Preparation method of bionic bone replacement prosthesis based on TPMS (Tire Pressure Monitor System) structure and replacement prosthesis

Abstract

The invention discloses a preparation method of a bionic bone replacement prosthesis based on a TPMS (Tire Pressure Monitor System) structure and the replacement prosthesis, and relates to a bone prosthesis technology, the preparation method comprises the following steps: S1, based on the structural information of a host femoral head, obtaining the specification and size of each part structure, and establishing a three-dimensional prosthesis model; s2, an alloy material is selected, and a tail end support is prepared through hollow design and trepanning; s3, constructing a bone scaffold matched with the mechanical structure trend of the host bone trabecula by designing a three-period small curved surface structure and adjusting functional parameters, and obtaining a hollow prosthesis by assembling an end face connecting structure; s4, selecting a multi-layer bionic cartilage material, and preparing an outer cartilage cup by matching the multi-layer bionic cartilage material with the surface radian of the femoral head of the host; and S5, the structures of all the parts are assembled and embedded according to the sequence, and cross bolts are embedded. The hollow-out design with sparse inside and dense outside is adopted, so that the prosthesis transmits load more uniformly, stress of surrounding bones is relieved, and bone ingrowth is promoted.

Description

Technical Field

[0001] The present invention relates to the technical field of bone prosthesis, and in particular to a preparation method of a bionic bone replacement prosthesis based on a TPMS structure and a replacement prosthesis. Background Art

[0002] Osteonecrosis of the Femoral Head (ONFH) is a progressive, complex, multifactorial disease characterized by impaired blood supply within the femoral head, which results in the destruction of bone tissue and limited regenerative capacity. The progression of ONFH is usually characterized by a gradual decrease in blood supply, which prevents bone cells from obtaining adequate oxygen and nutrients, ultimately leading to bone tissue necrosis. Early diagnosis and treatment of the condition are critical because once collapse of the femoral head occurs, functional damage to the hip joint becomes irreversible. The clinical progression of osteonecrosis can be classified using the ARCO (Association of Circulatory Osteopathy) staging system, which is divided into four stages. The stages are differentiated based on the severity of the lesion, the area of ​​necrosis, and whether bone collapse has occurred.

[0003] For ARCO stages I and II, which are the early stages when the femoral head has not yet collapsed significantly but necrosis exists, some protective interventions are usually recommended clinically. Common treatments include core decompression, which is to restore blood flow by reducing pressure inside the femoral head. In addition, bone grafting may be chosen clinically to help rebuild the bone structure, or osteotomy to reduce the burden on the necrotic site by changing the gravity-bearing line. However, when the disease progresses to stage IV, the femoral head has undergone severe collapse and deformation, often accompanied by secondary hip osteoarthritis. At this time, the only effective treatment is total hip replacement. This surgery involves the complete removal of the femoral head and part of the acetabulum and replacing them with an artificial joint, thereby restoring the function of the hip joint and the patient's mobility.

[0004] Although these surgical procedures are common in clinical practice, their application is challenging due to the unique anatomy of the femoral head. Compared with other joints such as the knee, the femoral head has a greater curvature and is located in a more hidden position, making surgical operations more difficult.

[0005] In addition to core decompression, some researchers have proposed the implantation of porous tantalum rods, or the use of non-vascularized fibula transplants and vascularized fibula transplants. The goal of these technologies is to provide support by implanting structural materials and to prevent further collapse of the femoral head. However, each of these methods has certain limitations. First, although porous tantalum rods can provide certain support, their structural strength is often insufficient to maintain the load-bearing function of the femoral head for a long time. Although fibula transplants can provide the possibility of bone integration, their surgery is complicated and the recovery time is long, and they also face the problem of unsatisfactory bone integration. These methods have not yet achieved the desired results in terms of structural support, effective bone integration, and simplicity of surgery.

[0006] Currently, no effective solution has been proposed for the problems in the related technologies. Summary of the invention

[0007] 1. Technical issues to be resolved

[0008] In view of the deficiencies in the prior art, the present invention provides a method for preparing a bionic bone replacement prosthesis based on a TPMS structure and a replacement prosthesis, which has the advantages of a porous structure to match the Young's modulus of human bones and reduce the burden of the bone scaffold on the human body, thereby solving the problem that traditional technology cannot provide strong structural support.

