Modular system tibial component

Abstract

The present invention relates to the field of medical devices, and discloses a modular system tibial component, comprising a tibial support base, a metal sleeve, a PE sleeve, and a screw. The upper surface of the tibial support base is polished, a groove is provided on one side of the tibial support base, a tapered dovetail is provided in the middle of the tibial support base, a tapered hole is provided on the top of the tibial support base, the tapered hole of the tibial support base is used to connect a metal sleeve or a PE sleeve, a column is provided at the bottom of the tibial support base, a cavity is provided at the bottom of the column, and a first internal thread is provided in the middle of the column. By combining the tapered dovetail, tapered hole, and column on the tibial support base with components such as the metal sleeve, the PE sleeve, the fixed tibial pad, and the rotating tibial pad, flexible combinations can be made according to different surgical requirements, thereby greatly reducing the doctor's need to adjust the osteotomy plan during the operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a modular system tibial component. BACKGROUND

[0002] In the modern medical field, knee joint disease is a common and serious condition that affects the quality of life of patients. For patients with severe conditions, knee replacement surgery is an effective treatment. As the key implant for knee replacement surgery, the performance and design of the knee prosthesis are directly related to the success rate of the surgery and the rehabilitation effect of the patient after the surgery. With the continuous development of medical technology and the improvement of patients' requirements for the quality of life, higher requirements are put forward for the performance, adaptability and personalized customization of knee prostheses.

[0003] Traditional tibial components mostly use a single design and manufacturing process, and the adaptability between the components of the prosthesis is poor. During the surgery, the doctor needs to select the appropriate prosthesis according to the specific condition of the patient, but different types of prostheses often correspond to different osteotomy methods and osteotomy amounts, which requires the doctor to frequently adjust the osteotomy plan during the surgery, increasing the complexity and uncertainty of the surgery. SUMMARY

[0004] In view of the deficiencies of the prior art, the present application provides a modular system tibial component to solve the problem of poor adaptability between the components of the traditional tibial component prosthesis, which increases the complexity and uncertainty of the surgery.

[0005] To achieve the above purpose, the present application is realized by the following technical scheme: a modular system tibial component, comprising 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 formed on one side of the tibial tray base body, a tapered dovetail is arranged in the middle of the tibial tray base body, a tapered hole is formed 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 stand is formed at the bottom of the tibial tray base body, a cavity is formed at the bottom of the stand, a first internal thread is arranged in the middle of the stand, and the cavity and the first internal thread of the stand are used to connect the screw.

[0006] Preferably, a second internal thread is symmetrically formed in the middle of the metal sleeve, 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 stand, the second internal thread of the metal sleeve and the external thread of the screw match.

[0008] Preferably, it further comprises a fixed tibial pad, a dovetail groove is formed 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 for revision by cooperating with a metal sleeve and a screw to connect it to the tibial support base to form a fixed prosthesis. The fixed tibial pad is also used for revision by cooperating with a PE sleeve and a pin to connect it to the tibial support base to form a hinged prosthesis.

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

[0011] Preferably, when the rotating tibial pad is used for revision, it is connected to the tibial support base through cooperation with a metal sleeve and a screw to form a rotating prosthesis, and the limiting groove is used to connect with the tapered dovetail.

[0012] Preferably, the tibial support base comprises the following percentages of raw materials: 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 method for preparing the tibial support base comprises the following steps:

[0014] S1. Melting: Add raw materials according to the percentage into a vacuum induction melting furnace, evacuate the furnace, and heat to melt the raw materials. Stir the melt during melting. After the raw materials are completely melted, refine them to remove impurities and gases to obtain a molten alloy.

[0015] S2. Preforming: The alloy liquid is divided into two parts. One part is prepared into a cobalt-chromium-molybdenum-based powder through gas atomization powder making technology. Then, selective laser melting technology is used to print the tibial support base blank using the cobalt-chromium-molybdenum-based powder according to the patient's CT data;

[0016] S3. Casting: A mold is made based on 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.

[0017] S4. Heat treatment: The casting is subjected to solution treatment, quenching and aging treatment in sequence to obtain a treated part;

[0018] S5. Machining: Rough machining and fine machining are performed on the workpiece in sequence to obtain the processed part;

[0019] S6. Surface treatment: Clean, passivate and coat the workpiece to complete the preparation.

