Trabecular metal total ankle prosthesis

Abstract

The present invention provides a trabecular metal total ankle prosthesis, which belongs to the technical field of ankle prostheses. It includes a talar connecting frame, a joint device is fixedly installed on the top of the talar connecting frame, and a tibial connecting part is fixedly installed on the top of the joint device. The core of this application is the joint device. The articulated ball can be freely rotated in the articulated groove of the fixed seat, which allows the device to adapt to the human ankle joint and adaptively adjust the rotation angle. The wear-resistant ceramic gasket fits the articulated ball, which greatly improves the friction resistance. The lubricating balls arranged at equal intervals on the outer end of the articulated ball provide self-lubrication. In particular, the elastic capsule cooperates with the one-way valve. When the articulated ball rotates, the fixed seat squeezes the elastic capsule so that it can absorb the tissue lubricating fluid from the outside through the piston pumping function, and then evenly transports it to the articulated ball and the wear-resistant ceramic gasket surface through the linear guide hole, thereby comprehensively improving the lubrication performance, reducing wear, and ensuring the smooth operation of the joint.

Description

Technical Field

[0001] The present invention relates to the technical field of ankle joint prostheses, and more particularly to a trabecular metal total ankle joint prosthesis. Background Art

[0002] Ankle replacement surgery is an important treatment for ankle diseases or injuries, with trabecular all-metal ankle prostheses playing a key role. These prostheses are generally made of titanium alloys, cobalt-chromium-molybdenum, and other metal materials, simulating the morphology, structure, and function of the human ankle joint. They consist of a tibial prosthesis, a talar prosthesis, and a connecting section. They are designed to replace severely damaged ankle joints, helping patients relieve pain and restore joint function. The trabecular structure within them promotes bone growth and enhances the stability of the prosthesis's integration with the human skeleton.

[0003] In the prior art, an ankle prosthesis, such as that disclosed in Publication No. CN214632512U, has some innovative design features. A large number of ceramic gaskets are evenly fixed within the movable groove at the bottom of the tibial prosthesis support portion, forming a smooth curved surface. The upper half of the movable ball of the talar prosthesis is slidably connected to the groove. Furthermore, a honeycomb layer structure promotes bone ingrowth to prevent prosthesis loosening. Metal-polymer friction is converted to ceramic-metal friction to reduce the friction coefficient and minimize metal ion precipitation. Furthermore, a support plate is fixed to the talar screw via a fixing plate and a stop plate to enhance stability.

[0004] However, this existing solution still has obvious defects. Its ceramic gasket is located in the inner gap between the movable groove and the movable ball, and is in contact with the movable ball over a large area. During the joint linkage process, the rotation angle of the movable ball is limited, and most of the time it can only rotate 30-40 degrees. Due to the limited rotation angle and the large contact area between the gasket and the ball, when the joint moves, it is difficult for the tissue lubricating fluid to contact the movable ball evenly and cannot penetrate evenly into all contact areas. Dry grinding is very likely to occur, which in turn causes severe friction of the ceramic gasket, which not only affects the service life of the prosthesis, but may also reduce the patient's postoperative joint movement experience and affect the rehabilitation effect. Therefore, it is necessary to improve the design of the existing ankle prosthesis to overcome the above-mentioned technical bottlenecks and improve the overall performance and clinical application effect of the ankle prosthesis. Summary of the Invention

[0005] In view of the problem of poor lubrication ability in the prior art, the present invention aims to provide a trabecular metal total ankle prosthesis.

[0006] To solve the above problems, the present invention adopts the following technical solutions.

[0007] A trabecular metal total ankle prosthesis comprises a talar connecting frame, a joint device is fixedly mounted on the top of the talar connecting frame, and a tibial connecting portion is fixedly mounted on the top of the joint device;

[0008] The joint device includes a fixing seat, an articulation groove is provided inside the fixing seat, an articulation ball is movably installed inside the articulation groove, the bottom of the articulation ball is connected to the top of the talar connecting frame, a wear-resistant ceramic gasket is fixedly connected to the inside of the articulation groove, the inner side of the wear-resistant ceramic gasket is connected to the outer surface of the articulation ball, self-lubricating mechanisms are provided at equal intervals on the outer surface of the articulation ball, linear guide holes are provided at equal intervals inside the articulation ball, and the inner ends of the linear guide holes are connected to the interior of the self-lubricating mechanism.

