, the mechanical properties and surface wear resistance of the tibial tray matrix are improved. Mold preheating can reduce the cooling rate difference of the alloy liquid during casting, reduce the stress concentration inside the casting, and prevent the generation of cracks. The Al2O3 ceramic fiber mesh reinforcing layer forms a good interfacial bond with the alloy matrix. The ceramic fiber has high hardness and high wear resistance, which can effectively improve the wear resistance of the surface of the tibial tray matrix, extend the wear life of its abrasion with components such as polyethylene liners, and at the same time enhance the overall mechanical strength.

[0044] S4. Heat treatment: The casting is successively subjected to solution treatment, quenching and aging treatment to obtain a treated part; the solution treatment in S4 is to heat the casting to 1100 - 1200 °C and hold for 1 - 2 hours, quenching is to cool the casting after solution treatment in a quenching medium, and aging treatment is to heat the quenched casting to 700 - 800 °C and hold for 4 - 6 hours.

[0045] Specifically, by subjecting the casting to solution treatment, quenching, and aging treatment in sequence, a treated part is obtained, thereby further improving the microstructure and properties of the alloy. The solution treatment enables various elements in the alloy to fully dissolve in the cobalt matrix, forming a uniform solid-solution structure, laying a foundation for subsequent strengthening treatment. During the quenching process, the rapid cooling method causes martensitic transformation or other strengthening phases to occur in the alloy, increasing the strength and hardness of the alloy. The aging treatment is carried out by holding at a lower temperature, causing solute atoms in the alloy to diffuse and precipitate, further strengthening the lattice structure of the alloy, increasing the strength, hardness, and toughness of the alloy, while eliminating the internal stress generated during the quenching process and improving the dimensional stability of the casting.

[0046] S5. Machining: The treated part is successively subjected to rough machining and finish machining to obtain a machined part; in S5, rough machining is to remove the surface allowance of the treated part by a lathe and a milling machine, with the machining accuracy controlled within ±0.5 mm, and finish machining is to perform finish machining on the treated part after rough machining using grinding and polishing processes, so that the surface roughness Ra reaches 0.4 - 0.8 μm and the dimensional accuracy is controlled within ±0.05 mm.

[0047] Specifically, by successively subjecting the treated part to rough machining and finish machining, a machined part is obtained, thereby ensuring the dimensional accuracy and surface quality of the tibial tray matrix. Rough machining can quickly remove the excess material on the surface of the treated part, making the treated part close to the designed size and providing a good foundation for finish machining. Finish machining further improves the surface flatness and smoothness of the treated part through grinding and polishing processes, bringing the surface roughness to a suitable range, while ensuring the dimensional accuracy of each part, ensuring the precise fit of the tibial tray matrix with other components, and improving the assembly quality and service performance of the tibial component of the entire modular system.

[0048] S6. Surface treatment: The machined part is cleaned, passivated, and coated to complete the preparation; in S6, the passivation treatment is to immerse the machined part in a passivation solution containing nitric acid and potassium dichromate for 15 - 30 minutes at a passivation solution temperature of 40 - 60 °C, and the coating treatment is to coat a hydroxyapatite coating on the surface of the machined part after passivation treatment, with the coating thickness of 50 - 100 μm.

[0049] Specifically, the preparation is completed by cleaning, passivating and coating the workpiece, thereby improving the corrosion resistance and biocompatibility of the tibial support base. The cleaning process can remove impurities such as oil, iron filings, etc. on the surface of the workpiece, providing a clean surface for subsequent passivation and coating treatments. The passivation treatment forms a dense oxide film on the surface of the workpiece, which can effectively prevent the external medium from corroding the alloy and improve the corrosion resistance of the alloy. The hydroxyapatite coating has good biological activity and biocompatibility, and is similar to the composition of human bone tissue. It can promote the adhesion, proliferation and differentiation of bone cells, accelerate the integration of bone tissue and the tibial support base, and improve the stability of the prosthesis and the long-term use effect.

[0050] The following is further introduced in conjunction with specific embodiments: Embodiment 1: The present embodiment provides a tibial support base 1 comprising the following percentages of raw materials: 30% chromium, 7% molybdenum, 0.25% nitrogen, 0.5% niobium, ≤0.5% silicon, ≤0.5% manganese, ≤0.14% carbon, ≤0.75% iron, ≤0.2% nickel, ≤0.02% phosphorus, ≤0.01% calcium, 0.05% yttrium, and the remainder is cobalt.