[0020] Preferably, the temperature of heating in S1 is 1500-1700 DEG C, the time is 2-4 hours, and the stirring rate is 50-150 r / min.

[0021] The sphericity of the cobalt-chromium-molybdenum-based powder in S2 is greater than or equal to 90%, the oxygen content is less than or equal to 0.02%, the particle size is 15-45 mu m, and the pore structure of the tibial tray base blank is a gradient porosity structure, the porosity gradually decreases from the surface to the inside, the surface porosity is 60%-80%, and the internal porosity is 20%-40%.

[0022] The preheating temperature in S3 is 200-300 DEG C, the preheating time is 1-2 hours, the ceramic fiber is Al2O3 ceramic fiber, the diameter is 5-15 mu m, and the length is 1-5 mm.

[0023] The solid solution treatment in S4 is heating the casting to 1100-1200 DEG C and holding for 1-2 hours, the quenching is cooling the casting after the solid solution treatment in a quenching medium, and the aging treatment is heating the casting after the quenching to 700-800 DEG C and holding for 4-6 hours.

[0024] The rough machining in S5 is removing the surface excess amount of the processed piece through a lathe and a milling machine, the machining precision is controlled within ±0.5 mm, the finish machining is adopting grinding and polishing processes to finish machine the processed piece after rough machining, so that the surface roughness Ra reaches 0.4-0.8 mu m, and the size precision is controlled within ±0.05 mm.

[0025] The passivation treatment in S6 is soaking the machined piece in a passivation liquid containing nitric acid and potassium dichromate, the soaking time is 15-30 minutes, the passivation liquid temperature is 40-60 DEG C, and the coating treatment is coating a hydroxyapatite coating on the surface of the machined piece after the passivation treatment, and the coating thickness is 50-100 mu m.

[0026] The application provides a modular system tibial component.

[0027] 1、The application combines the tapered dovetail, the tapered hole and the column on the tibial tray base with the metal sleeve, the PE sleeve, the fixed tibial pad and the rotating tibial pad, so that different combinations can be flexibly made according to different surgical requirements, the adjustment requirement of the doctor to the osteotomy scheme in the surgical process is greatly reduced, and in the continuous selection, the osteotomy scheme of the tibial side in the operation is always unchanged, and the base component of the tibial side is unchanged, so that the problem of poor adaptability between the components of the traditional tibial component prosthesis is solved, and the complexity and uncertainty of the operation are increased.

[0028] 2、The tibial tray base body of the present application is tightly matched with the metal sleeve and the outer wall of the PE sleeve through the tapered hole at the top of the tibial tray base body, the first internal thread of the stand and the second internal thread of the metal sleeve are matched with the external thread of the screw, double fixation is realized, the loosening phenomenon of the components during use is effectively prevented, the stability of the prosthesis in the human knee joint is ensured, and the service life of the prosthesis is improved.

[0029] 3、The present application improves the strength, hardness and corrosion resistance of the alloy by chromium, molybdenum and other elements, so that it can withstand the pressure and friction generated by the daily activities of the knee joint; nitrogen element solid solution strengthening further enhances the strength; niobium element refines the grain structure and improves the fatigue resistance; yttrium element 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 base body remains stable during long-term use, reduces the risk of wear and damage, and provides better support and protection for patients.

[0030] 4、The tibial tray base body blank printed by using selective laser melting technology has a gradient porosity structure, the surface porosity is large, providing sufficient space for the adhesion, proliferation and differentiation of bone cells; the internal porosity is small, ensuring the strength and stability of the base body, in addition, the hydroxyapatite coating coated during surface treatment is similar to the composition of human bone tissue, which can promote the adhesion, proliferation and differentiation of bone cells, accelerate the integration of bone tissue and tibial tray base body, improve the stability of the prosthesis, help patients recover after surgery and improve the quality of life.