[0009] (II) Technical solution

[0010] In order to achieve the above advantages of having a porous structure to match the Young's modulus of human bones and reduce the burden of the bone scaffold on the human body, the specific technical solutions adopted by the present invention are as follows:

[0011] According to one aspect of the present invention, a method for preparing a bionic bone replacement prosthesis based on a TPMS structure is provided, the method comprising the following steps:

[0012] S1. Based on the structural information of the host femoral head, obtain the specifications and dimensions of each part of the structure, establish a three-dimensional prosthesis model, and set the design dimensions and preparation conditions of each part of the structure;

[0013] S2. Select alloy materials, and prepare the tail bracket through hollow design and opening;

[0014] S3, through the design of the three-periodic small curved surface structure and the adjustment of the functional parameters, a bone scaffold matching the mechanical structure trend of the host trabecular bone is constructed, and a hollow prosthesis is obtained by assembling the end surface connection structure;

[0015] S4, selecting a multi-layer bionic cartilage material, preparing a cartilage outer cup by adapting it to the surface curvature of the host femoral head, and grafting it on the surface of the outer cup bracket to form a bionic soft-hard integrated material;

[0016] S5. Assemble and insert each part of the structure in sequence, embed the cross bolts, and fix them at the bottom of the tail end bracket by cross fixing to form a bionic bone replacement prosthesis.

[0017] Furthermore, alloy materials are selected, and the tail bracket is prepared by hollow design and opening, including:

[0018] S21, selecting a biocompatible alloy material as a substrate for preparing the tail end stent, wherein the alloy material includes titanium alloy and tantalum material;

[0019] S22. Prepare a tail end bracket of a hollow tubular structure according to the designed dimensions, and open a plurality of side openings on the circumference of the tail end bracket through strength structure and stress distribution calculations;

[0020] S23. A connection hole for connecting with the hollow prosthesis is reserved on the end surface of the rear end bracket.

[0021] Furthermore, through the design of the three-periodic small curved surface structure and the adjustment of the functional parameters, a bone scaffold matching the mechanical structure trend of the host trabecular bone is constructed, and through the assembly of the end surface connection structure, a hollow prosthesis is obtained, including:

[0022] S31, selecting a plurality of basic unit cell structures of three-periodic small curved surface structures, and changing the geometric properties of the basic unit cell structures by adjusting functional parameters of the basic unit cell structures;

[0023] S32, fusing multiple basic unit cell structures, using a type change function to determine the transition surface boundary of the fusion area, performing type changes in different directions and planes, and fusing them into a porous structure;

[0024] S33. Using finite element analysis to simulate the mechanical properties of the porous structure, adjusting the wall thickness of the porous structure according to the stress distribution, and adjusting the mechanical response of different basic unit cell structures in different directions;

[0025] S34. The porous structure is printed into a solid body by 3D printing technology, and a connecting structure is arranged on the upper and lower end surfaces of the solid body to prepare a hollow prosthesis.

[0026] Furthermore, the type change function includes a Gaussian radial basis function and a S-shaped function.

[0027] Furthermore, a multi-layer bionic cartilage material is selected, and a cartilage outer cup is prepared by adapting the surface curvature of the host femoral head, and grafted on the surface of the outer cup bracket to form a bionic soft-hard integrated material including:

[0028] S41. Select composite hydrogel as a multilayer bionic cartilage material, customize it by 3D printing according to the surface curvature of the same position on the healthy side, and prepare a cartilage outer cup that fits the curvature surface of the host femoral head in its original state;

[0029] S42. Select ultra-high molecular weight polyethylene that has been oxidized and esterified to prepare an outer cup bracket, and graft the cartilage outer cup onto the surface of the outer cup bracket to form a bionic soft-hard integrated material.

[0030] Furthermore, the composite hydrogel includes polyvinyl alcohol, hydroxyapatite and polyacrylic acid.

[0031] Further, the various partial structures are assembled and placed in sequence, and the cross bolts are embedded, and the cross bolts are fixed to the bottom of the tail bracket to prepare the bionic bone replacement prosthesis, including:

[0032] S51, connecting the tail end bracket, the hollow prosthesis, the outer cup bracket and the cartilage outer cup in order from bottom to top;

[0033] S52. Two cross bolts are obliquely inserted into the reserved holes inside the rear end bracket. The two cross bolts form a cross structure to prepare a bionic bone replacement prosthesis.