[0009] Optionally, lubricating balls are rotatably connected to the upper end of the outer surface of the articulated ball at equal intervals, and the outer sides of the lubricating balls are fitted and connected to the inner wall of a wear-resistant ceramic gasket, which is made of wear-resistant zirconia ceramic material.

[0010] Optionally, the self-lubricating mechanism includes an elastic sac, which is arranged in a ring shape at equal intervals and fixedly connected to the lower end of the outer surface of the hinged ball. The outer bottom and the inner bottom of the elastic sac are fixedly connected to a one-way valve, the one-way valve output end located on the outside is connected to the interior of the elastic sac, and the one-way valve output end located on the inner end is connected to the linear guide hole input end, and the elastic sac is made of polycarbonate polyurethane material.

[0011] Optionally, the tibial connecting part includes a connecting main pipe, a tibial connecting frame is fixedly installed on the top of the connecting main pipe, the connecting main pipe is fixedly connected to the top of the fixing seat, and the outer surface of the connecting main pipe is provided with outer large holes at equal intervals.

[0012] Optionally, inner micropores are arranged at equal intervals on the inner wall of the connecting main pipe and around the outer macropores, and the aperture of the outer macropores is larger than that of the inner micropores.

[0013] Optionally, microspheres are provided inside the inner micropores, and the microspheres are loaded with bone morphogenetic protein and vascular endothelial growth factor.

[0014] Optionally, mounting frames are fixedly connected to both sides of the bottom of the talar connecting frame, and mounting holes are provided at the lower ends of the mounting frames.

[0015] Optionally, the outer surfaces of the connecting main tube, tibial connecting frame, articulated ball and talar connecting frame are all provided with an antibacterial composite coating, and the antibacterial composite coating is configured as a coating of silver nanoparticles or quaternary ammonium compounds doped in a HA coating.

[0016] Compared with the prior art, the technical solution provided by the present invention has at least the following beneficial effects:

[0017] In the above scheme, the core of this ankle joint prosthesis lies in the joint device. The articulated ball can rotate freely in the articulated groove of the fixed seat, allowing the device to adapt to the human ankle joint and adaptively adjust the rotation angle. The wear-resistant ceramic gasket fits the articulated ball, greatly improving the friction resistance. The lubricating balls arranged at equal intervals on the outer end of the articulated ball provide self-lubrication. In particular, the elastic capsule cooperates with the one-way valve. When the articulated ball rotates, the fixed seat squeezes the elastic capsule, causing it to absorb tissue lubricating fluid from the outside through the piston pumping function, and then evenly transport it to the surface of the articulated ball and the wear-resistant ceramic gasket through the linear guide hole, thereby comprehensively improving the lubrication performance, reducing wear, and ensuring smooth operation of the joint.

[0018] In ankle prosthesis applications, the tibial connection plays a key role. The tibial connection frame at the top of the main connection tube ensures a secure connection to the tibia. The main connection tube is fixed to the top of the fixing seat to enhance the overall structural stability. The outer surface of the main connection tube has large pores of 500-800μm, which facilitate bone tissue ingrowth and enhance the prosthesis anchoring effect. The inner pores of 100-200μm increase the surface area, adsorb growth factors and support vascularization. PLGA microspheres loaded with BMP-2 and VEGF in the micropores control the degradation rate of the microspheres, continuously release growth factors, and directionally activate osteoblast differentiation and angiogenesis, forming a synergistic "bone-vascular synchronous growth" effect, greatly accelerating bone healing and strengthening the integration of the prosthesis and the tibia.