[0051] The preparation method of the tibial support base 1 comprises the following steps: S1. Melting: adding raw materials into a vacuum induction melting furnace according to percentage, heating the raw materials after vacuuming to melt them, stirring the molten liquid during melting, and refining the raw materials to remove impurities and gases after they are completely melted to obtain alloy liquid; S2, preforming: the alloy liquid is divided into two parts, one of which is prepared into cobalt-chromium-molybdenum-based powder by gas atomization powder making technology, and then the cobalt-chromium-molybdenum-based powder is used to print the tibial support body blank by selective laser melting technology according to the patient's CT data; S3, casting: a mold is made according to the tibial tray base blank and preheated, a ceramic fiber mesh reinforcement layer is pre-placed on the surface of the 3D printed base, another portion of the alloy liquid is cast into the mold with the reinforcement layer, and naturally cooled and solidified in the mold to obtain a casting; S4, heat treatment: the casting is subjected to solution treatment, quenching and aging treatment in sequence to obtain a treated part; S5. Mechanical processing: rough machining and fine machining are performed on the processed parts in sequence to obtain processed parts; S6. Surface treatment: Clean, passivate and coat the workpiece to complete the preparation.

[0052] In S1, the heating temperature is 1600°C, the time is 3 hours, and the stirring rate is 100 r / min; The sphericity of the cobalt-chromium-molybdenum-based powder in S2 is ≥90%, the oxygen content is ≤0.02%, the particle size is 30 μm, the pore structure of the tibial tray matrix blank is a gradient porosity structure, and its porosity gradually decreases from the surface to the inside, with the surface porosity being 70% and the internal porosity being 30%; In S3, the preheating temperature is 250 °C, the preheating time is 1.5 hours, the ceramic fiber is Al2O3 ceramic fiber, its diameter is 10 μm, and its length is 3 mm; In S4, the solution treatment is to heat the casting to 1150 °C and hold for 1.5 hours, the quenching is to cool the casting after solution treatment in a quenching medium, and the aging treatment is to heat the quenched casting to 750 °C and hold for 5 hours; In S5, rough machining is to remove the surface allowance of the workpiece through a lathe and a milling machine, and the machining accuracy is controlled within ±0.5 mm. Finish machining is to perform finish machining on the workpiece after rough machining using grinding and polishing processes to make its surface roughness Ra reach 0.6 μm, and the dimensional accuracy is controlled within ±0.05 mm; In S6, the passivation treatment is to immerse the workpiece in a passivation solution containing nitric acid and potassium dichromate for 22.5 minutes, and the temperature of the passivation solution is 50 °C. The coating treatment is to coat a hydroxyapatite coating on the surface of the workpiece after passivation treatment, and the coating thickness is 75 μm.

[0053] Example 2: The difference between this example and the above Example 1 is: This example provides a tibial tray matrix 1 including the following percentage raw materials: chromium 26%, molybdenum 5%, nitrogen 0.15%, niobium 0.1%, silicon ≤0.5%, manganese ≤0.5%, carbon ≤0.14%, iron ≤0.75%, nickel ≤0.2%, phosphorus ≤0.02%, calcium ≤0.01%, yttrium 0.01%, and the balance is cobalt.

[0054] Example 3: The difference between this example and the above Example 1 is: This example provides a tibial tray matrix 1 including the following percentage raw materials: chromium 28%, molybdenum 6%, nitrogen 0.2%, niobium 0.3%, silicon ≤0.5%, manganese ≤0.5%, carbon ≤0.14%, iron ≤0.75%, nickel ≤0.2%, phosphorus ≤0.02%, calcium ≤0.01%, yttrium 0.03%, and the balance is cobalt.

[0055] Table 1: Comparison Example 1 Example 2 Example 3 Standard value Tensile strength (MPa) 1100 950 1030 800 Fatigue limit (MPa) 550 450 500 400 Corrosion resistance (mm / year) 0.005 0.008 0.0065 0.05 The comparison in the above table is for the traditional tibial tray matrix. It can be seen from Table 1 that different components of carbon, silicon, manganese, phosphorus, sulfur, nickel, chromium, copper, nitrogen, and iron can affect the tensile strength, fatigue limit, and corrosion resistance of the tibial tray matrix, thereby optimizing the performance of the tibial tray matrix, extending the service life of the prosthesis, and solving the problem that the poor anti-fatigue performance of the traditional tibial tray matrix easily causes wear during the use of the prosthesis, affecting the rehabilitation effect and quality of life of the patient.

[0056] Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A modular system tibial component, comprising a tibial tray base body (1), a metal sleeve (6), a PE sleeve (7), and a screw (8), characterized in that: The upper surface of the tibial tray base body (1) is polished. A groove (2) is provided on one side of the tibial tray base body (1). A tapered dovetail (3) is provided in the middle of the tibial tray base body (1). A tapered hole (5) is provided at the top of the tibial tray base body (1). The tapered hole (5) of the tibial tray base body (1) is used to connect a metal sleeve (6) or a PE sleeve (7). A column (4) is provided at the bottom of the tibial tray base body (1). A cavity (12) is provided at the bottom of the column (4). A first internal thread (11) is provided in the middle of the column (4). The cavity (12) and the first internal thread (11) of the column (4) are used to connect a screw (8).

2. The modular system tibial component according to claim 1, wherein: Symmetrically arranged second internal threads (13) are provided in the middle of the metal sleeve (6). The outer wall of the metal sleeve (6) matches the tapered hole (5).