[0034] According to another aspect of the present invention, a bionic bone replacement prosthesis based on the TPMS structure is also provided, including a tail end bracket, a cross bolt is inserted at the bottom of the tail end bracket; a hollow prosthesis is arranged at the top of the tail end bracket, an outer cup bracket is arranged at the top of the hollow prosthesis, and a cartilage outer cup is arranged at the top of the outer cup bracket; the tail end bracket is a tubular hollow structure, a plurality of end openings are opened on the outer side of the circumference of the bottom of the tail end bracket, and a plurality of middle openings are opened on the outer side of the circumference of the middle part of the tail end bracket.

[0035] Furthermore, a mounting hole is provided at the top of the tail end bracket, and a connecting pin matching the mounting hole is provided at the bottom of the hollow prosthesis; an anti-deflection groove is provided on one side of the mounting hole, and an anti-deflection protrusion matching the anti-deflection groove is provided on one side of the connecting pin.

[0036] Furthermore, the hollow prosthesis has a hollow porous structure in the middle part, and the porous structure is a three-period minimal surface porous structure; and a plurality of connecting grooves are provided at the top of the hollow prosthesis, and a plurality of umbrella-shaped connecting columns matching the connecting grooves are provided at the bottom of the outer cup bracket.

[0037] (III) Beneficial effects

[0038] Compared with the prior art, the present invention provides a method for preparing a bionic bone replacement prosthesis based on a TPMS structure and a replacement prosthesis, which has the following beneficial effects:

[0039] (1) By adopting a hollow design with sparse inside and dense outside, the prosthesis can transfer load more evenly, which helps to reduce the stress of surrounding bones and promote bone ingrowth; the design with dense proximal end and sparse distal end is similar to the structural characteristics of trabeculae, which is conducive to more stable bone ingrowth; that is, by hollowing out a large space at the tail end of the prosthesis to fill in the autologous bone blocks, using the autologous bone blocks to fill the inside of the prosthesis can avoid the rejection reactions and complications that may be caused by the implantation of allogeneic tissue; because the autologous bone blocks come from the patient, the possibility of immune rejection is reduced, which helps to improve the success rate of implantation and long-term effects.

[0040] (2) By adopting the TPMS porous structure fusion design, it is possible to manufacture bone replacement prostheses with superior mechanical properties and adaptability to the biological environment, meet different clinical application needs, effectively solve the problem of stress shielding between the bone scaffold and the host human bone, and reduce the burden of the bone scaffold on the human body.

[0041] (3) By extending the connecting pin outward, the connecting part does not occupy the hollow structure position inside the hollow prosthesis, thereby maintaining the advantages of the hollow structure to the greatest extent, such as reducing weight and promoting blood circulation. It can effectively avoid wasting the internal space of the prosthesis due to the connecting part, and improve the functionality and performance of the prosthesis. In addition, by designing cross bolts on the tail end bracket, the cross-fixing design can provide more firm support and fixation at the implant site, reducing the possibility of displacement and loosening of the prosthesis during movement. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0043] Figure 1 is a flow chart of a method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to an embodiment of the present invention;

[0044] Figure 2 is a schematic structural diagram of a bionic bone replacement prosthesis based on a TPMS structure according to an embodiment of the present invention;

[0045] Figure 3 is a structural exploded diagram of a bionic bone replacement prosthesis based on a TPMS structure according to an embodiment of the present invention;

[0046] Figure 4 is a schematic diagram of the tail end bracket structure of a bionic bone replacement prosthesis based on a TPMS structure according to an embodiment of the present invention;

[0047] Figure 5is a schematic diagram of a hollow prosthesis structure in a bionic bone replacement prosthesis based on a TPMS structure according to an embodiment of the present invention;

[0048] Figure 6 is a schematic diagram of the structure of the outer cup bracket in the bionic bone replacement prosthesis based on the TPMS structure according to an embodiment of the present invention;

[0049] Figure 7 This is one of the implantation structure schematic diagrams of a bionic bone replacement prosthesis based on a TPMS structure according to an embodiment of the present invention;

[0050] Figure 8 This is the second schematic diagram of the implant structure of the bionic bone replacement prosthesis based on the TPMS structure according to an embodiment of the present invention.