[0019] The mounting frames and lower mounting holes on both sides of the bottom of the talar connector are conveniently and firmly connected to the talus, ensuring the continuity of the structure and function of the entire ankle joint prosthesis. The antibacterial composite coating coated on the outer surface of the connecting main tube, tibial connector, hinged ball and talar connector, whether it is HA coating doped with 0.5-1wt% silver nanoparticles or quaternary ammonium compounds, has strong antibacterial properties, can effectively inhibit bacterial growth, greatly reduce the risk of postoperative infection, and provide solid and powerful protection for the long-term stable operation of the prosthesis after implantation and the health of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings, which are incorporated herein and constitute a part of the specification, illustrate embodiments of the invention and, together with the description, further serve to explain the principles of the invention and to enable one skilled in the art to make and use the invention.

[0021] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention;

[0022] Figure 2 This is a schematic diagram of the front structure of the present invention in a separated state;

[0023] Figure 3 This is a schematic diagram of the structure of the present invention in a separated state when viewed from above;

[0024] Figure 4Schematic diagram of the tibial connection structure of the present invention;

[0025] Figure 5 It is a schematic diagram of the structure of the talar connecting frame and the articulated ball of the present invention;

[0026] Figure 6 This is a schematic diagram of the internal structure of the articulated ball of the present invention;

[0027] Figure 7 Schematic diagram of the cross-sectional structure of the outer macropores, inner micropores and microspheres of the present invention;

[0028] Figure 8 For the present invention Figure 4 A schematic diagram of the enlarged structure at point A;

[0029] Figure 9 For the present invention Figure 6 A schematic diagram of the enlarged structure at point B;

[0030] Figure 10 For the present invention Figure 7 Enlarged structural diagram at C.

[0031] [Reference Signs]

[0032] 1. Talus connector;

[0033] 2. Joint device; 21. Fixed seat; 22. Articulation groove; 23. Articulation ball; 24. Wear-resistant ceramic gasket; 25. Linear guide hole;

[0034] 26. Self-lubricating mechanism; 261. Elastic bladder; 262. One-way valve;

[0035] 27. Lubrication ball;

[0036] 3. Tibial connection; 31. Connecting main tube; 32. Tibial connection frame; 33. Outer layer macropores; 34. Inner layer micropores; 35. Microspheres;

[0037] 4. Mounting frame; 5. Antibacterial composite coating.

[0038] As shown in the figure, in order to clearly implement the structure of the embodiment of the present invention, specific structures and devices are marked in the figure, but this is only for illustrative purposes and is not intended to limit the present invention to the specific structure, device and environment. According to specific needs, ordinary technicians in this field can adjust or modify these devices and environments. DETAILED DESCRIPTION

[0039] The present invention is described in detail below with reference to the accompanying drawings and specific embodiments. It is also noted that, to provide a more detailed description, the following embodiments are best and preferred embodiments, and those skilled in the art may employ alternative methods for implementing certain known technologies. Furthermore, the accompanying drawings are intended only to provide a more detailed description of the embodiments and are not intended to limit the present invention.

[0040] It should be noted that references in the specification to "one embodiment," "an embodiment," "exemplary embodiments," "some embodiments," etc. indicate that the described embodiments may include specific features, structures, or characteristics, but not necessarily every embodiment will include such specific features, structures, or characteristics. Furthermore, when specific features, structures, or characteristics are described in conjunction with an embodiment, it is within the knowledge of persons skilled in the relevant art to implement such features, structures, or characteristics in conjunction with other embodiments (whether or not explicitly described).

[0041] In general, terms can be understood, at least in part, from their use in context. For example, depending at least in part on the context, the term "one or more" as used herein can be used to describe any feature, structure, or characteristic in the singular sense, or can be used to describe a combination of features, structures, or characteristics in the plural sense. Additionally, the term "based on" can be understood as not necessarily intended to convey an exclusive set of factors, but can instead, depending at least in part on the context, allow for the presence of other factors that are not necessarily explicitly described.

[0042] It will be understood that the meanings of “on,” “over,” and “above” in the present invention should be interpreted in the broadest manner, so that “on” means not only “directly on” something but also includes the meaning of being “on” something with intervening features or layers, and “on” or “above” means not only “on” or “above” something but also includes the meaning of being “on” or “above” something with no intervening features or layers.