[0031] 5、The present application preinstalls an Al2O3 ceramic fiber network reinforcement layer on the surface of the 3D printed base body, effectively improving the surface wear resistance of the tibial tray base body, the high hardness and high wear resistance of the ceramic fiber can prolong the wear life of the polyethylene liner and other components, at the same time, through melting, heat treatment and mechanical processing steps, the microstructure of the alloy is optimized, the mechanical properties of the tibial tray base body are further improved, and the strict requirements of knee replacement surgery on the performance of the components are better met. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 is a schematic diagram of the three-dimensional structure of the present application;

[0033] Figure 2 is a schematic diagram of the top view structure of the tibial tray base body of the present application;

[0034] Figure 3 is a schematic diagram of the internal structure of the tibial tray base body of the present application;

[0035] Figure 4 is a schematic diagram of the first internal thread of the present application;

[0036] Figure 5 is a schematic diagram of the three-dimensional structure of the metal sleeve of the present application;

[0037] Figure 6 It is the internal structure schematic view of the metal sleeve of the application;

[0038] Figure 7 It is the three-dimensional structure schematic view of the PE sleeve of the application;

[0039] Figure 8 It is the three-dimensional structure schematic view of the screw of the application;

[0040] Figure 9 It is the three-dimensional structure schematic view of the fixed tibial pad of the application;

[0041] Figure 10 It is the bottom view structure schematic view of the fixed tibial pad of the application;

[0042] Figure 11 It is the top view structure schematic view of the fixed tibial pad of the application;

[0043] Figure 12 It is the three-dimensional structure schematic view of the rotating tibial pad of the application;

[0044] Figure 13 It is the method flow chart of the preparation method of the tibial support base proposed by the application.

[0045] Wherein, 1, tibial support base; 2, groove; 3, tapered dovetail; 4, stand column; 5, tapered 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, limiting groove; 15, connecting column. DETAILED DESCRIPTION

[0046] The technical solutions of the application will be described clearly and completely below in combination with the drawings of the application. Obviously, the described embodiments are only some of the embodiments of the application, but not all the embodiments. Based on the embodiments in the application, all the other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the application.

[0047] Please refer to the drawings of the application Figure 1 - the drawings of the application Figure 8The embodiment of the present application provides a modular system tibial component, which comprises a tibial tray base body 1, a metal sleeve 6, a PE sleeve 7 and a screw 8, the upper surface of the tibial tray base body 1 is polished, a groove 2 is formed on one side of the tibial tray base body 1, a tapered dovetail 3 is arranged at the middle of the tibial tray base body 1, a tapered hole 5 is formed at the top of the tibial tray base body 1, the tapered hole 5 of the tibial tray base body 1 is used for connecting the metal sleeve 6 or the PE sleeve 7, a stand column 4 is formed at the bottom of the tibial tray base body 1, a cavity 12 is formed at the bottom of the stand column 4, a first internal thread 11 is arranged at the middle of the stand column 4, and the cavity 12 and the first internal thread 11 of the stand column 4 are used for connecting the screw 8; a second internal thread 13 is symmetrically formed at the middle of the metal sleeve 6, the outer wall of the metal sleeve 6 is matched with the tapered hole 5; the outer wall of the PE sleeve 7 is matched with the tapered hole 5, and the first internal thread 11 of the stand column 4, the second internal thread 13 of the metal sleeve 6 and the external thread of the screw 8 are matched.

[0048] Specifically, the upper surface of the tibial tray base body 1 is polished, the friction between the tibial tray base body 1 and other components is reduced, the wear degree is reduced, and the service life of the prosthesis is improved, the groove 2 formed on one side of the tibial tray base body 1 can be used for accommodating specific auxiliary instruments or soft tissues, which is helpful for the convenience of operation and can better adapt to the physiological structure of the human knee joint, the tapered dovetail 3 at the middle of the tibial tray base body 1 can not only be accurately matched with the dovetail groove at the bottom of the fixed tibial pad 10, but also can play an angle limiting role when matched with the rotating tibial pad 9, in the use scene 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, the cooperation of the limiting groove 14 and the tapered dovetail 3 can ensure that the rotating tibial pad 9 can rotate flexibly within a certain angle range, and meanwhile, the rotating tibial pad 9 cannot rotate excessively, so that the stability and safety of the prosthesis are ensured.

[0049] The tapered hole 5 formed at the top is matched with the outer wall of the metal sleeve 6 and the outer wall of the PE sleeve 7, so that the metal sleeve 6 and the PE sleeve 7 can be closely connected on the tibial tray base body 1, when the metal sleeve 6 is connected with the tapered hole 5, the second internal thread 13 symmetrically formed at the middle of the metal sleeve 6 and the first internal thread 11 at the middle of the stand column 4 of the tibial tray base body 1 are matched with the screw 8, so that stable connection is realized, this connection mode plays an important role in the initial knee replacement surgery (the metal sleeve 6 and the screw 8 can not be used) and the revision surgery, in the revision surgery, the cooperation of the metal sleeve 6, the screw 8 and the fixed tibial pad 10 can form a stable fixed prosthesis, after the PE sleeve 7 is connected with the tibial tray base body 1, the pin shaft of the hinge prosthesis is installed, so that the hinge prosthesis can realize specific activity function, and the special needs of patients in the knee joint activity are met.