[0051] In the figure:

[0052] 1. Tail end bracket; 2. Cross bolt; 3. Hollow prosthesis; 4. Outer cup bracket; 5. Cartilage outer cup; 6. End opening; 7. Middle opening; 8. Mounting hole; 9. Connecting pin; 10. Anti-deviation groove; 11. Anti-deviation protrusion; 12. Connecting groove; 13. Umbrella-shaped connecting column. DETAILED DESCRIPTION

[0053] To further illustrate each embodiment, the present invention provides drawings, which are part of the disclosure of the present invention and are mainly used to illustrate the embodiments and can be used in conjunction with the relevant descriptions in the specification to explain the operating principles of the embodiments. With reference to these contents, ordinary technicians in the field should be able to understand other possible implementations and advantages of the present invention. The components in the figures are not drawn to scale, and similar component symbols are generally used to represent similar components.

[0054] According to an embodiment of the present invention, a method for preparing a bionic bone replacement prosthesis based on a TPMS structure is provided.

[0055] The present invention is further described with reference to the accompanying drawings and specific embodiments. Figure 1 As shown, according to the method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to an embodiment of the present invention, the preparation method comprises the following steps:

[0056] S1. Based on the structural information of the host femoral head, the specifications and dimensions of each partial structure are obtained, a three-dimensional prosthesis model is established, and the design dimensions and preparation conditions of each partial structure are set.

[0057] S2. Select alloy material, and prepare tail end bracket 1 through hollow design and opening.

[0058] In one embodiment, alloy materials are selected, and the tail bracket is prepared by hollow design and opening, including:

[0059] S21. Selecting a biocompatible alloy material as a substrate for preparing the tail end bracket 1, wherein the alloy material includes titanium alloy and tantalum material.

[0060] S22. Prepare a tail end bracket 1 of a hollow tubular structure according to the design dimensions, and open a plurality of side openings on the circumference of the tail end bracket 1 through strength structure and stress distribution calculations.

[0061] S23, a connection hole for connecting with the hollow prosthesis 3 is reserved on the end surface of the tail end bracket 1.

[0062] S3. Through the design of a three-periodic small curved surface structure and the adjustment of functional parameters, a bone scaffold that matches the mechanical structural trend of the host trabecular bone is constructed, and a hollow prosthesis is obtained by assembling the end face connection structure.

[0063] Among them, through the design of the three-period small curved surface structure and the adjustment of functional parameters, a bionic hole matching the distribution of the host trabeculae is constructed, allowing trabeculae to grow in and reconstruct trabeculae, thereby strengthening the holding force of internal fixation and restoring stress conduction.

[0064] Specifically, in order to solve the problem of stress shielding between the bone scaffold and the human skeleton, the bone scaffold is generally designed to be a porous structure to match the Young's modulus of the human skeleton and reduce the burden of the bone scaffold on the human body. Triperiodic minimal surfaces (TPMS) can be defined by trigonometric functions.

[0065] The TPMS structure designed based on triply periodic minimal surfaces (TPMS) can be expressed by precise mathematical functions. The basic performance of the bone scaffold can be directly controlled by adjusting the functional parameters, and it has a controllable internal microstructure, including wall thickness, pore size, shape and porosity. Based on the common TMPS function expression, a new TMPS mathematical function expression is constructed, thereby constructing a new TMPS unit cell. The appropriate microstructure is the basis for achieving the ideal mechanical and biological properties of the bone scaffold.

[0066] Functional gradient TPMS can adjust parameters such as wall thickness, pore size, volume, density, etc. to create bone scaffolds that match the host bone, and combine bionic design to mimic the bone structure, so that the scaffold can adapt to the changes in bone morphology at the implantation site. Second, the new TMPS unit cell changes the gradient function in different directions and planes. When T x =ax+b, the new unit cell size changes gradually in the X-axis direction. When studying the radial gradient structure, At this time, c and d control the lattice to change along the radial direction with the unit cell size gradient; At this time, m and n control the lattice to change along the radial direction with the porosity gradient. (T x ,T y ,T z ) determines the size of the unit cell, and the parameter function C(x, y, z) represents the size of the surface offset, which controls the internal pore morphology of the porous structure.

[0067] For example, the Gyroid lattice changes gradient along the radial direction with the wall thickness and changes gradient along the height with the offset; the Diamond lattice changes gradient along the radial direction with the wall thickness.