[0043] Additionally, spatially relative terms such as "below," "beneath," "lower," "above," and "upper" may be used herein for descriptive convenience to describe the relationship of one element or feature to another element or features, as illustrated in the accompanying drawings. Spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. The device may be oriented in other ways, and the spatially relative descriptors used herein should be similarly interpreted accordingly.

[0044] like Figures 1 to 10As shown, the embodiment of the present invention provides a trabecular metal total ankle joint prosthesis, including a talar connecting frame 1, a joint device 2 is fixedly installed on the top of the talar connecting frame 1, and a tibial connecting part 3 is fixedly installed on the top of the joint device 2; the joint device 2 includes a fixing seat 21, a hinge groove 22 is provided inside the fixing seat 21, a hinge ball 23 is movably installed inside the hinge groove 22, the bottom of the hinge ball 23 is connected to the top of the talar connecting frame 1, a wear-resistant ceramic gasket 24 is fixedly connected to the inside of the hinge groove 22, the inner side of the wear-resistant ceramic gasket 24 is connected to the outer surface of the hinge ball 23, a self-lubricating mechanism 26 is equidistantly provided on the outer surface of the hinge ball 23, and linear guide holes 25 are equidistantly provided inside the hinge ball 23, the inner ends of the linear guide holes 25 are connected to the inner side of the self-lubricating mechanism 26. When the present trabecular metal total ankle joint prosthesis is working, the talar connecting frame 1 is responsible for connecting with the talus to play a supporting and connecting role, and the joint device 2 The hinge ball 23 in the hinge groove 22 inside the fixing seat 21 can move flexibly and is connected to the top of the talar connecting frame 1. It can rotate at multiple angles in the hinge groove 22 according to the needs of human movement to realize various activities of the ankle joint. The wear-resistant ceramic gasket 24 fixed in the hinge groove 22 is tightly fitted to the outer surface of the hinge ball 23. When the joint moves, it effectively reduces the friction loss between the hinge ball 23 and the hinge groove 22, thereby improving the durability of the prosthesis. The self-lubricating mechanism 26 arranged at equal intervals on the outer surface of the hinge ball 23 is connected to the interior of the hinge ball 23 through the linear guide hole 25. During the joint movement, the self-lubricating mechanism 26 is activated to transport lubricating material into the linear guide hole 25, and then the lubricating material is evenly guided to the contact part between the hinge ball 23 and the wear-resistant ceramic gasket 24 through the linear guide hole 25, thereby realizing continuous and uniform lubrication, ensuring the stable and smooth operation of the joint device 2, and then enabling the tibial connection part 3 to stably cooperate with the tibia with the movement of the joint device 2 to complete the function of the entire ankle joint prosthesis.

[0045] Please refer to Figures 1-6, the upper end of the outer surface of the hinge ball 23 is rotatably connected with lubricating balls 27 at equal intervals, and the outer side of the lubricating balls 27 is in contact with the inner wall of the wear-resistant ceramic gasket 24, which is made of wear-resistant zirconia ceramic material. When the trabecular metal total ankle prosthesis is running, the talus connecting frame 1 is connected to the talus to provide support for the entire device. In the joint device 2, the hinge ball 23 in the hinge groove 22 in the fixing seat 21 can rotate flexibly, driving the entire joint to simulate the movement of the human ankle joint, and the lubricating balls 27 rotatably connected at equal intervals on the upper end of the outer surface of the hinge ball 23 are in contact with the inner wall of the wear-resistant ceramic gasket 24 made of wear-resistant zirconia ceramic material. When the joint moves, the articulated ball 23 rotates and the lubricating ball 27 rolls accordingly. On the one hand, the lubricating ball 27 can reduce the direct friction between the articulated ball 23 and the wear-resistant ceramic gasket 24, and play a preliminary lubricating and buffering role; on the other hand, in conjunction with other self-lubricating mechanisms 26, it provides assistance for more efficient lubrication. The wear-resistant ceramic gasket 24 made of wear-resistant zirconia ceramic has good wear resistance and can effectively resist the friction generated by the articulated ball 23 and the lubricating ball 27 during movement, reduce the degree of wear, extend the service life of the prosthesis, ensure the stable and smooth operation of the entire joint device 2, make the tibial connection part 3 cooperate well with the tibia, and complete the various functions of the ankle joint.