[0050] The column 4 at the bottom of the tibial tray base 1, the cavity 12 at the bottom and the first internal thread 11 at the middle are used to connect the screw 8, in the actual installation process, the screw 8 enters the cavity 12, and after passing through the first internal thread 11 of the column 4, it is screwed into the second internal thread 13 of the metal sleeve 6, thereby achieving double fixation, greatly enhancing the firmness of the connection between the components, and effectively preventing loosening during use.

[0051] Through the structures such as the tapered dovetail 3, the tapered hole 5 and the column 4 on the tibial tray base 1, the metal sleeve 6, the PE sleeve 7, the fixed tibial pad 10 and the rotating tibial pad 9 can be flexibly combined according to different surgical needs. In the primary knee replacement surgery, the doctor can choose whether to use the metal sleeve 6 and the screw 8 according to the specific condition of the patient, and choose the appropriate type of tibial pad (fixed or rotating); in the revision surgery, the combination mode of the components can also be flexibly adjusted according to the patient's condition and the use of the previous prosthesis, to form a fixed prosthesis or a hinge prosthesis, thereby greatly reducing the doctor's adjustment needs for the osteotomy scheme during the surgery, and solving the problem of poor compatibility between the components of the traditional tibial component prosthesis, which increases the complexity and uncertainty of the surgery.

[0052] Please refer to the accompanying drawings Figure 9 - the accompanying drawings Figure 11 It also includes a fixed tibial pad 10, the bottom of which is provided with a dovetail groove for connecting with the tapered dovetail 3; the fixed tibial pad 10 is used to connect the tibial tray base 1 by cooperating with the metal sleeve 6 and the screw 8 during revision, to form a fixed prosthesis, and is also used to connect the tibial tray base 1 by cooperating with the PE sleeve 7 and the pin shaft during revision, to form a hinge prosthesis.

[0053] Specifically, the dovetail groove at the bottom of the fixed tibial pad 10 is connected with the tapered dovetail 3 of the tibial tray base 1, in the revision surgery, the fixed tibial pad 10 can form a fixed prosthesis by cooperating with the metal sleeve 6 and the screw 8, or can construct a hinge prosthesis by cooperating with the PE sleeve 7 and the pin shaft. Different combination modes provide doctors with more choices to adapt to the conditions of different patients and surgical needs Figure 12 It also includes a rotating tibial pad 9, the bottom of which is fixedly connected with a connecting column 15, and a limiting groove 14 is provided on one side of the rotating tibial pad 9; the rotating tibial pad 9 is used to connect the tibial tray base 1 by cooperating with the metal sleeve 6 and the screw 8 during revision, to form a rotating prosthesis, and the limiting groove 14 is used to connect with the tapered dovetail 3.

[0054] Specifically, the preliminary positioning is achieved by rotating the connecting column 15 at the bottom of the tibial pad 9 for insertion into the tapered hole 5 of the tibial tray base 1, and the limiting slot 14 opened on one side is connected with the tapered dovetail 3, so that the tibial pad 9 can rotate freely within a certain range in the rotating prosthesis, while being limited and constrained by the tapered dovetail 3, ensuring the stability and safety of rotation.

[0055] The tibial tray base 1 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 being cobalt.

[0056] Specifically, the addition of chromium and molybdenum can significantly improve the strength, hardness and corrosion resistance of the alloy, so that it can withstand various pressures and friction generated by the knee joint in daily activities. Chromium forms a dense chromium oxide protective film on the surface of the alloy, preventing the erosion of external media on the alloy, 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 crystal 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 during long-term use.

[0057] The addition of nitrogen element can play a role in solid solution strengthening, further enhancing the strength of the alloy. Nitrogen atoms are small and can dissolve in the lattice gap 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, the toughness of the alloy is not significantly reduced, so that the tibial tray base is not prone to deformation and fracture when subjected to greater pressure.