[0068] In one embodiment, a bone scaffold matching the mechanical structure trend of the host trabecular bone is constructed by designing a three-periodic small curved surface structure and adjusting the functional parameters, and a hollow prosthesis 3 is obtained by assembling the end surface connection structure, including:

[0069] S31. Select a basic unit cell structure of multiple three-periodic small curved surface structures, and change the geometric properties of the basic unit cell structure by adjusting the functional parameters of the basic unit cell structure.

[0070] S32. Multiple basic unit cell structures are fused, and the transition surface boundary of the fusion area is determined by using the type change function. Type changes are performed in different directions and planes, and fused into a porous structure, thereby constructing bionic holes that match the distribution of host trabeculae, allowing trabeculae to grow in and reconstruct trabeculae, thereby strengthening the holding force of internal fixation and restoring stress transmission.

[0071] In one embodiment, the category change function includes a Gaussian radial basis function (GRBF) and a Sigmoid function (SF).

[0072] Specifically, the new TMPS unit cell undergoes type changes in different directions and planes. The TPMS type change is based on the Gaussian radial basis function (GRBF) or the Sigmoid function (SF), which determines the transition surface boundary of the fusion area, fuses different TPMS structures, and constructs a complex TPMS porous structure.

[0073] 1. Based on the SF method, the transition surface boundary of the fusion area is determined, and the two new TMPS lattice structures are fused to construct a complex TPMS porous structure. The formula is as follows:

[0074] φ(x,y,z)=α(x,y,z)(φ1(x,y,z))+(1-α(x,y,z))(φ2(x,y,z))

[0075]

[0076] In the formula, φ(x,y,z) represents a composite function; α(x,y,z) represents a natural constant calculated by calculation; φ i represents two TPMS structure functions, i=1, 2; k represents the gradient coefficient, the larger the k value, the greater the transition mutation; G(x, y, z) represents the transition surface boundary.

[0077] Second, based on the GRBF method, the transition surface boundary of the fusion area is determined, and different TPMS structures are fused to construct a complex TPMS porous structure. The n TPMS structure combinations are designed as follows:

[0078]

[0079] Where n is the number of pore morphology types based on TPMS; α j (X) is the weight function of the jth pore morphology, and its expression is:

[0080]

[0081] Where σ is the transition gradient that can be changed; β ij is the weight function of the i-th point in the j-th region; X ij are the coordinates of the ith point in the jth region; m is the number of points in the jth region.

[0082] S33. Use finite element analysis to simulate the mechanical properties of the porous structure, adjust the wall thickness of the porous structure according to the stress distribution, and adjust the mechanical response of different basic unit cell structures in different directions.

[0083] S34. The porous structure is printed into a solid body by 3D printing technology, and a connecting structure is arranged on the upper and lower end surfaces of the solid body to prepare a hollow prosthesis.

[0084] S4. Select a multi-layer bionic cartilage material, prepare a cartilage outer cup 5 by adapting it to the surface curvature of the host femoral head, and graft it on the surface of the outer cup bracket 4 to form a bionic soft-hard integrated material.

[0085] In one embodiment, a multi-layer bionic cartilage material is selected, and the cartilage outer cup 5 is prepared by adapting to the surface curvature of the host femoral head, and is grafted on the surface of the outer cup bracket 4 to form a bionic soft-hard integrated material including:

[0086] S41. Select composite hydrogel as the multi-layer bionic cartilage material, customize it through 3D printing according to the surface curvature of the same position on the healthy side, and prepare a cartilage outer cup 5 that fits the curvature surface of the original state of the host femoral head.

[0087] The composite hydrogel includes polyvinyl alcohol, hydroxyapatite and polyacrylic acid.

[0088] S42, selecting ultra-high molecular weight polyethylene that has been oxidized and esterified to prepare the outer cup bracket 4, and grafting the cartilage outer cup 5 onto the surface of the outer cup bracket 4 to form a bionic soft-hard integrated material.

[0089] S5. Assemble and insert each part structure in sequence, embed the cross bolt 2, and fix it at the bottom of the tail end bracket 1 by cross fixing, so as to prepare a bionic bone replacement prosthesis.