[0046] Please refer to Figure 1-Figure 7 and Figure 9 The self-lubricating mechanism 26 includes an elastic capsule 261, which is arranged in a ring shape at equal intervals and fixedly connected to the lower end of the outer surface of the hinge ball 23. The outer bottom and inner bottom of the elastic capsule 261 are fixedly connected to a one-way valve 262. The output end of the one-way valve 262 located on the outside is connected to the interior of the elastic capsule 261, and the output end of the one-way valve 262 located on the inner end is connected to the input end of the linear guide hole 25. The elastic capsule 261 is made of polycarbonate polyurethane material. In the self-lubricating mechanism 26 of the present trabecular metal total ankle prosthesis, the elastic capsule 261 made of polycarbonate polyurethane material is arranged in a ring shape at equal intervals and fixed to the lower end of the outer surface of the hinge ball 23. When the joint movement drives the articulated ball 23 to rotate, the fixed seat 21 will periodically squeeze the elastic capsule 261. When under pressure, the elastic capsule 261 contracts, and the internal air is discharged through the inner one-way valve 262 through the linear guide hole 25. Due to the one-way flow of the outer one-way valve 262, the air is prevented from flowing out. When the articulated ball 23 rotates to relieve the pressure on the elastic capsule 261, the elastic capsule 261 quickly resets to generate negative pressure. At this time, the outer one-way valve 262 opens. When under pressure again, the elastic capsule 261 squeezes the internal lubricating fluid through the inner one-way valve 262 into the linear guide hole 25, and finally transports it to the surface of the articulated ball 23 and the wear-resistant ceramic gasket 24, realizing continuous and efficient self-lubrication function, ensuring stable and smooth operation of the joint.

[0047] Please refer to Figure 1-Figure 4 and Figure 7-10 The tibial connection part 3 includes a connecting main pipe 31, a tibial connection frame 32 is fixedly installed on the top of the connecting main pipe 31, and the connecting main pipe 31 is fixedly connected to the top of the fixing seat 21. The outer surface of the connecting main pipe 31 is evenly spaced with outer large holes 33. The inner wall of the connecting main pipe 31 and the inner wall of the outer large holes 33 are evenly spaced and arranged in a ring shape with inner micropores 34. The pore size of the outer large holes 33 is larger than that of the inner micropores 34, and the pore size of the outer large holes 33 is 500-800 μm. The pore size of the inner micropores 34 is 100-200 μm, and microspheres 35 are provided inside the inner micropores 34. The microspheres 35 are loaded with bone morphogenetic protein and vascular endothelial growth factor. The bottom two sides of the talar connecting frame 1 are fixedly connected with mounting frames 4. The lower end of the mounting frame 4 is provided with a mounting hole. The outer surfaces of the connecting main pipe 31, the tibial connecting frame 32, the hinge ball 23 and the talar connecting frame 1 are all provided with an antibacterial composite coating 5. The antibacterial composite coating 5 is set as silver nanoparticles doped in the HA coating ( 0.5-1wt%) or a coating of a quaternary ammonium salt compound, in the tibial connection part 3, the tibial connection frame 32 fixed on the top of the connecting main pipe 31 is used to be firmly connected to the tibia, the connecting main pipe 31 is fixed to the top of the fixing seat 21, ensuring the stability of the connection between the joint device 2 and the tibia, the outer surface of the connecting main pipe 31 is provided with an outer layer of large holes 33 with a pore size of 500-800μm, which provides a spacious channel for bone tissue growth and promotes the initial combination of the prosthesis and the surrounding bones, and the inner layer of micropores 34 with an internal pore size of 100-200μm, which is very The surface area is greatly increased, and mounting frames 4 with mounting holes are provided on both sides of the bottom of the talar connector 1 to facilitate connection with the talus, thereby ensuring the overall continuity of the ankle joint prosthesis. The antibacterial composite coating 5 on the outer surface of the connecting main pipe 31, the tibial connector 32, the hinge ball 23 and the talar connector 1, whether it is a HA coating doped with 0.5-1wt% silver nanoparticles or a quaternary ammonium compound coating, can rely on its strong antibacterial properties to effectively inhibit bacterial growth, reduce the risk of postoperative infection, ensure the long-term stable operation of the prosthesis, and provide protection for the patient's health.