3. A modular system tibial component according to claim 1, characterized in that: The outer wall of the PE sleeve (7) matches the tapered hole (5). The first internal thread (11) of the column (4), the second internal thread (13) of the metal sleeve (6) and the external thread of the screw (8) match each other.

4. A modular system tibial component according to claim 1, characterized in that: It further includes a fixed tibial pad (10). A dovetail groove is provided at the bottom of the fixed tibial pad (10). The dovetail groove is used to connect with the tapered dovetail (3).

5. A modular system tibial component according to claim 4, wherein: During revision, the fixed tibial pad (10) is used to be connected to the tibial tray base body (1) through cooperation with the metal sleeve (6) and the screw (8) to form a fixed prosthesis. During revision, the fixed tibial pad (10) is also used to be connected to the tibial tray base body (1) through cooperation with the PE sleeve (7) and a pin to form a hinge prosthesis.

6. A modular system tibial component according to claim 1, wherein: It further includes a rotating tibial pad (9). A connecting column (15) is fixedly connected to the bottom of the rotating tibial pad (9). A limiting groove (14) is provided on one side of the rotating tibial pad (9).

7. A modular system tibial component according to claim 6, wherein: During revision, the rotating tibial pad (9) is used to be connected to the tibial tray base body (1) through cooperation with the metal sleeve (6) and the screw (8) to form a rotating prosthesis. The limiting groove (14) is used to connect with the tapered dovetail (3).

8. A modular system tibial component according to claim 1, characterized in that: The tibial tray base body (1) comprises the following raw materials by percentage: 26%-30% of chromium, 5%-7% of molybdenum, 0.15%-0.25% of nitrogen, 0.1%-0.5% of niobium, ≤0.5% of silicon, ≤0.5% of manganese, ≤0.14% of carbon, ≤0.75% of iron, ≤0.2% of nickel, ≤0.02% of phosphorus, ≤0.01% of calcium, 0.01%-0.05% of yttrium, and the balance is cobalt.

9. A modular system tibial component according to claim 8, characterized in that: The preparation method of the tibial tray base body (1) comprises the following steps: S1. Melting: Add the raw materials into a vacuum induction melting furnace according to the percentage. After evacuating the air, heat to melt the raw materials. Stir the molten liquid during melting. After the raw materials are completely melted, conduct refining to remove impurities and gases to obtain an alloy liquid. S2. Pre-forming: Divide the alloy liquid into two parts. One part is prepared into cobalt-chromium-molybdenum-based powder through gas atomization powder preparation technology. Then, adopt the selective laser melting technology. According to the patient's CT data, use the cobalt-chromium-molybdenum-based powder to print the blank of the tibial tray base body. S3. Casting: Make a mold according to the tibial tray matrix blank and preheat it. Pre-place a ceramic fiber network reinforcement layer on the surface of the 3D-printed matrix. Pour another portion of alloy liquid into the mold with the reinforcement layer and let it cool and solidify naturally in the mold to obtain a casting; S4. Heat treatment: Perform solution treatment, quenching, and aging treatment on the casting in sequence to obtain a treated part; S5. Machining: Perform rough machining and finish machining on the treated part in sequence to obtain a machined part; S6. Surface treatment: Clean, passivate, and coat the machined part to complete the preparation.

10. A modular system tibial component according to claim 9, wherein: In the said S1, the heating temperature is 1500 - 1700 °C, the time is 2 - 4 hours, and the stirring rate is 50 - 150 r / min; In the said S2, the sphericity of the cobalt-chromium-molybdenum-based powder is ≥90%, the oxygen content is ≤0.02%, the particle size is 15 - 45 μm, the pore structure of the tibial tray matrix blank is a gradient porosity structure, and its porosity gradually decreases from the surface to the inside. The surface porosity is 60% - 80%, and the internal porosity is 20% - 40%; In the said S3, the preheating temperature is 200 - 300 °C, the preheating time is 1 - 2 hours, the ceramic fiber is Al2O3 ceramic fiber, its diameter is 5 - 15 μm, and its length is 1 - 5 mm; In the said S4, the solution treatment is to heat the casting to 1100 - 1200 °C and hold for 1 - 2 hours, the quenching is to cool the castings after solution treatment in a quenching medium, and the aging treatment is to heat the quenched castings to 700 - 800 °C and hold for 4 - 6 hours; In the said S5, the rough machining is to remove the surface allowance of the treated part by a lathe and a milling machine, and the machining accuracy is controlled within ±0.5 mm. The finish machining is to perform finish machining on the treated part after rough machining by grinding and polishing processes to make its surface roughness Ra reach 0.4 - 0.8 μm, and the dimensional accuracy is controlled within ±0.05 mm; In the said S6, the passivation treatment is to immerse the machined part in a passivation solution containing nitric acid and potassium dichromate for 15 - 30 minutes, and the temperature of the passivation solution is 40 - 60 °C. The coating treatment is to coat a hydroxyapatite coating on the surface of the machined part after passivation treatment, and the coating thickness is 50 - 100 μm.

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