[0058] The addition of niobium element can form stable carbides with carbon, refine the grain structure, improve the mechanical properties of the alloy, and improve its fatigue resistance. The carbides formed by the combination of niobium and carbon play a role in heterogeneous nucleation during alloy solidification and heat treatment, promoting grain refinement. Small grains can increase the grain boundary area, which can hinder crack propagation and improve the toughness and fatigue resistance of the alloy. In the frequent flexion and extension of the knee joint, this fatigue resistance can effectively prolong the service life of the tibial tray base.

[0059] By adding yttrium as a rare earth element, the oxidation resistance and thermal stability of the alloy can be improved, and the biocompatibility of the alloy is positively affected. Yttrium can combine with impurity elements in the alloy, reducing the segregation of impurities at the 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, improving the thermal stability of the alloy. In terms of biocompatibility, yttrium can adjust the charge distribution and chemical properties of the alloy surface, reduce the stimulation to the surrounding tissue, promote the adhesion, proliferation and differentiation of bone cells, and is conducive to the integration of bone tissue and tibial base body.

[0060] By strictly controlling the addition of silicon, manganese, carbon, iron, nickel, phosphorus and calcium elements, the purity and stability of the alloy can be improved, and the adverse effects of impurities on the performance of the alloy can be reduced. When the content of these elements is too high, harmful compounds or phases may be formed, which can reduce the strength, toughness and corrosion resistance of the alloy. Strict control of the content can ensure the uniformity and stability of the alloy composition and improve the comprehensive performance of the alloy.

[0061] By adding cobalt as a base element, the alloy provides basic strength and toughness. Cobalt has good high-temperature performance and corrosion resistance, and can remain stable in complex physiological environments. At the same time, the crystal structure and chemical properties of cobalt are conducive to the dissolution and uniform distribution of other alloy elements, providing a good foundation for other elements to function. It can also form solid solutions and intermetallic compounds with other elements, further strengthening the performance of the alloy and ensuring that the tibial base body can meet the requirements of knee replacement surgery.

[0062] Please refer to the accompanying Figure 13 The preparation method of the tibial base body 1 comprises the following steps:

[0063] S1, melting: the raw materials are added to the vacuum induction melting furnace according to the percentage, vacuum is drawn and the raw materials are heated to melt, the molten liquid is stirred during melting, and after the raw materials are completely melted, refining is carried out to remove impurities and gas to obtain an alloy liquid; the temperature of heating in S1 is 1500-1700℃, the time is 2-4 hours, and the stirring rate is 50-150r / min.

[0064] Specifically, the raw materials are added to the vacuum induction melting furnace according to the percentage, vacuum is drawn and the raw materials are heated to melt, the molten liquid is stirred during melting, and after the raw materials are completely melted, refining is carried out to remove impurities and gas to obtain an alloy liquid, thereby ensuring the uniformity and purity of the alloy composition. Heating the raw materials in a vacuum environment can avoid reactions between the raw materials and oxygen, nitrogen and other gases in the air, reducing the formation of impurities such as oxides and nitrides. Stirring the molten liquid helps to fully mix various alloy elements, ensuring that the alloy elements are uniformly distributed throughout the molten liquid. The refining process can remove gases (such as hydrogen and oxygen) and non-metallic inclusions in the molten liquid, improving the quality of the alloy liquid and laying a good foundation for subsequent preparation steps.

[0065] S2, preforming: the alloy liquid is divided into two parts, one of which is prepared into cobalt-chromium-molybdenum-based powder by gas atomization powdering technology, and then a tibial tray base body blank is printed by using the cobalt-chromium-molybdenum-based powder according to the CT data of the patient by using selective laser melting technology; 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, and the pore structure of the tibial tray base body blank is a gradient porosity structure, the porosity of which gradually decreases from the surface to the inside, the surface porosity is 60%-80%, and the internal porosity is 20%-40%.

[0066] Specifically, by dividing the alloy liquid into two parts, one of which is prepared into cobalt-chromium-molybdenum-based powder by gas atomization powdering technology, and then a tibial tray base body blank is printed by using the cobalt-chromium-molybdenum-based powder according to the CT data of the patient by using selective laser melting technology, the individual customization of the tibial tray base body is realized, the powder prepared by gas atomization powdering technology has high sphericity, low oxygen content and appropriate particle size, has good fluidity and spreadability, is conducive to the accurate forming of the selective laser melting technology, and according to the CT data of the patient for printing, the shape and size of the tibial tray base body blank can be perfectly matched with the knee joint bone structure of the patient, the adaptability of the prosthesis is improved, and the gradient porosity structure is conducive to the ingrowth of bone tissue, the larger porosity on the surface provides sufficient space for the adhesion and proliferation of bone cells, and the smaller porosity inside ensures the strength and stability of the tibial tray base body, and promotes the integration of bone tissue and the prosthesis.