[0048] The specific working process of the technical solution provided in this application is as follows:

[0049] This ankle joint frame is equipped with an innovative joint device 2, which demonstrates excellent performance and adaptability in practical applications. The core of the joint device 2 lies in the exquisite coordination between the articulation ball 23 and the fixing seat 21. The articulation ball 23 can flexibly rotate in the articulation groove 22 on the fixing seat 21. This design enables the ankle joint frame to adaptively adjust the rotation angle according to the human body's movement needs when adapting to the human ankle joint, effectively simulating the range of motion of the natural ankle joint and improving the patient's movement comfort and flexibility.

[0050] During the operation of the joint, the wear-resistant ceramic gasket 24 fits tightly against the articulated ball 23. With its excellent wear resistance, it greatly reduces the friction loss generated when the articulated ball 23 rotates, significantly extending the service life of the ankle joint frame. In addition, the lubricating balls 27 arranged at equal intervals on the upper end of the outer surface of the articulated ball 23 play an excellent self-lubricating function when the articulated ball 23 rotates. When the articulated ball 23 rotates, the fixed seat 21 applies a periodic extrusion force to the elastic capsule 261. During the extrusion stage, the elastic capsule 261 is compressed by the external force, and the internal air is quickly discharged; when the articulated ball 23 rotates to the other side, the pressure on the elastic capsule 261 is released, and then it expands and resets. During this process, the elastic capsule 261 passes through the outer one-way valve 26 2. The tissue lubricating fluid in the surrounding area is sucked in. Due to the one-way flow characteristics of the one-way valve 262, the tissue lubricating fluid can only enter the elastic capsule 261 in one direction. When the hinge ball 23 rotates and squeezes the elastic capsule 261 again, the outer one-way valve 262 prevents the liquid from flowing out in the opposite direction, while the inner one-way valve 262 allows the liquid to flow from the inside to the outside. Under the action of the squeezing force, the tissue lubricating fluid inside the elastic capsule 261 is transported to the top of the hinge ball 23 through the inner one-way valve 262 and the linear guide hole. The linear guide holes 25 are evenly distributed around the hinge ball 23, which can evenly infiltrate the tissue lubricating fluid into the surface of the hinge ball 23 and the wear-resistant ceramic gasket 24, thereby comprehensively improving the lubrication performance during joint rotation, effectively reducing wear and ensuring smooth operation of the joint.