[0090] In one embodiment, the bionic bone replacement prosthesis is prepared by assembling and inserting the various parts in sequence, embedding the cross bolts, and cross-fixing them at the bottom of the tail bracket, including:

[0091] S51, connecting the tail end support 1, the hollow prosthesis 3, the outer cup support 4 and the cartilage outer cup 5 in order from bottom to top.

[0092] S52, obliquely inserting two cross bolts 2 into the reserved holes inside the tail end bracket 1, the two cross bolts 2 form a cross structure, and a bionic bone replacement prosthesis is prepared.

[0093] According to another embodiment of the present invention, a bionic bone replacement prosthesis based on a TPMS structure is provided.

[0094] The present invention is further described with reference to the accompanying drawings and specific embodiments. Figure 2-Figure 8 As shown, the bionic bone replacement prosthesis based on the TPMS structure according to an embodiment of the present invention includes a tail end bracket 1, a cross bolt 2 is inserted at the bottom of the tail end bracket 1; a hollow prosthesis 3 is arranged at the top of the tail end bracket 1, an outer cup bracket 4 is arranged at the top of the hollow prosthesis 3, and a cartilage outer cup 5 is arranged at the top of the outer cup bracket 4; the tail end bracket 1 is a tubular hollow structure, a plurality of end openings 6 are opened on the outer side of the bottom circumference of the tail end bracket 1, and a plurality of middle openings 7 are opened on the outer side of the circumference of the middle part of the tail end bracket 1.

[0095] In one embodiment, a mounting hole 8 is provided at the top of the tail end bracket 1, and a connecting pin 9 matching the mounting hole 8 is provided at the bottom of the hollow prosthesis 3; an anti-deflection groove 10 is provided on one side inside the mounting hole 8, and an anti-deflection protrusion 11 matching the anti-deflection groove 10 is provided on one side of the connecting pin 9.

[0096] In one embodiment, the hollow prosthesis 3 has a hollow porous structure in the middle portion, and the porous structure is a three-period minimal surface porous structure; and a plurality of connecting grooves 12 are provided at the top of the hollow prosthesis 3, and a plurality of umbrella-shaped connecting columns 13 matching the connecting grooves 12 are provided at the bottom of the outer cup bracket 4.

[0097] In order to facilitate understanding of the above technical solutions of the present invention, the working principle or operation mode of the present invention in the actual process is described in detail below.

[0098] In practical application, the replacement prosthesis prepared by the present invention can have the following advantages:

[0099] 1. The cartilage outer cup 5 on the top surface of the partial replacement prosthesis is customized through 3D printing according to the surface curvature of the same position on the healthy side. It is designed to fit the original curvature surface of the femoral head to the greatest extent, provide more personalized and precise prosthesis adaptation, improve the stability and durability of the prosthesis, provide more natural joint movement, reduce damage to surrounding tissues, reduce postoperative complications, and improve the patient's recovery speed.

[0100] 2. Below the surface of the prosthesis, the hollow prosthesis 3 adopts a hollow design with sparse inside and dense outside, which makes the prosthesis transfer load more evenly, reduces the stress of the surrounding bones, and promotes bone growth. The design of dense proximal end and sparse distal end is similar to the characteristics of trabecular structure, which is conducive to more stable bone growth.

[0101] 3. The large space in the back half of the prosthesis is hollowed out, i.e., the tail bracket 1, so that the autologous bone can be filled in. Using the autologous bone to fill the inside of the prosthesis can avoid the rejection reaction and complications that may be caused by the implantation of allogeneic tissue. Since the autologous bone comes from the patient himself, the possibility of immune rejection is reduced, which helps to improve the success rate and long-term effect of the implant.

[0102] 4. The cross bolt 2 design with a cross setting at the tail end can provide more solid support and fixation at the implant site, reducing the possibility of displacement and loosening of the prosthesis during movement.

[0103] 5. The innovative point that the connecting pin at the bottom of the hollow prosthesis 3 in the middle design extends outwards ensures that the connecting part does not occupy the hollow structure position inside the prosthesis, thereby maintaining the advantages of the hollow structure to the greatest extent, such as reducing weight and promoting blood circulation. This design can effectively avoid the waste of internal space of the prosthesis by the connecting part and improve the functionality and performance of the prosthesis.