[0067] S3, casting: a mold is made according to the tibial tray base body blank and preheated, a ceramic fiber network reinforcing layer is prepositioned on the surface of the 3D-printed base body, the other part of the alloy liquid is cast into the mold with the reinforcing layer, and the mold is naturally cooled and solidified to obtain a casting; in S3, the preheating temperature is 200-300°C, the preheating time is 1-2 hours, the ceramic fiber is Al2O3 ceramic fiber, the diameter is 5-15 μm, and the length is 1-5 mm.

[0068] Specifically, by making a mold according to the tibial tray base body blank and preheating, a ceramic fiber network reinforcing layer is prepositioned on the surface of the 3D-printed base body, the other part of the alloy liquid is cast into the mold with the reinforcing layer, and the mold is naturally cooled and solidified to obtain a casting, thereby improving the mechanical properties and surface wear resistance of the tibial tray base body, the mold preheating can reduce the difference in cooling speed of the alloy liquid during casting, reduce the stress concentration inside the casting, prevent the generation of cracks, the Al2O3 ceramic fiber network reinforcing layer forms a good interface bonding with the alloy base body, the ceramic fiber has high hardness and high wear resistance, can effectively improve the wear resistance of the surface of the tibial tray base body, prolong the wear life of the polyethylene liner and other components, and at the same time, the mechanical strength of the whole is enhanced.

[0069] S4, heat treatment: the castings are sequentially subjected to solid solution treatment, quenching and aging treatment to obtain treated parts; the solid solution treatment in S4 is heating the castings to 1100-1200℃ and holding for 1-2 hours, the quenching is cooling the castings after solid solution treatment in quenching medium, and the aging treatment is heating the quenched castings to 700-800℃ and holding for 4-6 hours.

[0070] Specifically, by sequentially subjecting the castings to solid solution treatment, quenching and aging treatment, the treated parts are obtained, thereby further improving the microstructure and performance of the alloy. The solid solution treatment makes various elements in the alloy fully dissolve in the cobalt matrix to form a uniform solid solution structure, laying a foundation for subsequent strengthening treatment. The rapid cooling method in the quenching process causes the alloy to produce martensite phase change or other strengthening phases, thereby improving the strength and hardness of the alloy. The aging treatment is to diffuse and precipitate solute atoms in the alloy at a lower temperature, further strengthening the crystal lattice structure of the alloy, improving the strength, hardness and toughness of the alloy, and eliminating the internal stress generated in the quenching process, thereby improving the dimensional stability of the castings.

[0071] S5, mechanical processing: sequentially subjecting the treated parts to rough machining and finish machining to obtain machined parts; the rough machining in S5 is removing the excess material on the surface of the treated parts by lathe and milling machine, and the machining precision is controlled within ±0.5mm; the finish machining is finish machining the rough machined treated parts by grinding and polishing process, so that the surface roughness Ra reaches 0.4-0.8μm, and the dimensional accuracy is controlled within ±0.05mm.

[0072] Specifically, by sequentially subjecting the treated parts to rough machining and finish machining, the machined parts are obtained, thereby ensuring the dimensional accuracy and surface quality of the tibial tray substrate. The rough machining can quickly remove the excess material on the surface of the treated parts, making the treated parts close to the designed size, thereby providing a good foundation for finish machining. The finish machining further improves the surface flatness and smoothness of the treated parts by grinding and polishing process, so that the surface roughness reaches an appropriate range, while ensuring the dimensional accuracy of each part, ensuring the precise fit of the tibial tray substrate with other components, and improving the assembly quality and performance of the entire modular system tibial component.

[0073] S6, surface treatment: cleaning, passivation treatment and coating treatment are performed on the machined parts to complete the preparation; the passivation treatment in S6 is soaking the machined parts in a passivation solution containing nitric acid and potassium dichromate for 15-30 minutes at a temperature of 40-60℃, and the coating treatment is coating a hydroxyapatite coating on the surface of the machined parts after passivation treatment, and the coating thickness is 50-100μm.