[0051] The tibial connection portion 3 of the present device plays a key role in promoting bone growth and rapid bone integration in ankle prosthesis applications. The tibial connection frame 32 fixedly mounted on the top of the main connection pipe 31 is made of a high-strength, biocompatible material, ensuring a stable and reliable connection with the tibia. The main connection pipe 31 is fixed to the top of the fixing seat 21, further strengthening the stability of the overall structure, effectively dissipating the stress generated during joint movement, and improving the mechanical properties of the prosthesis in the body. The outer layer of large holes 33, evenly spaced around the outer surface of the main connection pipe 31, have a pore size precisely controlled at 500-800 μm, providing an ideal channel for bone tissue growth, greatly promoting the close integration of the prosthesis with the surrounding bone, and significantly enhancing the anchoring effect of the prosthesis in the tibia. The inner layer of micropores 34, evenly spaced and arranged in a ring shape on the inner wall of the outer layer of large holes 33, have a pore size of 100-200 μm. These micropores significantly increase the surface area, can efficiently absorb growth factors, and provide strong support for vascularization. The micropores contain bone morphogenetic material. The microspheres 35 of bone morphogenetic protein and vascular endothelial growth factor, bone morphogenetic protein and vascular endothelial growth factor can be recombinant human bone morphogenetic protein-2 or recombinant human vascular endothelial growth factor-165, which can be released when applied to human skeletal joints to promote bone growth, greatly accelerate the bone healing process, and significantly enhance the integration of the prosthesis and the tibia; the mounting frames 4 fixedly connected to both sides of the bottom of the talar connector 1 are scientifically and rationally designed, and the mounting holes opened at the lower ends of the mounting frames 4 provide a convenient and stable way for connection with the talus, ensuring the structural and functional consistency and integrity of the entire ankle joint prosthesis; the outer surfaces of the connecting main pipe 31, the tibial connector 32, the hinged ball 23 and the talar connector 1 are all coated with an antibacterial composite coating 5, and the coating material is selected from HA coating doped with 0.5-1wt% silver nanoparticles or quaternary ammonium compounds. These antibacterial components have strong antibacterial properties, can effectively inhibit the growth and reproduction of bacteria, significantly reduce the risk of postoperative infection, and provide solid and reliable protection for the long-term stable operation of the prosthesis after implantation and the patient's health.

[0052] This ankle prosthesis utilizes a precision spherical mating structure, with a hinged ball 23 rotating within ±30 degrees of freedom and working in conjunction with a fixed seat 21. Combined with a medical-grade silicone rubber elastic capsule 261, this intelligent lubrication system is constructed. This system utilizes a cam effect to drive the elastic capsule 261 to achieve piston-type fluid circulation. When the joint produces periodic displacement, the elastic capsule 261 absorbs synovial fluid at a rate of 2-5 μL / time through an outer one-way valve 262 (pore size 0.1-0.3 mm). When the hinged ball 23 rotates to its extreme position, an internal pressure of 20-50 kPa is generated, forcing the synovial fluid into a high-density microporous network (50-80 pores / cm²) through the inner one-way valve 262 (pore size 0.05-0.1 mm). The linear guide hole utilizes a bionic synovial villus structure, and a surface tension gradient design forms a uniform lubricating film (5-10 μm thick) at the interface between the ceramic gasket and the hinged ball 23, reducing the friction coefficient to 0.015-0.02 and significantly improving the smoothness of joint movement.

[0053] The tibial connection 3 utilizes a three-dimensional collaborative design, promoting bone integration through a triple mechanism of gradient pore structure, sustained growth factor release system, and dynamic stress stimulation. The outer layer of 500-800μm titanium alloy mesh and the inner layer of 100-200μm honeycomb micropores form graded bone ingrowth channels. Combined with microfluidically prepared PLGA microspheres 35, this achieves biphasic release of BMP-2 (30% burst release in 24 hours + >80% sustained release over 60 days). The integrated 0.2mm thick piezoelectric ceramic sheet generates a 10-50μA pulsed current when subjected to a load >150N. This activates osteoblast differentiation and angiogenesis by regulating the current density to 0.1-1.0mA / cm², creating a synergistic "bone-vascular synchronous growth" effect.

[0054] The surface protection adopts a multi-layer composite architecture, achieving long-lasting antibacterial properties through the synergistic effects of a nanostructured layer, a sustained-release antibacterial layer, and a biocompatible layer. The TiO2 nanotube array (tube diameter 50-100nm) prepared by micro-arc oxidation is loaded with 0.8-1.2mg / cm² of silver ions to form a physical barrier. The chitosan / quaternary ammonium salt coating (thickness 2-5μm) has a minimum inhibitory concentration of less than 5μg / mL against Staphylococcus aureus. PEG grafting modification reduces protein adsorption by more than 80%, effectively inhibiting bacterial adhesion and biofilm formation, and reducing the risk of postoperative infection.