[0104] 6. Designing the tail bracket 1 as a standardized production part can improve production efficiency and reduce costs. Standardized production can be mass-produced in an industrialized manner, reduce changes and errors in the production process, and ensure that the quality and performance of each prosthesis are stable and reliable.

[0105] 7. The cartilage outer cup 5 of the prosthesis is prepared with multilayer bionic cartilage materials based on the layered structure of natural human cartilage and the integrated structure of natural articular cartilage / bone using PVA / HA (polyvinyl alcohol / hydroxyapatite) composite hydrogel and PVA / HA / PAA (polyvinyl alcohol / hydroxyapatite / polyacrylic acid) composite hydrogel, and then the multilayer bionic cartilage materials are grafted onto oxidized esterified ultra-high molecular weight polyethylene to construct a bionic soft / hard integrated material.

[0106] In summary, with the help of the above technical scheme of the present invention, by adopting a hollow design with sparse inside and dense outside, the prosthesis can transfer load more evenly, which helps to reduce the stress of surrounding bones and promote bone ingrowth; the design with dense proximal end and sparse distal end is similar to the structural characteristics of trabeculae, which is conducive to more stable bone ingrowth stability; that is, by hollowing out a large space at the tail end of the prosthesis to fill in the body's own bone blocks, using the body's own bone blocks to fill the inside of the prosthesis can avoid the rejection reaction and complications that may be caused by the implantation of allogeneic tissue; because the body's own bone blocks come from the patient himself, the possibility of immune rejection is reduced, which helps to improve the success rate and long-term effect of implantation. By adopting the TPMS porous structure fusion design, a bone replacement prosthesis with superior mechanical properties and adaptability to the biological environment can be manufactured to meet different clinical application needs, effectively solve the problem of stress shielding between the bone scaffold and the host human skeleton, and reduce the burden of the bone scaffold on the human body.

[0107] By extending the connecting pin 9 outward, the connecting part will not occupy the hollow structure position inside the hollow prosthesis, thereby maintaining the advantages of the hollow structure to the greatest extent, such as reducing weight and promoting blood circulation, etc., and can effectively avoid wasting the internal space of the prosthesis due to the connecting part, thereby improving the functionality and performance of the prosthesis; and by designing cross bolts 2 at the tail end bracket 1, the cross-fixed design can provide more firm support and fixation at the implantation site, reducing the possibility of displacement and loosening of the prosthesis during movement.

[0108] In the present invention, unless otherwise clearly stipulated and limited, the terms such as "installation", "setting", "connection", "fixation" and "screw-on" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be the internal connection of two elements or the interaction relationship between two elements. Unless otherwise clearly defined, ordinary technicians in this field can understand the specific meanings of the above terms in the present invention according to the specific circumstances.

[0109] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. Preparation method of bionic bone replacement prosthesis based on TPMS structure, It is characterized in that The preparation method comprises the following steps: S1. Based on the structural information of the host femoral head, obtain the specifications and dimensions of each part of the structure, establish a three-dimensional prosthesis model, and set the design dimensions and preparation conditions of each part of the structure; S2. Selecting alloy materials, and preparing a tail end bracket (1) by hollow design and opening holes; S3, by designing a three-periodic small curved surface structure and adjusting functional parameters, a bone scaffold matching the mechanical structure trend of the host trabecular bone is constructed, and a hollow prosthesis (3) is obtained by assembling the end surface connection structure; S4, selecting a multi-layer bionic cartilage material, preparing a cartilage outer cup (5) by adapting it to the surface curvature of the host femoral head, and grafting it on the surface of the outer cup bracket (4) to form a bionic soft-hard integrated material; S5. Assemble and insert each part structure in sequence, embed the cross bolts (2), and cross-fix them at the bottom of the tail end bracket (1) to prepare a bionic bone replacement prosthesis.

2. The method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to claim 1, It is characterized in that The alloy material is selected, and the tail end bracket is prepared by hollow design and opening, which includes: S21, selecting a biocompatible alloy material as a substrate for preparing the tail end bracket (1), wherein the alloy material includes a titanium alloy and a tantalum material; S22, preparing the tail end bracket (1) of the hollow tubular structure according to the design dimensions, and opening a plurality of side openings on the circumference of the tail end bracket (1) through strength structure and stress distribution calculations; S23, a connection hole for connecting with the hollow prosthesis (3) is reserved on the end surface of the tail end bracket (1).