[0074] Specifically, the tibial tray base body is prepared by cleaning, passivation treatment and coating treatment, so that the corrosion resistance and biocompatibility of the tibial tray base body are improved. The cleaning process can remove oil stains, iron filings and other impurities on the surface of the workpiece, providing a clean surface for subsequent passivation and coating treatment. The passivation treatment forms a dense oxide film on the surface of the workpiece, which can effectively prevent the corrosion of external medium to the alloy and improve the corrosion resistance of the alloy. The hydroxyapatite coating has good bioactivity and biocompatibility, and 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 base body, and improve the stability and long-term use effect of the prosthesis.

[0075] Further description will be made in combination with specific embodiments:

[0076] Embodiment 1

[0077] The tibial tray base body 1 comprises the following percentage of raw materials: chromium 30%, molybdenum 7%, nitrogen 0.25%, niobium 0.5%, silicon ≤0.5%, manganese ≤0.5%, carbon ≤0.14%, iron ≤0.75%, nickel ≤0.2%, phosphorus ≤0.02%, calcium ≤0.01%, yttrium 0.05%, and the balance is cobalt.

[0078] The preparation method of the tibial tray base body 1 comprises the following steps:

[0079] S1, melting: the raw materials are added into a vacuum induction melting furnace according to the percentage, vacuumized and heated to melt the raw materials, the molten liquid is stirred during melting, and after the raw materials are completely melted, refining is performed to remove impurities and gas, to obtain an alloy liquid;

[0080] S2, preforming: the alloy liquid is divided into two parts, one part is prepared into a cobalt-chromium-molybdenum-based powder by gas atomization powder preparation technology, and then a cobalt-chromium-molybdenum-based powder is used to print a tibial tray base body blank according to the CT data of the patient by using selective laser melting technology;

[0081] S3, casting: a mold is made according to the tibial tray base body blank and preheated, a ceramic fiber mesh reinforcement layer is prepositioned on the surface of the 3D printed base body, the other part of the alloy liquid is cast into the mold with the reinforcement layer, and the mold is naturally cooled and solidified to obtain a casting;

[0082] S4, heat treatment: the casting is sequentially subjected to solid solution treatment, quenching and aging treatment to obtain a treated part;

[0083] S5, mechanical processing: the treated part is sequentially subjected to rough machining and finish machining to obtain a workpiece;

[0084] S6, surface treatment: the workpiece is cleaned, passivated and coated to complete the preparation.

[0085] The temperature of heating in S1 is 1600℃, the time is 3 hours, and the stirring rate is 100 r / min;

[0086] 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, and the pore structure of the tibial tray base blank is a gradient porosity structure, which gradually decreases from the surface to the inside, with a surface porosity of 70% and an internal porosity of 30%.

[0087] The preheating temperature in S3 is 250℃, the preheating time is 1.5 hours, the ceramic fiber is Al2O3 ceramic fiber, the diameter is 10 μm, and the length is 3 mm.

[0088] The solid solution treatment in S4 is heating the casting to 1150℃ and holding for 1.5 hours, the quenching is cooling the casting after the solid solution treatment in a quenching medium, and the aging treatment is heating the casting after quenching to 750℃ and holding for 5 hours.

[0089] The rough machining in S5 is removing the surface excess of the processed piece through a lathe and a milling machine, and the machining precision is controlled within ±0.5 mm; the finishing is finishing the processed piece after rough machining by adopting a grinding and polishing process, so that the surface roughness Ra reaches 0.6 μm, and the size precision is controlled within ±0.05 mm.

[0090] The passivation treatment in S6 is soaking the processed piece in a passivation liquid containing nitric acid and potassium dichromate, the soaking time is 22.5 minutes, the passivation liquid temperature is 50℃, and the coating treatment is coating a hydroxyapatite coating on the surface of the processed piece after passivation treatment, and the coating thickness is 75 μm.

[0091] Example 2:

[0092] The difference between this embodiment and the above-mentioned embodiment 1 is that:

[0093] This embodiment provides a tibial tray base 1 comprising 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.

[0094] Example 3:

[0095] The difference between this embodiment and the above-mentioned embodiment 1 is that:

[0096] The embodiment provides a tibial tray base 1 which comprises the following raw materials in percentage: 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.

[0097] Table 1:

[0098] 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

[0099] In the above table, the comparison is a traditional tibial tray base. It can be known from Table 1 that different amounts 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 base, so that the performance of the tibial tray base is optimized, the service life of the prosthesis is prolonged, and the problem that the traditional tibial tray base has poor fatigue resistance, so that the prosthesis is prone to wear during use, and the rehabilitation effect and the quality of life of the patient are affected is solved.