[0055] This device utilizes multidisciplinary manufacturing technologies, including five-axis CNC machining of 23 cobalt-chromium-molybdenum alloy articulated balls (Ra≤0.4μm) and SLM fabrication of a titanium alloy porous scaffold (porosity controlled at ±2%). The intelligent upgrade solution includes the integration of a micro-pressure sensor (accuracy ±0.5% FS) for real-time load monitoring, surface grafting of PEGDA hydrogel (swelling rate 300%), and the introduction of a biomimetic microvilli structure (50-100μm in height) to enhance lubrication performance while maintaining biocompatibility.

[0056] The present invention encompasses any alternatives, modifications, equivalents, and solutions that fall within the spirit and scope of the present invention. To provide a thorough understanding of the present invention, specific details are described in detail below in connection with the preferred embodiments of the present invention, but those skilled in the art will be able to fully understand the present invention without these detailed descriptions. Furthermore, to avoid unnecessary confusion regarding the essence of the present invention, well-known methods, processes, procedures, components, and circuits have not been described in detail.

[0057] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A trabecular metal total ankle prosthesis, comprising a talar connector, characterized in that: A joint device is fixedly installed on the top of the talar connecting frame, and a tibial connecting part is fixedly installed on the top of the joint device; The joint device includes a fixing seat, an articulation groove is provided inside the fixing seat, an articulation ball is movably installed inside the articulation groove, the bottom of the articulation ball is connected to the top of the talar connecting frame, a wear-resistant ceramic gasket is fixedly connected to the inside of the articulation groove, the inner side of the wear-resistant ceramic gasket is connected to the outer surface of the articulation ball, self-lubricating mechanisms are provided on the outer surface of the articulation ball at equal intervals, linear guide holes are provided inside the articulation ball at equal intervals, and the inner ends of the linear guide holes are connected to the interior of the self-lubricating mechanism; The upper end of the outer surface of the hinged ball is rotatably connected with lubricating balls at equal intervals, and the outer side of the lubricating balls is in contact with the inner wall of the wear-resistant ceramic gasket; The self-lubricating mechanism includes elastic capsules, which are arranged in a ring shape at equal intervals and fixedly connected to the lower end of the outer surface of the hinged ball. The outer bottom and the inner bottom of the elastic capsule are both fixedly connected to a one-way valve. The output end of the one-way valve located on the outer side is connected to the interior of the elastic capsule, and the output end of the one-way valve located on the inner end is connected to the input end of the linear guide hole. During joint movement, the self-lubricating mechanism is activated, delivering lubricating material into the linear guide hole, and then evenly guiding the lubricating material to the contact area between the hinge ball and the wear-resistant ceramic gasket through the linear guide hole.

2. The trabecular metal total ankle prosthesis according to claim 1, characterized in that: The wear-resistant ceramic gasket is made of wear-resistant zirconia ceramic material.

3. The trabecular metal total ankle prosthesis according to claim 1, characterized in that: The elastic capsule is made of polycarbonate polyurethane material.

4. The trabecular metal total ankle prosthesis according to claim 1, characterized in that: The tibial connecting part includes a connecting main pipe, a tibial connecting frame is fixedly installed on the top of the connecting main pipe, the connecting main pipe is fixedly connected to the top of the fixing seat, and the outer surface of the connecting main pipe is provided with outer large holes at equal intervals.

5. The trabecular metal total ankle prosthesis according to claim 4, characterized in that: Inner micropores are arranged at equal intervals inside the connecting main pipe and on the inner wall of the outer macropores. The aperture of the outer macropores is larger than that of the inner micropores.

6. The trabecular metal total ankle prosthesis according to claim 5, characterized in that: Microspheres are arranged inside the inner micropores, and the microspheres are loaded with bone morphogenetic protein and vascular endothelial growth factor.

7. The trabecular metal total ankle prosthesis according to claim 6, characterized in that: The bottom two sides of the talus connecting frame are fixedly connected with mounting frames, and the lower ends of the mounting frames are provided with mounting holes.

8. The trabecular metal total ankle prosthesis according to claim 7, characterized in that: The outer surfaces of the connecting main pipe, tibial connecting frame, hinge ball and talar connecting frame are all provided with an antibacterial composite coating, and the antibacterial composite coating is set as a coating of silver nanoparticles or quaternary ammonium salt compounds doped in the HA coating.

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