3. The method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to claim 1, It is characterized in that The method of constructing a bone scaffold that matches the mechanical structure trend of the host bone trabeculae by designing a three-periodic small curved surface structure and adjusting functional parameters, and obtaining a hollow prosthesis (3) by assembling an end surface connection structure includes: S31, selecting a plurality of basic unit cell structures of three-periodic small curved surface structures, and changing the geometric properties of the basic unit cell structures by adjusting functional parameters of the basic unit cell structures; S32, fusing the plurality of basic unit cell structures, using a type change function to determine a transition surface boundary of a fusion region, performing type changes in different directions and planes, and fusing them into a porous structure; S33, simulating the mechanical properties of the porous structure by finite element analysis, adjusting the wall thickness of the porous structure according to the stress distribution, and adjusting the mechanical responses of different basic unit cell structures in different directions; S34, printing the porous structure into a solid body by 3D printing technology, and configuring connecting structures on the upper and lower end surfaces of the solid body to prepare a hollow prosthesis.

4. The method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to claim 1, It is characterized in that The type change function includes a Gaussian radial basis function and a S-type function.

5. The method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to claim 1, It is characterized in that The method of selecting a multi-layer bionic cartilage material, adapting it to the surface curvature of the host femoral head, preparing a cartilage outer cup (5), and grafting it on the surface of the outer cup bracket (4) to form a bionic soft-hard integrated material comprises: S41, selecting a composite hydrogel as a multilayer bionic cartilage material, and customizing the surface curvature of the same position on the healthy side through 3D printing to prepare a cartilage outer cup (5) that fits the curvature of the host femoral head in its original state; S42, selecting ultra-high molecular weight polyethylene that has been oxidized and esterified to prepare an outer cup bracket (4), and grafting a cartilage outer cup (5) onto the surface of the outer cup bracket (4) to form a bionic soft-hard integrated material.

6. The method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to claim 1, It is characterized in that The composite hydrogel comprises polyvinyl alcohol, hydroxyapatite and polyacrylic acid.

7. The method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to claim 1, It is characterized in that The steps of assembling and inserting the various parts of the structure in sequence, embedding the cross bolts, and cross-fixing them at the bottom of the tail bracket to prepare the bionic bone replacement prosthesis include: S51, connecting the tail end bracket (1), the hollow prosthesis (3), the outer cup bracket (4) and the cartilage outer cup (5) in order from bottom to top; S52, obliquely inserting two cross bolts (2) into the reserved holes inside the tail end bracket (1), the two cross bolts (2) forming a cross structure, and preparing a bionic bone replacement prosthesis.

8. A bionic bone replacement prosthesis based on a TPMS structure, used to implement the method for preparing a bionic bone replacement prosthesis based on a TPMS structure according to any one of claims 1 to 7, It is characterized in that It comprises a tail end bracket (1), wherein a cross bolt (2) is inserted through the bottom of the tail end bracket (1); The top of the tail end bracket (1) is provided with a hollow prosthesis (3), the top of the hollow prosthesis (3) is provided with an outer cup bracket (4), and the top of the outer cup bracket (4) is provided with a cartilage outer cup (5); The tail end bracket (1) is a tubular hollow structure, a plurality of end openings (6) are provided on the outer side of the bottom circumference of the tail end bracket (1), and a plurality of middle openings (7) are provided on the outer side of the middle part circumference of the tail end bracket (1).

9. The bionic bone replacement prosthesis based on the TPMS structure according to claim 8, It is characterized in that The top of the tail end bracket (1) is provided with a mounting hole (8), and the bottom of the hollow prosthesis (3) is provided with a connecting pin (9) that matches the mounting hole (8); an anti-deflection groove (10) is provided on one side of the inside of the mounting hole (8), and an anti-deflection protrusion (11) that matches the anti-deflection groove (10) is provided on one side of the connecting pin (9).

10. The bionic bone replacement prosthesis based on the TPMS structure according to claim 8 or 9, It is characterized in that The hollow prosthesis (3) has a hollow porous structure in the middle part, and the porous structure is a three-period minimal surface porous structure; and a plurality of connecting grooves (12) are provided at the top of the hollow prosthesis (3), and a plurality of umbrella-shaped connecting columns (13) matching with the connecting grooves (12) are provided at the bottom of the outer cup bracket (4).

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