[0100] Although the embodiments of the present application have been shown and described, it can be understood by those skilled in the art that various changes, modifications, replacements and variations can be made to the embodiments without departing from the principles and spirits of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

Claims

1. A modular system tibial component, comprising a tibial support base (1), a metal sleeve (6), a PE sleeve (7), and a screw (8), characterized in that: 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 tapered dovetail (3) is provided in the middle of the tibial support base (1), a tapered hole (5) is provided on the top of the tibial support base (1), the tapered hole (5) of the tibial support base (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 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 a screw (8); It also includes a fixed tibial pad (10), which is used for forming a fixed prosthesis by cooperating with a metal sleeve (6) and a screw (8) to connect it to the tibial support base (1) during revision. The fixed tibial pad (10) is also used for forming a hinged prosthesis by cooperating with a PE sleeve (7) and a pin shaft to connect it to the tibial support base (1) during revision. It also includes a rotating tibial pad (9), which is used for revision and is connected to the tibial support base (1) by cooperating with the metal sleeve (6) and the screw (8) to form a rotating prosthesis.

2. A modular system tibial component according to claim 1, characterized in that: 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 tapered hole (5).

3. The modular system tibial component according to claim 1, characterized in that: The outer wall of the PE sleeve (7) matches the tapered 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).

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

5. The modular system tibial component according to claim 1, characterized in that: A connecting column (15) is fixedly connected to the bottom of the rotating tibial pad (9), and a limiting groove (14) is provided on one side of the rotating tibial pad (9), and the limiting groove (14) is used to connect to the tapered dovetail (3).

6. The modular system tibial component according to claim 1, characterized in that: The tibial support base (1) comprises the following raw materials in percentage: 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.

7. The modular system tibial component according to claim 6, characterized in that: The preparation method of the tibial support base (1) comprises the following steps: S1. Melting: Add raw materials according to the percentage into a vacuum induction melting furnace, evacuate the furnace, and heat to melt the raw materials. Stir the melt during melting. After the raw materials are completely melted, refine them to remove impurities and gases to obtain a molten alloy. S2. Preforming: The alloy liquid is divided into two parts. One part is prepared into a cobalt-chromium-molybdenum-based powder through gas atomization powder making technology. Then, selective laser melting technology is used to print the tibial support base blank using the cobalt-chromium-molybdenum-based powder according to the patient's CT data; S3. Casting: A mold is made based on 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. Machining: Rough machining and fine machining are performed on the workpiece in sequence to obtain the processed part; S6. Surface treatment: Clean, passivate and coat the workpiece to complete the preparation.

8. The modular system tibial component according to claim 7, characterized in that: The heating temperature in S1 is 1500-1700°C, the time is 2-4 hours, and the stirring rate is 50-150 r / min; The cobalt-chromium-molybdenum-based powder in S2 has a sphericity of ≥90%, an oxygen content of ≤0.02%, and a particle size of 15-45 μm. The tibial support base blank has a pore structure with a gradient porosity, wherein the porosity decreases gradually from the surface to the interior, with a surface porosity of 60%-80% and an internal porosity of 20%-40%. The preheating temperature in S3 is 200-300°C, the preheating time is 1-2 hours, and the ceramic fiber is Al2O3 ceramic fiber with a diameter of 5-15 μm and a length of 1-5 mm; The solution treatment in S4 is to heat the casting to 1100-1200° C. and keep it warm for 1-2 hours, the quenching is to place the casting after the solution treatment in a quenching medium and cool it, and the aging treatment is to heat the casting after the quenching to 700-800° C. and keep it warm for 4-6 hours; The rough machining in S5 is to remove the surface allowance of the processed part by lathe or milling machine, and the machining accuracy is controlled within ±0.5mm. The fine machining is to fine-machine the processed part after rough machining by grinding and polishing process, so that the surface roughness Ra reaches 0.4-0.8μm and the dimensional accuracy is controlled within ±0.05mm. The passivation treatment in S6 is to immerse the workpiece in a passivation solution containing nitric acid and potassium dichromate for 15-30 minutes at a temperature of 40-60°C. The coating treatment is to coat the surface of the workpiece after the passivation treatment with a hydroxyapatite coating with a coating thickness of 50-100 μm.

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